PERFLUOROOCTANE SULFONATE - What is RC?

UNITED
NATIONS
RC
UNEP/FAO/RC/CRC.7/7/Add.3
Rotterdam Convention on the Prior
Informed Consent Procedure for
Certain Hazardous Chemicals and
Pesticides in International Trade
Distr.: General
20 December 2010
English only
Chemical Review Committee
Seventh meeting
Rome, 28 March–1 April 2011
Item 4 (c) (iv) of the provisional agenda∗
Technical work: review of notifications
of final regulatory action: perfluorooctane sulfonate,
its salts and its precursors
Perfluorooctane sulfonate, its salts and its precursors
Note by the Secretariat
Addendum
Supporting documentation provided by Japan
The Secretariat has the honour to provide, in the annex to the present note, documentation
received from Japan to support its notifications of final regulatory action for perfluorooctane sulfonate,
its salts and perfluorooctane sulfonyl fluoride as industrial chemicals. The documentation has not been
formally edited.
∗
K1063379
UNEP/FAO/RC/CRC.7/1.
280111
UNEP/FAO/RC/CRC.7/7/Add.3
Annex
____________________
2
UNITED
NATIONS
SC
UNEP/POPS/POPRC.2/17/Add.5
Distr.: General
21 November 2006
Original: English
United Nations
Environment
Programme
Stockholm Convention on Persistent Organic Pollutants
Persistent Organic Pollutants Review Committee
Second meeting
Geneva, 6–10 November 2006
Report of the Persistent Organic Pollutants Review Committee
on the work of its second meeting
Addendum
Risk profile on perfluorooctane sulfonate
At its second meeting, the Persistent Organic Pollutants Review Committee adopted the risk
profile on perfluorooctane sulfonate, on the basis of the draft contained in document
UNEP/POPS/POPRC.2/11. The text of the risk profile, as amended, is provided below. It has not been
formally edited.
K0653903
151206
UNEP/POPS/POPRC.2/17/Add.5
PERFLUOROOCTANE SULFONATE
RISK PROFILE
Adopted by the Persistent Organic Pollutants Review Committee
at its second meeting
November 2006
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CONTENTS
1 INTRODUCTION ...................................................................................................................4
1.1 Chemical identity of the proposed substance....................................................................4
1.2 Conclusion of the POP Review Committee on Annex D information .............................6
1.3 Data sources ......................................................................................................................7
1.4 Summary of assessment and management under other programs ....................................7
1.5 Status of the chemical under international conventions ...................................................8
2 SUMMARY INFORMATION RELEVANT FOR THE RISK PROFILE.............................8
2.1 Sources..............................................................................................................................8
2.1.1 Production and trade ..................................................................................................8
2.1.2 Uses............................................................................................................................9
2.1.3 Releases to the environment ....................................................................................13
2.2 Environmental fate..........................................................................................................14
2.2.1 Persistence................................................................................................................14
2.2.2 Bioaccumulation ......................................................................................................14
2.2.3 Long-range environmental transport........................................................................17
2.3 Exposure .........................................................................................................................17
2.3.1 Measured environmental levels ...............................................................................18
2.3.2 Bioavailability..........................................................................................................24
2.4 Hazard assessment for endpoints of concern ..................................................................25
2.4.1 Mammalian toxicity .................................................................................................25
2.4.2 Ecotoxicity ...............................................................................................................26
3 SYNTHESIS OF THE INFORMATION ..............................................................................27
4 CONCLUDING STATEMENT ............................................................................................29
References:................................................................................................................................30
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EXECUTIVE SUMMARY
1 INTRODUCTION
1.1 Chemical Identity of the proposed substance
On July 14, 2005, the government of Sweden made a proposal for listing perfluorooctane sulfonate
(PFOS) and 96 PFOS-related substances in Annex A of the Stockholm Convention on Persistent
Organic Pollutants (POPs).
Chemical name: Perfluorooctane Sulfonate (PFOS)
Molecular formula: C8F17SO3PFOS, as an anion, does not have a specific CAS number. The parent sulfonic acid has a recognised
CAS number (CAS No. 1763-23-1). Some examples of its commercially important salts are listed
below:
Potassium salt (CAS No. 2795-39-3)
Diethanolamine salt (CAS No. 70225-14-8)
Ammonium salt (CAS No. 29081-56-9)
Lithium salt (CAS No. 29457-72-5)
Structural formula:
Figure 1. Structural formula of PFOS shown as its potassium salt
PFOS is a fully fluorinated anion, which is commonly used as a salt or incorporated into larger
polymers. PFOS and its closely related compounds, which contain PFOS impurities or substances
which can give rise to PFOS, are members of the large family of perfluoroalkyl sulfonate
substances. In its regulatory measures on PFOS, the EU has addressed all molecules having the
following molecular formula: C8F17SO2Y, where Y = OH, metal or other salt, halide, amide and
other derivatives including polymers (European Union 2006).
The physical and chemical properties of the potassium salt of PFOS are listed in Table 2.
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Table 2. Physical and chemical properties of PFOS potassium salt.
(Data from OECD, 2002, unless otherwise noted).
Property
Value
Appearance at normal temperature and
pressure
White powder
Molecular weight
538 g/mol
Vapour Pressure
3,31 x 10-4 Pa
Water solubility in pure water
519 mg/L (20 ± 0,5ºC)
680 mg/L (24 - 25ºC)
Melting point
> 400 ºC
Boiling point
Not measurable
Log KOW
Not measurable
Air-water partition coefficient
< 2 x 10-6 (3M, 2003a)
Henry’s Law Constant
3,09 x 10-9 atm m3/mol pure water
PFOS can be formed (by environmental microbial degradation or by metabolism in larger
organisms) from PFOS-related substances, i.e., molecules containing the PFOS-moiety depicted in
Figure 1. Although the ultimate net contribution of individual PFOS-related substances to the
environmental loadings of PFOS cannot be predicted readily, there is a potential that any molecule
containing the PFOS moiety could be a precursor to PFOS.
The majority of PFOS-related substances are polymers of high molecular weights in which PFOS is
only a fraction of the polymer and final product (OECD, 2002). PFOS-related substances have been
defined somewhat differently in different contexts and there are currently a number of lists of
PFOS-related substances (Table 3). The lists contain varying numbers of PFOS-related substances
that are thought to have the potential to break down to PFOS. The lists overlap to varying extents
depending on the substances under consideration and the overlap between national lists of existing
chemicals.
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Table 3. Number of PFOS-related substances as proposed by UK – DEFRA, US – EPA, OECD,
OSPAR, and Canada
Source
Number of PFOS-related
substances
RPA and BRE (2004) 96
1
US - EPA (2002,
2006)
881 + 1831
OECD (2002)
1721 (22 classes of
perfluoroalkyl sulfonate
substances)
OSPAR (2002)
48
Environment Canada
(2006)
57
Perfluorinated substances with different carbon chain lengths are included in the list.
A large number of substances may give rise to PFOS and thus contribute to the contamination
problem. DEFRA in the United Kingdom (RPA and BRE, 2004) has recently proposed a list of 96
PFOS-related substances. However, the properties of the 96 substances have not generally been
determined. According to 3M (submission to the secretariat of Stockholm Convention (SC), 2006),
they may have very different environmental characteristics such as solubility, stability and ability to
be absorbed or metabolised. Nevertheless, the document by the United Kingdom infers that all of
these substances would give rise to the final degradation product of PFOS (RPA and BRE, 2004).
Environment Canada’s ecological risk assessment defines PFOS precursors as substances
containing the perfluorooctylsulfonyl (C8F17SO2, C8F17SO3,, or C8F17SO2N) moiety that have the
potential to transform or degrade to PFOS (Environment Canada, 2006). The term “precursor”
applies to, but is not limited to, some 51 substances identified in the ecological assessment.
However, this list is not considered exhaustive, as there may be other perfluorinated alkyl
compounds that are also PFOS precursors. This information was compiled based on a survey to
industry, expert judgement and CATABOL modelling, in which 256 perfluorinated alkyl
compounds were examined to determine whether non-fluorinated components of each substance
were expected to degrade chemically and/or biochemically and whether the final perfluorinated
degradation product was predicted to be PFOS. While the assessment did not consider the additive
effects of PFOS and its precursors, it is recognized that the precursors to PFOS contribute to the
ultimate environmental loading of PFOS. Precursors may also play a key role in the long-range
transport and subsequent degradation to PFOS in remote areas, such as the Canadian Arctic.
1.2 Conclusion of the POP Review Committee on Annex D information
The Persistent Organic Pollutants Review Committee (POPRC) evaluated Annex D information at
the First meeting of the POPRC, Geneva, 7-11 November 2005, and concluded that PFOS
information meets the screening criteria specified in Annex D (decision POPRC-1/7:
Perfluorooctane sulfonate).
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1.3 Data sources
This document on PFOS mainly builds on information that has been gathered in the hazard
assessment report prepared by the UK and the USA for the OECD, and in the UK risk reduction
strategy:
OECD (2002) Co-operation on Existing Chemicals - Hazard Assessment of Perfluorooctane
Sulfonate and its Salts, Environment Directorate Joint Meeting of the Chemicals Committee and the
Working Party on Chemicals, Pesticides and Biotechnology, Organisation for Economic Cooperation and Development, Paris, 21 November 2002.
RPA AND BRE (2004) Perfluorooctane Sulfonate – Risk reduction strategy and analysis of
advantages and drawbacks, Final Report prepared for Department for Environment, Food and
Rural Affairs and the Environment Agency for England and Wales.
Recent relevant information from the open scientific literature (up to May 2006) is also included.
Data submitted by Parties and observers, which have been considered, are also included in this
report when they add new information.
1.4 Summary of assessment and management under other programs
The hazard assessment of PFOS, prepared by the OECD in 2002, concluded that the presence and
the persistence of PFOS in the environment, as well as its toxicity and bioaccumulation potential,
indicate a cause of concern for the environment and human health.
An environmental risk assessment, prepared by the UK-Environment Agency, and discussed by the
EU member states under the umbrella of the existing substances regulation (ESR DIR 793/93)
shows that PFOS is of concern.
The final Environment Canada/Health Canada assessments of PFOS, its salts and its precursors
were released in July 2006. The ecological risk assessment has concluded that PFOS and its salts
are persistent and bioaccumulative, and that PFOS, its salts and its precursors have immediate or
long-term harmful effects on the environment (Environment Canada, 2006).
The EU has recently decided on restrictions on the marketing and use of PFOS (European Union,
2006). The measures cover PFOS acid, its salts and PFOS derivatives, including PFOS polymers.
The decision prohibits the placing on the market and use of these compounds as a substance or
constituent of preparations in a concentration equal to or higher than 0,005% by mass. Furthermore,
semi-finished products and articles, containing PFOS more than 0,1% by mass are prohibited.
Some derogations are, however, granted in the decision. These include certain uses in
photolithography processes, in photographic coatings and in metal plating, hydraulic fluids for
aviation and fire fighting foams that have already been placed on the market.
The UK and Sweden have proposed the following classification for PFOS in EU (2005):
T Toxic
R40 Carcinogen category 3; limited evidence of carcinogenic effect
R48/25 Toxic; danger of serious damage to health by prolonged exposure if swallowed
R61 May cause harm to the unborn child
R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment has.
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Norway is now considering a proposal to prohibit the use of fire fighting foams containing PFOS
and PFOS-related compounds, which is the major use of these compounds today in Norway.
The Environmental Protection Agency (EPA) in the USA finalized two Significant New Use Rules
(SNURs) in 2002, requiring companies to inform the EPA before manufacturing or importing 88
listed PFOS-related substances. The EPA proposed an additional SNUR under section 5(a)(2) of the
Toxic Substances Control Act (TSCA) in March 2006 to include within the scope of this regulation
another 183 perfluoroalkyl sulfonates with carbon chain lengths of five carbons and higher. The
EPA further proposed an amendment to the Polymer Exemption rule in March 2006 which would
remove from exemption polymers containing certain perfluoroalkyl moieties consisting of CF3- or
longer chains, and would require that new chemical notifications be submitted on such polymers.
1.5 Status of the chemical under international conventions
OSPAR: PFOS was added to the list of Chemicals for Priority Action in June 2003.
Persistent Organic Pollutants Protocol to the Long-Range Transboundary Air Pollution Convention
(“LRTAP”): The Executive Body of the UNECE LRTAP Convention agreed that PFOS be
considered a POP as defined under the Protocol on POPs and requested that the UNECE Task
Force on POPs continue with the review of the substance and exploring management strategies.
2 SUMMARY INFORMATION RELEVANT FOR THE RISK PROFILE
2.1 Sources
2.1.1 Production and trade
The main production process of PFOS and PFOS-related substances is electro-chemical
fluorination (ECF), utilized by 3M, the major global producer of PFOS and PFOS-related
substances prior to 2000.
Direct fluorination, electro-chemical fluorination ( ECF):
C8H17SO2Cl + 18 HF → C8F17SO2F + HCl + by products
The reaction product, perfluorooctanesulfonyl fluoride (PFOSF)1 is the primary intermediate for
synthesis of PFOS and PFOS-related substances. The ECF method results in a mixture of isomers
and homologues with about 35-40% 8-carbon straight chain PFOSF. However, the commercial
PFOSF products were a mixture of approximately 70% linear and 30% branched PFOSF derivate
impurities. The global production of PFOSF by 3M until the production ceased is estimated to have
been 13,670 metric tonnes (1985 to 2002), with the largest yearly production volume, 3700 metric
tonnes of PFOS and PFOS related substances, in 2000 (3M, Submission to SC, 2006). PFOSF may
be further reacted with methyl- or ethylamine to form N-ethyl- and N-methyl perfluorooctane
sulfamide and subsequently with ethylene carbonate resulting in N-ethyl- and -methylperfluorooctane sulfamidoethanol (N-EtFOSE and N-MeFOSE). N-EtFOSE and N-MeFOSE were
the principal building blocks of 3M’s product lines. PFOS is formed after the chemical or
enzymatic hydrolysis of PFOSF (3M, 1999).
Other production methods for perfluoroalkylated substances are telomerisation and oligomerisation.
However, to which extent these methods are applied for production of PFOS and PFOS-related
substances is not evident.
1
8
In the OECD report, 2002, perfluorooctanesulfonyl fluoride is abbreviated POSF.
UNEP/POPS/POPRC.2/17/Add.5
On 16 May 2000, 3M announced that the company would phase-out the manufacture of PFOS and
PFOS-related substances voluntarily from 2001 onwards. By the end of 2000, about 90 % of 3M’s
production of these substances had stopped and in the beginning of 2003 the production ceased
completely.
3M´s voluntary phase-out of PFOS production has led to a reduction in the use of PFOS-related
substances. This is due not only to the limited availability of these substances (3M had at the time
the greatest production capacity of PFOS-related substances in the world), but also to action within
the relevant industry sectors to decrease companies´ dependence on these substances.
The US Environmental Protection Agency (US EPA) compiled a list of non-US companies which
are believed to supply PFOS-related substances to the global market. Of these (and excluding the
plant of 3M in Belgium), six plants are located in Europe, six are located in Asia (of which four are
in Japan) and one in Latin America (OECD, 2002). However, this list may not be exhaustive or
current.
According to the recent submission from Japan to the secretariat of the Stockholm Convention,
2006, there is one manufacturer in Japan still producing PFOS and with a production amount of 110 tonnes (2005). The submission from Brazil states that lithium salt of PFOS is produced but that
no quantitative data is available.
2.1.2 Uses
Perfluorinated substances with long carbon chains, including PFOS, are both lipid-repellent and
water-repellent. Therefore, the PFOS-related substances are used as surface-active agents in
different applications. The extreme persistence of these substances makes them suitable for high
temperature applications and for applications in contact with strong acids or bases. It is the very
strong carbon-fluorine binding property that causes the persistence of perfluorinated substances.
The historical use of PFOS-related substances in the following applications has been confirmed in
the US and the EU.
•
Fire fighting foams
•
Carpets
•
Leather/apparel
•
Textiles/upholstery
•
Paper and packaging
•
Coatings and coating additives
•
Industrial and household cleaning products
•
Pesticides and insecticides
In the UK study (RPA and BRE, 2004), detailed information has been received from the following
sectors that currently use PFOS-related substances:
•
Use of existing fire fighting foam stock
•
Photographic industry
•
Photolithography and semiconductor
•
Hydraulic fluids
•
Metal plating
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The sectors presented above account for the UK but are considered to be representative for EU.
However, deviation in the current use pattern between EU countries cannot be excluded.
PFOS and its precursors are not manufactured in Canada but rather are imported as chemicals or
products for Canadian uses. They may also be components in imported manufactured articles. It is
estimated that the majority of PFOS has been used as water, oil, soil and grease repellents (e.g. on
fabric, leather, paper, packaging, rugs and carpets) and as surfactants (e.g. in fire fighting foams
and coating additives) (Environment Canada, 2006).
PFOS and its precursors are not manufactured in the US, but can be imported either as chemicals or
in products for the specific limited uses that were excluded from regulation. These comprise use as
an anti-erosion additive in aviation hydraulic fluids; use as a component of a photoresist substance,
including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used
in a photomicrolithography process to produce semiconductors or similar components of electronic
or other miniaturized devices; use in coatings for surface tension, static discharge, and adhesion
control for analog and digital imaging films, papers, and printing plates, or as a surfactant in
mixtures used to process imaging films; and use as an intermediate only to produce other chemical
substances to be used solely for these uses. Historically, PFOS and its precursors were also used as
surfactants in fire fighting foams and in industrial and household cleaning products; in carpet,
textile, leather, and paper coatings; and in termite and ant bait insecticide products. Stocks of PFOS
and PFOS-containing products that were in existence at the time the US regulations were
promulgated in 2002 could continue to be used in any application until they were consumed
without violating the regulation, except that the PFOS-related insecticide products are subject to a
phase-out agreement prohibiting their use after 2015.
The table below outlines the estimated current demand for PFOS-related substances in these
applications in the EU (RPA and BRE, 2004).
Estimated Current (2004) Demand for PFOS Related Substances in the EU
Industry Sector
Quantity (kg/year)
Photographic industry
1,000
Photolithographic and semi-conductors
470
Hydraulic fluids
730
Metal plating
10,000
In the survey on production and use of PFOS and related substances performed by OECD in 2004
(published 2005), data concerning PFOS were difficult to separate from data on other
perfluoroalkyl sulfonates.
Fire Fighting Foams
The fire fighting foams can be grouped in two main categories:
•
Fluorine-containing foam types (some of them consist of PFOS-related substances)
•
Fluorine-free foam types
Since the announcement of the voluntary cessation of production of PFOS-related substances by
3M, the presence of PFOS in fire fighting foams has gradually decreased (RPA and BRE, 2004).
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Historically, in Canada, the most significant imports of PFOS, itself, were in the form of the
potassium salt, used for fire-fighting foams (Environment Canada, 2006). Canada has also
identified that existing stocks of PFOS-containing fire fighting foams could be a continued
significant source of releases.
An industry survey conducted in the US by the Fire Fighting Foam Coalition in 2004 reported that
the total inventory of aqueous film-forming foam in the US was approximately 9.9 million gallons,
of which about 45% was PFOS-based stocks produced before 2003, with the other 55% comprised
of telomer-based foams.
Textile, Carpet and Leather Protection
PFOS-related substances have been used to provide soil, oil and water resistance to textiles,
apparels, home furnishings and upholstery, carpets, and leather products. Since 3M´s withdrawal
from the market, PFOS-related substances are used to a much smaller extent for these applications
(RPA AND BRE, 2004).
Paper and Packaging Protection
PFOS-related substances have been used in the packaging and paper industries in both food
packaging and commercial applications to impart grease, oil and water resistance to paper,
paperboard and packaging substrates. According to 3M, fluorochemicals were used for both food
contact applications (plates, food containers, bags and wraps) and non-food applications (folding
cartons, containers and carbonless forms and masking papers). Since 3M´s withdrawal from the
market, PFOS related substances are used to a much smaller extent for these applications (RPA and
BRE, 2004).
Coatings and Coating Additives
3M indicates that prior to its voluntary phase-out of PFOS production, the company would sell
fluorochemical polymer coatings and coating additives which were used undiluted or diluted with
water or butyl acetate to impart soil or water repellence to surfaces (including printing circuit
boards and photographic film) (RPA and BRE, 2004).These polymers contained fluorocarbon
residuals at a concentration of 4% or less. Other applications for aqueous coatings are to protect
tile, marble and concrete. It is unclear which of these products were actually based on PFOS-related
substances.
A survey in the UK among members of the British Coatings Federation (BCF) showed that the use
of PFOS-related substances for these purposes is very limited (RPA and BRE, 2004).
Industrial and Household Cleaning Products (Surfactants)
3M PFOS-based products were sold in the past to a variety of formulators to improve the wetting of
water-based products marketed as alkaline cleaners, floor polishes (to improve wetting and
levelling), denture cleansers and shampoos. Several of these products (alkaline cleaners, floor
polishes, shampoos) were marketed to consumers; some products were also sold to janitorial and
commercial services. A number of the alkaline cleaners were spray-applied.
With regard to the UK cleaning products industry, the responses received do not indicate the use of
PFOS-related substances in industrial and household cleaning products. Based on information
provided in product registers, the Swedish National Chemicals Inspectorate (KemI) has indicated
that PFOS-related substances are still being used in Sweden for both industrial and household use
(RPA and BRE, 2004).
Photographic Industry
PFOS-based chemicals are used for the following purposes in mixtures, in coatings applied to
photographic films, papers, and printing plates (RPA and BRE, 2004):
• Surfactants
•
Electrostatic charge control agents;
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•
Friction control agents;
•
Dirt repellent agents; and
•
Adhesion control agents
Photolithography and Semiconductors
Photoresist
Semiconductor manufacturing comprises up to 500 steps, of which there are four fundamental
physical processes:
•
Implant
•
Deposition
•
Etch
•
Photolithography
Photolithography is the most important step towards the successful implementation of each of the
other steps and, indeed, the overall process. It shapes and isolates the junctions and transistors; it
defines the metallic interconnects; it delineates the electrical paths that form the transistors; and
joins them together. Photolithography reportedly represents 150 of the total of 500 steps mentioned
above. Photolithography is also integral to the miniaturization of semiconductors (RPA and BRE,
2004).
PFOS is used as a photoacid generator (PAG) in a mechanism called chemical amplification that
increases the sensitivity of photoresist to allow etching images smaller than wavelength of light.
Antireflective Coatings
A number of resist suppliers sell antireflective coatings (ARC), subdivided into Top (TARC) and
Bottom (BARC) coatings and used in combination with deep ultra violet (DUV) photoresist. The
process involves placing a thin, top coating on the resist to reduce reflective light, in much the same
way and for the same purposes that eyeglasses and camera lenses are coated.
Hydraulic Fluids for the Aviation Industry
Hydraulic fluids were initially used in aircraft to apply brake pressure. As larger and faster aircraft
were designed, greater use of hydraulic fluids became necessary. An increase in the number of
hydraulic fluid fires in the 1940s necessitated work towards developing fire resistant fluids. The
first of these fluids was developed around 1948, when fire resistant hydraulic fluids based on
phosphate ester chemistry were developed.
Perfluorinated anions act by altering the electrical potential at the metal surface, thereby preventing
the electrochemical oxidation of the metal surface under high fluid flow conditions (RPA and BRE,
2004). As a result, hydraulic fluids based on phosphate ester technology and incorporating additives
based on perfluorinated anions are used in all commercial aircraft, and in many military and general
aviation aircraft throughout the world, as well as by every airframe manufacturer (RPA and BRE,
2004).
Metal Plating
The main uses of PFOS-related substances in metal plating are for chromium plating, and anodising
and acid pickling. PFOS related substances lower the surface tension of the plating solution so that
mist containing chromic acid from the plating activity is trapped in solution and is not released to
air (RPA and BRE, 2004).
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Other
There is information on other historical or current PFOS applications such as in pesticides, medical
applications, mining and oil surfactants, flame retardants and in adhesives. Based on current
understanding, these applications represent a minor part of known PFOS applications and are
therefore not further elaborated in this profile.
2.1.3 Releases to the environment
There is to date very limited information regarding the emissions and pathways of PFOS to the
environment. The occurrence of PFOS in the environment is a result of anthropogenic
manufacturing and use, since PFOS is not a naturally occurring substance.
Releases of PFOS and its related substances are likely to occur during their whole life cycle. They
can be released at their production, at their assembly into a commercial product, during the
distribution and industrial or consumer use as well as from landfills and sewage treatment plants
after the use of the products (3M, 2000).
Manufacturing processes constitute a major source of PFOS to the local environment. During these
processes, volatile PFOS-related substances may be released to the atmosphere. PFOS and PFOSrelated substances could also be released via sewage effluents (3M, 2000). High local emissions are
indicated by one study that showed extremely high concentrations of PFOS in wood mice collected
in the immediate vicinity to 3M’s fluorochemical plant in Antwerpen, Belgium (Hoff et al., 2004).
High concentrations of PFOS were also found in liver and blood from fish collected in the
Mississippi River at the immediate vicinity of another 3M fluorochemical plant at Cottage Grove in
Minnesota (MPCA, 2006).
Fire training areas have also been revealed to constitute a source of PFOS emissions due to the
presence of PFOS in fire-fighting foams. High levels of PFOS have been detected in neighbouring
wetlands of such an area in Sweden (Swedish EPA, 2004) as well as in groundwater in the US close
to a fire-training area (Moody et al., 2003).
An investigation on the uses of PFOS and PFOS-related compounds in Norway in 2005 shows that
approximately 90% of the total use is in fire extinguishers (Submission to SC, 2006). Estimated
releases of PFOS related to fire extinguishers are at least 57 tonnes since 1980 to 2003 (2002; 13-15
tonnes). Remaining quantities of fire extinguisher foam in Norway are estimated to be a minimum
of 1.4 million litres, which corresponds to an amount of approximately 22 tonnes PFOS. Releases
from the municipal sector in Norway, 2002, were estimated to be 5-7 tonnes (Submission to SC,
2006).
The use of PFOS in semiconductors is estimated to result in a release of 43 kg per year in the EU,
according to the Semiconductur Industry Association (SIA) (SIA, Submission to SC, 2006). This
corresponds to 12 % of the total PFOS use in this application. PFOS released in the USA from
semiconductors is estimated to be in the same range (SIA, 2006).
The releases of sulfonated perfluorochemicals, including PFOS or PFOS-related substances, from
different product usages have been estimated (3M Speciality Materials, 2002). For example,
garments treated with home-applied products, are expected to lose 73 % of the treatment during
cleaning over a 2-year life span. A loss of 34 % to air is expected from spray can products during
use, while up to 12.5 % of the original content may be remaining in the cans at the time of disposal.
One route for PFOS and PFOS-related substances to the environment may be through sewage
treatment plants (STPs) and landfills, where elevated concentrations have been observed compared
to background concentrations. Once released from STPs, PFOS will partially adsorb to sediment
and organic matter. A substantial amount of PFOS may also end up in agricultural soil, due to the
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application of sewage sludge. The primary compartments for PFOS are therefore believed to be
water, sediment and soil (RIKZ, 2002).
Dispersion of PFOS in the environment is thought to occur through transport in surface water, or
oceanic currents (Yamashita et al., 2005, Caliebe et al., 2004), transport in air (volatile PFOSrelated substances), adsorption to particles (in water, sediment or air) and through living organisms
(3M, 2003a).
One major obstacle when trying to estimate the releases of PFOS to the environment is that PFOS
can be formed through degradation of PFOS-related substances. The rate and the extent of that
formation are presently unknown. In a study on Swedish STPs, higher concentrations of PFOS were
found in the effluents compared to incoming sewage water, which could indicate that PFOS was
formed from PFOS-related substances (Posner and Järnberg, 2004).
2.2 Environmental fate
2.2.1 Persistence
PFOS is extremely persistent. It does not hydrolyse, photolyse or biodegrade in any environmental
condition tested (OECD, 2002).
A study on the hydrolysis of PFOS in water has been performed following US-EPA OPPTS
protocol 835.2210. The study was conducted at pH varying from 1.5 – 11.0 and at a temperature of
50°C, to facilitate hydrolysis, but did not indicate any degradation of PFOS. The half-life of PFOS
was set to be greater than 41 years.
A study on the photolysis of PFOS in water following US-EPA OPPTS protocol 835.5270 has been
conducted. No evidence of direct or indirect photolysis was observed under any of the conditions
tested. The indirect photolytic half-life of PFOS at 25°C was calculated to be more than 3.7 years.
Biodegradation of PFOS has been evaluated in a variety of tests. Aerobic biodegradation of PFOS
has been tested in activated sewage sludge, sediment cultures and soil cultures in several studies.
Anaerobic biodegradation has been tested in sewage sludge. None of the studies demonstrated any
signs of biodegradation.
Modelling with a simulator program of microbial degradation, the CATABOL system, and expert
judgment predicted that of 171 studied perfluorinated substances over 99% would biodegrade to
extremely persistent perfluorinated acids. Of them, 109 substances were predicted to end up as
perfluorinated sulfonic acids, including PFOS, and 61 as perfluorinated carboxylic acids (Dimitrov
et al., 2004).
The only known condition whereby PFOS is degraded is through high temperature incineration
under correct operating conditions (3M, 2003a). Potential degradation at low temperature
incineration is unknown.
2.2.2 Bioaccumulation
It should be noted that PFOS does not follow the “classical” pattern of partitioning into fatty tissues
followed by accumulation, which is typical of many persistent organic pollutants. This is because
PFOS is both hydrophobic and lipophobic. Instead, PFOS binds preferentially to proteins in the
plasma, such as albumin and β-lipoproteins (Kerstner-Wood et al., 2003), and in the liver, such as
liver fatty acid binding protein (L-FABP; Luebker et al., 2002). Because of the unusual physicalchemical characteristics of PFOS, the mechanism of bioaccumulation probably differs from other
POPs.
14
UNEP/POPS/POPRC.2/17/Add.5
In a study following OECD protocol 305, the bioaccumulation of PFOS in bluegill sunfish
(Lepomis macrochirus) has been tested. The whole-fish kinetic bioconcentration factor (BCFK)
was determined to be 2796 (3M, 2002).
In another study on rainbow trout (Oncorhynchus mykiss), a bioconcentration factor (BCF) in liver
and plasma was estimated to be 2900 and 3100, respectively (Martin, et al., 2003).
When strictly looking at the BCF values, it is clear that these values are below the numeric BCF
criteria in Stockholm Convention Annex D (the reported BCF values are below 5000) but, in this
particular case, as noted above, the BCF numeric criteria may not adequately represent the
bioaccumulation potential of the substance. Monitoring data from top predators at various locations
show highly elevated levels of PFOS and demonstrate substantial bioaccumulation and
biomagnification (BMF) properties of PFOS. It is notable that the concentrations of PFOS found in
livers of Arctic polar bears exceed the concentrations of all other known individual organohalogens
(Martin et al., 2004a). Based on the concentration of PFOS in predators (e.g., the polar bear) in
relation to the concentration in their principal food (e.g., seals), hypothetical BMF values can be
calculated. Such data are reported in Table 4. It should be noted that there are uncertainties in these
comparisons. Even if either liver or blood concentrations are compared in two species, species
differences in specific protein binding in that particular compartment may affect the concentration
in the organ without having affected the whole-body concentration of the substance.
Table 4. Measured concentrations of PFOS in biota from various locations. Calculated BMF is
shown where applicable.
Species and
Location
Concentrations of PFOS
-
• Polar Bear,
Canadian Arctic
• Arctic fox,
Canadian Arctic
Concentrations of PFOS in liver
(1700 – > 4000 ng/g) exceeding all
other individual organohalogens.
Reference
Martin et al.,
2004a.
-
BMF > 160 based on concentrations
in Arctic seals.
-
Very high concentrations of PFOS in Martin et al.,
liver (6.1 - 1400 ng/g)
2004a.
-
Very high concentrations of PFOS in
liver (40 - 4870 ng/g).
Giesy and
BMF = 22 based on data from fish in Kannan, 2001
the same area.
-
nother mink study also show very
high concentrations of PFOS in liver
(1280 - 59 500 ng/g, mean 18 000
ng/g,)
-
BMF ~145 to ~4000 based on data
from their prey such as crayfish
(whole body), carp (muscle) and
turtles (liver
• Mink, US
Kannan et al.,
2005
15
UNEP/POPS/POPRC.2/17/Add.5
• Bald Eagle, US
• Dolphin, US
• Seal in the
Bothnian Sea,
Finland
-
Very high concentrations of PFOS in Giesy and
plasma (1 – 2570 ng/g).
Kannan 2001.
-
Very high concentrations of PFOS in
3M, 2003a.
liver (10 – 1520 ng/g).
-
Very high concentrations of PFOS in
liver (130 – 1100 ng/g).
Kannan et al.,
BMF > 60 based on data from salmon 2002
in the same area.
-
In a study by Kannan et al. (2005), the whole body BCF for round gobies (Neogobius
melanostomus) was calculated to be approximately 2400, which is comparable with laboratory data.
PFOS concentrations in fish (whole body of round gobies) compared to concentrations in liver of
salmon results in BMFs of approximately 10-20. In bald eagles, the mean PFOS concentration in
the livers, 400 ng/g ww, gives a BMF of four to five when compared to fish at higher trophic levels
in the study. For mink, BMFs from 145 to 4000 can be calculated when based on the mean liver
concentration, 18 000 ng/g ww, compared to their prey items such as crayfish (whole body), carp
(muscles) and turtles (liver).
In general, data show that animals at higher trophic levels have higher concentrations of PFOS than
animals at lower trophic levels, indicating that biomagnification is taking place. For instance, a
trophic magnification factor (TMF) of 5,9 was calculated for PFOS based on a pelagic food web
including: one invertebrate species, Mysis; two forage fish species, rainbow smelt and alewife; and
a top predator fish species, lake trout. A diet-weighted bioaccumulation factor of approximately 3
was determined for the trout (Martin et al., (2004b).
Morikawa et al. (2005) showed a high bioaccumulation in turtles. Results from a study performed
by Tomy et al. (2004a) indicated that PFOS biomagnified in an eastern Arctic marine food web
(liver concentrations of PFOS were used for seabirds and marine mammals). Houde et al. (2006)
showed PFOS biomagnification in the Atlantic Ocean bottlenose dolphin food web.
A study by Bossi et al. (2005a) further supports that biomagnification is taking place. In this study,
a preliminary screening of PFOS and related compounds has been performed in liver samples of
fish, birds and marine mammals from Greenland and the Faroe Islands. PFOS was the predominant
fluorochemical in the biota analyzed, followed by perfluorooctane sulfonamide (PFOSA). The
results from Greenland showed a biomagnification of PFOS along the marine food chain (shorthorn
sculpin < ringed seal < polar bear).
It is assumed that the main and most relevant route of exposure to PFOS for birds is through the
diet as biomagnification in bird tissues can occur this way. BMFs above one are reported for
several bird species collected in the Gulf of Gdansk (Gulkowska et. al. 2005). Kannan et al. (2005)
reported a BMF of 10 to 20 in bald eagles (relative to prey items). Tomy et al. (2004a) calculated a
trophic level BMF for black-legged kittiwake:cod of 5.1 and a BMF for glaucous gull:cod of 9.0.
Newsted et al. (2005) indicated that PFOS has relatively shorter half-lives in blood and liver tissue
in birds compared to mammals. For example, the estimated elimination half-life for PFOS from
serum is 13.6 days in male mallards whereas in male rats, it is greater than 90 days. A recent study
has suggested that PFOS is excreted relatively rapidly from birds (Kannan et al., 2005). However,
if birds are chronically exposed to PFOS in their diet, biomagnification can still occur.
Environmental monitoring of birds in northern parts of their range in fact indicates accumulation of
PFOS.
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UNEP/POPS/POPRC.2/17/Add.5
The fact that PFOS binds to proteins leads to the relevant question -- at what concentrations of
PFOS will the binding sites on these proteins be saturated? Serum albumin is most likely the
binding pool of PFOS (Jones et al., 2003) and several studies have been carried out with regard to
bioconcentration in plasma. In Ankley et al. (2005), the bioconcentration in fish was studied at
concentrations of PFOS in water up to 1 mg /L; the concentration of PFOS in water and plasma
followed an almost linear relationship in the doses tested up to 0.3 mg/l without any signs of
saturation (1 mg/l was not tested due to mortality at that dose). This is far above environmentally
relevant concentrations.
In a study by 3M (2003a), the bioconcentration factor (BCF) in whole fish was determined to be
approximately 2800 at a PFOS concentration of 86 µg/l, based on calculations of uptake and
depuration of PFOS. Steady-state levels were attained after 49 days of exposure. Depuration
occurred slowly and 50% clearance for whole fish tissues was estimated to be 152 days. Due to
mortality, a BCF could not be calculated for the other concentration used, 870 µg/l. Thus, it is not
likely that saturation of serum protein binding sites will limit the bioconcentration of PFOS in fish.
In Cynomolgus monkeys, cumulative doses of PFOS (0,03, 0,15, or 0,75 mg/kg/day, orally, for 182
days) showed a linear increase in plasma at the low- and mid-dose groups while a nonlinear
response was showed in the high-dose group (Covance Laboratories, Inc. 2002a). We are not aware
of similar data in other mammals, but considering the high level of bioaccumulation observed in
mammals, and that mammalian serum contains high concentrations of protein, binding sites are not
likely to limit the bioaccumulation of PFOS in environmentally exposed mammals.
2.2.3 Long-range environmental transport
The potassium salt of PFOS has a measured vapour pressure of 3.31 x 10-4 Pa (OECD, 2002). Due
to this vapour pressure and a low air-water partition coefficient (< 2x10-6), PFOS itself is not
expected to volatilise significantly. It is therefore assumed to be transported in the atmosphere
predominantly bound to particles, because of its surface-active properties, rather than in a gaseous
state.
Some of the PFOS-related substances have a considerably higher vapour pressure than PFOS itself,
and are as a result more likely to be volatile. The vapour pressures of precursors, such as NEtFOSEA and N-MeFOSEA, may exceed 0.5 Pa (1000 times greater than that of PFOS) (Giesy and
Kannan 2002). Other PFOS precursors considered volatile include N-EtFOSE alcohol, N-MeFOSE
alcohol, N-MeFOSA and N-EtFOSA (3M, 2000). These precursors to PFOS could evaporate into
the atmosphere and be more widely transported through air than is possible for PFOS itself. Once
in the atmosphere, they can remain in gas phase, condense on particles present in the atmosphere
and be carried or settle out with them, or be washed out with rain (3M, 2000). Martin et al. (2002)
measured the air in Toronto and Long Point, Ontario, for some precursors of PFOS. They found an
average N-MeFOSE alcohol concentration of 101 pg/m3 in Toronto and 35 pg/m3 at Long Point.
The average concentrations of N-EtFOSE alcohol were 205 pg/m3 in Toronto and 76 pg/m3 in Long
Point.
For precursors released to water, the vapour pressure may be significant enough to allow the
substance to enter into the atmosphere. For N-EtFOSE alcohol, the tendency to leave the water
phase is indicated by its relatively high Henry’s law constant (1.9 × 103 Pa·m3·mol-1) (Hekster et al.
2002). It has been reported that when these PFOS precursors are present as residuals in products,
they could evaporate into the atmosphere when the products containing them are sprayed and dried
(3M, 2000).
17
UNEP/POPS/POPRC.2/17/Add.5
PFOS has been detected in rainwater from an urban center in Canada with a concentration of 0.59
ng/L. Whether or not PFOS originates from precursors either being transported and subsequently
wet deposited and degraded to PFOS, or atmospherically degraded and then wet deposited, is
unclear. Measurements of potential precursors for PFOS were not performed in this study (Loewen
et al, 2005)
The atmospheric half-life of PFOS is expected to be greater than two days. This statement, while
not specifically tested, is based on the fact that PFOS has exhibited extreme resistance to
degradation in all tests performed. However, an atmospheric half-life of 114 days has been
calculated for PFOS using an AOP computer modeling program v1.91 (Environment Agency,,
2004). The indirect photolytic half-life of PFOS at 25°C has been estimated to be more than 3.7
years (OECD, 2002).
How perfluoralkyl acid substances have come to be globally disseminated in the environment has
been the key question, since, for example, the vapour pressure and Henry’s law constant of PFOS
indicates it is too involatile and therefore unlikely to enter directly into the atmosphere (Stock et al.
2004). Therefore it has been hypothesized that PFOS must be globally distributed via more
volatile, neutral airborne contaminants that undergo long-range transport and then degrade to yield
the free acids.
In support, Stock et al. (2004) have recently reported that polyfluorinated sulfonamides are widely
distributed throughout the North American troposphere. Mean concentrations ranged from 22-403
pg/m3 with the dominant polyfluorinated contaminant dependent on the sampling location.
High mean concentrations of N-methyl perfluorooctane sulfonamidoethanol (NMeFOSE) of 359
pg/m3, were identified in the air of Griffin, Georgia. The authors speculate that, as Griffin is
located in the midst of the main carpet manufacturing and treatment zone of the US, it probably is
entering the environment from carpet treatment products, many of which consist of fluorinated
molecules linked to polymeric materials. For example, it is possible that free chemical may be left
in the carpet fibres, with publicly available information on 3M produced products indicating the
concentration of free polyfluorinated sulfonamides is typically 1-2% or less. Alternatively, it is
postulated that chemically bound NMeFOSE may also be released from carpets due to chemical,
physical, and/or biological degradation processes.
Support for this hypothesis comes from Shoeib et al. (2004), who measured both NMeFOSE and
the related N-ethyl perfluorooctane sulfonamidoethanol (NEtFOSE) in both indoor and outdoor air.
Mean indoor air concentrations for these were 2590 and 770 pg/m3, respectively, and the ratios
between indoor and outdoor air were 110 and 85, respectively. Again carpets were identified as a
possible source of NMeFOSE, and high usage of paper in the building as a possible source of
NEtFOSE. Paper products were also suggested by Stock et al. (2004) as a possible source for the
high levels of NEtFOSE in the air of Reno, Nevada.
Recently Dinglasan-Panlilio and Maybury (2006) have demonstrated that residual fluorinated
substances detected in materials, including 0.39% of a perfluoroalkyl sulfonamido alcohol present
in a commercially available carpet protector product, are the likely sources for these volatile
precursors. Further N-methyl perfluorobutane sulfonamidoethanol (NMeFBSE) has been
demonstrated in the laboratory to degrade to perfluorobutane sulfonate (PFBS), albeit in low yield
(D'eon et al, 2006).
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UNEP/POPS/POPRC.2/17/Add.5
PFOS has been measured in a wide range of biota in the Northern Hemisphere such as the Canadian
Arctic, Sweden, the US and the Netherlands. In a study by Martin et al. (2004a), the levels of PFOS
were measured in liver samples from biota in the Canadian Arctic and were found in the vast
majority of the species examined. The presence of PFOS in Arctic biota, far from anthropogenic
sources, demonstrates the potential of PFOS for long-range transport. The mechanisms of this
transport are not known, but it could be due to the transport of volatile PFOS-related substances
that eventually degrade to PFOS.
While precursors will undergo degradation once released to the environment, transformation rates
may vary widely. Precursors that reach a remote region through the atmosphere or other media
may be subject to both abiotic and biotic degradation routes to PFOS (Giesy and Kannan 2002a;
Hekster et al. 2002). The mechanisms of this degradation are not well understood. When rats
metabolize N-MeFOSE-based compounds, several metabolites have been confirmed in tissue
samples, including PFOS and N-MeFOSE alcohol (3M Environmental Laboratory 2001a, 2001b).
PFOS appears to be the final product of rat and probably other vertebrate metabolism of POSFbased substances.
A recent study performed with rainbow trout (Onchorhynchus mykiss) liver microsomes has
demonstrated that N-ethyl perfluorooctanesulfonamide (N-EtPFOSA) is a precursor of PFOS in fish
(Tomy et al., 2004b). These findings combined with the recent measurements of concentrations up
to 92.8 ± 41.9 ng/g wet weight of N-EtPFOSA in aquatic organisms from Arctic regions (Tomy et
al., 2004a) strengthen the hypothesis that perfluorinated sulfonamides are one of the volatile
precursors of PFOS transported over long distances to the Arctic. However, the hypothesis that
these volatile precursors reach the Arctic latitudes by atmospheric transport has not yet been
confirmed by atmospheric measurements (Bossi et al., 2005b)
2.3 Exposure
2.3.1 Measured environmental levels
A screening study was assigned by the Swedish Environmental Protection Agency (Swedish EPA)
and performed by ITM, Institute of Applied Environmental Research, on the levels of PFOS in the
Swedish environment (Swedish EPA, 2004). The results showed highly elevated levels of PFOS in
a wetland in the vicinity of a fire drill area with a declining gradient out in the adjacent bay (2.2 –
0.2µg/L). Elevated levels were also detected outside sewage treatment plants (STPs) and landfills.
Effluents from STPs contained levels of PFOS up to 0.020 µg/L and leachate levels from landfills
were between 0.038 – 0.152 µg/L.
The occurrence of PFOS and other perfluoroalkyl sulfonate substances in open ocean waters such
as the Atlantic and the Pacific Ocean have been investigated. The detection of PFOS in oceanic
waters suggests another potential long-range transport mechanism to remote locations such as the
Arctic. The results showed that PFOS is present in central to western Pacific Ocean regions in
concentrations ranging from 15 – 56 pg/L, comparable to the concentrations in the mid-Atlantic
ocean. These values appear to be the background values for remote marine waters far from local
sources (Taniyasu et al., 2004). PFOS was also detected in oceanic waters in several coastal
seawaters from Asian countries (Japan, China, and Korea) at concentrations ranging from 1.1 - 57
700 pg.L-1 (Jin et al., 2004; Yamashita et al., 2005). PFOS was also observed in the North Sea
(estuary of the river Elbe, German Bight, southern and eastern North Sea) (Caliebe et al., 2004).
In a study in cities across China, PFOS was detected in all water samples (surface and sea water,
groundwater, municipal and industrial effluents and tap water), showing that PFOS pollution
existed generally in water compartments in China. Concentrations were generally at levels of
approximately 1 ngéL (Jin et al., 2004).
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UNEP/POPS/POPRC.2/17/Add.5
Studies in the US have identified the presence of PFOS in surface water and sediment downstream
of a production facility, as well as in wastewater treatment plant effluent, sewage sludge and
landfill leachate at a number of urban centres in the US (3M Multi City study, reviewed in OECD
(2002) and 3M (2003a). Four of the cities (Decatur (AL), Mobile, Columbus (GA), Pensacola) were
cities that have manufacturing or industrial use of fluorochemicals; two of the cities (Cleveland
(TN), Port St. Lucie) were control cities that do not have significant fluorochemical activities. The
ranges of PFOS levels in these cities are provided in Table 5.
Table 5. Environmental Levels of PFOS in Six US Urban Centres in the US (from OECD, 2002)
Medium
Range of PFOS levels (µg/L or µg/kg)
Municipal wastewater treatment
plant effluent
0.041 - 5.29
Municipal wastewater treatment
plant sludge
0.2 - 3.120 (dry weight)
Drinking water
ND - 0.063
Sediment
ND - 53.1 (dry weight)
Surface water
ND - 0.138
‘Quiet’ water
ND - 2.93
Note: ND: not detected
The control cities’ samples generally inhabited the lower end of the above ranges, except for the
municipal wastewater treatment plant effluent and sludge findings for one of the control cities
(Cleveland), which were intermediate in their ranges, and the ‘quiet’ water samples at control city
(Port St. Lucie), which were the highest. In Canada, suspended sediment samples were collected
annually at Niagara-on-the-Lake in the Niagara River over a 22 year period (1980-2002). PFOS
concentrations ranged from 5 to 1100 pg.g-1 (Furdui et al., 2005). Preliminary findings suggest that
PFOS concentrations increased during the study period from < 400 pg.g-1 in the early 1980s to >
1000 pg.g-1 in 2002.
Samples of effluent from fifteen representative industry sectors have been analysed for PFOS
(Hohenblum et al, 2003). The industry sectors were printing (1 site), electronics (3), leather, metals,
paper (6), photographic and textiles (2). The PFOS levels ranged from 0-2.5 µg/L (2.5 µg/L for
leather, 0.120 µg/l for metal, 0.140-1.2 µg/l at four paper sites, 1.2 µg/l for photographic, not found
in textiles or electronics).
Groundwater from below an air force base in Michigan, US, has been sampled (Moody et al, 2003).
Fire fighting foams containing PFOS had been used there in training exercises from the 1950s to
1993 when the base was decommissioned. The groundwater was found to contain PFOS, at levels
from 4 - 110 μg/l.
Sixteen Great Lakes water samples (eight locations) were analysed for perfluorooctane surfactants.
PFOS was present in all samples with a concentration range of 21-70 ng/L. Three PFOS precursors
were also found in the water samples. N-EtFOSAA (4.2-11 ng/L) and PFOSA (0.6 -1.3 ng/L) were
present in nearly all samples while PFOSulfinate was identified at six out of eight locations (2.2-17
ng/L) (Boulanger et al, 2004). PFOS was detected in surface water as a result of a spill of firefighting foam from the Toronto International Airport into nearby Etobicoke Creek. Concentrations
20
UNEP/POPS/POPRC.2/17/Add.5
of PFOS ranging from <0.017 to 2210 µg.L-1 were detected in creek water samples over a 153-day
sampling period. PFOS was not detected at the upstream sample site (Moody et al. 2003).
PFOS and related fluorochemicals have been detected in animals in a number of studies in a variety
of locations around the globe. Generally, the highest concentrations are found in top predators in
food chains containing fish. The highest North American or circumpolar concentration of PFOS in
mammal tissue reported in the published literature is 59 500 µg.kg-1 ww in mink liver from USA
(Kannan et al., 2005a).
Martin et al. (2004a) measured the levels of PFOS in liver samples from biota in the Canadian
Arctic. PFOS was found in the vast majority of the samples and higher levels were found in animals
at the top of the food chain. The highest levels were found in polar bear, with a mean level of 3100
ng/g from seven animals (maximum value > 4000 ng/g). The concentrations of PFOS in polar bear
are 5-10 times higher than the concentration of all other perfluoroalkyl substances and were higher
than any other previously reported concentrations of persistent organochlorine chemicals (e.g.,
PCBs, chlordane or hexachlorocyclohexane) in polar bear fat (Martin et al., 2004a). PFOSA, a
precursor to PFOS, was also found in most of the samples. The concentration of PFOSA was higher
than that of PFOS in fish, but not in mammals. This could indicate that PFOSA has been
metabolised to PFOS in mammals and the high concentrations may be the result of both direct
exposure to PFOS and metabolism from PFOSA.
PFOS is found in birds worldwide. In North America, PFOS has been found in eagles in the Great
Lakes, mallards in the Niagara River, loons in northern Quebec, gulls in the Arctic and in Canadian
migratory species in the United States (e.g., common loon in North Carolina). In Canadian or
Canada-US migratory species, concentrations have been measured in liver ranging from not
detectable to 1780 ng/g for loon in northern Quebec and bald eagle in Michigan, in blood plasma
ranging from <1- 2220 ng/g blood plasma in bald eagles, and in eggs and egg yolk ranging from
21-220 ng/g in double-crested cormorant in Manitoba. In several monitoring studies, piscivorous
water birds were found to have some of the highest liver and serum PFOS concentrations compared
to other species (Newsted et al., 2005). In a study of birds in the Niagara River Region, piscivorous
birds (common merganser, bufflehead) contained significantly greater PFOS concentrations than
non-piscivorous birds (Sinclair et al., 2006). Preliminary data on temporal trends show an increase
in bird PFOS concentrations, in two Canadian Arctic species (thick-billed murres and northern
fulmars) from 1993 to 2004 (Butt et al., 2005). It is noted that concentrations of PFOS in plasma
have been reported in eagle, gulls and cormorants around the Great Lakes and in the Norwegian
Arctic ranging from <1 ng/g to 2220 ng/g .
Kannan and Giesy (2002b) have summarised results of analyses on archived tissue samples. The
tissues analysed came from marine mammals, birds, fish, reptiles and amphibians from around the
world, including the Arctic and Antarctic Oceans. Samples collected in the 1990s were used.
Around 1700 samples were analysed, with concentrations in liver, egg yolk, muscle or blood
plasma determined. The detection limit varied from 1 ng/g to 35 ng/g wet weight. A summary of
the results is shown in Table 6.
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UNEP/POPS/POPRC.2/17/Add.5
Table 6. Maximum concentrations of PFOS in various species as well as frequency of detection.
Based on Kannan and Giesy (2002a)
Frequency of
Species
Maximum concentration ng/g wwt
Marine mammals
1520
77%
Mink and otter
4900
100%
Birds
2570
60%
Fish
1000
38%
detection
PFOS was detectable in most of the samples, including those from remote marine locations, at
concentrations >1 ng/g. The authors compared the results from remote areas with those from more
industrial locations and noted that PFOS is widely distributed in remote regions, including the Polar
Regions, but that the levels found in more urban and industrial areas (e.g. the Baltic, Great Lakes)
are several times higher. The tissues of fish-eating birds in Canada, Italy, Japan and Korea all
contained detectable levels of PFOS, suggesting that they are exposed through the fish they
consume. A summary of several studies is given in Table 7.
Table 7. Monitored levels of PFOS in animals (data from selected studies, based on OECD, 2002)
Reported Highest
Description
Reference
Concentrations
Location
(Max, Mean)
Global monitoring
survey of marine
mammals
(Florida,
California,
A
Alaska, northern
Baltic Sea,
Mediterranean
Sea, Arctic, Sable
Island (Canada)
Survey of
mammals, birds
and fish in the
Canadian Arctic
22
Bottlenose dolphin
(liver, n = 26):
Max: 1520 ng/g wet wt.
Florida
Mean: 420 ng/g wet wt.
Ringed seal (liver, n =
81):
Max: 1100 ng/g wet wt.
Northern Baltic
Sea
Mean: 240 ng/g wet wt.
Polar bear (liver, n = 7):
B
Max: > 4000 ng/g wet
wt.
Mean: 3100 ng/g wet
wt.
Canadian Arctic
UNEP/POPS/POPRC.2/17/Add.5
Reported Highest
Description
Reference
Concentrations
Location
(Max, Mean)
Arctic fox (liver, n =
10):
Max: 1400 ng/g wet wt.
Mean: 250 ng/g wet wt.
Fish (muscle, n = 172):
Survey of fish
(US, Europe,
North Pacific
Ocean, Antarctic)
Max: 923 ng/g wet wt.
C
Belgian estuary
Mean. 40 ng/g wet wt.
Carp (muscle, n = 10):
Max: 296 ng/g wet wt.
US Great Lakes
Mean: 120 ng/g wet wt.
Survey of fisheating birds (US,
Baltic Sea,
Mediterranean
Sea, Japanese
coast, Korean
coast)
D
Bald eagle (plasma, n =
42):
Max: 2570 ng/mL
Midwest US
Mean: 520 ng/mL
Mink (liver, n = 77):
Max: 4870 ng/g wet wt.
Survey of mink
and river otter in
the US
E
Mean: 1220 ng/g wet
wt.
River otter (liver, n =
5):
Max: 994 ng/g wet wt.
US
US
Mean: 330 ng/g wet wt.
Survey of oysters
in the US
(Chesapeake Bay
& Gulf of
Mexico)
F
Oyster (Whole body, n
=77) Max: 100 ng/g wet
US
wt.
Mean: 60 ng/g wet wt.
Fish samples
upstream and
downstream of
3M facility in
Decatur,
Alabama, US
G
Swedish urban
and background
H
Fish (whole body):
Mean (upstream): 59.1
µg/kg wet wt.
Decatur, US
Mean (downstream):
1,332 µg/kg wet wt.
Perch: 3 - 8 ng/g (urban
sites in the vicinity of
Sweden (Lake
Mälaren)
23
UNEP/POPS/POPRC.2/17/Add.5
Reported Highest
Description
Reference
Concentrations
Location
(Max, Mean)
municipal STPs); 20-44
ng/g in Lake Mälaren
and near Stockholm
fish samples
Sources: A: 3M (2003a), B: Martin et al. (2004a); C: Giesy and Kannan (2001c) in 3M (2003a); D:
Giesy and Kannan (2001b) in 3M (2003); E: Giesy and Kannan (2001d) in 3M (2003a); F: Giesy
and Kannan (2001e) in 3M (2003); G: Giesy and Newsted (2001) in OECD (2002); H: Holmström
et al. (2003).
Concentrations of PFOS in guillemot (Uria aalge) eggs from Stora Karlsö in the Baltic Sea have
been measured retrospectively from 1968 to 2003 (Holmström et al, 2005). The results shown in
Figure 2 display a trend of increasing concentrations since 1968 (17 – 623 ng/g).
T e mporal tre nd in G uille mot e ggs, Stora K arlsö
values with error bars : mean v alue +/- 95% c onf idenc e interv al
v alues w ithout error bars : pooled s amples
1400
Konc PFOS, ng/g
1200
1000
800
600
400
200
0
1965
1970
1975
1980
1985
1990
1995
2000
2005
Ye a r s a m ple d
Figure 2. Measured concentrations of PFOS in Guillemot (Uria aalge) eggs sampled at Stora
Karlsö in the Baltic Sea between the years 1968 – 2003. The graph is taken from the report
“Screening av perfluorerade ämnen” by the Swedish EPA, Environmental Assessment Department
(2004).
2.3.2 Bioavailability
Studies on fish have shown that PFOS has bioconcentration properties. In studies on bluegill
sunfish (Lepomis macrochirus) and rainbow trout (Oncorhynchus mykiss), bioconcentration factors
(BCFs) have been estimated to be 2796 (whole fish) as well as 2900 (liver) and 3100 (plasma),
respectively. The major route of uptake is believed to be through the gills (Martin et al., 2003).
Since PFOS is released from sewage treatment plants to the environment i.e. through water, one
major route for PFOS into local food chains could be through fish. PFOS has shown a high oral
uptake (95%) within 24 hours in the gastro-intestinal (GI) tract in studies on rats (OECD, 2002).
Taken together, this could constitute the basis of the highly elevated levels that have been observed
in top predators in food chains containing fish.
24
UNEP/POPS/POPRC.2/17/Add.5
This could also be corroborated by two separate human monitoring studies on the Swedish
population where the levels of PFOS in whole blood was higher (27.2 ng/g, 3.0 – 67, n = 10) in
females with a high consumption of fish (Berglund, 2004) compared to samples from females in the
general population (17.8 (ng/g, 4.6 – 33, n = 26) (Kärrman et al., 2004).
In humans, the highest concentrations of PFOS have been detected in workers at 3M’s
manufacturing plant for perfluorochemicals in Decatur, US, where the levels in serum in the last
year of measurement (2000) ranged between 0.06 – 10.06 ug/g (n = 263, OECD, 2002).
In a study of the general population, blood samples from families including three generations living
in 12 European countries were tested for a large number of chemicals including PFOS and PFOSA.
PFOS was present in 37 of 38 samples with concentrations from 0.36 to 35.3 ng/g blood, while
PFOSA was present in 36 of 38 samples with concentrations from 0.15 to 2.04 ng/g blood (WWF,
2005).
Pooled serum samples from 3802 Australian residents, collected 2002-2003 and divided in relation
to age, gender and region, were analysed for perfluoroalkylsulfonates, perfluoroalkylcarboxylates
and PFOSA (Kärrman et al., 2006). PFOS and PFOSA were quantified in all pooled serum samples
with a total range of 12.7-29.5 ng/ml (mean 17.2 ng/ml) and 0.36-2.4 ng/ml (mean 0.81 ng/ml),
respectively. For PFOS, a significant correlation between age and concentration was shown. No
substantial difference was found in levels of perfluorinated compounds between the urban and rural
regions. According to gender some differences were shown for some of the age groups.
2.4 Hazard assessment for endpoints of concern
2.4.1 Mammalian Toxicity
Evidence of the mammalian toxicity of PFOS is available from acute, sub-chronic and chronic
exposures to rats, sub-chronic exposures to monkeys, and a two-generation study on rats. Results
are available from reproductive and teratogenicity studies on rats and rabbits. Details of these
studies are not included here, they can be found in the assessment made by OECD (2002). The
most relevant data for this risk profile are:
• A 90-day study on rhesus monkeys exposed to PFOS potassium salt via gavage at the doses 0,
0.5, 1.5 and 4.5 mg/kg bw/day. At 4.5 mg/kg bw/day all monkeys (4) died or were sacrificed in
moribound condition. No deaths were observed at 0.5 or 1.5 mg/kg bw/day, but there were signs
of gastrointestinal toxicity. A NOAEL could not be established since the lowest dose was a
LOAEL (Goldenthal et al., 1978a).
• A 90-day oral repeated dose toxicity study in rats that were fed diets containing 0, 30, 100, 300,
1000 and 3000 mg PFOS potassium salt per kg diet. All rats died when fed diets containing 300
mg/kg PFOS and above (equivalent to 18 mg/kg bw/day and above). At 100 mg/kg (6 mg/kg
bw/day), 50% (5/10) of the animals died. All rats receiving diets containing 30 mg/kg PFOS (2.0
mg/kg/day) survived until the end of the study, but small changes in body and organ weights were
reported. Since the lowest dose tested was a LOAEL, a NOAEL could not be established
(Goldenthal et al., 1978b).
• A two-generation reproductive toxicity study on rats that were fed PFOS potassium salt via
gavage at the doses 0.1, 0.4, 1.6, and 3.2 mg/kg bw/day. At the doses 1.6 and 3.2 mg/kg bw/day a
significant reduction in the viability of the F1 generation was observed. In the 1.6 mg/kg bw/day
group, 34% (86/254) of the F1 pups died within four days after birth. In the 3.2 mg/kg bw/day
group, 45% (71/156), of the F1 pups died within one day after delivery. None of these pups
survived beyond day 4. Maternal toxicity at 1.6 and 3.2 mg/kg bw/day was manifested as reduced
25
UNEP/POPS/POPRC.2/17/Add.5
food consumption, body weight gain, and terminal bodyweight. Localised alopecia was also
observed at 3.2 mg/kg bw/day. The LOAEL in this study was 0.4 mg/kg bw/day based on
significant reductions in pup weight gain in the F1 generation animals. The NOAEL was 0.1
mg/kg bw/day (Christian et al., 1999). A new study by Luebker et al. (2005) supports these
results.
• Cynomolgus monkeys administered PFOS for 26 weeks were observed to have thymic atrophy
(females), and reduced high density lipoprotein, cholesterol, triiodothyronine, total bilirubin
levels (males) (Covance Laboratories, Inc. 2002a). The LOEL dose was 0.03 mg.kg-1 bw/day at
which average mean female and male concentrations in sera and liver were 19.8 µg.mL-1 and 14.5
µg.g-1, respectively.
• A 2-year dietary rat study in which histopathological effects in the liver were seen in males and
females at intakes as low as 0.06–0.23 mg PFOS/kg bw per day and 0.07–0.21 mg PFOS/kg bw
per day, respectively (Covance Laboratories, Inc. 2002b). Average values were determined for
males and females to establish LOELs of 40.8 ug/g in liver and 13.9 mg/L in serum.
A study by Grasty et al. (2003) concluded that exposure of pregnant rats to PFOS late in gestation,
at 25 mg/kg b.w. PFOS by oral gavage on gestation day (GD) 17-20 or 50 mg/kg PFOS on GD 1920, is sufficient to induce 100% pup mortality and that the causative factor may be inhibition of
lung maturation. However, in a subsequent study by Grasty et al. (2005), the mechanism behind
pup mortality could not be established.
2.4.2 Ecotoxicity
Environmental toxicity data for PFOS is predominantly found for aquatic organisms such as fish,
invertebrates and algae, and for birds.
PFOS has shown moderate acute toxicity to fish. The lowest observed LC50 (96h) was estimated to
be 4.7 mg/l in a study where fathead minnow (Pimephales promelas) were exposed to the lithium
salt of PFOS. The lowest NOEC, 0.3 mg/l, has been observed in Pimephales promelas at prolonged
exposure (42d) and was based on mortality (OECD, 2002). The lowest LC50 (96h) for aquatic
invertebrates has been observed in the mysid shrimp (Mysidopsis bahia) and was estimated to be
3.6 mg/l. The lowest NOEC value has been observed in Mysidopsis bahia at 0.25 mg/l (OECD,
2002).
A study by Macdonald et al. (2004) reported a 10-day NOEC of 0.0491 mg/L for the growth and
survival of the aquatic midge (Chironomous tentans). The authors concluded that PFOS is 2-3
orders of magnitude more toxic to chironomids than to other aquatic organisms possibly through
some kind of interaction with haemoglobin, which is present at all levels of dissolved oxygen (DO)
in chironomids as opposed to daphnids, where haemoglobin is produced only in response to
declining DO levels.
The most sensitive algae appear to be the green algae Pseudokirchnerilla subcapitata with a IC50
(96h, cell density) of 48.2 mg/L. The lowest NOEC value for algae was determined in the same
study for Pseudokirchnerilla subcapitata, 5.3 mg/L (Boudreau et al., 2003).
Mallard and bobwhite quail were exposed to PFOS in feed for up to 21 weeks and a variety of
endpoints examined including changes in adult body and organ weights, feed consumption rate,
fertility, hatchability, and offspring survival. At a dose of 10 mg/kg diet PFOS, effects in male
mallards (Anas platyrhyncos) included reduced testes size and decreased spermatogenesis (3M,
2003b). At this dose, the concentrations of PFOS in serum and liver were 87.3 ug/mL and 60.9
ug/g, respectively (3M, 2004). For quail (Colinus virginianus), at 10 mg/kg in diet, minor effects
were observed in adults, including an increase in liver weight (females), an increase in the
incidence of small testes size (males), and reduction in survivability in quail chicks as a percentage
26
UNEP/POPS/POPRC.2/17/Add.5
of eggs set. Concentrations in serum and liver of adult quail females was 84 µg.mL-1 serum (week
5, pre-reproductive phase), and 8.7 µg.mL-1 serum (week 21) and 4.9 µg.kg-1 wet weight liver; in
adult quail males, concentrations were 141 µg.mL-1 serum and 88.5 µg.g-1 wet weight liver (3M,
2003c).
3 SYNTHESIS OF THE INFORMATION
Perfluorooctane sulfonate (PFOS) is a fully fluorinated anion, which is commonly used as a salt in
some applications or incorporated into larger polymers. Due to its surface-active properties, it has
historically been used in a wide variety of applications, typically including fire fighting foams and
surface resistance/repellency to oil, water, grease or soil. PFOS can be formed by degradation from
a large group of related substances, referred to as PFOS-related substances (see definition on page
4).
Due to their intrinsic properties, PFOS and its related substances have been used in a wide variety
of applications. While historically, PFOS and PFOS-related substances have been used in eight
different sectors as shown in Section 2.1.2. above, the present use in industrialized countries seems
to be limited to five sectors, see 2.1.2. It is not known whether this also reflects the global use.
PFOS and PFOS-related substances can be released to the environment at their manufacture, during
their use in industrial and consumer applications and from disposal of the chemicals or of products
or articles containing them after their use.
The rate and the extent of the formation of PFOS from its related chemicals are largely unknown.
Lack of data makes it very difficult to estimate the net contribution of the transformation of each of
the PFOS-related substances to the environmental loadings of PFOS. However, based on its
extreme stability, it is expected that PFOS is likely to be the final degradation product of all PFOSrelated substances.
PFOS is extremely persistent. It has not shown any degradation in tests of hydrolysis, photolysis or
biodegradation in any environmental condition tested. The only known condition whereby PFOS is
degraded is through high temperature incineration.
With regard to bioaccumulation potential, PFOS meets the Annex D criteria given the highly
elevated concentrations that have been found in top predators such as the polar bear, seal, bald
eagle and mink. Based on the concentrations found in their prey, high BMFs have been estimated
for these predators. BCF values in fish, although (rather) high do not in themselves meet the
specific numeric criteria. However, due to the properties of PFOS, which binds preferentially to
proteins in non-lipid tissues, application of numeric criteria for BCF or BAF, which are derived
based on consideration of lipid-partitioning substances, may be inappropriate for PFOS. Most
notable and alarming are the high concentrations of PFOS that have been found in Arctic animals,
far from anthropogenic sources. PFOS has been detected in higher trophic level biota and predators
such as fish, piscivorous birds, mink, and Arctic biota. Also, predator species, such as eagles, have
been shown to accumulate higher PFOS concentrations than birds from lower trophic levels. Even
with reductions in manufacturing of PFOS by some manufacturers, wildlife, such as birds, can
continue to be exposed to persistent and bioaccumulative substances such as PFOS simply by virtue
of its persistence and long-term accumulation.
According to available data, PFOS meets the criteria for the potential for long-range transport. This
is evident through monitoring data showing highly elevated levels of PFOS in various parts of the
northern hemisphere. It is especially evident in the Arctic biota, far from anthropogenic sources.
PFOS also fulfils the specific criteria for atmospheric half-life.
27
UNEP/POPS/POPRC.2/17/Add.5
PFOS fulfils the criteria for adverse effects. It has demonstrated toxicity towards mammals in subchronic repeated dose studies at low concentrations, as well as rat reproductive toxicity with
mortality of pups occurring shortly after birth. PFOS is toxic to aquatic organisms with mysid
shrimp and Chironomus tentans being the most sensitive organisms.
Table 8. POP characteristics of PFOS (studies performed with the potassium salt of
PFOS, unless otherwise noted).
Criterion
Persistence
Bioaccumulation
Meets the criterion
(Yes/No)
Yes
Yes
Remark
Extremely persistent. No degradation
recorded in chemical or biological
tests
Found in highly elevated
concentrations in top predators.
Calculated hypothetical BMFs = 22 160.
BCF in fish = 2796 - 3100.
Potential for LongRange
Environmental
Transport
Yes
Atmospheric half life > 2 days
(estimated value based on photolytic
half life > 3.7 years)
Sub-chronic exposure: Mortality in
monkeys at 4.5 mg/kg bw/day.
Reproductive toxicity: mortality in
rat pups at 1.6 mg/kg bw/day.
Toxicity
Yes
Acute toxicity to Mysid shrimp
(Mysidopsis bahia): LC50 (96h) = 3.6
mg/L
Acute toxicity to fish, Fathead
minnow (Pimephales promelas):
LC50 = 4.7 mg/L1
1
The study compound was the lithium salt of PFOS
A risk quotient analysis, where known or potential exposures are integrated with known or potential
adverse environmental effects, have been performed on PFOS for the wildlife in Canada
(Environment Canada, 2006). The results indicate that the higher trophic level mammals may be at
risk at current environmental concentrations of PFOS.
In the risk quotient analyses for polar bear, the highest concentration was found in South Hudson
Bay with a maximum concentration of 3.77 µg.g-1 ww liver (range 2.00-3.77 µg.g-1, mean 2.73
µg.g-1 ww liver, Smithwick et al. 2005). In comparing this value of 3.77 µg.g-1 ww liver of PFOS in
polar bear with a critical toxicity value of 40.8 µg.g-1 ww liver for histopathological effects in liver
28
UNEP/POPS/POPRC.2/17/Add.5
of rats (a 2-year study, Covance Laboratories, Inc. 2002), the difference is only about a factor 10.
Using an application factor of 1002, as was used in the Canadian Ecological Screening Assessment
Report, a risk quotient of 9.2 was calculated, where values above one indicate risk. Risk quotients
were also calculated on toxicological endpoints from other studies in rats and monkeys but with the
same maximum exposure concentration from the south Hudson Bay polar bear, showing risk
quotients from 2.1 to 19.
Concentrations in Canadian Arctic polar bear are among the highest in polar bears worldwide but
the exposure concentrations are not considered an anomaly given similar concentrations in polar
bears in other North America and European Arctic locations and high concentrations in other
wildlife globally as shown above.
Risk quotients were also calculated for a number of bird species that are native to Canada,
including many piscivorous birds and migratory species. The range of risk quotients is either above
or approaching one that indicates potential for harm at concentrations observed in native species,
including migratory species (Environment Canada, 2006).
4 CONCLUDING STATEMENT
PFOS is a synthetic substance of anthropogenic origin with no known natural occurrence. It can be
concluded therefore that the presence of PFOS and its precursors in the environment are the result
of anthropogenic activities and that PFOS found in remote areas far from possible sources has been
brought there through long-range environmental transport. While PFOS related substances may be
degraded to PFOS, PFOS itself is extremely persistent in all media and can bioaccumulate and
biomagnify in mammals and piscivorous birds.
The voluntary phase out of PFOS production by the major producer in the USA has led to a
reduction in the current use of PFOS-related substances. However, it can be assumed that it is still
produced in some countries and it continues to be used in many countries. Given the inherent
properties of PFOS,3 together with demonstrated or potential environmental concentrations that
may exceed the effect levels for certain higher trophic level biota such as piscivorous birds and
mammals; and given the widespread occurrence of PFOS in biota, including in remote areas; and
given that PFOS precursors may contribute to the overall presence of PFOS in the environment, it
is concluded that PFOS is likely, as a result of its long-range environmental transport, to lead to
significant adverse human health and environmental effects, such that global action is warranted.
2
An application factor of 100 applied for extrapolation from laboratory to field conditions and for intraspecies and interspecies
variations in sensitivity, and extrapolation from the observed effects level to a no-effect level.
3
A decision on the inclusion of PFOS precursors has been postponed until the Committee has
evaluated the information requested under Annex F.
29
UNEP/POPS/POPRC.2/17/Add.5
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74 (5) 405-16. Erratum in: Birth Defects Res (Part B). Dev Reprod Toxicol. 2006 Feb;77(1):87.
Gulkowska, A., Falandysz, J., Taniyasu, S., Bochentin, I., So, M.K., Yamashita, N., 2005. Perfluorinated
chemicals in blood of fishes and waterfowl from the Gulf of Gdańsk, Baltic Sea. Presentation at
International Symposium on Fluorinated Organics in the Environment, Toronto, Ontario, Canada, August
18-20, 2005.
Hekster, F.M., P. de Voogt, A.M.,. Pijinenburg C.M and Laane R.W.P.M., 2002. Perfluoroalkylated
substances — aquatic environmental assessment. Report RIKZ/2002.043. Prepared at the University of
Amsterdam and RIKZ (The State Institute for Coast and Sea), July 1, 2002. 99 pp.
Hoff, P.T, Scheirs, J., Van de Vijver, K., Van Dongen, W., Esmans, E.L, Blust, R., De Coen, W., 2004.
Biochemical Effect Evaluation of Perfluoroctane Sulfonic Acid-Contaminated Wood Mice. Environmental
Health Perspectives, 112 (6):681 – 686.
Holmström K. E., Järnberg U. and Bignert A., 2005. Temporal Trends of PFOS and PFOA in Guillemot
Eggs from the Baltic Sea, 1968 – 2003. Env. Sci. Tech., 39 (1):80-84.
Holmström K.E., Järnberg, U., Berggren, D., Johansson, C., Balk, L., 2003. Perfluorooctane sulfonate
concentrations in Swedish urban and background fish samples. (abstract).
Hohenblum, P., Scharf, S. and Sitka, A., 2003. Perfluorinated anionic surfactants in Austrian industrial
effluents. Vom Wasser, 101:155-164.
Houde, M., Bujas, T.A.D., Small, J., Wells, R., Fair, P., Bossart, G.D., Solomon, K.R., and Muir, D.C.G.,
2006. Biomagnification of Perfluoroalkyl Compounds in the Bottlenose Dolphin (Tursiops truncatus) Food
Web. Environ. Sci. Technol., 40 (13), 4138 -4144, 2006 (Web release date: May 25, 2006)
Jones P.D., Hu W., De Coen W., Newsted J.L. and Giesy J..P., 2003. Binding of perfluorinated fatty acids
to serum proteins. Environ Toxicol Chem.22(11):2639-49.
Kannan, K. and Giesy, J.P., 2002a. Global distribution and bioaccumulation of perfluorinated hydrocarbons.
Organohalogen Compounds, 59:267-270.
Kannan, K., Corsolini, S., Falandysz, J., Oehme, G., Focardi, S. and Giesy, J.P., 2002b.
Perfluorooctanesulfonate and related Fluorinated Hydrocarbons in Marine Mammals, Fishes and Birds from
Coasts of the Baltic and the Mediterranean Seas Environ. Sci. Technol.,36:3210 – 3216.
32
UNEP/POPS/POPRC.2/17/Add.5
Kannan K., Tao L., Sinclair E., Pastva S.D., Jude D.J. and Giesy J.P., 2005. Perfluorinated compounds in
aquatic organisms at various trophic levels in a Great Lakes food chain. Arch Environ Contam Toxicol. 48
(4): 559-66.
Kerstner-Wood, C., Coward, L. and Gorman, G., 2003. Protein Binding of perfluorbutane sulfonate,
perfluorohexanesulfonate, perfluoroooctane sulfonate and perfluorooctanoate to plasma (human, rat,
monkey), and various human-derived plasma protein fractions. Southern Research Corporation, Study
9921.7. Unpublished report. Available on USEPA Administrative Record AR-226.
Kärrman A., Van Bavel, B., Hardell, L., Järnberg, U,.and Lindström, G., 2004. Perfluoroalkylated
compounds in whole blood and plasma from the Swedish population. Report to Swedish EPA, HÄMI 215
0213, dnr 721-4007-02 Mm.
Kärrman A., .Mueller J.F., van Bavel B., Harden F., Toms L-M. L. and Lindström G., 2006. Levels of 12
Perfluorinated Chemicals in Pooled Australian Serum, Collected 2002-2003, in Relation to Age, Gender, and
Region. Environ. Sci. Technol. 40, 3742-3748
Loewen M., Halldorson T., Wang F., Tomy G., 2005. Fluorotelomer carboxylic acids and PFOS in rainwater
from an urban center in Canada. Env. Sci Tech. 39 (9) 2944-51.
Luebker D.J., Case M.T., York R.G., Moore J.A., Hansen K.J. and Butenhoff J.L., 2005. Two-generation
reproduction andcross-foster studies of perfluorooctanesulfonate (PFOS) in rats. Toxicology. 215 (1-2): 12648.
Luebeker D.J., Hansen K.J, Bass N.M, Butenhoff J.L. and Secat A.M., 2002. Interactions of fluorochemicals
with rat liver fatty acid-binding protein.
Toxicology, 15 (3): 175-85.
MacDonald, M.M., Warne, A.L., Stock, N.L., Mabury, S.A., Soloman, K.R. and Sibley, P.K., 2004. Toxicity
of perfluorooctane sulfonic acid and perfluorooctanoic acid to Chironomus tentans. Environmental
Toxicology and Chemistry. 23 (9): 2116-2123
Martin, J.W., Muir, D.C.G., Moody, C.A., Ellis, D.A., Kwan, W.C., Solomon, K.R., and Mabury, S.A.,
2002. Collection of airborne fluorinated organics and analysis by gaschromatography/chemical ionization
mass spectrometry, Anal. Chem., 74, 584-590
Martin, J.W., Mabury, S.A., Solomon, K.R. and Muir D.C.G., 2003. Bioconcentration and Tissue
Distribution of Perfluorinated Acids in Rainbow Trout (Oncorhynchus Mykiss). Env. Tox. Chem., 22 (1),
196-204.
Martin, J.W., Smithwick, M.M., Braune, B.M., Hoekstra, P.F., Muir, D.C.G. and Mabury, S.A., 2004a.
Identification of long chain perfluorinated acids in biota from the Canadian arctic. Environ. Sci. Technol.,
38, 373-380.
Martin J.W., Whittle D.M., Muir D.C.G., and Mabury S.A., 2004b. Perfluoroalkyl Contaminants in a Food
Web from Lake Ontario. Environ. Sci. Technol.: 38, 5379-5385.
MPCA , 2006. Investigation of perfluorochemical contamination in Minnesota: Phase one Report to Senate
Environment Committee. Minnesota Pollution Control Agency.
Moody C.A., Hebert G.N., Strauss S.H. and Field J.A., 2003. Occurrence and persistence of
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Morikawa A, Kamei N, Harada K, Inoue K, Yoshinaga T, Saito N, and Koizumi A., 2005.The
bioconcentration factor of perfluorooctane sulfonate is significantly larger than that of perfluorooctanoate in
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Perfluorooctane Sulfonate. Environ Sci Technol. 139(23):9357-62.
33
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Toxicology 50: 398-410.
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Alcohols and Sulfonamides in the North American Troposphere. Environmental Science and Technology,
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Taniyasu S., Kannan K., Horii Y. and Yamashita N., 2002. The first environmental survey of
perfluorooctane sulfonate (PFOS) and related compounds in Japan. Organohalogen Compounds, 59:311314.
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____________________
34
この化学物質の審査及び製造等の規制に関する法律施行令の翻訳は平成十九年政令第
三百二十二号までの改正（未施行）について「法令用語日英標準対訳辞書（平成１９年
３月版）に準拠して作成したものです。なお、この法令の翻訳は公定訳ではありません。
法的効力を有するのは日本語の法令自体であり、翻訳はあくまでその理解を助けるため
の参考資料です。この翻訳の利用に伴って発生した問題について、一切の責任を負いか
ねますので、法律上の問題に関しては、官報に掲載された日本語の法令を参照してくだ
さい。
This English translation of the Order for Enforcement of the Act on the
Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. has
been prepared (up to the revisions of Cabinet Order No. 322 of 2007 (Yet to enter
into force)) in compliance with the Standard Bilingual Dictionary March 2007
edition. This is an unofficial translation. Only the original Japanese texts of laws
and regulations have legal effect, and the translations are to be used solely as
reference material to aid in the understanding of Japanese laws and regulations.
The Government of Japan shall not be responsible for the accuracy, reliability or
currency of the legislative material provided in this Website, or for any consequence
resulting from use of the information in this Website. For all purposes of
interpreting and applying law to any legal issue or dispute, users should consult the
original Japanese texts published in the Official Gazette.
Order for Enforcement of the Act on the Evaluation of Chemical
Substances and Regulation of Their Manufacture, etc. (Cabinet
Order No. 202 of June 7, 1974)
The Cabinet shall enact this Cabinet Order pursuant to paragraph (2) of Article 2,
the proviso of paragraph (1) of Article 3, paragraph (1) of Article 13, Article 14, and
Article 28 of the Act on the Evaluation of Chemical Substances and Regulation of
Their Manufacture, etc. (Act No. 117 of 1973).
Article 1 (Class I Specified Chemical Substances)
The Class I Specified Chemical Substances set forth in paragraph (2) of Article 2 of
the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (hereinafter referred to as the “Act”) shall be the following
chemical substances:
(i) Polychlorinated biphenyls
(ii) Polychlorinated naphthalenes (limited to those containing three or more
chlorine atoms)
(iii) Hexachlorobenzene
(iv)
1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-exo-1,4-endo-5,8-dimethano-nap
hthalene (also known as Aldrin; referred to as “Aldrin” in item (iii) of the table
in Article 3)
(v)
-1-
1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-exo-1,4-endo-5,8-di
methano naphthalene (also known as Dieldrin; referred to as “Dieldrin” in item
(iv) of the table in Article 3)
(vi)
1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-endo-1,4-endo-5,8dimethano naphthalene (also known as Endrin)
(vii) 1,1,1-Trichloro-2,2-bis(4-chlorophenyl) ethane (also known as DDT; referred to
as “DDT” in item (iii) of the table in Article 3)
(viii)
Mixture
of
1,2,4,5,6,7,8,8-Octachloro-2,3,3a,4,7,7a-hexahydro-4,7-methano-1H-indene,1,4,5,6,
7,8,8-heptachloro-3a,4,7,7a-tetrahydro-4,7-methano-1H-indene
and
their
analogous compounds (also known as Chlordane or Heptachlor; referred to as
“Chlordanes” in item (v) of the table in Article 3)
(ix) Bis(tributyltin) oxide
(x)
N,N’-Ditolyl-p-phenylenediamine,
N-tolyl-N’-xylyl-p-phenylenediamine,
or
N,N’-dixylyl-p-phenylenediamine
(xi) 2,4,6-Tri- tert-butylphenol
(xii) Polychloro-2,2-dimethyl-3-methylidenebicyclo[2.2.1]heptane (also known as
Toxaphene)
(xiii) Dodecachloropentacyclo [5.3.0.02,6.03,9.04,8] decane (also known as Mirex;
referred to as “Mirex” in item (ix) of the table in Article 3)
(xiv) 2,2,2- Trichloro-1,1- bis(4-chlorophenyl) ethanol (also known as Kelthane or
Dicofol)
(xv) Hexachlorobuta-1,3-diene
(xvi) Phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylethyl)Article 1-2 (Class II Specified Chemical Substances)
The Class II Specified Chemical Substances set forth in paragraph (3) of Article 2
of the Act shall be the following chemical substances:
(i) Trichloroethylene
(ii) Tetrachloroethylene
(iii) Carbon tetrachloride
(iv) Triphenyltin=N,N-dimethyldithiocarbamate
(v) Triphenyltin=fluoride
(vi) Triphenyltin=acetate
(vii) Triphenyltin=chloride
(viii) Triphenyltin=hydroxide
(ix) Triphenyltin=salts of fatty acid (limited to those containing 9, 10 or 11 carbon
atoms in the fatty acid)
(x) Triphenyltin=chloroacetate
-2-
(xi) Tributyltin=methacrylate
(xii) Bis(tributyltin)=fumarate
(xiii) Tributyltin=fluoride
(xiv) Bis(tributyltin)=2,3-dibromosuccinate
(xv) Tributyltin=acetate
(xvi) Tributyltin=laurate
(xvii) Bis(tributyltin)=phthalate
(xviii)
Poly(Alkyl=acrylate-co-methyl=methacrylate-co-tributyltin=methacrylate)
(limited to those containing 8 carbon atoms in alkyl group of alkyl=acrylate)
(xix) Tributyltin=sulfamate
(xx) Bis(tributyltin)=maleate
(xxi) Tributyltin=chloride
(xxii) Mixture of tributyltin=cyclopentanecarboxylate and its analogous compounds
(also known as Tributyltin=naphthenate)
(xxiii)
Mixture
of
tributyltin=1,2,3,4,4a,4b,5,6,10,10a-decahydro-7-isopropyl-
1,4a-dimethyl-1-phenanthrenecarboxylate and its analogous compounds (also
known as Tributyltin salt of rosin)
Article 2 (Cases Not Requiring Notification of the Manufacture or Import of New
Chemical Substances)
(1) The cases specified by the Cabinet Order set forth in item (iv) of paragraph (1) of
Article 3 of the Act shall be the following cases:
(i) Where a person intends to manufacture or import a new chemical substance as
an intermediate of another chemical substance, and has taken the necessary
measures to prevent environmental pollution from said new chemical substance
during the period until said new chemical substance is transformed into another
chemical substance
(ii) Where a person intends to manufacture or import a new chemical substance to
be used in such a way as to prevent any emission outside the facility or
equipment, and has taken the necessary measures to prevent environmental
pollution from said new chemical substance during the period until said new
chemical substance is disposed of
(iii) Where a person intends to manufacture or import a new chemical substance
for the purpose of export (limited to cases where the said export is to a region
that has been designated as a region where the necessary measures have been
taken to prevent environmental pollution from the new chemical substance by an
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment), and the person has taken the necessary measures to prevent
environmental pollution from said new chemical substance during the period
-3-
until said new chemical substance is exported
(2) The quantity specified by the Cabinet Order set forth in item (v) of paragraph (1)
of Article 3 of the Act shall be 1 ton.
Article 2-2 (Cases Subject to Exception to Evaluation)
The quantity specified by the Cabinet Order set forth in item (i) of paragraph (4) of
Article 4-2 of the Act shall be 10 tons.
Article 3 (Products Whose Import is Prohibited When Class I Specified Chemical
Substances are Used)
The products specified by the Cabinet Order set forth in paragraph (1) of Article 13
of the Act shall be those listed in the right-hand column of the following table for
each Class I Specified Chemical Substance listed in the left-hand column of said
table (excluding products designated by the Minister of Economy, Trade and Industry
as being difficult to be substituted for by equivalent products produced in Japan and
whose import is especially necessary in view of their usage).
Class I Specified Chemical Substances
Products
(i) Polychlorinated biphenyls
(i) Lubricating, cutting, and hydraulic
oils
(ii) Adhesives (excluding those of animal
and botanical origin), putty and filling
materials for closing or sealing
(iii)
Paints
(excluding
water-based
paints), printing inks, and carbonless
copying paper
(iv) Heating or cooling devices with
liquid heating medium
(v) Oil-filled transformers and paper
condensers, and oil-filled condensers and
organic-coated condensers
(vi) Air conditioners, television receivers,
and microwave ovens
(ii)
Polychlorinated
naphthalenes (i) Lubricating and cutting oils
(limited to those containing three or (ii) Wood antiseptics, insecticides, and
more chlorine atoms)
fungicides
(iii)
Paints
(limited
to
those
for
antiseptic, insecticidal, and fungicidal
use)
(iii) Aldrin and DDT
(i) Wood antiseptics, insecticides, and
-4-
fungicides
(ii)
Paints
(limited
to
those
for
antiseptic, insecticidal, and fungicidal
use)
(iv) Dieldrin
(i) Wood antiseptics, insecticides, and
fungicides
(ii)
Paints
(limited
to
those
for
antiseptic, insecticidal, and fungicidal
use)
(iii) Wool (excluding greased wool)
(v) Chlordanes
(i) Wood antiseptics and insecticides
(ii) Wood adhesives
(iii) Paints (limited to antiseptic and
insecticidal use)
(iv) Wood treated with antiseptics and
insecticides
(v) Plywood treated with antiseptics and
insecticides
(vi) Bis(tributyltin)=oxide
(i) Antiseptics and fungicides
(ii) Paints (limited to those used to
prevent shellfishes, algae, and other
living organisms in water from adhering
to surfaces) and printing inks
(iii) Fishnet
(vii) N,N’- Ditolyl-p-phenylenediamine, (i) Rubber antioxidants
N-tolyl-N’-xylyl-p-phenylenediamine,
or (ii) Styrene-butadiene rubber
N,N’-dixylyl-p-phenylenediamine
(viii) 2,4,6-Tri- tert-butylphenol
(i)
Antioxidant
and
other
prepared
additives (limited to those for lubricating
and fuel oils)
(ii) Lubricating oils
(ix) Mirex
Wood insecticides
(x)
(i) Decorative laminate
Phenol,
2 - ( 2 H - b e n z o t r i a z o l - 2 - y l ) - 4 , 6 - b i s ( 1 , (ii) Adhesives (excluding those of animal
1-dimethylethyl)-
and botanical origin), putty, and filling
materials for closing or sealing
(iii) Paints and printing ink
(iv) Helmets
(v) Radiator grills and other auto parts
(excluding those made of metals)
-5-
(vi) Lighting covers
(vii) Lenses for protective spectacles and
frames for spectacles
(viii) Deodorants
(ix) Waxes
(x) Surf-boards
(xi) Inked ribbons
(xii) Photographic paper
(xiii) Buttons
(xiv) Tubes, bathtubs, and other plastic
products (limited to molded products)
Article 4 (Products Whose Planned Quantity of Import, etc., Needs to be Notified
When Class II Specified Chemical Substances are Used)
The products specified by the Cabinet Order set forth in paragraph (1) of Article 26
of the Act shall be paints (limited to those used to prevent shellfishes, algae, and
other living organisms in water from adhering to surfaces) for Class II Specified
Chemical Substances listed in items (xi) to (xxiii) of Article 1-2 (referred to as
“Tributyltin compounds” in item (iii) of the table in the following Article).
Article 5 (Products for Which Labeling on Containers, etc. is Required When Class II
Specified Chemical Substances are Used)
The products specified by the Cabinet Order set forth in paragraph (1) of Article 28
of the Act shall be those listed in the right-hand column of the following table for
each Class II Specified Chemical Substance listed in the left-hand column of said
table.
Class II Specified Chemical Substances
Products
(i) Trichloriethylene
(i) Adhesives (excluding those of animal
and botanical origin)
(ii) Paints (excluding water-based paints)
(iii) Metalworking fluids
(iv) Cleaning agents
(ii) Tetrachloroethylene
(i) Vulcanized agents
(ii) Adhesives (excluding those of animal
and botanical origin)
(iii)
Paints
(excluding
water-based
paints)
(iv) Cleaning agents
(v) Finishing agents for textile goods
-6-
(iii) Tributyltin compounds
(i) Antiseptics and fungicides
(ii) Paints (limited to those used to
prevent shellfishes, algae, and other
living organisms in water from adhering
to surfaces)
Article 6 (Fees)
Fees which a person listed in the left-hand column of the following table shall pay
under the provisions of Article 35 of the Act shall be as shown in the middle column
of said table (or as shown in the right-hand column of said table in the case of an
electronic application (which means an application filed using an electronic data
processing system prescribed in paragraph (1) of Article 3 of the Act on the Use of
Information and Communications Technologies for Administrative Procedures (Act
No. 151 of 2002) pursuant to the provisions of said paragraph; the same shall apply
hereinafter).
Persons who shall pay fees
Amount
Amount in the case of
an
electronic
application
(i) Persons seeking to obtain permission 220,600 yen
213,700 yen
under paragraph (1) of Article 6 of the Act
(ii) Persons seeking to obtain permission 121,700 yen
117,200 yen
under paragraph (1) of Article 10 of the Act
(iii) Persons seeking to obtain permission 46,700 yen
39,900 yen
under paragraph (1) of Article 11 of the Act
Article 7 (Advisory Councils, etc., Specified by the Cabinet Order)
(1) The advisory councils set forth in paragraph (1) of Article 41 of the Act which are
specified by the Cabinet Order shall be those listed in the right-hand column of the
following table for the respective Minister listed in the left-hand column of said
table.
Minister of Health, Labour and Welfare
Pharmaceutical
Affairs
and
Food
Sanitation Council
Minister of Economy, Trade and Industry
Chemical Substances Council
Minister of the Environment
Central Environment Council
(2) The advisory councils set forth in paragraph (2) of Article 41 of the Act which are
specified by the Cabinet Order shall be what are listed in the right-hand column of
the following table for the respective Minister listed in the left-hand column of said
-7-
table.
Minister of Economy, Trade and Industry
Chemical Substances Council
Minister of the Environment
Central Environment Council
Supplementary Provisions (Extract)
(Effective Date)
(1) This Cabinet Order shall come into effect as from June 10, 1974; provided,
however, that the provisions of Article 3 shall come into effect as from August 1,
1974.
(Repeal of the Cabinet Order to Specify Cases Not Requiring Notification of the
Manufacture or Import of New Chemical Substances under Paragraph (1) of Article 3
of the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc.)
(2) The Cabinet Order to Specify Cases Not Requiring Notification of the
Manufacture or Import of New Chemical Substances under Paragraph (1) of Article
3 of the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (Cabinet Order No. 102 of 1974) shall be repealed.
Supplementary Provisions (Cabinet Order No. 225 of August 14, 1979)
This Cabinet Order shall come into effect as from August 20, 1979; provided,
however, that the provisions for revising Article 3 shall come into effect as from
October 11, 1979.
Supplementary Provisions (Cabinet Order No. 302 of October 2, 1981)
This Cabinet Order shall come into effect as from October 12, 1981; provided,
however, that the provisions for revising Article 3 shall come into effect as from
December 1, 1981.
Supplementary Provisions (Cabinet Order No. 97 of April 13, 1984)
This Cabinet Order shall come into effect as from April 20, 1984.
Supplementary Provisions (Cabinet Order No. 297 of September 17, 1986)
This Cabinet Order shall come into effect as from the day of promulgation;
-8-
provided, however, that the provisions for revising Article 3 shall come into effect as
from November 21, 1986.
Supplementary Provisions (Cabinet Order No. 335 of October 31, 1986)
(Extract)
(Effective Date)
(1) This Cabinet Order shall come into effect as from the day of enforcement of the
Act on the Partial Revision of the Act on the Evaluation of Chemical Substances
and Regulation of Their Manufacture, etc. (April 1, 1987); provided, however, that
the provisions for revising item (ii) of paragraph (1) of Article 2 shall come into
effect as from March 1, 1987.
Supplementary Provisions (Cabinet Order No. 49 of March 20, 1987) (Extract)
(1) This Cabinet Order shall come into effect as from April 1, 1987.
Supplementary Provisions (Cabinet Order No. 59 of March 22, 1989) (Extract)
(1) This Cabinet Order shall come into effect as from April 1, 1989.
Supplementary Provisions (Cabinet Order No. 75 of March 29, 1989)
This Cabinet Order shall come into effect as from April 1, 1989.
Supplementary Provisions (Cabinet Order No. 351 of December 27, 1989)
(Effective Date)
(1) This Cabinet Order shall come into effect as from January 6, 1990; provided,
however, that the provisions for revising Article 3 shall come into effect as from
March 1, 1990.
(Transitional Measures)
(2) With regard to the application of penal provisions to acts committed prior to the
enforcement of the provisions for revising Article 1-2, the provisions then in force
shall remain applicable.
Supplementary Provisions (Cabinet Order No. 259 of September 12, 1990)
(Effective Date)
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(1) This Cabinet Order shall come into effect as from the day of promulgation.
(Transitional Measures)
(2) With regard to the application of penal provisions to acts committed prior to the
enforcement of the provisions for revising Article 1-2, the provisions then in force
shall remain applicable.
Supplementary Provisions (Cabinet Order No. 49 of March 25, 1991)
This Cabinet Order shall come into effect as from April 1, 1991.
Supplementary Provisions (Cabinet Order No. 77 of March 24, 1994) (Extract)
(1) This Cabinet Order shall come into effect as from April 1, 1994.
Supplementary Provisions (Cabinet Order No. 67 of March 24, 1997)
(Effective Date)
(1) This Cabinet Order shall come into effect as from April 1, 1997.
(Transitional Measures)
(2) The provisions then in force shall remain applicable to fees to be paid by a person
who intends to take the Information Technology Engineers Examination which has
been publicly notified prior to the enforcement of this Cabinet Order.
Supplementary Provisions (Cabinet Order No. 98 of March 24, 2000)
(Effective Date)
(1) This Cabinet Order shall come into effect as from April 1, 2000; provided,
however, that the provisions of Article 19 shall come into effect as from June 1,
2000.
(Transitional Measures)
(2) The provisions then in force shall remain applicable to fees to be paid by a person
who intends to take a Second-Class electrician’s examination which has been
publicly notified prior to the enforcement of this Cabinet Order.
Supplementary Provisions (Cabinet Order No. 311 of June 7, 2000) (Extract)
Article 1 (Effective Date)
- 10 -
This Cabinet Order shall come into effect as from the date of enforcement of the
Act on the Partial Revision of the Cabinet Act (Act No. 88 of 1999) (January 6, 2001).
Supplementary Provisions (Cabinet Order No. 542 of December 27, 2000)
This Cabinet Order shall come into effect as from January 6, 2001; provided,
however, that the provisions for revising Article 3 shall come into effect as from July
1, 2001.
Supplementary Provisions (Cabinet Order No. 287 of September 4, 2002)
This Cabinet Order shall come into effect as from the day of promulgation;
provided, however, that the provisions for revising Article 3 shall come into effect as
from November 1, 2002.
Supplementary Provisions (Cabinet Order No. 5 of January 15, 2003)
This Cabinet Order shall come into effect as from March 15, 2003.
Supplementary Provisions (Cabinet Order No. 419 of September 19, 2003)
(Effective Date)
(1) This Cabinet Order shall come into effect as from the date of enforcement of the
Act on the Partial Revision of the Act on the Evaluation of Chemical Substances
and Regulation of Their Manufacture, etc. (hereinafter referred to as the “Revising
Act”) (April 1, 2004).
(Persons Subject to Transitional Measures pertaining to Confirmation)
(2) The persons specified by the Cabinet Order set forth in Article 2 of the
Supplementary Provisions of the Revising Act shall be those who manufacture or
import a new chemical substance as an intermediate of medicines pertaining to the
permission prescribed in paragraph (1) of Article 12 or paragraph (1) of Article 18
of the Pharmaceutical Affairs Act (Act No. 145 of 1960)
Supplementary Provisions (Cabinet Order No. 57 of March 24, 2004) (Extract)
This Cabinet Order shall come into effect as from March 31, 2004.
Supplementary Provisions (Cabinet Order No. 134 of April 1, 2005)
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This Cabinet Order shall come into effect as from the day of promulgation.
Supplementary Provisions (Cabinet Order No. 322 of October 31, 2007)
This Cabinet Order shall come into effect as from November 10, 2007; provided,
however, that the provisions for revising Article 3 shall come into effect as from May
1, 2008.
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この化学物質の審査及び製造等の規制に関する法律の翻訳は平成十七年法律第三十三
号までの改正（平成１７年１０月１日施行）について「法令用語日英標準対訳辞書（平
成１９年３月版）に準拠して作成したものです。
なお、この法令の翻訳は公定訳ではありません。法的効力を有するのは日本語の法令
自体であり、翻訳はあくまでその理解を助けるための参考資料です。この翻訳の利用
に伴って発生した問題について、一切の責任を負いかねますので、法律上の問題に関
しては、官報に掲載された日本語の法令を参照してください。
This English translation of the Act on the Evaluation of Chemical Substances and
Regulation of Their Manufacture, etc. has been prepared (up to the revisions of Act No.
33 of 2005 (Effective October 1, 2005)) in compliance with the Standard Bilingual
Dictionary March 2007 edition . This is an unofficial translation. Only the original
Japanese texts of laws and regulations have legal effect, and the translations are to
be used solely as reference material to aid in the understanding of Japanese laws
and regulations. The Government of Japan shall not be responsible for the
accuracy, reliability or currency of the legislative material provided in this Website,
or for any consequence resulting from use of the information in this Website. For
all purposes of interpreting and applying law to any legal issue or dispute, users
should consult the original Japanese texts published in the Official Gazette.
Act on the Evaluation of Chemical Substances and Regulation of
Their Manufacture, etc.
(Act No. 117 of October 16, 1973)
Chapter 1 General Provisions
Article 1 (Purpose)
The purpose of this Act is to establish a system to evaluate, before manufacture or
import, whether or not new chemical substances have properties such as persistence, and
to implement necessary regulations with respect to the manufacture, import, use, etc. of
chemical substances, with due consideration to their properties, etc., in order to prevent
environmental pollution caused by chemical substances that are persistent and pose a
risk of impairing human health or interfering with the inhabitation and/or growth of flora
and fauna.
Article 2 (Definitions, etc.)
(1) The term “chemical substance” as used in this Act means a chemical compound
obtained by causing chemical reactions to elements or compounds (excluding a
radioactive substance and the following substances):
(i) Any specified poison prescribed in paragraph (3) of Article 2 of the Poisonous and
Deleterious Substances Control Act (Act No. 303 of 1950)
(ii) Any stimulant prescribed in paragraph (1) of Article 2 of the Stimulant Drug
Control Act (Act No. 252 of 1951) and any raw material for stimulants prescribed in
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paragraph (5) of said Article
(iii) Any narcotic prescribed in item (i) of Article 2 of the Narcotics and Psychotropics
Control Act (Act No. 14 of 1953)
(2) The term “Class I Specified Chemical Substance” as used in this Act means a
chemical substance that falls under either of the following items and is specified by a
Cabinet Order:
(i) A chemical substance that falls under (a) and (b):
(a) A chemical substance that is not likely to undergo a chemical transformation
through natural processes and is bioaccumulative
(b) A chemical substance that falls under either of the following:
1. A chemical substance that poses a risk of impairing human health if ingested
continuously
2. A chemical substance that, if ingested continuously, poses a risk of interfering
with the inhabitation and/or growth of animals at the top of the food chain
(which mean animals that fall under the category of flora and fauna in the
human living environment [which mean flora and fauna for which interference
with their inhabitation and/or growth would pose a risk of interfering with the
preservation of the human living environment; the same shall apply hereinafter]
for which chemical substances falling under (a) are most likely to bioaccumulate
through the food chain; the same shall apply hereinafter)
(ii) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by chemical transformation through natural
processes falls under (a) and (b) of the preceding item
(3) The term “Class II Specified Chemical Substance” as used in this Act means a
chemical substance that falls under either of the following items and is thought to pose
a risk of causing damage pertaining to human health or damage pertaining to the
inhabitation and/or growth of flora and fauna in the human living environment
because a considerable amount of the chemical substance remains in the environment
over a substantially extensive area or it is reasonably likely that such a situation will
arise in the near future in view of the state of its manufacture, import, use, etc., and is
specified by a Cabinet Order:
(i) A chemical substance that falls under either (a) or (b):
(a) A chemical substance (excluding one that falls under item (i) of the preceding
paragraph) that is not likely to undergo a chemical transformation through
natural processes, and poses a risk of impairing human health if ingested
continuously
(b) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
-2-
processes falls under (a)
(ii) Any chemical substance that falls under either (a) or (b):
(a) A chemical substance (excluding one that falls under item (i) of the preceding
paragraph) that is not likely to undergo a chemical transformation through
natural processes, and that poses a risk of interfering with the inhabitation and/or
growth of flora and fauna in the human living environment if the flora and fauna
continuously ingest or are exposed to said chemical substance
(b) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
processes falls under (a)
(4) The term “Type I Monitoring Chemical Substance” as used in this Act means a
chemical substance (excluding a new chemical substance) that falls under either of the
following items and has been designated by the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment:
(i) A chemical substance that falls under (a) of item (i) of paragraph (2), and where it is
unclear whether or not (b) of said item applies
(ii) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
processes falls under the preceding item
(5) The term “Type II Monitoring Chemical Substance” as used in this Act means a
chemical substance suspected of falling under item (i) of paragraph (3) (including a
chemical substance that falls under said item but has not been designated as a Class II
Specified Chemical Substance) and has been designated by the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of
the Environment.
(6) The term “Type III Monitoring Chemical Substance” as used in this Act means a
chemical substance that falls under either of the following items and has been
designated by the Minister of Economy, Trade and Industry and the Minister of the
Environment:
(i) A chemical substance that is not likely to undergo a chemical transformation
through natural processes, and poses a risk of interfering with the inhabitation
and/or growth of flora and fauna (excluding one that falls under item (i) of paragraph
(2) and one that falls under (a) of item (ii) of paragraph (3) which has been
designated as a Class II Specified Chemical Substance)
(ii) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
-3-
processes falls under the preceding item
(7) The term “new chemical substance” as used in this Act means a chemical substance
other than the chemical substances listed in the following items:
(i) A chemical substance for which public notice has been given by the Minister of
Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment pursuant to the provisions of paragraph (4) of Article 4
(including the cases where it is applied mutatis mutandis pursuant to paragraph (9)
of Article 4-2 by replacing the terms, and the cases in which it is applied mutatis
mutandis pursuant to paragraph (2) of Article 5-2)
(ii) A Class I Specified Chemical Substance
(iii) A Class II Specified Chemical Substance
(iv) A Type II Monitoring Chemical Substance (including one for which designation has
been rescinded pursuant to the provisions of item (ii) of Article 25)
(v) A Type III Monitoring Chemical Substance
(vi) A chemical substance (excluding any of those set forth in the preceding items)
listed in the List of Existing Chemical Substances prescribed in paragraph (1) of
Article 2 of the Supplementary Provisions of this Act that has been publicly notified
by the Minister of International Trade and Industry pursuant to the provisions of
paragraph (4) of said Article
(8) The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment shall make the designation set forth in
paragraph (5) based on the results of the tests prescribed in paragraph (7) of Article 4
(including the cases where it is applied mutatis mutandis pursuant to paragraph (9) of
Article 4-2).
(9) When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, or the Minister of the Environment has designated a chemical substance
as a Type I Monitoring Chemical Substance or Type II Monitoring Chemical Substance
pursuant to the provisions of paragraph (4) or (5), he/she shall give public notice of its
name without delay.
(10) When the Minister of Economy, Trade and Industry or the Minister of the
Environment has designated a chemical substance as a Type III Monitoring Chemical
Substance pursuant to the provisions of paragraph (6), he/she shall give public notice of
its name without delay.
Chapter 2 Evaluation and Regulation Concerning New Chemical Substances
Article 3 (Notification of Manufacture, etc.)
(1) A person who intends to manufacture or import a new chemical substance shall notify
the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment, in advance, of the name of said new
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chemical substance and other matters specified by an Ordinance of the Ministry of
Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade and
Industry, and Ordinance of the Ministry of the Environment, pursuant to the
provisions of an Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment; provided, however, that this shall not apply to a case that falls under
any of the following items:
(i) Where a person intends to import, from a person who has submitted a notification
under paragraph (1) of Article 5-2 and has received notice to the effect that the new
chemical substance to which said notification pertains falls under item (v) of
paragraph (1) of the following Article in accordance with the provisions of paragraph
(1) or (2) of said Article as applied mutatis mutandis pursuant to paragraph (2) of
Article 5-2, the new chemical substance to which said notification pertains
(ii) Where a person intends to manufacture or import a new substance for testing and
research purposes
(iii) Where a person intends to manufacture or import a new chemical substance as a
reagent (which means a chemical substance used for the detection or quantification
of a substance by a chemical process, or for the experimental synthesis of a
substance, or for the measurement of the physical characteristics of a substance; the
same shall apply hereinafter)
(iv) Where a person has received a confirmation from the Minister of Health, Labour
and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment, pursuant to the provisions of an Ordinance of the Ministry of Health,
Labour and Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and
Ordinance of the Ministry of the Environment, to the effect that the manufacture or
import falls under a case specified by a Cabinet Order as one where the new
chemical substance does not pose a risk of causing environmental pollution in
consideration of the intended method of handling said new chemical substance and
other matters, and said new chemical substance will be manufactured or imported in
accordance with the particulars for which said confirmation has been received
(v) Where the planned quantity of manufacture or planned quantity of import (in the
case of a person who intends to manufacture and import said new chemical
substance, the sum of these quantities; the same shall apply in paragraph (1) and
item (i) of paragraph (4) of Article 4-2) of said new chemical substance in one fiscal
year is not more than the quantity specified by a Cabinet Order, and where a person
has received a confirmation from the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment, in
accordance with an Ordinance of the Ministry of Health, Labour and Welfare,
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the
Ministry of the Environment, to the effect that, as determined by already available
-5-
knowledge, etc., said new chemical substance is not one that poses a risk of causing
damage to human health or damage to the inhabitation and/or growth of flora and
fauna in the human living environment by causing environmental pollution, and that
person shall manufacture or import said new chemical substance in a quantity of no
more than that to which said confirmation pertains during the relevant fiscal year
(2) In cases where the sum of the planned quantity of manufacture and planned quantity
of import to which the confirmation under the provisions of item (v) of the preceding
paragraph pertains (including the planned quantity of manufacture and planned
quantity of import to which the confirmation under the provisions of paragraph (4) of
Article 4-2 pertains) relating to a single new chemical substance exceeds the quantity
specified by a Cabinet Order set forth in said item, the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment shall not issue the confirmation under said item.
(3) In any of the following cases, the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment shall
rescind the confirmation set forth in item (iv) of paragraph (1):
(i) Where the person who has received the confirmation under item (iv) of paragraph
(1) had received said confirmation by wrongful means
(ii) Where the person who has received the confirmation under item (iv) of paragraph
(1) is found not to be manufacturing or importing the new chemical substance to
which said confirmation pertains in accordance with the particulars for which said
confirmation has been received
(iii) In addition to the cases set forth in the preceding items, where it is found that the
new chemical substance to which the confirmation under item (iv) of paragraph (1)
pertains poses a risk of causing environmental pollution
(4) In any of the following cases, the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment shall
rescind the confirmation under item (v) of paragraph (1):
(i) Where the person who has received the confirmation under item (v) of paragraph (1)
had received said confirmation by wrongful means
(ii) Where the person who has received the confirmation under item (v) of paragraph
(1) is found not to be manufacturing or importing the new chemical substance to
which said confirmation pertains in excess of the quantity to which said confirmation
pertains
(iii) In addition to the cases set forth in the preceding items, where it is found that the
new chemical substance to which the confirmation under item (v) of paragraph (1)
pertains poses a risk of causing damage to human health or damage to the
inhabitation and/or growth of flora and fauna in the human living environment by
causing environmental pollution
-6-
Article 4 (Evaluation)
(1) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have received a notification under
paragraph (1) of the preceding Article, they shall make a determination as to which of
the following items the new chemical substance falls under, within three months from
the date of receipt of the notification, based on the available knowledge on the
composition, properties, etc., of the new chemical substance to which said notification
pertains, and shall notify the result thereof to the person who has given the
notification:
(i) A substance that falls under any of the items of paragraph (2) of Article 2
(ii) A substance that is suspected of falling under item (i) of paragraph (3) of Article 2
(including a substance that falls under said item; the same shall apply in item (iv))
and that falls under neither of the items of paragraph (6) of said Article
(iii) A substance that is not suspected of falling under item (i), paragraph (3) of Article
2 and that falls under either of the items of paragraph (6) of said Article
(iv) A substance that is suspected of falling under item (i), paragraph (3) of Article 2
and that falls under either of the items of paragraph (6) of said Article
(v) A substance that falls under neither of the items of paragraph (2) of Article 2 and
neither of the items of paragraph (6) of said Article and that is not suspected of
falling under item (i) of paragraph (3) of said Article
(vi) A substance where it is unclear as to whether or not it falls under items (i) to (iv)
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have determined that a new
chemical substance to which a notification under paragraph (1) of the preceding Article
pertains falls under item (vi) of the preceding paragraph, they shall promptly make a
determination as to which one of items (i) to (v) of said paragraph the new chemical
substance falls under, based on the results of tests conducted on the new chemical
substance, and shall notify the result thereof to the person who has given the
notification.
(3) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment find it necessary in order to make a
determination under the preceding paragraph, they may request the person who has
given the notification under paragraph (1) of the preceding Article to submit materials
stating the results of tests prescribed in paragraph (7) relating to the properties of the
new chemical substance to which said notification pertains and any other documents
specified by an Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment.
(4) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have given notice to the effect that
-7-
the new chemical substance to which a notification under paragraph (1) of the
preceding Article pertains falls under item (v) of paragraph (1), pursuant to the
provisions of paragraph (1) or (2), they shall give public notice of the name of said new
chemical substance, in accordance with an Ordinance of the Ministry of Health, Labour
and Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and
Ordinance of the Ministry of the Environment.
(5) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have given notice to the effect that
the new chemical substance to which a notification under paragraph (1) of the
preceding Article pertains falls under item (ii) or item (iv) of paragraph (1), pursuant to
the provisions of paragraph (1) or (2), they shall make a designation under the
provisions of paragraph (5) of Article 2 with regard to said chemical substance without
delay.
(6) Where the Minister of Economy, Trade and Industry and the Minister of the
Environment have given notice to the effect that the new chemical substance to which
a notification under paragraph (1) of the preceding Article pertains falls under item (iii)
or item (iv) of paragraph (1), pursuant to the provisions of paragraph (1) or (2), they
shall make a designation under the provisions of paragraph (6) of Article 2 with regard
to said chemical substance without delay.
(7) The items to be tested and any other technical matters necessary for making a
determination under paragraphs (1) and (2) of this Article shall be specified by an
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of
Economy, Trade and Industry, and Ordinance of the Ministry of the Environment.
(8) In determining the order under the preceding paragraph, efforts shall be made to
consider fully the international trends regarding the establishment of items to be
tested relating to the evaluation of the safety of chemical substances, and other trends
regarding the technical standards relating to the evaluation of the safety of chemical
substances.
Article 4-2 (Exception to Evaluation in the Case Where the Planned Quantity of
Manufacture etc., is Not More Than a Certain Quantity, etc.)
(1) A person who intends to give a notification under paragraph (1) of Article 3 and for
whom the planned quantity of manufacture or planned quantity of import of the new
chemical substance to which the notification pertains during one fiscal year will be not
more than the quantity specified by the Cabinet Order set forth in item (i) of
paragraph (4) may, when giving the notification, make a request to the Minister of
Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment, pursuant to the provisions of an Ordinance of the
Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade
and Industry, and Ordinance of the Ministry of the Environment, to make a
-8-
determination as to whether or not said new chemical substance falls under either of
the following items in the case where it falls under item (vi) of paragraph (1) of the
preceding Article:
(i) A chemical substance that falls under (a) and (b):
(a) A chemical substance that is not likely to undergo a chemical transformation
through natural processes and is not bioaccumulative
(b) A chemical substance where it is unclear as to whether or not it falls under items
(ii) to (iv) of paragraph (1) of the preceding Article
(ii) In the case of a new chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
processes falls under the preceding item
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have received a request under the
preceding paragraph, if they find that the new chemical substance to which said
request pertains falls under item (vi) of said paragraph at the time of making a
determination under item (i) of the preceding Article, they shall, notwithstanding the
provisions of said paragraph, make a determination as to which of the following items
said new chemical substance falls under, in lieu of a determination to the effect that it
falls under item (vi) of paragraph (1) of the preceding Article, based on already
available knowledge on the composition, properties, etc., of the new chemical substance
to which said request pertains, within three months from the date of receipt of a
notification under item (i) of Article 3, and shall notify the result thereof to the person
who has made the request under the preceding paragraph; in this case, the provisions
of paragraph (2) of said Article shall not apply:
(i) A substance that falls under any of the items of the preceding paragraph
(ii) A substance that does not fall under any of the items of the preceding paragraph
(iii) A chemical substance where it is unclear as to whether or not it falls under any of
the items of the preceding paragraph
(3) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have determined that the new
chemical substance to which a request under paragraph (1) pertains falls under item
(iii) of the preceding paragraph, they shall promptly make a determination as to which
one of items (i) or (ii) of said paragraph said new chemical substance falls under, based
on the results of tests conducted on said new chemical substance, and shall notify the
result thereof to the person who has made the request.
(4) A person who has received notice to the effect that the new chemical substance to
which a request made under the provisions of paragraph (2) or the preceding
paragraph pertains falls under item (i) of paragraph (2) may make a request in
advance, each fiscal year, to the Minister of Health, Labour and Welfare, the Minister
-9-
of Economy, Trade and Industry, and the Minister of the Environment and receive a
confirmation to the effect that the manufacture or import of the new chemical
substance to which said notice pertains falls under the following items, pursuant to the
provisions of an Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment:
(i) The planned quantity of manufacture or planned quantity of import of said new
chemical substance during the fiscal year to which the request pertains is not more
than the quantity specified by a Cabinet Order.
(ii) Determined by already available knowledge, etc., the new chemical substance is not
one that poses a risk of causing damage to human health or damage to the
inhabitation and/or growth of flora and fauna in the human living environment by
causing environmental pollution.
(5) In cases where the sum of the planned quantity of manufacture and planned quantity
of import to which the confirmation under the provisions of the preceding paragraph
pertains (including the planned quantity of manufacture and planned quantity of
import to which the confirmation under the provisions of item (v) of paragraph (1) of
Article 3 pertains) relating to a single new chemical substance exceeds the quantity
specified by a Cabinet Order set forth in item (i) of the preceding paragraph, the
Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry,
and the Minister of the Environment shall not issue the confirmation under said item.
(6) In any of the following cases, the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment shall
rescind the confirmation set forth in paragraph (4):
(i) Where the person who has received the confirmation under paragraph (4) has
received said confirmation by wrongful means
(ii) Where the person who has received the confirmation under paragraph (4) is found
to be manufacturing or importing the new chemical substance to which said
confirmation pertains in excess of the quantity to which said confirmation pertains
(iii) In addition to the cases set forth in the preceding items, where it is found that the
new chemical substance to which the confirmation under paragraph (4) pertains
poses a risk of causing damage to human health or damage to the inhabitation
and/or growth of flora and fauna in the human living environment by causing
environmental pollution
(7) A person who has received notice to the effect that the new chemical substance to
which his/her request pertains falls under item (i) of paragraph (2), pursuant to the
provisions of paragraph (2) or paragraph (3) may, when he/she finds it necessary, make
a request to the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment to make a determination
under the following paragraph with regard to the new chemical substance to which
- 10 -
said notice pertains, pursuant to the provisions of an Ordinance of the Ministry of
Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade and
Industry, and Ordinance of the Ministry of the Environment.
(8) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have given notice to the effect that
the new chemical substance to which a request under paragraph (1) pertains falls
under item (ii) of paragraph (2), pursuant to the provisions of paragraph (2) or
paragraph (3), where they have not issued a confirmation to the effect that the
manufacture or import of the new chemical substance to which a request under
paragraph (4) pertains falls under the items of said paragraph, where they have
rescinded the confirmation under said paragraph, or where they have received a
request under the preceding paragraph, they shall promptly make a determination as
to which one of items (i) to (v) of paragraph (1) of Article 4 said new chemical
substance falls under, based on the results of tests conducted on said new chemical
substance, and shall notify the result thereof to the person who has made the request
under paragraph (1) with regard to the new chemical substance.
(9) The provisions of paragraph (7) and paragraph (8) of the preceding Article shall apply
mutatis mutandis to a determination under paragraph (2), the provisions of paragraph
(3), paragraph (7) and paragraph (8) of said Article shall apply mutatis mutandis to a
determination under paragraph (3), and the provisions of paragraph (3) to paragraph
(8) of said Article shall apply mutatis mutandis to a determination under the preceding
paragraph. In these cases, the phrase “paragraph (1) or paragraph (2)” in the
provisions of paragraph (4) to paragraph (6) of said Article shall be deemed to be
replaced with “paragraph (8) of Article 4-2.”
Article 5 (Restrictions on Manufacture, etc.)
A person who has given a notification under paragraph (1) of Article 3 shall not
manufacture or import the new chemical substance to which the notification pertains
pursuant to the provisions of paragraph (1) or (2) of Article 4 or paragraph (8) of the
preceding Article until after the receipt of notice prescribed in the provisions of
paragraphs (4) to (6) of Article 4 (including the cases where it is applied mutatis
mutandis pursuant to paragraph (9) of the preceding Article) relating to said new
chemical substance; provided, however, that this shall not apply to either of the following
cases:
(i) Where the manufacture or import of the new chemical substance to which said
notification pertains falls under any of the items of paragraph (1) of Article 3
(ii) Where, in the case that the person has received a confirmation under the provisions
of paragraph (4) of the preceding Article regarding the manufacture or import of the
new chemical substance to which said notification pertains, the quantity of
manufacture or import of said new chemical substance shall be not more than the
- 11 -
quantity to which said confirmation pertains
Article 5-2 (Evaluation, etc., of a New Chemical Substance Pertaining to a Manufacturer,
etc., in a Foreign State)
(1) A person who intends to manufacture in a foreign state a new chemical substance to
be exported to Japan or a person who intends to export a new chemical substance to
Japan may, in advance, notify the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment of the
name of said new chemical substance and any other matters specified by an Ordinance
of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment, pursuant to
the provisions of an Ordinance of the Ministry of Health, Labour and Welfare,
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the
Ministry of the Environment.
(2) The provisions of Article 4 shall apply mutatis mutandis to the notification under the
preceding paragraph. In this case, the term “within three months” in paragraph (1) of
said Article shall be deemed to be replaced with “within four months.”
Chapter 3 Regulations Concerning Class I Specified Chemical Substances, etc.
Section 1 Measures Concerning Type I Monitoring Chemical Substance
Article 5-3 (Notification of the Quantity of Manufacture, etc.)
(1) A person who has manufactured or imported any Type I Monitoring Chemical
Substance shall, each fiscal year, notify the Minister of Economy, Trade and Industry
of the quantity of manufacture or the quantity of import in the preceding fiscal year
and other matters specified by an Ordinance of the Ministry of Economy, Trade and
Industry for each Type I Monitoring Chemical Substance, pursuant to the provisions of
an Ordinance of the Ministry of Economy, Trade and Industry; provided, however, that
this shall not apply to the case where the person has manufactured or imported a Type
I Monitoring Chemical Substance for testing and research purposes.
(2) The Minister of Economy, Trade and Industry shall publicize, each fiscal year, the
sum of the quantity of manufacture and quantity of import in the preceding fiscal year
to which the notification under the preceding paragraph pertains for each Type I
Monitoring Chemical Substance; provided, however, that this shall not apply to the
case where the sum of the quantity of manufacture and quantity of import for one Type
I Monitoring Chemical Substance is less than the quantity specified by an Ordinance of
the Ministry of Economy, Trade and Industry.
Article 5-4 (Study of Hazardous Properties of Type I Monitoring Chemical Substances)
- 12 -
(1) In the case where the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment find sufficient
reason to suspect that any single Type I Monitoring Chemical Substance falls under
any of the items of paragraph (2) of Article 2, if they have found it necessary to make a
determination as to whether or not said Type I Monitoring Chemical Substance falls
under any of the items of said paragraph since said Type I Monitoring Chemical
Substance poses a risk of causing environmental pollution if said Type I Monitoring
Chemical Substance falls under any of the items of said paragraph, in view of the state
of its manufacture, import, use, etc., they may, pursuant to the provisions of an
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of
Economy, Trade and Industry, and Ordinance of the Ministry of the Environment,
instruct a person operating the business of manufacturing or importing of said Type I
Monitoring Chemical Substance (including a person who has been operating such
business formerly and who is specified by an Ordinance of the Ministry of Economy,
Trade and Industry) to conduct a study of the hazardous properties specified by an
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of
Economy, Trade and Industry, and Ordinance of the Ministry of the Environment
(which means a study on the effects of said chemical substance on human health or on
the life and/or growth of animals at the top of the food chain if ingested continuously;
the same shall apply in paragraph (3)) and to report the results thereof.
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have received a report under the
preceding paragraph, they shall make a determination as to whether or not the Type I
Monitoring Chemical Substance to which said report pertains falls under any one of
the items of paragraph (2) of Article 2 and notify the result thereof to the person who
has made the report.
(3) The Minister of Economy, Trade and Industry may, when he/she finds it particularly
necessary for ensuring that the expenses for the study of the hazardous properties to
which the instruction under the provisions of paragraph (1) pertains are shared out
fairly among the business operators concerned, establish standards concerning the
method and proportions of the sharing of the expenses required for said study of the
hazardous properties.
Article 5-5 (Rescission of Designation as Type I Monitoring Chemical Substance)
When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment find that a Type I Monitoring Chemical
Substance falls under either of the following items, they shall rescind the designation and
publicize to that effect without delay:
(i) Where said chemical substance has been designated as a Class I Specified Chemical
Substance
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(ii) Where said chemical substance has been found not to fall under any of the items of
paragraph (2) of Article 2, based on a report under paragraph (1) of the preceding
Article or on knowledge that has been otherwise obtained
Section 2 Regulations Concerning Class I Specified Chemical Substances
Article 6 (Permission to Manufacture)
(1) A person who intends to operate a business of manufacturing a Class I Specified
Chemical Substance shall obtain permission from the Minister of Economy, Trade and
Industry for each Class I Specified Chemical Substance and for each place of business.
(2) A person who intends to obtain permission under the preceding paragraph shall
submit a written application stating the following matters to the Minister of Economy,
Trade and Industry:
(i) The name and domicile, and in the case of a juridical person the name of the
representative person
(ii) The location of the place of business
(iii) The name of the Class I Specified Chemical Substance
(iv) The structure and capacity of the manufacturing equipment
(3) Where the Minister of Economy, Trade and Industry has granted permission under
paragraph (1), he/she shall notify the Minister of the Environment to that effect
without delay.
Article 7
No person other than one who has obtained permission under paragraph (1) of the
preceding Article shall manufacture a Class I Specified Chemical Substance; provided,
however, that this shall not apply to the case where a person manufactures a Class I
Specified Chemical Substance for testing and research purposes.
Article 8 (Disqualification Clause)
Permission under paragraph (1) of Article 6 shall not be granted to a person who falls
under any of the following items:
(i) A person who has been sentenced to a fine or severer punishment for violation of
this Act or any order based on this Act where two years have yet to elapse since the
day on which execution of the sentence has been completed or the sentence has
become no longer applicable
(ii) A person whose permission has been rescinded pursuant to the provisions of Article
21 and for whom two years have yet to elapse since the date of the rescission
(iii) An adult ward
(iv) A juridical person where the officers who carry out its operations include a
person(s) who falls under any of the preceding three items
- 14 -
Article 9 (Standards for Permission)
The Minister of Economy, Trade and Industry shall not grant permission under
paragraph (1) of Article 6, unless he/she finds that the application for permission under
said paragraph conforms to the following items:
(i) The permission, if granted, shall not result in the capacity to manufacture said
Class I Specified Chemical Substance excessively in light of the demand for said
Class I Specified Chemical Substance.
(ii) The manufacturing equipment shall conform to the technical standards specified by
an Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment.
(iii) The applicant shall have a sufficient fiscal basis and technical capacity to
implement the business appropriately.
Article 10 (Permission for Changes, etc.)
(1) A person who has obtained permission under paragraph (1) of Article 6 (hereinafter
referred to as a “permitted manufacturer”) shall receive the permission of the Ministry
of Economy, Trade and Industry if he/she intends to make changes to the matters set
forth in item (iv) of paragraph (2) of said Article; provided, however, that this shall not
apply to the case where a person intends to make minor changes specified by an
Ordinance of the Ministry of Economy, Trade and Industry.
(2) Where a permitted manufacturer has made changes to the matters set forth in item
(i) or (ii) of paragraph (2) of Article 6 or has made minor changes specified by an
Ordinance of the Ministry of Economy, Trade and Industry as set forth in the proviso
to the preceding paragraph, he/she shall notify the Minister of Economy, Trade and
Industry to that effect without delay.
(3) The provisions of the preceding Article shall apply mutatis mutandis to the
permission under paragraph (1).
(4) The provisions of paragraph (3) of Article 6 shall apply mutatis mutandis to the
permission under paragraph (1) and the notification under paragraph (2).
Article 11 (Permission to Import)
(1) A person who intends to import a Class I Specified Chemical Substance shall obtain
permission from the Minister of Economy, Trade and Industry; provided, however, that
this shall not apply to the case where a person intends to import a Class I Specified
Chemical Substance for testing and research purposes.
(2) A person who intends to obtain permission under the preceding paragraph shall
submit a written application stating the following matters to the Minister of Economy,
Trade and Industry:
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(i) The name and domicile, and in the case of a juridical person the name of the
representative person
(ii) The name of the Class I Specified Chemical Substance
(iii) The import quantity
(3) The provisions of paragraph (3) of Article 6 shall apply mutatis mutandis to the
permission under paragraph (1).
Article 12 (Standards for Permission, etc.)
(1) Where the Minister of Economy, Trade and Industry has received an application for
permission under paragraph (1) of the preceding Article, he/she shall not grant
permission under said paragraph unless he/she finds that the import of the Class I
Specified Chemical Substance to which said application pertains is necessary for
meeting the demand for said Class I Specified Chemical Substance.
(2) The provisions of Article 8 shall apply mutatis mutandis to the permission under
paragraph (1) of the preceding Article.
Article 13 (Restrictions on Import of Products)
(1) No person shall import any product that is specified by a Cabinet Order and in which
a Class I Specified Chemical Substance is used (hereinafter referred to as a “product
using a Class I Specified Chemical Substance”).
(2) The Cabinet Order under the preceding paragraph shall be established for each Class
I Specified Chemical Substance by giving consideration to such matters as the
circumstances of the use of said Class I Specified Chemical Substance overseas.
Article 14 (Restrictions on Use)
No person shall use a Class I Specified Chemical Substance for any usages other than
those specified by a Cabinet Order for each Class I Specified Chemical Substance as
being compliant with the following requirements; provided, however, that this shall not
apply to the case where a person uses a Class I Specified Chemical Substance for testing
and research purposes:
(i) It shall be difficult to substitute said chemical substance with any other substance
with regard to said usage.
(ii) Said usage shall not be related to the manufacture or processing of products
provided mainly for use in the daily lives of general consumers, and the use of said
Class I Specified Chemical Substance for said usage shall not pose a risk of causing
environmental pollution attributable to said Class I Specified Chemical Substance.
Article 15 (Notification of Use)
(1) A person who intends to use a Class I Specified Chemical Substance on a regular
basis shall notify the competent minister of the following matters, in advance, for each
- 16 -
place of business; provided, however, that this shall not apply to the case where a
person intends to use a Class I Specified Chemical Substance on a regular basis for
testing and research purposes:
(i) The name and domicile, and in the case of a juridical person the name of the
representative person
(ii) The location of the place of business
(iii) The name of the Class I Specified Chemical Substance and the usage
(2) Where a person who has given a notification under the preceding paragraph
(hereinafter referred to as a “notifying user”) has made any changes to the matters
under the items of the preceding paragraph, he/she shall notify the competent minister
to that effect without delay.
(3) The provisions of paragraph (3) of Article 6 shall apply mutatis mutandis to the
notification under the preceding two paragraphs.
Article 16 (Succession)
(1) Where a permitted manufacturer, a person who has obtained permission under
paragraph (1) of Article 11 (hereinafter referred to as a “permitted importer”), or a
notifying user has become subject to inheritance or a merger, the heir (where there are
two or more heirs and an heir who should succeed to the business has been selected by
their unanimous consent, such person who has been selected) or the juridical person
surviving the merger or the juridical person incorporated by the merger shall succeed
to the status of the permitted manufacturer, the permitted importer, or the notifying
user.
(2) A person who has succeeded to the status of permitted manufacturer, permitted
importer, or notifying user pursuant to the provisions of the preceding paragraph shall
notify the Minister of Economy, Trade and Industry, in the case of a person who has
succeeded to the status of permitted manufacturer or a permitted importer, and notify
the competent minister, in the case of a person who has succeeded to the status of
notifying user, to that effect without delay together with a document proving such fact.
(3) The provisions of paragraph (3) of Article 6 shall apply mutatis mutandis to the
notification under the preceding paragraph. In this case, the term “Minister of
Economy, Trade and Industry” in paragraph (3) of said Article shall be deemed to be
replaced with “Minister of Economy, Trade and Industry or the competent minister.”
Article 17 (Obligation of Conformity to Standards)
(1) A permitted manufacturer shall maintain its manufacturing equipment in such a
manner as to conform to the technical standards specified by an Ordinance of the
Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade
and Industry, and Ordinance of the Ministry of the Environment under item (ii) of
Article 9.
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(2) Where a notifying user uses a Class I Specified Chemical Substance, he/she shall
follow the technical standards specified by an ordinance of the competent ministry.
Article 18 (Order for Improvement)
(1) Where the Minister of Economy, Trade and Industry finds that the manufacturing
equipment of a permitted manufacturer does not conform to the technical standards
specified by an Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment under item (ii) of Article 9, he/she may order said permitted
manufacturer to repair or remodel the manufacturing equipment or to take any other
necessary measures.
(2) Where the competent minister finds that a notifying user fails to use a Class I
Specified Chemical Substance in accordance with the technical standards specified by
an ordinance of the competent ministry under paragraph (2) of the preceding Article,
he/she may order said notifying user to take the necessary measures for improving the
method of use of the Class I Specified Chemical Substance.
Article 19 (Books)
(1) A permitted manufacturer shall keep books and enter therein the items specified by
an Ordinance of the Ministry of Economy, Trade and Industry with respect to the
manufacture of the Class I Specified Chemical Substance.
(2) The books under the preceding paragraph shall be preserved in accordance with the
provisions of an Ordinance of the Ministry of Economy, Trade and Industry.
(3) The provisions of the preceding two paragraphs shall apply mutatis mutandis to a
notifying user. In this case, the term “an Ordinance of the Ministry of Economy, Trade
and Industry” in these provisions shall be deemed to be replaced with “ministerial
ordinance of the competent ministry.”
Article 20 (Notification of Abolition)
(1) Where a permitted manufacturer or a notifying user has abolished his/her business,
he/she shall notify the Minister of Economy, Trade and Industry, in the case of a
permitted manufacturer, and notify the competent minister, in the case of a notifying
user, to that effect without delay.
(2) Where a permitted manufacturer has discontinued his/her business, the relevant
permission shall lose its effect.
(3) The provisions of paragraph (3) of Article 6 shall apply mutatis mutandis to the
notification under paragraph (1). In this case, the term “Minister of Economy, Trade
and Industry” in paragraph (3) of said Article shall be deemed to be replaced with
“Minister of Economy, Trade and Industry or the competent minister.”
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Article 21 (Rescission of Permission, etc.)
(1) Where a permitted manufacturer falls under any of the following items, the Minister
of Economy, Trade and Industry may rescind the relevant permission or order the
suspension of business for a specified period:
(i) Where the permitted manufacturer has fallen under item (i), (iii) or (iv) of Article 8
(ii) Where the permitted manufacturer has made any changes to matters for which
permission must be obtained pursuant to the provisions of paragraph (1) of Article
10 without obtaining such permission
(iii) Where the permitted manufacturer has violated an order under the provisions of
paragraph (1) of Article 18
(iv) Where the permitted manufacturer has violated the conditions under paragraph (1)
of Article 31
(2) Where a permitted importer has fallen under item (i), (iii) or (iv) of Article 8 as
applied mutatis mutandis pursuant to paragraph (2) of Article 12, the Minister of
Economy, Trade and Industry may rescind the relevant permission, but only prior to
the import of the Class I Specified Chemical Substance to which the permission
pertains.
(3) The provisions of paragraph (3) of Article 6 shall apply mutatis mutandis to the
rescission of permission under the preceding two paragraphs or an order to suspend
business under paragraph (1).
Article 22 (Order to Take Measures in Connection with Designation, etc. of Class I
Specified Chemical Substances)
(1) Where any chemical substance has been designated as a Class I Specified Chemical
Substance, if the competent ministers find it particularly necessary for preventing the
spread of environmental pollution attributable to said chemical substance, they may, to
the extent necessary, order persons who were operating the business of manufacturing
or importing said chemical substance or a product in which said chemical substance is
used at the time of said designation to make efforts to recall said chemical substance or
said product and to take any other measures necessary for preventing the spread of
environmental pollution attributable to said chemical substance.
(2) Where any product has been designated as a product using a Class I Specified
Chemical Substance, if the competent ministers find it particularly necessary for
preventing the spread of environmental pollution attributable to the Class I Specified
Chemical Substance being used in said product, they may, to the extent necessary,
order persons who were operating the business of importing said product at the time of
said designation to make efforts to recall said product which they imported and to take
any other measures necessary for preventing the spread of environmental pollution
attributable to the Class I Specified Chemical Substance being used in said product.
(3) In any of the cases listed in the following items, if the competent ministers find it
- 19 -
particularly
necessary
for
preventing
the
spread
of
environmental
pollution
attributable to the Class I Specified Chemical Substance, they may, to the extent
necessary, order the persons respectively specified in those items to make efforts to
recall the Class I Specified Chemical Substance which they manufactured, imported or
used or the product using a Class I Specified Chemical Substance which they imported
and to take any other measures necessary for preventing the spread of environmental
pollution attributable to said Class I Specified Chemical Substance:
(i) Where a Class I Specified Chemical Substance has been manufactured in violation
of the provisions of Article 7-the person who has manufactured said Class I Specified
Chemical Substance
(ii) Where a Class I Specified Chemical Substance has been imported in violation of the
provisions of paragraph (1) of Article 11-the person who has imported said Class I
Specified Chemical Substance
(iii) Where a product using a Class I Specified Chemical Substance has been imported
in violation of the provisions of paragraph (1) of Article 13-the person who has
imported said product using a Class I Specified Chemical Substance
(iv) Where a Class I Specified Chemical Substance has been used in violation of the
provisions of Article 14-the person who has used said Class I Specified Chemical
Substance
Chapter 4 Regulations Concerning Class II Specified Chemical Substances, etc.
Section 1 Measures Concerning Type II Monitoring Chemical Substances
Article 23 (Notification of the Quantity of Manufacture, etc.)
(1) A person who has manufactured or imported any Type II Monitoring Chemical
Substance shall, each fiscal year, notify the Minister of Economy, Trade and Industry
of the quantity of manufacture or quantity of import in the preceding fiscal year and
other matters specified by an Ordinance of the Ministry of Economy, Trade and
Industry for each Type II Monitoring Chemical Substance, pursuant to the provisions
of an Ordinance of the Ministry of Economy, Trade and Industry; provided, however,
that this shall not apply to the case where the person has manufactured or imported a
Type II Monitoring Chemical Substance for testing and research purposes.
(2) The Minister of Economy, Trade and Industry shall publicize, each fiscal year, the
sum of the quantity of manufacture and quantity of import in the preceding fiscal year
to which the notification under the preceding paragraph pertains for each Type II
Monitoring Chemical Substance; provided, however, that this shall not apply to the
case where the sum of the quantity of manufacture and quantity of import for one Type
II Monitoring Chemical Substance is less than the quantity specified by an Ordinance
of the Ministry of Economy, Trade and Industry.
- 20 -
Article 24 (Study of Hazardous Properties of Type II Monitoring Chemical Substances)
(1) In the case where the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment have, with regard
to any single Type II Monitoring Chemical Substance, found it necessary to make a
determination as to whether or not said Type II Monitoring Chemical Substance falls
under item (i) of paragraph (3) of Article 2 since said Type II Monitoring Chemical
Substance poses a risk of causing damage to human health through environmental
pollution if said Type II Monitoring Chemical Substance falls under said item, in view
of the results of the tests under paragraph (8) of Article 2 and other available
knowledge concerning said Type II Monitoring Chemical Substance as well as the state
of its manufacture, import, use, etc., they may, pursuant to the provisions of an
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of
Economy, Trade and Industry, and Ordinance of the Ministry of the Environment,
instruct a person operating the business of manufacturing or importing said Type II
Monitoring Chemical Substance (including a person who has operated such business
formerly and who is specified by an Ordinance of the Ministry of Economy, Trade and
Industry) to conduct a study of the hazardous properties specified by an Ordinance of
the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment (which means a
study on the effects of said chemical substance on human health if ingested
continuously; the same shall apply in paragraph (3)) and to report the results thereof.
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have received a report under the
preceding paragraph, they shall make a determination as to whether or not the Type II
Monitoring Chemical Substance to which said report pertains falls under item (i) of
paragraph (3) of Article 2 and notify the result thereof to the person who has made the
report.
(3) The Minister of Economy, Trade and Industry may, when he/she finds it particularly
necessary for ensuring that the expenses for the study of the hazardous properties to
which the instruction under the provisions of paragraph (1) pertains are shared out
fairly among the business operators concerned, establish standards concerning the
method and proportions of the sharing of expenses required for said study of hazardous
properties.
Article 25 (Rescission of Designation as a Type II Monitoring Chemical Substance)
When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment find that a Type II Monitoring Chemical
Substance falls under either of the following items, they shall rescind the designation and
publicize to that effect without delay:
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(i) Where said chemical substance has been designated as a Class II Specified Chemical
Substance as a result of falling under item (i) of paragraph (3) of Article 2 (including
the case where a Type II Monitoring Chemical Substance has been designated as a
Class II Specified Chemical Substance as a result of falling under item (ii) of said
paragraph and said Type II Monitoring Chemical Substance has been found
subsequently to fall under item (i) of said paragraph)
(ii) Where said chemical substance has been found not to fall under item (i) of
paragraph (3) of Article 2, based on a report under paragraph (1) of the preceding
Article or on knowledge that has been otherwise obtained.
Section 2 Measures Concerning Type III Monitoring Chemical Substances
Article 25-2 (Notification of the Quantity of Manufacture, etc.)
(1) A person who has manufactured or imported any Type III Monitoring Chemical
Substance (excluding one that has been publicly notified by the Minister of Economy,
Trade and Industry and the Minister of the Environment pursuant to the provisions of
paragraph (2) of Article 25-4; hereinafter the same shall apply in this Article and the
following Article) shall, each fiscal year, notify the Minister of Economy, Trade and
Industry of the quantity of manufacture or quantity of import in the preceding fiscal
year and any other matters specified by an Ordinance of the Ministry of Economy,
Trade and Industry for each Type III Monitoring Chemical Substance, pursuant to the
provisions of an Ordinance of the Ministry of Economy, Trade and Industry; provided,
however, that this shall not apply to the case where the person has manufactured or
imported a Type III Monitoring Chemical Substance for testing and research purposes.
(2) The Minister of Economy, Trade and Industry shall publicize, each fiscal year, the
sum of the quantity of manufacture and quantity of import in the preceding fiscal year
to which the notification under the preceding paragraph pertains for each Type III
Monitoring Chemical Substance; provided, however, that this shall not apply to the
case where the sum of the quantity of manufacture and quantity of import for one Type
III Monitoring Chemical Substance is less than the quantity specified by an Ordinance
of the Ministry of Economy, Trade and Industry.
Article 25-3 (Study of Hazardous Properties of Type III Monitoring Chemical Substances)
(1) In the case that the Minister of Economy, Trade and Industry and the Minister of the
Environment have, with regard to any single Type III Monitoring Chemical Substance,
found it necessary to make a determination as to whether or not said Type III
Monitoring Chemical Substance falls under item (ii) of paragraph (3) of Article 2 since
said Type III Monitoring Chemical Substance poses a risk of causing damage to the
inhabitation and/or growth of flora and fauna in the human living environment
through environmental pollution if said Type III Monitoring Chemical Substance falls
- 22 -
under said item, in view of the results of the tests prescribed in paragraph (7) of
Article 4 (including the cases where it is applied mutatis mutandis pursuant to
paragraph (9) of Article 4-2) and any other available knowledge concerning said Type
III Monitoring Chemical Substance as well as the state of its manufacture, import, use,
etc., they may, pursuant to the provisions of an Ordinance of the Ministry of Economy,
Trade and Industry and Ordinance of the Ministry of the Environment, instruct a
person operating the business of manufacturing or importing said Type III Monitoring
Chemical Substance (including a person who operated such business formerly and who
is specified by an Ordinance of the Ministry of Economy, Trade and Industry) to
conduct a study of the hazardous properties specified by an Ordinance of the Ministry
of Economy, Trade and Industry and Ordinance of the Ministry of the Environment
(which means a study on the effects of said chemical substance on the inhabitation
and/or growth of flora and fauna in the human living environment if ingested
continuously; the same shall apply in paragraph (3)) and to report the results thereof.
(2) Where the Minister of Economy, Trade and Industry and the Minister of the
Environment have received a report under the preceding paragraph, they shall make a
determination as to whether or not the Type III Monitoring Chemical Substance to
which said report pertains falls under item (ii) of paragraph (3) of Article 2 and notify
the result thereof to the person who has made the report.
(3) The Minister of Economy, Trade and Industry may, when he/she finds it particularly
necessary for ensuring that the expenses for the study of hazardous properties to which
the instruction under the provisions of paragraph (1) pertains are shared out fairly
among the business operators concerned, he/she may establish standards concerning
the method and proportions of the sharing of expenses required for said study of
hazardous properties.
Article 25-4 (Rescission of Designation as a Type III Monitoring Chemical Substance)
(1) Where a Type III Monitoring Chemical Substance has been designated as a Class II
Specified Chemical Substance as a result of falling under item (ii) of paragraph (3) of
Article 2 (including the case where a Type III Monitoring Chemical Substance has been
designated as a Class II Specified Chemical Substance as a result of falling under item
(i) of said paragraph and said Type III Monitoring Chemical Substance has been found
subsequently to fall under item (ii) of said paragraph), the Minister of Economy, Trade
and Industry and the Minister of the Environment shall rescind the designation as a
Type III Monitoring Chemical Substance and publicize to that effect without delay.
(2) Where the Minister of Economy, Trade and Industry and the Minister of the
Environment have found that a Type III Monitoring Chemical Substance does not fall
under item (ii) of paragraph (3) of Article 2, based on a report under paragraph (1) of
the preceding Article or on knowledge that has been otherwise obtained, they shall give
public notice of the name of said Type III Monitoring Chemical Substance without
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delay.
Section 3 Regulations Concerning Class II Specified Chemical Substances
Article 26 (Notification of the Planned Quantity of Manufacture, etc.)
(1) A person who manufactures or imports a Class II Specified Chemical Substance, or a
person who imports a product that is specified by Cabinet Order and in which a Class
II Specified Chemical Substance is used (hereinafter referred to as a “product using a
Class II Specified Chemical Substance”) shall, for each Class II Specified Chemical
Substance or each product using a Class II Specified Chemical Substance, notify the
Minister of Economy, Trade and Industry, each fiscal year, of the planned quantity of
manufacture or planned quantity of import of said Class II Specified Chemical
Substance or the planned quantity of import of said product using a Class II Specified
Chemical Substance, and other matters specified by an Ordinance of the Ministry of
Economy, Trade and Industry, pursuant to the provisions of an Ordinance of the
Ministry of Economy, Trade and Industry; provided, however, that this shall not apply
to the case where a person manufactures or imports a Class II Specified Chemical
Substance or imports a product using a Class II Specified Chemical Substance for
testing and research purposes.
(2) Where a person who has given a notification under the provisions of the preceding
paragraph has made changes to the matters to which the notification under said
paragraph pertains, he/she shall notify the Minister of Economy, Trade and Industry to
that effect without delay.
(3) A person who has given a notification under the provisions of paragraph (1) shall not
manufacture or import in excess of the planned quantity of manufacture or the planned
quantity of import to which said notification pertains (where a notification of change
under the provisions of the preceding paragraph has been given, such quantity after
the change).
(4) In the case of the occurrence of a situation where it is necessary to restrict the
manufacture or import of a Class II Specified Chemical Substance or the import of a
product using a Class II Specified Chemical Substance in order to prevent damage to
human health or to the inhabitation and/or growth of flora and fauna in the human
living environment through environmental pollution attributable to said Class II
Chemical Substance, in light of the state of the manufacture, import, use, etc. of said
Class II Specified Chemical Substance or product using a Class II Specified Chemical
Substance as well as the effects of the implementation of measures under the
provisions of the following Article and Article 28 taken in relation to said Class II
Specified Chemical Substance, the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment shall
make an acknowledgement to that effect, pursuant to the provisions of an Ordinance of
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the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment.
(5) Where the acknowledgment under the preceding paragraph has been made, the
Minister of Economy, Trade and Industry may order the person who has given a
notification under the provisions of paragraph (1) to change the planned quantity of
manufacture or the planned quantity of import to which said notification pertains
(where a notification of change under the provisions of paragraph (2) has been given,
the quantity after the change). In this case, the provisions of paragraph (3) shall apply
mutatis mutandis.
(6) A person who has given a notification under the provisions of paragraph (1) shall,
each fiscal year, notify the Minister of Economy, Trade and Industry of the quantity of
manufacture or the quantity of import in the preceding fiscal year and other matters
specified by an Ordinance of the Ministry of Economy, Trade and Industry, for each
Class II Specified Chemical Substance or each product using a Class II Specified
Chemical Substance, pursuant to the provisions of an Ordinance of the Ministry of
Economy, Trade and Industry.
(7) The provisions of paragraph (2) of Article 13 shall apply mutatis mutandis to the
Cabinet Order set forth in paragraph (1).
Article 27 (Publication of Technical Guidelines, etc.)
(1) For each Class II Specified Chemical Substance, the competent ministers shall
publicize technical guidelines on measures to be taken by persons who operate the
business of manufacturing said Class II Specified Chemical Substance, persons who
use said Class II Specified Chemical Substance on a regular basis, and any other
persons who handle said Class II Specified Chemical Substance on a regular basis
(hereinafter referred to as a “handler” in this section) in order to prevent
environmental pollution attributable to the Class II Specified Chemical Substance they
handle.
(2) Where the competent ministers have publicized technical guidelines pursuant to the
provisions of the preceding paragraph, if they find it necessary, they may make a
necessary recommendation to a handler of said Class II Specified Chemical Substance
with regard to the measures that should be taken for preventing environmental
pollution attributable to said Class II Specified Chemical Substance, by taking said
technical guidelines into consideration.
Article 28 (Labeling, etc.)
(1) For each Class II Specified Chemical Substance, the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment shall determine and publicize the labeling information with respect to
measures, etc., for preventing environmental pollution attributable to said Class II
- 25 -
Specified Chemical Substances, to be indicated on containers, packaging, or invoices for
the Class II Specified Chemical Substance or products that are specified by a Cabinet
Order and in which the Class II Specified Chemical Substance is used.
(2) Where a handler transfers or provides a Class II Specified Chemical Substance or a
product that is specified by a Cabinet Order and in which a Class II Specified Chemical
Substance is used as set forth in the preceding paragraph, he/she shall, pursuant to
the provisions of an Ordinance of the Ministry of Health, Labour and Welfare,
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the
Ministry of the Environment, implement labeling in accordance with the public notice
given pursuant to the provisions of said paragraph.
(3) In the case where any handler has violated the provisions of the preceding paragraph,
the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment may recommend said handler to
implement labeling in accordance with the public notice given pursuant to the
provisions of paragraph (1).
Chapter 5 Miscellaneous Provisions
Article 29 (Recommendations)
(1) Where the competent ministers find a sufficient reason to suspect that a chemical
substance other than a Class I Specified Chemical Substance falls under any of the
items of paragraph (2) of Article 2, they may, to the extent necessary for preventing the
spread of environmental pollution attributable to said chemical substance, make any
necessary recommendation concerning a restriction on the manufacture, import, use,
etc. of said chemical substance to a person operating the business of manufacturing or
importing said chemical substance or to a person using said chemical substance on a
regular basis.
(2) Where the competent ministers find a sufficient reason to suspect that a chemical
substance other than a Class II Specified Chemical Substance falls under the
requirements set forth in paragraph (3) of Article 2, they may, to the extent necessary
for preventing the spread of environmental pollution attributable to said chemical
substance, make any necessary recommendation concerning a restriction on the
manufacture or import of said chemical substance or an improvement in the method of
use of said chemical substance to a person operating the business of manufacturing or
importing said chemical substance or to a person using said chemical substance on a
regular basis.
Article 30 (Guidance and Advice)
Where the competent ministers find it particularly necessary for preventing
environmental pollution attributable to a Type I Monitoring Chemical Substance, a Type
- 26 -
II Monitoring Chemical Substance or a Type III Monitoring Chemical Substance
(hereinafter collectively referred to as a “monitoring chemical substance”) or a Class II
Specified Chemical Substance, they may provide a person operating the business of
manufacturing said monitoring chemical substance or Class II Specified Chemical
Substance, or a person using said monitoring chemical substance or Class II Specified
Chemical Substance on a regular basis, or any other person handling said monitoring
chemical substance or Class II Specified Chemical Substance on a regular basis with the
necessary guidance and advice concerning the method of handling the chemical
substance.
Article 31 (Conditions for Permission)
(1) Conditions may be attached to any permission, and the conditions attached may be
changed.
(2) The conditions under the preceding paragraph shall be limited to the minimum
required for ensuring the secure implementation of the matters to which the
permission pertains, and shall not impose undue obligations on the person who obtains
the permission.
Article 31-2 (Reporting, etc., of Hazardous Properties)
(1) A person operating the business of manufacturing or importing any monitoring
chemical substance, any Class II Specified Chemical Substance, any chemical
substance that has been publicly notified pursuant to the provisions of paragraph (4) of
Article 4 (including the cases in which it is applied mutatis mutandis pursuant to
paragraph (9) of Article 4-2 and the cases in which it is applied mutatis mutandis
pursuant to paragraph (2) of Article 5-2), any new chemical substance to which the
confirmation under item (v) of paragraph (1) of Article 3 or paragraph (4) of Article 4-2
pertains, or any chemical substance listed in the List of Existing Chemical Substances
prescribed in paragraph (1) of Article 2 of the Supplementary Provisions that has been
publicly notified by the Minister of International Trade and Industry pursuant to the
provisions of paragraph (4) of said Article (hereinafter referred to as a “substance
subject to reporting”) shall, when he/she has conducted tests pertaining to the items to
be tested prescribed in paragraph (7) of Article 4 or pertaining to the studies of
hazardous properties prescribed in paragraph (1) of Article 5-4, paragraph (1) of Article
24, or paragraph (1) of Article 25-3 (including the cases in which knowledge equivalent
to that which would be obtained from said tests [limited to knowledge that is not
publicly known] has been obtained) with regard to the substance subject to reporting
he/she has manufactured or imported and if he/she has obtained, as a result thereof,
knowledge specified by an Ordinance of the Ministry of Health, Labour and Welfare,
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the
Ministry of the Environment as one indicating that the substance subject to reporting
- 27 -
possesses the following properties, report to the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment to that effect and the details of said knowledge, pursuant to the
provisions of an Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment; provided, however, that this shall not apply to the case where said
person has obtained said knowledge as a result of a study of hazardous properties to
which an instruction under the provisions of paragraph (1) of Article 5-4, paragraph (1)
of Article 24, or paragraph (1) of Article 25-3 pertains and is reporting the details of
said knowledge pursuant to these provisions:
(i) The substance subject to reporting is not likely to undergo a chemical
transformation through natural processes.
(ii) The substance subject to reporting is bioaccumulative.
(iii) The substance subject to reporting poses a risk of impairing human health if
ingested continuously.
(iv) The substance subject to reporting poses a risk of interfering with the inhabitation
and/or growth of flora and fauna.
(v) In the case that the substance subject to reporting is likely to undergo a chemical
transformation through natural processes, it is one where the chemical substance
(including an element) generated by the chemical transformation through natural
processes falls under any of the preceding items.
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade
and Industry, and the Minister of the Environment have found, based on a report
under the preceding paragraph or knowledge that has been otherwise obtained, that
any substance subject to reporting falls under any of the items of paragraph (2), any of
the items of paragraph (3), any of the items of paragraph (4), or any of the items of
paragraph (6) of Article 2, or is suspected of falling under item (i) of paragraph (3) of
said Article, they shall make a designation as a Class I Specified Chemical Substance
and take any other necessary measures without delay.
Article 32 (Collection of Reports)
(1) The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment may, to the extent necessary for
enforcing this Act, have a person who has received a confirmation under item (iv) or
item (v) of paragraph (1) of Article 3 or under paragraph (4) of Article 4-2 make a
report concerning his/her operations.
(2) The Minister of Economy, Trade and Industry or the competent minister may, to the
extent necessary for enforcing this Act, have, respectively, a permitted manufacturer, a
permitted importer, a notifying user, or a person who has given a notification under
the provisions of paragraph (1) of Article 26 make a report concerning his/her
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operations.
(3) The competent ministers may, to the extent necessary for enforcing this Act, have a
person prescribed in Article 22 or Article 29 make a report concerning his/her
operations.
Article 33 (On-Site Inspections, etc.)
(1) The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment may, to the extent necessary for
enforcing this Act, have their officials enter the offices or any other places of business
of a person who has received a confirmation under item (iv) or (v) of paragraph (1) of
Article 3 or paragraph (4) of Article 4-2, inspect the books, documents, and any other
articles, ask questions of the relevant persons, or sample the smallest quantity of
chemical substances necessary for testing.
(2) The Minister of Economy, Trade and Industry or the competent minister may, to the
extent necessary for enforcing this Act, have their officials enter the offices or any
other places of business of a permitted manufacturer, permitted importer, notifying
user or person who has given a notification under the provisions of paragraph (1) of
Article 26, inspect the books, documents, and any other articles, ask questions of the
relevant persons, or sample the smallest quantity of chemical substances necessary for
testing.
(3) The competent ministers may, to the extent necessary for enforcing this Act, have
their officials enter the offices or any other places of business of a person prescribed in
Article 22, inspect the books, documents and any other articles, ask questions of the
relevant persons, or sample the smallest quantity of chemical substances necessary for
testing.
(4) Where an official enters a site pursuant to the provisions of the preceding three
paragraphs, he/she shall carry an identification card and present it to the relevant
persons.
(5) Where the Minister of Economy, Trade and Industry finds it necessary, he/she may
have the National Institute of Technology and Evaluation (hereinafter referred to as
“NITE”) conduct the on-site inspection, questioning, or taking of samples under the
provisions of paragraphs (1) to (3).
(6) Where the Minister of Economy, Trade and Industry has NITE conduct the on-site
inspection, questioning, or taking of samples pursuant to the provisions of the
preceding paragraph, he/she shall instruct NITE to conduct such on-site inspection,
questioning or taking of samples by indicating the place of said on-site inspection and
any other necessary matters.
(7) Where NITE has conducted the on-site inspection, questioning, or taking of samples
prescribed in paragraph (5), in accordance with the instructions under the preceding
paragraph, it shall report the results thereof to the Minister of Economy, Trade and
- 29 -
Industry.
(8) Where an official of NITE enters a site pursuant to the provisions of paragraph (5),
he/she shall carry an identification card and present it to the relevant persons.
(9) The authority for the on-site inspection, questioning, and taking of samples under the
provisions of paragraphs (1) to (3) shall not be construed as an authority granted for
the purpose of criminal investigation.
Article 33-2 (Orders to NITE)
Where the Minister of Economy, Trade and Industry finds it necessary for securing the
proper implementation of operations relating to the on-site inspection, questioning, or
taking of samples prescribed in paragraph (5) of the preceding Article, he/she may issue
the necessary orders concerning said operations to NITE.
Article 33-3 (Request for Examination Regarding the Taking of Samples by NITE )
Any person who is dissatisfied with the taking of samples by NITE may file a request
for examination under the Administrative Appeals Act (Act No. 160 of 1962) with the
Minister of Economy, Trade and Industry.
Article 34 (Requests)
Where the Minister of the Environment finds it necessary to achieve the purpose of
this Act, he/she may request the ministers listed in the following items to take the
measures set forth respectively in those items:
(i) An order prescribed in paragraph (1) of Article 18-the Minister of Economy, Trade
and Industry
(ii) An order prescribed in paragraph (2) of Article 18-the competent minister
Article 35 (Fees)
A person who intends to obtain permission under paragraph (1) of Article 6, paragraph
(1) of Article 10, or paragraph (1) of Article 11 shall pay a fee of the amount specified by
a Cabinet Order in consideration of the actual expenses.
Article 36 (Special Provisions on Hearings)
(1) Where the Minister of Economy, Trade and Industry intends to issue an order under
the provisions of paragraph (1) of Article 21, he/she shall hold a hearing, regardless of
the category of the procedure for hearing statements of opinion under the provisions of
paragraph (1) of Article 13 of the Administrative Procedure Act (Act No. 88, 1993).
(2) The proceedings on the date of a hearing to which a disposition under the provisions
of Article 21 pertains shall be held in public.
(3) The presiding official of a hearing under the preceding paragraph shall, where an
interested person to which said disposition pertains has requested to intervene in the
- 30 -
hearing process pursuant to the provisions of paragraph (1) of Article 17 of the
Administrative Procedure Act, permit said person to do so.
Article 37 (Hearing of Opinion in Procedures for Objection)
(1) A decision on an objection against any disposition under the provisions of this Act
(excluding a decision to dismiss the objection) shall be made after giving an advance
notice with a reasonable period of time to the person to which the disposition pertains
and after a public hearing of opinions.
(2) The date, location, and details of the case shall be indicated in a prior notice under
the preceding paragraph.
(3) At a hearing of opinions under paragraph (1), the person to which said disposition
pertains and the interested person shall be given an opportunity to produce evidence
and state their opinions with regard to the case.
Article 38 (Transitional Measures)
Where an order is established, revised, or abolished based on the provisions of this Act,
required transitional measures (including transitional measures concerning penal
provisions) may be specified by said order to the extent found reasonably necessary in
line with the establishment, revision or abolition thereof.
Article 39 (Competent Ministers, etc.)
(1) The competent ministers under this Act shall be as follows:
(i) With regard to a notification under the provisions of Article 15, paragraph (2) of
Article 16, or paragraph (1) of Article 20, an order under the provisions of paragraph
(2) of Article 18, the collection of reports under the provisions of paragraph (2) of
Article 32, or the inspection, questioning, or taking of samples under the provisions
of paragraph (2) of Article 33, the minister having jurisdiction over the business
operated by the person giving such a notification or the person subject to such an
order, the collection of reports or inspection, questioning, or taking of samples
(ii) With regard to an order under the provisions of Article 22, the publication of
technical guidelines under the provisions of paragraph (1) of Article 27, a
recommendation under the provisions of paragraph (2) of said Article or Article 29,
guidance and advice (excluding those pertaining to a Type III Monitoring Chemical
Substance) under the provisions of Article 30, the collection of reports under the
provisions of paragraph (3) of Article 32, or the inspection, questioning or taking of
samples under the provisions of paragraph (3) or Article 33, the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, the Minister of
the Environment and the minister having jurisdiction over the business operated by
the person subject to such an order, the publication of technical guidelines,
recommendation,
guidance
and
advice,
- 31 -
collection
of
reports
or
inspection,
questioning, or taking of samples
(iii) With regard to guidance and advice (limited to those pertaining to a Type III
Monitoring Chemical Substance) under the provisions of Article 30, the Minister of
Economy, Trade and Industry, the Minister of the Environment, and the minister
having jurisdiction over the business operated by the person subject to such guidance
and advice
(2) An ordinance of the competent ministry under this Act shall be as follows:
(i) With regard to the keeping, entering, and preservation of books under the provisions
of paragraphs (1) and (2) of Article 19 as applied mutatis mutandis pursuant to
paragraph (3) of said Article, an order issued by the minister having jurisdiction over
the business operated by a person using a Class I Specified Chemical Substance
(ii) With regard to the technical standards under the provisions of paragraph (2) of
Article 17, an order issued by the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, the Minister of the Environment and the
minister having jurisdiction over the business operated by a person using a Class I
Specified Chemical Substance
Article 39-2 (Delegation of Authority)
The authority of the Minister of the Environment prescribed in this Act may be
delegated to the Director Generals of the Regional Environment Offices.
Article 40 (Relationship with Other Acts)
The provisions of Article 3, paragraph (1) of Article 5-2, paragraph (1) of Article 5-3,
paragraph (1) of Article 5-4, paragraph (1) of Article 6, Article 7, paragraph (1) of Article
11, Article 14, paragraph (1) of Article 15, paragraphs (1) and (3) of Article 22, paragraph
(1) of Article 23, paragraph (1) of Article 24, paragraph (1) of Article 25-2, paragraph (1)
of Article 25-3, paragraph (1) of Article 26, paragraph (1) of Article 27, paragraph (1) of
Article 28, Article 29, Article 30 and paragraph (1) of Article 31-2 shall not apply to the
chemical substances which constitute the articles listed in the following items, the
provisions of paragraph (1) or Article 13 and Article 22 shall not apply to the products
listed in the following items in which Class I Specified Chemical Substances are used; the
provisions of paragraph (1) of Article 26 and paragraph (1) of Article 28 shall not apply to
the articles listed in the following items in which Class II Specified Chemical Substances
are used, and the provisions of Article 14, paragraph (1) of Article 15, paragraph (3) of
Article 22, paragraph (1) of Article 27, paragraph (1) of Article 28, Article 29 and Article
30 shall not apply to the use of chemical substances as raw materials for the articles
listed in the following items, but the Acts set forth in the following items shall apply to
them respectively:
(i) Food prescribed in paragraph (1) of Article 4 of the Food Sanitation Act (Act No. 233
of 1947), additives prescribed in paragraph (2) of said Article, containers and
- 32 -
packaging prescribed in paragraph (5) of said Article, toys prescribed in paragraph
(1) of Article 29 of said Act, and detergents prescribed in paragraph (2) of said
Article
(ii) Agricultural chemicals prescribed in paragraph (1) of Article 1-2 of the Agricultural
Chemicals Regulation Act (Act No. 82 of 1948)
(iii) Ordinary fertilizers prescribed in paragraph (2) of Article 2 of the Fertilizers
Regulation Act (Act No. 127 of 1950)
(iv) Feeds prescribed in paragraph (2) of Article 2 of the Act on Safety Assurance and
Quality Improvement of Feeds (Act No. 35 of 1953) and feed additives prescribed in
paragraph (3) of said Article
(v) Drugs prescribed in paragraph (1) of Article 2 of the Pharmaceutical Affairs Act
(Act No. 145 of 1960), quasi-drugs prescribed in paragraph (2) of said Article,
cosmetics prescribed in paragraph (3) of said Article, and medical equipment
prescribed in paragraph (4) of said Article
Article 41 (Hearing of Opinion of Councils)
(1) In the following cases, the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment shall hear the
opinions of the councils, etc., (organizations prescribed in Article 8 of the National
Government Organization Act [Act No. 120 of 1948]; the same shall apply in the
following paragraph) that are specified by a Cabinet Order, in advance:
(i) When intending to plan out the establishment or revision of a Cabinet Order under
paragraph (2) of Article 2 (excluding the case of intending to plan out such
establishment or revision based on a determination under paragraph (1) or (2) of
Article 4, paragraph (8) of Article 4-2, or paragraph (2) of Article 5-4), or when
intending to plan out the establishment or revision of a Cabinet Order under
paragraph (3) of Article 2, paragraph (1) of Article 13, Article 14 or paragraph (1) of
Article 26
(ii) When intending to make a designation under paragraph (4) or (5) of Article 2
(excluding the case of intending to make such designation based on a determination
under paragraph (1) or (2) of Article 4 or paragraph (8) of Article 4-2)
(iii) When intending to make a determination under paragraph (1) or (2) of Article 4,
paragraph (2), (3) or (8) of Article 4-2, paragraph (2) of Article 5-4, or paragraph (2)
of Article 24
(iv) When intending to give an instruction under paragraph (1) of Article 5-4 or
paragraph (1) of Article 24
(v) When intending to make an acknowledgment under paragraph (4) of Article 26
(2) The Minister of Economy, Trade and Industry and the Minister of the Environment
shall hear the opinions of councils, etc., specified by a Cabinet Order, in advance, when
intending to make a designation under paragraph (6) of Article 2 (excluding the case of
- 33 -
intending to make such designation based on a determination under paragraph (1) or
(2) of Article 4 or paragraph (8) of Article 4-2), when intending to give an instruction
under paragraph (1) of Article 25-3, or when intending to make a determination under
paragraph (2) of said Article.
Chapter 6 Penal Provisions
Article 42
A person who falls under any of the following items shall be punished by imprisonment
with work for not more than three years or a fine of not more than one million yen, or
both:
(i) A person who has operated the business of manufacturing a Class I Specified
Chemical Substance without obtaining permission under paragraph (1) of Article 6
(ii) A person who has violated the provisions of Article 7, paragraph (1) of Article 13, or
Article 14
(iii) A person who has imported a Class I Specified Chemical Substance in violation of
the provisions of paragraph (1) of Article 11
(iv) A person who has violated an order to suspend business under the provisions of
paragraph (1) of Article 21
(v) A person who has violated an order under the provisions of paragraph (3) Article 22
Article 43
A person who falls under any of the following items shall be punished by imprisonment
with work for not more than one year or a fine of not more than five hundred thousand
yen, or both:
(i) A person who has manufactured or imported a new chemical substance in violation
of the provisions of paragraph (1) of Article 3
(ii) A person who has violated the provisions of Article 5
(iii) A person who has violated an instruction under the provisions of paragraph (1) of
Article 5-4, paragraph (1) of Article 24, or paragraph (1) of Article 25-3
(iv) A person who has manufactured or imported a Class II Specified Chemical
Substance or has imported a product using a Class II Specified Chemical Substance
in violation of the provisions of paragraph (1) or (3) of Article 26 (including the cases
where it is applied mutatis mutandis pursuant to paragraph (5) of said Article)
Article 44
A person who falls under any of the following items shall be punished by imprisonment
with work for not more than six months or a fine of not more than five hundred thousand
yen, or both:
(i) A person who has made changes in the structure or capacity of manufacturing
- 34 -
equipment in violation of the provisions of paragraph (1) of Article 10
(ii) A person who has failed to give a notification or has given a false notification in
violation of the provisions of paragraph (1) of Article 15
(iii) A person who has violated an order under the provisions of Article 18 or paragraph
(1) or (2) of Article 22
Article 45
A person who falls under any of the following items shall be punished by a fine of not
more than three hundred thousand yen:
(i) A person who has failed to keep books or make entries in them or has made false
entries in them in violation of the provisions of paragraph (1) of Article 19 (including
the cases where it is applied mutatis mutandis pursuant to paragraph (3) of said
Article), or has failed to preserve the books in violation of the provisions of
paragraph (2) of said Article (including the cases where it is applied mutatis
mutandis pursuant to paragraph (3) of said Article)
(ii) A person who has failed to give a notification under the provisions of paragraph (1)
of Article 5-3, paragraph (1) of Article 23, paragraph (1) of Article 25-2, or paragraph
(6) of Article 26 or has given a false notification
(iii) A person who has failed to make a report under the provisions of Article 32 or has
made a false report
(iv) A person who has refused, obstructed, or evaded an inspection or the taking of
samples under the provisions of paragraphs (1) to (3) of Article 33 or has refused to
answer or has given a false answer to the questioning under these provisions
Article 46
Where the representative person of a juridical person, or an agent, employee or any
other worker of a juridical person or individual has committed an act in violation of any
of the provisions listed in the following items with regard to the business of said juridical
person or individual, not only the offender shall be punished but also said juridical
person shall be punished by the fine prescribed in said relevant item or said individual
shall be punished by the fine prescribed in the relevant Article:
(i) Article 42-A fine of not more than one hundred million yen
(ii) Item (i), (ii) or (iv) of Article 43-A fine of not more than five hundred thousand yen
(iii) Item (iii) of Article 43, Article 44, or the preceding Article-The fine prescribed in
the relevant Article
Article 47
A person who falls under either of the following items shall be punished by a non-penal
fine of not more than two hundred thousand yen:
(i) A person who has failed to give a notification under the provisions of paragraph (2)
- 35 -
of Article 10, paragraph (2) of Article 15, paragraph (2) of Article 16, paragraph (1) of
Article 20, or paragraph (2) of Article 26 or has given a false notification
(ii) A person who has failed to make a report under the provisions of paragraph (1) of
31-2 or has submitted a false report
Article 48
In the case where an order under the provisions of Article 33-2 has been violated, an
officer or officers of NITE who have committed said act in violation shall be punished by
a non-penal fine of not more than two hundred thousand yen.
Supplementary Provisions (Extract)
Article 1 (Effective Date)
This Act shall come into effect as from the day on which six months have elapsed from
the day of promulgation; provided, however, that the provisions of the following Article
shall come into effect as from the day of promulgation.
Article 2 (List of Existing Chemical Substances)
(1) The Minister of International Trade and Industry shall prepare a list (hereinafter
referred to as the “List of Existing Chemical Substances”) of the names of chemical
substances that were manufactured or imported on a regular basis at the time of the
promulgation of this Act (excluding those that were manufactured or imported for
testing and research purposes and those that were manufactured or imported as
reagents) and give public notice of it within three months from the day of the
promulgation of this Act.
(2) Any person may, when he/she finds it necessary to correct the List of Existing
Chemical Substances of which public notice has been given pursuant to the provisions
of the preceding paragraph, propose to that effect to the Minister of International
Trade and Industry, pursuant to the provisions of an Ordinance of the Ministry of
International Trade and Industry, only within one month from the day of the
publication of the List of Existing Chemical Substances.
(3) In the case where a proposal under the preceding paragraph has been made, if the
Minister of International Trade and Industry finds grounds for said proposal, he/she
shall add the name of the chemical substance to which said proposal pertains to the
List of Existing Chemical Substances or delete it from the List of Existing Chemical
Substances, and shall notify the person who has made the proposal to that effect.
(4) The Minister of International Trade and Industry shall give public notice of the List of
Existing Chemical Substances that has undergone any additions or deletions under the
provisions of the preceding paragraph by one month prior to the date of enforcement of
this Act.
- 36 -
Article 3 (Transitional Measures)
The provisions of paragraph (1) of Article 3 shall apply to a person who was, at the
time of the enforcement of this Act, operating the business of manufacturing or importing
any chemical substances other than the chemical substances listed in the List of Existing
Chemical Substances of which public notice has been given pursuant to the provisions of
paragraph (4) of the preceding Article, by deeming said person to be a person prescribed
in paragraph (1) of Article 3. In this case, the term “in advance” shall be deemed to be
replaced with “within one month from the day of the enforcement of this Act.”
Article 4
Where tests prescribed in paragraph (7) of Article 4 have been conducted (including the
case where knowledge equivalent to that which would be obtained from said tests has
been obtained) on any of the chemical substances listed in the List of Existing Chemical
Substances of which public notice has been given by the Minister of International Trade
and Industry pursuant to the provisions of paragraph (4) of Article 2 of the
Supplementary Provisions (including chemical substances that have come to be newly
manufactured or imported after the enforcement of this Act, other than the chemical
substances listed in items (2) to (4) of paragraph (7) of Article 2 [for chemical substances
listed in item (iii) of the same Article, they shall be limited to substances that fall under
item (i) of paragraph (3) of the same Article]) for which the Minister of Health, Labour
and Welfare, the Minister of Economy, Trade and Industry and the Minister of the
Environment find it necessary to conduct said tests, the results of said tests (including
the knowledge obtained in the case where knowledge equivalent to that which would be
obtained from said tests has been obtained) shall be deemed to be the results of the tests
under paragraph (7) of Article 4 with regard to the application of the provisions of
paragraph (8) of Article 2.
- 37 -
Chemical Substances Control Law
(CSCL)
March 2010
Chemical Safety Office, Chemical Management Policy Division,
Manufacturing Industries Bureau
Ministry of Economy, Trade and Industry
http://www.meti.go.jp/policy/chemical_management/chemical_wondertown/index.html
Contents
1. The Chemical Substance Control Law: the current
version
- The Current Version of the Chemical Substances
Control Law: Overview
- Chemical Substances Subject to the Chemical
Substance Control Law
- The Current Version of the Chemical Substance
Control Law: the Whole Picture
- Restrictions according to the Properties, etc. of
Chemical Substances
2. Chemical Substance Control Law: Amendment
- Amendment of the Chemical Substance Control
Law: Overview
- Shift To Risk-based Management
- Key Points of the Amendment of the Chemical
Substance Control Law
- The Chemical Substance Control Law after the
Amendment: the Whole Picture (First Phase)
- The Chemical Substance Control Law after the
Amendment: the Whole Picture (Second Phase)
- Restrictions according to the Properties, etc. of
the Chemical Substance (after Amendment)
3. Specific Items of the Amendment
(1) First Phase of Amendment (Enacted on April 1st, 2010)
(a) Not persistent substances will be included
(b) Confirmation System for Polymers of Low Concern
(c) Information Delivery in the Supply Chain
(d) Measures concerning Class I Specified Chemical
Substances
(e) Measures concerning Class II Specified Chemical
Substances
(f) Other Measures (notification for other laws and
ordinances relevant)
(2) Second Phase of Amendment (Enacted on April 1st, 2011)
(a) Notification of the amount of manufacturing or import
for general chemical substances
(b) Priority Assessment Chemical Substances (New
Category)
(c) Handling of the Monitoring Chemical Substances
4. Order for Enforcement of the Amended Chemical
Substance Control Law
- Order for Enforcement of the Amended Chemical
Substance Control Law: Overview
1
1. The Chemical Substances Control Law:
the current
c rrent version
ersion
2
The Current Version of the Chemical Substance
Control Law: Overview
[Purpose]
The purpose of this Act is to evaluate, before manufacture or import, whether or not new chemical
substances have properties such as persistence, and to implement necessary regulations, in order to
prevent environmental pollution caused by chemical substances that are persistent and pose a risk of
impairing human health or interfering with the inhabitation and/or growth of flora and fauna.
[Evaluation Criteria]
(1) Persistence (environmental persistence), (2) Bioaccumulation potential, (3) Toxicity for humans or
flora and fauna
[Key Points]
- Notification and evaluation of new chemical substances (i.e., chemical substances that were newly
y
manufactured or imported in or after 1973 and have not been evaluated) prior to the manufacture or
import.
- Manufacture and/or import of these substances will be permitted without notification and/or evaluation
upon confirmation by the government in such cases as the substance is manufactured or imported within
a limited volume (the national total tonnage 1 ton), and the substance is an intermediate or a closed
system.
- Manufacture and/or import of these substances up to 10 tons (i.e., “low production”) will be permitted
without toxicity evaluation if persistence and low bioaccumulation potential are confirmed as a result of
the evaluation.
- The existing chemical substances (i.e., the chemical substances manufactured or imported in or before
1973) are to be studied and evaluated by the government.
- The chemical substance will be subject to regulation (e.g., obligation of notification on the amount to be
manufactured/imported, limitation on manufacturing, import and/or use) according to its properties found
in the evaluation.
3
Chemical Substances Subject to the Chemical
Substance Control Law
“Chemical substances” refers to compounds that are obtained by a chemical reaction on an element
or a compound.
The chemical substances subject to the Chemical Substance Control Law are those used for
general industrial chemical products. Those substances that are subject to other regulations that are
equally or more stringent regulations (Poisonous and Deleterious Substances Control Act) or more
specific to the usage of the substance (Food Sanitation Act) are exempted from this law.
Regulations on
manufacturing, etc.
Regulations on
emissions
Regulations on
waste
Chemical substances subject to
the Chemical Substance Control Law
Chemical substances
- Elements and natural products
General usage (industrial)
- General industrial chemical
products
Specific usage
[Food Sanitation Law]
Foods, additives, containers and packaging, toys and
detergents
[Agricultural Chemicals Regulation Act] Agricultural chemicals
[Fertilizers Regulation Act] Ordinary fertilizers
[Act on Safety Assurance and Quality Improvement of Feeds]
Feeds and feed additives
[Pharmaceutical Affairs Act]
Drugs, quasi-drugs, cosmetics, and medical equipments
[Water Pollution
Control Act]
[Air Pollution Control
Law]
[Soil Contamination
Countermeasures
Act]
[Waste
Management and
Public Cleansing
Law]
[Law concerning Prevention of Radiation Hazards due to Radioisotopes, etc.] Radioactive substances
[Poisonous and Deleterious Substances Control Act] Specified poison
[Stimulant Drug Control Act] Stimulant and raw materials for stimulants
[Narcotics and Psychotropics Control Act] Narcotic
4
The Current Version of the Chemical Substance
Control Law: the Whole Picture
Existing chemical substances
New chemical substances
(Approx. 20,600 substances)
Total manufacturing and
import/year > 1 ton/year
(Chemical substances that were already manufactured/imported at
the time of the promulgation of the Chemical Substance Control Law)
Persistent. Highly bioaccumulative.
Long-term toxicity for humans or
predator animals at higher trophic
level
Total manufacturing and
import/year 1 ton/year
Notification and evaluation
(Data are submitted by private corporations)
Not readily biodegradable /not highly
bioaccumulative
Hazard assessment and evaluation
(by the government)
Persistent
/highly bioaccumulative
Suspected long-term toxicity
for humans
Substances specified by
Cabinet order
(e.g., intermediates)
Not readily
biodegradable /not highly
bio accumulative
10 ton/year
Confirmation
(approval for
manufacturing
and/or import)
Suspected toxicity for flora
and fauna
Type I Monitoring Chemical
Substances (36 substances)
Class II Monitoring Chemical
Substances (952 substances)
Class III Monitoring Chemical
Substances (157 substances)
[Persistent. Highly bioaccumulative.
Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported/ usage, etc.
[Persistent. Not highly bioaccumulative.
Suspected long-term toxicity for humans]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
[Persistent. Not highly bioaccumulative.
Suspected long-term toxicity for flora and fauna]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
Investigation of
toxicity directed
Has long-term toxicity to
humans or predator animals
at higher trophic level
Investigation of
toxicity directed
Has long-term toxicity for
humans
Investigation of
toxicity directed
Has long-term toxicity for
flora and fauna in the
human living environment
Class I Specified Chemical Substances (16 substances)
Class II Specified Chemical Substances (23 substances)
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity for predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by Cabinet order is prohibited
- Any uses other than specified by Cabinet order are prohibited
- Criteria in handling of the substance must be met
- Implementation of recallsand other measures may be ordered
[Persistent. Not highly bioaccumulative. Has toxicity for humans or
long-term toxicity for flora and fauna in the human living environment]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, the government issues orders to change the planned manufacture
and import amounts
5
- The government provides technical guidelines, recommendations
- Mandatory labeling for the products specified by cabinet order
Restrictions according to the Properties, etc. of
Chemical Substances
The Chemical Substance Control Law regulates the restrictions and measures according to the
properties the substance (e.g., persistence, bioaccumulation, long-term toxicity for humans, and
long-term toxicity for flora and fauna) and the residual conditions in the environment.
Regulatory Classification
Restrictions
Class I Specified Chemical Substances
(16 substances including PCBs)
Chemical substances that are persistent, are highly
bioaccumulative, and have long-term toxicity for
humans or long-term toxicity for flora and fauna.
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Any use other than specified by Cabinet order uses are prohibited
- Import of certain products specified by Cabinet order is prohibited
- Implementation of recall and other measures may be ordered (in case when the substance
and/or product is specified and when the statutes are not complied with)
Class II Specified Chemical Substances
(23 substances including trichloroethylene)
Ch i l substances
Chemical
b t
th
thatt are persistent
i t t and
dh
have
toxicity for humans or long-term toxicity for flora and
fauna in the human living environment
- Mandatory reporting of planned and actual amounts manufactured and/or imported, usage, etc.
- If deemed necessary, the government issues orders to change the planned manufacture and
i
import
t amounts
t
- The government provides technical guidelines, recommendations for handling
- Mandatory and recommended labeling
Type I Monitoring Chemical Substances
(36 substances including cyclododecan)
Existing chemical substances that are confirmed to
be persistent and highly bioaccumulative
- Mandatory reporting of actual amounts manufactured and/or imported, usage, etc.
- Name of the substance and reported amounts of manufacturing and/or import is publicized by
the government for the substances whose total volume is at least 1 ton.
- Guidelines, advice, etc. (when necessary to prevent environmental pollution)
- When necessary, government directs manufacturers and importers to investigate the longterm toxicity for humans or for predator animals at higher trophic level
Type II Monitoring Chemical Substances
(952 substances including chloroform)
Chemical substances that are not highly
accumulative but are not readily biodegradable and
suspected to have long-term toxicity
- Mandatory reporting of actual amounts manufactured and/or imported, usage, etc.
- Name of the substance and reported amounts of manufacturing and/or import is publicized by
the government for the substances whose total volume is at least 100 tons.
- When necessary, the government directs manufacturers and importers to investigate the longterm toxicity for humans
- Mandatory reporting of actual amounts manufactured and/or imported, usage, etc.
Type III Monitoring Chemical Substances
(157 substances including cadmium nitrate) - Name of the substance and reported amounts of manufacturing and/or import is publicized by
the government for the substances whose total volume is at least 100 tons.
Chemical substances that are persistent and have
6
- When necessary, the government directs manufacturers and importers to
toxicity for general flora and fauna (ecotoxicity)
investigate the long-term toxicity for flora and fauna in the human living environment
2. Chemical Substance Control Law:
Amendment
7
Amendment of the Chemical Substance Control
Law: Overview
The current regulations and measures are reviewed and new measures necessary to rationalize regulations are implemented to
reflect international trends. The amendment is also aimed at preventing the adverse influence of harmful chemical substances on
humans, flora and fauna through implementation of comprehensive chemical substance management.
Background and Needs of Amendment
1. Increased concerns for chemical substances
(to ensure safety of the pubic both physically and mentally)
2. Needs to achieve international goals in chemical substance management
To minimize the significant adverse effect of chemical substances on
human health and environment by 2020 (Agreement in the Environmental
Summit in 2002).
- New regulations (REACH) are already implemented in 2007 in Europe.
The Chemical Substance Control Law (enactment in 1973) requires all
“new chemical substances” (those manufactured or imported for the first
time at the time of enactment or later) to go through prior evaluation.
Existing chemical substances at the time of enactment have been subject
to hazard assessment by the government, but assessment has not been
completed for many of these chemical substances.
Amendment: Overview
(1) Measures for the existing chemical substances
Manufacturers and/or importers of all chemical substances,
including existing chemical substances, will have an
obligation to report the amount, etc. when manufacturing or
importing more than a certain amount of the substance.
Upon reception of the above report, the government will
narrow down and prioritize the chemical substances for
detailed safety assessment.
assessment The manufacturers and/or
importers will be requested to submit information on the
level/ type of hazard. Influences of such chemicals on human
health, etc. will be evaluated and classified.
Based on the results, manufacturing and use of the
hazardous chemical substances and products containing
these substances will be restricted.
3. Unconformity with international conventions
In an international convention (the Stockholm Convention), an agreement
was made on exceptional use of certain substances that are subject to
banning.
With the current law, provisions on exceptional use are restrictive,
imposing concern that certain uses that are essential to the industries of
Japan cannot be ensured.
(2) Ensuring conformity with international rules
Use under strict management will be ensured when a
chemical substance is newly added to the list of restriction
substances in international conventions.
- Use for semiconductors, etc.
(Reference) Related occurrences 1973 Chemical Substance Control Law enacted
2002 Agreement achieved at the Environmental Summit
2004 Stockholm Convention came into effect
2007 REACH came into effect (Europe)
2020 Each state will complete safety assessment
2018 Deadline of final registration for REACH
8
Shift To Risk-based Management
In recent years, chemical substance management policies in the world have shown a shift from
“hazard-based management” that only takes the intrinsic hazardous properties of chemical
substances into account to “risk-based management” that also take emissions (exposure) to the
environment into consideration.
Risk
Hazard:
=
Hazard
Environmental release
(exposure)
Potential of chemical substances to impose undesired influence on humans and flora and fauna
in the environment
Exposures: Amount (concentration) of chemical substances that are exposed to humans and flora and fauna
The regulation regime will be shifted from the current system that is solely based on
the hazard of chemical substances to a “risk-based” system where “environmental
release (exposure)” (i.e., likelihood of the chemical substance to impose influence
on humans and/or flora and fauna) is additionally taken into account.
9
(Reference) WSSD: Goal for 2020
The World Summit on Sustainable Development (WSSD) in 2002 agreed to achieve, by 2020, a
situation where chemicals are used and produced in ways that lead to the minimization of
significant adverse effects on human health and the environment.
The most important key to meet the WSSD goal is a shift from “hazard-based management” that is
solely based on the intrinsic hazard of chemical substances to “risk-based management” that also
takes the release (exposure) of chemical substances to humans and the environment into account.
Items relevant to chemical substances
・Renew the commitment, as advanced in Agenda 21, to sound management of
chemicals throughout their life cycle and of hazardous wastes
・aiming to achieve by 2020 that chemicals are used and produced in ways that lead
to the minimization of significant adverse effects on human health and the
environment, using transparent science-based risk assessment procedures and
science-based risk management procedures, taking into account the precautionary
approach, as set out in principle 15 of the Rio Declaration on Environment and
Development.
In 2002, the Johannesburg Plan
of Implementation was adopted
as a guideline to implement the
items in the Agenda 21 agreed at
the World Summit on Sustainable
Development.
10
(Reference) International Trend
(Measures taken in Europe)
In Europe, a new regulation for chemical substances, Registration, Evaluation, Authorization and
Restriction of Chemical (REACH) became effective in June 2007. REACH is unique in that
(1) Manufacturers and importers of all chemical substances (both new and existing substances) are
obliged to register, (2) Chemical substances incorporated into an article, such as electronic and
electric devices, are subject to mandatory registration, (3) The major body of risk assessment is
shifted to business, and (4) Authorization is required for use, etc. of certain substances, such as
carcinogenetic substances. The EU is planning to achieve the 2020 goal through the thorough
implementation of risk-based management using REACH regulation.
Obligated parties: Manufacturers or importers (including downstream users) within the EU territory, as well as agents
designated by companies outside of the EU territory.
Obligation: (1) Chemical substances (including ingredients of a preparation) must be registered at the European Chemical
Agency (ECHA) with the results of safety assessment and other information. The registrars join the
Substance Information Exchange Forum (SIEF) to share the assessment costs.
(2) Manufacturers and importers of articles have to notify the ECHA if their article contains a “substance of very
high concern” by 0.1% (w/w) and provide information on the substance to the businesses. Chemical
substances with an intended release (e.g., ink in ballpoint pens) in an article have to be registered.
(3) Use and market launch of carcinogenic, mutagenic, and reprotoxic (CMR) substances, etc. are prohibited
except for the specific cases where authorization is given.
Timeline: June 1st, 2007: Enactment (ECHA starts operation)
June 1st to December 1st, 2008: Preregistration (Extended registration deadlines below are applied after preregistration)
November 30th, 2011: Registration deadline for chemical substances manufactured and/or imported in
volumes 1,000 tons/year.
June 1st, 2011: Notification of SVHC in articles begins
May 31st, 2013: Registration deadline for all substances manufactured or imported in volumes 100
11
May 31st, 2018: Registration deadline for all substances manufactured or imported in volumes 10
(Reference) Detailed Timeline for REACH
Timeline for substances (registration, etc.)
Timeline for articles (notification, etc.)
June 1st, 2008: REACH regulations start operation
June 1st, 2008 to December 1st, 2008: Preregistration
(registration can be extended by preregistration)
October 28th, 2008: Obligation to report information
starts for 15 SVHC substances according to the
Article 33
By December 1st, 2008: EU member states establish penalties for infringements of REACH and report to EC
Starting February 2009: Substance Information
Exchange Forum (SIEF) is in operation (to discuss how
to share substance safety data, etc. necessary for
registration)
Candidate list discussed and determined
November 30th, 2010: Registration deadline for
substances manufactured or imported in volume
1,000 tons/year, CMR (carcinogenic, mutagenic, and
reprotoxic) substances in volume 1 tons/year, and
substances classified as “very toxic to aquatic
organisms and may cause long-term adverse effects in
the aquatic environment” in volume I 100 tons/year.
March 2009: Discussion and addition of SVHC
substances to the list starts (public consultation
starts)
May 31st, 2011: Notification deadline for SVHC
substances (those listed 6 months earlier or before)
Starting June 1st, 2011: SVHC substances must be
notified within 6 months after publishing on the list
May 31st, 2013: Registration deadline for substances
manufactured or imported in volume I 100 tons/year
but < 1,000 tons/year
May 31st, 2018: Registration deadline for substances
manufactured or imported in volume 1 tons/year but <
100 tons/year
12
(Reference) REACH Preregistration Status
Preregistration Status (as of December 7th, 2008):
- Number of companies signed up through REACH-IT:
65,000 (82% consists of small and
medium-sized enterprises)
- Number of registrations:
2,600,000
Germany: 820,000; UK: 440,000; France: 340,000;
Poland: 190,000; Netherland: 130,000; Italy: 120,000
- Number of substances registered: 150,000
Substances without EINECS number: 26,500 (substances with
CA number: 17,000)
17 000)
Multicomponent substance: 14,500
While most SIEFs are expected to consist of 1 to 9 companies,
2 SIEFs have already been signed up by more than 5,000 companies.
- Challenges: - Many cases of registration were made directly from outside the EU territory,
which have been deleted.
-Some articles and “cow”s were preregistered.
-3 organizations which are believed to be “Only Representative” entities
made about 1,500 cases of preregistration without declaring its
representation of companies located outside the EU territory.
13
(Reference) International Trend
(Response by the U.S.)
The U.S. has been evaluating the risk of all chemical substances launched on the market through
the Toxic Substances Control Act (TSCA) and the US Challenge Program, a program to collect
safety information of high production volume (HPV) chemical substances with the cooperation of
the private sector. More recently, a collaborative framework was established with Canada and
Mexico. With these measures, the U.S. is planning to achieve the 2020 goal.
Measures taken by the U.S.
In 1998, the US Challenge Program (a program to collect and make publicly available data on
safety of HPV with cooperation of companies) was started.
In 2005, the chemical industry in the U.S. voluntarily started extending its work on HPV.
In 2007, the leaders of the U.S., Canada and Mexico agreed to develop a regional cooperation
in chemical substance regulation. The U.S. Environmental Protection Agency (EPA) started
publishing the evaluation results of safety information collected through the US Challenge program.
By 2012, EPA will complete the risk evaluation of HPVs and finish the validation procedures of
safety information on chemical substances in volume of at least 10 tons/year.
(Source: U.S. Environmental Protection Agency)
14
Key Points of Amendment of the Chemical
Substance Control Law
(1) Introduction of a comprehensive control system that covers the existing chemical substances
(a) Companies that manufacture or import any chemical substance, including existing substances, in excess of the
specified amounts will be newly obliged to notify the quantity and use information for each fiscal year.
(b) Chemical substances which the government identifies, from the content of their notifications and available
knowledge of their hazardous properties, as having higher priority in risk assessment will be designated as Priority
Assessment Chemical Substances” (PACs)“.
(c) Manufacturers and importers of those PACs may be required to submit information on hazardous properties and
companies handling them may be required to report their uses as necessary.
(d) Among the PACs that are deemed, as a result of the information gathering and the risk assessment, to raise
concerns about adverse effects on humans or flora and fauna will be subject to regulations on manufacture and
use as “ClassⅡSpecified
ClassⅡSpecified Chemical Substances,
Substances,” as in the existing Law.
(e) In addition to “chemical substances that are persistent in the environment,” which have been subject to control
under the current Law, “chemical substances that are not persistent in the environment” will be regulated in the
amended Law.
(2) Appropriate control of chemical substances in the supply chain
To prevent environmental pollution by the Specified Chemical Substances and products containing them, the
amended Law will require companies handling them to adhere to specific handling standards and oblige these
companies to label the products with necessary information for transactions.
(3) Rationalization of evaluation and regulation systems in light of international trends
The government will eliminate international inconsistencies in its regulations, for example, by reviewing
regulations on the Class I Specified Chemical Substances in order to permit the exceptional use of the substances
listed under the Stockholm Convention under strict control.
15
The Chemical Substance Control Law after
the Amendment: the Whole Picture (First Phase)
Existing chemical substances
New chemical substances
(Approx. 20,600 substances)
(Chemical substances that were already manufactured/imported at
the time of the promulgation of the Chemical Substance Control Law)
Total manufacturing and
import/year > 1 ton/year
Persistent. Highly bioaccumulative.
Long-term toxicity for humans or
predator animals at higher trophic
level
Including
substances not
highly persistent
Substances specified by
Cabinet order
(e.g., intermediates)
Polymers of Low
Concern
Notification and evaluation
(Data are submitted by private corporations)
Not readily biodegradable
/not highly bioaccumulative
10 ton/year
Not readily biodegradable /not highly
bioaccumulative
Hazard assessment and evaluation
(by the government)
Persistent/
highly bioaccumulative
Total manufacturing
and import/year
1 ton/year
Suspected long-term toxicity
for humans
Confirmation
(approval for
manufacturing
and/or import)
Suspected long-term toxicity
for flora and fauna
Including
substances not
highly persistent
Type I Monitoring Chemical
Substances
Class II Monitoring Chemical
Substances
Class III Monitoring Chemical
Substances
[Persistent. Highly bioaccumulative.
Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
[Persistent. Not highly bioaccumulative.
Suspected long-term toxicity for humans]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
[Persistent. Not highly bioaccumulative.
Suspected long-term toxicity for flora and fauna]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
Investigation of
toxicity directed
Has long-term toxicity to
humans or predator animals at
higher trophic level
Class I Specified Chemical Substance
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by cabinet order is prohibited
- Any uses other than specified by Cabinet order (for international consistency of
requirements) are prohibited
- Standards in handling of the substance and products specified by cabinet order
(products containing the substances) must be met. Mandatory labeling
- Implementation of recall and other measures may be ordered
Investigation of
toxicity directed
Including
substances not
highly persistent
Has long-term toxicity for
humans
Investigation of
toxicity directed
Has long-term toxicity for
flora and fauna in the human
living environment
Class II Specified Chemical Substance
[Persistent. Not highly bioaccumulative. Has toxicity for humans or
long-term toxicity for flora and fauna in the human living environment]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, government issues orders to change the planned manufacture and
import amounts
- The government provides technical guidelines, recommendations on substances and
products specified by cabinet order
16
(products containing the substances)
- Mandatory labeling for the products specified by cabinet order
The Chemical Substance Control Law after the
Amendment: the Whole Picture (Second Phase)
Existing chemical substances
New chemical substances
(Approx. 20,600 substances)
(Chemical substances that were already manufactured/imported at the time
of the promulgation of the Chemical Substance Control Law)
Total manufacturing and
import/year > 1 ton/year
Total manufacturing and
import/year 1 ton/year
Substances specified
by cabinet order
(e.g., intermediates)
Polymers of
Low Concern
General chemical substances
(7,000 to 8,000 estimated)
Mandatory reporting of amounts manufactured and/or imported, usage, etc.
Notification and evaluation
(Data are submitted by private corporations)
Risk to humans or flora and
fauna in the human living
environment is sufficiently low
Decision based on exposure,
hazard, etc.
Decision based on exposure,
hazard, etc.
Priority Assessment Chemical Substances (PACs)
(Approx 1,000
(Approx.
1 000 substances are expected to be specified)
[Persistent. Highly bioaccumulative. Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
- Companies handling these substances are obliged to
make utmost efforts to disclose information
Report of handling status is required
Investigation of toxicity directed
Has long-term toxicity to humans or
predator animals at higher trophic level
Class I Specified Chemical Substances
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity for predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by Cabinet order is prohibited
- Any uses other than specified by Cabinet order (for international consistency of
requirements) are prohibited
- Standards in handling of the substance and products specified by Cabinet order
(products containing the substances) must be met. Mandatory labeling
- Implementation of recall and other measures may be ordered
Confirmation
(approval for
manufacturing
and/or import)
Risk to humans or flora and fauna in the human living environment
is not sufficiently low
Persistent.
Highly bioaccumulative
Monitoring Chemical Substances
Not readily
biodegradable/not
highly bioaccumulative
10 ton/year
[Persistent. Not highly bioaccumulative. Suspected long-term toxicity for humans]
- Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc.
- Companies handling these substances are obliged to make utmost efforts to disclose information
Note: Type II and Type III Monitoring Chemical Substance discontinued. Priority Assessment Chemical
Substances may be specified from the substances previously categorized in these types
Including
substances not
highly persistent
Including
substances not
highly persistent
Report of toxicity and handling status is required
Investigation of toxicity directed
Has risk for humans or flora and fauna
in the human living environment
Class II Specified Chemical Substances
[Persistent. Not highly bioaccumulative. Has toxicity for humans or
long-term toxicity for flora and fauna in the human living environment]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, government issues orders to change the planned manufacture and
import amounts
- The government provides technical guidelines, recommendations on substances and
products specified by Cabinet order (products containing the substances) 17
- Mandatory labeling for the products specified by Cabinet order
Restrictions according to the Properties, etc. of
Chemical Substances (after Amendment)
Regulatory Classification
Class I Specified Chemical Substances (16 substances including PCB)
Chemical substances that are persistent, are highly bioaccumulative and have longterm toxicity for humans or long-term toxicity for flora and fauna.
Remain effective
Restrictions
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Any use other than specified by Cabinet order uses are prohibited
- Import of certain products specified by Cabinet order is prohibited
- Implementation of recall and other measures may be ordered (in case when the
substance and/or product is specified and when the statutes are not complied with)
Class II Specified Chemical Substances (23 substances including trichloroethylene) - Mandatory reporting of planned and actual amounts manufactured and/or imported,
Chemical substances that are persistent and have toxicity for humans or long-term
usage, etc.
toxicity for flora and fauna in the human living environment
- If deemed necessary, government issues orders to change the planned manufacture
and import amounts
Remain effective (including not
- The government provides technical guidelines, recommendations for handling
- Mandatory and recommended labeling
highly persistent substances)
Type I Monitoring Chemical Substances (36 substances including cyclododecan)
Existing chemical substances that are confirmed to be persistent and highly
bioaccumulative
Monitoring Chemical Substances
- Mandatory reporting of actual amounts manufactured and/or imported, usage, etc.
- Name of the substance and reported amounts of manufacturing and/or import is
publicized by the government for the substances whose total volume is at least 1 ton.
- Guidelines, advice, etc. (when necessary to prevent environmental pollution)
- When necessary, the government directs manufacturers and importers to investigate
long-term toxicity for humans or for predator animals at higher trophic level
Type II Monitoring Chemical Substances (952 substances including chloroform)
- Mandatory reporting of actual amounts manufactured and/or imported, usage, etc.
Chemical substances that are not highly accumulative but are not readily biodegradable - Name of the substance and reported amounts of manufacturing and/or import is
and suspected to have long-term toxicity
publicized by the government for the substances whose total volume is at least 100 tons.
Discontinued (Some substances are - When necessary, government directs manufacturers and importers to investigate longterm toxicity for humans
specified as Priority Assessment
Chemical Substances)
Type III Monitoring Chemical Substances (157 substances including cadmium
nitrate)
Chemical substances that are persistent and have toxicity for general flora and fauna
(ecotoxicity)
Priority Assessment Chemical Substances
(Sufficiently low risk of the substance cannot be confirmed)
- Mandatory reporting of actual amounts manufactured and/or imported, usage, etc.
- Name of the substance and reported amounts of manufacturing and/or import is
publicized by the government for the substances whose total volume is at least 100 tons.
- When necessary, the government directs manufacturers and importers to investigate
long-term toxicity for flora and fauna in the human living environment
General Chemical Substances
(Sufficiently low risk of the substance can be confirmed)
18
3. Specific
p
Items of the Amendment
19
(1) First Phase of Amendment
(a) Readily biodegradable substances will be included
While only persistent chemical substances are classified into Class II Specified Chemical
Substances, Type II Monitoring Chemical Substances, and Type III Monitoring Chemical
Substances under the current Law, chemical substances that are readily biodegradable will
become subject to control under the amended Law.
- More stringent control of the volume of manufacture and import of these substances is needed for
chemical substances even when they are readily biodegradable . This is based in a concern that
these substances impose adverse effects on humans or flora and fauna if released into the
environment at the amount exceeding the degradable amount in the environment.
- The 2020 Goal of the WSSD requires establishment of a system for phase-by-phase implementation
of safety assessment for all chemical substances distributed in Japan.
- European countries, the U.S. and other countries in the international community do not limit their
regulation of chemical substances to persistent substances. Safety is ensured through measures
including restrictions on manufacture and import that are determined based on the data on toxicity
and the status of environmental release of chemical substances.
20
(b) Confirmation System for Polymers of
Low Concern
Polymers of Low Concern (PLCs) will be exempted from mandatory notification of manufacture
and import for new chemical substances and will become subject to confirmation based on existing
knowledge.
- Polymers (macromolecular compounds made of a number of low molecular compounds bonded) that
meet a certain criteria do not penetrate the plasma membrane due to their high molecular weights,
imposing low effects on human health and/or growth of plants and animals as validated by the
international community.
- In the light of these circumstances, mandatory notification under the Chemical Substance Control Law
may be exempted for the manufacture or import of a new chemical substance if the substance is a
Polymer and is confirmed by the three relevant ministers to meet the criteria for “Polymers of Low
Concern” (PLCs) that are not concerned to impose adverse effects on human health, inhabitation of
plants and animals in the human living environment, etc prior to those manufacture or import.
- When specified as a PLC, the manufacturer or importer may be subject to obligatory report and on-site
inspection.
21
(c) Information Delivery in the Supply Chain
When Type I Monitoring Chemical Substances are transferred between business entities, the
entity transferring the substance is obliged to make utmost efforts to inform the recipient that the
substance is specified as the Type I Monitoring Chemical Substance among other information.
For Class II Specified Chemical Substances and Type I Monitoring Chemical Substances, the
three relevant ministries and ministers may instruct the business entity handling the substance to
report the status of transaction.
Supply chain
Control of chemical substances in the supply chain
Articles
Chemical substances/preparation
p p
Manufacturer of
raw materials
Primary processing manufacturer
Parts manufacturer
Manufacturer of assembled products
General consumers
Supply chain
Chemical preparation
/products
Manufacturer of raw materials
Primary processing
manufacturer
Manufacture
and import
(Examples of measures)
- Prohibition of manufacture and
import
- Restriction on manufacture and
import
- Reduction of release through
improvement of manufacturing
facilities
- Control of intermediates
Articles
Part
manufacturer
Use and
processing
(Examples of control)
- Restriction on use and intended use
- Reduction of amount of use through
improvement of manufacturing facilities
- Review the needs and possibility of overuse
- Improvement of recovery rate, achievement
of thorough reuse, measures on handling
- Shifting to alternative substance
22
(d) Measures concerning the Class I Specified
Chemical Substances
Use of Class I Specified Chemical Substances are permitted as a case of “essential use” when
substation to an alternative substance is very difficult and the substance does not impose adverse
effects on human health or on the environment (mitigation of requirements).
Labeling and other identification and compliance with the standards are imposed as obligations
concerning Class I Specified Chemical Substances and products containing such substances
(enhancement of management).
< Summary of the Cabinet order >
- The 12 substances, including Perfluorooctane sulfonic acid and its salt forms (Perfluorooctane
sulfonate: PFOS), that were specified by the Stockholm Convention in May 2009 will be designated as
the Class I Specified Chemical Substances
- For PFOS, the use for manufacture of etching agent and resist for semiconductors and use for
manufacture of industrial photo films will be designated as the authorized uses (designated as
“essential uses”).
- For the purpose of environmental pollution prevention, etching agent and resist for semiconductors,
industrial photo films and fire-extinguishing foam, etc. containing PFOS will be designated as products
for which handling business entity is obliged to meet the handling standards and to apply proper
labeling.
- Products containing the 12 substances described above will be designated as import prohibited items
23
(additives for surface treatment agents for plating, aviation hydraulic fluids, etc.).
(Reference) Stockholm Convention
The Stockholm Convention, in order to protect human health and environment from Persistent
Organic Pollutants (POPs), prohibits or restricts the manufacturing, use and international trade of
chemical substances that are (1) toxic, (2) persistent, (3) bioaccumulative, and (4) having potential
for long-range environmental transport.
In the COP4 in May 2009, twelve new substances, including PFOS, are newly designated as the
substances subject to the convention.
- Currently,
C
l 9 substances
b
are designated
d i
d as substances
b
ffor which
hi h specific
ifi measures are required.
i d
(Annex A: Elimination; Annex B: Restriction; Annex C: Unintentional production)
(aldrin, chlordane, dieldrin, endrin, heptachlor, hexachlorobenzene, mirex, toxaphene,
polychlorinated biphenyls, DDT, polychlorinated dibenzo-p-dioxins, and polychlorinated
dibenzofurans)
- In the Chemical Substance Control Law of Japan, these substances, except for unintentional
production, are designated as the Class I Specified Chemical Substances in the Law.
24
(e) Measures concerning the Class II Specified
Chemical Substances
In the current Law, the government provides technical guidelines and recommendations to prevent
environmental pollution for Class II Specified Chemical Substances. After the amendment, such
technical guidelines and recommendations will be given for the products containing a Class II
Specified Chemical Substance designated by cabinet order.
In the current Law, labeling for the products specified by cabinet order containing Class II
Specified Chemical Substances are obliged to the business entities that handle Class II Specified
Chemical Substances. After the amendment, such labeling will be also mandatory for business
entities that handle products containing Class II Specified Chemical Substances.
25
(f) Other Measures (Notification for other laws
and ordinances relevant)
<Notification to relevant ministries and agencies>
Control and management of chemical substances are subject to, in addition to the Chemical Substance
Control Law, the Poisonous and Deleterious Substances Control Act, the Industrial Safety and Health
Act, the Pharmaceutical Affairs Act, the Air Pollution Control Law, and the Water Pollution Control Act
among others.
In the current Chemical Substance Control Law, information on toxicity for new chemical substances can
be collected before the substance is launched on the market. When new findings are obtained regarding
the properties, etc. of the chemical substance based on the Chemical Substance Control Law, such
findings are notified to the relevant ministries and/or agencies.
<Collection of information and on-site inspection>
The range of collection of information and on-site inspection is extended to business entities that handle
the products containing the Class I Specified Chemical Substances designated by Cabinet order.
<Guideline and advice>
The range of guideline and advice by the government is extended to include the business entities that
handle products containing the Class II Specified Chemical Substances designated by Cabinet order.
26
(2) Second Phase of Amendment
(a) Notification of the amount of manufacturing or import for general chemical
substances
Companies that manufacture or import 1 ton or more of chemical substances must notify the
amount of manufacturing or import, use and other information for each fiscal year.
Notified chemical substances are assessed for their risk, and designated as a PACs (Priority
Assessment Chemical Substances), if necessary.
- S
Substances
b t
exempted
t d ffrom mandatory
d t
notification
tifi ti will
ill b
be lilimited
it d tto (1) chemical
h i l substances
b t
used
d ffor
research purposes, (2) chemical substances less than 1 ton in volume, and (3) chemical substances
that are known to impose low risk (e.g., water and carbon dioxide).
- When toxicity information that has not been publicly known is obtained for substances that are subject
to notification, such information must be reported to the three ministries (the Ministry of Economy,
Trade and Industry; Ministry of Health, Labour and Welfare; and Ministry of the Environment).
- Notification for the Specified Chemical Substances, the PACs, and the Monitoring Chemical
Substances will be carried out according to each regulation and therefore not necessary for this
regulation.
27
(b) Priority Assessment Chemical Substances
(New Category)
Chemical substances that are deemed as high risk are designated from those subject to notification as
PACs(Priority Assessment Chemical Substances)
Companies that manufacture or import any of the PACs at volume of 1 ton or higher are obliged to
notify the amount of manufacture or import, usage and other information for each year
Detailed risk assessment will be carried out in a stepwise manner, and, when found necessary; the
substance will be designated as a Class II Specified Chemical Substance if necessary.
When publicly unknown information is obtained, it must be notified to the three relevant ministries
(“obligation to use best efforts”).
Manufacturers, importers and users of the PACs have the following obligations, etc. as listed below.
(1) Manufacturers and importers:
-Manufacturers and importers are obliged to report the amount of manufacture and/or import, as
well as the usage of the substances
-Manufacturers and importers are obliged to make best efforts to disclose information obtained
through the supply chain
-The government may request the manufacturers and importers to carry out simple toxicity tests
-The government may instruct the manufacturers and importers to submit toxicity data
(2) Users:
-Companies that use these substances are obliged to make their best efforts to notify relevant
information
-The government may request the companies to report the handling status
28
(c) Handling of the Monitoring Chemical
Substances
Classifications of Type II Monitoring Chemical Substances and Type III Monitoring Chemical
Substances are to be discontinued after the PACs (Priority Assessment Chemical Substances)
are established
Classification of Type I Monitoring Chemical Substances will be renamed “Monitoring Chemical
Substances” and remain effective
- Under the system of Type II Monitoring Chemical Substances, chemical substances that pose a risk
of harming human health are designated and the manufacturers and importers of such substances
are requested to report the amount of manufacture or import
- Under the system of Type III Monitoring Chemical Substances, chemical substances that have a
risk of imposing adverse effects on the habitats of or the growth of plants and animals are
designated and the manufacturers and importers of such substances are requested to report the
amount of manufacture or import
- Classifications of Type II and Type III Monitoring Chemical Substances are to be discontinued after
the new classification of the PACs is made effective under the amended Law in order to assess the
toxicity of the substances to human health and flora and fauna
- The classification of Type I Monitoring Chemical Substances, the “predecessor” of Class I Specified
Chemical Substances
29
4. Order for Enforcement of the Amended
Chemical Substance
S bstance Control La
Law
30
Order for Enforcement of the Amended Chemical Substance Control Law:
Overview
1. Items related to Specified Chemical Substances
(1) Addition of new substances to Class I Specified Chemical Substances
- 12 substances subject to the Stockholm Convention are designated as substances to be added to the class
(2) Addition of products containing a Class I Specified Chemical Substance for import prohibited items
- Products that contain a Class I Specified Chemical Substance and cause environmental pollution are prohibited for import
(12 products containing 3 substances, including PFOS, are designated)
(3) Designation of certain Class I Specified Chemical Substances for an exceptional usage (essential use)
- When a certain substance classified in the Class I Specified Chemical Substance is essential for the manufacturing of a product, the use
of such substance may be permitted as an exception if technical standards and labeling obligations are met
(3 Usages are designated for PFOS. (Use of foam distinguisher agents is not designated as a usage essential for manufacturing but technical standards and
mandatory
d t
llabeling
b li are iimposed
d on th
their
i use.))
(4) Designation of products containing Class II Specified Chemical Substances
- Compliance with the technical guidelines are newly imposed on the products containing a Class II Specified Chemical Substance
- Handling companies of products containing a Class II Specified Chemical Substance are obliged to conduct mandatory labeling
(8 products containing 3 substances are designated)
2. Notification of general chemical substances, etc.
- The minimum amount of manufacture or import of general chemical substances and the Priority Assessment Chemical Substances
subject to notification is set as 1 ton/fiscal year/company
Reference: Dates of enforcement (Date of promulgation: October 30th, 2009)
- April 1st, 2010:
Class I Specified Chemical Substances are to be added. Essential uses are to be added. Products containing Class II Specified
Chemical Substances are to be designated
- May 1st, 2010:
Import of prohibited products are to be added
31
- October 1st, 2010:
Obligation to meet the standards and mandatory labeling for products containing a Class I Specified Chemical Substance
- April 1st, 2011:
Notification of general chemical substances and Priority Assessment Chemical Substances
(Reference (1)) Order for Enforcement of the Amended Chemical Substance
Control Law
1. Class I Specified Chemical Substances
(1) Perfluorooctane sulfonate (PFOS) or its salts
(2) Erfluorooctane sulfonyl fluoride (PFOSF)
(3) Pentachlorobenzene
(4) r-1, c-2, t-3, c-4, t-5, t-6- hexachlorocyclohexane (i.e., -hexachlorocyclohexane)
(5) r-1, t-2, c-3, t-4, c-5, t-6- hexachlorocyclohexane (i.e., -hexachlorocyclohexane)
(6) r-1, c-2, t-3, c-4, c-5, t-6- hexachlorocyclohexane (i.e., -hexachlorocyclohexane)
(7) Decachloropentacyclo [5. 3. 0. 02,6. 03,9, 04,8] decane-5-one (i.e., chlordecone)
(8) Hexabromobiphenyl
(9) Tetrabromo (phenoxybenzene) (i.e., tetrabromodiphenyl ether)
(10) Pentabromo (phenoxybenzene) (i.e., pentabromodiphenyl ether)
(11) Hexabromo (phenoxybenzene) (i.e., hexabromodiphenyl ether)
(12) Heptabromo (phenoxybenzene) (i.e., heptabromodiphenyl ether)
2. Import prohibited products
<PFOS or its salts>
(1) Aviation hydraulic fluids
(2) Treating agents for yarn
(3) Etching agents for metal processing
(4) Etching agents for semiconductors (excluding high-frequency compound semiconductors to allow radio equipment to transmit waves
of 3 megahertz or higher)
(5) Surface treating agents for metal plating or additives to prepare the agents
(6) Anti-reflective coatings for semiconductors
(7) Abrasive compounds
(8) Fire extinguishers, agents for fire extinguishers, and fire-extinguishing foam
(9) Insecticides for termites and termite repellents
(10) Printing paper
<Tetrabromodiphenyl ether, pentabromodiphenyl ether>
(1) Paints
(2) Adhesives
32
(Reference (2)) Order for Enforcement of the Amended Chemical Substance
Control Law
3. Essential uses of Class I Specified Chemical Substances
<PFOS or its salts>
(1) Manufacture of etching agents for semiconductors (limited to voltage filters and high-frequency compound semiconductors to allow
radio equipment to transmit waves of 3 megahertz or higher)
(2) Manufacture of semiconductor resists
(3) Manufacture of photo films for industrial purposes
4. Products containing a Class I Specified Chemical Substance that is subject to obligation to meet technical standards and
mandatory labeling
<PFOS or its salts>
(1) Etching agents for semiconductors (limited to voltage filters and high-frequency compound semiconductors to allow radio equipment
to transmit waves of 3 megahertz or higher.)
(2) Semiconductor resists
(3) Photo films for industrial purposes
(4) Fire extinguishers,
extinguishers agents for fire extinguishers,
extinguishers and fire-extinguishing
fire extinguishing foam
5. Products containing a Class II Specified Chemical Substance that is subject to obligation to meet technical standards and
mandatory labeling
<Trichloroethylene>
(1) Adhesives (excluding adhesives of animal or plant origins)
(2) Paints (excluding water-based paints)
(3) Metal processing oil
(4) Detergents
<Tetrachloroethylene>
(1) Vulcanizing agents
(2) Adhesives (excluding adhesives of animal or plant origins)
(3) Paints (excluding water-based paints)
(4) Detergents
(5) Finishing/processing agents for fiber products
<Tributyltine compounds>
33
(1) Antiseptic agents and anti-mold agents
(2) Paints (limited to paints used to prevent live growth of crustaceans, algae and other aquatic life on the hulls)
Useful URLs for the Information on the Chemical Substance Control Law
<Ministry of Economy, Trade and Industry>
http://www.meti.go.jp/policy/chemical_management/index.html
<Ministry of the Environment>
http://www.env.go.jp/chemi/kagaku/index.html
<Ministry of Health, Labour and Welfare>
http://www.nihs.go.jp/mhlw/chemical/kashin/kashin.html
<Public Comment (Ministry of Economy, Trade and Industry)>
http://www.meti.go.jp/feedback/index.html
34
Thank
a you
you.
35
Information submitted to Secretariat of the Rotterdam Convention From Japan
Information on PFOS, PFOSF and PBDE
November 12, 2010
Information requested
Information submitted from Japan
by the letter on 26
October, 2010
(1) Supporting
-
The Chemical Substances Control Law (CSCL) and its Enforcement Order
document of
URL: http://www.meti.go.jp/policy/chemical_management/english/files/CSCL_English.pdf
Japan’s
(The listing of PFOS and Penta-BDE as Class I Specified Chemical under CSCL by 2009 revision is explained in page 31-32.)
notifications on
-
Final Regulatory
Action regarding
Full text of CSCL (text not reflecting the latest revision in 2009)
URL: http://www.env.go.jp/en/laws/chemi/cscl/CSCL_law.pdf
-
PFOS and
Full text of CSCL Enforcement Order (text not reflecting the latest revision in 2009)
URL: http://www.env.go.jp/en/laws/chemi/cscl/CSCL_CO.pdf
Penta-BDE
(2) Any
documentation
Please refer the following documents;
(a) Report of the Persistent Organic Pollutants Review Committee on the work of its second
meeting, Addendum, Risk profile on
referenced in the
perfluorooctane sulfonate (UNEP/POPS/POPRC.2/17/Add.5)
notification
URL:http://chm.pops.int/Convention/POPsReviewCommittee/POPRCMeetings/POPRC2documents/tabid/106/language/en-US/Default.aspx
(b) Report of the Persistent Organic Pollutants Review Committee on the work of its second meeting, Addendum, Risk profile on commercial
pentabromodiphenyl ether (UNEP/POPS/POPRC.2/17/Add.1)
(3) Information on
-
There is no production of PFOS or Penta-BDE in Japan.
ongoing
-
Photo - resists are produced and exported which using PFOS.
international trade
-
As for PFOS, the latest import of the chemical to Japan was in 2009 (dates not specified).
Penta-BDE has not been imported to Japan.
Information requested by the letter on 4th November, 2010
(1)
Section 3 information of Final Regulatory Measures from
Information submitted from Japan
-
Japan on PFOS, PFOSF and Penta-BDE
-
Item 3.1: Other classification systems
PFOS
Japan CSCL : Class I Specified Chemical Substance
PFOSF
Japan CSCL : Class I Specified Chemical Substance
Penta BDE
Japan CSCL : Class I Specified Chemical Substance
For other items not filled in Japan’s FRM notifications, Japan does not have information for
these columns. (Draft of revised Japan’s FRM notifications are attached to this sheet)
(2) Eco-toxicologial and hazard classification data
-
Eco-toxicologial and hazard classification data of PFOS
Hazardous to the aquatic environment (acute)：Category 2
Hazardous to the aquatic environment (chronic): Category 2
Information submitted to Secretariat of the Rotterdam Convention From Japan
Information on Hexa BDE, Hepta BDE, Tetra BDE
January 17, 2011
Information requested by the E-mail on 18, Nov, 2010
Information submitted from Japan
(1)
-
Section 3 information of Final Regulatory Measures from
Japan on Hexa BDE, Hepta BDE, Tetra BDE
-
Item 3.1: Other classification systems
Hexa BDE
Japan CSCL : Class I Specified Chemical Substance
Hepta BDE
Japan CSCL : Class I Specified Chemical Substance
Tetra BDE
Japan CSCL : Class I Specified Chemical Substance
For other items of Section 3 not filled in Japan’s FRM notifications, Japan does not have
information for these columns.
(2) Supporting document of Japan’s notifications on Final
-
Regulatory Action regarding
Hexa BDE, Hepta BDE, Tetra BDE
The Chemical Substances Control Law (CSCL) and its Enforcement Order
URL: http://www.meti.go.jp/policy/chemical_management/english/files/CSCL_English.pdf
-
Full text of CSCL (text not reflecting the latest revision in 2009)
URL: http://www.env.go.jp/en/laws/chemi/cscl/CSCL_law.pdf
-
Full text of CSCL Enforcement Order (text not reflecting the latest revision in 2009)
URL: http://www.env.go.jp/en/laws/chemi/cscl/CSCL_CO.pdf
(3) Any documentation referenced in the notification
“Report of the Persistent Organic Pollutants Review Committee
on the work of its second meeting Addendum Risk profile on commercial pentabromodiphenyl
ether” (UNEP/POPS/POPRC.2/17/Add.1)
“Report of the Persistent Organic Pollutants Review Committee on the work of its third meeting
Addendum Risk profile on commercial octabromodiphenyl ether”
(UNEP/POPS/POPRC.3/20/Add.6)
(4) Trade name of PFOS, PentaBDE, HeptaBDE, HexaBDE,
1763-23-1 (PFOS-H)： Sumiresist PAR-707A2E
Sumiresist TS-1896A35
TetraBDE
For other chemicals, there has been no trade recent years in Japan, so there are no trade
names.
Additional information regarding the final regulatory action on PFOS and its salts,
PBDE, pentachlorobenzene, and octa BDE
by the Government of Japan
18 March, 2011
I. Evaluation on the individual chemical substances subject to the final regulatory action
・ Evaluations on biodegradability, bioaccumulation potential, and long-term toxicity for
humans or ecological systems are conducted by a joint deliberative meeting council with
experts established by the Ministry of Health, Labour and Welfare, Ministry of Economy,
Trade and Industry, and Ministry of the Environment based on the CSCL. They are
designed to determine the designation of chemical substances as the Class I Specified
Chemical Substance subject to regulatory actions including the prohibition of the
manufacture/import with some exceptions.
・ As for PFOS and its salts, PBDE, pentachlorobenzene, and octa BDE, evaluations on
biodegradability, bioaccumulation potential, and long-term toxicity were conducted on the
basis of available information including the risk profiles prepared for the Stockholm
Convention. As a result, they were designated as the Class I Specified Chemical
Substances.
・ Following the completion of the aforementioned evaluations on biodegradability,
bioaccumulation potential, and long-term toxicity, evaluations from the perspective on their
use and risk
were conducted to decide on regulatory actions including the prohibition of
import of products using Class I Specified Chemical Substances, limited usages allowed
exceptionally in cases which they are essential in the manufacture of products (essential
use), and recall of the said product.(see attachment I)
Individual outcomes of the evaluations are as follows.
・ With respect to pentachlorobenzene and octabromodiphenyl ether commercial mixtures, it
has been determined that little risk exists associated with them on the ground that no record
of their manufacture/import/use exists in Japan, and therefore no environmental pollution
has been confirmed to date in Japan. Moreover, this trend is most likely to continue in the
years to come. These findings led to the conclusion that implementation of the prohibition of
import of a product using a Class I Specified Chemical Substance and recall of the said
product is not necessary.
・ With respect to PFOS and its salts, and pentabromodiphenyl ether commercial mixtures,
the import prohibition was placed on products using these chemical substances that might
possibly be imported into Japan in the future, and would pose a risk of environmental
1
pollution in the case that there was no import restriction in place, given their usages and
waste disposal. This decision was based on outcomes from a survey conducted to
investigate the status of domestic use of the Class I Specified Chemical Substances, status
of import of products using them, and status of their use in foreign countries.
・ Furthermore, while PFOS and its salts have been manufactured/imported/used
domestically, they are allowed exceptionally in cases where they are essential in the
manufacture of products, as far as it can be judged based on the data from an
environmental risk evaluation that there is no risk of environmental pollution. (See the
attachment I)
・ Attached materials (Attachment II, III, and IV) to the present note are a material prepared by
the joint deliberative meeting council that includes contents related to the evaluations on
biodegradability, bioaccumulation potential, and long-term toxicity as well as risk evaluation.
They are available only in Japanese.
・ For the reference purpose, the abstract of the material mentioned above has been
prepared in English and attached to the present note as attachment I.
2
II. Relevant legal system in Japan-CSCL
(A provisional English translation of the CSCL is found in attachment V)
The CSCL is designed to prevent environmental pollution due to chemical substances that have
properties of persistency with a possibility to pose a risk of impairing human health or the
inhabitation and/or growth of flora and fauna.
Under the CSCL, a review is undertaken to determine whether or not chemical substances have
properties 1-4 listed below. Considerations are also made in conducting the review to reflect a
possibility of their releases to the environment with focus on factors such as a method of handling
chemical substances and their amounts used/imported.
1.
Degree to which the chemical transformation occurs through natural processes
(Biodegradability)
2.
Degree to which chemical substances accumulate in organisms (Bioaccumulation
potential)
3.
Degree to which human health can be impaired with a continuous ingestion (Long-term
toxicity for humans)
4.
Degree to which the inhabitation and/or growth of flora and fauna are impaired
(Ecological toxicity)
Depending on the hazardous properties of given chemical substances, they are classified into the
Class I Specified Chemical Substance, Class II Specified Chemical Substance, Type I Monitoring
Chemical Substance, Type II Monitoring Chemical Substance, and Type III Monitoring Chemical
Substance.
The following actions are to be conducted in accordance with the classification.
Note that while the following descriptions only include perspectives on biodegradability,
bioaccumulation potential, and toxicity, regulatory actions are determined based on the results of
the review that reflects a possibility of releases of chemical substances to the environment with
focus on factors such as their usages and amounts used/imported, as mentioned above.
1.
Class I Specified Chemical Substance (for example, PCB)
・ Chemical substances that are persistent, highly bioaccumulative, and have long-term
toxicity for humans or chronic toxicity for animals at the top of the food chain.
・ Regulatory actions include prior permission required for manufacture and/or import,
restriction on use, restriction of import of certain products specified by a Cabinet order,
implementation of recall and other measures.
・ These actions are subject to the notification of the final regulatory action.
3
2.
Class II Specified Chemical Substance (for example, trichlorethylene)
・ Chemical substances that are persistent, and have long-term toxicity for humans or
flora and fauna in the human living environment
3.
Type I Monitoring Chemical Substance
・ Existing chemicals that are found to have persistency with a high bioaccumulation
potential
4.
Type II Monitoring Chemical Substance(for example, chloroform）
・ Chemical substances that are not highly bioaccumulative, but persistent with
suspected long-term toxicity for humans
5.
Type III Monitoring Chemical Substance
・ Chemical substances that are persistent and have toxicity for flora and fauna in general
(ecological toxicity)
The CSCL was amended in 2009, and the following schemes 1-3 will be introduced in April, 2011.
And yet The designation criteria and regulatory actions with respect to the Class I Specified
Chemical Substance for which the final regulatory action applies basically remain unchanged.
1.
Mandatory reporting of actual amounts manufactured and/or imported to be imposed on
businesses who manufacture/import more than a certain amount of chemical substances
including the existing ones.
2.
Priority to be determined to select priority assessment chemical substances subject to
detailed risk evaluation, based on the reports mentioned above and existing knowledge
concerning hazard.
3.
Subsequently, hazardous chemical substances and products using them can be made
subject to regulatory actions designed to restrict their manufacture/use.
4
List of Attachments
Attachment I:
Future measures for 9 types of chemical substances (12 chemical
substances) deemed appropriate as Class I Specified Chemical Substances
(Abstract of the Council document in English)
Attachment II:
Future measures for 9 types of chemical substances (12 chemical
substances) deemed appropriate as Class I Specified Chemical Substances
(Full text of the Council Document in Japanese)
Attachment III:
A Preliminary Environmental Risk Assessments on PFOS and its salts
(document provided for the Council’s evaluation, full text in Japanese)
Attachment IV:
A Risk Assessment of PFOS and its salts (document provided for the
Council’s evaluation, full text in Japanese)
Attachment V:
A provisional English translation of the CSCL
Attachment VI:
Main points of CSCL amendments (presentation material in English)
5
Attachment I
Future measures for 9 types of chemical substances
(12 chemical substances) deemed appropriate as
Class I Specified Chemical Substances
(Abstract)
2. Regulatory measures in connection with designation of Class I Specified Chemical Substances
2-2. Usage (essential use) permitted with the use of Class I Specified Chemical Substances
(2) Risk of causing damage pertaining to human health or damage pertaining to the growth of
flora and fauna in the human living environment through environmental pollution attributable to
the use of Class I Specified Chemical Substances
Other than the three usages (i.e., (i) Production of etching agent (limited to ceramic filter or the
compound-semi-conductor which makes it possible for the radio equipment to send and receive an equal
to or more than 3 MHz frequency electric wave), (ii) Production of photo-resist for semi-conductor, and
(iii) Production of photographic film for industry), PFOS or its salts have been used to date in the
manufacturing of the anti-reflective coating for semi-conductor, industrial surface preparation agent for
metal plating, and fire-fighting foam, etc.
The initial ecological risk assessment of PFOS and its salts was conducted on the basis of environmental
monitoring data collected from FY2002 through FY2007 by the Ministry of the Environment. It was
shown that the estimated maximum exposure amount based on environmental concentrations was below
the acceptable amounts (i.e., the no observed adverse effect level for humans /estimated
no-observed-effect concentration for flora and fauna in the human living environment based on toxicity
data with respect to PFOS and its salts).
Meanwhile, the risk evaluation focusing on the Tokyo Bay was conducted by the NITE (Incorporated
Administrative Agency, National Institute of Technology and Evaluation). The results showed that
environmental concentrations of PFOS and its salts decreased rapidly in association with the reduction
of their releases. The risk evaluation taking into account biological concentration caused by the said
three usages and the use of fire-fighting foam at the time of an accident also showed that the estimated
maximum exposure amount was below the acceptable amount/acceptable concentration for humans,
flora and fauna in the human living environment, and predator animals at higher trophic level (refer to
reference material 8).
If the use of PFOS and its salts remained restricted to the three usages in years to come that have low
substitutability, from the perspective of regulations such as the Act on the Evaluation of Chemical
Substances and Regulation of Their Manufacture, etc, based on currently available information, it could
be judged that they pose little risk of causing damage to humans, and flora and fauna in the human living
environment, considering that their amount used would decrease, followed by their reduced releases to
the environment.
In addition, it would become possible to reduce their releases to the environment by making sure that the
relevant businesses comply with technical guidelines as for the said three usages.
1
Table 2-3. Initial environmental risk evaluation for PFOS and its salts based on environmental
monitoring data
○
Health Risk
Acceptable Human
Intake*
Estimated Maximum
Exposure Amount
μg/kg/day
Drinking water/food
0.0067
approximately
0.3 μg/kg/day
Ground water/food
0.01 μg/kg/day
*No observed adverse effect level, etc divided by safey factor 100.
μg= Fraction of a millionth of a gram
○ Ecological Risk
Estimated
Estimated Maximum
No-Observed-Effect
Exposure Amount
Concentration*
Public water area
11 μg/L
/fresh water
23 μg/L
Public water area
0.028 μg/L
/sea water
*Calculated with safety factor 10.
【Source】Ministry of the Environment “Environmental Risk Evaluation of Chemicals (6th editio
n)”(Reference): As for toxicity data, data with the most severe toxicity were used derived from
various toxicity assays
Table 2-4. Results from the Environmental Survey of Chemicals
with respect to PFOS (FY14-FY17)
Organism(μg/g-wet)
Water
Bottom sediment
(μg/L)
(μg/g-dry)
Shellfish
Fish
No. detected
/sample No.
FY14
FY15
FY17
60/60
-
-
-
Detection range
0.00007-0.024
-
-
-
Detection limit
No. detected
/sample No.
0.00004
-
-
-
-
25/60
-
27/27
Detection range
-
0.00011-0.0015
-
0.00016-0.016
Detection limit
-
0.000096
-
0.000033
No. detected
/sample No.
Detection range
21/21
21/21
17/18
55/57
0.00009-0.016
0.000026-0.00085
0.000018-0.0016
0.0066-0.025
Detection limit
0.00005
0.0000072
0.000018
0.000018
【Reference】 Ministry of the Environment “Chemicals in the Environment”
2
(3) Permitted usage
According to the discussions made above, it is appropriate to make exceptions to permit the use of PFOS
and its salts, as for the following 3 usages (the expressions are subject to future changes).
It is hoped, however, that substitutions will be made with safer alternatives as soon as possible through
various means such as technological development in the future, even for these usages. The competent
ministers need to verify the status of use and progress toward substitutions.
Also, the competent ministers need to implement environmental monitoring surveys of the 12 substances
on a continuing basis, particularly of PFOS and its salts whose use is permitted.
1. Manufacturing of the photosensitive film of semiconductors
2. Manufacturing of the etching agent for the piezoelectric ceramic filter or composite
semiconductor for high frequency band
3. Manufacturing of photographic film for industrial use
2-5. Other necessary measures
Where any chemical substance has been designated as a Class I Specified Chemical Substance or any
product has been designated as a product using a Class I Specified Chemical Substance, if the competent
ministers find it particularly necessary for preventing the spread of environmental pollution, they may, to
the extent necessary, order persons who were operating the business of manufacturing or importing said
chemical substance or said product to make efforts to recall said chemical substance or said product
(Article 22 of the revised Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc).
Also, the competent ministers may make any necessary recommendation concerning a restriction on the
manufacture, import, use of said chemical substance or said product (Article 29 of the revised Act on the
Evaluation of Chemical Substances and Regulation of Their Manufacture).
Currently, out of the 12 chemical substances, only PFOS, its salts and PFOSF are manufactured,
imported and used domestically. As for usages other than the 3 usages permitted after their designation
as a Class I Specified Chemical Substance, their substitutions had been completed, or efforts are under
way to enable their substitutions.
Also, currently, it can be said that little risk exists that causes damage to humans, and flora and fauna in
the human living environment through environmental pollution attributable to PFOS and its salts, as
discussed above.
In addition, as for the 11 chemical substances other than PFOS, environmental pollution has not been
confirmed due to their uses in the past that requires efforts to recall them.
Accordingly, the necessity has not been confirmed so far to issue order to recall said products, or make a
recommendation concerning the restriction of their manufacturing, import and use.
It is necessary, however, to deal appropriately with stockpiles of products using PFOS and its salts no
longer necessary according to the relevant regulations for disposal, if there are any substitutes available.
3
資料２
第一種特定化学物質に指定することが適当とされた
ペルフルオロ（オクタン－１－スルホン酸）（別名ＰＦＯＳ）
又はその塩など
９種類の物質（１２物質）の今後の対策について
平成２１年７月２３日（木）
厚生労働省医薬食品局審査管理課化学物質安全対策室
経済産業省製造産業局化学物質管理課化学物質安全室
環境省総合環境政策局環境保健部企画課化学物質審査室
１．検討の背景
「残留性有機汚染物質に関するストックホルム条約」（以下、「ストックホルム条約」
という。）では、難分解性、生物蓄積性、毒性及び長距離移動性を有する残留性有
機汚染物質を定め、人の健康の保護、及び環境の保全を図るため、各国が国際的
に協調して、当該物質の製造・使用・輸出入を原則的に禁止する等の措置を講じる
こととされている。我が国は、これまで条約の対象物質については、「化学物質の審
査及び製造等の規制に関する法律」（以下、「化審法」という。）、「農薬取締法」、
「薬事法」、及び「外国為替及び外国貿易法」に基づき、所要の措置を講じてきた。
化審法においては、条約の廃絶・制限の対象となった物質については、第一種特
定化学物質に指定し、その製造、使用等を制限することにより、同条約の義務を履
行してきた。
今般、本年５月に、ストックホルム条約の第４回締約国会議が開催され、ペルフル
オロ（オクタン－１－スルホン酸）（以下「ＰＦＯＳ」という。）等の９種類の化学物質（１２
物質）を新たに同条約の廃絶・制限の対象物質とすることが決定された。これら１２
物質については、締約国会議の下部会合である残留性有機汚染物質検討委員会
において、科学的知見に基づき検討され、締約国会議に対して廃絶・制限等に関
する提案がなされたものである。今後、締約国各国に対して、条約事務局より、１２
物質を対象物質に追加すること等に関する決定の通知がなされると、締約国は通
知から１年以内に、決定を遵守するための所要の措置を講じることとなっている。
本年６月２６日に、化学物質審議会審査部会及び中央環境審議会環境保健部
会化学物質審査小委員会において、新たに条約の対象となった１２物質について
は、難分解性、高蓄積性であり、人や高次捕食動物への毒性を有するものであるこ
とから、化審法の第一種特定化学物質に指定することが適当であるとの結論が得ら
れた（薬事・食品衛生審議会薬事分科会化学物質安全対策部会においては７月23
日に審議）。今後、これら１２物質を第一種特定化学物質に指定するにあたっての
化審法上の所要の措置について検討する必要がある。
1
表２－１．新たにストックホルム条約の対象となった１２物質
物質名称
締約国の
主な用途
現在の
化審法上の扱い
①ペルフルオロ（オクタン－１－スルホン
酸）（別名ＰＦＯＳ）又はその塩
撥水撥油剤、
界面活性剤
第二種監視化学物質
②ペルフルオロ（オクタン－１－スルホニ
ル）＝フルオリド（別名ＰＦＯＳＦ）
ＰＦＯＳ、その塩、
又はＰＦＯＳ類縁
物質の原料
既存化学物質
③ペンタクロロベンゼン
農薬
既存化学物質
④ｒ－１，ｃ－２，ｔ－３，ｃ－４，ｔ－５，ｔ－６
－ヘキサクロロシクロヘキサン（別名ア
ルファ－ヘキサクロロシクロヘキサン）
リンデンの副生
成物
既存化学物質
⑤ｒ－１，ｔ－２，ｃ－３，ｔ－４，ｃ－５，ｔ－６
－ヘキサクロロシクロヘキサン（別名ベ
ータ－ヘキサクロロシクロヘキサン
リンデンの副生
成物
既存化学物質
⑥ｒ－１，ｃ－２，ｔ－３，ｃ－４，ｃ－５，ｔ－６ 農薬
－ヘキサクロロシクロヘキサン（別名ガ
ンマ－ヘキサクロロシクロヘキサン又
はリンデン）
既存化学物質
⑦デカクロロペンタシクロ［５．３．０．０２，
６
．０３，９．０４，８］デカン－５－オン（別名
クロルデコン）
農薬
新規化学物質
⑧ヘキサブロモビフェニル
難燃剤
新規化学物質
⑨テトラブロモ（フェノキシベンゼン）（別
名テトラブロモジフェニルエーテル）
難燃剤
既存化学物質
⑩ペンタブロモ（フェノキシベンゼン）（別
名ペンタブロモジフェニルエーテル）
難燃剤
新規化学物質
⑪ヘキサブロモ（フェノキシベンゼン）（別
名ヘキサブロモジフェニルエーテル）
難燃剤
既存化学物質
⑫ヘプタブロモ（フェノキシベンゼン）（別
名ヘプタブロモジフェニルエーテル）
難燃剤
新規化学物質
２．第一種特定化学物質の指定に伴う規制措置について
第一種特定化学物質の指定に伴う規制措置については、本年５月に公布された
化審法の一部を改正する法律（以下「一部改正法」という。）において、ストックホル
2
ム条約における例外的使用の規定との整合を図り、その使用にあたっての厳格な
管理を実施する観点から、所要の見直しが行われた。改正化審法の施行について
は、一部改正法の附則により公布後１年以内に施行することとされており、本年５月
のストックホルム条約の決定に対応するための措置については改正化審法の施行
によって対応することとなる。他方で、ストックホルム条約で決定された事項について
は、その通知より１年以内に国内での実施措置を完了させる必要がある。したがっ
て、改正化審法の施行日については来年４月を目途に検討を進めることとするのが
適当である。なお、第一種特定化学物質に指定された場合、改正化審法によって、
具体的には主に以下の規制が行われる。
１） 第一種特定化学物質の製造・輸入は、国による事前の許可が必要となる。許
可の基準は、主に、製造・輸入数量が需要量に照らし過大でないことのほか、
別途定める製造設備に関する技術上の基準に適合していることである。
２） 第一種特定化学物質の使用は、政令で指定された用途（いわゆるエッセンシ
ャルユース）以外は禁止される。指定された用途についての使用者はあらか
じめ国に使用の届出をしなければならない。
３） 第一種特定化学物質、又は政令で指定された製品で第一種特定化学物質
が使用されているものについては、その取扱事業者に、別途定める取扱上の
技術基準に従う義務及びその使用に関し環境汚染を防止する措置等に関す
る表示の義務が課される。
４） 政令で指定された製品で、第一種特定化学物質が使用されているものにつ
いては、その輸入が禁止される。
５） 環境の汚染を防止するために必要であると認められる場合は、第一種特定
化学物質又はその使用製品を指定する際に、それらの製造・輸入業者に当
該製品等の回収等の必要な措置をとるべきことを命令することができる。
※ 上記の１）～５）のうち、第一種特定化学物質の使用を認める用途（エッセンシャルユー
ス）、第一種特定化学物質が使用されている場合に技術上の基準適合義務や表示義
務がかかる製品、及び、第一種特定化学物質が使用されている場合に輸入を禁止す
る製品の指定については、審議会の付議事項となっている（改正化審法第４１条）。
これらの措置を具体的にどのように講じる必要があるかを検討するために、我が
国おける１２物質の最新の製造・輸入・使用の実態についての調査を本年３月３日
から４月２０日にかけて実施した。調査の実施にあたっては、経済産業省のホームペ
ージに掲載しつつ、化学物質の製造事業者や輸入事業者等に対して、広く調査へ
の協力を依頼した。調査方法は次のようなものである。
3
・調査対象物質の製造・輸入事業者と含有製品の輸入事業者に、製造・輸入・出
荷・使用の状況等に関する調査票の記載を依頼。
・製造・輸入事業者からサプライチェーンを通じて使用事業者に当該調査票を伝
達してもらい、使用事業者に調査票の記載を依頼。
・製造・輸入事業者及び使用事業者から、調査対象物質に関する自社製品につ
いての過去３年間（平成１８年４月～平成２１年３月）の製造・輸入・出荷・使用の
状況等について記載した調査票を、行政が直接回収。
なお、調査の実施にあたっては、調査結果を化審法における所要の措置を講じ
る上での基礎資料とする旨、また、調査結果を踏まえて代替が困難である場合の用
途の指定を検討する旨を明記した。
２－１．第一種特定化学物質の製造・輸入の許可の今後の見通しについて
今回規制対象となる１２物質のうち、上記の実態調査の結果、我が国で過去３年
間において製造・輸入の実態があったのは、ＰＦＯＳ又はその塩とペルフルオロ（オ
クタン－１－スルホニル）＝フルオリド（以下「ＰＦＯＳＦ」という）のみであった。
ＰＦＯＳ又はその塩については、平成１４年度に第二種監視化学物質に指定され
ており、過去の製造・輸入数量についての届出は、毎年、合計１０トン前後で推移し
てきている。これらのうち大半は国内に出荷されており、半導体用反射防止剤、レジ
スト、金属メッキのミスト防止剤、泡消火薬剤などを製造する際に、用途により０．００
０５～１５．０％程度の範囲で添加されてきたが、今般のストックホルム条約による規
制の動向を踏まえ、関連業界では、代替物質への転換が進められており、平成２０
年度の製造・輸入量は減少している。この傾向は平成２１年度も続くものと予想され、
特に平成２２年度以降は、後述（２－２参照）のように代替が困難で使用を認める用
途等の需要を満たす範囲でしか製造・輸入がなされないこととなると、その数量は更
に減少することが見込まれる。
ＰＦＯＳ又はその塩以外のＰＦＯＳＦを含む１１物質については、後述（２－２参照）
のように、現状において、代替が困難で使用を認める用途がないことから、試験研
究用を除いて、今後、国内で、製造・輸入の許可がなされる見通しはない。なお、我
が国で過去３年間において製造・輸入の実態があったＰＦＯＳＦについては、上記の
実態調査の結果、平成２２年度以降の製造・輸入の予定はなかった（使用の予定も
なかった）。
4
表２－２．ＰＦＯＳ又はその塩に関する過去３年間の製造・輸入数量
（単位：トン）
製造数量
輸入数量
国内出荷量
輸出
平成１８年度
6.5
0.2
6.7
0.1 未満
平成１９年度
8.0
0.3
8.5
0.1 未満
平成２０年度
5.5
0.3
6.2
0.1 未満
（化審法に基づく届出数量、経済産業省調査）
今後、第一種特定化学物質としてその製造・輸入を許可することが想定されるの
はＰＦＯＳ又はその塩のみであると見込まれることから、設備の整備には時間を要す
ることにかんがみ、必要に応じ、あらかじめ、ＰＦＯＳ又はその塩の製造設備につい
て、技術上の基準を策定する必要がある。なお、現状において、予定している者は
ないものの、ＰＦＯＳＦからＰＦＯＳ又はその塩を製造する場合や、ＰＦＯＳ塩からＰＦＯ
Ｓのその他の塩を製造する場合は、第一種特定化学物質の製造と同時に第一種特
定化学物質の使用にあたるため、後述（２－２）の使用を認める用途に指定すること
についての検討が必要になりうる点についての留意が必要である。技術上の基準
の策定にあたって考慮すべき主な要素としては、以下のようなものが考えられるが、
策定の際には、これらを基本とし、必要に応じて、専門家の意見を聴取する。
【製造設備の技術上の基準の策定にあたって考慮すべきと考えられる主な要素】
・ 想定される反応プロセス等に適切に対応して製造設備が設計されていること
・ 当該第一種特定化学物質による腐食やその漏洩を防止するための適切な材
料が製造設備に用いられていること
・ 投入される原材料と製造される第一種特定化学物質の収支を適切に管理でき
る機能を有していること
・ 未反応物や精製後の残渣を含めて、第一種特定化学物質の環境中への放出
が最小限になるよう十分な機能を備えていること。
２－２．第一種特定化学物質の使用を認める用途（エッセンシャルユース）について
ストックホルム条約では、廃絶・制限の対象となった物質について、他の物質への
代替が困難である場合、人へのばく露及び環境への放出を防止し又は最小限にす
るような方法で行われていることを確保するための適当な措置がとられていることを
条件に、締約国会議で合意された用途については、製造又は使用等についての禁
止の適用を除外する仕組みがある。今般、ストックホルム条約の対象物質に追加さ
れることが決定した１２物質についても、製造・使用等の禁止に関する適用除外とす
る用途が認められている。１２物質のうち、我が国で使用の実態がある（※後段で詳
5
述）ＰＦＯＳ又はその塩については、半導体（反射防止剤・レジスト、特定のエッチン
グ液）、写真感光材料、泡消火薬剤等の用途を適用除外とすることが認められてい
る。
他方、改正化審法でも同様に、（１）他の物による代替が困難であり、かつ、（２）
第一種特定化学物質が使用されることにより、環境の汚染が生じて人の健康に係る
被害又は生活環境動植物の生息若しくは生育に係る被害を生ずるおそれがないこ
とを、第一種特定化学物質の使用を認めることのできる要件として掲げている（改正
化審法第１４条）。したがって、ストックホルム条約において認められた適用除外の
用途のうち、我が国における現状に照らして、上記の（１）、（２）を満たしたものにつ
いては、当該第一種特定化学物質の使用を認めることが可能である。なお、認めら
れた用途について第一種特定化学物質を使用しようとする者は、改正化審法に基
づき、使用する第一種特定化学物質の名称、用途等を主務大臣に届け出る義務
が生じる。また、第一種特定化学物質及びこれを使用した製品については、後述
（２－３参照）する取扱上の技術上の基準に適合する義務が生じ、第一種特定化学
物質を使用した製品については表示の義務が生じる。
（１）他の物による代替が困難である事例
上記の実態調査の結果、我が国で過去３年間において使用の実態があったのは、
１２物質のうちＰＦＯＳ又はその塩とＰＦＯＳＦのみであった。ＰＦＯＳ又はその塩に関し
ては、１２物質を第一種特定化学物質として指定する改正化審法の施行（来年４月
を予定）以降において、継続して使用の予定があり、他の物質又は物による代替が
困難であると判断される事例としては、以下の３つがあった。個別の事例については、
事業者等に対して綿密なヒアリング調査等を実施した。ＰＦＯＳＦに関しては、ＰＦＯＳ、
その塩、ＰＦＯＳ類縁物質の製造に使用されているが、改正化審法の施行以降の使
用の予定は確認されなかった。
①半導体用のレジストの製造
②圧電フィルタ用又は高周波に用いる化合物半導体用のエッチング剤の製造
③業務用写真フィルムの製造
なお、他の物による代替が困難であるかについては、個別の用途ごとに、第一種
特定化学物質（この場合ＰＦＯＳのこと）と、当該第一種特定化学物質以外の化学物
質又はその他の物を用いた場合とを比較して、当該用途において求められる機能・
性能が同等程度実現されているかといった観点等から総合的に勘案して判断する
こととなる。具体的には、例えば、機能・性能等が同等程度実現されている代替物
質（又は物）が存在しない場合は、代替困難と判断される。
6
①半導体用のレジストの製造
・ 半導体用のレジストとは、樹脂（ポリマー）、感光剤、添加剤、溶剤を主成分と
する混合物（調剤）で、半導体の製造に使用される（感光性を有するため、フォ
トマスクを用いて露光・現像を行うことにより、半導体の表面に画像層のパター
ンを形成することに使用される）。
・ 最先端の微細なパターンを持つ半導体の製造においては、従来、ＰＦＯＳ又は
その塩を感光剤とするレジストが用いられている。
・ レジストは、高度な計算のもと、特定のパターンを形成するために、特定の樹脂
に対して、非常に酸性の強い有機酸で特定の拡散度を持つ感光剤を組み合
わせて製造される。そのため、感光剤を代替物質に置き換えるには強い有機
酸であり、かつ、同様の拡散度を持つことが要求される。しかしながら、特に、
拡散度は感光剤の鎖長に支配されるため、感光剤としてＰＦＯＳ又はその塩を
使用している場合、ＰＦＯＳ又はその塩と同様の鎖長を持つ強酸性の物質は見
つかっていない。
・ また、市販の半導体の製造に関して、特定のパターンの形成のために特定の
樹脂に対する特定の感光剤という組合せとなっているＰＦＯＳ又はその塩が使
用されているレジストについて、感光剤をＰＦＯＳ又はその塩以外の代替物質
に代替した上で、半導体としての同様の性能を保ちつつパターンを変え、かつ、
パターンを実現するために新たに代替物質に対応する樹脂に変更することも
非常に困難である。
・ したがって、既に上市されている特定の半導体用のレジストの製造は、ＰＦＯＳ
又はその塩を使用する以外の代替手段がない状況であり、代替が困難と判断
される。
・ 仮に、半導体用のレジストの製造にＰＦＯＳ又はその塩を使用することをエッセ
ンシャルユースとして認めない場合、最先端の半導体が使用されているＩＴ製
品の供給に甚大な影響が出ることが想定される。
・ なお、現在のところ、関連業界では、今後、新たに開発される半導体の製造に
使用するレジストについては、ＰＦＯＳ又はその塩を使用しない感光剤と樹脂、
パターンの組合せに変更するよう開発が進められているが、開発には長期間を
要すると言われている。
7
②の１
圧電フィルタ用エッチング剤の製造
・ 圧電フィルタとは、特定の周波数を選択的に通過させ、受信感度を高めるため
の電子部品であり、ＦＭラジオ、ＴＶ、コードレス電話などの汎用品だけでなく警
察無線にも使用されている。
・ 圧電フィルタ用のエッチング剤とは、圧電フィルタを製造する際に、圧電素子
の表面の電極を設定したパターンどおりに溶解する強酸の水溶液である。
・ パターンは電極の間隔が数百μｍ以下の微細なものであり、エッチングの際に
気泡が発生し電極表面に付着すると、溶け残りが発生し正確なパターンが形
成されない。
・ 気泡を発生させないためには、強酸の中でエッチング溶液の表面張力を安定
して下げる必要があり、エッチング剤に高い界面活性効果を持つＰＦＯＳ又は
その塩を添加している。
・ 現在のところ、関連業界では代替物質の開発が進められている段階であるが、
ＰＦＯＳ又はその塩に替わる物質は見つかっていない。また、圧電フィルタの性
能を維持するため、電極の間隔を気泡が発生しても問題が生じない範囲まで
広げることは困難である。
・ したがって、圧電フィルタ用のエッチング剤の製造は、ＰＦＯＳ又はその塩を使
用する以外に、代替手段がない状態にあり、代替困難と判断される。
・ 仮に、圧電フィルタ用のエッチング液の製造にＰＦＯＳ又はその塩を使用するこ
とをエッセンシャルユースとして認めない場合、圧電フィルタが使用されている
ＦＭラジオ、ＴＶ、コードレス電話などの汎用品や警察無線の供給に甚大な影
響が出ることが想定される。
②の２ 高周波に用いる化合物半導体用のエッチング剤の製造
・ 高周波に用いる化合物半導体とは、大容量通信を可能とする電子部品であり、
携帯電話や衛星放送の受信設備等のＩＴ機器に多く使用されている。
・ 高周波に用いる化合物半導体用のエッチング剤とは、高周波に用いる化合物
半導体を製造する工程において、基盤に微細なリセス（溝）を形成させる強酸
の水溶液である。
・ リセスは、数μm 単位の微細なものであり、エッチング形状、エッチング表面を
均質に得る必要がある。
・ そのためには、均一に溶解し、分解、吸着されず、表面に残留しないような界
面活性剤の添加が求められるところ、このような機能・性能を持つＰＦＯＳ又は
その塩がエッチング剤に添加されている。
・ 現在のところ、関連業界では代替物質の開発が進められている段階であるが、
ＰＦＯＳ又はその塩に替わる物質は見つかっていない。また、高周波に用いる
8
化合物半導体の性能を維持するためには、リセスの形状のガタつきやエッチン
グ表面の荒れを抑えて、エッチング形状、エッチング表面を均質に得る必要が
ある。
・ したがって、高周波に用いる化合物半導体用のエッチング剤の製造は、ＰＦＯ
Ｓ又はその塩を使用する以外に、代替手段がない状態にあり、代替困難と判
断される。
・ 仮に、高周波に用いる化合物半導体用のエッチング液の製造にＰＦＯＳ又はそ
の塩を使用することをエッセンシャルユースとして認めない場合、携帯電話や
衛星放送の受信設備等の大容量を通信しているＩＴ機器の供給に甚大な影響
が出ることが想定される。
③業務用写真フィルムの製造
・ 業務用写真フィルムとは、光や放射線などを用いた画像情報を記録するため
のメディアのうち、映画や印刷といった用途に用いられるものを指す。
・ 業務用写真フィルムは極めてムラが少ない精緻な画像の再現を可能とする記
録メディアであることが求められ、これを実現するべく、感材の正帯電を防止し、
高速で均一に塗布されるような動的表面張力を有し、フィルム内や現像液中で
析出しないような溶解性を有するＰＦＯＳ又はその塩が写真用フィルムに添加さ
れている。
・ 現在のところ、関連業界では代替物質の開発が進められている段階であるが、
ＰＦＯＳ又はその塩に替わる物質は見つかっていない。
・ したがって、業務用写真フィルムの製造は、ＰＦＯＳ又はその塩を使用する以外
に、代替手段がない状態にあり、代替困難と判断される。
・ 仮に、業務用写真フィルムの製造にＰＦＯＳ又はその塩を使用することをエッセ
ンシャルユースとして認めない場合、映画用フィルムや印刷用フィルムの画像
の精度が落ち、フィルムの機能が低下することが想定される。
（２）第一種特定化学物質の使用による環境の汚染を通じた人の健康に係る被害又は
生活環境動植物の生息若しくは生育に係る被害を生ずるおそれ
ＰＦＯＳ又はその塩は、（１）の３つの事例の他にも、半導体用反射防止剤や工業
用のメッキ処理剤、泡消火薬剤などを製造する際にこれまで使用されてきた。
環境省が平成１４年度から１９年度に実施した環境モニタリングデータに基づいて
ＰＦＯＳ及びその塩に関する環境リスク初期評価を実施し、環境濃度を基にした予
測最大ばく露量と、ＰＦＯＳ及びその塩の毒性データを基にした人及び生活環境動
植物の無毒性量・予測無影響濃度を比較した結果、許容量等の方が大きかった。
なお、本環境リスク評価においては、今後更なる情報収集等に努める必要があると
9
されている（参考資料７参照）。
また、東京湾をモデルとして NITE（独立行政法人 製品評価技術基盤機構）が行
ったリスク評価では、ＰＦＯＳ又はその塩の排出削減に伴って速やかに環境濃度が
低下するとの結果とともに、(１)の 3 つの事例及び泡消化薬剤の事故時の使用を前
提として生物濃縮を加味したリスク評価によって、予測最大暴露量が人、生活環境
動植物及び高次捕食動物の許容量・許容濃度より小さくなるとの結果が得られてい
る（参考資料８参照）。
今後、ＰＦＯＳ又はその塩の使用を（１）の代替困難な３用途に限定した場合、従
前よりもＰＦＯＳ又はその塩の使用量が減少するため、環境中への排出量が減少す
ることをかんがみれば、現時点で得られている情報に基づき、化審法による規制等
の観点から、当該３種類の用途による人又は生活環境動植物への被害を生ずるお
それがあるとは言えないと判断できる。加えて、当該３種類の用途については、今後、
取扱事業者が取扱上の技術指針を遵守することで、環境中への排出量を低減する
ことが可能である。
表２－３．環境モニタリングデータに基づくＰＦＯＳ及びその塩の環境リスク初期評価
○ 健康リスク
人の許容摂取量（注）
飲料水／食物
0.3 μg／kg／day
地下水／食物
予測最大暴露量
0.0067
μg／kg／day
程度
0.01 μg／kg／day
（注）無毒性量等を不確実係数を１００として除したもの。μg=百万分の１グラム
○ 生態リスク
予測無影響濃度(注)
公共用水域・淡水
公共用水域・海水
23 μg／L
予測最大暴露量
11 μg／L
0.028 μg／L
（注）不確実係数を１０として計算。
【出典】環境省 「化学物質の環境リスク評価（第６巻）」
（参考）：毒性データは、各種の毒性試験により得られたデータのなかで最も強い毒性を示
したものを使用。
10
表２－４．ＰＦＯＳに関する化学物質環境実態調査結果（平成１４～１７年度）
検出数／検体数
平成 14
底質
(μg/L)
(μg/g-dry)
貝
魚
-
-
-
0.00007～
-
-
-
0.00004
-
-
-
検出数／検体数
-
25/60
-
27/27
検出範囲
-
0.00011～
-
0.00016～
検出範囲
0.024
検出限界値
年度
0.0015
検出限界値
検出数／検体数
平成 17
生物(μg/g-wet)
60/60
年度
平成 15
水質
検出範囲
年度
検出限界値
0.016
-
0.000096
-
0.000033
21/21
21/21
17/18
55/57
0.00009～
0.000026～
0.000018
0.0066～
0.016
0.00085
～0.0016
0.025
0.00005
0.0000072
0.000018
0.000018
【出典】環境省 「化学物質と環境」
（３）使用を認める用途
（１）、（２）より、以下の３種類の用途（表現の仕方については今後、変更がありう
る）については、ＰＦＯＳ又はその塩の使用を例外的に認めることが妥当である。但し、
これらの用途については、今後の技術開発等により、可及的速やかに他のより安全
な物質への代替を進めていくことが望まれるものであり、国は、使用の状況や代替
に向けた進捗状況を把握する必要がある。また、国は１２物質のうち、特に、使用を
認めるＰＦＯＳ及びその塩について、継続的に環境モニタリング調査等を実施すべ
きである。
①半導体用のレジストの製造
②圧電フィルタ用又は高周波に用いる化合物半導体用のエッチング剤の製造
③業務用写真フィルムの製造
２－３．第一種特定化学物質が使用されている製品等の取扱いについて
１２物質が第一種特定化学物質に指定された後は、第一種特定化学物質の使用
は２－２で認められた用途のみであり、製造・輸入が行われるのは２－２の用途の需
要が存在するもの又は試験研究用に限られる。また、第一種特定化学物質が使用
された製品の製造も、２－２で認められた用途に限られる。したがって、第一種特定
化学物質の指定が行われる来年４月以降において、国内で製造の見込みのある第
一種特定化学物質が使用されている製品は、半導体用のレジスト、圧電フィルタ用
11
又は高周波に用いる化合物半導体用のエッチング剤及び業務用写真フィルムに限
られることとなる。
また、既に在庫等の形態で製品として存在している第一種特定化学物質が使用
されている製品については、上記の実態調査の結果によると、来年４月以降も当該
製品の使用を継続する可能性があって、環境汚染の可能性がある製品として泡消
火薬剤が挙げられた。泡消火薬剤は、希釈して業務用消火器用の消火薬剤として
も使用されている。泡消火薬剤については、代替物質が既に存在し、今後、新たに
ＰＦＯＳ又はその塩を使用して製造・輸入される予定はないものの、消火設備団体が
別途、調査した結果では、既に相当数量のものが、全国の地下駐車場等の消火設
備に設置されていることが判明している。これらの泡消火薬剤についても、今後、速
やかに代替製品に取り替えることが望ましいが、既に相当数量が全国の様々な箇
所に配備されている中、ＰＦＯＳを含む泡消火薬剤が配備されている場所を特定し
て、短期間で代替製品に取り替えることは、災害時にのみ使用するという製品の性
質も加味すれば、非常に困難である。
これらの４つの製品（半導体用のレジスト、圧電フィルタ用又は高周波に用いる化
合物半導体用のエッチング剤、業務用写真フィルム及び泡消火薬剤、消火器用消
火薬剤（業務用のものに限る。）及び業務用消火器）については、製品の使用の形
態から環境を汚染する可能性があるので、取扱事業者は、別途定める取扱上の技
術基準を遵守するとともに、別途定められた環境汚染を防止するための措置等に
関する表示を行わなければならない（改正化審法第１７条）。ただし、基準適合義務
及び表示義務の要件を満たすためには、製造現場の点検・表示ラベルの作成等が
必要となる。また、既に市場に流通している出荷分の管理・把握が困難で、義務を
課すことに時間を要するのが実態である。そのため、一定の猶予期間を設けること
についても検討する必要がある。
また、国は、取扱上の技術基準が遵守され、表示が徹底されるように、各製品に
関係する事業者と協力し、取扱事業者への周知に務めるべきである。加えて、第一
種特定化学物質が使用されている疑いのある製品についても、必要に応じて、環
境汚染の可能性も含めて情報収集・調査を実施する必要がある。事業者は、製品
中の第一種特定化学物質の含有状況について、新たな事実等が判明すれば、迅
速に国へ情報を提供することが望まれる。
12
表２－５．ＰＦＯＳ又はその塩を使用している場合は取扱上の技術基準に適合し、
環境汚染防止のための表示義務がかかる製品
製品※１
ＨＳコード※２
半導体用のレジスト
3707
エッチング剤（圧電フィルタ用又は高周波に用いる化合物半導体用
のものに限る。）
2834、3824
業務用写真フィルム
3701、3702
泡消火薬剤、消火器用消火薬剤（業務用のものに限る。）及び業務
用消火器
3813、8424
※１：製品についての表現の仕方については今後、変更がありうる。
※２：Harmonized Commodity Description and Coding System。「商品の名称及び分類についての
統一システム」の略称。国際貿易商品の名称及び分類を世界的に統一したシステムを指す。
今後、ＰＦＯＳ又はその塩、あるいはこれらを使用している上記の４製品について
は、取扱いにおける技術上の基準及び環境汚染を防止するための措置等に関する
表示の内容を策定する必要がある。技術上の基準や表示の内容の策定にあたって
考慮すべき主な要素としては、以下のようなものが考えられる。今後、これらを基本
とし、個別製品の取扱の実態を踏まえて、必要に応じて専門家の意見を聴取しつつ、
技術上の基準や表示の内容を策定する必要がある。
【取扱い上の技術基準の策定にあたって考慮すべきと考えられる主な要素】
・ 厳重に保管し、保管時の漏洩等のおそれがないよう必要な措置を講じること。
・ 取扱現場や保管庫には、ＰＦＯＳ又はその塩を取り扱っていることを表示するこ
と。
・ 外部に流出しないように必要な措置を講じること。こぼれた場合は、速やかに
拭き取る等の措置を講じること。そのために必要な器具については、一定の場
所に保管していること。
・ 取扱いに係る作業要領を策定し、管理責任者を選出すること。
・ 排ガス、廃液等については、関係法令に従って、適切に廃棄すること。
【環境汚染を防止するための措置等に関する表示について考慮すべきと考えられ
る主な要素】
・ 第一種特定化学物質が使用されていること及び当該物質の名称
・ 製品中の成分及び第一種特定化学物質の含有量
・ 使用上の注意
・ 不慮の事故等により、第一種特定化学物質が漏出した場合等の措置
13
※ なお、製造事業者等により、既に表示がなされている場合は、特に必要と認め
られない限りにおいて、販売業者等が表示を行う必要はないと考えられる。
２－４．第一種特定化学物質が使用されている製品の輸入の禁止について
１２物質については、第一種特定化学物質の指定に伴って、以降、製造、輸入及
び使用が制限されることとなる。また、第一種特定化学物質が使用されている製品
で、国内に輸入されるおそれがあり、使用の形態、廃棄の状況等からみて輸入を制
限しない場合に環境汚染が生じるおそれがある製品については、過去の製造・輸
入の状況や海外における使用の状況等を考慮して、政令で指定して、輸入を禁止
する措置をとることとされている（改正化審法第１３条）。
そこで、国内におけるこれまでの第一種特定化学物質の使用状況及び第一種特
定化学物質が使用されている製品の輸入の状況、及び、海外における第一種特定
化学物質の使用の状況を調査した。前者については、先述の実態調査を活用し、
後者については、世界各国の在外公館宛に公電を送付し、調査を依頼した。その
他、統計報告調整法に基づく承認統計として、原則３年に１度、化学物質管理対策
の推進のために実施している製造・輸入量調査の結果を活用した。
これらの調査の結果、過去１０年に、国内において輸入若しくは生産されていた、
又は、海外において生産されていた第一種特定化学物質が使用された製品のうち、
今後、輸入されるおそれが否定できず、かつ、製品の使用から廃棄に至る過程で環
境を汚染する可能性が否定できない製品は、１２物質のうち、ＰＦＯＳ又はその塩、
テトラブロモジフェニルエーテル、ペンタブロモジフェニルエーテルの３物質におい
て、合計１１製品が該当すると考えられた（表２－９、２－１０）。こられの製品につい
ては、第一種特定化学物質が含まれている場合に輸入を禁止する必要がある。な
お、輸入通関時のチェックの容易性についても考慮し、原則、ＨＳコードで同一の類
に属するものを製品の指定単位とした。
詳細については、以下のとおりである。
ＰＦＯＳ又はその塩については、国内外の製造実績、輸入実績は表２－６のとおり
であり、表中の品目(1)～(14）については、過去１０年内に、当該物質使用製品を輸
入していたこと又は海外で製造されていたことが実績等により認められるか、あるい
は日本国内で当該物質使用製品を製造していた実績があるため、今後国内に輸入
される可能性がある。このうち、品目(1)～(3)については、２－２で示された「代替が
困難なため例外的に第一種特定化学物質の使用を認めた用途」に関する製品で
14
あり、国内での製造・使用が認められるものであることから、内外無差別の観点から、
当該製品の輸入についても同様に認められることとなる。品目(12)については、海
外における今後の製造の見込み、国内における使用の形態、環境汚染の可能性
等の実態が不明であるため、現時点で、輸入禁止製品として指定すべきかどうかは
判断できない。品目(13)については、化審法の「化学物質」に該当する。品目(15)～
(21)については、ストックホルム条約で例外使用が認められた製品であるが、国内外
の製造実績及び国内への輸入実績の詳細が不明である。一方、品目(4)～(11)と
（14）については、輸入を制限しない場合には、使用の形態から直接、環境を汚染
するおそれがあるため、輸入禁止製品とすべきと考えられる。
テトラブロモジフェニルエーテルについては、国内外の製造実績、輸入実績は表
２－７のとおりであり、表中の品目については、過去１０年内に、海外で製造されて
いたことが実績等により認められるため、今後国内に輸入される可能性がある。この
うち、「ポリウレタンフォーム」については、海外における今後の製造の見込み、国内
における使用の形態、環境汚染の可能性等の実態が不明であるため、現時点で、
輸入禁止製品として指定すべきかどうかは判断できない。一方、「接着剤」と「塗料」
については、輸入を制限しない場合には、使用の形態から直接、環境を汚染する
おそれがあるため、輸入禁止製品とすべきと考えられる。
ペンタブロモジフェニルエーテルについては、国内外の製造実績、輸入実績は
表２－８のとおりであり、表中の品目については、過去１０年内に、海外で製造され
ていたことが実績等により認められるため、今後国内に輸入される可能性がある。こ
のうち、「ポリウレタンフォーム」については、海外における今後の製造の見込み、国
内における使用の形態、環境汚染の可能性等の実態が不明であるため、現時点で、
輸入禁止製品として指定すべきかどうかは判断できない。一方、「接着剤」と「塗料」
については、輸入を制限しない場合には、使用の形態から直接、環境を汚染する
おそれがあるため、輸入禁止製品とすべきと考えられる。
以上をまとめると、表２－９、表２－１０に掲げる製品については、第一種特定化学
物質が含まれている場合に輸入を禁止する必要がある。輸入を禁止する際には、
貿易の技術的障害(ＴＢＴ：Technical Barriers to Trade)に関する協定（ＴＢＴ協定）の
履行にも留意する必要がある。
なお、ストックホルム条約の締約国会合で認められたＰＦＯＳの用途のうち、皮革・
衣料品、繊維・室内装飾材、紙・包装材、コーティング材・コーティング用添加剤、ゴ
ム・プラスチック等は、添加・含有の有無を把握するべき対象としての製品の括りが
15
大き過ぎることと、当該申し出を行った当事国でさえもその詳細を把握できていない
こと、また、わが国の現状に照らすとこれらの製品にＰＦＯＳ又はその塩等が広く使
用されているとは考えられず、製品がより具体的に特定されないと事業者に過度な
負担を強いるおそれがあることから、現時点で、規制対象製品として一律に指定す
ることは適切ではないと考えられる。加えて、今後、国内に輸入される可能性がある
事務機器用のゴム・プラスチック部品、ポリウレタンフォーム、ABS樹脂（ヘキサブロ
モジフェニルエーテル、ヘプタブロモジフェニルエーテルを使用しているABS樹脂
は、輸入実績は不明だが過去１０年間における国内外の製造実績がある）等につい
ては、海外における今後の製造の見込み、国内における使用の形態、環境汚染の
可能性等の実態が不明であるため、現時点で、輸入を禁止するべきか判断できな
いと考えられる。しかしながら、これらの製品については、国が早急に製品のより具
体的な特定や使用等の実態、環境汚染の可能性等について調査し、仮に、それら
の特定された製品によって環境汚染が生じるおそれが認められれば、追加して指
定することによって対応する必要がある。
16
表２－６．ＰＦＯＳ又はその塩を使用している製品の製造・輸入実績等について
PFOS 又はその塩を
製造実績
輸入
使用している製品
国内 海外
実績
あり
(1) 半導体用のレジスト
詳細
(2) 業務用写真フィルム
(3)
(4)
不明
金属用又は半導体（高周波に用いる化合物
半導体を除く。）用のエッチング剤
使用を認める用途に
指定
（２－２参照）
詳細
不明
泡消火薬剤、消火器用消火薬剤（業務用の
あり
ものに限る。）及び業務用消火器
あり
(5) 半導体用の反射防止剤
(6)
備考
金属用又は半導体用のエッチング剤（第３条
実績 詳細
あり 不明
の３に掲げる製品を除く。）
(7) 工業用のメッキ処理剤
基準①及び基準②
を満足
(8) 工業用の研磨剤
又は
(9) 紡糸用の処理剤
(10) 防虫剤（ありの防除用のものに限る。）
一部
(11) 印画紙
詳細
不明
実績
基準①のみ満足
あり
(12) 事務機器用のゴム・プラスチック部品
基準②は詳細不明
(13) 半導体用光酸発生剤
化審法上、化学物質
(14) 航空機用の作動油
あり
あり
①及び②を満足
詳細
詳細
具体的な製品の
不明
不明
特定困難
(15) 化学由来の石油採掘剤
(16) カーペット
(17) 皮革・衣料品
実績
(18) 繊維・室内装飾材
なし
(19) 紙・包装材
(20) コーティング材・コーティング用添加剤
(21) ゴム・プラスチック
（参考）【輸入禁止製品の政令指定の考え方】
第一種特定化学物質が使用されていると考えられる製品のうち、次の①及び②の基準に該当す
るものについては、政令指定し、輸入の制限をすることが適当であると考えられる。
基準①：次の要件のいずれかを満たし、国内に輸入されるおそれがあること。
（ア）第一種特定化学物質が使用されている製品を過去１０年内に輸入していたことが実績又
は公電、公文書、海外規格若しくはこれらに準ずる性格を有する情報 (以下、｢実績等｣
17
という。) により認められるとき。
（イ）第一種特定化学物質が使用されている製品が過去１０年内に海外において生産されて
いたことが実績等により認められるとき。
（ウ）第一種特定化学物質が当該製品に使用されていることが一般的であって、過去１０年内
に日本国内で第一種特定化学物質が使用された当該製品の生産の実績があるとき。
（エ）ただし、（ア）､（イ）､（ウ）の要件に合致するものであっても、下記の要件のいずれかに該
当する場合は、掲名の対象から除外するものとする。
（ａ）関連製品等との競合による制約により、今後、輸入されるおそれのないもの。
（ｂ）技術的進歩等により、今後、海外において生産されるおそれ可能性のないもの。
（ｃ）国内規格、商慣行等の理由で、今後、日本に輸入されるおそれのないもの。
基準②：次の要件のいずれかを満たさないため、輸入を制限しない場合には、環境汚染のおそ
れがあると考えられること。
（ア）当該製品の使用が、環境へ直接放出される形態をとるものではないこと。
（イ）使用から廃棄に至る間の管理体制が確立されていること。
（ウ）廃棄が適切に行いうるよう制度的に担保されていること。
表２－７．テトラブロモジフェニルエーテルを使用している製品の製造・輸入実績
等について
製造実績
テトラブロモジフェニルエーテル
を使用している製品
国内
海外
輸入
実績
接着剤
備考
基準①及び基準②
塗料
実績
実績
詳細
を満足
ポリウレタンフォーム（成型品）
なし
あり
不明
基準①のみ満足
基準②は詳細不明
（参考）輸入禁止製品の政令指定の考え方は表２－６と同様。
表２－８．ペンタブロモジフェニルエーテルを使用している製品の製造・輸入実績
等について
製造実績
ペンタブロモジフェニルエーテル
を使用している製品
国内
輸入
海外 実績
接着剤
あり
塗料
実績
実績
ポリウレタンフォーム（成型品）
なし
あり
（参考）輸入禁止製品の政令指定の考え方は表２－６と同様。
18
備考
基準①及び基準②
を満足
詳細
不明
基準①のみ満足
基準②は詳細不明
表２－９．ＰＦＯＳ又はその塩を使用している場合は輸入を禁止すべき製品
製品※
ＨＳコード
航空機用の作動油
2710、2901、3403
紡糸用の処理剤
3809
金属用又は半導体（高周波に用いる化合物半導体を除く。）
用のエッチング剤
3707
工業用のメッキ処理剤
3402
半導体の製造に使用する反射防止剤
3208
工業用の研磨剤
2917
泡消火薬剤、消火器用消火薬剤（業務用のものに限る。）及
び業務用消火器
3813
防虫剤（ありの防除用のものに限る。）
3808
印画紙
3703
※：製品についての表現の仕方については今後、変更がありうる。
表２－１０．テトラブロモジフェニルエーテル又はペンタブロモジフェニルエーテル
を使用している場合は輸入を禁止すべき製品
製品※
ＨＳコード
塗料
3208、3209、3210
接着剤
3506
※：製品についての表現の仕方については今後、変更がありうる。
２－５．その他の必要な措置について
第一種特定化学物質及びそれが使用される製品の指定にあたっては、環境汚
染の進行を防止するために特に必要があると認められる時は、必要な限度におい
て、その製造事業者や輸入事業者に対し、当該物質等の回収等の措置を命ずるこ
とができる（改正化審法第２２条）。また、製造・輸入・使用の制限に関し必要な勧告
をすることができる（改正化審法第２９条）。
現状において、１２物質のうち、国内で製造・輸入・使用の実態があるのは、ＰＦＯ
Ｓ又はその塩とＰＦＯＳＦのみであり、現在のところ、２－２で第一種特定化学物質と
して指定した後も使用を認めることとする３用途以外については、代替物質への転
換が済んでいるか、又は転換に向けた取り組みが進められているところである。また、
２－２（２）のように、現状において、ＰＦＯＳ又はその塩の環境汚染による人又は生
活環境動植物への被害を生ずるおそれがあるとはいえない。加えて、ＰＦＯＳ以外
の１１物質については、過去の使用がある場合、その使用により現在、回収を要する
19
と考えられる程の環境汚染が生じているとの状況は認められない。したがって、現時
点では、製品の回収等を命令する必要性は認められず、製造・輸入・使用の制限に
関し、勧告を行う必要性も認められないと考えられる。ただし、代替物質があること等
により、不要となった在庫のＰＦＯＳ又はその塩やそれらを使用している製品につい
ては、廃棄等の関係法令等に従って、適切に措置する必要がある。
３．今後の進め方について
今後、関係政令案について、パブリックコメントやＴＢＴ通報を実施した上で、公布
を経て、改正化審法の施行後、速やかに１２物質を第一種特定化学物質に指定す
るとともに、２．で検討した必要な措置を講じるべきである。なお、パブリックコメントや
ＴＢＴ通報等において、新たな実態、妥当な事例が追加的に判明した場合、２．に
掲げる必要な措置の対象に追加することも検討する必要がある。
【参考】今後の予定（※不確定要素を含むため、前後する可能性がある。）
平成２１年 ８月
政令改正案に関するパブリックコメント
平成２１年 ８月
ＴＢＴ通報
平成２１年１０月
改正政令の公布
平成２２年 ４月
改正政令の施行
20
参考資料７
ペルフルオロ（オクタン-1-スルホン酸）の環境リスク初期評価
（化学物質の環境リスク評価（第 6 巻）
抜粋）
１．物質に関する基本的事項
（1）分子式・分子量・構造式
物質名： ペルフルオロオクタンスルホン酸及びその塩
（Perfluorooctane Sulfonate：PFOS）
CAS 番号： 1763-23-1 (酸)
CAS 番号： 29081-56-9 (アンモニウム塩)
CAS 番号： 70225-14-8 (ジエタノールアミン(DEA)塩)
CAS 番号： 2795-39-3 (カリウム塩)
CAS 番号： 29457-72-5 (リチウム塩)
化審法官報公示整理番号：2-1595 (パーフルオルオクタンスルホン酸)、2-2810 (パーフ
ロロアルキル(C=4～12)スルフォン酸塩 (Na, K, Li))
化管法政令番号：
RTECS 番号：RG9701600(酸)、RG9701850(カリウム塩)、RG9701750(リチウム塩)
分子式：C8F17O3SX(X は H, K など)
分子量：500.13 (酸）
換算係数：1 ppm = 20.46 mg/m3 (酸、気体、25℃)
構造式：
O
F3C
(CF2)7
S
OX
O
X=H、K など
（2）物理化学的性状
本物質のカリウム塩は白色の粉末である1)。
＞400℃2)
融点
沸点
比重
蒸気圧
～0.63)、～1.1 (リチウム塩)3)、～1.1 (アンモニウ
ム塩)3)、～1.1 (ジエタノールアミン塩)3)
6.4×10-3 mmHg (酸、25℃、MPBPWIN4)により計
算) (=0.85 Pa)、
1.43×10-11 mmHg (25℃、MPBPWIN4)により計算)
(=1.9×10-9 Pa)
分配係数(1-ｵｸﾀﾉｰﾙ/水) (log Kow)
解離定数(pKa)
水溶性(水溶解度)
備考
519 mg/L (20±0.5℃)1)、680 mg/L (24～25℃)1)、
570 mg/L3)、370 mg/L (淡水)3)、
12.4 mg/L (未ろ過海水)3)、25 mg/L (ろ過海水)3)、
12.4 mg/L (天然海水、22～23℃)3)
20.0 mg/L (3.5%NaCl 溶液、22～24℃)3)
特に断りがない限りカリウム塩としての値
1
（3）環境運命に関する基礎的事項
本物質の分解性及び濃縮性は次のとおりである。
生物分解性
好気的分解（難分解性と判断される物質）5)
分解率：BOD 0%、TOC 6%、LC-MS 3%（試験期間：4 週間、被験物質濃度：100
mg/L、活性汚泥濃度：30 mg/L）6)
嫌気的分解
下水汚泥を用いた嫌気的分解試験において、生分解の兆候は見られなかった1)。
化学分解性
加水分解しない1)。
生物濃縮性
生物濃縮係数(BCF)：（高濃縮性ではないと判断される物質）5)
210～850（試験生物：コイ、試験期間：58 日間、試験濃度：20µg/L）6)
200～1500（試験生物：コイ、試験期間：58 日間、試験濃度：2µg/L）6)
（備考：定常状態における BCF:720(試験濃度：20 µg/L)）6)
1124（可食部、試験生物：ブルーギル、試験期間：62 日間、試験濃度：86 µg/L）2)
4013（非可食部、試験生物：ブルーギル、試験期間：62 日間、試験濃度：86µg/L）2)
2796（全魚体、試験生物：ブルーギル、試験期間：62 日間、試験濃度：86µg/L）2)
土壌吸着性
土壌吸着定数(Kd)：18.3 (粘土)7)、9.72 (Clay Loam)7)、35.3 (Sandy Loam)7)、7.42 (河川底
質)7)
土壌吸着定数(Koc)：704 (粘土)7)、374 (Clay Loam)7)、1260(Sandy Loam)7)、571 (河川底
質) 7)
備考
特に断りがない限りカリウム塩としての値
（4）製造輸入量及び用途
①
生産量・輸入量等
PFOS の平成 17 年における生産量は 1～10t/年であり、1 製造業者で生産されている1)。
PFOS の半導体工業における消費量を表 1.1 に示す8)。
表 1.1
平成(年度)
消費量(kg)
半導体工業における消費量
15
16
3,926
2,762
2
17
1,178
金属メッキ工程における PFOS を含有する表面処理剤の推定使用量は 2～3t/年である8)。フォトマ
スク（半導体及び液晶ディスプレィ）製造工程における PFOS 及びその類縁化合物(PFOS 骨格を持
つ物質、以下同様)の推定使用量は約 0.07t/年である9)。写真工業における平成 16 年の使用量は
3.6t/年である8)。PFOS を含む泡消火剤の備蓄量は、約 21,000t（PFOS 換算量：200t 未満）である9)。
②
用
途
PFOS 及びその類縁化合物の主な用途は、半導体工業、金属メッキ、フォトマスク（半導体、液晶
ディスプレィ）、写真工業、泡消火剤である8)。また、代替が困難な用途としては、半導体（反射防止
膜及びフォトレジスト）、フォトマスク（半導体及び液晶ディスプレィ）、写真感光剤、メッキ（クロムメッキ
等）、泡消火剤、医療機器（カテーテル及び留置針）、電気電子部品（プリンター・複写機用転写ベ
ルト・ゴムローラー等）である10)。
PFOS の類縁化合物が微生物分解やより大型の生物による代謝を受け、PFOS が生成される可能
性が指摘されている1)。
（5）環境施策上の位置付け
ペルフルオロオクタンスルホン酸及びそのカリウム塩、リチウム塩は化学物質審査規制法
第二種監視化学物質（通し番号:681（酸）
、685（カリウム塩）
、683（リチウム塩）
）に指定さ
れている。
3
２．ばく露評価
環境リスクの初期評価のため、わが国の一般的な国民の健康や水生生物の生存・生育を確
保する観点から、実測データをもとに基本的には化学物質の環境からのばく露を中心に評価
することとし、データの信頼性を確認した上で安全側に立った評価の観点から原則として最
大濃度により評価を行っている。
（1）環境中への排出量
本物質は化学物質排出把握管理促進法（化管法）第一種指定化学物質ではないため、排出
量及び移動量は得られなかった。
（2）媒体別分配割合の予測
本物質の信頼できる log Kow が得られておらず、媒体別分配割合の予測は行わなかった。
（3）各媒体中の存在量の概要
本物質の環境中等の濃度について情報の整理を行った。媒体ごとにデータの信頼性が確認
された調査例のうち、より広範囲の地域で調査が実施されたものを抽出した結果を表 2.1 に
示す。
表 2.1
幾何
平均値
媒体
算術
平均値
各媒体中の存在状況
最小値
最大値
検出
下限値
検出率
調査
地域
<0.00000009
0.00003
0.00000009
19/20
全国
2004
1)
測定年度 文献
一般環境大気
µg/m3 0.0000018 0.000004
室内空気
µg/m3
食物
µg/g
0.000013
0.000020
<0.0000033
0.00012
0.0000033
46/50
全国
2004
1)
飲料水
µg/L
0.00083
0.0034
<0.0001
0.012
0.0001
4/6
全国
2003
2) a)
0.00097
0.0065
0.0001
0.047
-
9/9
全国
2002
3)
3/3
大阪市
2007
4)
14/14
大阪府
2006
5)
1/1
大阪市
2006
4)
0.003
地下水
µg/L
土壌
µg/g
公共用水域・淡水
µg/L
0.003
0.0025
0.0035
0.001
b)
b)
0.0038
0.0054
0.00030
0.020
0.0001
0.0024
0.0024
0.0024
0.0024
0.001 b)
b)
0.0017
0.0023
0.001
0.0049
0.001
3/3
大阪市
2005
4)
0.0064
0.0097
<0.005
0.037
0.005 b)
11/19
東京都
2005
6)
0.013
0.037
0.029
0.075
0.0003
0.01
0.095
0.14
0.0002
0.005
8/8
2/2
大阪府
大阪市
2007
2006
7)
8)
0.00037
0.00060
0.00014
0.0024
0.00005 b)
7/7
東京都、
茨城県
2005
9)
0.0027
0.0058
0.000097
0.013
0.00005
5/5
全国
2005
10)
4
媒体
公共用水域・海水
底質(公共用水域・淡水)
底質(公共用水域・海水)
µg/L
µg/g
µg/g
幾何
平均値
算術
平均値
最小値
最大値
検出
下限値
検出率
調査
地域
0.0015
0.0039
0.00024
0.037
0.00004
79/79
全国
2003
2)
0.0023
0.0058
0.00020
0.018
0.00004
9/9
全国
2002
11)
0.015
0.030
0.0009
0.28
0.0002
~0.002 b)
25/25 大阪府、大
阪市
2007
12)
0.038
0.052
0.0080
0.18
0.002 b)
16/16
大阪市
2007
13) c)
0.0035
0.0074
<0.001
0.044
0.001~0.002 38/59
兵庫県
2007
14)
0.0016
0.0058
<0.002
0.061
0.002
3/17
兵庫県
2006
14)
0.67
3.5
0.0092
11
-
9/9
埼玉県
2006
15)d)
0.0088
0.025
0.00033
0.11
-
14/14
東京都
2005
16)
2004
17) e)
2003
2)
0.029
0.049
0.003
0.11
0.0098
0.026
0.0014
0.53
0.00004
0.011
0.015
0.0029
0.037
-
0.015
0.044
0.0007
0.16
-
0.0089
0.0091
0.0073
0.011
0.00005
2/2
0.0019
0.0058
0.00061
0.028
0.00004
0.0010
0.0021
0.00011
0.0066
0.0033
0.0050
0.0013
0.011
0.0061
0.0063
0.0044
0.006
0.006
0.006
魚類(公共用水域・海水)
µg/g
µg/g
貝類(公共用水域・淡水)
µg/g
貝類(公共用水域・海水)
µg/g
0.00005
6/6
東京都、神
奈川県
52/52
大阪府
10/10 大阪府、京 2003~2004 18)
都府
20/20
~2002
3)
東京都
2005
10)
6/6
愛知県、大
阪市
全国
2003
2)
0.00004
11/11
全国
2002
11)
-
3/3
大阪府
2007
20)
0.0087
0.002 b)
4/4
大阪市
2007
13) c)
0.006
-
1/1
兵庫県
2007
14)
2004
17) e)
全国
2005
10)
b)
0.0032
0.0034
0.0020
0.0062
0.00005
0.00026
0.00035
0.00011
0.00080
0.0000072
4/4
0.00014
0.00030
<0.000096
0.0012
0.000096
4/9
全国
2003
19)
0.00040
0.0016
<0.0001
0.0043
0.0001
2/3
大阪府
2007
21)
0.00021
0.00026
0.000082
0.00035
0.0000072
3/3
2005
10)
<0.000096
0.00021
0.000096
4/11
川崎市、愛
知県、大阪
市
全国
2003
19)
新潟県、鳥
取県、高知
県
滋賀県、鳥
取県、高知
県
2005
10)
2003
19)
<0.000096 <0.000096
魚類(公共用水域・淡水)
b)
測定年度 文献
10/10 千葉県、東
京都、神奈
0.0011
0.0013
0.00064
0.0023
0.000018
3/3
0.0020
0.0047
0.00048
0.012
0.000033
3/3
0.00052
0.0015
<0.000018
0.0055
0.000018
15/16
全国
2005
10)
0.0011
0.0021
0.00021
0.0068
0.000033
6/6
全国
2003
19)
0.000083
0.00030
<0.000018
0.0014
0.000018
5/6
全国
2005
10)
注：a）各府県(兵庫県、大阪府、京都府、岩手県、宮城県、秋田県)5 検体の幾何平均値(報告値)をもとに集計。検
出率は府県数より算出。
b）検出下限値の欄の斜体で示されている値は、定量下限値として報告されている値を示す。
c）大阪府との連携調査地点を除く
5
d）ろ液とろ過残渣抽出液(超音波抽出)の合計値。検出下限値はろ液 0.00005 μg/L、ろ過残渣 0.0002 μg/L。
e）溶存態濃度。
（4）人に対するばく露量の推定（一日ばく露量の予測最大量）
一般環境大気、飲料水及び食物の実測値を用いて、人に対するばく露の推定を行った（表
2.2）。化学物質の人による一日ばく露量の算出に際しては、人の一日の呼吸量、飲水量及び
食事量をそれぞれ 15 m3、2 L 及び 2,000 g と仮定し、体重を 50 kg と仮定している。
表 2.2
媒
各媒体中の濃度と一日ばく露量
体
濃
度
一
日
ば
く
大気
一般環境大気
0.0000018 µg/m3 程度 (2004)
0.00000054 µg/kg/day 程度
室内空気
データは得られなかった
データは得られなかった
露
量
平
水質
飲料水
地下水
0.00097 µg/L 程度 (2002)
0.000039 µg/kg/day 程度
限られた地域で 0.037 µg/L の報告がある 限られた地域で 0.0015 µg/kg/day の報告
(2006)
がある
公共用水域・淡水
0.0027 µg/L 程度 (2005) (限られた地域で 0.00011 µg/kg/day 程度 (限られた地域で
0.67 µg/L 程度の報告がある (2006))
0.027 µg/kg/day 程度の報告がある)
食
土
0.000013 µg/g 程度 (2004)
データは得られなかった
0.00052 µg/kg/day 程度
データは得られなかった
大気
一般環境大気
0.00003 µg/m3 程度 (2004)
0.000009 µg/kg/day 程度
最
室内空気
データは得られなかった
データは得られなかった
大
水質
飲料水
地下水
均
値
物
壌
公共用水域・淡水
食
土
物
壌
0.047 µg/L 程度 (2002)
0.0019 µg/kg/day 程度
限られた地域で 0.14 µg/L の報告がある 限られた地域で 0.0056 µg/kg/day の報告
(2006)
がある
0.037 µg/L 程度 (2003) (限られた地域で 0.0015 µg/kg/day 程度 (限られた地域で
11 µg/L 程度の報告がある (2006))
0.44 µg/kg/day 程度の報告がある)
0.00012 µg/g 程度 (2004)
データは得られなかった
0.0048 µg/kg/day 程度
データは得られなかった
人の一日ばく露量の集計結果を表 2.3 に示す。
吸入ばく露の予測最大ばく露濃度は、一般環境大気のデータから 0.00003 µg/m3 程度となっ
た。
経口ばく露の予測最大ばく露量は、飲料水及び食物のデータから算定すると 0.0067
µg/kg/day 程度であった。なお、仮に地下水及び食物のデータから算定した経口ばく露の予測
最大ばく露量は 0.0104 µg/kg/day となった。
表 2.3
媒体
大気
一般環境大気
室内空気
飲料水
人の一日ばく露量
平均ばく露量（μg/kg/day）
0.00000054
予測最大ばく露量（μg/kg/day）
0.000009
0.000039
0.0019
6
水質
地下水
公共用水域・淡水
食物
土壌
{0.0015}
(0.00011) {0.027}
0.00052
{0.0056}
(0.0015) {0.44}
0.0048
0.000559
0.0067
経口ばく露量合計
0.00055954
0.006709
総ばく露量
注：1）アンダーラインを付した値は、ばく露量が「検出下限値未満」とされたものであることを示す
2）総ばく露量は、吸入ばく露として一般環境大気を用いて算定したものである
3）（ ）内の数字は、経口ばく露量合計の算出に用いていない
4）{ }内の数字は、限られた地域における調査データから算出したものである
（5）水生生物に対するばく露の推定（水質に係る予測環境中濃度：PEC）
本物質の水生生物に対するばく露の推定の観点から、水質中濃度を表 2.4 のように整理し
た。本物質の公共用水域における濃度は、全国レベルで行われた調査では、最大値が公共用
水域淡水域では 0.037 µg/L 程度、海水域では 0.028 µg/L 程度となったが、限られた地域を対
象とした環境調査により、公共用水域の淡水域で最大 11 µg/L 程度の報告があり、このほかに
も地域レベルで行われた複数の環境調査で 0.037 µg/L より高い検出濃度が報告されている。
これらを総合的に勘案し、安全側の評価値としての予測環境中濃度（PEC）は、淡水域の PEC
で 11 µg/L 程度、海水域で 0.028 µg/L 程度と設定することとした。
表 2.4
水 域
淡 水
海 水
平
公共用水域濃度
均
最
大 値
0.0027 µg/L 程度 (2005) [ 0.037 µg/L 程度 (2003) [限ら
限られた地域で 0.67 µg/L れた地域で 11 µg/L 程度の報
程度の報告がある (2006)]
告がある (2006)]
0.0019 µg/L 程度 (2003)
0.028 µg/L 程度 (2003)
注：1）環境中濃度での（ ）内の数値は測定年度を示す
2）公共用水域･淡水は､河川河口域を含む
7
３．健康リスクの初期評価
健康リスクの初期評価として、ヒトに対する化学物質の影響についてのリスク評価を行っ
た。
（1）体内動態、代謝
本物質は消化管から容易に吸収される。
14
C でラベルした本物質の K 塩 4.2 mg/kg を雄ラットに強制経口投与した結果、24 時間で投
与した放射活性の 1.55％、48 時間で 3.24％が糞中に排泄された。24 時間後の消化管（内容物
を含む）の放射活性と糞中排泄の合計は約 5％であったため、消化管組織内の放射活性や消
化管内に排泄された放射活性もあったことを考慮すると、24 時間で少なくとも 95％以上が吸
収されていたことになる。尿中への排泄は 1～2％/日で、血漿中の半減期は 179 時間（7.5 日）
であった 1) 。
14
C でラベルした K 塩 4.2 mg/kg を雄ラットに静脈内投与した結果、89 日間で投与した放射
活性の 30.2％が尿中に、12.6％が糞中（64 日以降は検出限界値未満）に排泄され
2)
、合計で
42.8％であったことから、体外排泄の半減期は 89 日以上であった。放射活性から求めた 89
日後の本物質の分布は肝臓で 20.6 µg/g、血漿で 2.2 µg/g、腎臓及び肺で 1.1 µg/g、筋肉や皮膚、
骨髄、脾臓などの組織では 0.2～0.6 µg/g の範囲にあり、脂肪組織では皮下脂肪で 0.2 µg/g、腹
部脂肪で 0.08 µg/g 以下と異なった分布がみられ、眼球で 0.16 µg/g が検出されたが、脳への分
布はなかった。
これは投与量の 25.2％が肝臓に、
2.8％が血漿中に分布していたことになるが、
腎臓や肺、精巣、脾臓でみられた低濃度の放射活性のある程度はこれらの臓器に残存してい
た血液によると思われた 2) 。
ラットに交尾前 42 日から妊娠 20 日まで 0～3.2 mg/kg/day の K 塩を強制経口投与した結果、
妊娠 21 日目の母ラット及び胎仔の肝臓、血清で本物質は用量に依存して増加し、母ラットで
は本物質は血清中よりも肝臓で高かった。胎仔では血清中濃度は母ラットと同程度であった
が、肝臓では母ラットの半分以下の濃度であった 3) 。また、雌ラットに交尾前 43 日から交尾
終了日まで 0、0.1、1.6 mg/kg/day の K 塩を強制経口投与し、自然分娩させて哺育させた結果、
授乳 22 日目の母ラット及び仔の肝臓で本物質の濃度は同程度であり、血清中よりも肝臓では
るかに多かった 4) 。
雌雄のカニクイザルに 2 mg/kg の K 塩を静脈内投与した結果、血清中での本物質の半減期
は雄で 132 日（122～146 日）、雌で 110 日（88～138 日）で、明瞭な性差はなかった 5, 6) 。ま
た、6 ヵ月間強制経口投与した実験では、0.03、0.15 mg/kg/day 群の血清中の本物質濃度は時
間とともに直線的に増加したが、0.75 mg/kg/day 群では非直線的な増加を示し、約 20 週で横
ばいとなった。27 週以降の回復期間中の血清中濃度は 0.15 mg/kg/day 群では直線的、0.75
mg/kg/day 群では多相性の減少を示し、両群の半減期は 0.75 mg/kg/day 群＞0.15 mg/kg/day 群
の関係にあったが、1 年間の回復期間の終わりが近づくにつれて両群とも類似した傾き（約
200 日の半減期）を示すようになり、性差を示す証拠もなかった 7, 8) 。
雄ラットに 14C でラベルした K 塩（3.4 mg/kg）を静脈内投与し、コレスチラミン（陰イオ
ン交換樹脂で吸収されない）を 4％濃度で 21 日間混餌投与した結果、本物質の糞中への排泄
は 9.5 倍増加し、肝臓、血漿及び赤血球中の濃度は有意に減少したことから、本物質は腸肝
8
循環することが示された 9) 。
国内 3 地域の男女 205 人（女性 93 人）を対象とした調査では、3 地域の男女で血清中の本
物質濃度に有意な性差（男性＞女性）がみられ、高濃度地域ほどその差は大きかった 10) 。ア
メリカのフッ素化学工場の退職者 3 人を 5.5 年間追跡した調査で、血清中の本物質の半減期
は 1,428 日（約 4 年）であった 11) 。また、退職者 26 人（うち女性 2 人）について 5.5 年間定
期的に採血した結果、血清中の半減期は 5.4 年（95％CI：3.9～6.9 年）で実験動物に比べて長
く、調査開始時の濃度（0.145～3.49 µg/mL）や年齢、性、勤続年数、退職から初回採血まで
の時間との間に関連はみられなかった 12, 13) 。
アメリカ、イタリアなど 10 ヵ国の住民（n=20～175）について本物質の血中濃度を調べた
調査では、アメリカ及びポーランドが 0.03 µg/mL 超、インドが 0.003 µg/mL 未満でその他の
国は 0.003～0.029 µg/mL の範囲にあり、日本では女性、ポーランドでは男性で有意に高かっ
たが、他の国では性差はなく、年令による変化もなかった 14) 。国内の地域住民を対象とした
調査では、男性では本物質の血清中濃度に年令による変化はなかったが、女性では月経の有
無で有意に異なり、閉経期の女性で高く、60 才を超えた頃に男性の濃度レベルに達した。ま
た、本物質の腎クリアランスは糸球体濾過率の 1/105（n=20）と極めて低く、ヒトでは尿細管
からの能動的分泌が欠如していることを示唆するものと思われた 15) 。
ヒトの血漿タンパク質との結合を調べた in vitro 実験では、本物質はアルブミンの 99.8％、
β-リポタンパクの 95.6％、α-グロブリンの 59.4％、γ-グロブリンの 24.1％、フィブリノー
ゲン及びα-2-マクログロブリン、トランスフェリンの 0.1％未満と結合した 16) 。
なお、2-(N-エチルペルフルオロオクタンスルホンアミド)エチルアルコール（N-EtFOSE）
のような本物質の誘導体は代謝によって本物質を生じるが 17, 18) 、本物質は代謝されないと考
えられている 9, 18, 19) 。
（2）一般毒性及び生殖・発生毒性
① 急性毒性
動物種
ラット
ラット
ラット
ラット
ラット
ラット
ラット
ラット
経路
経口
経口
経口
経口
経口
経口
経口
吸入
致死量、中毒量等
154 mg/kg 20) （酸）
LD50
TDLo
15 mg/kg 20) （酸）
TDLo
0.75 mg/kg 20) （酸）
LD50
251 mg/kg 21) （K 塩）
LD50
233 mg/kg 21) （雄、K 塩）
271 mg/kg 21) （雌、K 塩）
LD50
LD50 50～1,500 mg/kg 21) （K 塩）
LC50
5,200 mg/m3 22) （K 塩）
本物質の K 塩はウサギの眼を刺激したが、皮膚を刺激しなかった 23) 。
K 塩を経口投与したラットで最も頻発した症状は活動低下、四肢の緊張低下、運動失調で、
剖検では泌尿生殖部の着色（黄変）
、胃の拡張と腺粘膜の充血、肺のうっ血がみられた 21) 。
9
② 中・長期毒性
ア）本物質はラットやマウスへの短期間投与で肝臓のペルオキシソーム増殖作用を示し 24～26) 、
ヒトやラット、マウスの細胞を用いた in vitro 試験でペルオキシソーム増殖応答受容体
（PPARα）を活性化させるが 27, 28, 29) 、PPARαの活性化能は PFOA よりも低い 28, 29) 。ラ
ットの雌雄に本物質を繰り返し投与した試験では、ぺルオキシソーム増殖の指標としたパ
ルミトイル CoA 酸化酵素活性は、4 週間後の雄の肝臓で約 2 倍高かったが、14、53 週後に
は肝細胞の増殖を示す結果がみられなかった 30, 31) 。また、本物質を 6 ヵ月間投与したサル
の肝臓でも、ペルオキシソーム増殖はみられなかったことから 8) 、ラットやサルの試験で
みられた肝臓への影響はペルオキシソーム増殖作用を介したものではないと考えられてい
る 8, 19) 。
なお、本物質を腹腔内投与した 24 時間後の胸腺を用いたトキシコゲノミクスでは、副甲
状腺ホルモン（PTH）の遺伝子に発現上昇がみられただけで、PTH が PPARαや PPARβ/
δの標的遺伝子であるという報告はないことから、PPAR を活性化した結果とは考えにく
かった 32) 。
イ）Sprague-Dawley ラット雌雄各 5 匹を 1 群とし、K 塩を 0、0.003、0.01、0.03、0.1、0.3％
（0、2、6、18、60、200 mg/kg/day）の濃度で 90 日間混餌投与した結果、0.3％群は 7～8
日、0.1％群は 8～14 日、0.03％群は 13～28 日目に全数が死亡し、これらの群ではるい痩、
取り扱い時の痙攣、円背位姿勢、眼周囲の赤色汚染物や肛門性器部に黄色の汚染物、易刺
激性、活動低下、口や鼻の周囲で湿った赤色の分泌物がみられた。0.01％群でも雄 3 匹、
雌 2 匹が死亡し、生き残ったラットでは体重は約 16％低く、赤血球数、ヘモグロビン濃度、
ヘマトクリット値、網状赤血球数、白血球数の有意な減少、雄で肝臓の相対重量、雌で肝
臓の絶対及び相対重量、雌雄で腎臓の相対重量の有意な増加を認めた。0.003％群で死亡は
なかったが、体重は約 8％低く、雌で肝臓の絶対及び相対重量の有意な増加、雄で副腎の
絶対及び相対重量、甲状腺及び副甲状腺の絶対重量、脳下垂体の絶対重量の有意な減少を
認めた。しかし、雄の臓器重量の変化は高用量群でみられなかった変化であったことから、
生物学的な意義は不明であった。剖検では 0.003％以上の群で肝臓の退色や腫脹、胃の腺粘
膜の退色がみられ、肝細胞の肥大と限局性の壊死は雄の方が顕著であった。このほかにも
特に 0.03％以上の群で胸腺のリンパ濾胞細胞の減少、脾臓の軽度の萎縮とリンパ濾胞及び
細胞の減少、腸間膜リンパ節でリンパ濾胞及び細胞の減少、前胃で粘膜の過角化症と棘細
胞症、腺胃粘膜で出血、小腸で絨毛の高さや密度の減少、骨格筋の萎縮、皮膚で表皮の角
質増殖と肥厚がみられた 33) 。この結果から、LOAEL は 0.003％（2 mg/kg/day）であった。
ウ）Sprague-Dawley ラット雌雄に K 塩を 0、0.00005、0.0002、0.0005、0.002％の濃度で 2 年
間混餌投与した下記エ）の実験の一環として、一部のラットを 4、14 週間後にそれぞれ雌
雄各 5 匹を屠殺し、各 10 匹から採血した。その結果、4 週間の投与では 0.002％群の雄で
肝臓相対重量の有意な増加と血糖値の有意な減少を認め、ペルオキシソーム増殖の指標で
ある肝臓のパルミトイル CoA 酸化酵素活性は約 2 倍（有意差あり）高かった。14 週間の投
与では 0.002％群の雄で肝臓の絶対及び相対重量、桿状核好中球、GPT、尿素窒素の有意な
増加とコレステロールの有意な減少、0.002％群の雌で肝臓相対重量、尿素窒素の有意な増
加を認めた。また、0.0005％以上の群の雄及び 0.002％群の雌の肝臓で肝細胞の肥大と空胞
10
化がみられ、それらの発生率と影響度合いは 0.002％群の雄で増大する傾向にあった。なお、
増殖性細胞核抗原による標識細胞率を指標とした肝細胞の増殖は 4、14 週間の投与ではみ
られず、ペルオキシソーム増殖の指標となる肝臓のパルミトイル CoA 酸化酵素活性の上昇
も 14 週間の投与ではみられなかった。各濃度群の用量は 4 週間投与の雄で 0、0.05、0.18、
0.37、1.51 mg/kg/day、雌で 0、0.05、0.22、0.47、1.77 mg/kg/day、14 週間投与の雄で 0、0.03、
0.13、0.34、1.33 mg/kg/day、雌で 0、0.04、0.15、0.40、1.56 mg/kg/day であった 30, 31) 。この
結果から、NOAEL は雄で 0.0002％（0.13 mg/kg/day）、雌で 0.0005％（0.4 mg/kg/day）であ
った。
エ）Sprague-Dawley ラット雌雄各 60～70 匹を 1 群とし、K 塩を 0、0.00005、0.0002、0.0005、
0.002％の濃度で 104 週間混餌投与した結果、雄の 0.0005％以上の群で実験終了時の生存率
が有意に高かったことから、雄では生存率の有意な増加傾向がみられ、雌では 0.0002％群
の生存率は有意に低かったが、体重への影響は雌雄の全群でみられなかった。雄の肝臓で
は 0.00005％以上の群で嚢胞様変性、0.0002％以上の群で肝細胞の肥大、0.0005％以上の群
で肝細胞の空胞化、0.002％群で肝細胞内の好酸性顆粒や色素沈着、壊死の発生率に有意な
増加を認めたが、嚢胞様変性については老化に伴う変化で、本物質の投与によるものでは
ないと考えられた。また、雌の肝臓では 0.0005％以上の群で肝細胞の肥大や好酸性顆粒、
色素沈着したマクロファージの浸潤、0.002％群で肝細胞の着色沈着や壊死、リンパ組織球
の浸潤、門脈周囲の肝細胞肥大の発生率に有意な増加を認めた。このほか、53 週目に実施
した BrdU 染色法による肝細胞の検査では上記イ）と同様に、細胞増殖の有意な増加はみ
られなかった。摂餌量と餌中濃度から数週間ごとに求めた各濃度群の用量はそれぞれ雄で
0、0.015～0.057、0.064～0.23、0.15～0.57、0.64～2.21 mg/kg/day、雌で 0、0.015～0.052、
0.073～0.21、0.19～0.56、0.84～2.15 mg/kg/day の範囲にあった 34, 35) 。この結果から、NOAEL
は雄で 0.00005％（0.015～0.057 mg/kg/day）、雌で 0.0002％（0.073～0.21 mg/kg/day）であ
った。
オ）アカゲザル雌雄各 2 匹を 1 群とし、0、10、30、100、300 mg/kg/day の K 塩を 90 日間の
予定で強制経口投与した結果、300 mg/kg/day 群は 2～4 日、100 mg/kg/day 群は 3～5 日、30
mg/kg/day 群は 7～10 日、10 mg/kg/day 群は 11～20 日目にすべて死亡し、活動低下、下痢
を伴った嘔吐、
体の硬直、全身性の振戦、
攣縮、衰弱、
痙攣がみられた。
剖検では 100 mg/kg/day
以上の群の肝臓で退色（黄褐色）がみられたが、組織に変化はなかった。また、10 mg/kg/day
以上の群の副腎皮質でうっ血、出血、脂質の枯渇がみられた 36) 。
カ）アカゲザル雌雄各 2 匹を 1 群とし、0、0.5、1.5、4.5 mg/kg/day の K 塩を 90 日間強制経
口投与した実験では、4.5 mg/kg/day 群の全数が 5～7 週目に死亡又は瀕死となって屠殺した。
4.5 mg/kg/day 群では 1～2 週目から食欲不振、嘔吐、黒色便、脱水症状などの胃腸管への毒
性兆候を示し、死亡直前には全個体で活動性が低下し、重度の硬直性、痙攣、全身の震え、
はいつくばりをみせた。体重は 5 週目には約 22％減少し、30 日後の検査では血清コレステ
ロールの有意な減少と ALP 活性の 50％低下がみられた。剖検で臓器重量への影響はなかっ
たが、雌雄の全数の副腎で著明なび漫性の脂肪枯渇がみられ、雄 1 匹と雌 2 匹の膵臓で酵
素原顆粒の減少による外分泌細胞の中程度のび漫性萎縮、雄 2 匹と雌 1 匹の気管支腺では
漿液細胞の顆粒減少による中程度のび漫性萎縮がみられた。0.5、1.5 mg/kg/day 群では死亡
はなかったが、下痢や粘液便、血便などの胃腸管への毒性が認められ、投与期間の終わり
11
頃には 1.5 mg/kg/day 群で食欲不振、脱水症状、全身性の振戦がみられた。0.5、1.5 mg/kg/day
群で組織への影響はなかったが、1.5 mg/kg/day 群の雌で ALP 活性及び血清カリウム量の有
意な低下がみられ、1 匹では血清コレステロールも低かった
37)
。この結果から、LOAEL
は 0.5 mg/kg/day であった。
キ）カニクイザル雌雄各 4～6 匹を 1 群とし、0、0.03、0.15、0.75 mg/kg/day の K 塩をカプセ
ルに入れて 6 ヵ月間経口投与した試験では、0.75 mg/kg/day 群の雄 1 匹が 23 週目に死亡し、
もう 1 匹の雄も 26 週目に瀕死となって屠殺したが、これらでは摂餌量の減少や活動低下、
努力性呼吸などの症状がみられ、最初の 1 匹の死因は重度の急性炎症を伴った肺の壊死で、
もう 1 匹は高カリウム血症が示唆された。有意差のあった影響は 0.75 mg/kg/day 群に限ら
れ、体重増加の抑制（減少）、肝臓の絶対及び相対重量の増加、血清総コレステロールの
低下、甲状腺刺激ホルモン（TSH）の上昇とトリヨードサイロニン（T3）の低下（甲状腺
機能低下の証拠はなし）、エストラジオールの低下、肝細胞の肥大と空胞化などがあった。
パルミトイル CoA 酸化酵素活性を指標とした肝細胞のペルオキシソーム増殖は 0.75
mg/kg/day 群の雌で有意に増加したが、生物学的意義の判断基準である 2 倍増加を超えるも
のではなかった。また、増殖性細胞核抗原による標識細胞率を指標とした肝臓、膵臓、精
巣の細胞増殖にも影響はなかった。本物質は対照群の血清、肝臓からもわずかに検出され
たが、本物質の肝臓：血清中の濃度比は 0.9：1（0.15 mg/kg/day 群の雄）～2.7：1（対照群
の雌）の範囲にあり、用量依存性はなかった。肝臓中の本物質も 6 ヵ月間の総投与量に対
して 4.4％（0.15 mg/kg/day 群の雄）～8.7％（0.03 mg/kg/day 群の雌）の範囲にあり、投与
量や性との間に明らかな関連はなかった。1 年間の回復期間を設けて 0、0.15、0.75 mg/kg/day
群の雌雄各 2 匹を飼育したところ、0.75 mg/kg/day 群でみられた影響は完全に回復した。な
お、0.15 mg/kg/day 群でも雄で TSH の上昇、雌雄で T3 の低下に有意差があったが、確認の
ため他機関で実施した分析では 0.15 mg/kg/day 群の有意差はなかった 7, 8) 。この結果から、
NOAEL は 0.15 mg/kg/day であった。
③ 生殖・発生毒性
ア）Sprague-Dawley ラット雌 22 匹を 1 群とし、0、1、5、10 mg/kg/day の K 塩を妊娠 6 日目
から 15 日目まで強制経口投与した結果、10 mg/kg/day 群で妊娠 12～20 日目の体重は有意
に低く、着床数や黄体数、生存胎仔数の減少がみられたが、有意差はなかった。胎仔では
1 mg/kg/day 以上の群で眼（レンズ）の奇形が発生し（対照群では発生なし）、片方又は両
方の眼に奇形のあった胎仔の発生率は 10 mg/kg/day 群で有意に高かった 38) 。
この結果から、
母ラットで NOAEL は 5 mg/kg/day、胎仔で LOAEL は 1 mg/kg/day であった。
イ）Sprague-Dawley ラット雌 25 匹を 1 群とし、0、1、5、10 mg/kg/day の K 塩を妊娠 6 日目
から 15 日目まで強制経口投与した結果、5 mg/kg/day 以上の群で円背位姿勢、食欲不振、
血液の混じった腟排泄物や着色尿、脱毛、粗毛などがみられ、体重増加の有意な抑制、摂
餌量の減少を認め、10 mg/kg/day 群で妊娠子宮の重量は有意に低く、胃腸障害の発生率増
加がみられ、妊娠 17 日目に 2 匹が死亡した。妊娠率や黄体数、着床数や着床部位に有意な
差はなかった。後期胚損失率、全胚吸収、死亡胎仔数などに用量に依存した増加傾向がみ
られたが、いずれも有意差はなかった。5 mg/kg/day 以上の群で胎仔の体重は有意に低く、
12
10 mg/kg/day 群で外表系及び内臓系奇形（口蓋裂や皮下浮腫、停留睾丸）、骨化遅延（頭
蓋骨、胸郭、胸帯、脊椎など）の発生率に有意な増加を認め、肋骨及び胸骨分節の変異も
みられた。なお、これらの奇形や変異は主に、雄又は雌の仔の平均体重が有意に低かった
母ラットから産まれた仔にみられた 39) 。この結果から、母ラット及び胎仔で NOAEL は 1
mg/kg/day であった。
ウ）Sprague-Dawley ラット雌に 0、1、2、3、5、10 mg/kg/day の K 塩を妊娠 2 日目から 20 日
目まで、CD-1 マウス雌に 0、1、5、10、15、20 mg/kg/day の K 塩を妊娠 1 日目から 17 日
目まで強制経口投与した結果、ラットでは 2 mg/kg/day 以上の群で用量に依存した体重増加
の有意な抑制、10 mg/kg/day 群で肝臓相対重量の有意な増加、血清中のコレステロール、
トリグリセリドの有意な減少を認めた。また、1 mg/kg/day 以上の群で血清中のサイロキシ
ン（T4）、トリヨードサイロニン（T3）の有意な減少がみられたが、甲状腺刺激ホルモン
（TSH）に差はなかった。生存胎仔数や後期胚損失率に影響はなかったが、10 mg/kg/day
群の胎仔の体重は有意に低く、主に 10 mg/kg/day 群で口蓋裂、胸骨分節の欠損、全身水腫、
右心房の拡大、心室中隔欠損の発生率に有意な増加がみられた。
マウスでは体重増加の有意な抑制は妊娠後期の 20 mg/kg/day 群に限られたが、肝臓の絶
対及び相対重量は 5 mg/kg/day 以上の群で有意に増加し、15 mg/kg/day 以上の群では対照群
の約 2 倍もあった。また、5 mg/kg/day 以上の群で血清中のトリグリセリドの有意な減少を
認めたが、コレステロールに有意な差はなかった。20 mg/kg/day 群で後期胚損失率の有意
な増加がみられ、胎仔の体重は 15 mg/kg/day 以上の群でわずかだが有意に低く、胎仔の肝
臓の絶対及び相対重量は 20 mg/kg/day 群で有意に高く、10 mg/kg/day 以上の群で右心房の
拡大、15 mg/kg/day 以上の群で口蓋裂、胸骨分節の欠損、心室中隔欠損の発生率に有意な
増加がみられた 40, 41) 。
この結果から、母ラットで LOAEL は 1 mg/kg/day、胎仔で NOAEL は 5 mg/kg/day、母マ
ウスで NOAEL は 1 mg/kg/day、胎仔で NOAEL は 5 mg/kg/day であった。なお、著者らはこ
れらの結果にベンチマークドーズ法を適用し、5％の発生率に相当する用量の 95％信頼限
界の下限値（BMDL 5 ）として、ラット、マウスの体重増加の抑制でそれぞれ 0.150、3.14
mg/kg/day、T4 濃度で 0.046、0.352 mg/kg/day、胸骨分節の欠損で 0.122、0.016 mg/kg/day、
口蓋裂で 3.33、3.53 mg/kg/day と算出している。
エ）Sprague-Dawley ラット雌に 0、1、2、3、5、10 mg/kg/day の K 塩を妊娠 2 日目から 21 日
目まで、CD-1 マウス雌に 0、1、5、10、15、20 mg/kg/day の K 塩を妊娠 1 日目から 18 日
目まで強制経口投与し、自然分娩させて新生仔を観察した結果、全群で死産はなく、当初
は活動的であったが、ラットの 10 mg/kg/day 群及びマウスの 20 mg/kg/day 群では 30～60 分
以内に蒼白、不活発となって瀕死となり、間もなく全数が死亡した。ラットの 5 mg/kg/day
群及びマウスの 15 mg/kg/day 群でも新生仔は瀕死となり、8～12 時間は生存したものの、
24 時間以内に 95％以上が死亡し、ラットの 3 mg/kg/day 群及びマウスの 10 mg/kg/day 群で
も 24 時間以内に約 50％の新生仔が死亡した。生後 1 週間以降の死亡率に有意な差はなか
ったが、離乳時の生存率はラットで 2 mg/kg/day 以上の群、マウスでは 10 mg/kg/day 以上の
群で有意に低かった。5 mg/kg/day 群のラット新生仔をすぐに対照群の母ラットで哺育させ
ても、仔の生存率に改善はなく、対照群の新生仔を 5 mg/kg/day 群の母ラットに哺育させて
も 3 日間の仔の生存率に変化はなかった。マウスでは仔の LD50 は 10 mg/kg/day と推定され
13
たが、1、5 mg/kg/day 群の生存率には対照群と差がなかった。新生仔死亡の原因は不明で
あったが、妊娠後期に発達する器官系が本物質に対して脆弱なためではないかとした仮説
が考えられている。
ラットの生存仔では 2 mg/kg/day 以上の群で授乳期に体重増加の抑制がみられ、5
mg/kg/day 群では 22 週頃まで持続した。2 mg/kg/day 以上の群の仔で開眼にわずかだが有意
な遅延がみられたが、腟開口や包皮分離、発情周期に影響はなかった。血清中の T4 濃度の
有意な抑制は 1 mg/kg/day 以上の群でみられ、総 T4 濃度は離乳時までに回復したが、遊離
T4 濃度の抑制は実験終了時（生後 35 日）まで持続した。T3 や TSH に影響はなく、前頭葉
前部のコリンアセチルトランスフェラーゼ活性はわずかだが有意に低下したが、海馬の酵
素活性に変化はなかった。このほか、3 mg/kg/day 群の仔で迷路学習試験の成績に影響はな
かった。
マウスの生存仔では 10 mg/kg/day 群で体重増加の抑制傾向がみられ、5 mg/kg/day 以上の
群で肝臓の絶対及び相対重量の有意な増加、1 mg/kg/day 以上の群で有意ではあるが 0.3 日
とごく軽微な開眼の遅延を認めた 42) 。
これらの結果から、ラット及びマウスの仔で LOAEL は 1 mg/kg/day であった。
オ）ニュージーランド白ウサギ雌 22 匹を 1 群とし、0、0.1、1、2.5、3.75 mg/kg/day を妊娠 7
日目から 20 日目まで強制経口投与した結果、2.5 mg/kg/day 群の 1 匹、3.75 mg/kg/day 群の
10 匹が流産し、1 mg/kg/day 以上の群で体重増加の有意な抑制が投与期間中にみられた。胎
仔では 2.5 mg/kg/day 以上の群で体重が有意に低く、胸骨分節や舌骨、中手骨、恥骨で若干
の骨化遅延がみられた以外には影響はなかった 43,
44)
。この結果から、母ウサギで NOAEL
は 0.1 mg/kg/day、胎仔で NOAEL は 1 mg/kg/day であった。
カ）Sprague-Dawley ラット雌雄各 35 匹を 1 群とし、0、0.1、0.4、1.6、3.2 mg/kg/day の K 塩
を交尾前 42 日（F1 は 68 日）から交尾期間を通して強制経口投与し、雌には妊娠、授乳期
間にも投与した二世代試験では、1.6 mg/kg/day 以上の群で新生仔の生存率が著しく低下し
たため、F1 世代は 0～0.4 mg/kg/day 群に限って実施した。F0 世代では、0.4 mg/kg/day 以上
の群の雄で体重増加の有意な抑制を認め、雌では交尾前の 1.6 mg/kg/day 以上の群、妊娠中
の 3.2 mg/kg/day 群で体重増加の有意な抑制を認めたが、
授乳中の雌には有意差はなかった。
発情周期や受胎率などのパラメーターに変化はなく、妊娠 10 日目に実施した雌の帝王切開
でも黄体数や着床数、生存胎仔数に有意な差はなかった。しかし、自然分娩させた 3.2
mg/kg/day 群で妊娠期間の短縮、着床痕数の減少、死産や生後 4 日までに仔が全数死亡した
母ラット数の増加に有意差を認め、新生仔（F1）の 45.5％が生まれた日に死亡し、残りも
翌日までに死亡した。1.6 mg/kg/day 群でも F1 の 10.6％が産まれた日に死亡し、生後 4 日ま
でに 33.9％が死亡した。新生仔の死因は不明であったが、剖検した仔の約 75％で胃にミル
クがなかった。出生時体重は 1.6 mg/kg/day 以上の群で有意に低く、1.6 mg/kg/day 群の生存
仔では授乳期の体重増加も有意に低く、耳介の展開、開眼、平面立ち直り反応及び空中立
ち直り反応の出現時期に有意な遅延がみられ、0.4 mg/kg/day 群の仔でも開眼時期の遅延に
有意差があった。F1 では最高用量の 0.4 mg/kg/day 群でも体重や性成熟、受動的回避学習、
迷路学習への影響はなく、妊娠期間や着床数、出生仔数などの繁殖成績、出生仔の生存率
にも影響はなかったが、0.4 mg/kg/day 群の仔（F2）で生後 4～14 日目の体重増加に有意な
抑制がみられた 3, 45) 。著者らは F1 の 0.4 mg/kg/day 群で開眼遅延は 0.6 日と軽微であったこ
14
とから悪影響の所見とは考えられないとしていたが、用量依存的に認められた影響である
ため、無視できないと判断した。この結果から、NOAEL は生殖機能については F0 で 3.2
mg/kg/day 以上、F1 では 0.4 mg/kg/day 以上、繁殖成績については F0 で 1.6 mg/kg/day、F1 で
0.4 mg/kg/day であり、
親世代への全体的影響は F0 で 0.1 mg/kg/day、F1 で 0.4 mg/kg/day 以上、
仔への影響は F1、F2 で 0.1 mg/kg/day であった。
キ）Sprague-Dawley ラット雌 25 匹を 1 群とし、0、1.6 mg/kg/day の K 塩を 42 日間強制経口投
与した後に無処置の雄と交尾させ、さらに妊娠期間にも投与して自然分娩させ、A）対照
群の母ラットとばく露（1.6 mg/kg/day）群の新生仔、B）対照群の母ラットとその新生仔、
C）ばく露群の母ラットとその新生仔、D）ばく露群の母ラットと対照群の新生仔の 4 群に
分けて生後 21 日目までばく露群の母ラットに投与を継続した。その結果、生後 2～4 日目
の仔の死亡率は C 群で約 19％、A 群で約 9％、B 群で 1.6％、D 群で 1.1％であり、生後 4
～21 日目の体重は B 群に比べて A、C、D 群で低く、中でも C 群の体重が最も低かった。
このため、新生仔の生存率低下は主に子宮内でのばく露に起因した影響であることが示唆
された。なお、ばく露群の母ラットでは交尾前～妊娠期間に体重増加の抑制、交尾前～授
乳期間に摂餌量の減少、妊娠期間の短縮、着床数や産仔数の減少がみられた 4, 45) 。
ク）Sprague-Dawley ラット雌 10～15 匹を 1 群とし、K 塩 0、25 mg/kg/day の 4 日間の強制経
口投与を妊娠 2～5 日目、6～9 日目、10～13 日目、14～17 日目、17～20 日目までの各群に
ついて実施し、自然分娩させて生後 10 日目まで観察した。その結果、25 mg/kg/day 群では
いずれも投与期間に母ラットの体重増加に有意な抑制を認め、妊娠 2～5、6～9、10～13 日
目の投与群では妊娠 6、10、17 日目の体重も有意に低かった。出生仔数には影響はなかっ
たが、妊娠 2～5、6～9、10～13 日目の投与群で出生時体重は有意に低かった。対照群で新
生仔の生存率は 100％に近かったが、25 mg/kg/day 群では生存率の低下がみられ、特に妊娠
の後期に投与した群で生存率の低下は著しく、妊娠 2～5 日目の投与群では生後 10 日目の
生存率は約 60％であったが、妊娠 17～20 日目の投与群では新生仔の 60％以上が産まれた
日に死亡し、翌日にはほぼ 100％となった。また、妊娠 19～20 日目の 2 日間に 0、25、50
mg/kg/day を強制経口投与した結果、25 mg/kg/day 以上の群の母ラットで体重増加の有意な
抑制、産仔数の有意な減少を認め、25 mg/kg/day 以上の群で出生時体重は有意に低かった。
また、新生仔の生存率は生後 0 日目の各群で 100、94、29％、生後 1 日目で 99、82、3.5％、
生後 5 日目で 98、66、3％であった。本物質の新生仔死亡に対する感受性は妊娠後期（妊
娠 17 日目以降）が最も高く、新生仔は呼吸困難で死亡することから、肺の組織や肺胞表面
活性物質などの成熟阻害が関与していると思われた 46) 。しかし、その後の実験で肺胞表面
活性物質の組成と量は正常であり 45, 47) 、さらに脂質やグルコース利用、甲状腺ホルモンの
減少による生存率の低下でもないことが示された 48) 。結局、妊娠中および授乳を通じて母
ラットから仔へ移行する本物質の濃度とだけ、死亡率が強く相関することが確認されたが、
そのメカニズムについては不明である。
ケ）Wistar ラット雄 9 匹を 1 群とし、0、0.5、1.5、4.5 mg/kg/day を 65 日間混餌投与した結果、
0.5 mg/kg/day 以上の群で体重増加の有意な抑制と精巣絶対重量の有意な減少を認めたが、
精巣の相対重量に有意な変化はなかった。1.5 mg/kg/day 以上の群で精子数、精巣に特異的
な乳酸脱水素酵素アイソザイム（LDH-x）活性及びソルビトールデヒドロゲナーゼ（SDH）
活性の有意な低下と精子奇形の有意な増加、4.5 mg/kg/day 群で精巣のマロニルジアルデヒ
15
ド（MDA）産生の有意な増加と精子運動性の有意な低下を認めた 49) 。この結果から、LOAEL
は 0.5 mg/kg/day であった。
④ ヒトへの影響
ア）フッ化ペルフルオロオクチルスルホニル（Perfluorooctylsulfonyl fluoride；POSF）をベー
スとしたフッ素化合物製造工場の労働者の血液中で本物質が検出されるが、これは程度は
不明であるものの、POSF やその誘導体が本物質に分解や代謝されたためと考えられている。
1961 年から製造を開始したアメリカ（アラバマ州）の POSF 製造工場とその風上に立地す
る POSF の生産を行っていない同社のフィルム工場に 1 年以上勤務した労働者 2,083 人（退
職者含む）を対象とした死亡率調査では、労働者の作業履歴と血清中の本物質濃度から、
982 人（女性 156 人、勤務年数中央値 16.7 年）が高ばく露、289 人（85 人、10.4 年）が低
ばく露、812 人（112 人、9.9 年）が非ばく露に分類される作業に従事しており、1998 年末
の時点で死亡はそれぞれ 65 人、27 人、53 人であった。また、高ばく露の作業に 1 年以上
従事した労働者は 782 人で、死亡は 53 人、高ばく露又は低ばく露の作業に合計で 1 年以上
従事した労働者は 1,065 人で、死亡は 29 人であった。これらの労働者について同州の死亡
率をもとに年令、性、暦時間で調整して標準化死亡比（SMR）を求めた結果、いずれの群
においても全死亡はアラバマ州一般の死亡よりも有意に低くなっており、がん以外の死因
では有意な差は認められなかった 50) 。
イ）上記アラバマ州の両工場のコホート（2,083 人）では、2002 年末までに 188 人（女性 11
人）がさらに死亡しており、残りの 1,895 人については健康状態や妊娠・出産などに関す
るアンケート調査を実施したところ、1,400 人（女性 263 人）から回答があり、各種疾患や
妊娠・出産の調査項目で調整後のオッズ比が有意な増加を示すものはなかった 51) 。
ウ）上記の両工場の労働者の中から、1993～1998 年の間に 1 年以上勤務した労働者各 652 人
（女性 122 人）、659 人（女性 101 人）を対象にして、医療機関での一連の受診記録をも
とに疾病の発生状況を把握し、疾病の観察値と同社の全米労働者をもとに得られた期待値
から、フィルム工場労働者に対する POSF 工場労働者の相対リスク（RR）を算出した。そ
の結果、RR の有意な増加を示した疾患は急性胆嚢炎 8.6（95％CI: 1.1～>100）、膀胱炎 1.5
（95％CI: 1.0～2.2）のみで、内分泌障害や心臓血管障害、生殖・発生障害などで RR の有
意な増加を示したがん以外の疾患はなかった。また、この中から両工場で 10 年以上勤務し
た労働者各 211 人（女性 15 人）、345 人（女性 37 人）について同様の検討を行ったとこ
ろ、胆管障害 2.6（95％CI: 1.2～5.5）、急性胆嚢炎 25（95％CI: 2.1～>100）、急性膵臓炎
5.5（1.0～56）、膀胱炎 2.4（95％CI: 1.2～4.8）、尿路感染症 2.1（95％CI: 1.2～3.5）で RR
の有意な増加がみられただけであった 52) 。
エ）アメリカ（アラバマ州）及びベルギー（アントワープ）の POSF 工場で実施した 2000 年
の調査では、血清中の本物質濃度はアメリカの工場の労働者（263 人、うち女性 48 人）で
平均 1.32 ppm（0.06～10.06 ppm）、ベルギーの工場の労働者（255 人、うち女性 49 人）で
0.80 ppm（0.04～6.24 ppm）であった。これら労働者を対象とした血液、臨床化学成分、甲
状腺機能、尿の各検査で異常はみられなかった 53, 54) 。血清中の濃度測定は 1994/1995 年、
1997 年にも実施しており、これらのどちらか、あるいは両方と 2000 年の調査で共通する
16
労働者は 174 人であった。このため、174 人について血清中の本物質と脂質、肝酵素など
について長期的に解析した結果、本物質との間に有意な関連を示す成分はなかった 54, 55) 。
オ）ボルチモアの病院で 2004 年 11 月から 2005 年 3 月に生まれた正常な単胎児のうち、臍帯
血の得られた 293 人の調査では、本物質は 99％以上の臍帯血清から検出され、中央値は 5
ng/mL（検出限界値未満 (0.2 ng/mL)～34.8 ng/mL）であり、本物質と PFOA が環境中で広
く検出されていることを示すように、臍帯血清中の本物質と PFOA の間には高い関連があ
った。臍帯血清中の本物質濃度と在胎週齢で調整した出生時の体重、頭囲長、ポンデラル
指数（肥満度の一つで、体重の立方根を 100 倍して身長(cm)で除した値）の間には有意な
負の関連があり、在胎週齢、身長では有意な関連はみられなかった。一般に頭囲長は帝王
切開＞普通分娩の関係にあることから、分娩方法から 2 群に分けて検討したところ、有意
な負の関連は普通分娩（全体の 77.8％）による頭囲長に限られた 56) 。
カ）デンマークの国民出生コホート（1996～2002 年）から無作為に抽出した 1,387 人の妊婦
とその正常な単胎児の調査では、妊娠 4～14 週の母体血漿中の本物質濃度は 35.3 ng/mL（6.4
～106.7 ng/mL）であったが、母体血漿中の本物質濃度と出生時体重、在胎週齡の間には有
意な関係はなかった 57) 。
キ）国内で 15 人の妊婦を対象に実施された調査では、本物質の血清中濃度（4.9～17.6 ng/mL）
と臍帯血清中濃度（1.6～5.3 ng/mL）には高い関連がみられたが、血清中濃度と妊婦の年令
や肥満度、臍帯血清中濃度と新生児の性、出生時体重、甲状腺ホルモン指数（TSH、遊離
T4）との間にはいずれも関連はみられなかった 58) 。
（3）発がん性
① 主要な機関による発がんの可能性の分類
国際的に主要な機関での評価に基づく本物質の発がんの可能性の分類については、表 3.2
に示すとおりである。
表 3.2
機 関（年）
主要な機関による発がんの可能性の分類
分
類
WHO
IARC
－
EU
EU
－
EPA
－
ACGIH
－
NTP
－
日本産業衛生学会
－
USA
日本
ドイツ DFG
－
② 発がん性の知見
○遺伝子傷害性に関する知見
in vitro 試験系では、本物質の K 塩は代謝活性化系（S9）添加の有無にかかわらずネズミ
チフス菌 59, 60) 、酵母 59) 、大腸菌 60) で遺伝子突然変異、ヒト全血培養リンパ球 61) で染色
17
体異常を誘発しなかった。また、ラット肝初代培養細胞 62) で不定期 DNA 合成を誘発しな
かった。
本物質のジエタノールアンモニウム塩は S9 添加の有無にかかわらずネズミチフス菌、酵
母で遺伝子突然変異を誘発しなかった 63) 。
in vivo 試験系では、K 塩は経口投与したマウスの骨髄で小核を誘発しなかった 64) 。
なお、本物質はラットの肝臓上皮細胞（WB-F344）を用いた in vitro 試験
65)
、K 塩はラ
ットの肝臓上皮細胞（WB-F344）、イルカの腎臓上皮細胞（CDK）を用いた in vitro 試験、
ラットに経口投与した in vivo 試験で細胞間コミュニケーション阻害を誘発した 66) 。
○実験動物に関する発がん性の知見
Sprague-Dawley ラット雌雄各 60～70 匹を 1 群とし、K 塩を 0、0.00005、0.0002、0.0005、
0.002％の濃度で 104 週間混餌投与、雌雄各 40 匹を 0.002％の濃度で 52 週間混餌投与した後
にさらに 52 週間飼育（回復群）した結果、雄の 0.0005％以上の群で実験終了時の生存率が
有意に高かったことから、雄では生存率の有意な増加傾向がみられ、雌では 0.0002％群の
生存率は有意に低かったが、体重への影響は雌雄の全群でみられなかった。104 週間投与で
は、肝細胞腺腫が雄の各群で 0/60、3/50、3/50、1/50、7/60 匹に、雌で 0/60、1/50、1/49、
1/50、5/60 匹にみられ、雌雄ともに有意な増加傾向にあって、0.002％群の発生率は有意に
高かった。雌では 0.002％群の 1/60 匹で肝細胞癌もみられ、これを合わせた肝腫瘍の発生
率も有意に高かった。さらに雌では 0.0005％群で甲状腺の濾胞腺腫が 2/50 匹に、濾胞癌が
1/50 匹にみられ、ともに有意な発生率の増加ではなかったが、濾胞腺腫と濾胞癌を合わせ
た発生率は有意に高かった。この他にも雌では 23/60、30/50、22/48、26/50、15/60 匹に乳
腺線維腫又は乳腺腺腫がみられ、0.00005％群の発生率は有意に高く、0.002％群の発生率は
有意に低かったことから、有意な減少傾向にあった。乳腺癌は 11/60、12/50、15/48、11/50、
14/60 匹にみられ、いずれの群にも有意差はなかったが、これらを合わせた乳腺腫瘍は 29/60、
36/50、31/48、29/50、24/60 匹にみられ、0.00005％及び 0.0002％群で有意に高かった。一方、
0.002％濃度で 52 週間混餌投与した回復群では肝臓や乳腺の腫瘍に有意な発生増加はなか
ったが、雄の甲状腺で 9/39 匹に濾胞腺腫、1/39 匹に濾胞癌の発生があり、濾胞腺腫の発生
率は有意に高く、104 週間投与の 0.002％群（雄）と比較してもその発生率は有意に高かっ
た。濾胞腺腫と濾胞癌を合わせた発生率には有意差はなかったが、104 週間投与との比較で
はその発生率は有意に高かった 34, 35) 。
このほか、本物質の誘導体 N-EtFOSE を 0、0.0001、0.0003、0.003、0.01、0.03％の濃度
で雌雄のラットに 104 週間混餌投与した実験では、7 週目までに 0.03%群の全数が死亡ある
いは瀕死となって屠殺した以外には各群で生存率に有意差はなかった。0.01％群の雄で甲状
腺濾胞腺腫、雌で肝細胞腺腫、乳腺の線維腺腫、線維腺腫と腺腫を合わせた乳腺腫瘍の発
生率に有意な増加がみられた。また、0.02％濃度で 52 週間混餌投与し、その後さらに 52
週間飼育した回復群の雌雄では、有意な発生率の増加を示した腫瘍はなかった 67, 68) 。
○ヒトに関する発がん性の知見
1961 年から製造を開始したアラバマ州の POSF 製造工場とその風上に立地する同社のフ
18
ィルム工場に 1 年以上勤務した労働者 2,083 人
（退職者含む）を対象とした死亡率調査では、
労働者の作業履歴と本物質の血清中濃度から、982 人が高ばく露、289 人が低ばく露、812
人が非ばく露に分類される作業に従事しており、1998 年末の時点でそれぞれ 18 人、6 人、
15 人ががんにより死亡していた。また、高ばく露の作業に 1 年以上従事した労働者は 782
人で、14 人ががんにより死亡していた。これらの労働者について同州の死亡率をもとに年
令、性、暦時間で調整して求めた全がんの SMR に有意な増加はなかったが、高ばく露群で
膀胱がんの SMR は 12.77（95％CI: 2.63～37.35）と有意に高く、高ばく露の作業に 1 年以上
従事した労働者で SMR は 16.12（95％CI: 3.32～47.14）とさらに増加した。膀胱がんの 3
例はすべて高ばく露群の男性労働者で、いずれも 5 年以上の従事者であり、この条件で膀
胱がんの SMR を求めると、25.5（期待値 0.12 人）となった。しかし、彼らはいずれも本物
質の生産部門における職歴は長くないため、本物質が原因とは断定できず、単なる偶然の
結果の可能性は除外できないと考えられた 50) 。
上記アラバマ州の両工場のコホート（2,083 人）では、2002 年末までに 188 人（女性 11
人）がさらに死亡しており、残りの 1,895 人については健康状態や妊娠・出産などに関する
アンケート調査を実施したところ、1,400 人（女性 263 人）から回答があった。その結果、
結腸がん 22 人、悪性黒色腫 39 人、前立腺がん 29 人であったが、確定診断ではそれぞれ 12、
8、22 人であり、特に悪性黒色腫については 5 人が基底細胞癌、6 人が扁平上皮癌、1 人が
不明で、2 人は癌でなかった。この他にも乳がんの 4 人があったが、1 人は低ばく露群で 8
年間、2 人は高ばく露群で 1 年未満の労働者であったため、検討対象から除外した。このた
め、結腸がん、前立腺がんについては回答の人数、悪性黒色腫については確定診断の人数
をもとに年令等で調整したオッズ比を求めたところ、いずれも有意な増加はみられなかっ
た 51) 。膀胱がんについては 50 才以上の 11 人（男性 9 人、女性 2 人）で、全米の人口をも
とに算出した標準化罹患比（SIR）に有意な増加はなかった。また、高ばく露に 1 年未満、
1～5 年未満、5～10 年未満、10 年以上従事した場合の重み付け累積ばく露で整理し、1 年
未満を対照にして相対リスクを求めたところ、
それぞれ 0.83
（95％CI: 0.15～4.65）、
1.92（95％
CI: 0.30～12.06）
、1.52（95％CI: 0.21～10.99）であった。なお、11 人中 2 人は本物質にばく
露される場所での作業歴がなく、アンケートの回答によって膀胱がんを把握した 6 人中 5
人が喫煙者であり、2 人だけが高ばく露の作業に 1 年以上従事していた。しかし、調査対象
者の数が十分ではないことや症例の確認の不完全性などのため、はっきりとした結論を出
すことはできないと考えられた 69) 。
上記の両工場の労働者の中から、1993～1998 年の間に 1 年以上勤務した労働者各 652 人
（女性 122 人）
、659 人（女性 101 人）を対象にして、医療機関での一連の受診記録をもと
に疾病の発生状況を把握し、疾病の観察値と同社の全米労働者をもとに得られた期待値か
ら、フィルム工場労働者に対する POSF 工場労働者の相対リスク（RR）を算出した。その
結果、がん及び良性腫瘍としては良性の結腸ポリープ及び皮膚腫瘍が件数のほとんどを占
めていたが、RR の有意な増加は皮膚の悪性黒色腫 12（95％CI: 1.0～>100）に限られた。ま
た、この中から両工場で 10 年以上勤務した労働者各 211 人（女性 15 人）
、345 人（女性 37
人）について同様の検討を行ったところ、RR の有意な増加は良性の結腸ポリープ 2.4（95％
CI: 1.3～4.5）にみられただけであった 52) 。
19
一般に、化学物質による膀胱がんでは、遺伝子傷害性あるいは尿中に沈殿して上皮を傷
つけるメカニズムが推定されているが、本物質には遺伝子傷害性がないと考えられること、
労働者の血清中濃度レベルでは尿中でも溶解（溶解度 305 µg/mL）していること、ラットや
サルの実験で尿路系の腫瘍や炎症がみられなかったことから、膀胱がんと本物質の関連性
については疑問視されている 50, 69) 。
（4）健康リスクの評価
①評価に用いる指標の設定
非発がん影響については一般毒性及び生殖・発生毒性等に関する知見が得られているが、
発がん性については十分な知見が得られず、ヒトに対する発がん性の有無については判断で
きない。このため、閾値の存在を前提とする有害性について、非発がん影響に関する知見に
基づき無毒性量等を設定することとする。
経口ばく露については、中・長期毒性エ）のラットの試験から得られた K 塩の NOAEL
0.00005％（0.015～0.057 mg/kg/day、雄の肝細胞肥大）から用量範囲の平均をとって 0.036
mg/kg/day とし、
本物質に換算した 0.03 mg/kg/day が信頼性のある最も低用量の知見と判断し、
これを無毒性量等に設定する。
吸入ばく露については、無毒性量等の設定はできなかった。
②健康リスクの初期評価結果
表 3.3
ばく露経路・媒体
経口
注：（
飲料水
・食物
地下水
・食物
経口ばく露による健康リスク（MOE の算定）
平均ばく露量
予測最大ばく露量
0.00056 µg/kg/day 程度
0.0067 µg/kg/day 程度
MOE
無毒性量等
450
0.03 mg/kg/day ラット
（0.002 µg/kg/day）
（0.01 µg/kg/day）
（300）
）内の数値は、参考として算出したものを示す。
経口ばく露については、飲料水・食物を摂取すると仮定した場合、平均ばく露量は 0.00056
µg/kg/day 程度、予測最大ばく露量は 0.0067 µg/kg/day 程度であった。無毒性量等 0.03 mg/kg/day
と予測最大ばく露量から、動物実験結果より設定された知見であるために 10 で除して求めた
MOE（Margin of Exposure）は 450 となる。また、参考として地下水・食物を摂取した場合を
算出すると、予測最大ばく露量は 0.01 µg/kg/day で、MOE は 300 となる。
表 3.4
ばく露経路・媒体
吸入
吸入ばく露による健康リスク（MOE の算定）
平均ばく露濃度
予測最大ばく露濃度
環境大気
0.0000018 µg/m3 程度
0.00003 µg/m3 程度
室内空気
－
－
MOE
無毒性量等
－
－
－
－
吸入ばく露については、無毒性量等が設定できず、健康リスクの判定はできなかった。
なお、参考として、吸収率 100％と仮定して経口ばく露の無毒性量等を吸入ばく露の無毒性
20
量等に換算すると 0.1 mg/m3 となるが、これと予測最大ばく露濃度から算出した MOE は一般
環境大気で 330,000 となる。
本物質の代謝・動態には大きな種差や性差がみられ、特にヒトの血清中の半減期（5.4 年）
は実験動物に比べてはるかに長い。このため、本物質についてはばく露の量や濃度ではなく、
体内負荷量に着目した評価の方がより適切であると考えられ、体内負荷量による MOE を試算
したところ、その値は上記 MOE と大きく異なったが、作用メカニズムに関する知見などが十
分に得られていないことから、リスクの判定は難しいと考えられた。
従って、本物質の健康リスクについては情報収集に努める必要があると考えられる。
［ 判定基準 ］
MOE＝10
詳細な評価を行う
候補と考えられる。
MOE＝100
情報収集に努める必要
があると考えられる。
21
現時点では作業は必要
ないと考えられる。
4．生態リスクの初期評価
水生生物の生態リスクに関する初期評価をペルフルオロオクタンスルホン酸当たりの毒性
値で行った。
（1）水生生物に対する毒性値の概要
本物質の水生生物に対する毒性値に関する知見を収集し、その信頼性を確認したものを生
物群（藻類、甲殻類、魚類及びその他）ごとに整理すると表 4.1 のとおりとなった。表中の報
告値は原著に記載されている値であり、塩濃度の場合にはペルフルオロオクタンスルホン酸
当たりに換算し、毒性値に示した。
表 4.1
生物 急 慢 毒性値
群 性 性 [µg/L]*1
藻類
○
○
報告値
[µg/L]*2
生物名
水生生物に対する毒性値の概要
生物分類
3,200
Skeletonema
costatum
珪藻類
＞2,970*6 ＞3,200
Skeletonema
costatum
珪藻類
2,970*6
Pseudokirchne
○
○
5,300
8,200
9,270
○
○
40,800
48,200
○
64,900
○
64,900
○
65,900
○
68,600
○
76,100
○
81,600
○
○
5,300 riella
緑藻類
subcapitata
Chlorella
8,200
緑藻類
vulgaris
Pseudokirchne
10,000 riella
緑藻類
subcapitata
Pseudokirchne
44,000 riella
緑藻類
subcapitata
Pseudokirchne
48,200 riella
緑藻類
subcapitata
Pseudokirchne
70,000 riella
緑藻類
subcapitata
Pseudokirchne
70,000 riella
緑藻類
subcapitata
Pseudokirchne
71,000 riella
緑藻類
subcapitata
Pseudokirchne
74,000 riella
緑藻類
subcapitata
Pseudokirchne
82,000 riella
緑藻類
subcapitata
Chlorella
81,600
緑藻類
vulgaris
Anabaena
藍藻類
flos-aquae
Pseudokirchne
111,000 120,000 riella
緑藻類
subcapitata
87,000
93,800
エンドポイント
／影響内容
NOEC
GRO(RATE,
AUG, 細胞数)
EC50
GRO(RATE,
AUG, 細胞数)
ばく露 試験の信 採用の
期間
頼性／ 可能性
[日] Reliability*3 *4
文献
No.*5
被験
物質
4
1
C*7
5)-39
(海水)
カリウ
ム塩
4
1
C*8
5)-39
(海水)
カリウ
ム塩
NOEC GRO(細
胞数)
4
B
B*7
4)-2007068
カリウ
ム塩
NOEC
GRO(細胞数)
4
B
B
4)-2007068
カリウ
ム塩
EC10
GRO(細胞数)
4
2
-
5)-13
カリウ
ム塩*11
NOEC
GRO(RATE, 細
胞数, AUG)
4
1
-
5)-2
カリウ
ム塩
EC50
GRO (細胞数)
4
B
B*8
4)-2007068
カリウ
ム塩
NOEC
GRO(RATE, 細
胞数, AUG)
3
1
-
5)-2
カリウ
ム塩
EC50
GRO(細胞数)
3
1
-
5)-2
カリウ
ム塩
EC50
GRO(AUG,
胞数)
4
1
-
5)-2
カリウ
ム塩
EC50
GRO (AUG)
3
1
-
5)-2
カリウ
ム塩
EC50
GRO(細胞数)
4
1
-
5)-13
カリウ
ム塩*11
EC50
GRO (細胞数)
4
B
B
4)-2007068
NOEC
GRO(RATE)
4
1
-
5)-36
EC50
GRO (RATE)
3
1
-
5)-2
22
細
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
生物 急 慢 毒性値
群 性 性 [µg/L]*1
生物名
生物分類
Pseudokirchne
117,000 126,000 riella
緑藻類
subcapitata
Anabaena
163,000 176,000
藍藻類
flos-aquae
○
○
○
○
甲殻
類
報告値
[µg/L]*2
○
-
EC50
GRO(RATE)
4
1
-
4
1
-
283,000 305,000
Navicula
pelliculosa
珪藻類
EC50
GRO(RATE)
4
1
-
NOEC REP
35
1
B
IMM
2
2
C*9
MOR
4
1
B
28
2
C
2
2
-
21
1
B
2
2
C
232
250
Americamysis
アミ科
bahia
11,300 Daphnia
(3,960) magna
3,600
Americamysis
アミ科
bahia
6,490
7,000
Daphnia
magna
8,250
8,900Artemia sp.
○
1
NOEC
GRO(RATE)
3,340
○
4
珪藻類
○
○
EC50
GRO (RATE)
Navicula
pelliculosa
2,400
○
ばく露 試験の信 採用の
期間
頼性／ 可能性
[日] Reliability*3 *4
191,000 206,000
○
○
エンドポイント
／影響内容
オオミジンコ EL50
LC50
オオミジンコ NOEC
アルテミア属 LC50
REP
MOR
NOEC REP/
MOR/GRO
11,100
12,000
Daphnia
magna
オオミジンコ
25,000
27,000
Daphnia
magna
オオミジンコ EC50
25,000
25,000
Daphnia
magna
オオミジンコ NOEC REP
21
B
B
210,000 Daphnia
(51,500) magna
オオミジンコ EC50
IMM
2
2
C
IMM
○
50,700
○
53,800
58,000
Daphnia
magna
オオミジンコ EC50
IMM
2
2
C
○
56,600
61,000
Daphnia
magna
オオミジンコ EC50
IMM
2
1
B
○
67,200
67,200
Daphnia
magna
オオミジンコ EC50
IMM
2
B
B
134,000 134,000
Daphnia
pulicaria
ミジンコ属
EC50
IMM
2
B
B
Lepomis
macrochirus
ブルーギル
NOEC MOR
62
1
C*10
○
魚類
文献
No.*5
被験
物質
5)-2
カリウ
ム塩
カリウ
ム塩
カリウ
5)-38
ム塩
カリウ
5)-38
ム塩
5)-10
カリウ
(海水)
ム塩
ジデシ
ルジメ
5)-29
チルア
ンモニ
ウム塩
5)-7
カリウ
(海水)
ム塩
カリウ
5)-15
ム塩*11
5)-32
カリウ
(海水)
ム塩*11
カリウ
5)-9
ム塩
カリウ
5)-15
ム塩*11
カリウ
4)-2007068
ム塩
リチウ
5)-17
ム塩
カリウ
5)-33
ム塩*11
カリウ
5)-3
ム塩
カリウ
4)-2007068
ム塩
カリウ
4)-2007068
ム塩
カリウ
5)-41
ム塩
カリウ
5)-8
ム塩
カリウ
ム塩（同
5)-14
位体ラ
ベル）*11
リチウ
5)-16
ム塩
5)-36
○
86-870
86-870
○
278
300
Pimephales
promelas
ファットヘッ
NOEC MOR
ドミノー（胚）
47
A
A
○
927
1,000
Pimephales
promelas
ファットヘッ
NOEC
ドミノー
30
2
-
2
C*12
2
C*12
5)-20
4
(止水式)
4
(止水式)
○
4,590
19,000 Pimephales
(4,660) promelas
ファットヘッ
LC50
ドミノー
MOR
○
6,400
31,000 Lepomis
(7,750) macrochirus
ブルーギル
LC50
MOR
Oncorhynchus
LC50
ニジマス
mykiss
Pimephales ファットヘッ
LC50
8,810 9,500 promelas
ドミノー
Oncorhynchus
12,700 13,700
LC50
ニジマス
mykiss
Cyprinodon キプリノドン
LC50
＞13,900*6 ＞15,000
variegatus
科
MOR
4
2
C*13
5)-31
MOR
4
1
A
5)-1
MOR
4
2
-
MOR
4
1
-
○
○
○
○
7,230
7,800
23
5)-30
(海水)
5)-43
(海水)
DEA 塩
カリウ
ム塩*11
カリウ
ム塩
カリウ
ム塩*11
カリウ
ム塩
生物 急 慢 毒性値
群 性 性 [µg/L]*1
○
20,400
○
119,000
その
他
報告値
[µg/L]*2
22,000
生物名
生物分類
Oncorhynchus
ニジマス
mykiss
562,000 Pimephales
(197,000) promelas
エンドポイント
／影響内容
LC50
MOR
ファットヘッ
LL50
ドミノー
ばく露 試験の信 採用の
期間
頼性／ 可能性
[日] Reliability*3 *4
4
1
-
5)-42
4
(止水式)
2
-
5)-28
○
＜2.3
<2.3
Chironomus
tentans
ユスリカ属
NOEC EMRG 最長 63
A
A
4)-2007069
○
21.7
21.7
Chironomus
tentans
ユスリカ属
NOEC GRO
20
A
B
4)-2007069
87.2
87.2
Chironomus
tentans
ユスリカ属
EC50
10
A
B
4)-2007069
112
B
B
4)-2007070
4
1
-
5)-4
(海水)
7
B
A
4)-2007068
4
2
-
5)-40
4
2
-
5)-40
7
B
A
4)-2007068
4
1
-
5)-5
7
1
-
5)-37
○
300
○
○
300Rana pipiens アカガエル科 NOEC
バージニアガ
EC50 GRO
キ
NOEC
6,600Lemna gibba イボウキクサ
GRO(Biomass)
アフリカツメ
EC50 MALF
12,100Xenopus laevis
ガエル(胚)
アフリカツメ
LC50 MOR
13,800Xenopus laevis
ガエル(胚)
EC50
31,100Lemna gibba イボウキクサ
GRO(Biomass)
＞2,780 ＞3,000
6,600
○
○
11,200
○
12,800
○
31,100
○
54,700
○
GRO
59,000
Crassostrea
virginica
Unio
イシガイ属
complamatus
100,000 108,000Lemna gibba イボウキクサ
LC50
MOR
IC50 GRO
(葉状体数)
被験
物質
文献
No.*5
カリウ
ム塩
ジデシ
ルジメ
チルア
ンモニ
ウム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
カリウ
ム塩
毒性値（太字）
：PNEC 導出の際に参照した知見として本文で言及したもの
： PNEC 導出の根拠として採用されたもの
毒性値（太字下線）
試験の信頼性：本初期評価における信頼性ランク
A：試験は信頼できる、B：試験は条件付きで信頼できる、C：試験の信頼性は低い、D：信頼性の判定不可
E：信頼性は低くないと考えられるが、原著にあたって確認したものではない
採用の可能性：PNEC 導出への採用の可能性ランク
A：毒性値は採用できる、B：毒性値は条件付きで採用できる、C：毒性値は採用できない
エンドポイント
EC10 (10% Effective Concentration) : 10%影響濃度、EC50 (Median Effective Concentration) : 半数影響濃度、
EL50 (Median Effective Loading rate) : 半数影響負荷率、IC50 (Median Inhibition Concentration) : 半数阻害濃度、
LC50 (Median Lethal Concentration) : 半数致死濃度、LL50 (Median Lethal Loading rate) : 半数致死負荷率、
NOEC (No Observed Effect Concentration) : 無影響濃度
影響内容
EMRG (Adult Emergence) : 羽化、GRO (Growth) : 生長（植物）、成長（動物）
、IMM (Immobilization) : 遊泳阻害、
MALF (Malformation) : 奇形、MOR (Mortality) : 死亡、REP (Reproduction) : 繁殖、再生産、
（
）内：毒性値の算出方法
AUG（Area Under Growth Curve) ：生長曲線下の面積により求める方法（面積法）
RATE：生長速度より求める方法（速度法）
*1
ペルフルオロオクタンスルホン酸当たりの値
*2
カッコ内の数字は、純度補正値
*3
数値は PFOS 及びその塩類の有害性評価（OECD, 2002）Robust summary に記載されている Klimisch ranking を示す
*4
「－」は当分科会において採用の可能性を判断していない
*5
文献 No.の「5)-」のあとに続く数字は、PFOS 及びその塩類の有害性評価（OECD, 2002）Robust summary の Study reference
number
*6 限度試験（毒性値を求めるのではなく、定められた濃度において毒性の有無を調べる試験）
*7
限度試験より得られた 2,970µg/L ではなく、確定値である 5,300µg/L を PNEC 導出の根拠とした
*8
限度試験より得られた 2,970µg/L 超ではなく、確定値である 48,200µg/L を PNEC 導出の根拠とした
*9
試験媒体は WAF（水適応性画分）。PFOS 及びその塩類の有害性評価（OECD, 2002）において評価に用いないとされた毒
性値のため PNEC 導出の根拠として用いない
24
*10
設定濃度が 2 濃度区と少なく、幅のある毒性値のため PNEC 導出の根拠として用いない
*11
試薬純度不明
*12
試験は止水式で 4 日間実施され、かつ被験物質濃度の測定が行われていないため、PNEC 導出の根拠として用いない
*13
被験物質のストック溶液調製時に濁りがみられ、かつ被験物質濃度の測定が行われていないため、PNEC 導出の根拠とし
て用いない
信頼性が認められた知見のうち、生物群ごとに急性毒性値及び慢性毒性値のそれぞれにつ
いて最も小さい毒性値を予測無影響濃度（PNEC）導出のために採用した。その知見の概要は
以下のとおりである。
1）藻類
Boudreau ら 4)-2007068 は米国 ASTM の試験方法（Designation E 1218-97a、1999）及び Geis ら
（2000）の試験方法に準拠し、緑藻類 Pseudokirchneriella subcapitata の生長阻害試験を実施し
た。試験は 2 回以上行われ、被験物質として PFOS カリウム塩（C8F17SO3K）が用いられた。
設定試験濃度は 0、28、56、113、225、450 mg/L（公比 2）及び 0、12.5、25、50、100、200、
400 mg/L（公比 2）であった。毒性値の算出には設定濃度が用いられた。96 時間半数影響濃
度（EC50）は 48,200 µg/L、96 時間無影響濃度（NOEC）は 5,300 µg/L であった。
2）甲殻類
3M 社 5)-7 は米国 EPA の試験法（OPPTS 850.1035）に準拠し、アミ科 Americamysis bahia の急
性毒性試験を GLP 試験として実施した。試験は止水式で行われ、被験物質として PFOS カリ
ウム塩（C8F17SO3K）が用いられた。試験用水には塩分濃度を 20‰に調整したろ過天然海水が
使用され、設定試験濃度区は 0、1.1、1.8、3.0、4.9、8.2 mg/L(公比 約 1.6)であり、被験物質の
実測濃度の平均は 0.115 未満、0.57、1.1、1.9、3.0、5.4 mg/L であった。実測濃度（算術平均
値）に基づく 96 時間半数致死濃度（LC50）は 3,340 µg/L（ペルフルオロオクタンスルホン酸
当たりに換算）であった。
また、3M 社 5)-10 は米国 EPA の試験法（OPPTS 850.1350）に準拠し、アミ科 Americamysis bahia
のライフサイクル毒性試験を GLP 試験として実施した。試験は流水式（換水率 約 11 回/24 時
間）で行われ、被験物質として PFOS カリウム塩（C8F17SO3K）が用いられた。試験用水には
塩分濃度を 20‰に調整したろ過天然海水が使用され、設定試験濃度区は 0、0.086、0.17、0.34、
0.69、1.4、2.7 mg/L(公比 約 2)であった。被験物質の実測濃度の平均は 0.0458 未満、0.057、0.12、
0.25、0.55、1.3、2.6 mg/L であった。繁殖阻害に関する 35 日間無影響濃度（NOEC）は、実測
濃度（算術平均値）に基づき 232 µg/L（ペルフルオロオクタンスルホン酸当たりに換算）であ
った。
なお、淡水産のオオミジンコ Daphnia magna に関する急性毒性値、慢性毒性値は、それぞれ
遊泳阻害に関する 48 時間半数影響濃度（EC50）56,600 µg/L（ペルフルオロオクタンスルホン
酸当たりに換算）
、繁殖阻害に関する 21 日間無影響濃度（NOEC）11,100 µg/L（ペルフルオロ
オクタンスルホン酸当たりに換算）という報告がある。
3）魚類
3M 社 5)-1 は OECD テストガイドライン No.203
（1992）、
米国 EPA の試験法
（OPPTS 850.1075）
に準拠し、ファットヘッドミノーPimephales promelas の急性毒性試験を GLP 試験として実施
25
した。試験は止水式で行われ、被験物質として PFOS カリウム塩（C8F17SO3K）が用いられた。
試験用水にはろ過地下水（硬度 131mg/L as CaCO3）が使用された。設定試験濃度区は 0、3.6、
5.9、9.9、16、27mg/L(公比 約 1.6)であり、被験物質の実測濃度の平均は 0.458 未満、3.3、5.6、
9.5、17、28mg/L であった。実測濃度（算術平均値）に基づく 96 時間半数致死濃度（LC50）
は 8,810µg/L（ペルフルオロオクタンスルホン酸当たりに換算）であった。
また、3M 社 5)-8 は OECD テストガイドライン No.210（1992）、米国 EPA の試験法（OPPTS
850.1400、1996；540/9-86-138、1986）
、及び米国 ASTM の試験法（E-1241-88、1988）に準拠
し、ファットヘッドミノーPimephales promelas の胚を用いて魚類初期生活段階毒性試験を
GLP 試験として実施した。試験は流水式（換水率 6 回/24 時間）で行われ、被験物質として
PFOS カリウム塩（C8F17SO3K）が用いられた。試験用水にはろ過地下水（硬度 126mg/L as
CaCO3）が使用された。設定試験濃度は 0、0.14、0.29、0.57、1.1、2.3、4.6mg/L(公比 約 2)
であり、被験物質の実測濃度の平均は 0.0458 未満、0.15、0.30、0.60、1.2、2.4、4.6mg/L であ
った。死亡に関する 47 日間無影響濃度（NOEC）は実測濃度（算術平均値）に基づき 278µg/L
（ペルフルオロオクタンスルホン酸当たりに換算）であった。
4）その他
MacDonald ら 4)-2007069 は米国 EPA の試験方法（EPA-600-R99-064、2000）及び米国 ASTM の
標準法（E-1706-00、2002）に準拠し、ユスリカ属 Chironomus tentans の 10 日齢幼虫を用いて
急性毒性試験を実施した。試験は半止水式（48 時間毎換水）で行われ、被験物質として PFOS
カリウム塩（C8F17SO3K）が用いられた。試験用水には ASTM 硬水が用いられた。設定試験
濃度は 0、1、5、10、20、40、80、150 µg/L であり、被験物質の実測濃度は試験終了時に 0.8、
4.6、11.5、24.1、49.1、96.2、150.1 µg/L であった。成長阻害に関する 10 日間半数影響濃度（EC50）
は、実測濃度（試験終了時）に基づき 87.2 µg/L であった。
また、MacDonald ら
4)-2007069
は Benoit ら（1997）の試験方法、米国 EPA の試験方法
（EPA-600-R99-064、2000）及び米国 ASTM の標準法（E-1706-00、2002）に準拠し、ユスリ
カ属 Chironomus tentans の 24 時間以内齢幼虫を用いて慢性毒性試験を実施した。試験は半止
水式（48 時間毎換水）で行われ、被験物質として PFOS カリウム塩（C8F17SO3K）が用いられ
た。試験用水には ASTM 硬水が用いられた。設定試験濃度は 0、1、5、10、50、100 µg/L で
あり、被験物質の実測濃度は試験終了時に 2.3、14.4、21.7、94.9、149.0 µg/L であった。試験
は羽化後の成体から卵を採取しふ化率までを検討した。羽化阻害に関する最長 63 日間無影響
濃度（NOEC）は、実測濃度（試験終了時）に基づき 2.3 µg/L 未満であった。
（2）予測無影響濃度（PNEC）の設定
急性毒性及び慢性毒性のそれぞれについて、上記本文で示した毒性値に情報量に応じたア
セスメント係数を適用し予測無影響濃度（PNEC）を求めた。
急性毒性値
藻類
Pseudokirchneriella subcapitata
生長阻害；96 時間 EC50
甲殻類
Americamysis bahia
96 時間 LC50
3,340 µg/L
魚類
Pimephales promelas
96 時間 LC50
8,810 µg/L
26
48,200 µg/L
その他
成長阻害；10 日間 EC50
Chironomus tentans
87.2 µg/L
アセスメント係数：100［3 生物群（藻類、甲殻類、魚類）及びその他の生物について信頼
できる知見が得られたため］
これらの毒性値のうちその他の生物を除いた最も小さい値（甲殻類の 3,340 µg/L）をアセス
メント係数 100 で除することにより、急性毒性値に基づく PNEC 値 33 µg/L が得られた。な
お、その他生物を採用した場合、急性毒性値に基づく PNEC の参考値は 0.87 µg/L となる。
慢性毒性値
藻類
Pseudokirchneriella subcapitata
生長阻害；96 時間 NOEC
5,300 µg/L
甲殻類
Americamysis bahia
繁殖阻害；35 日間 NOEC
232 µg/L
魚類
Pimephales promelas
死亡；47 日間 NOEC
278 µg/L
その他
Chironomus tentans
羽化阻害
＜2.3 µg/L
；最長 63 日間 NOEC
アセスメント係数：10［3 生物群（藻類、甲殻類、魚類）及びその他の生物について信頼で
きる知見が得られたため］
これらの毒性値のうちその他の生物を除いた最も小さい値（甲殻類の 232 µg/L）をアセス
メント係数 10 で除することにより、
慢性毒性値に基づく PNEC 値 23 µg/L が得られた。
なお、
その他生物を採用した場合、慢性毒性値に基づく PNEC の参考値は 0.23µg/L 未満となる。
本物質の PNEC としては甲殻類の慢性毒性値から得られた 23 µg/L を採用する。なお、そ
の他の生物を用いた場合の PNEC の参考値は、0.23 µg/L 未満となる。
（3） 生態リスクの初期評価結果
表 4.2
生態リスクの初期評価結果
水質
平均濃度
公共用水域・淡水
0.0027 µg/L程度 (2005) [
限られた地域で0.67 µg/L程
度の報告がある (2006)]
0.0019 µg/L程度 (2003)
公共用水域・海水
最大濃度（PEC）
PNEC
11 µg/L程度 (2006)
23
（<0.23）
0.028 µg/L程度 (2003)
µg/L
PEC/
PNEC 比
0.5
（>48）
0.001
（>0.1）
注：1）水質中濃度の（ ）内の数値は測定年度を示す
2）公共用水域･淡水は､河川河口域を含む
3）PNEC、PEC/PNEC 比の（ ）内の数値はその他の生物の毒性値を用いた場合
［ 判定基準 ］ PEC/PNEC＝0.1
現時点では作業は必要
ないと考えられる。
PEC/PNEC＝1
情報収集に努める必要
があると考えられる。
詳細な評価を行う
候補と考えられる。
本物質の公共用水域における濃度は、平均濃度でみると淡水域では 0.0027 µg/L 程度、海水
27
域では 0.0019 µg/L 程度であった。安全側の評価値として設定された予測環境中濃度（PEC）
は、淡水域で 11 µg/L 程度、海水域は 0.028 µg/L 程度であった。
予測環境中濃度（PEC）と予測無影響濃度（PNEC）の比は、淡水域では 0.5、海水域では
0.001 となるため、情報収集に努める必要があると考えられる。なお、公共用水域の淡水域で
PEC 設定根拠とした調査では、全 9 地点中 5 地点で PEC/PNEC 比が 0.1 以上であった。
本物質については、環境中への排出を抑制する取り組みが行われているところもあるが、
これまでに実施された調査における検出状況等を踏まえると、環境中濃度の推移を広く把握
する必要があると考えられる。
28
5．引用文献等
（1）物質に関する基本的事項
1)
UNEP (2006): Report of the Persistent Organic Pollutants Review Committee on the work of its
second meeting Risk profile on perfluorooctane sulfonate. UNEP/POPS/POPRC.2/17/Add.5.
2)
3M (2003): Environmental and Health Assessment of Perfluorooctane Sulfonic Acid and its Salts,
August 20, 2003.
3)
OECD (2002): Co-operation on Existing Chemicals - Hazard Assessment of Perfluorooctane
Sulfonate and its Salts.ENV/JM/RD(2002)17/FINAL.JT00135607.
4)
U.S. Environmental Protection Agency, MPBPWINTM v.l.41.
5)
経済産業公報 (2002.3.26).
6)
独立行政法人製品評価技術基盤機構：既存化学物質安全性点検データ,
(http://www.safe.nite.go.jp/japan/Haz_start.html, 2007.9.4 現在).
7)
Ellefson, M.E. (2001): Soil Adsorption/Desorption Study of Potassium Perfluorooctanesulfonate
(PFOS). 3M Environmental Laboratory. Project Number E00-1311.
8)
Ministry of Foreign Affairs (2007): Responses to request for information on Annex F
requirements for the proposed POPs substances, perfluorooctane sulfonate (PFOS) and
PFOS-related substances, Feb. 9, 2007,
(http://www.pops.int/documents/meetings/poprc/prepdocs/annexFsubmissions/submissions.htm,
2007.9.4 現在).
9)
UNEP
(2007):
Draft
Risk
Management
Evaluation:
perfluorooctane
sulfonate.
UNEP/POPS/POPRC.3/13.
10) 経済産業省 (2007)：PFOS 製造禁止に伴う PFOS 等の使用と代替可能性に関する調査の結
果について,
(http://www.meti.go.jp/policy/chemical_management/03kanri/c05temp4.htm, 2007.9.5 現在).
（2）ばく露評価
1)
環境省環境保健部環境安全課 (2006) : 平成 16 年度化学物質環境実態調査.
2)
Saito N, Harada K, Inoue K, Sasaki K, Yoshinaga T, Koizumi A. (2004) : Perfluorooctanoate and
perfluorooctane sulfonate concentrations in surface water in Japan. J Occup Health 46:49-59.
3)
K.Harada, N. Saito, K. Inoue, A. Koizumi (2003): Perfluorooctane Sulfonate Contamination of
Drinking Water in the Tama River, Japan: Estimated Effects on Resident Serum Levels. Bull.
Environ. Contam. Toxicol. 71:31-36.
4)
大阪市水道局水道原水および浄水の測定結果.
5)
大阪府 (2007) : 水道水中におけるパーフルオロオクタンスルホン酸（PFOS）、パーフル
オロオクタン酸（PFOA）調査結果について. (http://www.pref.osaka.jp/fumin/html/15938.html,
2008.2.1 現在)
29
6)
三矢律子、染谷暁子、細田憲男、松崎智洋、大原憲司 (2007) : PFOS 及び PFOA の実態調
査と浄水処理における除去性. 第 58 回全国水道研究発表会講演集. 554-555.
7)
大阪府 (2007) : パーフルオロオクタン酸(PFOA)及びパーフルオロオクタンスルホン酸
(PFOS)に係る河川等の調査結果について. (http://www.epcc.pref.osaka.jp/press/h19/0831_2/,
2007.9.24 現在); 大阪府 (2007) : 神崎川水域におけるパーフルオロオクタン酸（PFOA）
等に係る水質調査結果等について. (http://www.pref.osaka.jp/fumin/html/17827.html,
2007.12.26 現在)
8)
小泉昭夫、大野佐代子、原田浩二、浅川明弘、井上佳代子 (2007) : 難分解性
Perfluorooctanoic acid(PFOA)による地下水汚染. 第 80 回日本産業衛生学会.
(http://hes.pbh.med.kyoto-u.ac.jp/pfcreview/pdf/j109.pdf, 2007.7.28 現在)
9)
南山瑞彦、山懸弘樹 (2005) : 6. 土壌地下水汚染が水域に及ぼす影響に関する研究. 平成
16 年度下水道関係調査研究年次報告書集. 157-160.
10) 環境省環境保健部環境安全課 (2007) : 平成 17 年度化学物質環境実態調査結果.
11) 環境省環境保健部環境安全課 (2004) : 平成 14 年度化学物質環境汚染実態調査.
12) 大阪府 (2007) : パーフルオロオクタン酸(PFOA)及びパーフルオロオクタンスルホン酸
(PFOS)に係る河川等の調査結果について. (http://www.epcc.pref.osaka.jp/press/h19/0831_2/,
2007.9.24 現在); 大阪府 (2007) : 神崎川水域におけるパーフルオロオクタン酸（PFOA）
等 に 係 る 水 質 調 査 結 果 等 に つ い て . (http://www.pref.osaka.jp/fumin/html/17827.html,
2007.12.26 現在); 大阪市 (2007) : 大阪市内公共用水域におけるパーフルオロオクタン酸
（PFOA）及びパーフルオロオクタンスルホン酸（PFOS）に係る調査結果を公表します.
(http://www.city.osaka.jp/oshirase/kankyojigyo/html/info610011071120132446.html, 2007.12.28
現在)
13) 大阪市 (2007) : 大阪市内公共用水域におけるパーフルオロオクタン酸（PFOA）及びパ
ー フ ル オ ロ オ ク タ ン ス ル ホ ン 酸 （ PFOS ） に 係 る 調 査 結 果 を 公 表 し ま す .
(http://www.city.osaka.jp/oshirase/kankyojigyo/html/info610011071120132446.html, 2007.12.28
現在)
14) 兵庫県健康生活部環境管理局水質課 (2007) : パーフルオロオクタン酸(PFOA)に係る河
川の環境調査及び下水道の調査結果について.
(http://web.pref.hyogo.jp/press/press_ac021_00001847.html, 2007.7.18 現在)
15) 杉崎三男、細野繁雄、茂木茂 (2007) : 有機ハロゲン化合物の環境動態に関する基礎的研
究. 埼玉県環境科学国際センター報(平成 18 年度). 第 7 号.
(http://www.pref.saitama.lg.jp/A09/BA30/labo/report/no7/2006_84.pdf, 2007.10.2 現在); 茂木
茂、細野繁雄、杉崎三男 (2007): 埼玉県内の河川水中 PFOS、PFOA の分布. 第 16 回環境
化学討論会予稿集. 490-491.
16) 国立環境研究所（2006）：有機フッ素化合物等 POPs 様汚染物質の発生源評価・対策並
びに汚染実態解明のための基盤技術開発に関する研究（特別研究）.
17) 小高良介、益永茂樹 (2006)：東京湾におけるフッ素系界面活性剤の環境挙動. 水環境学
会誌. 29(4):221-228.
18) Akiko Morikawa, Naoya Kamei, Kouji Harada, Kayoko Inoue, Takeo Yoshinaga, Norimitsu
Saito and Akio Koizumi (2006) : The bioconcentration factor of perfluorooctane sulfonate is
30
significantly larger than that of perfluorooctanoate in wild turtles (Trachemys scripta elegans and
Chinemys reevesii): An Ai river ecological study in Japan. Ecotoxicology and Environmental
Safety 65:14-21.
19) 環境省環境保健部環境安全課 (2005) : 平成 15 年度化学物質環境実態調査.
20) 大阪府 (2007) : パーフルオロオクタン酸(PFOA)及びパーフルオロオクタンスルホン酸
(PFOS)に係る河川等の調査結果について. (http://www.epcc.pref.osaka.jp/press/h19/0831_2/,
2007.9.24 現在)
21) 大阪府 (2007) : 神崎川水域におけるパーフルオロオクタン酸（PFOA）等に係る水質調
査結果等について. (http://www.pref.osaka.jp/fumin/html/17827.html, 2007.12.26 現在)
（3）健康リスクの初期評価
1) Johnson, J.D., S.J. Gibson and R.E. Ober (1979): Absorption of FC-95-14C in rats after a single oral
dose. Riker Laboratories, Inc. U.S.EPA AR226-0007.
2) Johnson, J.D., S.J. Gibson, and R.E. Ober (1979): Extent and route of excretion and tissue
distribution of total-carbon-14 in rats after a single intravenous dose of FC-95-14C. Riker
Laboratories, Inc. U.S.EPA AR226-0006.
3) Christian, M.S., A.M. Hoberman and R.G. York (1999): Combined (oral) gavage fertility,
developmental and perinatal/postnatal reproduction toxicity study of PFOS in rats. Protocol No.
418-008. Study No. 6295.9. Argus Research Laboratories, Inc. U.S.EPA AR226-0563,
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4) Christian, M.S., A.M. Hoberman and R.G. York (1999): Oral (gavage) cross-fostering study of
PFOS in rats. Protocol No. 418-014. Study No. T-6295.13. Argus Research Laboratories, Inc.
U.S.EPA AR226-0571, AR226-0553.
5)
Noker,
P.E.
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Gorman
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A
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6329-268. Covance Laboratories Inc. U.S.EPA AR 226-1102.
8) Seacat, A.M., P.J. Thomford, K.J. Hansen, G.W. Olsen, M.T. Case and J.L. Butenhoff (2002):
Subchronic toxicity studies on perfluorooctanesulfonate potassium salt in cynomolgus monkeys.
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carbon-14 in rats after administration of ammonium [14C]perfluorooctanoate or potassium
[14C]perfluorooctanesulfonate. Fundam. Appl. Toxicol. 4: 972-976.
31
10) Harada, K., N.Saito, K. Inoue, T. Yoshinaga, T. Watanabe, S. Sasaki, S.Kamiyama and A.
Koizumi (2004): The influence of time, sex and geographic factors on levels of perfluorooctane
sulfonate and perfluorooctanoate in human serum over the last 25 years. J. Occup. Health. 46:
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11) 3M Company (2000): Determination of serum half-lives of several fluorochemicals.
FYI-0700-1378. 3M Company. U.S.EPA AR226-0610.
12) Olsen, G., D. Ehresman, J. Froehlich, J. Burris and J. Butenhoff (2005): Evaluation of the half-life
(t1/2) of elimination of perfluorooctanesulfonate (PFOS), perfluorohexanesulfonate (PFHS) and
perfluorooctanoate (PFOA) from human serum. International symposium on fluorinated alkyl
organics in environment. August 2005. Toronto, Canada.
13) Olsen, G.W., J.M. Burris, D.J. Ehresman, J.W. Froehlich, A.M. Seacat, J.L. Butenhoff and L.R.
Zobel
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Half-life
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perfluorohexanesulfonate, and perfluorooctanoate in retired fluorochemical production workers.
Environ. Health Perspect. 115: 1298-1305.
14) Kannan, K., S. Corsolini, J. Falandysz, G. Fillmann, K.S. Kumar, B.G. Loganathan, M.A. Mohd, J.
Olivero, N. Van Wouwe, J.H. Yang, and K.M. Aldoust (2004): Perfluorooctanesulfonate and
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33
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44) Case, M.T., R.G. York and M.S. Christian (2001): Rat and rabbit oral developmental toxicology
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Two-generation reproduction and cross-foster studies of perfluorooctanesulfonate (PFOS) in rats.
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perfluorooctane sulfonate-induced neonatal mortality in the Sprague-Dawley rat. Birth Defects
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47) Grasty, R.C., N. Roberts, G. Klinefelter, J.A. Bjork, K.B. Wallace, C.S. Lau and J.M. Rogers
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perinatal rat. Birth Defects Res. Part A: Clin. Mol. Teratol. 73: 314.
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51) Grice, M.M., B.H. Alexander, R. Hoffbeck and D.M. Kampa (2007): Self-reported medical
conditions in perfluorooctanesulfonyl fluoride manufacturing workers. J. Occup. Environ. Med.
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52) Olsen, G.W., M.M. Burlew, J.C. Marshall, J.M. Burris and J.H. Mandel (2004): Analysis of
episodes of care in a perfluorooctanesulfonyl fluoride production facility. J. Occup. Environ. Med.
46: 837-846.
53) Olsen, G.W., M.M. Burlew, J.M. Burris, J.H. Mandel (2001): A cross-sectional analysis of serum
perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) in relation to clinical chemistry,
thyroid hormone, hematology and urinalysis results from male and female employee participants
of the 2000 Antwerp and Decatur fluorochemical medical surveillance program. Final report. 3M
Medical Department. U.S.EPA AR226-1047.
54) Olsen, G.W., J.M. Burris, M.M. Burlew and J.H. Mandel (2003): Epidemiologic assessment of
worker serum perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) concentrations
and medical surveillance examinations. J. Occup. Environ. Med. 45: 260-270.
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serum perfluorooctanesulfonate (PFOS) and perfluorooctanoate (PFOA) levels in relation to lipid
and hepatic clinical chemistry test results from male employee participants of the 1994/95, 1997,
and 2000 fluorochemical medical surveillance program. 3M Final Report. U.S.EPA AR226-1088.
56) Apelberg, B.J., F.R. Witter, J.B. Herbstman, A.M. Calafat, R.U. Halden, L.L. Needham and L.R.
Goldman (2007): Cord serum concentrations of perfluorooctane sulfonate (PFOS) and
perfluorooctanoate (PFOA) in relation to weight and size at birth. Environ. Health Perspect. 115:
1670-1676.
57) Fei, C., J.K. McLaughlin, R.E. Tarone and J. Olsen (2007): Perfluorinated chemicals and fetal
growth: A study within the Danish National Birth Cohort. Environ. Health Perspect. 115:
1677-1682.
58) Inoue, K., F. Okada, R. Ito, S. Kato, S. Sasaki, S. Nakajima, A. Uno, Y. Saijo, F. Sata, Y.
Yoshimura, R. Kishi and H. Nakazawa (2004): Perfluorooctane sulfonate (PFOS) and related
perfluorinated compounds in human maternal and cord blood samples: assessment of PFOS
exposure in a susceptible population during pregnancy. Environ. Health Perspect. 112:
1204-1207.
59) Litton Bionetics, Inc. (1978): Mutagenicity evaluation of T-2014 CoC in the Ames
Salmonella/microsome plate test. U.S.EPA AR226-0128.
60) Mecchi, M. S. (1999): Salmonella- Eschericia coli/mammalian-microsome reverse mutation assay
with PFOS. Covance study No. 20784-0-409. Covance Laboratories Inc. U.S.EPA AR226-0133.
61) Murli, H. (1999): Chromosomal aberrations in human whole blood lymphocytes with PFOS.
Covance study No. 20784-0-449. Covance Laboratories Inc. U.S.EPA AR226-0131.
35
62) Cifone, M.A. (1999): Unscheduled DNA synthesis in rat liver primary cell cultures with PFOS.
Covance study No. 20780-0-447. Covance Laboratories Inc. U.S.EPA AR226-0132.
63) Simmon, V.F. (1978): in vitro microbiological mutagenicity assays of 3M Company compounds
T-2247 CoC and T-2248 CoC. SRI International. U.S.EPA AR226-0134.
64) Murli, H. (1996): Mutagenicity test on T-6295 in an in vivo mouse micronucleus assay. Covance
study No. 17403-0-455. Corning Hazleton Inc. U.S.EPA AR226-0130.
65) Upham, B.L., N.D. Deocampo, B. Wurl and J.E Trosko (1998): Inhibition of gap junctional
intercellular communication by perfluorinated fatty acids is dependent on the chain length of the
fluorinated tail. Int. J. Cancer. 78: 491-495.
66) Hu, W., P.D. Jones, B.L. Upham, J.E. Trosko, C. Lau and J.P. Giesy (2002): Inhibition of gap
junctional intercellular communication by perfluorinated compounds in rat liver and dolphin
kidney epithelial cell lines in vitro and Sprague-Dawley rats in vivo. Toxicol. Sci. 68: 429-436.
67) Thomford, P.J. (2001): 104-Week dietary carcinogenicity study with narrow range (98.1%)
N-ethylperfluorooctanesulfonamido ethanol in rats. Covance study No. 6329-212 and 228.
Covance Laboratories Inc. U.S.EPA AR226-1068a, AR226-0267.
68) Thomford, P.J., A.M. Seacat and J.L. Butenhoff (2002): Terminal observations in
Sprague-Dawley rats after lifetime dietary exposure to N-ethylperfluorooctanesulfonamido
ethanol. Toxicol. Sci. 66 (Suppl.): 185-186.
69) Alexander, B.H. and G.W. Olsen (2007): Bladder cancer in perfluorooctanesulfonyl fluoride
manufacturing workers. Ann. Epidemiol. 17: 471-478.
（4）生態リスクの初期評価
1)-：U.S.EPA「AQUIRE」；該当なし
2)：環境省(庁)データ；該当なし
3)：(独)国立環境研究所：化学物質環境リスク評価検討調査報告書；該当なし
4)-：その他
2007068：Boudreau, T.M., P.K. Sibley, S.A. Mabury, D.G.C. Muir, K.R. Solomon (2003):
Laboratory Evaluation of Toxicity of Perfluorooctane Sulfonate (PFOS) on Selenastrum
capricornutum, Chlorella vulgaris, Lemna gibba, Daphnia magna, and Daphnia pulicaria. Arch.
Environ. Contam. Toxicol. 44: 307-313.
2007069：MacDonald, M.M., A.L. Warne, N.L. Stock, S.A. Mabury, K.R. Solomon, and P.K.
Sibley (2004): Toxicity of Perfluorooctane Sulfonic acid and Perfluorooctanoic acid to
Chironomus tentans. Environmental Toxicology and Chemistry. 23: 2116-2123.
2007070：Ankley, G.T., D.W. Kuehl, M.D. Kahl, K.M. Jensen, B.C. Butterworth, and J.W. Nichols
(2004): Partial life-cycle toxicity and bioconcentration modeling of Perfluorooctanesulfonate in
the northern leopard frog (Rana pipiens). Environmental Toxicology and Chemistry, 23:
2745-2755.
5)-：OECD (2002): Co-operation on Existing Chemicals - Hazard Assessment of Perfluorooctane
Sulfonate and its Salts. ENV/JM/RD (2002) 17/FINAL.JT00135607.
36
1：Robust Study Report Reference No. 1 –
96-Hour Static Acute Toxicity Test with the Fathead
Minnow (Pimephales promelas).
2：Robust Study Report Reference No. 2 –
96-Hour Toxicity Test with the Freshwater Alga
(Selenastrum capricornutum).
3：Robust Study Report Reference No. 3 - 48-Hour Static Acute Toxicity Test with the Cladoceran
(Daphnia magna).
4：Robust Study Report Reference No. 4 - 96-Hour Shell Deposition Test with the Eastern Oyster
(Crassostrea virginica).
5：Robust Study Report Reference No. 5 - 96-Hour Static Acute Toxicity Test with the Freshwater
Mussel (Unio complamatus).
7：Robust Study Report Reference No. 7 - 96-Hour Static Acute Toxicity Test with the Saltwater
Mysid (Mysidopsis bahia).
8：Robust Study Report Reference No. 8 - Early Life-Stage Toxicity Test with the Fathead Minnow
(Pimephales promelas).
9：Robust Study Report Reference No. 9 - Semi-Static Life-Cycle Toxicity Test with the Cladoceran
(Daphnia magna).
10：Robust Study Report Reference No. 10 - Flow-through Life-Cycle Toxicity Test with the
Saltwater Mysid (Mysidopsis bahia).
13：Robust Report Reference No. 13 - Multi-Phase Exposure / Recovery Algal Assay Test.
14：Robust Study Report Reference No. 14 - The Effects of Continuous Aqueous Exposure to
14C-78.02 on Hatchability of Eggs and Growth and Survival of Fry of Fathead Minnow
(Pimephales promelas) Summary of histopathological examinations of Fathead Minnow
(Pimephales promelas) exposed to78.02 for 30 Days.
15：Robust Study Report Reference No. 15 - Effect of Potassium Perfluorooctanesulfonate on
Survival, etc. (Daphnid reproduction).
16：Robust Study Report Reference No. 16 -
Pimephales promelas
96-hour Toxicity Test Data
Summary. Sample FC-94-X (Li salt of PFOS).
17：Robust Study Report Reference No. 17 - 48-hour Acute Toxicity to Daphnia, Daphnia magna.
FC-94-X (Li salt of PFOS).
20：Robust Study Report Reference No. 20 - 96-hour Acute Toxicity Test on Bluegill Sunfish
(FC-99,DEA salt of PFOS).
28：Robust Study Report Reference No. 28 –
Acute toxicity of P3025 Developmental Material to
Fathead minnow (Pimephales promelas).
29：Robust Study Report Reference No. 29 –
Acute toxicity of P3025 Developmental Material
Daphnia magna.
30：Robust Study Report Reference No. 30 - Acute toxicity of PFOS to Rainbow trout in saltwater.
31：Robust Study Report Reference No. 31 - Acute toxicity of PFOS to Rainbow trout in freshwater.
32：Robust Study Report Reference No. 32 - Acute toxicity of PFOS to Artemia sp..
33：Robust Study Report Reference No. 33 - Acute toxicity of PFOS to Daphnia magna.
37
36：Robust Study Report Reference No. 36 - PFOS: A 96-hour toxicity test with the freshwater alga
(Anabaena flos-aquae).
37：Robust Study Report Reference No. 37 - PFOS: A 7-day toxicity test with Duckweed (Lemna
gibba G3).
38：Robust Study Report Reference No. 38 - PFOS: A 96-hour toxicity test with freshwater diatom
(Navicula pelliculosa).
39：Robust Study Report Reference No. 39 - PFOS: A 96-hour toxicity test with the marine diatom
(Skeletonema costatum).
40：Robust Study Report Reference No. 40 - PFOS: A frog embryo teratogenesis assay –
Xenopus
(FETAX).
41：Robust Study Report Reference No. 41 - Perfluorooctanesulfonate, Potassium salt (PFOS): A
flowthrough bioconcentration test with the Bluegill (Lepomis macrochirus).
42：Robust Study Report Reference No. 42 - Perfluorooctanesulfonate, Potassium salt (PFOS):
96-Hour Static Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss) in
freshwater.
43：Robust Study Report Reference No. 43 - Perfluorooctanesulfonate, Potassium salt (PFOS):
96-Hour Semi-Static Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus)
in saltwater.
38
参考資料８
ペルフルオロ（オクタン-1-スルホン酸）及びその塩のリスク評価
独立行政法人
製品評価技術基盤機構
化学物質管理センター
目
リスク評価課
次
１. 概要 .......................................................................................................................................... 1
２. 試算条件等 ............................................................................................................................... 2
２.１ 対象物質 ................................................................................................................................. 2
２.２ リスク評価の対象と有害性情報 ............................................................................................ 2
２.３ 暴露評価に用いた物理化学的性状等 ..................................................................................... 3
２.４ 環境分配モデル ...................................................................................................................... 4
２.５ 人と高次捕食動物の暴露シナリオ ......................................................................................... 5
２.６ 推計排出量 ............................................................................................................................. 6
２.７ 環境中濃度の計算条件 ........................................................................................................... 8
３. 試算結果 ................................................................................................................................... 8
３.１ 環境中濃度推計結果............................................................................................................... 8
３.２ モデル推計濃度に基づくリスク評価結果 .............................................................................. 9
４. モデル推計濃度と環境モニタリング濃度との比較 ................................................................ 10
５. 資料 ........................................................................................................................................ 13
５.１ 参考資料 ............................................................................................................................... 13
５.２ 添付資料 ............................................................................................................................... 14
１. 概要
ペルフルオロ（オクタン-1-スルホン酸）（別名 PFOS）及びその塩の例外的使用に係るリスク
の試算を実施した。
PFOS 及びその塩を対象物質として、排出量を推計し、それを元に環境中濃度を推計し、人、
高次捕食動物、水生生物それぞれの暴露量を数理モデルで推計した。排出量の推計は経済産業省
指定の条件で行った（２.６参照）。数理モデルの適用等については、以下の資料を主に参考にし
た（以下、「UK 評価書」と表記。）。
UK Environmental Agency, 2004, Environmental Risk Evaluation Report:
perfluorooctanesulphonate (PFOS).
http://www.environment-agency.gov.uk/commondata/105385/pfos_rer_sept04_864557.pdf
モデル推計による環境中濃度の経年変化の予測では、当該物質は排出量が低減すると比較的速
やかに環境中濃度も低減すると推計された。
モデル予測濃度を用いたリスク評価の結果では、高次捕食動物については、平成 20 年度までの
排出量におけるリスク評価（魚類中濃度）では「リスク懸念」とされたものの、平成 22 年度以降
においては「懸念なし」と推計された。また、人の健康、水生生物のリスク評価では、いずれの
条件においても「懸念なし」と推計された。
モデル予測濃度と環境モニタリングデータの比較では、海水中濃度と底質濃度では、比較的良
1
く一致している一方で、魚類中濃度では乖離が見られており、この結果、モニタリング濃度に基
づくリスク評価では、高次捕食動物についても、
「リスク懸念なし」との結果が得られている。こ
れは、モデル推計に適用したＢＣＦ及びＢＭＦについては安全側に推計された値を用いたことに
よると考えられる。
以上を総合し、ＰＦＯＳの例外的使用に関する本リスク試算では、人の健康、高次捕食動物、
水生生物に対してリスク懸念はないと予測された。
２. 試算条件等
２.１ 対象物質
PFOS に関連する第二種監視化学物質は４物質（スルホン酸、Li、Na、K の塩）が指定されて
いる。これらに経済産業省調査対象である物質群（アンモニウム塩を含むオニウム塩）を追加し、
以下の物質群を「PFOS 及びその塩」として評価対象物質とした。
対象物質一覧
通し番号
681
683
684
685
―
―
CAS 番号
1763-23-1
29457-72-5
4021-47-0
2795-39-3
29081-56-9
―
名称
ペルフルオロオクタンスルホン酸
リチウム=ペルフルオロオクタンスルホナート
ナトリウム=ペルフルオロオクタンスルホナート
カリウム=ペルフルオロオクタンスルホナート
ペルフルオロオクタンスルホン酸アンモニウム
ペルフルオロオクタンスルホン酸のオニウム塩（ｱﾝﾓﾆｳﾑ塩を除く）
２.２ リスク評価の対象と有害性情報

リスク評価の対象とそれに用いた有害性情報は以下の通り。

高次捕食毒物の評価には、鳥類の繁殖試験による LOAEC 10ppm（PNEC 換算 0.033 mg/kg
餌）とラット二世代生殖発生毒性試験による NOAEL 0.1 mg/kg/day（PNEC 換算 0.067
mg/kg 餌）の二種類で試算をした。
ﾘｽｸ
評価
対象
人健
康
リスク評価対象とリスク評価に用いる有害性情報
PNEC 等
不確実係数積
有害性データ
(NOEC/
備考
(Ufs)
Ufs)
NOAEL 0.5 ppm
・環境省の初期評価のキース
(K 塩の 104 週混餌投与による発
タディも同様（UK 評価書は
がん性試験で、雄ラットにみられ
100
0.0003
人の評価はしていない）
た肝細胞肥大、NOAEL 0.5ppm よ 種差 10×個体 mg/kg/da ・摂取量への換算は、環境省環
り。Thomford, 2002)
差 10
y
境リスク評価書と同じ
NOAEL0.03mg/kg/day とし
ている。
2
LOAEC 10 ppm
(ウズラへの 21 週混餌投与(0, 10,
50, 150ppm) による長期繁殖試
験で、ふ化 14 日雛の生存率の低
下 の LOAEC 10ppm よ り 。
Newsted et al., 2007)
高次
捕食
動物
水生
生物
NOAEL 0.1mg/kg/day
(SD ラットへの強制経口投与(0,
0.1, 0.4, 1.6, 3.2 mg/kg/day) によ
る二世代生殖発生毒性試験で以下
の影響の NOAEL 0.1mg/kg/day
より
・ F0: 全体的影響
・ F1: 開眼遅延（用量依存）
・ F2: 体重増加抑制)
（OECD, 2002）
NOEC 0.232 mg/L
（以下３種の最小値、いずれも K
塩による)
・藻類慢性 NOEC: 5.3 mg/L
(緑藻類、4 日間、生長阻害(細胞
数)、Boudreau et al., 2003)
・甲殻類慢性 NOEC:0.232 mg/L
(アミ科、35 日間、繁殖阻害、
OECD, 2002)
・魚類慢性 NOEC: 0.278 mg/L
(ファットヘッドミノー(胚)、47
日間、死亡、OECD, 2002)
300
鳥類の長期毒性
試験結果の
NOEC に対す
る Assessment
Factors 30（種
差と実験室から
野外への外挿）
と LOEC から
NOEC の外挿
10 より（30×
10）
0.033
mg/kg 餌
30
哺乳類の長期毒
性試験結果の
NOEC に対す
る Assessment
Factors 30（種
差と実験室から
野外への外挿）
より
0.067
mg/kg 餌
10
（3 種の慢性毒
性値が得られて
いるため。野外
への外挿）
0.023
mg/L
・Assessment Factors 30 は
EU のリスク評価技術ガイ
ダンスに基づく
・LOAEC から NOAEC への
外挿は U.S.EPA より
・UK 評価書も 3M のデータと
して掲載しているが UF は
30 としておりリスク評価に
は用いていない
・UK 評価書は人健康に用い
た 肝 細 胞 肥 大 の NOAEL
（NOAEC 換算 0.017mg/kg
餌）を採用しているが生態の
評価には over-conservative
との認識も示し、本 NOAEC
を Alternative proposed と
している
・Assessment Factors 30 は
EU のリスク評価技術ガイ
ダンスに基づく
・餌中濃度に換算
・環境省の初期評価のキース
タディも同様
・淡水と海水の区別はしてい
ない
なお、底生生物に対するリスク評価については、｢EU のリスク評価技術ガイダンスにある平衡
分配法は PFOS の性状からみて適用できない｣との OECD のハザード評価書の考察に基づき、こ
こでは行わなかった。
２.３ 暴露評価に用いた物理化学的性状等

物理化学的性状は K 塩で得られており、
「PFOS 及びその塩」をこの性状で代表させた（UK
評価書と同様の扱い）。

いずれも出典は UK 評価書だが、底質-水分配係数と浮遊物質-水分配係数については、ここ
で使用したモデル（SAFECAS）の設定に合わせ、換算しなおした。
3
項目
分子量
蒸気圧
水溶解度
ヘンリー則定数
底質-水分配係数
浮遊物質-水分配係数
魚への生物濃縮係数
生物蓄積係数
環境中分解速度
モデル推計に使用した物理化学的性状等一覧
記号
値
単位
備考
MW
538
－
実測値だが不純物の影響が示唆
VP
3.31×10-4
Pa
されており、UK 評価書では
limitation 付で採用されている
WS
519
ｍg/L
20℃
H
3.19×10-4
Pa･m3/mol
蒸気圧と水溶解度による計算値
Ksed-water
9.2
－
実測値より換算
Ksusp-water
2.64
－
実測値より換算
BCFfish
2796
L/kg
実測からの推計値
EU の技術ガイダンスのデフォ
BMF
2
－
ルト設定より
ゼロ
実測の底質固相と間隙水の分配係数 Kpsed（平衡状態の底質固相中濃度と間隙水中濃度の比
[L/kg]）を底質（もしくは浮遊物質）バルクの平衡分配係数にするため、EU-TGD の以下の式で
換算した。
Ksed-water = F water + Fsolid×Kpsed×RHOsolid／1000
Ksed-water
：底質バルクの平衡分配係数
[-]
Kpsed
：底質固相と間隙水の分配係数＝8.7 [L/kg]
（UK 評価書より）
F water
：底質中の水の体積比＝0.5
（SAFECAS の設定より）
Fsolid
：底質中の固体の体積比＝0.5
（SAFECAS の設定より）
RHOsolid
：固体の密度＝2000 [kg/m3]
（SAFECAS の設定より）
Ksusp-water = F water + Fsolid×Kpsed×RHOsolid／1000
Ksusp-water ：浮遊粒子バルクの平衡分配係数
[-]
Kpsed
：底質固相と間隙水の分配係数＝8.7 [L/kg]
（UK 評価書より）
F water
：浮遊物質の水の体積比＝0.9
（SAFECAS の設定より）
Fsolid
：浮遊物質の固体の体積比＝0.1
（SAFECAS の設定より）
RHOsolid
：固体の密度＝2000 [kg/m3]
（SAFECAS の設定より）
２.４ 環境分配モデル

東京湾を想定した水域と底質の 2 コンパートメントモデル SAFECAS（Simplified Approach
for Fate Evaluation of Chemicals in Aquatic Systems）を使用した。ただし、非定常計算が
できるように改良した。
4
(化学物質審議会安全対策部会第３回安全対策小委員会 参考資料２より)

SAFECAS は、化学物質審議会安全対策部会安全対策小委員会における監視化学物質の環境
中濃度の推計や、平成 15 年の化審法改正における少量新規の数量設定のためのシミュレーシ
ョン等において、適用実績がある（東京湾及び瀬戸内海を想定した設定で使用された）。

SAFECAS の東京湾のパラメータは、国土技術政策総合研究所の東京湾内湾のデータ
(http://www.meic.go.jp/kowan/main.html) に更新した。
東京湾のパラメータ
項目
外湾
内湾（本計算で使用）
評価面積 [m2]
1.38×109
9.22×108
水域面積 [m2]
1.38×109
9.22×108
水深
[m]
45
16
水域体積
[m3]
6.21×1010
1.48×1010
45.6
45
滞留時間 [day]

SAFECAS のようなボックスモデルでは、上図のような物質収支に基づくボックス毎の物質
残存量を計算し、ボックス体積で割ることで濃度を算出するため、ボックス体積（環境の大
きさ）を例えば 2 倍にすれば、
（他の条件がすべて同じの場合）予測濃度は 2 分の１になると
いう関係がある（MNSEM2 も EUSES といった他のボックスモデルも同様）。

PFOS 及びその塩は logKow が測定できないため、環境分配モデルの適用においては、logKow
や logKoc の替わりに、底質-水分配係数等で数式を置き換え、モデルを適用した（UK 評価
書と同様のアプローチ）
。
２.５ 人と高次捕食動物の暴露シナリオ
下図のような暴露シナリオを想定し、2.4 のモデルによる推計水中濃度を用いて人と高次捕食動
物の暴露量を推計した。
5
餌生物のBCFが
魚のBCFと同じ
と仮定
化学物質
魚類中濃度 ＝BCF×水中濃度+ BMF ’ ×餌中濃度
＝BCF×水中濃度+ BMF ’ ×BCF×水中濃度
＝BCF×水中濃度×（１ + BMF ’ ）
一定速度で排出
＝BCF×水中濃度×BMF ←EU-TGDの式
（この式で魚中濃度を出している。すなわち水からと餌からの両方の濃縮を想定）
東京湾の海水
エラ呼吸
エラ呼吸
平衡分配
摂取
東京湾の魚に濃縮
摂取
人
※PFOSの摂取に関しては
東京湾の魚のみ考慮
摂取
高次捕食動物
東京湾の魚の餌生物
（エビ、小魚など）に濃縮
東京湾の底質
水中濃度
魚類中濃度
BCF
BMF
餌生物中濃度
暴露シナリオと魚類中濃度の推計式
２.６ 推計排出量
平成 18～20 年度の３年間と、例外的使用適用後の平成２２年度以降に分けて設定した。
なお、PFOS の推計排出量は「PFOS 及びその塩」として、各物質（スルホン酸、Li、Na、K
の塩等）の数量をそのまま用い、合算して求めた。すなわち、分子量を用いて PFOS 分に換算す
ることはしていない（UK 評価書と同様の扱い）
。
(1) 泡消火薬剤について
泡消火薬剤（消火器用消火薬剤を含む。）はガソリンや軽油等から生じる火災を消し止めるため
に使用されることから、駐車場や空港、消防所又はコンビナートに配備されており、PFOS 量と
して日本全体に 148.8t の消火薬剤が備置されている。その内、東京湾へ排出される可能性がある
泡消火薬剤の割合は、東京湾流域（東京都、神奈川県、千葉県、埼玉県を想定）の人口割合であ
る 27％を用いることとした。
一方、泡消火薬剤の納品先及び使用実績から、現在の環境への排出係数は 1.8%、今後、点検時
の放出を行わない等の対策を講じた場合の環境への排出係数は 0.16％である。
以上のことより、泡消火薬剤による東京湾への推計排出量は以下の通りとした。
6
東京湾への泡消火薬剤の推計排出量 （経済産業省調査に基づく試算）
東京湾へ排出さ
全国の在庫量
れる可能性があ
排出係数
東京湾への
[トン]
る消火薬剤の割
推計排出量[kg]
A
合
C
A×B×C
B
148.8
27%
1.8%
723
年度
平成２０年度以前
148.8
平成２２年度以降(予定)
27%
0.16%
64
(2) 泡消火薬剤以外の用途について
PFOS の泡消火薬剤以外の用途として、半導体用レジスト・反射防止剤、金属めっき処理剤、
写真フィルム又は印画紙等の用途がある。各用途別の平成 18～20 年における東京湾への推計排
出量は、経済産業省の調査に基づく試算により以下の通りとした。
東京湾への泡消火薬剤以外の推計排出量
（平成２０年度以前）
用途別推計排出量 [kg]
（経済産業省調査に基づく試算）
合計推計
排出量
[kg]
年度
半導体用レジ
スト・反射防止
剤
金属めっき処
理剤
写真フィルム
又は印画紙
その他
平成１８年度
93
222
1
334
650
平成１９年度
129
196
3
451
779
平成２０年度
105
50
1
133
289
※全国排出量のうち東京湾へ排出される割合については、金属メッキ処理剤については工業統計の当該用途に関
連する産業分類の出荷額の割合に基づき２４％とし、金属メッキ処理剤以外については１００％とした。
一方、平成２２年度以降は、例外的使用のみを認めた場合の環境への排出量となり、以下の通
りである。
東京湾への泡消火薬剤以外の推計排出量
（平成２２年度以降）
年度
（経済産業省調査に基づく試算）
用途別推計排出量 [kg]
②圧電フィルタ用又
は高周波に用いる化
③業務用写真フィル
①半導体用レジスト
合物半導体用のエッ
ム
チング剤
平成２２年度
以降(予想)
8.4
0.7
0.1
(3) 推計排出量の合計
(1)及び(2)より東京湾への PFOS の推計排出量は以下の通りとなる。
7
合計推計
排出量
[kg]
9.2
年度
東京湾への推計排出量
（経済産業省調査に基づく試算）
泡消火薬剤の
泡消火薬剤以外の
合計推計排出量
環境放出量[kg]
用途からの排出量[kg]
[kg]
平成１８年度
723
650
1,373
平成１９年度
723
779
1,502
平成２０年度
723
289
1012
平成２２年度以降
(予想)
64
10
74
２.７ 環境中濃度の計算条件

上記 2.5 で設定した排出速度（1,373kg/year(平成１８年度)、1,502kg/year(平成１９年度)、
1,012kg/year(平成２０年度)、74kg/year(平成２２年度以降)）で水域に排出し続けるという
条件で、SAFECAS を用いて定常状態に達した濃度を計算。

魚類中濃度は、水中の定常濃度に BCF（2796）と BMF（2）を乗じて計算（2.5 参照）。

参考までに、5 年間、一定の排出速度（上記の通り）で水域に排出し、その後排出をゼロと
して 10 年後までの濃度変化も計算。
３. 試算結果
３.１ 環境中濃度推計結果
2.3 に示した物理化学的性状等と 2.5 の推計排出量を 2.4 の環境分配モデルに入力し、水域に排
出し続けた場合の環境中の定常状態濃度を推計した。このうち水中濃度と魚類中濃度をリスク評
価に使用した。
環境中の予測定常濃度一覧
年度
水中濃度[mg/L]
魚類中濃度[mg/kg]
底質中濃度[mg/kg]
平成 18 年度
1.6×10-5
8.9×10-2
2.7×10-3
平成 19 年度
1.7×10-5
9.7×10-2
3.0×10-3
平成 20 年度
1.2×10-5
6.6×10-2
2.0×10-3
平成 22 年度以降
8.6×10-7
4.8×10-3
1.5×10-4
■濃度の時系列変化（参考）
各年度の排出水準を前提とした水中濃度、底質中濃度の経年変化（一定水準の排出が５年継続
し、その後排出を停止した場合）を以下に示す。これによれば、排出が始まると水中濃度、底質
中濃度とも比較的早く定常濃度に達し、排出がなくなると速やかに、この区画中からは消失する
と予測された。
PFOS は他の POPｓ物質と比較すると、水と底質の分配において比較的、水にも分配している
こと、このモデル計算では水域の水の滞留時間は 45 日としていること等から、環境中のこの二つ
の区画の中の消長としてはこのようになったと考えられる。
8
2.0E-05
平成19年度
1.8E-05
水中濃度[mg/L]
1.6E-05
平成18年度
1.4E-05
1.2E-05
平成20年度
1.0E-05
8.0E-06
6.0E-06
4.0E-06
2.0E-06
平成22年度以降
0.0E+00
0
1
2
3
4
5
6
7
8
9
10
経年変化[年] 計算条件：　1～5年　一定量で排出
6～10年　排出ゼロ
水中濃度の時系列予測結果
3.5E-03
平成19年度
底質中濃度[mg/kg]
3.0E-03
平成18年度
2.5E-03
2.0E-03
平成20年度
1.5E-03
1.0E-03
5.0E-04
平成22年度以降
0.0E+00
0
1
2
3
4
5
6
7
8
9
10
経年変化[年] 計算条件：　1～5年　一定量で排出
6～10年　排出ゼロ
底質中濃度の時系列予測結果
３.２ モデル推計濃度に基づくリスク評価結果
環境中の予測定常濃度を用いてリスク評価を行った。
人の健康のリスク評価では、いずれの条件においても「懸念なし」と推計された。
高次捕食動物のリスク評価では、平成 20 年度までの推計排出量におけるリスク評価（魚体内濃
度）では「リスク懸念」
、平成 22 年度以降においては「懸念なし」と推計された（PNEC＝0.033
。
mg/kg 餌を用いた場合）
9
水生生物のリスク評価では、いずれの条件においても「懸念なし」と推計された。
対象
有害性
人健康
TDI＝
0.0003
mg/kg/day
人の健康に対するリスク評価結果
推計摂取量
年度
[mg/kg/day]
平成１８年度
0.00017
ハザード比
（HQ＝推計摂取量／TDI）
0.57 (懸念なし)
平成１9 年度
0.00019
0.62
(懸念なし)
平成２０年度
0.00013
0.42
(懸念なし)
平成２２年度以降
0.0000092
0.031 (懸念なし)
※推計摂取量＝魚類中濃度×魚摂取量／体重
魚類中濃度＝水中濃度×BCF×BMF
魚摂取量：95.6g/人/day 注）、体重：50kg
注）
平成 12 年国民栄養調査による 15 歳以上における平均魚介類摂取量（出典：産業技術総合研究所 化学物質
リスク管理研究センター、暴露係数ハンドブック、http://unit.aist.go.jp/riss/crm/exposurefactors/）
なお、魚摂取量を高暴露集団の魚介類多食者を想定した場合は 268g/day となり、これを用いると平成 18～
20 年度ではハザード比は 1 を超え（1.2～1.7）リスク懸念と推計されるものの、４．に記載のとおり、魚体
中濃度が高めに推定されていることが影響しているものと考えられる。
（高暴露集団の魚摂取量 268g/day の
出典：第９回中央環境審議会環境保健部会資料 4 その 6「第一種特定化学物質を１トン環境中に放出した場合
の環境中濃度の予測」、平成 15 年、http://www.env.go.jp/council/05hoken/y053-05/mat04-6.pdf）
対象
高次捕食
動物（魚食
性哺乳類、
魚食性鳥
類）
有害性
高次捕食動物に対するリスク評価結果
餌(魚)中濃度
年度
[mg/kg 餌]
0.089
平成１８年度
HQ
2.7
(懸念)
平成１9 年度
0.097
2.9
(懸念)
平成２０年度
0.066
2.0
(懸念)
平成２２年度以降
0.0048
平成１８年度
0.089
1.3
(懸念)
平成１9 年度
0.097
1.5
(懸念)
平成２０年度
0.066
0.98
(懸念なし)
平成２２年度以降
0.0048
0.072
(懸念なし)
PNEC＝
0.033 mg/kg 餌
PNEC＝
0.067 mg/kg 餌
0.15
(懸念なし)
※餌(魚)中濃度＝水中濃度×BCF×BMF （BMF の設定は UK 評価書と EU のリスク評価ガイダンスに基づいた。
）
対象
水生生物
水生生物のリスク評価結果
水中濃度
年度
[mg/L]
0.000016
平成１８年度
0.00069
(懸念なし)
平成１9 年度
0.000017
0.00076
(懸念なし)
平成２０年度
0.000012
0.00051
(懸念なし)
平成２２年度以降
0.00000086
0.000037
(懸念なし)
有害性
PNEC＝
0.023 mg/L
HQ
※淡水と海水の区別はしていない。
４. モデル推計濃度と環境モニタリング濃度との比較
3.1 に示した推計濃度（水中濃度、底質中濃度、魚類中濃度）と、環境モニタリングによる測定
値とを比較した。環境モニタリング情報は、環境省の「化学物質の環境リスク評価
10
第６巻, ペ
ルフルオロオクタンスルホン酸及びその塩」で整理されていた情報から、以下のように抜粋・整
理し、推計値との比較を図示した。魚類中濃度のみ、UK 評価書から米国の濃度も比較対象とし
て示した。
公共用水域・淡水
複数の調査それぞれの幾何平均値、最大値の調査間の min と max
（検出率は複数調査でのべ 286/321）
公共用水域・海水
同上（検出率は複数調査でのべ 37/37）
底質（公共用水域・淡水） 同上（検出率は複数調査でのべ 10/16）
底質（公共用水域・海水） 同上（検出率は複数調査でのべ 7/14）
魚類（公共用水域・淡水） 同上（検出率は複数調査でのべ 6/6）
魚類（公共用水域・海水） 同上（検出率は複数調査でのべ 21/22）
魚類（米国の３M 工場の上・下流）
各図の左端のプロットが推計値であり、他は測定値である。
水中濃度と底質中濃度の推計値は、国内で測定された濃度の範囲内であった。
現況の排出量レベルを想定した魚類中濃度のモデル推計値（平成 18～20 年度）は、国内で測
定された範囲よりも高めに推計された。これには、以下のような理由が考えられる。魚類中濃度
の推計に用いた BCF の値（2796）は、56 日間の試験期間でも定常に達していないとして取り込
み速度と排泄速度の比から推定された kinetic BCF である（OECD 有害性評価書のロバストサマ
リには単純に濃度比をとった Whole fish の BCF は 859 等とある）。PFOS が生体に蓄積される機
構は脂溶性の物質と異なるとされている。ここでの kinetic BCF の値には、脂溶性物質などと比
較して排泄されにくい PFOS の性質が排泄速度を通じて反映されていると考えられる。そのため、
この kinetic BCF については安全側に推計された数値と考えられる。また、この kinetic BCF か
ら逆算して求めた logKow に基づいて設定された BMF についても、安全側に設定されていると
考えられる。
環境モニタリングによる魚類中濃度を使用して高次捕食動物のリスク評価を行うと、魚類中濃
度の図に示すとおり、東京湾から採取した魚（海水魚における最大値 0.0068 mg/kg）も含め最も
高濃度の淡水魚（0.012 mg/kg）でもリスク懸念なしと推計される。
さらに、人の健康に関して環境モニタリングによる魚類中濃度を使用してリスク評価を行うと、
東京湾から採取した魚（海水魚における最大値 0.0068 mg/kg）で HQ は 0.04、最も高濃度の淡
水魚（0.012 mg/kg）で HQ は 0.08 となり、いずれでもリスク懸念なしと推計される。
11
■水中濃度
1.0E+02
水生生物に対する PNEC=23
11
水中濃度[μg/L]
1.0E+01
1.0E+00
0.67
1.0E-01
0.028
0.012～
0.017
0.0089
0.013
1.0E-02
0.0015
1.0E-03
0.00086
0.006
0.001
海 水 （幾 何 平 均 値 ）
海 水 （最 大 値 ）
淡 水 （幾 何 平 均 値 ）
淡 水 （最 大 値 ）
推計濃度
1.0E-04
最小値
最大値
平成18年度
平成19年度
平成20年度
平成22年度以降
■底質中濃度
1.0E+00
最小値
最大値
平成18年度
平成19年度
平成20年度
平成22年度以降
底質中濃度[mg/kg]
1.0E-01
1.0E-02
0.0020～
0.0030
1.0E-03
0.0043
0.0008
0.00035
0.0004
1.0E-04
0.00021
0.00021
0.00014
0.00015
0.000048
海 水 （幾 何 平 均 値 ）
12
海 水 （最 大 値 ）
淡 水 （幾 何 平 均 値 ）
淡 水 （最 大 値 ）
推計濃度
1.0E-05
■魚類中濃度
最小値
最大値
平成18年度
平成19年度
平成20年度
平成22年度以降
1.0E+00
魚類中濃度[ｍg/kg]
0.066～0.097
1.0E-01
1.0E-02
0.133
0.0591
高次捕食動物に対する PNEC=0.033 (鳥類繁殖試験による）
0.012
0.0068
0.0048
0.0023 0.002
1.0E-03
0.0055
0.0011
0.0011
0.00052
U S の 3 M工 場 の下 流
U S の 3 M工 場 の上 流
海 水 （幾 何 平 均 値 ）
海 水 （最 大 値 ）
淡 水 （幾 何 平 均 値 ）
淡 水 （最 大 値 ）
推計濃度
1.0E-04
５. 資料
５.１ 参考資料
・ 環境省環境保健部環境リスク評価室, 2008, 化学物質の環境リスク評価
第６巻, ペルフルオ
ロオクタンスルホン酸及びその塩
http://www.env.go.jp/chemi/report/h19-03/pdf/chpt1/1-2-2-19.pdf
・ UK のＰＦＯＳのリスク評価書
UK Environmental Agency, 2004, Environmental Risk Evaluation Report: perfluorooctane
sulphonate (PFOS).
http://www.environment-agency.gov.uk/commondata/105385/pfos_rer_sept04_864557.pdf
・ OECD の PFOS とその塩の有害性評価書
OECD, 2002, Hazard Assessment of perfluorooctane sulphonate (PFOS) and Its Sals.
ENV/JM/RD(2002)17/FINAL
http://www.oecd.org/dataoecd/23/18/2382880.pdf
・ 鳥類の繁殖試験に関わる資料
Newsted, J.L. et al., 2007. Effects of perfluorooctane sulphonate on malloard and northern
bobwhite quail exposed chronically via the diet. Environmental Toxicology and
Pharmaclogy, Vol.23, 1-9.
Giesy, J. 2004. Toxicological perspectives on perfluorinated compounds in avian species.
Organohalogen Compounds, Vol.66, 4086-4089.
・ 数理モデル SAFECAS 関連資料
13
化学物質審議会安全対策部会第３回安全対策小委員会資料
Yoshida, K., Shigeoka, T. and Yamauchi, F. 1987. Evaluation of Aquatic Environmental
Fate of 2,4,6-torichlorophenol with Mathematical Model. Chemosphere, Vol. 16,
2351-2544.
５.２ 添付資料
・ 高次捕食動物のリスク評価に用いる有害性情報の候補の一覧表
14
15
繁殖
繁殖
マガモ
Mallard Duck
ウズラ
Nothern
bobwhite quail
14週
Ｓｐｒａｇｕｅ－Ｄａｗ
ｌｅｙラット（下記の 中期毒性
実験の一部）
雄：肝細胞肥大
雄：肝細胞肥大
F0 ： 全体的影響
強制経口 F1 ： 開眼遅延(用量依
0、0.1、 存）
二世代 0.4、1.6、 F2 ： 体重増加抑制
3.2mg/kg/
day
F1 ： 繁殖成績
雄：肝細胞空胞化
雌：肝細胞肥大、好酸性
顆粒、色素沈着マクロ
ファージの浸潤
30
30
30
90
900
300
30
300
30
0 . 0 6 7 mg/kg food
0 . 0 6 7 mg/kg food
0.4 mg/kg/day
2 m g/ kg fo o d
30
0 . 0 6 7 mg/ kg fo o d
備考
・子の生存率低下は「ふ化率の ・LOAECなのでUFが大
低下又はそれに準じて毒性学 ・LOAECからNOAECの外挿10はEPAより
的に重要な影響」と判断
・UK評価書では何故か考慮していない
・精子形成の減少は「ふ化率の ・LOAECなのでUFが大
低下又はそれに準じて毒性学 ・LOAECからNOAECの外挿10はEPAより
的に重要な影響」と判断
・UK評価書では何故か考慮していない
理由
・環境省　環境リスク評
価書　p.15
・UK評価書p.57
・環境省　環境リスク評
価書　p.11
・UK評価書p.57
・環境省　環境リスク評
価書　p.10
・環境省　環境リスク評
価書　p.10
・UK評価書 p.58
・UK評価書 p.58
・UK評価書 p.58
出典
イ ほ乳類の生殖能及び後世代に及ぼす影響に関する試験において、死亡、生殖能又は後世代の発生に及ぼす影響その他これらに準じて毒性学的に重要な影響がみられたもの
ロ 鳥類の繁殖に及ぼす影響に関する試験において、死亡、産卵数の低下、ふ化率の低下その他これらに準じて毒性学的に重要な影響がみられたもの
補足説明：
個体群の存続は、集団を構成する齢（ライフステージ）別の繁殖率と生存率に左右されます。この場合、F0やF2への影
響がその齢の生存率又は繁殖率を低下させることにつながると判断されれば、「死亡、生殖能又は後世代の発生に及
ぼす影響その他これらに準じて毒性学的に重要な影響」に該当するということになるのだと思います。
（○）
・死亡、生殖能又は後世代の発
生に及ぼす影響その他これらに
準じて毒性学的に重要な影
響？
・強制経口投与の毒性値（mg/kg/day）をEU・UK評価書でAlternative
TGDの換算方式で餌中濃度に換算
proposed
・上記NOAECの一つ上の用量のエンドポイント
・UK評価書でAlternative proposed
・LOAECからNOAECへの外挿に公比を用いた
ら上に同じ
・種の存続との関連が不明瞭
・UK評価書でも"it may be an overconservative choice of endpoint for the
assessment of secondary poisoning."との認
識
補足説明：個体群の存続は、集団を構成する齢（ライフステージ）別の繁殖率と生存率に左右さ
れます。繁殖率の表し方の一例では、以下のように雌１個体あたりの巣立ちヒナの数で表します。
この右辺のいずれかを低下させる影響は繁殖率への影響と言え、この場合、子の生存率低下
は三つめの項の低下と捉えられます。
巣立ちヒナ数＝産卵数×ふ化率×ふ化から巣立ちまでの生存率
○
○
高次捕食
動物リスク
評価に推奨
（前回試算 ・最小のPNEC
0 . 0 1 7 mg/kg food
で採用） ・UK評価書でもキースタディ
0.022 mg/kg food
0.033 mg/kg food
0 . 0 3 3 mg/ kg fo o d
0.333 mg/kg food
0 . 0 3 3 mg/ kg fo o d
0.333 mg/kg food
0.073 mg/kg food
PNEC（餌中濃度）
↓強制経口投与試験によるNOAELをNOAECに換算
NOAEC
6 m g/ kg fo o d
30
0 . 2 0 0 mg/ kg fo o d
NOAEL
0.1 mg/kg/day
2 ppm
2 ppm
0 . 5 ppm
2 mg/kg food
30 mg/kg food
1 0 m g/ kg fo o d
10 mg/kg food
1 0 m g/ kg fo o d
10 mg/kg food
3000
Ufs
↓強制経口投与試験によるNOAELをNOAECに換算
NOAEC （ 雌）
NOAEL
NOAEC
LOAEC
NOAEC
NOAEC
胸腺リンパ濾胞細胞減少 LOAEC
死亡、体重、餌摂取量、
NOAEC
肝重量、病理（雌）
混餌
0、10、50、 親： t o ac c e le r at e t h e
150ppm po st - r e pr o du c t ive
LOAEC
ph ase r e gr e ssio n
子： 生存率低下
LOAEC 雄
単位
220 mg/kg food
毒性の
数値
「高次捕食動物の生息又は生育に支障を及ぼすおそれがあるものであること」の中身（有害性情報の報告に関する省令より）
Ｓｐｒａｇｕｅ－Ｄａｗ 生殖・発
ｌｅｙラット
生
LC50
毒性種類
親：死亡、体重、肝重量、
繁殖
NOAEC雌
子：生存、体重、肝重量
死亡
エンドポイント
混餌
0、10、50、
150ppm 睾丸サイズ 小、 精子形
成の減少
用量
混餌
Ｓｐｒａｇｕｅ－Ｄａｗ 発がん、
104週 0.5、2、5、
雄：肝細胞肥大
ｌｅｙラット
長期毒性
20ｐｐｍ
90日
21週
21週
5日
試験期
間
Ｓｐｒａｇｕｅ－Ｄａｗ 中・長期
ｌｅｙラット
毒性
ほ乳類
急性
試験種類
ウズラ
Nothern bobtail
quail
鳥類
対象種
Provisional translation (ver. November 12 2010)
*This is a provisional translation (NOT a final version) of Act on the Evaluation
of Chemical Substances and Regulation of Their Manufacture, etc. which come into
effect as of April 1 2011.
Only the original Japanese texts of laws and regulations have legal effect.
The Government of Japan shall not be responsible for the accuracy, reliability or
currency of the legislative material in this document. For all purposes of
interpreting and applying law to any legal issue or dispute, users should consult
the original Japanese texts published in the Official Gazette.
Act on the Evaluation of Chemical Substances and
Regulation of Their Manufacture, etc. (Act No. 117 of
October 16, 1973)
Contents
Chapter I General Provisions (Articles 1 and 2)
Chapter II Evaluation and Regulation Concerning New Chemical Substances
(Articles 3 to 7)
Chapter III Notification for General Chemical Substances, etc. (Article 8)
Chapter IV Measures Concerning Chemical Substances Requiring Priority
Assessment (Articles 9 to 12)
Chapter V Regulations, etc. Concerning Class I Specified Chemical Substances
Section 1 Measures Concerning the Monitoring Chemical Substances (Articles 13
to 16)
Section 2 Regulations Concerning Class I Specified Chemical Substances (Articles
17 to 34)
Chapter VI Regulations Concerning Class II Specified Chemical Substances (Articles
35 to 37)
Chapter VII Miscellaneous Provisions (Articles 38 to 56)
Chapter VIII Penal Provisions (Articles 57 to 63)
Supplementary Provisions
1
Provisional translation (ver. November 12 2010)
Chapter I General Provisions
(Purpose)
Article 1 The purpose of this Act is to establish a system for evaluating the
properties of new chemical substances before their manufacture or import and for
implementing necessary regulations with respect to the manufacture, import, use,
etc. of chemical substances, with due consideration to their properties, etc., in order
to prevent environmental pollution caused by persistent chemical substances that
pose a risk of impairing human health or interfering with the inhabitation and/or
growth of flora and fauna.
(Definitions, etc.)
Article 2 (1) The term "chemical substance" as used in this Act means a chemical
compound obtained by causing chemical reactions to elements or compounds
(excluding a radioactive substance and the following substances):
(i) Any specified poison prescribed in paragraph (3) of Article 2 of the Poisonous and
Deleterious Substances Control Act (Act No. 303 of 1950)
(ii) Any stimulant prescribed in paragraph (1) of Article 2 of the Stimulant Drug
Control Act (Act No. 252 of 1951) and any raw material for stimulants prescribed
in paragraph (5) of said Article
(iii) Any narcotic prescribed in item (i) of Article 2 of the Narcotics and
Psychotropics Control Act (Act No. 14 of 1953)
(2) The term "class I specified chemical substance" as used in this Act means a
chemical substance that falls under either of the following items and is specified
by Cabinet Order:
(i) A chemical substance that falls under (a) and (b):
(a) A chemical substance that is not likely to undergo a chemical transformation
through natural processes and is bioaccumulative
(b) A chemical substance that falls under either of the following:
1. A chemical substance that poses a risk of impairing human health if
ingested continuously
2. A chemical substance that, if ingested continuously, poses a risk of
interfering with the inhabitation and/or growth of predator animals at
higher trophic level (which mean animals that fall under the category of
flora and fauna in the human living environment [which means flora and
2
Provisional translation (ver. November 12 2010)
fauna for which interference with their inhabitation and/or growth would
pose a risk of interfering with the preservation of the human living
environment; the same shall apply hereinafter] for which chemical
substances falling under (a) are most likely to bioaccumulate through the
food chain; the same shall apply hereinafter)
(ii) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by chemical transformation through natural
processes falls under (a) and (b) of the preceding item
(3) The term "class II specified chemical substance" as used in this Act means a
chemical substance that is specified by Cabinet Order and falls under either of the
following items and is thought to pose a risk of causing damage to human health or
damage to the inhabitation and/or growth of flora and fauna in the human living
environment due to a considerable amount of the chemical substance remaining in
the environment over a substantially extensive area or because it is reasonably
likely that such a situation will arise in the near future in view of its properties and
manufacture, import, use, etc.:
(i) A chemical substance that falls under either (a) or (b):
(a) A chemical substance (excluding one that falls under item (i) of the preceding
paragraph) that is likely to pose a risk of impairing human health if ingested
continuously
(b) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through
natural processes falls under (a) (limited to a chemical substance that is not
likely to undergo a chemical transformation through natural procsses).
(ii) Any chemical substance that falls under either (a) or (b):
(a) A chemical substance (excluding one that falls under item (i) of the preceding
paragraph) that is likely to pose a risk of interfering with the inhabitation
and/or growth of flora and fauna in the human living environment if the flora
and fauna continuously ingest or are exposed to said chemical substance
(b) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through
natural processes falls under (a) (limited to a chemical substance that is likely
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Provisional translation (ver. November 12 2010)
to undergo a chemical transformation through natural processes).
(4) The term "monitoring chemical substance" as used in this Act means a chemical
substance (excluding a new chemical substance) that falls under either of the
following items and has been designated by the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment:
(i) A chemical substance that falls under (a) of item (i) of paragraph (2), and where
it is unclear whether or not (b) of said item applies
(ii) In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
processes falls under the preceding item
(5) The term "chemical substances requiring prior assessment" as used in this Act
means chemical substances for which it is not clear whether they fall under either
of the items of paragraph (3) from the perspective of currently available knowledge
on the chemical substances, which are found to remain in the environment in
considerable amounts or are expected to remain in such a situation in view of the
knowledge and the state of manufacture, import, etc., and which are found to be
likely to damage human health or to damage the inhabitation and/or growth of flora
and fauna in the human living environment through environmental pollution by
the chemical substance; they are therefore designated by the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment as chemical substances that are found to require
priority assessment of the likelihood of the chemical substances having the above
risks through the collection of information on their properties and through the
clarification of the status of their use, etc.
(6) The term "new chemical substance" as used in this Act means a chemical
substance other than the chemical substances listed in the following items:
(i) A chemical substance for which public notice has been given by the Minister of
Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment pursuant to the provisions of paragraph (4) of Article
4 (including the cases where it is applied mutatis mutandis pursuant to paragraph
(9) of Article 5 by replacing the terms, and the cases in which it is applied mutatis
mutandis pursuant to paragraph (2) of Article 7)
(ii) A class I specified chemical substance
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(iii) A class II specified chemical substance
(iv) A chemical substance requiring priority assessment (including one for which
the designation has been rescinded pursuant to the provisions of Article 11 [limited
to the part pertaining to (d) of item (ii)])
(v) A chemical substance (excluding any of those set forth in the preceding items)
listed in the list of existing chemical substances prescribed in paragraph (1) of
Article 2 of the Supplementary Provisions of this Act that has been publicly notified
by the Minister of International Trade and Industry pursuant to the provisions of
paragraph (4) of said Article
(vi) A chemical substance (excluding any of those set forth in the preceding items)
listed in the list prescribed in Article 4 of the Supplementary Provisions of this Act
that is publicized by the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment
(7) The term "general chemical substance" as used in this Act means a chemical
substance listed in the following (excluding chemical substances requiring priority
assessment, monitoring chemical substances, class I specified chemical substances,
and class II specified chemical substances):
(i) A chemical substance listed in items (i), (v) or (vi) of the preceding paragraph
(ii) A chemical substance for which designation as a chemical substance requiring
priority assessment is rescinded pursuant to the provisions of Article 11 (limited to
the part pertaining to (d) of item (ii))
(8) When the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, or the Minister of the Environment has designated a chemical
substance as a monitoring chemical substance or chemical substance requiring
priority assessment pursuant to the provisions of paragraph (4) or (5), he/she shall
give public notice of its name without delay.
Chapter II Evaluation and Regulation Concerning New Chemical Substances
(Notification of Manufacture, etc.)
Article 3 (1) A person who intends to manufacture or import a new chemical
substance shall notify the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment, in advance, of
the name of said new chemical substance and other matters specified by Ordinance
of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of
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Provisional translation (ver. November 12 2010)
Economy, Trade and Industry, and Ordinance of the Ministry of the Environment,
pursuant to the provisions of Ordinance of the Ministry of Health, Labour and
Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance
of the Ministry of the Environment; provided, however, that this shall not apply to
a case that falls under any of the following items:
(i) Where a person intends to import from a person who has submitted a notification
under paragraph (1) of Article 7 and has received notice to the effect that the new
chemical substance to which said notification pertains falls under any of items (ii)
through (v) of paragraph (1) of the following Article in accordance with the
provisions of paragraph (1) or (2) of said Article as applied mutatis mutandis
pursuant to paragraph (2) of Article7, the new chemical substance to which said
notification pertains
(ii) Where a person intends to manufacture or import a new substance for testing
and research purposes
(iii) Where a person intends to manufacture or import a new chemical substance as
a reagent (which means a chemical substance used for the detection or
quantification of a substance by a chemical process, or for the experimental
synthesis of a substance, or for the measurement of the physical characteristics of a
substance; the same shall apply hereinafter)
(iv) Where a person has received a confirmation from the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment, pursuant to the provisions of Ordinance of the
Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment, to the
effect that the manufacture or import falls under a case specified by Cabinet Order
as one where the new chemical substance does not pose a risk of causing
environmental pollution in consideration of the intended method of handling said
new chemical substance and other matters, and said new chemical substance will
be manufactured or imported in accordance with the particulars for which said
confirmation has been received
(v) Where the planned quantity of manufacture or planned quantity of import (in
the case of a person who intends to manufacture and import said new chemical
substance, the sum of these quantities; the same shall apply in paragraph (1) and
item (i) of paragraph (4) of Article 5) of said new chemical substance in one fiscal
year is not more than the quantity specified by Cabinet Order, and where a person
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Provisional translation (ver. November 12 2010)
has received a confirmation from the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment, in
accordance with Ordinance of the Ministry of Health, Labour and Welfare,
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the
Ministry of the Environment, to the effect that, as determined by already available
knowledge, etc., said new chemical substance is not one that poses a risk of causing
damage to human health or damage to the inhabitation and/or growth of flora and
fauna in the human living environment by causing environmental pollution, and
that person shall manufacture or import said new chemical substance in a quantity
of no more than that to which said confirmation pertains during the relevant fiscal
year
(vi) Where the new chemical substance is a polymer and where a person has
received confirmation from the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment,
pursuant to the provisions of Ordinance of the Ministry of Health, Labour and
Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance
of the Ministry of the Environment, to the effect that the new chemical substance
does not pose a risk of causing damage to human health or damage to the
inhabitation and/or growth of flora and fauna in the human living environment by
causing environmental pollution; and said new chemical substance will be
manufactured or imported
(2) In cases where the sum of the planned quantity of manufacture and planned
quantity of import to which the confirmation under the provisions of item (v) of the
preceding paragraph pertains (including the planned quantity of manufacture and
planned quantity of import to which the confirmation under the provisions of
paragraph (4) of Article 5 pertains) relating to a single new chemical substance
exceeds the quantity specified by Cabinet Order set forth in said item, the Minister
of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and
the Minister of the Environment shall not issue the confirmation under said item.
(3) In any of the cases listed in the following items, the Minister of Health, Labour
and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment shall rescind the confirmation set forth in item (iv) of paragraph (1):
(i) Where the person who has received the confirmation under item (iv) of
paragraph (1) receives said confirmation by wrongful means
(ii) Where the person who has received the confirmation under item (iv) of
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Provisional translation (ver. November 12 2010)
paragraph (1) is found not to be manufacturing or importing the new chemical
substance to which said confirmation pertains in accordance with the particulars
for which said confirmation has been received
(iii) In addition to the cases set forth in the preceding items, where it is found that
the new chemical substance to which the confirmation under item (iv) of paragraph
(1) pertains poses a risk of causing environmental pollution
(4) In any of the cases listed in the following items, the Minister of Health, Labour
and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment shall rescind the confirmation under item (v) of paragraph (1):
(i) Where the person who has received the confirmation under item (v) of paragraph
(1) had received said confirmation by wrongful means
(ii) Where the person who has received the confirmation under item (v) of
paragraph (1) is found to be manufacturing or importing the new chemical
substance to which said confirmation pertains in excess of the quantity to which
said confirmation pertains
(iii) In addition to the cases set forth in the preceding items, where it is found that
the new chemical substance to which the confirmation under item (v) of paragraph
(1) pertains poses a risk of causing damage to human health or damage to the
inhabitation and/or growth of flora and fauna in the human living environment by
causing environmental pollution
5. In any of the cases listed in the following items, the Minister of Health, Labour
and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment shall rescind confirmation under item (vi) of paragraph (1):
(i) Where the person who has received confirmation under item (vi) of paragraph (1)
receives said confirmation by wrongful means
(ii) Where it is found that the new chemical substance pertaining to the
confirmation set forth in item (vi) of paragraph (1) poses a risk of causing damage to
human health or damage to the inhabitation and/or growth of flora and fauna in the
human living environment by causing environmental pollution
(Evaluation)
Article 4 (1) Where the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment have received a
notification under paragraph (1) of the preceding Article, they shall make a
determination as to which of the following items the new chemical substance falls
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Provisional translation (ver. November 12 2010)
under, within three months from the date of receipt of the notification, based on the
available knowledge on the composition, properties, etc., of the new chemical
substance to which said notification pertains, and shall notify the result thereof to
the person who has given the notification:
(i) A chemical substance that falls under any of the items of paragraph (2) of Article
2
(ii) A chemical substance that falls under (a) and does not fall under (b):
(a) A chemical substance that falls under any of the following:
1. A chemical substance that is suspected to fall under (a) of item (i) of paragraph
(3) of Article 2 (including those that fall under (a) of said item and limited to
chemical substances that are not likely to undergo a chemical transformation
through natural processes)
2. In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through
natural processes falls under 1
(b) A chemical substance that falls under any of the following:
1. A chemical substance that is likely to pose a risk of interfering with the
inhabitation and/or growth of flora and fauna (limited to chemical substances
that are not likely to undergo a chemical transformation through natural
processes and excluding those that fall under item (i) of paragraph (2) of Article
2)
2. In the case of a chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through
natural processes falls under 1
(iii) A chemical substance that does not fall under (a) of the preceding item and that
falls under (b) in said item
(iv) A chemical substance that falls under both (a) and (b) of item (ii)
(v) A chemical substance that does not fall under item (i) or (a) or (b) of item (ii)
(vi) A substance where it is unclear as to whether or not it falls under items (i) to
(iv)
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have determined that a
new chemical substance to which a notification under paragraph (1) of the
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Provisional translation (ver. November 12 2010)
preceding Article pertains falls under item (vi) of the preceding paragraph, they
shall promptly make a determination as to which one of items (i) through (v) of said
paragraph the new chemical substance falls under, based on the results of tests
conducted on the new chemical substance, and shall notify the result thereof to the
person who has given the notification.
(3) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment find it necessary in order
to make a determination under the preceding paragraph, they may request the
person who has given the notification under paragraph (1) of the preceding Article
to submit materials stating the results of tests prescribed in paragraph (5) relating
to the properties of the new chemical substance to which said notification pertains
and any other documents specified by Ordinance of the Ministry of Health, Labour
and Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and
Ordinance of the Ministry of the Environment.
(4) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have given notice to the
effect that the new chemical substance to which notification under paragraph (1) of
the preceding Article pertains falls under any of items (ii) through (v) of paragraph
(1), pursuant to the provisions of paragraph (1) or (2), they shall give public notice
of the name of said new chemical substance, in accordance with Ordinance of the
Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment; provided,
however, that this shall not apply to a new chemical substance that has been
designated pursuant to the provisions of paragraph (5) of Article 2.
(5) The items to be tested and any other technical matters necessary for making a
determination under paragraphs (1) and (2) of this Article shall be specified by
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment.
(6) In determining the order under the preceding paragraph, efforts shall be made to
consider fully the international trends regarding the establishment of items to be
tested relating to the evaluation of the safety of chemical substances, and other
trends regarding the technical standards relating to the evaluation of the safety of
chemical substances.
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Provisional translation (ver. November 12 2010)
(Exception to Evaluation in the Case Where the Planned Quantity of Manufacture
etc., is Not More Than a Certain Quantity, etc.)
Article 5 (1) A person who intends to give a notification under paragraph (1) of
Article 3 and for whom the planned quantity of manufacture or planned quantity of
import of the new chemical substance to which the notification pertains during one
fiscal year will be not more than the quantity specified by the Cabinet Order set
forth in item (i) of paragraph (4) may, when giving the notification, make a request
to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment, pursuant to the provisions of
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment, to make a determination as to whether or not said new chemical
substance falls under either of the following items in the case where it falls under
item (vi) of paragraph (1) of the preceding Article:
(i) A chemical substance that falls under (a) and (b):
(a) A chemical substance that is not likely to undergo a chemical transformation
through natural processes and is not bioaccumulative
(b) A chemical substance where it is unclear as to whether or not it falls under
items (ii) through (iv) of paragraph (1) of the preceding Article
(ii) In the case of a new chemical substance that is likely to undergo a chemical
transformation through natural processes, one where the chemical substance
(including an element) generated by the chemical transformation through natural
processes falls under the preceding item
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have received a request
under the preceding paragraph, if they find that the new chemical substance to
which said request pertains falls under item (vi) of said paragraph at the time of
making a determination under item (i) of the preceding Article, they shall,
notwithstanding the provisions of said paragraph, make a determination as to
which of the following items said new chemical substance falls under, in lieu of a
determination to the effect that it falls under item (vi) of paragraph (1) of the
preceding Article, based on already available knowledge on the composition,
properties, etc., of the new chemical substance to which said request pertains,
within three months from the date of receipt of a notification under item (i) of
Article 3, and shall notify the result thereof to the person who has made the request
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Provisional translation (ver. November 12 2010)
under the preceding paragraph; in this case, the provisions of paragraph (2) of said
Article shall not apply:
(i) A substance that falls under any of the items of the preceding paragraph
(ii) A substance that does not fall under any of the items of the preceding paragraph
(iii) A chemical substance where it is unclear as to whether or not it falls under any
of the items of the preceding paragraph
(3) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have determined that the
new chemical substance to which a request under paragraph (1) pertains falls
under item (iii) of the preceding paragraph, they shall promptly make a
determination as to which one of items (i) or (ii) of said paragraph said new
chemical substance falls under, based on the results of tests conducted on said new
chemical substance, and shall notify the result thereof to the person who has made
the request.
(4) A person who has received notice to the effect that the new chemical substance to
which a request made under the provisions of paragraph (2) or the preceding
paragraph pertains falls under item (i) of paragraph (2) may make a request in
advance, each fiscal year, to the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment and
receive a confirmation to the effect that the manufacture or import of the new
chemical substance to which said notice pertains falls under the following items,
pursuant to the provisions of Ordinance of the Ministry of Health, Labour and
Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance
of the Ministry of the Environment:
(i) The planned quantity of manufacture or planned quantity of import of said new
chemical substance during the fiscal year to which the request pertains is not more
than the quantity specified by Cabinet Order.
(ii) Determined by already available knowledge, etc., the new chemical substance is
not one that poses a risk of causing damage to human health or damage to the
inhabitation and/or growth of flora and fauna in the human living environment by
causing environmental pollution.
(5) In cases where the sum of the planned quantity of manufacture and planned
quantity of import to which the confirmation under the provisions of the preceding
paragraph pertains (including the planned quantity of manufacture and planned
quantity of import to which the confirmation under the provisions of item (v) of
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Provisional translation (ver. November 12 2010)
paragraph (1) of Article 3 pertains) relating to a single new chemical substance
exceeds the quantity specified by Cabinet Order set forth in item (i) of the preceding
paragraph, the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment shall not issue the
confirmation under said item.
(6) In any of the cases listed in the following items, the Minister of Health, Labour
and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment shall rescind the confirmation set forth in paragraph (4):
(i) Where the person who has received the confirmation under paragraph (4) has
received said confirmation by wrongful means
(ii) Where the person who has received the confirmation under paragraph (4) is
found to be manufacturing or importing the new chemical substance to which said
confirmation pertains in excess of the quantity to which said confirmation pertains
(iii) In addition to the cases set forth in the preceding items, where it is found that
the new chemical substance to which the confirmation under paragraph (4) pertains
poses a risk of causing damage to human health or damage to the inhabitation
and/or growth of flora and fauna in the human living environment by causing
environmental pollution
(7) A person who has received notice to the effect that the new chemical substance to
which his/her request pertains falls under item (i) of paragraph (2), pursuant to the
provisions of paragraph (2) or paragraph (3) may, when he/she finds it necessary,
make a request to the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment to make a
determination under the following paragraph with regard to the new chemical
substance to which said notice pertains, pursuant to the provisions of Ordinance of
the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment.
(8) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have given notice to the
effect that the new chemical substance to which a request under paragraph (1)
pertains falls under item (ii) of paragraph (2), pursuant to the provisions of
paragraph (2) or paragraph (3), where they have not issued a confirmation to the
effect that the manufacture or import of the new chemical substance to which a
request under paragraph (4) pertains falls under the items of said paragraph,
where they have rescinded the confirmation under said paragraph, or where they
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Provisional translation (ver. November 12 2010)
have received a request under the preceding paragraph, they shall promptly make a
determination as to which one of items (i) through (v) of paragraph (1) of Article 4
said new chemical substance falls under, based on the results of tests conducted on
said new chemical substance, and shall notify the result thereof to the person who
has made the request under paragraph (1) with regard to the new chemical
substance.
(9) The provisions of paragraph (5) and paragraph (6) of the preceding Article shall
apply mutatis mutandis to a determination under paragraph (2), the provisions of
paragraph (3), paragraph (5) and paragraph (6) of said Article shall apply mutatis
mutandis to a determination under paragraph (3), and the provisions of paragraphs
(3) through (6) of said Article shall apply mutatis mutandis to a determination
under the preceding paragraph. In these cases, the phrase "paragraph (1) or
paragraph (2)" in paragraph (4) of said Article shall be deemed to be replaced with
"paragraph (8) of Article 5."
(Restrictions on Manufacture, etc.)
Article 6 A person who has given a notification under paragraph (1) of Article 3
shall not manufacture or import the new chemical substance to which the
notification pertains pursuant to the provisions of paragraph (1) or (2) of Article 4
or paragraph (8) of the preceding Article until after the receipt of notice prescribed
in the provisions of paragraph (4) of Article 4 (including the cases where it is
applied mutatis mutandis pursuant to paragraph (9) of the preceding Article by
replacing the terms) relating to said new chemical substance; provided, however,
that this shall not apply to either of the following cases:
(i) Where the manufacture or import of the new chemical substance to which said
notification pertains falls under any of the items of paragraph (1) of Article 3
(ii) In the case where the person has received confirmation under the provisions of
paragraph (4) of the preceding Article regarding the manufacture or import of the
new chemical substance to which said notification pertains (excluding cases where
confirmation is rescinded pursuant to the provisions of paragraph (6) of said
Article), where the quantity of manufacture or import of said new chemical
substance shall be not more than the quantity to which said confirmation pertains
(Evaluation, etc., of a New Chemical Substance Pertaining to a Manufacturer, etc.,
in a Foreign State)
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Provisional translation (ver. November 12 2010)
Article 7 (1) A person who intends to manufacture in a foreign state a new chemical
substance to be exported to Japan or a person who intends to export a new chemical
substance to Japan may, in advance, notify the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
Environment of the name of said new chemical substance and any other matters
specified by Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment, pursuant to the provisions of Ordinance of the Ministry of Health,
Labour and Welfare, Ordinance of the Ministry of Economy, Trade and Industry,
and Ordinance of the Ministry of the Environment.
(2) The provisions of Article 4 shall apply mutatis mutandis to the notification under
the preceding paragraph. In this case, the term "within three months" in paragraph
(1) of said Article shall be deemed to be replaced with "within four months."
Chapter III Notification for General Chemical Substances
(Notification of Quantity, etc. of Manufacture)
Article 8 A person who manufactures or imports general chemical substances shall
in every fiscal year, pursuant to Ordinance of the Ministry of Economy, Trade and
Industry, notify the Minister of Economy, Trade and Industry of the quantity of
manufacture, quantity of import or other matters specified by Ordinance of the
Ministry of Economy, Trade and Industry for each general chemical substance in
the preceding fiscal year; provided, however, that this shall not apply if the person
falls under any of the following items:
(i) Where a person manufactures or imports a general chemical substance for
testing and research purposes
(ii) With regard to a general chemical substance, where the quantity of
manufacture or quantity of import of the general chemical substance by the person
(in the case of a person who manufactures and imports said general chemical
substance, the sum of these quantities) is less than the quantity specified by
Cabinet Order
(iii) Where a person manufactures or imports a chemical substance that is found
not to fall under any of the items of paragraph (2) or the items of paragraph (3) of
Article 2 and other chemical substances that are specified by the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the
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Provisional translation (ver. November 12 2010)
Minister of the Environment as chemical substances for which it is not found
necessary to conduct an assessment as prescribed in paragraph (5) of said Article
(2) The provisions of the preceding paragraph (excluding item (iii)) shall apply
mutatis mutandis to a person who manufactures or imports a new chemical
substance pertaining to the notice prescribed in paragraph (4) of Article 4
(including cases where it is applied mutatis mutandis pursuant to paragraph (9) of
Article 5 by replacing the terms) (this person shall be limited to a person who has
received said notification) and to a person who imports a new chemical substance
pertaining to notification as prescribed in paragraph (4) of Article 4 as applied
mutatis mutandis pursuant to paragraph (2) of the preceding Article from a person
who has received said notification.
Chapter IV Measures for Chemical Substances Requiring Priority Assessment
(Notification of Quantity, etc. of Manufacture)
Article 9 (1) A person who manufactures or imports a chemical substance requiring
priority assessment (excluding one that is designated as a class II specified
chemical substance by falling under any of the items of paragraph (3) of Article 2;
the same shall apply hereinafter in this Article, and in Articles 12 and 41) shall in
every fiscal year, pursuant to Ordinance of the Ministry of Economy, Trade and
Industry, notify the Minister of Economy, Trade and Industry of the quantity of
manufacture, quantity of import or other matters specified by Ordinance of the
Ministry of Economy, Trade and Industry for each general chemical substance in
the preceding fiscal year; provided, however, that this shall not apply if the person
falls under any of the following items:
(i) Where a person manufactures or imports a chemical substance requiring priority
assessment for testing and research purposes
(ii) With regard to a chemical substance requiring priority assessment, where the
quantity of manufacture or quantity of import of the chemical substance requiring
priority assessment pertaining to the person (in the case of a person who
manufactures and imports said chemical substance requiring priority assessment,
the sum of these quantities) is less than the quantity specified by Cabinet Order
(2) The Minister of Economy, Trade and Industry shall, in every fiscal year, publicize
the sum of the quantity of manufacture and quantity of import in the preceding
paragraph pertaining to the notification set forth in the preceding paragraph;
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Provisional translation (ver. November 12 2010)
provided, however, that this shall not apply when the sum of the quantity of
manufacture and quantity of import of a chemical substance requiring priority
assessment is less than the quantity specified by Ordinance of the Ministry of
Economy, Trade and Industry.
(Study of Hazardous Properties of Chemical Substances Requiring Priority
Assessment)
Article 10 (1) Where the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment find it
necessary to conduct the assessment prescribed in paragraph (5) of Article 2 for a
chemical substance requiring priority assessment, they may request that a person
who engages in the business of manufacturing or importing said chemical
substance requiring priority assessment (including a person who used to engage in
these businesses and is specified by Ordinance of the Economy, Trade and Industry;
the same shall apply in the following paragraph) submit materials in which the
results of the tests that are prescribed in paragraph (5) of Article 4 on the
properties of said chemical substance requiring priority assessment and that are
specified by Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment.
(2) With regard to a chemical substance requiring priority assessment, where it is
found that there are reasons to suspect that it falls under any of the items of
paragraph (3) of Article 2 from the perspective of the results of tests set forth in the
preceding paragraph and other already available knowledge on said chemical
substance requiring priority assessment and if said chemical substance requiring
priority assessment falls under any of the items of said paragraph based on its
properties and the status of its manufacture, import, use, etc., it is expected that
said chemical substance requiring priority assessment is likely to cause damage to
human health or damage to the inhabitation and/or growth of flora and fauna in the
human living environment by causing environmental pollution; so that when the
Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment find it necessary to judge whether or
not said chemical substance requiring priority assessment falls under any of the
items of said paragraph, they may instruct a person who engages in the
manufacture or import of said chemical substance requiring priority assessment to
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Provisional translation (ver. November 12 2010)
conduct a study of hazardous properties as specified by Ordinance of the Ministry of
Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade and
Industry, and Ordinance of the Ministry of the Environment (the study means a
study of the effects of said chemical substance on human health and its effects on
the inhabitation and/or growth of flora and fauna in the human living environment
if ingested continuously; the same shall apply in paragraph (4)) and report the
results.
(3) Where the report set forth in the preceding paragraph is made, the Minister of
Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment shall judge whether or not the chemical substance
requiring priority assessment pertaining to said report falls under any of the items
of paragraph (3) of Article 2 and notify the person who made the report of the
results.
(4) Where the Minister of Economy, Trade and Industry finds it particularly
necessary to ensure that the expenses required for the tests pertaining to the
request pursuant to the provisions of paragraph (1) or the study of hazardous
properties pertaining to the instruction pursuant to the provisions of paragraph (2)
are divided fairly among the business operators concerned, he/she may establish
standards concerning the method and proportion for sharing the expenses required
for said tests or said study of hazardous properties.
(Rescission of Designation as a Chemical Substance Requiring Priority Assessment
Article 11 Where a chemical substance requiring priority assessment falls under
any of the following items, the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment
shall rescind the designation and publicize the rescission without delay:
(i) Where the chemical substance requiring priority assessment is designated as a
class I specified chemical substance, a class II specified chemical substance
(limited to cases where it falls under all of the items of paragraph (3) of Article 2)
or a monitoring chemical substance
(ii) Where the chemical substance requiring priority assessment falls under any of
the following (a) through (d) based on the submission of materials set forth in
paragraph (1) of the preceding Article, the report set forth in paragraph (2) of
said Article or on knowledge that has been otherwise obtained and the status of
its manufacture, import, use, etc.:
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Provisional translation (ver. November 12 2010)
(a) Where said chemical substance requiring priority assessment is designated as
a class II specified chemical substance falling under item (i) of paragraph (3) of
Article 2, when it is found that said chemical substance requiring priority
assessment is not likely to cause damage to the inhabitation and/or growth of
flora and fauna in the human living environment by causing environmental
pollution
(b) Where said chemical substance requiring priority assessment is designated as
a class II specified chemical substance falling under item (ii) of paragraph (3) of
Article 2, when it is found that said chemical substance requiring priority
assessment is not likely to cause damage to human health by causing
environmental pollution
(c) Where said chemical substance requiring priority assessment is designated as a
class II specified chemical substance falling under any of the items of paragraph
(3) of Article 2, when it is found that said chemical substance requiring priority
assessment falls under an item other than said item
(d) Where it is found that said chemical substance requiring priority assessment is
not likely to cause either damage to human health or damage to the inhabitation
and/or growth of flora and fauna in the human living environment by causing
environmental pollution
(Provision of Information)
Article 12 Where a person who engages in the business of manufacturing a
chemical substance requiring priority assessment, a person who uses a chemical
substance requiring priority assessment as his/her business and any other person
who handles a chemical substance requiring priority assessment as his/her
business (hereinafter collectively referred to as a "business operator handling a
chemical substance requiring priority assessment") transfers or provides a chemical
substance requiring priority assessment to another business operator, he/she shall
endeavor to provide information to the other party to whom he/she makes the
transfer or provision to the effect that the name of said chemical substance
requiring priority assessment and the substance to be transferred or provided is a
chemical substance requiring priority assessment.
Chapter V Regulations, etc. Concerning Class I Specified Chemical Substances
Section 1 Measures Concerning Monitoring Chemical Substances
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(Notification of the Quantity of Manufacture, etc.)
Article 13 (1) A person who has manufactured or imported any monitoring chemical
substance shall, each fiscal year, notify the Minister of Economy, Trade and
Industry of the quantity of manufacture or the quantity of import in the preceding
fiscal year and other matters specified by Ordinance of the Ministry of Economy,
Trade and Industry for each monitoring chemical substance, pursuant to the
provisions of Ordinance of the Ministry of Economy, Trade and Industry; provided,
however, that this shall not apply to the case where the person has manufactured
or imported a monitoring chemical substance for testing and research purposes.
(2) The Minister of Economy, Trade and Industry shall publicize, each fiscal year,
the sum of the quantity of manufacture and quantity of import in the preceding
fiscal year to which the notification under the preceding paragraph pertains for
each monitoring chemical substance; provided, however, that this shall not apply to
the case where the sum of the quantity of manufacture and quantity of import for
one monitoring chemical substance is less than the quantity specified by Ordinance
of the Ministry of Economy, Trade and Industry.
(Study of Hazardous Properties of Monitoring Chemical Substances)
Article 14 (1) In the case where the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment
find sufficient reason to suspect that any single monitoring chemical substance falls
under any of the items of paragraph (2) of Article 2, if they have found it necessary
to make a determination as to whether or not said monitoring chemical substance
falls under any of the items of said paragraph since said monitoring chemical
substance is expected to poses a risk of causing environmental pollution if said
monitoring chemical substance falls under any of the items of said paragraph, in
view of the state of its manufacture, import, use, etc., they may instruct pursuant to
the provisions of Ordinance of the Ministry of Health, Labour and Welfare,
Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the
Ministry of the Environment a person engages in the business of manufacturing or
importing of said monitoring chemical substance (including a person who engaged
in such business and who is specified by Ordinance of the Ministry of Economy,
Trade and Industry) to conduct a study of the hazardous properties specified by
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
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Provisional translation (ver. November 12 2010)
Environment (which means a study on the effects of said chemical substance on
human health or on the life and/or growth of predator animals at higher trophic
level if ingested continuously; the same shall apply in paragraph (3)) and to report
the results thereof.
(2) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have received a report
under the preceding paragraph, they shall make a determination as to whether or
not the monitoring chemical substance to which said report pertains falls under any
one of the items of paragraph (2) of Article 2 and notify the result thereof to the
person who has made the report.
(3) When the Minister of Economy, Trade and Industry finds it particularly
necessary for ensuring that the expenses for the study of the hazardous properties
to which the instruction under the provisions of paragraph (1) pertains are shared
out fairly among the business operators concerned, he/she may establish standards
concerning the method and proportions of the sharing of the expenses required for
said study of the hazardous properties.
(Rescission of Designation as Monitoring Chemical Substance)
Article 15 When the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment find that a
monitoring chemical substance falls under either of the following items, they shall
rescind the designation and publicize to that effect without delay:
(i) Where said chemical substance is designated as a class I specified chemical
substance
(ii) Where said chemical substance is found not to fall under any of the items of
paragraph (2) of Article 2, based on a report under paragraph (1) of the preceding
Article or on knowledge that has been otherwise obtained
(Provision of Information)
Article 16 Where a person who engages in the business of manufacturing a
monitoring chemical substance, a person who uses a monitoring chemical substance
as his/her business and any other person who handles a monitoring chemical
substance as his/her business (hereinafter collectively referred to as a "business
operator handling a monitoring chemical substance") transfers or provides a
monitoring chemical substance to another business operator, he/she shall endeavor
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Provisional translation (ver. November 12 2010)
to provide information to the other party to whom he/she makes the transfer or
provision to the effect that the name of said monitoring chemical substance and the
substance to be transferred or provided is a monitoring chemical substance.
Section 2 Regulations Concerning Class I Specified Chemical Substances
(Permission to Manufacture)
Article 17 (1) A person who intends to operate a business of manufacturing a class I
specified chemical substance shall obtain permission from the Minister of Economy,
Trade and Industry for each class I specified chemical substance and for each place
of business.
(2) A person who intends to obtain permission under the preceding paragraph shall
submit a written application stating the following matters to the Minister of
Economy, Trade and Industry:
(i) The name and domicile, and in the case of a juridical person the name of the
representative person
(ii) The location of the place of business
(iii) The name of the class I specified chemical substance
(iv) The structure and capacity of the manufacturing equipment
(3) Where the Minister of Economy, Trade and Industry has granted permission
under paragraph (1), he/she shall notify the Minister of the Environment to that
effect without delay.
Article 18 No person other than one who has obtained permission under paragraph
(1) of the preceding Article shall manufacture a class I specified chemical
substance; provided, however, that this shall not apply to the case where a person
manufactures a class I specified chemical substance for testing and research
purposes.
(Disqualification Clause)
Article 19 Permission under paragraph (1) of Article 17 shall not be granted to a
person who falls under any of the following items:
(i) A person who has been sentenced to a fine or severer punishment for violation of
this Act or any order based on this Act where two years have yet to elapse since the
day on which execution of the sentence has been completed or the sentence has
become no longer applicable
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Provisional translation (ver. November 12 2010)
(ii) A person whose permission has been rescinded pursuant to the provisions of
Article 33 and for whom two years have yet to elapse since the date of the rescission
(iii) An adult ward
(iv) A juridical person where the officers who carry out its operations include a
person(s) who falls under any of the preceding three items
(Standards for Permission)
Article 20 The Minister of Economy, Trade and Industry shall not grant permission
under paragraph (1) of Article 17, unless he/she finds that the application for
permission under said paragraph conforms to the following items:
(i) The permission, if granted, shall not result in the capacity to manufacture said
class I specified chemical substance excessively in light of the demand for said class
I specified chemical substance
(ii) The manufacturing equipment shall conform to the technical standards
specified by Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of
the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment.
(iii) The applicant shall have a sufficient fiscal basis and technical capacity to
implement the business appropriately.
(Permission for Changes, etc.)
Article 21 (1) A person who has obtained permission under paragraph (1) of Article
17 (hereinafter referred to as a "permitted manufacturer") shall receive the
permission of the Ministry of Economy, Trade and Industry if he/she intends to
make changes to the matters set forth in item (iv) of paragraph (2) of said Article;
provided, however, that this shall not apply to the case where a person intends to
make minor changes specified by Ordinance of the Ministry of Economy, Trade and
Industry.
(2) Where a permitted manufacturer has made changes to the matters set forth in
item (i) or (ii) of paragraph (2) of Article 17 or has made minor changes specified by
Ordinance of the Ministry of Economy, Trade and Industry as set forth in the
proviso to the preceding paragraph, he/she shall notify the Minister of Economy,
Trade and Industry to that effect without delay.
(3) The provisions of the preceding Article shall apply mutatis mutandis to the
permission under paragraph (1).
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Provisional translation (ver. November 12 2010)
(4) The provisions of paragraph (3) of Article 17 shall apply mutatis mutandis to the
permission under paragraph (1) and the notification under paragraph (2).
(Permission to Import)
Article 22 (1) A person who intends to import a class I specified chemical substance
shall obtain permission from the Minister of Economy, Trade and Industry;
provided, however, that this shall not apply to the case where a person intends to
import a class I specified chemical substance for testing and research purposes.
(2) A person who intends to obtain permission under the preceding paragraph shall
submit a written application stating the following matters to the Minister of
Economy, Trade and Industry:
(i) The name and domicile, and in the case of a juridical person the name of the
representative person
(ii) The name of the class I specified chemical substance
(iii) The import quantity
(3) The provisions of paragraph (3) of Article 17 shall apply mutatis mutandis to the
permission under paragraph (1).
(Standards for Permission, etc.)
Article 23 (1) Where the Minister of Economy, Trade and Industry has received an
application for permission under paragraph (1) of the preceding Article, he/she
shall not grant permission under said paragraph unless he/she finds that the
import of the class I specified chemical substance to which said application pertains
is necessary for meeting the demand for said class I specified chemical substance.
(2) The provisions of Article 19 shall apply mutatis mutandis to the permission
under paragraph (1) of the preceding Article.
(Restrictions on Import of Products)
Article 24 (1) No person shall import any product that is specified by Cabinet Order
and in which a class I specified chemical substance is used (hereinafter referred to
as a "product using a class I specified chemical substance").
(2) The Cabinet Order under the preceding paragraph shall be established for each
class I specified chemical substance by giving consideration to such matters as the
circumstances of the use of said class I specified chemical substance overseas.
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Provisional translation (ver. November 12 2010)
(Restrictions on Use)
Article 25 No person shall use a class I specified chemical substance for any usages
other than those specified by Cabinet Order for each class I specified chemical
substance as being compliant with the following requirements; provided, however,
that this shall not apply to the case where a person uses a class I specified chemical
substance for testing and research purposes:
(i) It shall be difficult to substitute said chemical substance with any other
substance with regard to said usage.
(ii) It shall not be likely to pose a risk of causing damage to human health or
damage to the inhabitation and/or growth of flora and fauna in the human living
environment by causing environmental pollution attributable to said class I
specified chemical substance that is used for said usage.
(Notification of Use)
Article 26 (1) A person who intends to use a class I specified chemical substance as
his/her business shall notify the competent minister of the following matters, in
advance, for each place of business; provided, however, that this shall not apply to
the case where a person intends to use a class I specified chemical substance as
his/her business for testing and research purposes:
(i) The name and domicile, and in the case of a juridical person the name of the
representative person
(ii) The location of the place of business
(iii) The name of the class I specified chemical substance and the usage
(2) Where a person who has given a notification under the preceding paragraph
(hereinafter referred to as a "notifying user") has made any changes to the matters
under the items of the preceding paragraph, he/she shall notify the competent
minister to that effect without delay.
(3) The provisions of paragraph (3) of Article 17 shall apply mutatis mutandis to the
notification under the preceding two paragraphs.
(Succession)
Article 27 (1) Where a permitted manufacturer, a person who has obtained
permission under paragraph (1) of Article 22 (hereinafter referred to as a
"permitted importer"), or a notifying user has become subject to inheritance or a
merger, the heir (where there are two or more heirs and an heir who should succeed
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Provisional translation (ver. November 12 2010)
to the business has been selected by their unanimous consent, such person who has
been selected) or the juridical person surviving the merger or the juridical person
incorporated by the merger shall succeed to the status of the permitted
manufacturer, the permitted importer, or the notifying user.
(2) A person who has succeeded to the status of permitted manufacturer, permitted
importer, or notifying user pursuant to the provisions of the preceding paragraph
shall notify the Minister of Economy, Trade and Industry, in the case of a person
who has succeeded to the status of permitted manufacturer or a permitted importer,
and notify the competent minister, in the case of a person who has succeeded to the
status of notifying user, to that effect without delay together with a document
proving such fact.
(3) The provisions of paragraph (3) of Article 17 shall apply mutatis mutandis to the
notification under the preceding paragraph. In this case, the term "Minister of
Economy, Trade and Industry" in paragraph (3) of said Article shall be deemed to
be replaced with "Minister of Economy, Trade and Industry or the competent
minister."
(Obligation of Conformity to Standards)
Article 28 (1) A permitted manufacturer shall maintain its manufacturing
equipment in such a manner as to conform to the technical standards specified by
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment under item (ii) of Article 20.
(2) Where a permitted manufacturer, a person who uses a class I specified chemical
substance or any product that is specified by Cabinet Order and in which a class I
specified chemical substance is used (hereinafter collectively referred to as a "class
I specified chemical substance, etc.") as his/her business or any other person who
handles a class I specified chemical substance, etc. as his/her business (hereinafter
referred to as a "business operator handling a class I specified chemical substance,
etc.") handles a class I specified chemical substance, etc., he/she shall follow the
technical standards specified by ordinance of the competent ministry.
(Labeling, etc.)
Article 29 (1) For each class I specified chemical substance, the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the
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Provisional translation (ver. November 12 2010)
Minister of the Environment shall determine and publicize the labeling information
with respect to measures, etc., for preventing the environmental pollution
attributable to said class I specified chemical substances, to be indicated on
containers, packaging, or invoices for the class I specified chemical substance, etc.
(2) Where a business operator handling a class I chemical substance, etc. transfers
or provides a class I specified chemical substance, etc., he/she shall implement
labeling, pursuant to the provisions of Ordinance of the Ministry of Health, Labour
and Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and
Ordinance of the Ministry of the Environment, in accordance with the public notice
given pursuant to the provisions of the preceding paragraph.
(Order for Improvement)
Article 30 (1) Where the Minister of Economy, Trade and Industry finds that the
manufacturing equipment of a permitted manufacturer does not conform to the
technical standards specified by Ordinance of the Ministry of Health, Labour and
Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance
of the Ministry of the Environment under item (ii) of Article 20, he/she may order
said permitted manufacturer to repair or remodel the manufacturing equipment or
to take any other necessary measures.
(2) Where the competent minister finds that a business operator handling a class I
chemical substance, etc. fails to use a class I specified chemical substance, etc. in
accordance with the technical standards specified by ordinance of the competent
ministry under paragraph (2) of Article 28, he/she may order said business operator
handling the class I chemical substance, etc. to take the necessary measures for
improving the method of handling the class I specified chemical substance, etc.
(3) Where any business operator handling a class I chemical substance, etc. violates
the provisions of paragraph (2) of the preceding Article, the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment may order said business operator handling the class I
chemical substance, etc. to implement labeling in accordance with the public notice
given pursuant to the provisions of paragraph (1) of said Article.
(Books)
Article 31 (1) A permitted manufacturer shall keep books and enter therein the
items specified by Ordinance of the Ministry of Economy, Trade and Industry with
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Provisional translation (ver. November 12 2010)
respect to the manufacture of the class I specified chemical substance.
(2) The books under the preceding paragraph shall be preserved in accordance with
the provisions of Ordinance of the Ministry of Economy, Trade and Industry.
(3) The provisions of the preceding two paragraphs shall apply mutatis mutandis to
a notifying user. In this case, the term "Ordinance of the Ministry of Economy,
Trade and Industry" in these provisions shall be deemed to be replaced with
"ordinance of the competent ministry."
(Notification of Abolition)
Article 32 (1) Where a permitted manufacturer or a notifying user has abolished
his/her business, he/she shall notify the Minister of Economy, Trade and Industry,
in the case of a permitted manufacturer, and notify the competent minister, in the
case of a notifying user, to that effect without delay.
(2) Where a permitted manufacturer has discontinued his/her business, the relevant
permission shall lose its effect.
(3) The provisions of paragraph (3) of Article 17 shall apply mutatis mutandis to the
notification under paragraph (1). In this case, the term "Minister of Economy,
Trade and Industry" in paragraph (3) of said Article shall be deemed to be replaced
with "Minister of Economy, Trade and Industry or the competent minister."
(Rescission of Permission, etc.)
Article 33 (1) Where a permitted manufacturer falls under any of the following items,
the Minister of Economy, Trade and Industry may rescind the relevant permission
or order the suspension of business for a specified period:
(i) Where the permitted manufacturer has fallen under item (i), (iii) or (iv) of Article
19
(ii) Where the permitted manufacturer has made any changes to matters for which
permission must be obtained pursuant to the provisions of paragraph (1) of Article
21 without obtaining such permission
(iii) Where the permitted manufacturer has violated an order under the provisions
of paragraph (1) of Article 30
(iv) Where the permitted manufacturer has violated the conditions under
paragraph (1) of Article 40
(2) Where a permitted importer has fallen under item (i), (iii) or (iv) of Article 19 as
applied mutatis mutandis pursuant to paragraph (2) of Article 23, the Minister of
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Provisional translation (ver. November 12 2010)
Economy, Trade and Industry may rescind the relevant permission, but only prior
to the import of the class I specified chemical substance to which the permission
pertains.
(3) The provisions of paragraph (3) of Article 17 shall apply mutatis mutandis to the
rescission of permission under the preceding two paragraphs or an order to suspend
business under paragraph (1).
(Order to Take Measures in Connection with Designation, etc. of Class I Specified
Chemical Substances)
Article 34 (1) Where any chemical substance has been designated as a class I
specified chemical substance, if the competent ministers find it particularly
necessary for preventing the spread of environmental pollution attributable to said
chemical substance, they may, to the extent necessary, order persons who were
operating the business of manufacturing or importing said chemical substance or a
product in which said chemical substance is used at the time of said designation to
make efforts to recall said chemical substance or said product and to take any other
measures necessary for preventing the spread of environmental pollution
attributable to said chemical substance.
(2) Where any product has been designated as a product using a class I specified
chemical substance, if the competent ministers find it particularly necessary for
preventing the spread of environmental pollution attributable to the class I
specified chemical substance being used in said product, they may, to the extent
necessary, order persons who were operating the business of importing said product
at the time of said designation to make efforts to recall said product which they
imported and to take any other measures necessary for preventing the spread of
environmental pollution attributable to the class I specified chemical substance
being used in said product.
(3) In any of the cases listed in the following items, if the competent ministers find it
particularly necessary for preventing the spread of environmental pollution
attributable to the class I specified chemical substance, they may, to the extent
necessary, order the persons respectively specified in those items to make efforts to
recall the class I specified chemical substance which they manufactured, imported
or used or the product using a class I specified chemical substance which they
imported and to take any other measures necessary for preventing the spread of
environmental pollution attributable to said class I specified chemical substance:
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Provisional translation (ver. November 12 2010)
(i) Where a class I specified chemical substance has been manufactured in violation
of the provisions of Article 18: the person who has manufactured said class I
specified chemical substance
(ii) Where a class I specified chemical substance has been imported in violation of
the provisions of paragraph (1) of Article 22: the person who has imported said class
I specified chemical substance
(iii) Where a product using a class I specified chemical substance has been imported
in violation of the provisions of paragraph (1) of Article 24: the person who has
imported said product using a class I specified chemical substance
(iv) Where a class I specified chemical substance has been used in violation of the
provisions of Article 25: the person who has used said class I specified chemical
substance
Chapter VI Regulations Concerning Class II Specified Chemical Substances
(Notification, etc. of the Planned Quantity of Manufacture)
Article 35 (1) A person who manufactures or imports a class II specified chemical
substance, or a person who imports a product that is specified by Cabinet Order and
in which a class II specified chemical substance is used (hereinafter referred to as a
"product using a class II specified chemical substance") shall, for each class II
specified chemical substance or each product using a class II specified chemical
substance, notify the Minister of Economy, Trade and Industry, each fiscal year, of
the planned quantity of manufacture or planned quantity of import of said class II
specified chemical substance or the planned quantity of import of said product
using a class II specified chemical substance, and other matters specified by
Ordinance of the Ministry of Economy, Trade and Industry, pursuant to the
provisions of Ordinance of the Ministry of Economy, Trade and Industry; provided,
however, that this shall not apply to the case where a person manufactures or
imports a class II specified chemical substance or imports a product using a class II
specified chemical substance for testing and research purposes.
(2) Where a person who has given a notification under the provisions of the
preceding paragraph has made changes to the matters to which the notification
under said paragraph pertains, he/she shall notify the Minister of Economy, Trade
and Industry to that effect without delay.
(3) A person who has given a notification under the provisions of paragraph (1) shall
not manufacture or import in excess of the planned quantity of manufacture or the
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Provisional translation (ver. November 12 2010)
planned quantity of import to which said notification pertains (where a notification
of change under the provisions of the preceding paragraph has been given, such
quantity after the change).
(4) In the case of the occurrence of a situation where it is necessary to restrict the
manufacture or import of a class II specified chemical substance or the import of a
product using a class II specified chemical substance in order to prevent damage to
human health or to the inhabitation and/or growth of flora and fauna in the human
living environment through environmental pollution attributable to said Class II
Chemical Substance, in light of the state of the manufacture, import, use, etc. of
said class II specified chemical substance or product using a class II specified
chemical substance as well as the effects, etc. of the implementation of measures
under the provisions of the following Article and Article 37 taken in relation to said
class II specified chemical substance, the Minister of Health, Labour and Welfare,
the Minister of Economy, Trade and Industry, and the Minister of the Environment
shall make an acknowledgement to that effect, pursuant to the provisions of
Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the
Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the
Environment.
(5) Where the acknowledgment under the preceding paragraph has been made, the
Minister of Economy, Trade and Industry may order the person who has given a
notification under the provisions of paragraph (1) to change the planned quantity of
manufacture or the planned quantity of import to which said notification pertains
(where a notification of change under the provisions of paragraph (2) has been
given, the quantity after the change). In this case, the provisions of paragraph (3)
shall apply mutatis mutandis.
(6) A person who has given a notification under the provisions of paragraph (1) shall,
each fiscal year, notify the Minister of Economy, Trade and Industry of the quantity
of manufacture or the quantity of import in the preceding fiscal year and other
matters specified by Ordinance of the Ministry of Economy, Trade and Industry, for
each class II specified chemical substance or each product using a class II specified
chemical substance, pursuant to the provisions of Ordinance of the Ministry of
Economy, Trade and Industry.
(7) The provisions of paragraph (2) of Article 24 shall apply mutatis mutandis to the
Cabinet Order set forth in paragraph (1).
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(Publication of Technical Guidelines, etc.)
Article 36 (1) For each class II specified chemical substance, the competent ministers
shall publish technical guidelines on the measures to be taken by persons who
operate the business of manufacturing said class II specified chemical substance,
persons who use said class II specified chemical substance or products that are
specified by Cabinet Order in which said class II specified chemical substance is
used (hereinafter collectively referred to as a "class II specified chemical substance,
etc.") as their businesses, and any other persons who handle said class II specified
chemical substance, etc. as their businesses (hereinafter referred to as a "business
operator handling a class II specified chemical substance, etc." in this Section) in
order to prevent environmental pollution attributable to the class II specified
chemical substance they handle.
(2) Where the competent ministers have published technical guidelines pursuant to
the provisions of the preceding paragraph, if they find it necessary, they may make
a necessary recommendation to a business operator handling a class II specified
chemical substance, etc. pertaining to said class II specified chemical substance
with regard to the measures that should be taken for preventing environmental
pollution attributable to said class II specified chemical substance, by taking said
technical guidelines into consideration.
(Labeling, etc.)
Article 37 (1) For each class II specified chemical substance, the Minister of Health,
Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment shall determine and publicize the labeling information
with respect to measures, etc., for preventing environmental pollution attributable
to said class II specified chemical substances, to be indicated on containers,
packaging, or invoices for the class II specified chemical substance, etc..
(2) Where a business operator handling a class II specified chemical substance, etc.
transfers or provides a class II specified chemical substance, etc.., he/she shall,
pursuant to the provisions of Ordinance of the Ministry of Health, Labour and
Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance
of the Ministry of the Environment, implement labeling in accordance with the
public notice given pursuant to the provisions of the preceding paragraph.
(3) In the case where any business operator handling a class II specified chemical
substance, etc. has violated the provisions of the preceding paragraph, the Minister
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of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and
the Minister of the Environment may recommend said business operator handling a
class II specified chemical substance, etc. to implement labeling in accordance with
the public notice given pursuant to the provisions of paragraph (1).
Chapter VII Miscellaneous Provisions
(Recommendations)
Article 38 (1) Where the competent ministers find a sufficient reason to suspect that
a chemical substance other than a class I specified chemical substance falls under
any of the items of paragraph (2) of Article 2, they may, to the extent necessary for
preventing the spread of environmental pollution attributable to said chemical
substance, make any necessary recommendation concerning a restriction on the
manufacture, import, use, etc. of said chemical substance to a person operating the
business of manufacturing or importing said chemical substance or to a person
using said chemical substance as his/her business.
(2) Where the competent ministers find a sufficient reason to suspect that a chemical
substance other than a class II specified chemical substance falls under the
requirements set forth in paragraph (3) of Article 2, they may, to the extent
necessary for preventing the spread of environmental pollution attributable to said
chemical substance, make any necessary recommendation concerning a restriction
on the manufacture or import of said chemical substance or an improvement in the
method of use of said chemical substance to a person operating the business of
manufacturing or importing said chemical substance or to a person using said
chemical substance as his/her business.
(Guidance and Advice)
Article 39 Where the competent ministers find it particularly necessary for
preventing environmental pollution attributable to a chemical substance requiring
priority assessment, a monitoring chemical substance or a class II specified
chemical substance, they may provide a business operator handling said chemical
substance requiring priority assessment pertaining to said chemical substance
requiring priority assessment, a business operator handling a monitoring chemical
substance, etc. pertaining to said monitoring chemical substance or a business
operator handling class II specified chemical substance, etc. pertaining to said class
II specified chemical substance with the necessary guidance and advice concerning
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the method of handling the each respective chemical substance.
(Conditions for Permission)
Article 40 (1) Conditions may be attached to any permission, and the conditions
attached may be changed.
(2) The conditions under the preceding paragraph shall be limited to the minimum
required for ensuring the secure implementation of the matters to which the
permission pertains, and shall not impose undue obligations on the person who
obtains the permission.
(Reporting, etc., of Hazardous Properties)
Article 41 (1) A person operating the business of manufacturing or importing any
chemical substance requiring priority assessment, any monitoring chemical
substance, any class II specified chemical substance or any general chemical
substance (hereinafter referred to as a "substance subject to reporting") shall, when
he/she has conducted tests for the items to be tested prescribed in paragraph (5) of
Article 4 or for the studies of hazardous properties prescribed in paragraph (2) of
Article 10 or paragraph (1) of Article 14 (including those cases in which knowledge
equivalent to that which would be obtained from said tests [limited to knowledge
that is not publicly known] has been obtained) with regard to the substance subject
to reporting that he/she has manufactured or imported and if he/she has obtained,
as a result thereof, knowledge specified by Ordinance of the Ministry of Health,
Labour and Welfare, Ordinance of the Ministry of Economy, Trade and Industry,
and Ordinance of the Ministry of the Environment that indicates that that the
substance subject to reporting possesses the following properties, he/she shall
report to the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment to that effect and provide
the details of said knowledge, pursuant to the provisions of Ordinance of the
Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy,
Trade and Industry, and Ordinance of the Ministry of the Environment; provided,
however, that this shall not apply to cases where said person has obtained said
knowledge as a result of a study of hazardous properties to which an instruction
under the provisions of paragraph (2) of Article 10 or paragraph (1) of Article 14
pertains and is reporting the details of said knowledge pursuant to these
provisions:
(i) The substance subject to reporting is not likely to undergo a chemical
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transformation through natural processes
(ii) The substance subject to reporting is bioaccumulative.
(iii) The substance subject to reporting poses a risk of impairing human health if
ingested continuously.
(iv) The substance subject to reporting poses a risk of interfering with the
inhabitation and/or growth of flora and fauna.
(v) In the case that the substance subject to reporting is likely to undergo a
chemical transformation through natural processes, it is one where the chemical
substance (including an element) generated by the chemical transformation
through natural processes falls under any of the preceding items.
(2) The provisions of the main clause of the preceding paragraph shall apply mutatis
mutandis to a person who engages in the business of manufacturing or importing a
new chemical substance pertaining to the confirmation set forth in items (v) or (vi)
of paragraph (1) of Article 3 or paragraph (4) of Article 5 (limited to a person who
obtains said confirmation), a person who engages in the business of manufacturing
or importing a new chemical substance pertaining to the notification prescribed in
paragraph (4) of Article 4 (including cases where it is applied mutatis mutandis
pursuant to paragraph (9) of Article 5 by replacing the terms) (limited to a person
who obtains said confirmation) and a person who imports a new chemical substance
pertaining to the notification prescribed in paragraph (4) of Article 4 as applied
mutatis mutandis pursuant to paragraph (2) of Article 7 from another person who
obtains said notification.
(3) Where a person who engages in the business of manufacturing or importing a
chemical substance requiring priority assessment, a monitoring chemical substance
or a class II specified chemical substance has knowledge of the composition,
properties, etc. of the chemical substance requiring priority assessment, the
monitoring chemical substance or the class II specified chemical substance that
he/she has manufactured or imported as specified by Ordinance of the Ministry of
Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade and
Industry, and Ordinance of the Ministry of the Environment (the knowledge is
limited to that which is not publicly known, and excluding that which is to be
reported pursuant to the provisions of paragraph (2) of Article 10, paragraph (1) of
Article 14 or paragraph (1) of this Article), he/she shall endeavor to report to that
effect and the details of said knowledge to the Minister of Health, Labour and
Welfare, the Minister of Economy, Trade and Industry, and the Minister of the
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Environment, pursuant to the provisions of Ordinance of the Ministry of Health,
Labour and Welfare, Ordinance of the Ministry of Economy, Trade and Industry,
and Ordinance of the Ministry of the Environment.
(4) Where the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment have found, based on a
report under paragraph (1) (including in cases as applied mutatis mutandis
pursuant to paragraph (2)) or the preceding paragraph or knowledge that has been
otherwise obtained, that any substance subject to reporting or any new chemical
substance pertaining to the report set forth in paragraph (1) as applied mutatis
mutandis pursuant to paragraph (2) falls under any of the items of paragraph (2),
any of the items of paragraph (3), any of the items of paragraph (4) of Article 2, they
shall make a designation as a class I specified chemical substance and take any
other necessary measures without delay.
(Reporting on the Status of Handling)
Article 42 The competent ministers may request that a business operator handling
a chemical substance requiring priority assessment, a business operator handling a
monitoring chemical substance or a business operator handling a class II specified
chemical substance, etc. report the status of their handling of a chemical substance
requiring priority assessment, a monitoring chemical substance or a class II
chemical substance, etc.
(Collection of Reports)
Article 43 (1) The Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment may, to the extent
necessary for enforcing this Act, have a person who has received a confirmation
under items (iv) through (vi) of paragraph (1) of Article 3 or under paragraph (4) of
Article 5 make a report concerning his/her operations.
(2) The Minister of Economy, Trade and Industry or the competent minister may, to
the extent necessary for enforcing this Act, have, respectively, a permitted
manufacturer, a permitted importer, a business operator handling class I specified
chemical substance, etc. or a person who has given a notification under the
provisions of paragraph (1) of Article 35 make a report concerning his/her
operations.
(3) The competent ministers may, to the extent necessary for enforcing this Act, have
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a person prescribed in Article 34 or Article 38 make a report concerning his/her
operations.
(On-Site Inspections, etc.)
Article 44 (1) The Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment may, to the extent
necessary for enforcing this Act, have their officials enter the offices or any other
places of business of a person who has received a confirmation under items (iv)
through (vi) of paragraph (1) of Article 3 or paragraph (4) of Article 5, inspect the
books, documents, and any other articles, ask questions of the relevant persons, or
sample the smallest quantity of chemical substances necessary for testing.
(2) The Minister of Economy, Trade and Industry or the competent minister may, to
the extent necessary for enforcing this Act, have their officials enter the offices or
any other places of business of a permitted manufacturer, a permitted importer, a
business operator handling a class I specified chemical substance, etc. or a person
who has given a notification under the provisions of paragraph (1) of Article 35,
inspect the books, documents, and any other articles, ask questions of the relevant
persons, or sample the smallest quantity of chemical substances necessary for
testing.
(3) The competent ministers may, to the extent necessary for enforcing this Act, have
their officials enter the offices or any other places of business of a person prescribed
in Article 34, inspect the books, documents and any other articles, ask questions of
the relevant persons, or sample the smallest quantity of chemical substances
necessary for testing.
(4) Where an official enters a site pursuant to the provisions of the preceding three
paragraphs, he/she shall carry an identification card and present it to the relevant
persons.
(5) Where the Minister of Economy, Trade and Industry finds it necessary, he/she
may have the National Institute of Technology and Evaluation (hereinafter referred
to as "NITE") conduct the on-site inspection, questioning, or taking of samples
under the provisions of paragraphs (1) through (3).
(6) Where the Minister of Economy, Trade and Industry has NITE conduct the
on-site inspection, questioning, or taking of samples pursuant to the provisions of
the preceding paragraph, he/she shall instruct NITE to conduct such on-site
inspection, questioning or taking of samples by indicating the place of said on-site
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inspection and any other necessary matters.
(7) Where NITE has conducted the on-site inspection, questioning, or taking of
samples prescribed in paragraph (5), in accordance with the instructions under the
preceding paragraph, it shall report the results thereof to the Minister of Economy,
Trade and Industry.
(8) Where an official of NITE enters a site pursuant to the provisions of paragraph
(5), he/she shall carry an identification card and present it to the relevant persons.
(9) The authority for the on-site inspection, questioning, and taking of samples
under the provisions of paragraphs (1) through (3) shall not be construed as an
authority granted for the purpose of criminal investigation.
(Orders to NITE)
Article 45 Where the Minister of Economy, Trade and Industry finds it necessary
for securing the proper implementation of operations relating to the on-site
inspection, questioning, or taking of samples prescribed in paragraph (5) of the
preceding Article, he/she may issue the necessary orders concerning said operations
to NITE.
(Request for Examination Regarding the Taking of Samples by NITE)
Article 46 Any person who is dissatisfied with the taking of samples by NITE may
file a request for examination under the Administrative Appeals Act (Act No. 160 of
1962) with the Minister of Economy, Trade and Industry.
(Notification)
Article 47 Where the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, or the Minister of the Environment obtains
knowledge, etc. of the properties, etc. of a chemical substance based on this Act, in
order to contribute to measures based on another Act concerning said chemical
substance, he/she shall notify. the Ministers governing the offices responsible for
the enforcement of said other Act of the details of said knowledge, etc where
needed.
(Requests)
Article 48 Where the Minister of the Environment finds it necessary to achieve the
purpose of this Act, he/she may request the ministers listed in the following items
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to take the measures set forth respectively in those items:
(i) An order prescribed in paragraph (1) of Article 30: the Minister of Economy,
Trade and Industry
(ii) An order prescribed in paragraph (2) of Article 30: the competent minister
(Fees)
Article 49 A person who intends to obtain permission under paragraph (1) of
Article 17, paragraph (1) of Article 21, or paragraph (1) of Article 22 shall pay a fee
of the amount specified by Cabinet Order in consideration of the actual expenses.
(Special Provisions on Hearings)
Article 50 (1) Where the Minister of Economy, Trade and Industry intends to issue
an order under the provisions of paragraph (1) of Article 33, he/she shall hold a
hearing, regardless of the category of the procedure for hearing statements of
opinion under the provisions of paragraph (1) of Article 13 of the Administrative
Procedure Act (Act No. 88, 1993).
(2) The proceedings on the date of a hearing to which a disposition under the
provisions of Article 33 pertains shall be held in public.
(3) The presiding official of a hearing under the preceding paragraph shall, where an
interested person to which said disposition pertains has requested to intervene in
the hearing process pursuant to the provisions of paragraph (1) of Article 17 of the
Administrative Procedure Act, permit said person to do so.
(Hearing of Opinion in Procedures for Objection)
Article 51 (1) A decision on an objection against any disposition under the provisions
of this Act (excluding a decision to dismiss the objection) shall be made after giving
an advance notice with a reasonable period of time to the person to which the
disposition pertains and after a public hearing of opinions.
(2) The date, location, and details of the case shall be indicated in a prior notice
under the preceding paragraph.
(3) At a hearing of opinions under paragraph (1), the person to which said disposition
pertains and the interested person shall be given an opportunity to produce
evidence and state their opinions with regard to the case.
(Transitional Measures)
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Article 52 Where an order is established, revised, or abolished based on the
provisions of this Act, required transitional measures (including transitional
measures concerning penal provisions) may be specified by said order to the extent
found reasonably necessary in line with the establishment, revision or abolition
thereof.
(Competent Ministers, etc.)
Article 53 (1) The competent ministers under this Act shall be as follows:
(i) With regard to a notification under the provisions of Article 26, paragraph (2) of
Article 27, or paragraph (1) of Article 32, an order under the provisions of
paragraph (2) of Article 30 (excluding an order given to a permitted manufacturer),
the collection of reports under the provisions of paragraph (2) of Article 43, or the
inspection, questioning, or taking of samples under the provisions of paragraph (2)
of Article 44, the minister having jurisdiction over the business operated by the
person giving such a notification or the person subject to such an order, the
collection of reports or inspection, questioning, or taking of samples
(ii) With regard to an order pursuant to the provisions of paragraph (2) of Article 30
(limited to an order given to a permitted manufacturer), the Minister of Economy,
Trade and Industry
(iii) With regard to an order under the provisions of Article 34, the publication of
technical guidelines under the provisions of paragraph (1) of Article 36, a
recommendation under the provisions of paragraph (2) of said Article or Article 38,
guidance and advice under the provisions of Article 39, the collection of reports
under the provisions of Article 42 or paragraph (3) of Article 43, or the inspection,
questioning or taking of samples under the provisions of paragraph (3) of Article 43,
the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, the Minister of the Environment and the minister having jurisdiction
over the business operated by the person subject to such an order, the publication of
technical guidelines, recommendation, guidance and advice, collection of reports or
inspection, questioning, or taking of samples
(2) Ordinance of the competent ministry under this Act shall be as follows:
(i) With regard to the keeping, entering, and preservation of books under the
provisions of paragraphs (1) and (2) of Article 31 as applied mutatis mutandis
pursuant to paragraph (3) of said Article, an order issued by the minister having
jurisdiction over the business operated by a person using a class I specified
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chemical substance
(ii) With regard to the technical standards under the provisions of paragraph (2) of
Article 28 (excluding the technical standards pertaining to permitted
manufacturers), an order issued by the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, the Minister of the Environment and the
minister having jurisdiction over the business operated by a business operator
handling a class I specified chemical substance, etc.
(iii) With regard to the technical standards under paragraph (2) of Article 28
(limited to the technical standards pertaining to permitted manufacturers), an
order issued by the Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry and the Minister of the Environment.
(Delegation of Authority)
Article 54 The authority of the Minister of the Environment prescribed in this Act
may be delegated to the Director Generals of the Regional Environment Offices,
pursuant to Ordinance of the Ministry of Environment.
(Relationship with Other Acts)
Article 55 The provisions of Article 3, paragraph (1) of Article 7, paragraph (1) of
Article 8 (including in cases as applied mutatis mutandis pursuant to paragraph (2)
of said Article), paragraph (1) of Article 9, paragraphs (1) and (2) of Article 10,
Article 12, paragraph (1) of Article 13, paragraph (1) of Article 14, Article 16,
paragraph (1) of Article 17, Article 18, paragraphs (1) of Article 22, Article 25,
paragraph (1) of Article 26, paragraph (2) of Article 28, paragraph (1) of Article 29,
paragraphs (1) and (3) of Article 34, paragraph (1) of Article 35, paragraph (1) of
Article 36, paragraph (1) of Article 37, Article 38, Article 39, paragraphs (1)
(including in cases as applied mutatis mutandis pursuant to paragraph (2) of
Article 40) and (3) of Article 40 and Article 42 shall not apply to the chemical
substances which constitute the articles listed in the following items; the provisions
of paragraph (1) of Article 24, paragraph (2) of Article 28, paragraph (1) of Article
29 and Article 34 shall not apply to the products listed in the following items in
which class I specified chemical substances are used; the provisions of paragraph
(1) of Article 35, paragraph (1) of Article 36, paragraph (1) of Article 37, Article 39
and Article 42 shall not apply to the articles listed in the following items in which
class II specified chemical substances are used; and the provisions of Article 12,
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Article 16, Article 25, paragraph (1) of Article 26, paragraph (2) of Article 28,
paragraph (1) of Article 29, paragraph (3) of Article 34, paragraph (1) of Article 36,
paragraph (1) of Article 37, Article 38, Article 39 and Article 42 shall not apply to
the use of chemical substances as raw materials for the articles listed in the
following items, but the Acts set forth in the following items shall apply to them
respectively:
(i) Food prescribed in paragraph (1) of Article 4 of the Food Sanitation Act (Act No.
233 of 1947), additives prescribed in paragraph (2) of said Article, containers and
packaging prescribed in paragraph (5) of said Article, toys prescribed in paragraph
(1) of Article 62 of said Act, and detergents prescribed in paragraph (2) of said
Article
(ii) Agricultural chemicals prescribed in paragraph (1) of Article 1-2 of the
Agricultural Chemicals Regulation Act (Act No. 82 of 1948)
(iii) Ordinary fertilizers prescribed in paragraph (2) of Article 2 of the Fertilizers
Regulation Act (Act No. 127 of 1950)
(iv) Feeds prescribed in paragraph (2) of Article 2 of the Act on Safety Assurance
and Quality Improvement of Feeds (Act No. 35 of 1953) and feed additives
prescribed in paragraph (3) of said Article
(v) Drugs prescribed in paragraph (1) of Article 2 of the Pharmaceutical Affairs Act
(Act No. 145 of 1960), quasi-drugs prescribed in paragraph (2) of said Article,
cosmetics prescribed in paragraph (3) of said Article, and medical equipment
prescribed in paragraph (4) of said Article
(Hearing of Opinion of Councils)
Article 56 (1) In the following cases, the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment
shall hear the opinions of the councils, etc., (organizations prescribed in Article 8 of
the National Government Organization Act [Act No. 120 of 1948]; the same shall
apply in the following paragraph) that are specified by Cabinet Order, in advance:
(i) When intending to plan out the establishment or revision of Cabinet Order under
paragraph (2) of Article 2 (excluding the case of intending to plan out such
establishment or revision based on a determination under paragraph (1) or (2) of
Article 4, paragraph (8) of Article 5, or paragraph (2) of Article 14), or when
intending to plan out the establishment or revision of Cabinet Order under
paragraph (3) of Article 2, paragraph (1) of Article 24, Article 25, paragraph (2) of
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Article 28, paragraph (1) of Article 35 or paragraph (1) of Article 36
(ii) When intending to make a designation under paragraph (4) or (5) of Article 2
(excluding the case of intending to make such designation in accordance with the
procedure as prescribed in the following paragraph)
(iii) When intending to make a determination under paragraph (1) or (2) of Article 4,
paragraph (2), (3) or (8) of Article 5, paragraph (3) of Article 10, or paragraph (2) of
Article 14
(iv) When intending to give an instruction under paragraph (2) of Article 10 or
paragraph (1) of Article 14
(v) When intending to make an acknowledgment under paragraph (4) of Article 35
(2) When the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry and the Minister of the Environment judge pursuant to the
provisions of paragraphs (1) or (2) of Article 4 or paragraph (8) of Article 5 that a
new chemical substance subject to the notification set forth in paragraph (1) of
Article 3 falls under any of items (ii) through (iv) of paragraph (1) of Article 4, they
shall hear the opinions of the councils, etc., specified by the Cabinet Order set forth
in the preceding paragraph without delay regarding whether or not it is necessary
to provide the designation set forth in paragraph (5) of Article 2 to said chemical
substance.
Chapter VIII Penal Provisions
Article 57 A person who falls under any of the following items shall be punished by
imprisonment with work for not more than three years or by a fine of not more than
one million yen, or both:
(i) A person who has operated the business of manufacturing a class I specified
chemical substance without obtaining permission under paragraph (1) of Article 17
(ii) A person who has violated the provisions of Article 18, paragraph (1) of Article
24, or Article 25
(iii) A person who has imported a class I specified chemical substance in violation of
the provisions of paragraph (1) of Article 22
(iv) A person who has violated an order to suspend business under the provisions of
paragraph (1) of Article 33
(v) A person who has violated an order under the provisions of paragraph (3) of
Article 34
Article 58 A person who falls under any of the following items shall be punished by
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imprisonment with work for not more than one year or by a fine of not more than
five hundred thousand yen, or both:
(i) A person who has manufactured or imported a new chemical substance in
violation of the provisions of paragraph (1) of Article 3
(ii) A person who has violated the provisions of Article 6
(iii) A person who has violated an instruction under the provisions of paragraph (2)
of Article 10 or paragraph (1) of Article 14
(iv) a person who has manufactured or imported a class II specified chemical
substance or has imported a product using a class II specified chemical substance in
violation of the provisions of paragraph (1) or (3) of Article 35 (including the cases
where it is applied mutatis mutandis pursuant to paragraph (5) of said Article).
Article 59 A person who falls under any of the following items shall be punished by
imprisonment with work for not more than six months or by a fine of not more than
five hundred thousand yen, or both:
(i) A person who has made changes in the structure or capacity of manufacturing
equipment in violation of the provisions of paragraph (1) of Article 21
(ii) A person who has failed to give a notification or has given a false notification in
violation of the provisions of paragraph (1) of Article 26
(iii) A person who has violated an order under the provisions of Article 30 or
paragraph (1) or (2) of Article 34
Article 60 A person who falls under any of the following items shall be punished by
a fine of not more than three hundred thousand yen:
(i) A person who has failed to keep books or make entries in them or has made false
entries in them in violation of the provisions of paragraph (1) of Article 31
(including the cases where it is applied mutatis mutandis pursuant to paragraph
(3) of said Article), or has failed to preserve the books in violation of the provisions
of paragraph (2) of said Article (including the cases where it is applied mutatis
mutandis pursuant to paragraph (3) of said Article)
(ii) A person who has failed to give a notification under the provisions of paragraph
(1) of Article 9, paragraph (1) of Article 13, paragraph (6) of Article 35 or has given
a false notification
(iii) A person who has failed to make a report under the provisions of Article 43 or
has made a false report
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(iv) A person who has refused, obstructed, or evaded an inspection or the taking of
samples under the provisions of paragraphs (1) through (3) of Article 44 or has
refused to answer or has given a false answer to the questioning under these
provisions
Article 61 Where the representative person of a juridical person, or an agent,
employee or any other worker of a juridical person or individual has committed an
act in violation of any of the provisions listed in the following items with regard to
the business of said juridical person or individual, not only the offender shall be
punished but also said juridical person shall be punished by the fine prescribed in
said relevant item or said individual shall be punished by the fine prescribed in the
relevant Article:
(i) Article 57 - A fine of not more than one hundred million yen;
(ii) Item (i), (ii) or (iv) of Article 58 - A fine of not more than five hundred thousand
yen
(iii) Item (iii) of Article 58, Article 59, or the preceding Article - The fine prescribed
in the relevant Article
Article 62 A person who falls under either of the following items shall be punished
by a non-penal fine of not more than two hundred thousand yen:
(i) A person who has failed to give notification under the provisions of paragraph (1)
of Article 8 (including in cases as applied mutatis mutandis pursuant to paragraph
(2) of said Article), paragraph (2) of Article 21, paragraph (2) of Article 26,
paragraph (2) of Article 27, paragraph (1) of Article 32 or paragraph (2) of Article 35
or has given a false notification
(ii) A person who has failed to make a report under the provisions of paragraph (1)
of 41 (including in cases where as applied mutatis mutandis pursuant to paragraph
(2) of said Article)or has submitted a false report
Article 63 In the case where an order under the provisions of Article 45 has been
violated, an officer or officers of NITE who have committed said act in violation
shall be punished by a non-penal fine of not more than two hundred thousand yen.
Supplementary Provisions [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day on which six months have
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elapsed from the day of promulgation; provided, however, that the provisions of the
following Article shall come into effect as from the day of promulgation.
(List of Existing Chemical Substances)
Article 2 (1) The Minister of International Trade and Industry shall prepare a list
(hereinafter referred to as the "list of existing chemical substances") of the names of
chemical substances that were manufactured or imported as a business at the time
of the promulgation of this Act (excluding those that were manufactured or
imported for testing and research purposes and those that were manufactured or
imported as reagents) and give public notice of it within three months from the day
of the promulgation of this Act.
(2) Any person may, when he/she finds it necessary to correct the list of existing
chemical substances of which public notice has been given pursuant to the
provisions of the preceding paragraph, propose to that effect to the Minister of
International Trade and Industry, pursuant to the provisions of Ordinance of the
Ministry of International Trade and Industry, only within one month from the day
of the publication of the list of existing chemical substances.
(3) In the case where a proposal under the preceding paragraph has been made, if
the Minister of International Trade and Industry finds grounds for said proposal,
he/she shall add the name of the chemical substance to which said proposal
pertains to the list of existing chemical substances or delete it from the list of
existing chemical substances, and shall notify the person who has made the
proposal to that effect.
(4) The Minister of International Trade and Industry shall give public notice of the
list of existing chemical substances that has undergone any additions or deletions
under the provisions of the preceding paragraph by one month prior to the date of
enforcement of this Act.
(Transitional Measures)
Article 3 The provisions of paragraph (1) of Article 3 shall apply to a person who
was, at the time of the enforcement of this Act, operating the business of
manufacturing or importing any chemical substances other than the chemical
substances listed in the list of existing chemical substances of which public notice
has been given pursuant to the provisions of paragraph (4) of the preceding Article,
by deeming said person to be a person prescribed in paragraph (1) of Article 3. In
this case, the term "in advance" as used in said paragraph shall be deemed to be
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Provisional translation (ver. November 12 2010)
replaced with "within one month from the day of the enforcement of this Act."
Article 4 Article 4 The Minister of Health, Labour and Welfare, the Minister of
Economy, Trade and Industry, and the Minister of the Environment shall prepare a
list in which the names of type II monitoring chemical substances as designated
pursuant to the provisions of paragraph (5) of Article 2 of the Act on the Evaluation
of Chemical Substances and Regulation of Their Manufacture, etc. prior to their
revision pursuant to the provisions of Article 2 of the Act on the Partial Revision of
the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (Act No.39 of 2009; hereinafter referred to as the "revising Act" in
this Article) and type III monitoring chemical substances as designated pursuant to
the provisions of paragraph (6) of Article 2 of the Act on the Evaluation of Chemical
Substances and Regulation of Their Manufacture, etc. prior to their revision
pursuant to the provisions of Article 2 of the revising Act, and shall publish the list
on the day of enforcement of the provisions listed in item (iii) of Article 1 of the
Supplementary Provisions of the revising Act.
Supplementary Provisions [Act No.68 of July 25, 1975] [Extract]
1. This Act shall come into effect as from the day specified by Cabinet Order within a
period not more than one year from the day of promulgation.
Supplementary Provisions [Act No.57 of May 25, 1983] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day specified by Cabinet Order
within a period not more than three months from the day of promulgation; provided,
however, that the provisions of Article 8 shall come into effect as from the day
specified by the Cabinet Order set forth in Article 1 of the Supplementary
Provisions of the Act for Partial Revision of the Fertilizer Control Act (Act No. 40 of
1983).
Supplementary Provisions [Act No.44 of May 7, 1986]
(Effective Date)
47
Provisional translation (ver. November 12 2010)
1. This Act shall come into effect as from the day specified by Cabinet Order within a
period not more than one year from the day of promulgation.
(Transitional Measures)
2. With regard to the application of penal provisions to acts committed prior to the
enforcement of this Act, the provisions then in force shall remain applicable.
Supplementary Provisions [Act No.33 of June 19, 1990] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day specified by Cabinet Order
within a period not more than six months from the day of promulgation.
Supplementary Provisions [Act No.89 of November 12, 1993] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day of enforcement of the
Administrative Procedure Act (Act No. 88 of 1993).
(Transitional Measures Concerning Adverse Dispositions Following Appeal, etc.)
Article 2 Where an appeal or other request has been filed or made prior to the
enforcement of this Act under the laws and regulations to a council or any other
panel to require the implementation of procedures equivalent to the procedures to
hold hearings or grant the opportunity for explanation and other procedures to hear
statements of opinions prescribed in Article 13 of the Administrative Procedure Act,
with regard to the procedures concerning adverse dispositions pertaining to said
appeal or other request, the provisions then in force shall remain applicable
notwithstanding the provisions for the relevant Acts revised by this Act.
(Transitional Measures Concerning Penal Provisions)
Article 13 With regard to the application of penal provisions to acts committed
prior to the enforcement of this Act, the provisions then in force shall remain
applicable.
(Transitional Measures for the Arrangement of Provisions for Hearings)
48
Provisional translation (ver. November 12 2010)
Article 14
Procedures for hearings (excluding those concerning adverse
dispositions) implemented under Acts prior to the enforcement of this Act or
incidental procedures shall be deemed to have been implemented under the
relevant provisions of the respective Acts revised by this Act.
(Delegation to Cabinet Orders)
Article 15 In addition to the transitional measures prescribed in Article 2 through
the preceding Article of these Supplementary Provisions, the necessary transitional
measures concerning the enforcement of this Act shall be specified by Cabinet
Order.
Supplementary Provisions [Act No.151 of December 8, 1999] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as of April 1, 2000.
Article 4 With regard to the application of penal provisions to acts committed prior
to the enforcement of this Act, the provisions then in force shall remain applicable.
Supplementary Provisions [Act No.160 of December 22, 1999] [Extract]
(Effective Date)
Article 1 This Act (excluding Articles 2 and 3) shall come into effect as from
January 6, 2001.
Supplementary Provisions [Act No.96 of July 31, 2002] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day specified by Cabinet Order
within a period not more than three years from the day of promulgation; provided,
however, that the provisions listed in the following items shall come into effect as
from the day specified in said items respectively:
(ii) The provisions of paragraph (2) of Article 2, Article 5, Article 17, Article 27, and
Articles 30 through 32 of the Supplementary Provisions - the day of promulgation
49
Provisional translation (ver. November 12 2010)
(Effects of Depositions, etc.)
Article 30 Any dispositions, procedures or other acts conducted prior to the
enforcement of this Act (or the respective provisions listed in the items of Article 1
of the Supplementary Provisions), pursuant to the provisions of the respective Acts
prior to the revision (including orders issued under them; hereinafter the same
shall apply in this Article) shall be, if the respective revised Acts contain provisions
corresponding to such provisions, deemed to have been conducted under the
relevant provisions of the respective revised Acts, except those otherwise provided
for by the Supplementary Provisions.
(Transitional Measures Concerning Penal Provisions)
Article 31 With regard to the application of penal provisions to acts committed
prior to the enforcement of this Act (or the respective provisions listed in the items
of Article 1 of the Supplementary Provisions) and acts committed after the
enforcement of this Act, in cases where the provisions then in force remain
applicable pursuant to the provisions of these Supplementary Provisions, the
provisions then in force shall remain applicable.
(Delegation to Cabinet Orders)
Article 32
In addition to the transitional measures prescribed in these
Supplementary Provisions, the necessary transitional measures concerning the
enforcement of this Act shall be specified by Cabinet Order.
Supplementary Provisions [Act No.49 of May 28, 2003] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day specified by Cabinet Order
within a period not more than one year from the day of promulgation; provided,
however, that the provisions of Article 3 of the Supplementary Provisions shall
come into effect as from the day specified by Cabinet Order within the period not
more than nine months from the day of promulgation.
(Transitional Measures Concerning Confirmation)
Article 2 A person who is specified by Cabinet Order among persons who actually
manufacture or import a new chemical substance at the enforcement of this Act by
50
Provisional translation (ver. November 12 2010)
falling under the cases specified by Cabinet Order under the proviso to Article 3 of
the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture. Etc. prior to the revision by this Act without making the notification
set forth in said Article may continue to manufacture or import said new chemical
substance without making the notification set forth in paragraph (1) of Article 3 of
the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture. etc. after the revision by this Act (hereinafter referred to as "new
Act") for the period from the day of enforcement of this Act (hereinafter referred to
as the "enforcement day") until a day when six months elapses, notwithstanding
the provisions of paragraph (1) of Article 3 of the new Act.
(Preparatory Actions)
Article 3 A person who intends to manufacture or import a new chemical substance
may obtain confirmation from the Minister of Health, Labour and Welfare, the
Minister of Economy, Trade and Industry, and the Minister of the Environment in
accordance with the provisions of item (v) of paragraph (1) of Article 3 of the new
Act even prior to the enforcement day. In this case, a person who obtains said
confirmation shall be deemed to have obtained confirmation from the Minister of
Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the
Minister of the Environment on the enforcement day, pursuant to the provisions of
said item.
(Transitional Measures Concerning Application of Penal Provisions)
Article 4 With regard to the application of penal provisions to acts committed prior
to the enforcement of this Act, the provisions then in force shall remain applicable.
(Delegation to Cabinet Orders)
Article 5
In addition to the transitional measures prescribed in these
Supplementary Provisions, the necessary transitional measures concerning the
enforcement of this Act shall be specified by Cabinet Order.
(Review)
Article 6 Where five years have elapsed after the enforcement of this Act, when the
government finds it necessary in consideration of the state of implementation of the
new Act, it shall review the provisions of the new Act and take necessary measures
51
Provisional translation (ver. November 12 2010)
based on the results.
Supplementary Provisions [Act No.55 of May 30, 2003] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day specified by Cabinet Order
within a period not more than three months from the day of promulgation; provided,
however, that the provisions listed in the following items shall come into effect as
from the day specified in said items respectively:
(iii) The provisions of Article 2 (excluding the provisions for revision listed in the
following item), Article 6 (excluding the provisions for revision listed in the
following item), Article 8 (excluding the provisions for revision listed in the
following item) and Article 10 of this Act; the provisions of Articles 2 through 5,
Article 8, Articles 16 through 18, Articles 21 through 26, Article 31, Article 33 and
Article 35 - the day specified by Cabinet Order within a period not more than nine
months from the day of promulgation
Supplementary Provisions [Act No.33 of April 27 of 2005] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as of October 1, 2005.
(Transitional Measures)
Article 24 Where an order is established, revised or abolished based on the
provisions of the respective Acts after their revision by this Act, the order may
provide necessary transitional measures (including transitional measures
concerning penal provisions) to the extent that it is judged reasonably necessary for
their establishment, revision or abolishment.
Supplementary Provisions [Act No.39 of May 20, 2009] [Extract]
(Effective Date)
Article 1 This Act shall come into effect as from the day specified by Cabinet Order
within a period not more than three years from the day of promulgation; provided,
however, that the provisions listed in the following items shall come into effect as
from the day specified in said items respectively:
52
Provisional translation (ver. November 12 2010)
(i) The provisions of paragraph (1) of the following Article and Article 5 of the
Supplementary Provisions - the day of promulgation
(iii) The provisions of Article 2 of this Act, Article 3 (excluding paragraph (3)) and
Article 7 of the Supplementary Provisions - the day specified by Cabinet Order
within a period not more than two years from the day of promulgation
(Transitional Measures)
Article 2 (1) The Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry, and the Minister of the Environment may hear the opinions of
a council, etc. as specified by Cabinet Order under paragraph (1) of Article 41 of the
Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. after the revision pursuant to the provisions of Article 1 of this
Act (hereinafter referred to as the "new Act" in this Article) in order to enact or
amend the Cabinet Order set forth in paragraph (2) of Article 17 or paragraph (1) of
Article 27 of the new Act, even prior to the enforcement of this Act.
(2) With regard to measures pursuant to the provisions of paragraph (4) of Article
31-2 of the new Act where the Minister of Health, Labour and Welfare, the Minister
of Economy, Trade and Industry, and the Minister of the Environment have found
that a substance subject to reporting (meaning a substance subject to reporting as
prescribed in paragraph (1) of Article 31-2 of the new Act) falls under any of the
items of paragraph (6) of Article 2 of the new Act or is suspected to fall under item
(i) of paragraph (3) of said Article, they shall be taken by considering whether or
not a considerable amounts of said substance subject to reporting are expected to
remain in the environment.
Article 3 (1) With regard to a report which shall be made by a person who is
instructed pursuant to the provisions of paragraph (1) of Article 24 or paragraph (1)
of Article 25-3 of the Act on the Evaluation of Chemical Substances and Regulation
of Their Manufacture, etc. prior to their revision pursuant to the provisions of
Article 2 of this Act (hereinafter referred to as the "former Act" in this Article) and
who actually engages at the time of the enforcement of the provisions listed in item
(iii) of Article 1 of the Supplementary Provisions in the business of manufacturing
or importing a type II monitoring chemical substance as prescribed in paragraph (5)
of Article 2 of the former Act (hereinafter referred to as a "type II monitoring
chemical substance" in the following paragraph) or a type III monitoring chemical
53
Provisional translation (ver. November 12 2010)
substance as prescribed in paragraph (6) of said Article of the former Act
(hereinafter referred to as a "type III monitoring chemical substance"), the
provisions then in force shall remain applicable.
(2) With regard to a report which shall be made by a person who actually engages at
the time of the enforcement of the provisions listed in item (iii) of Article 1 of the
Supplementary Provisions in the business of manufacturing or importing a type II
monitoring chemical substance or a type III monitoring chemical substance for
which the knowledge prescribed in paragraphs (1) or (3) of Article 31-2 of the
former Act is obtained with respect to a type II monitoring chemical substance or a
type III monitoring chemical substance, the provisions then in force shall remain
applicable.
(3) The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and
Industry, and the Minister of the Environment may hear the opinions of a council,
etc. as specified by Cabinet Order under paragraph (1) of Article 56 of the Act on
the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.
after their revision pursuant to the provisions of Article 2 of this Act (hereinafter
referred to as the "new Act" in this Article) in order to provide a designation under
paragraph (5) of Article 2 of the new Act, even prior to the day of enforcement of the
provisions listed in item (iii) of Article 1 of the Supplementary Provisions.
(4) A type I monitoring chemical substance that is actually designated pursuant to
the provisions of paragraph (4) of Article 2 of the former Act at the time of the
enforcement of the provisions listed in item (iii) of Article 1 of the Supplementary
Provisions shall be deemed to be a monitoring chemical substance as designated
pursuant to the provisions of paragraph (4) of Article 2 of the new Act.
(Transitional Measures Concerning Penal Provisions)
Article 4 With regard to the application of penal provisions to acts committed prior
to the enforcement of this Act (or the respective provisions listed in the items of
Article 1, item (iii) of the Supplementary Provisions) and acts committed after the
enforcement of this Act, in cases where the provisions then in force remain
applicable pursuant to the provisions of paragraphs (1) and (2) of the preceding
Article, the provisions then in force shall remain applicable.
(Delegation to Cabinet Orders)
Article 5 In addition to transitional measures prescribed in these Supplementary
54
Provisional translation (ver. November 12 2010)
Provisions, the necessary transitional measures concerning the enforcement of this
Act (including transitional measures concerning the penal provisions) shall be
specified by Cabinet Order.
(Review)
Article 6 Where five years has elapsed after the enforcement of this Act, when the
government finds it necessary in consideration of the state of implementation of the
Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. after the revision by this Act, it shall review the provisions of
said Act and take necessary measures based on the results.
55
Chemical Substances Control Law
January 2011
Chemical Safety Office, Chemical Management Policy Division,
Manufacturing Industries Bureau
Ministry of Economy, Trade and Industry
Contents
1. Chemical Substances Control Law: Scope
○ Chemical Substances Subject to the Chemical
Substance Control Law
2. Amendment of the Chemical Substances Control Law in
FY2009
(1) Amendment of the Chemical Substance Control Law:
Overview
(2) The Chemical Substance Control Law after the
Amendment: the Whole Picture (From April 1, 2010 to
March 31, 2011)
(3) The Chemical Substance Control Law after the
Amendment: the Whole Picture (From April 1,
1 2011)
3. Main Points of the Amended Chemical Substances
Control Law of FY2010
(1) The Chemical Substance Control Law after the
Amendment: the Whole Picture
(2) Non-Persistent Substances are Included
(3) Introduction of a Prior Confirmation System for
Polymers of Low Concern
(4) Information Delivery in the Supply Chain (Chemical
Substances Subject to Type I Monitoring)
(5) Measures Related to Class I Specified Chemical
Substances
(6) Measures Related to Class II Specified Chemical
Substances
(7) Summary
4. Main Points for Amended Chemical Substances Control Law of
FY2011 and Thereafter
(1) The Chemical Substance Control Law after the Amendment:
the Whole Picture
(2) Important Points for Amendment (Shift toward risk-based
management)
(3) Image of Screening Assessment and Risk Assessment
(4) Screening Assessment/Risk Assessment and Use Category
(5) Notification of the Amounts of Manufacture, Import, etc., for
General Chemical Substances
(6) Policy for Substances not Requiring Notification
(7) Notification of the Amounts of Manufacture, Import, etc.,
regarding Priority Assessment Chemical Substances (new
category)
(8) Information Delivery in the Supply Chain (Priority Assessment
Chemical Substances)
(9) Handling of the Monitoring Chemical Substances
(10) Reporting, etc., of Hazard Information
(11) Summary
1
1. Chemical Substances
Control Law: Scope
2
○ Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.
(Chemical Substances Control Law)
Purpose
Prevention of environmental pollution caused by those chemical substances that pose a
risk of impairing human health or interfere with the inhabitation and/or growth of flora and
fauna
Overview
○ Evaluation concerning New Chemical Substances
A Preliminary evaluation in connection with new substances that have not been
manufactured and/or imported so far in Japan.
○ Regulatory measures according to the properties of chemical substances
A Designation of “Specified Chemical Substances,” “Monitoring Chemical Substances,”
etc., according to their properties.
A Grasp the actual amounts manufactured and imported, instruct the study of hazardous
properties, the permission to manufacture and/or import, and restrictions on use, etc.
○ Other measures including reporting of hazardous properties on chemical substances, etc.
3
○ Chemical Substances Subject to the Chemical Substance Control Law
“Chemical substances” refers to chemical compound created by causing chemical reactions to
occur to elements or compounds.
The chemical substances subject to the Chemical Substance Control Law are those used for
general industrial chemical products. Those substances that are subject to other regulations that are
equally or more stringent regulations (Poisonous and Deleterious Substances Control Act) or more
specific to the usage of the substance (Food Sanitation Act) are exempted from this law.
Regulations on manufacturing, etc.
Regulations on emissions Regulations on waste
Chemical substances subject to
the Chemical Substance Control Law
Chemical substances
- Elements
El
t and
d natural
t l products
d t
General usage (industrial)
- General industrial chemical
products
Specific usage
[Food Sanitation Law]
Foods, additives, containers and packaging, toys and
detergents
[Agricultural Chemicals Regulation Act] Agricultural chemicals
[Fertilizers Regulation Act] Ordinary fertilizers
[Act on Safety Assurance and Quality Improvement of Feeds]
Feeds and feed additives
[Pharmaceutical Affairs Act]
Drugs, quasi-drugs, cosmetics, and medical equipment
[Water Pollution
Control Act]
[Air Pollution Control
Act]
[Soil Contamination
Countermeasures
Act]
[Waste
Management and
Public Cleansing
Act]
[Law concerning Prevention of Radiation Hazards due to Radioisotopes, etc.] Radioactive substances
[Poisonous and Deleterious Substances Control Act] Specified poisons
[Stimulant Drug Control Act] Stimulant and raw materials for stimulants
[Narcotics and Psychotropics Control Act] Narcotics
4
2. Amendment of the
Chemical Substances
Control Law in FY2009
5
(1) Amendment of the Chemical Substance Control Law: Overview
The current regulations and measures are reviewed and new measures necessary to rationalize regulations are implemented to
reflect international trends. The amendment is also aimed at preventing the adverse influence of harmful chemical substances on
humans, flora and fauna through implementation of comprehensive chemical substance management.
Background and Needs of Amendment
1. Increased concerns for chemical substances
(to ensure safety of the pubic both physically and mentally)
2. Needs to achieve international goals in chemical substance management
To minimize the significant adverse effects of chemical substances on
human health and the environment by 2020 (Agreement in the
Environmental Summit in 2002).
- New regulations (REACH) are already implemented in 2007 in Europe.
The Chemical Substance Control Law (enactment in 1973) requires all
“new chemical substances” (those manufactured or imported for the first
time at the time of enactment or later) to go through prior evaluation.
Existing chemical substances at the time of enactment have been subject
to hazard assessment by the government, but assessment has not been
completed for many of these chemical substances.
3. Unconformity with international conventions
In an international convention (the Stockholm Convention), an agreement
was made on exceptional use of certain substances that are subject to
banning.
With the current law, provisions on exceptional use are restrictive,
imposing concern that certain uses that are essential to the industries of
Japan cannot be ensured.
Amendment: Overview
(1) Measures for the existing chemical substances
Manufacturers and/or importers of all chemical substances,
including existing chemical substances, will have an
obligation to report the amount, etc. when manufacturing or
importing more than a certain amount of the substance.
Upon reception of the above report, the government will
narrow down and prioritize the chemical substances for
detailed safety assessment. The manufacturers and/or
importers will be requested to submit information on the
level/ type of hazard. Influences of such chemicals on human
health, etc. will be evaluated and classified.
Based on the results, manufacturing and use of the
hazardous chemical substances and products containing
these substances will be restricted.
(2) Ensuring conformity with international rules
Use under strict management will be ensured when a
chemical substance is newly added to the list of restriction
substances in international conventions.
- Use for semiconductors, etc.
(Reference) Related occurrences 1973 Chemical Substance Control Law enacted
2002 Agreement achieved at the Environmental Summit
2004 Stockholm Convention came into effect
2007 REACH came into effect (Europe)
2020 Each state will complete safety assessment
2018 Deadline of final registration for REACH
6
(2) The Chemical Substance Control Law after the Amendment:
the Whole Picture (From April 1, 2010 to March 31, 2011)
Existing chemical substances
New chemical substances
(Approx. 20,600 substances)
(Chemical substances that were already manufactured/imported at
the time of the promulgation of the Chemical Substance Control Law)
Total manufacturing and
import/year > 1 ton/year
Persistent. Highly bioaccumulative.
Long-term toxicity for humans or
predator animals at higher trophic
level
Total manufacturing
and import/year
1 ton/year
Persistent/
highly bioaccumulative
Polymers of Low
Concern
Notification and evaluation
(Data are submitted by private corporations)
Not readily biodegradable
/not highly bioaccumulative
10 ton/year
Not readily biodegradable /not highly
bioaccumulative
Hazard assessment and evaluation
(by the government)
Substances specified by
Cabinet order
(e.g., intermediates)
Suspected long-term toxicity
for humans
Confirmation
(approval for
manufacturing
and/or import)
Suspected long-term toxicity
for flora and fauna
Chemical Substances Subject to
Type I Monitoring
Chemical Substances Subject to
Type Ⅱ Monitoring
Chemical Substances Subject to
Type Ⅲ Monitoring
[Persistent. Highly bioaccumulative. Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
- Companies handling these substances are obliged to
make utmost efforts to disclose information
[Suspected long-term toxicity for humans]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
[Suspected long-term toxicity for flora and fauna]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
Designate a hazardous
Has long-term toxicity to
properties study
humans or predator animals at
higher trophic level
Class I Specified Chemical Substance
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by Cabinet order is prohibited
- Any uses other than specified by Cabinet order (for international consistency of
requirements) are prohibited
- Standards in handling of the substance and products specified by Cabinet order
(products containing the substances) must be met. Mandatory labeling
- Implementation of recall and other measures may be ordered
Designate a hazardous
properties study
Has long-term toxicity for
humans
Designate a hazardous
properties study
Has long-term toxicity for
flora and fauna in the human
living environment
Class II Specified Chemical Substance
[Has long-term toxicity for humans or flora and fauna in the human living
environment. Has risk. ]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, government issues orders to change the planned manufacture and
import amounts
- The government provides technical guidelines, recommendations on substances and
products specified by cabinet order (products containing the substances)
- Mandatory labeling for the products specified by Cabinet order
7
(3) The Chemical Substance Control Law after the Amendment:
the Whole Picture (From April 1, 2011)
Existing chemical substances (Approx. 20,600 substances)
(Chemical substances that were already manufactured/imported at the time of the
promulgation of the Chemical Substance Control Law)
Announced and assessed substances (Approx. 8,000 substances)
New chemical substances
Total manufacturing and
import/year > 1 ton/year
Total manufacturing and
import/year 1 ton/year
(excluding those subject to regulatory classification)
General chemical substances (7,000 to 8,000 estimated)
Notification and evaluation
(Data are submitted by private corporations)
Mandatory reporting of amounts manufactured and/or imported (I 1 ton/year,
usage, etc.
Risk to humans or flora and
fauna in the human living
environment is sufficiently low
Decision based on exposure,
hazard, etc.
Persistent.
Highly
g y bioaccumulative
Substances specified by
cabinet order
(e.g., intermediates)
Decision based on exposure,
hazard, etc.
Not readily
biodegradable/not
Persistent
highly bioaccumulative
10 ton/year
Polymers of Low
Concern
Confirmation
(approval for
manufacturing
and/or import)
Risk to humans or flora and fauna in the human living environment
is not sufficiently low
Priority
y Assessment Chemical Substances ((PACs))
Monitoring Chemical Substances
[Persistent. Highly bioaccumulative. Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
Report of handling status is required
Designate a hazardous properties study
Has long-term toxicity to humans or
predator animals at higher trophic level
Class I Specified Chemical Substances
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity for predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by Cabinet order is prohibited
- Any uses other than specified by Cabinet order (for international consistency of
requirements) are prohibited
- Standards in handling of the substance and products specified by Cabinet order
(products containing the substances) must be met. Mandatory labeling
p
y be ordered
- Implementation
of recall and other measures may
[Suspected long-term toxicity for humans or flora and fauna
in the human living environment. Suspected risk]
- Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc.
- Companies handling these substances are obliged to make utmost efforts to disclose information
Note: Type II and Type III Monitoring Chemical Substance discontinued. Priority Assessment Chemical
Substances may be specified from the substances previously categorized in these types
Report of toxicity and handling status is required
Designate a hazardous properties study
Has risk for humans or flora and fauna
in the human living environment
Class II Specified Chemical Substances
[Has long-term toxicity for humans or flora and fauna
in the human living environment. Has risk. ]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, government issues orders to change the planned manufacture and
import amounts
- The government provides technical guidelines, recommendations on substances and
products specified by Cabinet order (products containing the substances)
- Mandatory labeling for the products specified by Cabinet order
8
3. Main Points of the
Amended Chemical
Substances Control Law of
FY2010
9
9
(1) The Chemical Substance Control Law after the Amendment:
the Whole Picture (reposted)
Existing chemical substances
New chemical substances
(Approx. 20,600 substances)
(Chemical substances that were already manufactured/imported at
the time of the promulgation of the Chemical Substance Control Law)
Total manufacturing and
import/year > 1 ton/year
Persistent. Highly bioaccumulative.
Long-term toxicity for humans or
predator animals at higher trophic
level
Total manufacturing
and import/year
1 ton/year
Persistent/
highly bioaccumulative
Polymers of Low
Concern
Notification and evaluation
(Data are submitted by private corporations)
Not readily biodegradable
/not highly bioaccumulative
10 ton/year
Not readily biodegradable /not highly
bioaccumulative
Hazard assessment and evaluation
(by the government)
Substances specified by
Cabinet order
(e.g., intermediates)
Suspected long-term toxicity
for humans
Confirmation
(approval for
manufacturing
and/or import)
Suspected long-term toxicity
for flora and fauna
Chemical Substances Subject to
Type ⅠMonitoring
Chemical Substances Subject to
Type Ⅱ Monitoring
Chemical Substances Subject to
Type III Monitoring
[Persistent. Highly bioaccumulative. Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
- Companies handling these substances are obliged to
make utmost efforts to disclose information
[Suspected long-term toxicity for humans]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
[Suspected long-term toxicity for flora and fauna]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
Designate a hazardous
properties study
Has long-term toxicity to
humans or predator animals at
higher trophic level
Class I Specified Chemical Substance
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by Cabinet order is prohibited
- Any uses other than specified by Cabinet order (for international consistency of
requirements) are prohibited
- Standards in handling of the substance and products specified by Cabinet order
(products containing the substances) must be met. Mandatory labeling
- Implementation of recall and other measures may be ordered
Designate a hazardous
properties study
Has long-term toxicity for
humans
Designate a hazardous
properties study
Has long-term toxicity for
flora and fauna in the human
living environment
Class II Specified Chemical Substance
[Has long-term toxicity for humans or flora and fauna
in the human living environment. Has risk. ]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, government issues orders to change the planned manufacture and
import amounts
- The government provides technical guidelines, recommendations on substances and
products specified by cabinet order (products containing the substances)
- Mandatory labeling for the products specified by Cabinet order
10
(2) Non-Persistent Substances are Included
○Since April 2010, non-persistent substances are added to those designated as Class II
Specified Chemical Substances, Chemical Substances subject to Type II or Type III
Monitoring.
○ At a joint deliberative council meeting held in December last year between the
Ministry of Health, Labour and Welfare, the Ministry of Economy, Trade and Industry
and the Ministry of the Environment, 100 substances out of the existing nonpersistent substances were determined to be either Chemical Substances subject to
Type II or Type III Monitoring. They were designated as Chemical Substances
subject to Type II or Type III April 2010. (Among them are benzene, toluene,
styrene, etc.).
○ In addition, screening assessment will be carried out for all of the Chemical
Substances subject to Type II and Type III Monitoring in order to select Priority
Chemical Substances during this fiscal year.
11
(3) Introduction of a Prior Confirmation System for Polymers of Low Concern (1/2)
○ Polymers of low concern are those polymers among new chemical substances that
are confirmed by the Minister of Health, Labour and Welfare, the Minister of Economy,
Trade and Industry and the Minister of the Environment to have no risk of causing
damage to human health or the habitat, etc. of flora and fauna in the human living
environment.
*“Standards related to new chemical substances that are polymers and that do not pose a risk of causing
damage to human health or to the population and/or growth of flora and fauna in the human living environment
by causing environmental pollution” (Notification No.2 of 2009 by the Ministry of Health, Labour and Welfare,
the Ministry of Economy, Trade and Industry and the Ministry of the Environment)
1. Polymers shall be those that fall under items 1 and 2 below:
(1) Any chemical substance composed of an aggregation of those molecules that are produced by linkages
of one or more types of monomeric units, in which the total weight of those molecules that are composed of
3 or more linkages makes up 50% or more of the weight of the whole substance and the total weight of
those molecules with identical molecular weight is less than 50% of the weight of the whole substance; and
(2) Any chemical substance whose number average molecular weight is 1,000 or more.
○ In cases where the three Ministers confirm that a new chemical substance falls under
the category of polymers of low concern, the new chemical substance will be
exempted from mandatory notification of its manufacture and/or import.
○ Any person who has received confirmation of a polymer of low concern will be subject
to collect report and on-site inspection, as appropriate.
12
(3) Introduction of a Prior Confirmation System for Polymers of Low Concern (2/2)
(1) Outline of the Criteria for Verifying Polymers of Low Concern
○ A number average molecular weight of 1,000 or more
○ No observed changes in weight under acids or alkalis
○ No metal included except for Na, Mg, Ca and K
○ Insoluble in water or organic solvents. Dissolution therein indicates that the
polymer does not include any double or triple bonds between carbon atoms, any
epoxy group and any sulfonic acid group.
(2) Major Test Data Required at the Time of Application
○ Molecular weight distribution
○ Physicochemical property test
○ Solubility test with respect to acid/alkali and water/organic solvents.
(3) Characteristics of Application for Verifying Polymers of Low Concern
○ The period between application and sending of notice is 4 weeks or less.
Applications are accepted at any time.
○ Once the notice of confirmation is obtained, no further application is necessary.
○ No notification is required for the amount of manufacture, import, etc.
○ The names of verified chemical substances will not be made public.
13
(4) Information Delivery in the Supply Chain (Chemical Substances Subject to Type I Monitoring)
When Chemical Substances Subject to Type I Monitoring are transfers between business entities,
the entity transferring the substance is obliged to make utmost efforts to inform the recipient that
the substance is specified as the Type I Monitoring Chemical Substance etc.
For Class II Specified Chemical Substances and Chemical Substances Subject to Type I
Monitoring, the three relevant ministries and the competent ministers may instruct the business
entity handling the substance to report the status of transaction.
Supply chain
Control of chemical substances in the supply chain
Manufacturer of
raw materials
Primary processing manufacturer
Parts manufacturer
Manufacturer of assembled products
Articles
Chemical substances/preparation
General consumers
Supply chain
Chemical preparation
/products
Manufacturer of raw materials
Primary
processing
manufacturer
Manufacture
and import
(Examples of measures)
- Prohibition of manufacture
and import
- Restriction on manufacture
and import
- Reduction of release through
improvement of
manufacturing facilities
- Control of intermediates
Articles
Part
manufacturer
Use and
processing
(Examples of control)
- Restriction on use and intended use
- Reduction of amount of use through
improvement of manufacturing facilities
- Review the needs and possibility of
overuse
- Improvement of recovery rate,
achievement of thorough reuse,
measures on handling
- Shifting to alternative substance
14
(5) Measures Related to Class I Specified Chemical Substances
○ Starting from FY2010, the use of Class I Specified Chemical Substances is allowed
exceptionally in cases where they are essential in the manufacture of products, as far as there
is no risk of environmental pollution (Essential Use).
○ Specifically, 3 uses of PFOS have been designated as Essential Uses, namely: use of PFOS
to make semiconductor etching agents, resists and business-purpose photographic films.
Obligations Related to the Handling of Class I Specified Chemical Substances, etc.
○ Business operators handling PFOS, as well as of semiconductor etching agents, resists, business-purpose photographic films and fire
extinguishers/fire fighting chemicals for extinguishers/foam fire extinguishing agents (*), in which PFOS are used, need to satisfy the following
obligations:
1. Obligation to comply with the technical standards for handling these objects
(Th method
(The
th d off storage,
t
th method
the
th d off workk such
h as relocation,
l
ti
etc.,
t off the
th objects,
bj t the
th obligation
bli ti to
t keep
k
records
d off the
th amountt off storage,
t
etc., the handling of leakage, and the like.)
2. Obligation of labeling in cases of transfer or provision of any of these objects
(The fact that PFOS is contained, its percentage content, a precaution statement, the contact address of the person who placed the label)
○ The term “handlers” refers to licensed manufacturers, as well as business users, conveyors, storage business operators, etc., of Class I
Specified Chemical Substances, etc.
*Foam fire extinguishing agent are not designated as any Essential Use, but PFOS are already used in a considerable number of products
existing in the form of stock-piles, etc., and it is difficult to replace them with any alternate products in a short period of time in view of their
nature that they are used only at times of disasters. Thus, the technical standards for handling these objects and the obligation of labeling
have been set up with the aim of preventing any environmental pollution through them.
For reference: the past schedule for related regulations
• May 26, 2010
Publication of the technical standards for handling PFOS as well as semiconductor etching agents, resists and businesspurpose photographic films [(1)]
• September 3, 2010
Publication of the technical standards for handling foam fire extinguishing agents, etc., [(2)] as well as the matters to be
labeled regarding Class I Specified Chemical Substances and products containing such substances [(c)]
15
• October 1, 2010
Enforcement of the technical standards for handling the subject products [(1),(2)] and the matters to be labeling [(3)]
(6) Measures Related to Class II Specified Chemical Substances
○ In the past, technical guidelines for preventing environmental pollution have been announced
regarding Class II Specified Chemical Substances. From now on, technical guidelines will be
announced also regarding products using Class II Specified Chemical Substances designated
by any Cabinet Order.
○ In the past, business operators handling Class II Specified Chemical Substances have been
obliged to label products designated by any Cabinet Order in which Class II Specified Chemical
Substances are used. From now on, the obligation of labeling will also be assumed by handlers
of those products in which Class II Specified Chemical Substances are used.
○ Examples of products in which Class II Specified Chemical Substances are used:
Dry cleaning fluids, metal cleaning fluids, etc., in which tetrachloroethylene is used.
○ Technical Guidelines
The structure of facilities, inspection and control, work instructions, treatment at the time of leakage,
etc. are defined.
○ Obligation of Labeling
The fact that any Class II Specified Chemical Product is used in the product concerned, that the
product concerned might harm human health, as well as handling instructions, should be included on a
label on the container, packaging and invoice.
○ Handlers subject to the technical guidelines and the obligation of labeling:
In addition to manufacturers and importers of Class II Specified Chemical Substances, distributors, etc.,
16
of these substances are also subject to the guidelines and obligations.
(7) Summary
○ Non-persistent substances are also subject to control.
○ The polymers of low concern system is introduced to exclude polymers of low
concern as exceptions from the evaluation of new chemical substances.
○ International coordination is made for exceptional use of Class I Specified Chemical
Substances
Substances.
○ Technical guidelines are published and labeling are obligatory with regard to Class II
Specified Chemical Substances.
17
4. Main Points for the
Amended Chemical
Substances Control Law of
FY2011 and Thereafter
18
(1) The Chemical Substance Control Law after the Amendment:
the Whole Picture (From April 1, 2011) (reposted)
Existing chemical substances (Approx. 20,600 substances)
(Chemical substances that were already manufactured/imported at the time of the
promulgation of the Chemical Substance Control Law)
Announced and assessed substances (Approx. 8,000 substances)
New chemical substances
Total manufacturing and
import/year > 1 ton/year
Total manufacturing and
import/year 1 ton/year
(excluding those subject to regulatory classification)
General chemical substances (7,000 to 8,000 estimated)
Notification and evaluation
(Data are submitted by private corporations)
Mandatory reporting of amounts manufactured and/or imported (I 1 ton/year,
usage, etc.
Risk to humans or flora and
fauna in the human living
environment is sufficiently low
Decision based on exposure,
hazard, etc.
Persistent.
Highly
g y bioaccumulative
Substances specified by
cabinet order
(e.g., intermediates)
Decision based on exposure,
hazard, etc.
Not readily
biodegradable/not
Persistent
highly bioaccumulative
10 ton/year
Polymers of Low
Concern
Confirmation
(approval for
manufacturing
and/or import)
Risk to humans or flora and fauna in the human living environment
is not sufficiently low
Priority
y Assessment Chemical Substances ((PACs))
Monitoring Chemical Substances
[Persistent. Highly bioaccumulative. Toxicity unknown]
- Mandatory reporting of actual amounts manufactured
and/or imported, usage, etc.
Report of handling status is required
Designate a hazardous properties study
Has long-term toxicity to humans or
predator animals at higher trophic level
Class I Specified Chemical Substances
[Persistent. Highly bioaccumulative. Has long-term toxicity for humans or
long-term toxicity for predator animals at higher trophic level]
- Prior permission is required for manufacture and/or import (virtually prohibited)
- Import of certain products specified by Cabinet order is prohibited
- Any uses other than specified by Cabinet order (for international consistency of
requirements) are prohibited
- Standards in handling of the substance and products specified by Cabinet order
(products containing the substances) must be met. Mandatory labeling
p
y be ordered
- Implementation
of recall and other measures may
[Suspected long-term toxicity for humans or flora and fauna
in the human living environment. Suspected risk]
- Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc.
- Companies handling these substances are obliged to make utmost efforts to disclose information
Note: Type II and Type III Monitoring Chemical Substance discontinued. Priority Assessment Chemical
Substances may be specified from the substances previously categorized in these types
Report of toxicity and handling status is required
Designate a hazardous properties study
Has risk for humans or flora and fauna
in the human living environment
Class II Specified Chemical Substances
[Has long-term toxicity for humans or flora and fauna
in the human living environment. Has risk. ]
- Mandatory reporting of planned and actual amounts manufactured and imported
- If deemed necessary, government issues orders to change the planned manufacture and
import amounts
- The government provides technical guidelines, recommendations on substances and
products specified by Cabinet order (products containing the substances)
- Mandatory labeling for the products specified by Cabinet order
19
(2) Important Points for Amendment (Shift toward risk-based management)
Risk-based Management
Properties inherent in
chemical substances
Degree of Hazard
Exposure to chemical substances in
humans and/or organisms in the
environment
Degree of Exposure
Risk Assessment
The degree of risk is estimated through comparison
between the exposure and the hazard by chemical
substances (Risk Assessment).
Hazard > Amount of exposure: No need to be concerned
over the risk
(1) Even chemical
substances with
unconfirmed hazards can be
made the subject of
management whenever
there is concern over their
impact on human health.
(2) A variety of chemical
substances can be utilized if
the exposure, including the
manner of handling and
using the substances, is
controlled and managed to
eliminate risks.
(3) The exposure, as well as
the hazard, of chemical
substances exhibiting strong
toxicity can be strictly
controlled and managed.
20
(3) Image of Screening Assessment and Risk Assessment
Low Risk
Low Risk
Risk Assessment
(Secondary)
Degree of Hazard
High
Low
Risk
＝
High
Low
High
High
High
Cannot be determined to be sufficiently low-risk
High
High
High
Medi
um
High
High
Medi
um
Medi
um
High
Medi
um
Medi
um
Medi
um
Medi
um
Low
Low be determined to be
Can
sufficiently low-risk
Low
Unclassified
Hazard
×
No change from
the present state
General Chemical
Substances
Degree of Exposure
General Chemical
Substance
High
Priority
y Assessment
Chemical
cal Substance
Priority Assessment
Chemical Substance
Screening Assessment
General Chemical
Substances
Risk Assessment
(Primary)
Designate a
hazardous
properties
study
Class II Specified
Chemical Substances
Low Risk
Environmental Release
(Exposure)
21
(4) Screening Assessment/Risk Assessment and Use Category
What is Use Category?
○ A common use category is set up for chemical substances in order to classify them into about 50 use categories
and about 280 sub use categories.
○ An emission factor is established for each use category to estimate the amount of emission.
Amount of environmental release = amount of shipment (or amount of manufacture) × emission factor
(*The emission factor is lower for substances that fall under the category of polymers).
○ When the use information is unclear, “98 Other raw materials/additives” is selected.
When the sub use category is unclear, “z Others” is selected.
○ However, when “98 Other raw materials/additives” is selected,” a risk assessment (screening assessment) is
carried out on the assumption that the whole amount of the chemical substance handled might be released into the
environment
environment.
○ Therefore, it is important to grasp the precise use information in order that an appropriate assessment can be
implemented.
Object Substance
Fineness of the Use Employed
Digit Number of the Code to be Stated in a Notification
General chemical substance
Use category
Double digits (double-digit number)
Priority Assessment Chemical Substance (PACs)
Use category + sub use category
Triple digits ( double-digit number + single letter)
Monitoring chemical substance
Use category + sub use category
Triple digits (double-digit number + single letter)
Class II Specified Chemical Substance
Use category + sub use category
Triple digits (double-digit number +single letter)
New chemical substance
Use category
Double digits (double-digit number)
Low production volume (LPV) chemical substance
Use category
Double digits (double-digit number)
Small volume new chemical substance
Use category
Double digits (double-digit number)
Polymer of low concern
Use category
Double digits (double-digit number)
22
(Reference) Image of Use Category
Use categories (50 categories) are exclusively stated regarding
general chemical substances
Use Category
code
(#)
01 Intermediates
Use Category
Solvents
Solvents for paints, varnishes, coatings, printing inks, copying
02
and biocidal products
Sub Use
Category code
a
b
z
Synthetic raw materials, polymerization raw materials, prepolymers
Polymerization initiators
Others
a
Solvents for paints, solvent diluents
b
c
d
f
z
Solvents for paint removers,
Solvents for varnishes
Solvents for coatings, solvents for resist inks
Solvents for printing inks, solvents for electronic devices, solvents for inks and ink
detergents
S l
Solvents
t ffor bi
biocidal
id l products
d t
Others
a
Solvents for adhesives, solvents for pressure sensitive adhesives
b
c
d
z
Solvents for adhesive removers, solvents for paste removers
Solvents for adhesion
Solvents for sealants
Others
e
03
Solvents for adhesives, pressure sensitive adhesives and
sealants
Sub Use Category
Use category and sub use category (about 280 categories) are stated
regarding Monitoring Chemical Substances, Priority Assessment
Chemical Substances and Class II Specified Chemical Substances.
23
(5) Notification of the Amounts of Manufacture, Import, etc., for General Chemical Substances
(1) Subjects of Notification
○ Persons who have manufactured or imported general chemical substances, pursuant to the provisions of the Chemical Substances
Control Law.
○ Chemical substances manufactured or imported in an amount of 1 ton or more per company
○ (1) Chemical substances of less than 1 ton in amount, (2) Use for testing and research, and (3) Substances, etc., requiring no
notification designated by the 3 relevant Ministers
○ Chemical substances each of which makes up 10% or more by weight of a mixture
○ The manufacture of those chemical substances that are entirely consumed within the manufacturer company (intermediate products for
in-house use), regardless of whether this is within the same establishment or not, will be exempt from mandatory notification.
Caution: The import of those chemical substances to be consumed entirely within the importer company will be subject to mandatory notification.
(2) Details of Notification
○ The format prescribed by METI related Ordinance for Enforcement of Chemical Substances Control Law (Format No. 11) should be used.
○ The
Th amountt off manufacture,
f t
th
the amountt off import
i
t and
d the
th amountt off shipment
hi
t in
i the
th previous
i
year should
h ld b
be notified
tifi d iin 1 significant
i ifi
t
digit.
e.g.: 12,499t A10,000t, 1,894tA2,000t, 13t A10, 0.8tANo change required
○ The use should be notified according to about 50 use categories (double digits)
○ The CAS number (if known) should be stated (in the Other Numbers column).
(3) Time of Notification
○ Notification should be made between April 1 and June 30 inclusive
(by paper, electronically, by CD, etc.).
(4) Handling of Data Notified
○ These data should be used in the screening to select Priority Assessment
Chemical Substances from general chemical substances.
○ With regard to the amount of manufacture or import, the total national
amount should be announced in allowing for some margin.
However, consideration should be made in the case where the number of
manufacturers or importers is small.
What are General Chemical Substances?
(1) Chemical substances listed in the register of existing
chemical substances
(2) Newly announced chemical substances
(3) Former Class II and Class III Monitoring Chemical
Substances
*In respect to (1) to (3), substances designated as
Priority Assessment Chemical Substances, etc., are
excluded.
(4) Chemical substances for which the designation for
Priority Assessment Chemical Substance has been
cancelled
(5) New chemical substances before announcement,
which have received the notice of decision
24
(6) Policy for Substances not Requiring Notification (1/2)
(1) Basis for Selection
○ Chemical substances that are recognized from the results of determination by high molecular flow
scheme, etc., that they do not need to go through any risk assessment
○Chemical substances that essentially exist in nature in large amounts
・ Chemical substances that exist in nature, water areas or the atmosphere in large amounts such as
in the Earth’s crust
(Silicon dioxide, aluminum oxide, etc.)
・ Chemical substances that degrade in the environment exclusively into those ions indicated by
notice of existing knowledge
(Sodium chloride, magnesium sulfate, etc.) By
・ Chemical substances that are either essential or important for the biotic activities of living bodies
(Citric acid, oleic acid, etc.)
* Excluding those chemical substances that are subject to control by other laws and regulations
from the viewpoint of preventing human health hazards or environmental pollution
○ Chemical substances regarding which restriction on marketing might be imposed by other laws from
the viewpoint of preventing environmental pollution, as in the case of the Chemical Substances
Control Law.
・ Act Concerning the Maintenance of Quality of Gasoline, etc. (gasoline, kerosene, etc.)
25
(6) Policy for Substances not Requiring Notification (2/2)
(2) Polymers Not Requiring Notification
○ New chemical substances that received a determination equivalent to the non-hazardous
determination by High Molecular Flow Scheme in, or later, limited however, only to those substances
whose names have been announced. April 2004
○ New chemical substances that received a determination equivalent to non-hazardous determination
by High Molecular Flow Scheme during the period from April 1987 to March 2004. (Limited only to those
having no risk of ecological impact).
○ Existing chemical substances that are recognized to be either equivalent to non-hazardous
determination by High Molecular Flow Scheme or to satisfy the criteria for confirmation of polymers of
low concern.
(3) Publication of the List
○ The list was published as a result of collecting opinions: August 2010 ( consideration made for
publication of and/or addition to the list of candidates for Substances Not Requiring Notification).
○ Opinions collected again on the list of candidates for Substances Not Requiring Notification for
publication of the list in around January 2011.
○ Substances Not Requiring Notification will be announced by the end of March 2011.
○ Substances will be added every year.
*An advertisement is placed on the website of the Chemical Substances Control Law, asking for
provision of information on the safety assessment of polymers.
26
(Supplement) Frequently Asked Questions: About cases where notification is not required
The following cases are not subject to the obligation to notify the amount of manufacture or import of
general chemical substances or Priority Assessment Chemical Substances (PACs). (Notification is not
required). *”Implementation of the Law Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.”
(Notice by the Director General)
<1> Cases where notification is not necessary due to lack of applicability to “manufacturing” of chemical
substances as in the Chemical Substance Control Law
- Cases where chemical substances purchased from a company in Japan are sold as is
- Cases where chemical substances purchased from a company in Japan are made into a product
based on a mixing, forming, or purification process, etc. that does not cause chemical reactions
<2> Cases where notification is not necessary due to lack of applicability to “importing” of chemical
substances as in the Chemical Substance Control Law
(3) Cases where products that possess specific shapes or mixtures that are sold to general consumers
(“product” as in the Chemical Substance Control Law) are imported*1
*1 Please note that handling of products that make use of specified chemical substances differ.
<3> Other cases where notifications are specified as being unnecessary due to laws, etc.
(4) Cases where the total of the amount of chemical substances manufactured in Japan and the amount
of chemical substances imported into Japan during FY2010 is less than 1 ton per company for each
chemical substance
(5) Cases where chemical substances are manufactured or imported for testing and research purposes
(6) Cases where the substances have been confirmed as being an intermediate, etc., polymers of low
concern, or low production
(7) Cases where a substance excepted from notification*2 (substances designated by the 3 Ministers as
there being no necessity to conduct risk assessment) was manufactured or imported
27
*2 Substances excepted from notification are planned on being added every year.
(7) Notification of the Amounts of Manufacture, Import, etc., regarding Priority Assessment
Chemical Substances (new category) (1/2)
(1) Subjects of Notification
○ Notification is obligatory under the provisions of the Chemical Substances Control Law on persons who have
manufactured or imported Priority Assessment Chemical Substances.
○ Chemical substances that are manufactured or imported in an amount 1 ton or more per company regarding 1
chemical substance
○ Chemical substances containing 1% or more by weight of impurities in the case of mixtures (Intended products are
subject to the obligation of notification regardless of their percent by weight).
○ The manufacture of those chemical substances that are entirely consumed within the manufacturer company
(intermediate products for in-house use), regardless of whether this is within the same establishment or not, will be
exempt from mandatory notification.
Caution: The import of those chemical substances to be consumed entirely within the importer company will be subject to mandatory notification.
(2) Details of Notification
○ The format prescribed by METI related Ordinance for Enforcement of the Chemical Substances Control
Law(Format 12) should be used.
○ The amounts of manufacture, import and shipment (for each prefecture) in the previous fiscal year should be
notified using the actual figures.
○ Both the category of use (in double digits) and the detailed category of use (in single digit) should be notified
regarding use.
○ The CAS number (if known) should be stated (in the column Other Numbers).
(3) Time of Notification
○ Notification should be made between April 1 and June 30, inclusive (by paper, electronically, by CD, etc.)
(4) Handling of Notified Data
○ To be utilized for the risk assessment of Priority Assessment Chemical Substances
○ Substances for which the amounts of manufacture and import exceed 100 tons in total actual figures, the total
amount should be announced using the actual figure.
28
(7) Notification of the Amounts of Manufacture, Import, etc., regarding Priority Assessment
Chemical Substances (new category) (2/2)
General Chemical
Substances
Priority Assessment Chemical Substances
Place of
Manufacture
－
Name and location of establishment
Amounts of
Manufacture and
Import
Annual amounts of
manufacture and import
Annual amount of manufacture by prefecture
Amount of import by country or territory
Amount of
Shipment
By use category
By prefecture and by use category
Use Category
About 50 categories
About 280 categories
29
(8) Information Delivery in the Supply Chain (Priority Assessment Chemical Substances)
When Priority Assessment Chemical Substances are transferred between business entities, the
entity transferring the substance is obliged to make the utmost efforts to inform the recipient that
the substance is specified as the Priority Assessment Chemical Substance etc.
For Class II Specified Chemical Substances, Monitoring Chemical Substances, and Priority
Assessment Chemical Substances, the three relevant ministries and the competent ministers may
instruct the business entity handling the substance to report the status of transaction.
Supply chain
Control of chemical substances in the supply chain
Manufacturer of
raw materials
Primary processing manufacturer
Parts manufacturer
Manufacturer of assembled products
Articles
Chemical substances/preparation
General consumers
Supply chain
Chemical preparation
/products
Manufacturer of raw materials
Primary
processing
manufacturer
Manufacture
and import
(Examples of measures)
- Prohibition of manufacture
and import
- Restriction on manufacture
and import
- Reduction of release through
improvement of
manufacturing facilities
- Control of intermediates
Articles
Part
manufacturer
Use and
processing
(Examples of control)
- Restriction on use and intended use
- Reduction of amount of use through
improvement of manufacturing facilities
- Review the needs and possibility of
overuse
- Improvement of recovery rate,
achievement of thorough reuse,
measures on handling
- Shifting to alternative substance
30
(9) Handling of the Monitoring Chemical Substances
Classifications of Chemical Substances subject to Type II Monitoring and Type III Monitoring are
to be discontinued after the PACs (Priority Assessment Chemical Substances) are established
Classification of Chemical Substances subject to Type I Monitoring will be renamed “Monitoring
Chemical Substances” and remain effective
- Under the system of Chemical Substances subject to Type II Monitoring, chemical substances that
pose a risk of harming human health are designated and the manufacturers and importers of such
substances are requested to report the amount of manufacture or import.
- Under the system of Chemical Substances subject to Type III Monitoring, chemical substances that
have a risk of imposing adverse effects on the habitats of or the growth of plants and animals are
designated and the manufacturers and importers of such substances are requested to report the
amount of manufacture or import.
- Classifications of Chemical Substances subject to Type II and Type III Monitoring are to be
discontinued after the new classification of the PACs is made effective under the amended Law in
order to assess the toxicity of the substances to human health and flora and fauna.
- The classification of Chemical Substances subject to Type I Monitoring, the “predecessor” of
Class I Specified Chemical Substances.
31
(10) Reporting, etc., of Hazard Information (1/2)
○ Cases where reporting to any government
office is required
(1) Cases where a company already has any
unpublished knowledge within itself (cases for due
diligence).
・
Priority Assessment Chemical Substances,
Monitoring Chemical Substances and Class II
Specified Chemical Substances are subject to
mandatory notification.
・ No penalty will be applied.
(2) Cases where new tests, etc., have been
conducted to obtain knowledge concerning hazard
(obligatory cases)
・ General chemical substances, Priority Assessment
Chemical
Substances,
Monitoring
Chemical
Substances and Class II Specified Chemical
Substances are subject to mandatory notification.
・ Penalty will be applied.
○ Knowledge Subject to Reporting
・ Physicochemical properties (melting point, boiling point, etc.)
・ Degradability (photo degradability, hydrolizability, etc.)
・ Accumulative property (bioaccumulative property, etc.)
・ Toxicity, etc., to humans (chronic toxicity, teratogenicity,
pharmacological properties, etc.)
・ Toxicity to flora and fauna (impact on plants, birds and fish)
・ Other toxicologically important impacts (including any
knowledge about any product of a substance in cases where
the substance is susceptible to chemical change and the
product falls under any of the cases described above).
1) Knowledge of any persistent property
(substances shown to be persistent under persistence test in
microorganisms, etc.)
2) Knowledge of any high enrichment property
(substances shown to have high enrichment property in
enrichment test of fishes and shellfishes, etc.)
3) Knowledge of any long-term toxicity to human health
(chronic toxicity, teratogenicity, etc.)
4) Knowledge of any toxicity to flora and fauna
(toxicity to aquatic plants, impact on the reproduction of birds,
etc.)
5) Where chemical changes easily occur and the products fall
within the cases described above, knowledge about the
products.
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(10) Reporting, etc., of Hazard Information (2/2)
○ Cases where any government office
requires submission of information:
・Priority Assessment Chemical Substances are
the subjects. Test data will be used for risk
assessment.
・No penalty.
○ Cases where any government office
designate a hazardous properties study :
・Monitoring Chemical Substances and Priority
Assessment Chemical Substances are the
subjects. Test data will be used to determine
whether they fall under the category of Class I
or Class II Specified Chemical Substances.
・ Penalty will be imposed.
○ Test data subject to submission
1) Test data concerning physicochemical properties
2) Test data concerning degradability
3) Test data concerning the accumulative property
4) Test data concerning the impact on human health
(28-day toxicity test by repeated administration, Ames test,
chromosome aberration test, etc.)
5) Test data concerning the impact on flora and fauna in the
human living environment
(growth inhibition test on algae, acute swimming inhibition
test on water fleas, acute toxicity test on fish)
○ Items to which study is instructed
1) Investigation into the impact on human health
(carcinogenicity, teratogenicity, chronic toxicity,
mutagenicity, etc.)
[In the case of Monitoring Chemical Substances]
2) Investigation into the impact on higher order predators
(reproductive test in birds, reproductive test in mammals,
later-generation impact test)
[In the case of Priority Assessment Chemical Substances]
2) Investigation into the impact on flora and fauna in the
human living environment
(growth of algae, reproduction of water fleas, inhabitation
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of fish, etc.)
(Supplement) Frequently Asked Questions:
About cases where notification is not required (reposted)
The following cases are not subject to the obligation to notify the amount of manufacture or import of
general chemical substances or Priority Assessment Chemical Substances (PACs). (Notification is not
required). *”Implementation of the Law Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.”
(Notice by the Director General)
<1> Cases where notification is not necessary due to lack of applicability to “manufacturing” of chemical
substances as in the Chemical Substance Control Law
- Cases where chemical substances purchased from a company in Japan are sold as is
- Cases where chemical substances purchased from a company in Japan are made into a product
based on a mixing, forming, or purification process, etc. that does not cause chemical reactions
<2> Cases where notification is not necessary due to lack of applicability to “importing” of chemical
substances as in the Chemical Substance Control Law
(3) Cases where products that possess specific shapes or mixtures that are sold to general consumers
(“product” as in the Chemical Substance Control Law) are imported*1
*1 Please note that handling of products that make use of specified chemical substances differ.
<3> Other cases where notifications are specified as being unnecessary due to laws, etc.
(4) Cases where the total of the amount of chemical substances manufactured in Japan and the amount
of chemical substances imported into Japan during FY2010 is less than 1 ton per company for each
chemical substance
(5) Cases where chemical substances are manufactured or imported for testing and research purposes
(6) Cases where the substances have been confirmed as being an intermediate, etc., polymers of low
concern, or low production
(7) Cases where a substance excepted from notification*2 (substances designated by the 3 Ministers as
there being no necessity to conduct risk assessment) was manufactured or imported
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*2 Substances excepted from notification are planned on being added every year.
(11) Summary
○ Notification of general chemical substances will become obligatory (from FY2011)
The amounts of manufacture and import, the use information, etc., will have to be
notified regarding general chemical substances of 1 ton or more. However, there
will be some exceptions for which no notification is required.
○ A notification system will be started for Priority Assessment Chemical Substances
(from FY2011)
Initially, Priority Assessment Chemical Substances deriving from Class II and Class
III Monitoring
g Chemical Substances will be designated.
g
The amounts of manufacture and import, detailed use information, etc., will have to
be notified with respect to Priority Assessment Chemical Substances of 1 ton or
more.
○ Efforts at the supply-chain level are expected for distribution of information
regarding Priority Assessment Chemical Substances.
○ Hazard Report
Due diligence will be required for reporting already owned data.
In cases where any hazard data is newly obtained through testing, reporting of the
data will be obligatory.
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Useful URLs for the Information on the Chemical Substance Control Law
Ministry of Economy, Trade and Industry
http://www.meti.go.jp/policy/chemical_management/index.html
Please give us your comments and inquiries to:
[email protected]
Ministryy of the Environment
http://www.env.go.jp/chemi/kagaku/index.html
Ministry of Health, Labour and Welfare
http://www.nihs.go.jp/mhlw/chemical/kashin/kashin.html
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Thank you.
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