Chemical Regulation Policy
in Japan

Tokuya WADA
Chemicals Evaluation OfficeEnvironmental Health Department
Ministry of the Environment, Japan
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Contents
1. Overview
2. Recent trend on chemical regulations in Japan- Amendment of the Chemical Substances
Control Law
3. Summary of the Order for Enforcement of the
Chemical Substances Control Law
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1. Overview of Chemical
Management Policy in Japan3

Risks tohumanhealthDirectimpacts

Indirect
impacts(via
environment)

Workers’ health &safety- Labor Safety & Health Law-Explosives Control Law-High Pressure Gas Safety Law

Consumers’
health &safety-Poisonous and Deleterious Substances
Control Law- Food Sanitation Law- Law for the Control of Household ProductsContaining Harmful Substances

Public health &safety[emission regulation]- Waste Disposal Law- Air Pollution Control Law- Water Pollution Control Law[prior evaluation, production/importregulation] Act on the Evaluation ofChemical Substances and Regulation of
Their Manufacture, etc. (Chemical
Substances Control Law)

Risks to theenvironment

Preservation of theenvironment

Agricultural Chemicals
Regulation Law

Law for PRTR and Promotion ofChemical Management

Regulation Overview

4Chemical Substances Control Law
Monitoring
substances
Reporting ofproduction
volumePersistence &bioaccumulation
Persistence & suspectedlong-term human toxicity

Long-term toxicity
to humans or highpredators
Long-term toxicity
to humans & wildlife,
existence in theenvironment

Persistence &Eco-toxicity

Class I specified
substances
Ban on production
and useClass II specified
substances
Restriction on
production and use

Chemicals

Chemical Management Law
Existence in theenvironment

Toxicity to humans
or wildlife, orozone depletion

Potential existencein the environment

Type I substances
PRTR and MSDS
Type II substances䠖MSDS

Air Pollution Control Law
Human toxicity &potential exposure

Priority substances
Voluntary measures,env. monitoring

Concernfor healthdamageGuidancevaluesEnv. quality
standards,
emission
regulation

Water Pollution Control Law
Human or ecotoxicity, potential
exposure

Monitoring substances䠖
Guidance values, env
monitoring

Concernfor healthdamageEnv. quality
standards,
emission regulation

Regulation on emission or leaching under Soil Pollution Control Law, Waste Management Law,
etc.

Act on the Evaluation of Chemical Substances andRegulation of Their Manufacture, etc. (Chemical
Substances Control Law (CSCL))‫ی‬Enacted in 1973

(two major amendments in 1986 and 2003)
䕺 Aiming to prevent environmental pollution from PCBs andother hazardous chemicals⅌Based on two pillars:- prior evaluation of new chemicals- regulation on manufacture/import and use‫ی‬Excluded: specific chemicals covered by other regulations
e.g. agrochemicals, pharmaceuticals, food, fertilizers
䕺 Three Ministries are in charge: MHLW, METI, MOE
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Current (2003 Amended) CSCLNew Chemicals

Existing Chemicals> 1 ton/year≤ 1 ton/year

Specified Cases(e.g. intermediates)

Evaluation of PBT*
Evaluation of PBT*Type I
Monitoring Chemicals

Type II
Monitoring Chemicals

Order to investigate
long-term toxicity

Order to investigate
long-term toxicity

Class I
Specified Chemicals≤10 ton/year

Prior verification
And monitoring

Type III
Monitoring Chemicals

Order to Investigate
long-term toxicity

Class IISpecified Chemicals*P:Persistent
B:Bioaccumulation
T:Toxicity

Obligatory reporting of hazard information obtained by business7

Types of chemical regulated under CSCL
Name

Explanation

No. ofsubstancesClass-I Specified
ChemicalSubstances

Persistent, bioaccumulative, and hazardous (long-term
human toxicity or ecotoxicity to higher predators.

16

Class-II Specified
ChemicalSubstances

Persistent, hazardous (long-term human toxicity or
ecotoxicity to living organisms), with concern for long-term
existence in the environment.

23

Type-I Monitoring
ChemicalSubstances

Persistent and bioaccumulative,
but hazardous properties unknown.
(Candidates for the Class-I Specified Chems.)

36

Type-II Monitoring
ChemicalSubstances

Persistent and suspected as hazardous to human health.
(Candidates for the Class-II Specified Chems.)

952

Type-III Monitoring
ChemicalSubstances

Persistent and hazardous to living organisms.
(Candidates for the Class-II Specified Chems.)

157

Note: Number of chemicals as of October 2009.

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Regulation on Chemicals under CSCLClass I Specified
Chemicals-prior permission required for manufacture and/or import (Note:
Permission is prohibited virtually.)- prohibition of use unless authorized in advance- prohibition of import of products containing them- recovery of the products

Class II Specified
Chemicals- mandatory reporting of planned manufactured and/or imported
amounts- subject to governmental orders that require the change of planned
amounts- labeling- compliance with technical guideline provided by GOJ and/or
governmental recommendation on a legal basis- compliance with guidance provided by GOJ

Monitoring Chemicals(Type I, II and III)- mandatory reporting of manufactured and/or imported amountannually (Note: These amounts are announced publicly.)-compliance with guidance provided by GOJ-The GOJ can instruct manufacturer/importer investigate their longterm toxicity
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2. Recent trend on Chemical Regulationsin Japan- Amendment of the Chemical Substances
Control Law

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Amendment of CSCLØTo be reviewed after 5 years from 2003, the entry into force ofAmendment of CSCL (Supplementary Provisions Article 6)

Ø Schedule of legislative review
Jan. 2008 Started the deliberation for CSCL on the Central
Environment Council
эJoint deliberation with the Health Science Council and Industrial Structure
Council

Dec. in 2008 Report on the review of CSCL from the Council
To MOE
Feb. in 2009 Cabinet decision based on the review of CSCL
April in 2009 Deliberation of draft amended CSCL in the Dietwas started.
May in 2009 Amended CSCL was published11Summary of Amended CSCL in 2009 (1)To control chemical substances comprehensively, the government
reviews measures for the risk assessment of chemical substances andscope of the regulated chemical substances, while taking measures torationalize regulations in view of international trends.

Background and necessity of the amendment
1. Increasing public interest in chemical substances
2. Need to achieve international goals on chemicals management- There is a need to minimize adverse effects of all chemicals on human healthand the environment by 2020 (agreement in the World Summit on Sustainable
Development(WSSD), 2002).

3. Inconsistency with the international convention- Under the Stockholm Convention, the agreement was reached this spring toaccept certain exceptional uses of the newly prohibited chemicals.
- The existing law, which is more restrictive on exceptional uses, may fail topermit the uses essential to Japan.
12Summary of Amended CSCL in 2009 (2)(1) Measures for existing chemical substances- Companies that have manufactured or imported any chemical
substance, including existing one, in excess of the specified amounts
are newly obliged to notify applications containing quantity and otherinformation to the government.
- Upon receipt of those applications, the government screens andprioritizes substances subject to detailed risk assessment. The
manufacturers/importers may be required to submit information on
hazardous properties of these substance for government evaluation.
- Based on the evaluation, the government shall decide whether toregulate the manufacture/use of the substance and its product, etc.

(2) Ensuring international consistency- The government ensure that substances newly listed under theinternational convention can be used under strict control.
䠉 Uses for semiconductors, fire fighting foam, etc.

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Key Points of Amended CSCL in 2009 (1)Shift to Risk-based chemical management
Risk = Hazardousness 㽢 Amount of Exposure
Hazardousness: Potential adverse effects of chemicals for human healthand the environment
Amount of Exposure: Potential amount of chemicals which may expose forhuman and ecosystem

CURRENT CSCLAMENDED CSCL

Regulations were mainly
based onRegulations will be mainly
based on risks ofhazardousness ofchemicals

chemicals
14Key Points of Amended CSCL in 2009 (2)(1) Introduction of a comprehensive control system that covers theexisting chemical substances(a) Companies that have manufactured or imported any chemical substance, including
existing one, in excess of the specified amounts are newly obliged to notify quantity andother information for every fiscal year.
(b) Chemical substances which the government identifies from contents of the notifications
and available knowledge of their hazardous properties shall be designated as “Priority
Assessment Chemical Substances, which have higher priority in the risk assessment.”(c) Manufacturers and importers of the Priority Assessment Chemical Substances are
required to submit information on hazardous properties, and companies handling them
are required to report their uses when necessary.
(d) Among the Priority Assessment Chemical Substances, substances which raise concerns
about adverse effects on humans or the environment through the gathered informationand the risk assessment shall be subject to regulations on manufacture and use as“Specified Chemical Substances,” which category is stipulated in the current Law.
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Key Points of Amended CSCL in 2009 (2) cont’d(1)Introduction of the framework on comprehensive control thatcovers the existing chemical substances(e) In addition to “chemical substances which is persistent in the environment”, whichhave been under control, “chemical substances which is not persistent in theenvironment” are regulated in the amended law.

CURRENT CSCLAMENDED CSCL

to prevent environmental
pollution caused bychemical substances thatare persistent, becausesuch chemicals remain in
the environment for a longterm.

Non- persistent chemicals arealso regulated, because they
may have adverse effect on
the environment, when they
are emitted more than thatcan be decomposed throughnatural processes.
16Key Points of Amended CSCL in 2009 (3)(2) Appropriate control on chemical substances in the supply chain
To prevent environmental pollution by the Specified Chemical Substances andproducts containing those, the amended law requires companies handling thoseto adhere to specific handling standards and obliges them to label those asneeded for transactions.

CURRENT CSCLAMENDED CSCL

Companies manufacturing
and importing specified
chemicals are required toadhere tospecific handling standards
and to label those asneeded for transactions.

Companies handling specified
chemicals and products
containing those are also
required to adhere to
specific handling standards andto label them as needed fortransactions.
17Key Points of Amended CSCL in 2009 (4)(3) Rationalization of the framework on evaluation and regulation inlight of international trends
The government eliminates international inconsistencies in its regulations, for example, byreviewing regulations on Class I Specified Chemical Substances in order to permit the
exceptional use of substances that will be listed under the Stockholm Convention in the
future under strict control.

CURRENT CSCLAMENDED CSCLClass I Specified chemicals
could be only used, when
there is no substitute, andthey don’t use mainly inthe daily lives ofconsumers and have norisks of causing
environmental pollution.

Class I Specified chemicals are
permitted in case of the
exceptional use listed under
the Stockholm Convention.
While, obligations to adhere to
specific handling standards
and to label them are added.
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Key Points of Amended CSCL in 2009 (5)(4) Notify related ministers of information on
chemical substances
The government aims to allow related ministries
to share increased amounts of information
gathered under the amended law and enforce
more effective regulations on chemical
substances pursuant to relevant laws andordinances in the future under strict control.

Schedule of the Amended CSCL
2010. 4. 1. Enforcement of the amended CSCL
(Except obligation to notify quantity and otherinformation for any chemicals, and designationof the Priority Assessment Chemical
Substances etc.*)
2011. 4. 1. The unenforced regulations under the CSCL will
become effective20

3. Summary of the Order for
Enforcement of the Chemical
Substances Control Law

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Key Points of Amended the Order of CSCL (1)1. Specified Chemicals(1) Additional designation for Class I Specified Chemicals
12 new chemicals, which were added to the list chemicals in Annex
A, B or C of the Stockholm Convention, were designated as the Class
I Specified Chemicals under the CSCL.
ØPerfluorooctane-1- sulfonic acid (PFOS) or its saltsØPerfluorooctane-1- sulfonyl fluoride (PFOSF)
ØPentachlorobenzene
Ø1-alpha,2-alpha,3-beta,4-alpha,5-beta,6-beta-Hexachlorocyclohexane(alpha-Hexachlorocyclohexane)
Ø1-alpha,2-beta,3-alpha,4-beta,5-alpha,6-beta-Hexachlorocyclohexane(beta-Hexachlorocyclohexane)
Ø1-alpha,2-alpha,3-beta,4-alpha,5-alpha,6-beta-Hexachlorocyclohexane
Ø(gamma-1,2,3,4,5,6-Hexachlorocyclohexane or Lindane)ØDecachloropentacyclo[5.3.0.02,6.03,9.04,8]decan-5-one (Chlordecone)ØHexabromobiphenylØTetrabromophenoxybenzene (Tetrabromodiphenyl ether)ØPentabromobiphenyl (Pentabromodiphenyl ether)ØHexabromophenoxybenzene (Hexabromodiphenyl ether)ØHeptabromophenoxybenzene (Heptabromodiphenyl ether)22

(2) Addition of the Articles which Import are Prohibited
When Class I Specified Chemical Substances are included
14 Articles with 3 new Class I Specified Chemicals were prohibitedagainst their import[PFOS or its salts]ØAviation hydraulic fluidsØSpinning oilØEtching agent for processing of metalØEtching agent for semi-conductor production (exclude the compound-semi-conductor
which makes it possible for the radio equipment to send and receive an equal to or morethan 3 MHz frequency electric wave)ØSurface preparation agent or its preparation additives for metal platingØAnti-reflective coating for semi-conductor productionØAbrading agentØFire extinguisher, fire-extinguishing chemical for fire extinguisher and fire fighting foamØInsect baits(limited to insecticides for control of termites or ants)ØPhotographic paper[Tetrabromodiphenyl ether and Pentabromodiphenyl ether]ØPaints
ØAdhesives

(3) Essential Uses of Class I Specified Chemical SubstanceüClass I Specified Chemicals should not use in principle, however
the following exceptional uses would be acceptable;
Essential Uses of Class I Specified Chemical Substances[PFOS or its salt]ØProduction 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)ØProduction of photo-resist for semi-conductorØProduction of photographic film for industryüThose who use Class I Specified Chemical Substances in theirarticles shall follow the technical standards and implement
labeling to prevent the environmental pollution.
Articles with the Class I Specified Chemical Substance which must conform to the technical standards
and labeling[PFOS or its salt]ØProduction 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)ØPhoto-resist for semi-conductorØPhotographic film for industryØfire extinguisher, fire-extinguishing chemical for fire extinguisher and fire fighting foam for the24time being

(4) Designation of Articles with the Class II Specified Chemical
Substance which must conform to the technical standards andlabeling

ü 11 Articles with 3 Class II Specified Chemicals were designatedto impose new obligations of technical standards and labeling[Trichloriethylene]
Ø Adhesives (excluding those of animal and botanical origin)ØPaints (excluding water-based paints)ØMetalworking fluidsØCleaning agents[Tetrachloroethylene]ØVulcanized agentsØAdhesives (excluding those of animal and botanical origin)ØPaints (excluding water-based paints)ØCleaning agentsØFinishing agents for textile goods[Tributyltin compounds]ØAntiseptics and fungicidesØPaints (limited to those used to prevent shellfishes, algae, and other living organisms inwater from adhering to surfaces)25II. Measures Concerning General Chemical Substances, etc.
䞉Notification of General Chemicals and Chemical Substances
Requiring Priority Assessment should be obligated for those
who manufacture and/or import chemicals more than 1 ton per
year

III. Schedule (published 30 October, 2009)
䞉April 1st, 2009
→ Additional designation of Class I Specified Chemicals, their Essential uses
and Articles with the Class II Specified Chemical Substance which must conformto the technical standards and labeling
䞉May 1st, 2009
→ Additional designation of the Articles which Import are Prohibited When Class I
Specified Chemical Substances are included
䞉October 1st, 2009
→ Articles with the Class I Specified Chemical Substance must conform to thetechnical standards and labeling䞉April 1st, 2011
→ Notification of General Chemicals and Chemical Substances requiring priority
assessment

Future Challenges for Enforcement of
Amended CSCL
ØEvaluation methods to screen for the Chemical
Substances Requiring Priority Assessment and detailed
risk assessment of the Chemical Substances Requiring
Priority Assessment
ü What are hazardous data needed to assess the risk?
ü How to apply the information based on QSAR and Category
Approach in evaluation methods under the amended CSCL?
ü How to assess the exposure of chemicals?

ØRisk assessment methods with non-persistent chemicals
ü Are other specific assessment methods needed?
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Thank you for your attention!

JMoE’s website
http://www.env.go.jp/en/

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