Session 1, September 9, 2010
The 4th Tripartite Policy Dialogue on Chemical Management

Current Trend of Chemical
Management Policy in Japan

Tadahiro IKEMOTO
Chemicals Evaluation OfficeEnvironmental Health Department
Ministry of the Environment, Japan
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Contents
1. Overview
2. Current trend of chemical management in Japan (1)- Amendment to the Chemical Substances Control
Law in 2009
3. Current trend of chemical management in Japan (2)- Amendment to the Order for Enforcement of theChemical Substances Control Law in 20092

1. Overview of Chemical
Management Policy in Japan

3Regulation Overview
Act on the Evaluation of Chemical Substances and Regulationof Their Manufacture, etc. (Chemical Substances Control Law)
● Regulations on Manufacturing, etc.
- Elements and natural products- Chemical substances
General usage(industrial)- General industrial
chemical products

Specific usage-Foods, additives, containers and packaging, toys and detergents- Agricultural chemicals-Ordinary fertilizers- Feeds and feed additives- Drugs, quasi-drugs, cosmetics and medical equipments- Radioactive substances- Specified poison- Stimulant and raw materials for stimulants- Narcotic● Regulations on Emissions[Water Pollution Control] [Air Pollution Control] [Soil Contamination Countermeasures]● Regulations on Waste[Waste Management and Public Cleansing]4Act on the Evaluation of Chemical Substances andRegulation of Their Manufacture, etc.
(Chemical Substances Control Law (CSCL))◆Enacted in 1973

(two major amendments in 1986 and 2003)◆ Aiming to prevent environmental pollution from PCBs andother hazardous chemicals◆Based on two pillars:- prior evaluation of new chemicals- regulation on manufacture/import and use◆Excluded: specific chemicals covered by other regulations
e.g. agrochemicals, pharmaceuticals, food, fertilizers◆ Three Ministries are in charge: MHLW, METI, MOE(No role of local governments under CSCL)

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Current CSCL (As of April 2010)
Existing
Chemical Substances

New Chemical Substances
Specified Cases> 1 ton/year ≤ 1 ton/year (e.g., intermediates)

Polymersof Low Concern

Evaluation of PBT*
Prior verificationand monitoring

Evaluation of PBT*Type I Monitoring
Chemical SubstancesType II Monitoring
Chemical Substances

Order to investigate
long-term toxicity

Order to investigate
long-term toxicity

Class I Specified
Chemical SubstancesType III MonitoringChemical Substances

Order to Investigate
long-term toxicity

Class II Specified
Chemical Substances*P:Persistent
B:Bioaccumulation
T:Toxicity

Obligatory reporting of hazard information obtained by business6Types of chemicals regulated under CSCL
Name

Explanation

No. ofsubstances*Class-I Specified
ChemicalSubstances

Persistent, bioaccumulative, and toxicity (long-term toxicity forhumans or long-term toxicity for predator animals at higher
trophic level)

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Class-II Specified
ChemicalSubstances

Persistent, toxicity (long-term toxicity for humans or long-term
toxicity for flora and fauna in the human living environment) withconcern for a considerable amount of the chemical substanceremaining in the environment over a substantially extensive area

23

Type-I Monitoring
ChemicalSubstances

Persistent and bioaccumulative, but toxicity properties unknown(Candidates for the Class-I Specified Chemical Substances)37

Type-II Monitoring
ChemicalSubstances

Persistent and Suspected long-term toxicity for humans(Candidates for the Class-II Specified Chemical Substances)

1,070

Type-III Monitoring
ChemicalSubstances

Persistent and Suspected toxicity for flora and fauna(Candidates for the Class-II Specified Chemical Substances)277, Amended in 2009*, As of April 20107

2. Current trend of Chemical
Management in Japan (1)- Amendment to the Chemical Substances
Control Law in 20098

Summary of Amendment to CSCL in 2009 (1)To control chemical substances comprehensively, the government
reviews measures for the risk assessment of chemical substances andscope of the chemical substances regulated, 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 to accept
certain exceptional uses of the newly prohibited chemicals.
- The existing law, which is more restrictive on exceptional uses, may fail topermit the essential uses for Japan.
Japan9Summary of Amendment to CSCL in 2009 (2)(1) Measures for existing chemical substances- Companies that manufacture or import any chemical substance,
including existing one, in excess of the specified amounts are obliged
to notify applications containing quantity and other information 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 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 ensures that substances newly listed under theinternational convention can be used under strict control.
− Uses for semiconductors, fire fighting foam, etc.

10Key Points of Amendment in 2009 (1)(1) Shift to Risk-based chemical management
Risk = Hazard × Amount of Exposure
Hazard: Potential adverse effects of chemicals for human health and theenvironment
Amount of Exposure: Potential amount of chemicals which may expose
human and ecosystem

Before the Amendment

After the Amendment

Regulations are mainly
based on hazards ofRegulations shall bemainly based on risks ofchemicals

chemicals

11Key Points of Amendment in 2009 (2)(2) 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 “PriorityAssessment 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 “ClassII Specified Chemical Substances,” which category is stipulated in the current law.
12Key Points of Amendment in 2009 (2)(2) Introduction of a comprehensive control system that covers theexisting chemical substances(e) In addition to “chemical substances which is persistent in the environment,” which havebeen under control, “chemical substances which is not persistent in the environment”
are regulated in the amended law.

Before the Amendment

After the Amendment

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

Non- persistent chemicals arealso regulated,regulated because they
may have adverse effect on
the environment, when they
are emitted more than thatcan be decomposed throughnatural processes.
13Key Points of Amendment in 2009 (3)(3) Appropriate control on chemical substances in the supply chain
To prevent environmental pollution by Class II Specified Chemical Substances andproducts containing those, the law requires companies handling those to adhere tospecific handling standards and to label those as needed for transactions.

Before the Amendment

After the Amendment

Companies manufacturingand importing specified
chemicals are required toadhere to specific handlingstandards and to label
those as needed fortransactions.

Companies handling specified
chemicals and products
containing those are also
required to adhere to specifictechnical standards and tolabel them as needed fortransactions.
14Key Points of Amendment in 2009 (4)(4) 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 theexceptional use of substances that will be listed under the Stockholm Convention in
the future under strict control.

Before the Amendment

After the Amendment

Class I Specified Chemical
Substances could be only
used, when there is nosubstitute,substitute and they don’t
use mainly in the daily
lives of consumers andhave no risks of causing
environmental pollution.
pollution

Class I Specified Chemical
Substances are permitted incase of the exceptional use
listed under the Stockholm
Convention. While, obligations
to adhere to specific handlingstandards and label them are15added.
addedKey Points of Amendment in 2009 (5)(5) Notification to related Ministers of information
on chemical substances
The government aims toallow related Ministries to share increased
amounts of information gathered under theamended law
enforce more effective regulations on chemical
substances pursuant to relevant laws andordinances in the future under strict control
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Schedule of the Enforcement
2009.5.20 Promulgation
2010. 4. 1. Enforcement(Except obligation to notify quantity and otherinformation for any chemicals and designation of thePriority Assessment Chemical Substances, etc.)
2011. 4. 1. The unenforced regulations under CSCL will
become effective

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CSCL amended (April 1, 2011〜)
Existing Chemical Substances

New Chemical Substances
Specified Cases> 1 ton/year ≤ 1 ton/year (e.g.,intermediates)

Polymersof Low Concern

Evaluation of PBT*

Prior verificationand monitoring

General Chemical Substances

Determination by available
knowledge, the state of its
manufacture, import, etc.

Determination by available
knowledge, the state of its
manufacture, import, etc.

Monitoring Chemical Substances
if necessary

Instruction to report
the state of handling
if necessary

Order to investigate
long-term toxicity

Class I Specified
Chemical Substances

Priority Assessment
Chemical Substances
if necessary

Instruction to report
the state of handling
if necessary

Order to Investigate
long-term toxicity

Class II Specified
Chemical Substances*P:Persistent
B:Bioaccumulation
T:Toxicity

Obligatory reporting of hazard information obtained by business18

Types of chemicals regulated under CSCL
(April 1, 2011〜)
NameExplanation

Class-I Specified
ChemicalSubstances

Persistent, bioaccumulative, and toxicity (long-term toxicity for humans or longterm toxicity for predator animals at higher trophic level)

Class-II Specified
ChemicalSubstances

Toxicity (long-term toxicity for humans or long-term toxicity for flora and fauna in
the human living environment) with concern for a considerable amount of thechemical substance remaining in the environment over a substantially extensive
area

Monitoring
ChemicalSubstances

Persistent and bioaccumulative, but toxicity properties unknown(Candidates for the Class-I Specified Chemical Substances)

Priority Assessment
ChemicalSubstances

・Not found that it is clear chemical substance does not pose long-term toxicity
・Considerable amount of chemical substance remains in the environment
・Not thought not to pose a risk

Existing Chemical
Substances

Chemical substances that were already manufactured/imported at the time of thepromulgation of Chemical Substance Control Law (in 1973)

General ChemicalSubstances

Sufficiently low risk of the substance can be confirmed
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3. Current trend of Chemical
Management in Japan (2)- Amendment to the Order for Enforcement ofthe Chemical Substances Control Law in 200920

Key Points of Amendment in 2009
1. Specified Chemical Substances(1) Additional designation for Class I Specified Chemical Substances
12 new chemicals,chemicals added to the list chemicals in Annex A, B or C of
the Stockholm Convention, were designated the Class I Specified
Chemical Substances under CSCL (Enforced in April 1, 2010)
Perfluorooctane-1- sulfonic acid (PFOS) or its salts
Perfluorooctane-1- sulfonyl fluoride (PFOSF)
Pentachlorobenzene
1-alpha,2-alpha,3-beta,4-alpha,5-beta,6-beta-Hexachlorocyclohexane(alpha-Hexachlorocyclohexane)
1-alpha,2-beta,3-alpha,4-beta,5-alpha,6-beta-Hexachlorocyclohexane(beta-Hexachlorocyclohexane)
1-alpha,2-alpha,3-beta,4-alpha,5-alpha,6-beta-Hexachlorocyclohexane(gamma-1,2,3,4,5,6-Hexachlorocyclohexane or Lindane)
Decachloropentacyclo[5.3.0.02,6.03,9.04,8]decan-5-one (Chlordecone)
Hexabromobiphenyl
Tetrabromophenoxybenzene (Tetrabromodiphenyl ether)
Pentabromobiphenyl (Pentabromodiphenyl ether)
Hexabromophenoxybenzene (Hexabromodiphenyl ether)
Heptabromophenoxybenzene (Heptabromodiphenyl ether)21

(2) Addition of Articles containing Class I Specified Chemical Substances
for Import-prohibited Items
14 Articles with 3 new Class I Specified Chemical Substances wereprohibited against their import (Enforced in May 1, 2010)[PFOS and its salts]
Aviation hydraulic fluids
Spinning oil
Etching agent for processing of metal
Etching 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)
Surface preparation agent or its preparation additives for metal plating
Anti-reflective coating for semi-conductor production
Abrading agent
Fire extinguisher, fire-extinguishing chemical for fire extinguisher and fire fighting foam
Insect baits (limited to insecticides for control of termites or ants)
Photographic paper[Tetrabromodiphenyl ether and Pentabromodiphenyl ether]
PaintsAdhesives22(3) Essential Uses of Class I Specified Chemical SubstancesClass I Specified Chemical Substances should not be used in principle; however, thefollowing exceptional uses shall be acceptable (Enforced in April 1, 2010)
Essential Uses of Class I Specified Chemical Substances[PFOS or its salt]
Production of etching agent (limited to ceramic filter or the compound-semi-conductor whichmakes it possible for the radio equipment to send and receive an equal to or more than 3 MHz
frequency electric wave)
Production of photo-resist for semi-conductor
Production of photographic film for industryThose who use Class I Specified Chemical Substances in their articles shallfollow the technical standards and implement labeling to prevent theenvironmental pollution (Enforced in October 1,2010)
Articles with the Class I Specified Chemical Substances which shall conform to the technical standards
and labeling[PFOS or its salt]
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)
Photo-resist for semi-conductor
Photographic film for industry
fire extinguisher, fire-extinguishing chemical for fire extinguisher and fire fighting foam (for the23time being)(4) Designation of Articles with the Class II Specified ChemicalSubstances which must conform to the technical standards andlabeling
11 Articles with 3 Class II Specified Chemical Substances were designated to
impose new obligations of technical standards and labeling[Trichloriethylene]
Adhesives (excluding those of animal and botanical origin)
Paints (excluding water-based paints)
Metalworking fluids
Cleaning agents[Tetrachloroethylene]
Vulcanized agents
Adhesives (excluding those of animal and botanical origin)
Paints (excluding water-based paints)
Cleaning agents
Finishing agents for textile goods[Tributyltin compounds]
Antiseptics and fungicides
Paints (limited to those used to prevent shellfishes, algae, and other living organisms inwater from adhering to surfaces)24II. Measures Concerning General Chemical Substances, etc.
・The minimum amount of manufacture or import of General
Chemical Substances and Priority Assessment Chemical
Substances subject to notification is set as 1
ton/year/company

III. Schedule (Date of Promulgation: October 30, 2009)

・April 1, 2010
→ Additional designation of Class I Specified Chemical Substances, their Essential
uses and Articles with the Class II Specified Chemical Substance which shallconform to the technical standards and labeling・May 1, 2010
→ Additional designation of the Articles containing Class I Specified Chemical
Substances for import-prohibited items
・October 1, 2010
→ Articles with the Class I Specified Chemical Substances shall conform to thetechnical standards and labeling・April 1, 2011
→ Notification of General Chemical Substances and Chemical Substances requiring
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Priority Assessment

Future Challenges for Enforcement ofCSCL Amended
Establish overall road map of assessment
Review (if changes are introduced, or periodically)

Screening assessment to prioritize substances subject to detailed
assessment
Collect hazard information
Identify hazards and patterns of exposure

Detailed risk assessment to decide whether further measures need
to be introduced
Analyze risk in detail
Stepwise approach to improve the accuracy and efficiency of assessment
Comprehensive Management System for Chemical Substances26

Thank you for your kind attention!

MOEJ’s website（English）
http://www.env.go.jp/en/（中文）
http://www.env.go.jp/cn/（한국어）
http://www.env.go.jp/kr/
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