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Background and history of CSCL
Regulation under current CSCL
• Chemical types regulated• New chemicals / existing chemicals
Background of the amendment
New chemical management system• Risk assessment : tiered approach• Risk reduction : enhanced regulation on high risk chemicals
ScheduleBACKGROUND OF CSCL“Act on the Evaluation of Chemical Substances andRegulation of Their Manufacture, etc.”, abbreviated as“Chemical Substances Control Law” (CSCL), regulates
industrial chemicals in Japan.

ØØØEnacted in 1973
Originally aimed at preventing pollution of environment
from PCBs and other hazardous chemicals
Based on two pillars:- pre-marketing evaluation of new chemicals- regulation on manufacture/import and useRisks tohumanhealthDirectimpacts

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

IndirectPublic healthimpacts&(via
safetyenvironment)

Risks to theenvironmentPreservation of theenvironment[emission regulation]- Waste Disposal Law- Air Pollution Control Law- Water Pollution Control Law[prior evaluation,
production/import regulation]
Act on the Evaluation ofChemical Substances andRegulation of Their
Manufacture, etc. (Chemical
Substances Control Law)
Agricultural Chemicals
Regulation Law


Law for PRTR and
Promotion of Chemical
Management

COVERAGE OF CSCLHISTORYØ

1973 original law :•Ø1986 amendment :•Ø

Banned the production, import and use of persistent,
bioaccumulative and chronically toxic chemicals such as PCBs.

Regulated persistent and chronically toxic but nonbioaccumulating chemicals such as trichloroethylene, dependingon the situation where they remain in the environment.

2003 amendment :••The law introduced the regulation on persistent and ecotoxic
chemicals.
Chemicals with low possibility of exposure became exempt fromnotification or some of data requirement.

STRUCTURE OF CSCL
CSCL consists of two main features.
ØPre-marketing evaluation system for new chemicals

ØRegulation of chemicals specified according to thepotential for adverse effects

CSCL is enforced by three ministries.
ØØØ

Ministry of Health, Labour and Welfare
Ministry of Economy, Trade and Industry
Ministry of the EnvironmentExisting Chemicals

New Chemicals
Specified Cases> 1 ton/year ≤ 1 ton/year (e.g. intermediates)
Evaluation of PBT*

*P:Persistent
B:Bioaccumulation
T:Toxicity
Type I
Monitoring Chemicals

Order to investigate
long-term toxicity

Class I
Specified Chemicals

Evaluation of PBT*

≤10 ton/year

Prior verification
And monitoring

Type II
Type III
Monitoring Chemicals Monitoring Chemicals

Order to investigate
long-term toxicity

Order to Investigate
long-term toxicity

Class IISpecified Chemicals

Obligatory
reporting of
hazardinformation
obtained bybusinessCHEMICAL TYPES*as of Feb 2009.

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 longterm 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 humanhealth.
(Candidates for the Class-II Specified Chems.)

921

Type-III Monitoring
ChemicalSubstances

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

124
CHEMICAL TYPES (contd)
Class I
Specified
ChemicalSubstances-prior permission required for manufacture and/or import (Note: Permission isprohibited virtually.)- prohibition of use unless authorized in advance- prohibition of import of products containing them- recovery of the products

Class IISpecified
ChemicalSubstances- 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
ChemicalSubstances(Type I, II
and III)- mandatory reporting of manufactured and/or imported amount annually(Note: These amounts are announced publicly.)-compliance with guidance provided by GOJ-The GOJ can instruct manufacturer/importer investigate their long-term
toxicityNEW CHEMICALSManufacturers and importers of new chemicals must notify
the government before putting them into the market andsubmit data on their properties and toxicities.
The government evaluates the data and decides whether thechemicals fall within the types above-mentioned.

A new chemical is any chemical other than:ØØØChemicals in the Inventory of Existing Chemical Substances
Chemicals already designated as Specified or Monitoring Chemical
Substances
Chemicals already publicized as substances that do not need to be
designated as Specified or Monitoring Chemical Substances.
NEW CHEMICALS (contd)
Data to be submitted
Fate

Mammalian
toxicity

Ecotoxic
ity

Production
volume

1-10t

10t <

Ready biodegradabilityxx

Pow or bioconcentration in fish

x1)

x1)

Repeated dose 28-day oral toxicity in mammals

x1)

Bacterial reverse mutation test

x1)

Chromosome aberration in mammalian cell culturex1)

Mammalian chronic toxicity, toxicity to reproduction
and offspring, teratogenicity, carcinogenicity,
biotransformation and pharmacological effects

2)

Algae growth inhibition

x1)

Daphnia acute immobilisation

x1)

Fish acute toxicity

x1)

Avian reproduction toxicity, and mammalian toxicity
to reproduction and offspring2)

1) If a substance isfound to be readybiodegradable, othertests are not required.
However, tests for the
degradation products
are also required.
2) These tests are used
to designate achemical as a Class I
Specified Chemical
Substance. Therefore,
these tests are notrequired first.

NEW CHEMICALS (contd)
Number of the notifications

1996 1997

1998 1999 2000 2001 2002

2003 2004 2005

Japan
CSCL

320

325

352

323

373

322

292

362

426

443

EU
Directive

441

437

408

430

424

352

398

337

312

* 174

US
TSCA

1472

998 1105 1418

1233

948

1083

869

959

844

7HQWDWLYHILJXUHEXISTING CHEMICALSWhen the CSCL was passed in 1973, the Diet requested thatthe government should assess the safety of existing chemicals.
ØØ

Number of Existing Chemicals :about 20,000
Number of substances evaluated (as of March 2008) :Degradation & bioaccumulation

1543 by METI

Toxicity to human health326 by MHLW

Ecotoxicity

509 by MOE

Meanwhile, worldwide approaches to existing chemicals
were advanced in the 1990s. When the CSCL was amended
in 2003, the Diet resolved that government and industry
cooperate to investigate the safety of existing chemicals.
ØJapan Challenge Program (JPC) , announced in 2005, is now
under way => Next slideEXISTING CHEMICALS (contd)
The features of Japan Challenge Program (JPC) include;Ø Aim : accelerating collection of safety information for HPV
chemicalsØVoluntary Program•

Based on corporation between government and industryØInformation to be collected: OECD Screening Information Data
Set (SIDS)
ØCollected information will be made public• “Japan Chemicals Collaborative Knowledge Database (J-Check)
http://www.safe.nite.go.jp/jcheck/
EXISTING CHEMICALS (contd)ØTarget:ØProgress:••

imported in Japan over 1000 tons

Target of the
JCP program

Existing chemicals produced andCollecting by sponsoring comapnies(Core Target)

126 chemicals

Collection through international
cooperation (OECD HPV PGM ,US
Challenge Program etc)
(Japan contributes to OECD
program as well)

532 chemicals

June 2008: registered sponsors for 89 chemicals, with 105
companies and 3 associations (including 27 consortia)
participating
FY 2011: safety information on all chemicals will be public

BACKGROUND OF CSCL AMENDMENT
Schedule of legislative review
Ø PRTR Law䠖 To be reviewed 7 years after the entry into force (in 2007䠅
Ø CSCL䠖 To be reviewed 5 years after the entry into force of the 2003
Amendment of CSCL
Nov. 2006: Consulted the Central Environment Council on the future policy
for the environmental chemicals management
Aug. 2007: Interim report on the review of PRTR Law (Joint report with theIndustrial Structure Council)
Dec. 2008: Report on the review of CSCL (Joint report with the Health
Science Council and Industrial Structure Council
24 Feb 2009: Bill submitted to the Diet

Summary of the bill to amend the Chemical Substances Control Law
To comprehensively control chemical substances, the government reviews the measures for risk assessmentof chemical substances and the scope 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 (public safety
and security)
2. Need to achieve international goals on chemicals management- There is a need to minimize adverse effects of all chemicals
on human health and the environment by 2020 (agreement in
the World Summit on Sustainable Development, 2002).
- In Europe, a new regulation (REACH) entered into force
in 2007.
- Since the enactment of the Chemical Substances Control Law(in 1973), every new chemical substance has been subject topre-marketing evaluation.
- On the other hand, the government has been conducting safetyassessment of part of the existing chemical substances(chemicals in the market before the legislation) and not all ofthem have been assessed yet.
3. Inconsistency with the international treaty- Under the international treaty (Stockholm Convention), an
agreement is expected to be reached this spring to accept
certain exceptional uses of the newly prohibited chemicals.
- The existing law, which is more restrictive on exceptional
uses, may fail to ensure the uses essential to Japan.

Summary of the Amendment(1) Measures for existing chemical substances- Companies that have manufactured or imported any
chemical substance, including existing one, in excess of thespecified amounts are newly obliged to notify applications
containing quantity and other information to the government.
- Upon receipt of those applications, the government screensand prioritizes substances subject to detailed risk assessment.
For these substances, the manufacturers/importers may berequired to submit information on hazardous properties forgovernment evaluation.
- Based on the evaluation, the government decides whether toregulate the manufacture/use of the substance and its
product, etc.

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

(For reference)1973 Enactment of the Chemical Substances Control Law
Related moves 2002 World Summit on Sustainable Development
2004 Entry into force of the Stockholm Convention
2007 Entry into force of REACH (Europe)2020 Completion of safety confirmation by
respective countries
2018 REACH registration deadline

WSSD GOAL – BASIS FOR NEW CSCLWorld Summit on Sustainable Development (2002) agreed:Ø to achieve, by 2020,Ø that chemicals are used and produced in ways that lead to theminimization of significant adverse effects on human health and theenvironment,Ø using transparent science-based risk assessment procedures andscience-based risk management procedures,
Ø taking into account the precautionary approach, as set out in principle
15 of the Rio Declaration on Environment and Development
REACH Preambles mention WSSD 2020 goal and SAICM, and aims to finish
the registration of all chemicals by 2018.
US EPA announced the Chemical Assessment and Management Program(ChAMP)RISK ASSESSMENT :TIERED APPROACH
Ø Companies that have manufactured or imported any chemical substance inexcess of the specified amounts are newly obliged to notify quantity andother information for every fiscal year.
Ø 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 shall be designated as “Priority
Assessment Chemical Substances.”Ø Manufacturers and importers of those Priority Assessment Chemical
Substances may be required to submit information on hazardous properties
and companies handling them may be required to report their uses.
Ø Among the Priority Assessment Chemical Substances, substances whichraise concerns about adverse effects on humans or the environment throughthe information gathering and the risk assessment shall be subject toregulations on manufacture and use as “Specified Chemical Substances,” asin the existing Law.
Ø The amended law will cover non-persistent chemical substances, which
were not covered by the current law.

RISK ASSESSMENT (contd)<Current CSCL>
Pre-marketing

After marketingNewchemical
substances
Pre-marketing
evaluation
Hazardassessment

Low risk
Low risk

Type II andType III
monitoringchemical
substances

Existing
chemical
substanc
es etc.

Notification of
production/import
volumeRisk
assessment(I)

Instructionof study ofhazardous
properties

Risk
assessment(II)

Hazardassessment

Hazardassessment

persistenthighlyaccumulative

Type I monitoringchemical
substance
Notification of
production/import
volumeClass IISpecified
ChemicalSubstance
Regulation on
manufacture/i
mport etc.

Banmanufacture/i
mport/use

Instruction of study of hazardous
propertiesRISK ASSESSMENT (contd)<After the revision>
Pre-marketing

Review of the CSCL: procedural flow (image)

After marketingNewchemical
substances

Pre-marketing
evaluation
Hazard data,
Projected
manufacturing/i
mport volume,usage

Low risk
Low risk
Low risk

Existing
chemical
substanc Notificationofes etc.
Riskmanufactur
assessment
ing/import
volume,usage(screening)
Evaluation
based onexisting
information

Low risk

Risk
assessment(screening)cooperationof related
entities
hazardinformation(SIDS dataetc), detailed
usage

Instruction of
study ofhazardous
Risk
assessment properties(I)(long-term
toxicity test)

Risk
assessment(II)

Regulation on
manufacture/i
mport etc.

Banmanufacture/i
mport/use(permitting
essential use
under strict
condition)

persistenthighlyaccumulative

persistenthighlyaccumulative

Class IISpecified
ChemicalSubstance

Type I monitoringchemical
substance

Notification of production/import
volumeInstruction of study of hazardous
propertiesClass I
Specified
ChemicalSubstance

ASSESSMENT OF NEW CHEMICALSCurrent pre-marketing evaluation for new chemical substances will be kept inplace.
Exposure consideration will be introduced in addition to hazard consideration
under the current CSCL. Using the submitted hazard information, the planned
production volume and use category, the government will judge whether the
new chemicals should be nominated as Priority Assessment Chemical
Substances or not.
Some improvements will also be introduced for the effective and efficientevaluation of new chemicals, such asØ Enhanced use of QSAR (quantitative structure-activity relationships)
and chemical category approachØ Reduced requirements for Polymers of Low Concern (PLCs)REGULATION OF PRODUCTION etc
Chemicals identified through the phased risk assessment process will be
regulated as Class II Specified Chemicals.
The strict regulation of persistent, bio-accumulative and toxic substances(Class I Specified Chemicals) will kept in place, with some modifications :Ø The essential use of POPs permitted under the Stockholm Convention
will also permitted under the new CSCL.
Ø Secondly, the report proposes to strengthen the flow of information on
the safety of chemicals contained in products.
Ø Thirdly, the report proposes to introduce an obligation for information
sharing for Type I Monitoring Chemicals (persistent and bioaccumulating substances with insufficient knowledge on toxicity)”.



INFORMATION SHARING
In order to make safety (hazard) information of chemical
substances public, the government will improve the existing
databases such as J-CHECK, as well as enhancing
interconnection with international databases.
The new CSCL will stipulate that the information collectedunder CSCL should be used for chemical management under
different laws.

SOME OTHER TOPICS
East Asian Tripartite Cooperation - China, Japan and Korea
December 2006: At the 8th Tripartite Environmental Ministers
Meeting, held in Beijing, three ministers agreed to proceedwith information exchange regarding policies andregulations on chemicals management
March 2007: Working-level Meeting (Hayama, Japan)

November 2007: 1st Tripartite Policy Dialogue (Tokyo)
September 2008: 2nd Tripartite Policy Dialogue (Seoul)SOME OTHER TOPICS
Japan Network for Strategic Response to International
Chemicals Management
Ø Established in July 2007
Ø Information exchange network to co-operatively respond tointernational trend in chemicals regulation such as REACH
Ø Operates an informative website, mail magazines, electronicbulletin board, seminars
Ø 11 organizations form the management boardØ http://www.chemical-net.info/eng

INFORMATION SOURCES
Ministry of the Environment :http://www.env.go.jp/en/laws/chemi/cscl/index.html
NITE: http://www.safe.nite.go.jp/english/index.html

