Current Situation of Chemicals
Management Policy in Japan

Jiro Hiratsuka
Chemicals Evaluation OfficeEnvironmental Health Department
Ministry of the Environment, JapanCONTENTS
1. Chemicals Management System in Japan
1) Overview of Regulation on Chemicals
2) Chemical Substances Control Law (CSCL)

2. Risk Assessment
1) Monitoring
2) Pollutant Release and Transfer Register (PRTR)
3) Current Risk Assessment

3. Information Collection and Sharing
1) Evaluation of Existing Chemicals
2) Japan HPV Challenge Program3) Multi Stakeholder Involvement

4. Challenges and Future Efforts
1) Review and Revision of CSCL etc.
2) Cooperation among China, Japan and Korea

1. Chemicals Management Systemin Japan! Overview of Regulation on Chemicals! Chemicals Substances Control Law (CSCL)

Regulation Overview
Directimpacts

Indirectimpacts(viaenvironment)

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 Products
ࠉࠉContaining Harmful Substances

Public health &safety[emission regulation]- Waste Disposal Law- Air Pollution Control Law- Water Pollution Control Law[prior evaluation,production/import regulation]
Chemical Substances Control Law

Risks to theenvironment

Preservation of theenvironment

Agricultural Chemicals
Regulation Law

Law for PRTR and Promotionof Chemical Management

Risks tohumanhealthChemical Substances Control Law (CSCL)䕺Enacted in 1973

(two major amendments in 1986 and 2003)
䕺 Aiming to prevent pollution of environment fromPCBs and other hazardous chemicals⅌Based on two pillars:- prior evaluation of new chemicals- regulation on manufacture/import and use
䕺Excluded: specific chemicals covered by otherregulations e.g. agrochemicals, pharmaceuticals,food, fertilizer
䕺 Three Ministries are in charge: MHLW, METI, MOE(*No role of local governments under CSCL)

Current (2003 Amended) CSCL㻺㼑㼣㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟㻱㼤㼕㼟㼠㼕㼚㼓㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟㻪㻌㻝㻌㼠㼛㼚㻛㼥㼑㼍㼞! 㻝㻌㼠㼛㼚㻛㼥㼑㼍㼞㻿㼜㼑㼏㼕㼒㼕㼑㼐㻌㻯㼍㼟㼑㼟㻌㻔㼑㻚㼓㻚㻌㼕㼚㼠㼑㼞㼙㼑㼐㼕㼍㼠㼑㼟㻕㻱㼢㼍㼘㼡㼍㼠㼕㼛㼚㻌㼛㼒㻌㻼㻮㼀㻖㻖㻱㼢㼍㼘㼡㼍㼠㼕㼛㼚㻌㼛㼒㻌㻼㻮㼀㻖㻖㼀㼥㼜㼑㻌㻵㻌㻹㼛㼚㼕㼠㼛㼞㼕㼚㼓㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟㼀㼥㼜㼑㻌㻵㻵㻌㻹㼛㼚㼕㼠㼛㼞㼕㼚㼓㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟㻻㼞㼐㼑㼞㻌㼠㼛㻌㼕㼚㼢㼑㼟㼠㼕㼓㼍㼠㼑㻌㼘㼛㼚㼓㻙㼠㼑㼞㼙㻌㼠㼛㼤㼕㼏㼕㼠㼥㻻㼞㼐㼑㼞㻌㼠㼛㻌㼕㼚㼢㼑㼟㼠㼕㼓㼍㼠㼑㼘㼛㼚㼓㻙㼠㼑㼞㼙㻌㼠㼛㼤㼕㼏㼕㼠㼥㻯㼘㼍㼟㼟㻌㻵㻿㼜㼑㼏㼕㼒㼕㼑㼐㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟!㻝㻜㻌㼠㼛㼚㻛㼥㼑㼍㼞㻼㼞㼕㼛㼞㻌㼢㼑㼞㼕㼒㼕㼏㼍㼠㼕㼛㼚㻌㻭㼚㼐㻌㼙㼛㼚㼕㼠㼛㼞㼕㼚㼓㼀㼥㼜㼑㻌㻵㻵㻵㻹㼛㼚㼕㼠㼛㼞㼕㼚㼓㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟㻻㼞㼐㼑㼞㻌㼠㼛㻌㻵㼚㼢㼑㼟㼠㼕㼓㼍㼠㼑㼘㼛㼚㼓㻙㼠㼑㼞㼙㻌㼠㼛㼤㼕㼏㼕㼠㼥㻯㼘㼍㼟㼟㻌㻵㻵㻌㻿㼜㼑㼏㼕㼒㼕㼑㼐㻌㻯㼔㼑㼙㼕㼏㼍㼘㼟㻻㼎㼘㼕㼓㼍㼠㼛㼞㼥㻌㼞㼑㼜㼛㼞㼠㼕㼚㼓㻌㼛㼒㻌㼔㼍㼦㼍㼞㼐㻌㼕㼚㼒㼛㼞㼙㼍㼠㼕㼛㼚㻌㼛㼎㼠㼍㼕㼚㼑㼐㻌㼎㼥㻌㼎㼡㼟㼕㼚㼑㼟㼟㻌Types of chemicals regulated under CSCL
NameExplanation

No. ofsubstancesClass-I Specified
ChemicalSubstances

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

16

Class-II Specified
ChemicalSubstances

Persistent, hazardous (long-term humantoxicity or ecotoxicity to living organisms),
with concern for long-term existence in theenvironment.

23

Type-I Monitoring
ChemicalSubstances

Persistent and bioaccumulative,
but hazardous properties unknown.

36

Type-II Monitoring
ChemicalSubstances

Persistent and suspected as hazardous tohuman health.

Type-III Monitoring
ChemicalSubstances

Persistent and hazardous to living organisms.

(Candidates for the Class-I Specified Chems.)

876(Candidates for the Class-II Specified Chems.)

61(Candidates for the Class-II Specified Chems.)
Note: Number of chemicals as of November 2007.

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 SpecifiedChemicals- mandatory reporting of planned manufactured and/orimported amounts- subject to governmental orders that require the changeof planned amounts- labelling- compliance with technical guidance provided by GOJ
and/or governmental recommendation on a legal basis- compliance with guidance provided by GOJ䚷Monitoring Chemicals(Type I, II and III)- mandatory reporting of manufactured and/or imported
amount annually (Note: These amounts are announcedpublicly.)-compliance with guidance provided by GOJ-The GOJ can issue directions to investigate theirhazardous properties

Class I Specified Chemicals
1PCBs

2

Polychlorinated naphthalenes(only those containing more than 2 chlorine atoms in the molecule)

3HCB

4Aldrin

5Dieldrin

6Endrin

7DDT8

Chlordane or Heptachlor

9Bis(tributyltin) oxide

10N,N'-Ditolyl-p-phenylenediamine, N-Tolyl-N'-xylyl-phenylenediamine, or N,N'-Dixylyl-p-phenylenediamine

11

2,4,6-tri-tert-butylphenol

12Toxaphene

13

Mirex

14

kelthane or dicofol

15

hexachlorobuta-1,3-diene16

2-(2'-Hydroxy-3',5'-di-tert-butylphenyl)benzotriazole
Note: Yellow-colored rows are POPs covered by Stockholm Convention

Recent Issue: BAT approach to By-Product HCB" In Feb 2006, by-product HCB in TCPA (approx.
1,000"3,000 ppm) was revealed.
" Basic idea under CSCL on by-product Class I
Specified Chemicals is:- Basically, manufacturing/importing of HCB should not beallowed even if it was unintentional by-product.
- In case that the by-production is technically inevitable andthere is no suitable alternatives, the manufacturing/importis allowed only if the amount of by-product is reduced asmuch as possible based on the BAT (technically andeconomically Best Available Techniques).

Recent Issue: BAT approach to By-Product HCBCont ! d" In April 2006, three ministries set an Assessment
Committee on the BAT Levels.
" In Nov. 2006, the first report of the Committee waspublished: suggesting the BAT levels as- 200ppm for TCPA
- 10ppm for its derivative, Solvent Red 135" In Apr. 2007, the second report of the Committee waspublished: suggesting the BAT levels as- 10ppm for TCPA derivatives other than SR-135 andPigment Yellow 138- 10ppm for Pigment Green 36, Phthalocyanine derivatives" The BAT levels will be incorporated into CSCL after one
year (depending on the availability of low-HCB containing
TCPA and pigments).

2. Risk Assessment!Monitoring!PRTR!Current Risk Assessment

##Chemicals$Chemicals inin thethe Environment
Environment$JMoE
JMoE!! Environmental
Environmental Monitoring
Monitoring Report
Report- JMoE has issued #Chemicals in the Environment$ since
1974 on an annual basis.
- This environmental monitoring report presents the resultsof environmental surveys that JMoE has carried out in asystematic way to identify chemicals in the environment
and to monitor their levels.
http://www.env.go.jp/chemi/kurohon/index.html(in Japanese, FY2006)
http://www.env.go.jp/chemi/kurohon/en/http2005e/index.html(in English, FY2005)

JMoE! s Environmental
JMoE!sEnvironmental Monitoring
Monitoring Program
Program
1. The Initial Environmental Survey
2. The Advanced Environmental Survey
3. The Environmental Survey for Exposure Study
4. The Monitoring Investigation
5. The Environmental Survey for human biologicalsamplesModeling Analysis
of Environmental
Fate of Chemicals

Development ofAnalytical Method

Environmental
Specimen Bank
Coop With NIESJMoE! s POPs MonitoringConcentration of p,p!-DDT in Wildlife (shellfish, fish, birds) (geometric mean)

POPs Monitoring Network in East Asia
- Advocated in 2002 through the initiativeof JMoE
- to respond to #effective evaluation$ underthe POPs Convention- 4 technical workshops (in Dec. 2002,Dec. 2003, Oct. 2005 and Sep. 2006)
held with support of many East Asiancountries

Japan ! s Pollutant Release and Transfer Register

Report of theiremissions of 354
chemicals to central
government via local
governments

enterprises
Disclosure of data on
individual emission sources

MOE and METICitizens
Request of data disclosure

Improvement of public understanding
MOE and METI
estimate emissions
from non-points
sources.

Top Top
10 Chemicals
underunder
PRTRPRTR(F.Y.2002)
10 Chemicals
FY 2002
Concentration (䃛g/m3)
Emitted volume (ton/year)
TolueneXyleneMethylene chloride
Ethylbenzene
Leand and its compounds
Arsenic and its inorganic compounds
Trichloroethylene
N,N-Dimethylformaide
Sulfur dioxide
Manganese and its compounds

Examples of Use of PRTR Data
Concentration (䃛g/m3)

Source: Center for
Environmental Information
Science(http://www.prtr-net.jp)

Benzene(air)Risk Assessment
So far%- Initial risk assessment project started in 1997.
- completed initial risk assessment:
39 chemicals in 2002
13 chemicals in 2003
21 chemicals in 2004
20 chemicals in 2005
23 chemicals in 2006
116 chemicals in total

From now on⎔ቃ┬䛾ྲྀ⤌-Continued work on the initial risk assessment (ca. 20 chemicals /year)-Study on vulnerability of children!s health- Initiation of detailed risk assessment, if necessary

3. Information Collection and Sharing!Evaluation of Existing Chemicals!Japan HPV Challenge Program!Multi Stakeholder Involvement

Evaluation of Existing Chemicals
Additional r esolution of the Diet in 1973 (when CSCL was adopted)" the government would assess the safety of existing chemical
substances. "(Role shar ing among the gover nment and the industr y)
Collecting data (test)

Assessment

New Chemicals

Industry

Government

Existing Chemicals

Government

Government.Number of Existing Chemicals : about 20,000

Number of substances evaluated (until May 2007) :Degradation & bioaccumulation: 1525 (by METI)
Toxicity to human: 315 including (by MHLW)
Ecotoxicity: 485 including (by MOE)

Japan HPV Challenge Program
Background# Worldwide approaches to existing chemicals wereadvanced in the 1990s.
! Global cooperation, led by OECD since 1992. (Japan has been
contributing as well)! The US started #The US HPV Challenge Program$ in 1998.

# CSCL revision in 2003.
! The Diet passed an additional resolution that # the public andprivate sectors should jointly promote systematic collectionof data on existing chemical substances.$

Launched in June 2005.
Aiming at accelerating collection and dissemination ofsafety data on existing chemicals throughpartnership between of government and industry

Features of the Program
US HPV Challenge Program is the model of Japan!s
Program.

Two features;
1.

Voluntary program under cooperation between theprivate and public sectors!

2.

Safety data of high priority (HPV) existing chemicals arecollected voluntary by Sponsor companies (private sector).

The Collected Information will be publiclyavailable.
!
!

The collected safety information will be open to public via
website.
It can be utilized for various purpose; self-management
systems by companies, risk assessment by researchers,
and chemicals management policies by the government.

Targeted chemicals"""

Organic chemicals (except for Polymers)
Identify chemical substances based on the CAS
number. (not Japan!s CSCL number)
HPV : over total 1,000 tons per year (in Japan)(Based on METI!s # survey ofimport/manufacturing volume of chemicalsubstances in 2001$ )About 650 substances are the target of
the Program

NoInformation so farCollecting data through JapanHPV Challenge Program(Core Target)
140 chemicals

Information (to be) collected

Existing chemical substances produced andimported in Japan over 1000 tons

Targeted chemicals (Cont ! d)Collection through international
cooperation through the OECD
HPV program(Japan contributes to OECDprogram as well)

417 chemicals

Collection through the US
Challenge Program
95 chemicals

Target of theJapan HPVprogram
652 chemicals

Japan Challenge Program : Role of the GOJ
1. Administer the program (selecting target chemicals, disclose
progress of the program, secretariat of the promotional committee, etc.)

2. Establish website to release the collected data publicly
3. Check the reliability of data submitted by the Sponsor(METI: Physicochemical properties, Environmental fate and Pathways,
MOE: Ecotoxicity Tests, MHLW: Human Health Effects)* Keep getting data of existing chemicals that are manufactured
and imported less than total 1,000 tons per year
(Role sharing among three Ministries in terms of collecting data of non-HPV existing chemicals)

METI

Biodegradation, Bioaccumulation, Physicochemical properties

MOE

Acute toxicity to fish, Acute toxicity to aquatic invertebrates,Toxicity to aquatic plants

MHLW

Repeated dose toxicity, Genetic Toxicity (effects on the geneand chromosome)Japan Challenge Program : Role of Industry
Companies or Consortia (Sponsor) will collect data of#Core Target$ " Sponsorship is voluntary basis
1. Identify the target chemicals-Japan HPV target list does not change, meaning that Japan!sprogram does not have #no longer HPV$ scheme.
- They can use #Category approach$ like US HPV Program

2. Submit registration letter to the government
3. Submit test plans to the government
4. Make test if necessary and submit Robust Summary tothe government
Japan Chemical Industry Association (JCIA) plays
an important role to facilitate Sponsorship.

Data format for collection
Screening Information Data Set (SIDS): 䚷䚷! Physicochemical properties: Melting point, Boilingpoint, Relative density, Vapor pressure, Partition
coefficient, Water solubility, Dissociation constant! Environmental fate and Pathways:
Photodegradability, Stability in water,
Biodegradability, Transmigration and distribution! Ecotoxicity Tests: Acute toxicity to fish, Acutetoxicity to aquatic invertebrates, Toxicity to aquaticplants! Human Health Effects: Acute toxicity, Repeateddose toxicity, Genetic Toxicity (effects on the geneand chromosome), Reproductive toxicity

Program Flow
MHLW

METI

MOE

JCIA(industrialassociation)

Keep collecting
information by
the government#Three Ministries! committee$Manage the program, publicize its progress, etc.

Give advice on plans
and check theprogress

Ask forparticipation

Sponsors(private companies)
Collect data and makesummaryCre heclia kb t
da ilit y heta of

Facilitate
sponsorship bymember companies

Program Promotion
Committee(Comprised of NGOs, industries

JapanHPV

Collect data (lessthan 1,000 tonper year)

and academics)

Release safety information to be widely used.
(The government will make website)
Use the results

Self-management(MSDS, etc.)

Risk assessment

Assessment underregulatory
requirements

Current Situation(as of May 2007)& 74 companies and 3 associations has alreadyjoined the program as #Sponsors$ (including 19consortiums)& 16 categories has been formulated.
& Approx. 80 substances (of 140) has been
already sponsored.
& Sponsor companies are making test plan now.
(No data publicly available yet)
How to deal with Orphan candidates might
be the big issue soon.

Multi Stakeholders Involvement
Chemicals and the Environment Round Table (CERT)# 21 meetings since 2001
# Member: NGOs, Industry
Associations, Governments(national and local authorities)# Missions:
1. to gather a variety of opinions from the public byusing the Internet and having local meetings;2. to promote information sharing and mutual
understanding for reducing environmental risks
through dialogue among NGOs, industry andgovernment; and3. to disseminate, to citizens, industry andgovernment, information on the discussions andmutual understanding made at the meetings.

4. Challenges and Future Efforts!Review & Revision of CSCL etc.
!Cooperation among China, Japanand Korea

Review & Revision of CSCL etc.
2006 Apr. The 3rd Basic Environment PlanDec.
- Interim Report by the Subcommittee of Industrial Structure Council- 1st Meeting of Subcommittee of Central Environment Council2007 Aug. Interim report by Joint Session
2008 Interim Assessment of Japan HPV Challenge
Program2009 Review and Revision of CSCLCooperation among China, Japan and Korea
December 2006
$TEMM8 (Tripartite Environmental Ministers Meeting) was
held in Beijing and three ministers agreed to proceed withinformation exchange regarding policies and regulations on
chemicals management
March 2007
$1st International Workshop and Working-level Meeting atHayama# http://www.env.go.jp/en/chemi/temm.html# http://ncis.nier.go.kr/temm_cmp/index.html

November 2007
$Tripartite Policy Dialogue on Chemicals Management
December 2007
$TEMM9 will be held at ToyamaSummary# Risk Management- based on CSCL for human health and the environment# Risk Assessment- supported by relevant activities: environmental monitoring
and PRTR# Information Collection and Sharing
䚷- existing chemicals has become a big issue, like in othercountries- measures in cooperation with citizens, industry, andgovernment# Future- review process of legal scheme has started- policy dialogue among China, Japan and Korea

Thank you!