EU-India Environment ForumMumbai, 17 September 2008

Japan’s responses to REACH and Chemicals Management

Policy

Eisaku TODADirector, Chemicals Evaluation Office

Ministry of the Environment, Japan

Japan’s responses to REACH

• From trade and industry perspective– Commenting on REACH text, RIP guidance,

implementation, etc.– (Pre-)registration– Information exchange through the supply chain

• From chemicals management perspective– Share the same goal: WSSD 2020 target– Review of the Chemical Substances Control Law– Co-operation and harminisation through SAICM,

OECD, etc.

Commenting on REACH textsubmitted by the Government of Japan on 10 July 2003

In response to the Internet Consultation

• While appreciating EU attitude to protect the human health and the environment, expressed concern on its effects on trade and workability.

• Submitted specific comments from the viewpoint of:– Avoidance of excessive burden to companies– Ensuring equal treatment for non-EU companies– Ensuring REACH’s consistency with international arrangements– Ensuring transparency and equality in REACH and its

application

• Also expressed these concerns through diplomatic and other channels.

Commenting and clarifications on REACH Implementation

• The Government of Japan and industry associations (e.g. Japan Chemical Industry Association) commented and sought clarification on REACH implementation through:– Japan-EU Regulatory Policy Dialogue– WTO/TBT Committee etc

• The specific issues include:– Registration of monomers– Provisions for the Only Representatives

Some uncertainties already clarified• Where are the boundaries between substances,

preparations and articles? – Explained in RIP 3.8 Guidance

• Can a manufacturer in the upstream of non-EU supply chain nominate an Only Representative? –Yes

• Can a non-EU distributor nominate an Only Representative? – No

• If the same person/company is nominated as an Only Representative for the same substance by more than one companies, is the tonnage aggregated? – No (interpretation corrected)

Some uncertainties yet to be clarified• Can an Only Representative (OR) nominate a Third-Party

Representative?• Should a non-EU exporter of preparation provide the

downstream users with registration information (eg the name of OR) for ingredient substances (whereas the full ingredient information regarded as CBI)?

• How can an OR know all the downstream users?• If the exemption list is amended, what is the schedule for

(pre)registration for the substances that are removed from the exemption list?

• The SVHC threshold in articles is calculated as percentage of total weight of the article, but what does the objection of some member countries mean?

• What is the schedule for identifying SVHCs (in addition to the 16 substances)?

Raising awareness and facilitating company responses to REACH

• Ministry of the Environment organised a REACH Symposium in March 2007, and published a pamphlet on REACH

• Ministry of Economy, Trade and Industry held 22 seminars all over Japan in FY 2007, and published a guidance manual for small and medium sized enterprises.

• Japan Chemical Industry Association established a REACH Task Force and started consultation services

• Several other industry association provide similar services

• Many consultancies provide advice to companies

Japan Network for Strategic Response to International Chemicals Management

• Established in July 2007• Information exchange network to co-operatively respond to international

trend in chemicals regulation such as REACH• Operates an informative website, mail magazines, electronic bulletin

board, seminars• 11 organizations form the

management board– Asahi Kasei Co Ltd– Kao Co Ltd– Overseas Environmental

Cooperation Center– Ministry of the Environment– Ministry of Economy, Trade and

Industry– Ministry of Health, Labor and

Welfare– Sumitomo Chemicals Co Ltd– Institute for Global

Environmental Strategies– Nissan Co Ltd– Fujitsu Co Ltd– Mitsui Chemicals Co Ltd

http://www.chemical-net.info/eng

Companies’ responses to REACH• Pre-registration and preparation for registration

– Nomination of Only Representative• Company’s European subsidiary• Consultancy (European and Japanese)• Importer

– Responses to substance information exchange forum (SIEF)

• Participation in consortia• Anti-trust considerations

– Risk assessment• Collection of existing information• Test plans and risk assessment

• Responses to evaluation, authorisation and restriction

• Information exchange for substances in articles

Decision tree for responses to REACH- JCIA guidance -

Is your product exported to Europe?

Does any downstream user export products that use your product?

Is it an article?

Is it a mixture that does not involve chemical reaction?

Is it a polymer?

What are the ingredients? What are the ingredients for the polymer?

REACH does not apply to your product

N N

Y

N

Y

N N

Y

In principle you need registration and/or information provision for these substances

Step 1: your products

Preparation PolymerSubstance

Substance C

Go to Step 2

Substance B Substance CSubstance BSubstance A Substance A

Decision tree for responses to REACH- JCIA guidance -

Is a the substance released to the environment during the use of the product?

Does the article contain “substances of very high concern”?

Is the use of substances in the article restricted?

Check the authorisation list.

Check the restriction list.

In principle you need registration for the substance

Y

N

N

N

Y

You cannot export the article to Europe.

Step 2:Articles

You will need notification and information provision

Step 3:Authorisation

Step 4: Restriction

REACH does not apply to your product.

Y

An Example: C2C3 (ethylene & propylene) Task Force

• Japanese petrochemical companies decided to cooperatively register ethylene and propylene rather than leaving it to individual polymer producers or other downstream users (or importers).

• Members: Mitsui, Mitsubishi, Asahi, Chisso, Idemitsu, Tosoh, Showa Denko, Maruzen, Nippon Oil, Sumitomo

• Coordinated by Japan Petrochemical Industry Association

• Member companies contract the same OR (European consultancy) independently through its affiliate in Japan.

• The OR deals with (pre-)registration and SIEF activities.• A European law firm provides legal advice through the

OR’s affiliate.

Existing consortia (Information collected by JCIA, as of May 2008)

• Aluminium• Antimony• Beryllium• Cadmium• Calcium Carbide• Chlorine and chlorinated chemicals• Cobalt• Copper• Essential Oils of orange, bitter orange,

lemon and grapefruit• Ethanol• Ethylbenzene• Ferro-alloy• Fertiliser and related materials (FARM)• Flavours and Fragrances• Fluorocarbons and sulphur

hexafluoride• Formaldehyde• Formaca• Fuel Ether• Graphite• Gypsum• Lead

• Lubricating greases• Magnesium• Magnesium minerals• Manganese• Molybdenum• Nickel• Paper and Pulp• Phenolic Resins• Phthalate• Precious Metals• Selenium• Silicon• Silicones• Sodium hypochlorite• Styrene• Sulphuric acid• Tellurium• Tin• Tungsten• Vanadium• Vinyl Chloride• Zinc

Key Message from SAICMー WSSD 2020 Goal ー

• 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

Schedule of Regist rat ion

Reference: REACH in brief

need only hazard assessmentneed both hazard and risk assessment

May 31th,2018

May 31th,2013

Nov. 30th,2010

Dec. 1st,2008

Jun. 1st,2008

Jun. 1st,2007In case that pre- registration are notimplemented, it is treated as newchemicals

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≧ 1t / yCMR chemicals

≧ 100t/ yChemicals whichcould have long-term impacts onwater env. andgive high toxicityto aquatic animals.

European REACH: toward the 2020 goal

North American cooperation toward 20201995 North American Commission for Environmental

Cooperation（Canada, U.S. and Mexico）: started Sound Management of Chemicals （SMOC）program

2006 Established CEC Strategy toward 20202007 Leaders’ Summit (Montebello, Canada):

Agreements on the program to achieve the 2020 goals

Canada：Categorization and Chemical Management Plan– Categorization of 23,000 chemicals completed in 2006– Risk management measures for priority chemicals being established

US：Chemical Assessment and Management Plan (ChAMP)– Further promote the HPV Challenge Program (more than 1m pounds) – Assess 9,000 chemicals produced more than 25,000 pounds (11t)

annually and take the necessary measures by 2012.Mexico：Established Inventory of Chemical Substances

December 2006At the TEMM8 (Tripartite Environmental Ministers

Meeting) held in Beijing, three ministers agreed to proceed with information exchange regarding policies and regulations on chemicals management

March 2007Working-level Meeting (Hayama, Japan)

November 20071st Tripartite Policy Dialogue (Tokyo)

September 20082nd Tripartite Policy Dialogue (Seoul)Working on the comparison of GHS classification etc

East Asian Tripartite Cooperation East Asian Tripartite Cooperation -- China, Japan and Korea China, Japan and Korea --

Development of Japanese Chemicals Management Policy

1973 Chemical Substances Control Law (CSCL) enacted – Ban on production and use of persistent, bio-

accumulative and toxic substances (eg. PCBs)– Pre-marketing evaluation of new chemicals

1986 CSCL amended– regulation on persistent and toxic (but not bio-

accumulative) substances)1999 PRTR and MSDS Law enacted2003 CSCL amended

– introduced regulation based on ecological risk2005 Japan HPV Challenge Programme2006 SAICM adoptedAfter 2007: Review of PRTR Law After 2009: Review of CSCL

Industrial Safety and Health LawIndustrial Safety and Health Law○○ Ban on the production and use of substances harming workersBan on the production and use of substances harming workers’’ healthhealth○○ AuthorisationAuthorisation, labeling and MSDS for potentially harmful substances, labeling and MSDS for potentially harmful substances○○ Evaluation of Evaluation of mutagenicitymutagenicity of new chemicalsof new chemicals

Pharmaceutical Affairs LawPharmaceutical Affairs Law○○ Licensing of production and use of pharmaceuticals, cosmetics, eLicensing of production and use of pharmaceuticals, cosmetics, etc.tc.

Food Sanitation LawFood Sanitation Law○○ Standards and labeling for food and food additives.Standards and labeling for food and food additives.

Chemical Substances Control LawChemical Substances Control Law○○ Ban on production and use of PBT substancesBan on production and use of PBT substances○○ Restriction and Restriction and labellinglabelling of persistent and toxic substancesof persistent and toxic substances○○ Notification of production of substances of concernNotification of production of substances of concern○○ Notification and evaluation of new chemicals for PBT propertiesNotification and evaluation of new chemicals for PBT properties

Law for Controlling Household Products Containing HarmfulLaw for Controlling Household Products Containing HarmfulSubstances Substances

Chemical Management LawChemical Management Law○○ Register of releases and transfer of hazardous substancesRegister of releases and transfer of hazardous substances○○ Material Safety Data SheetMaterial Safety Data Sheet

Air Pollution Control Law, Water Pollution Control Law, etc.Air Pollution Control Law, Water Pollution Control Law, etc.○○ Environmental Quality Standards to protect human health and the Environmental Quality Standards to protect human health and the envenv○○ Regulates the emission, leaching etc. of hazardous substancesRegulates the emission, leaching etc. of hazardous substances

Poisonous Poisonous and and Deleterious Deleterious Substances Substances Control Control LawLaw-- Regulates Regulates production production and use of and use of poisonous poisonous and and deleterious deleterious substancessubstances-- Material Material safety data safety data sheetsheet-- Regulates Regulates the disposal the disposal of these of these substancessubstances

AgriculturAgricultur--al al Chemicals Chemicals Regulation Regulation LawLaw--Evaluation Evaluation of toxicity, of toxicity, persistence persistence etc. when etc. when licensing licensing agricultural agricultural chemicalschemicals-- LabelingLabeling--Regulation Regulation on the use on the use of of agricultural agricultural chemicalschemicals

OccupaOccupa--tionaltionalExposureExposure

Consumer Consumer exposureexposure

Exposure Exposure via the via the EnvironEnviron--mentment

Chemical regulations in JapanChemical regulations in Japan

CSCL: Testing requirements for new chemicals

1-10t 10t & overReady biodegradability x xBioaccumulation (Kow or BCF) x1) x1)

Mammalian 28-day repeated dose oral toxicity x1)

Bacterial reverse mutation x1)

Chromosome aberration in mammalian cell culture x1)

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

(x)2)

Algae growth inhibition x1)

Daphnia acute immobilisation x1)

Fish acute toxicity x1)

Avian reproduction toxicity (and mammalian toxicity to reproduction and offspring) (x)2)

1) For ready biodegradable substances, only ready biodegradability test is needed. However, other tests need to be performed for degradation products.

2) These tests are only needed for non-degradable and bioaccumulative substances.

Name Properties Regulation No. of substances

Class-I Specified Chemical Substances

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

Virtual ban on priduction and use

16

Class-II Specified Chemical Substances

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

Restriction of production and use (limiting production volume, labelling etc)

23

Type-I Monitoring Chemical Substances

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

Reporting on production volume

36

Type-II and III Monitoring Chemical Substances

Candidates for the Class-II Specified Chems. (Type II on health, type III on environment)

Reporting on production volume

Type II 876

Type III 61

Types of chemicals regulated under CSCL

Resolution of the Diet in 1973 (when CSCL was originally adopted) “ the government should assess the safety of existing chemical

substances. “

(Roles of the government and the industry)

Collecting data (test) Assessment New Chemicals Industry Government

Existing Chemicals Government Government

.Number of Existing Chemicals : about 20,000

Number of substances tested and evaluated (as of March 2008) :Degradation & bioaccumulation: 1543 (by METI)Mammalian toxicity to human: 327 (by MHLW)Ecotoxicity: 509 (by MOE) 23

Investigation of existing chemicals

Japan HPV Challenge ProgramJapan HPV Challenge Program� BackgroundBackground

International programs aimed at existing chemicalsRecommendation by the Diet in 2003 when revision of CSCL revision was adopted.

Launched in June 2005.Aiming at accelerating collection and release of information

on existing chemicals through partnership between of government and industry

� Modeled on US HPV Challenge ProgramUS HPV Challenge Program

Two features;1. Voluntary program under cooperation between the

private and public sectorsSafety data of high priority (HPV) existing chemicals are collected

voluntary by Sponsor companies (private sector).2. The Collected Information will be publicly available.24

No Information

so far

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chem

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sub

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prod

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Target of the Japan HPVprogram

Collecting data through Japan HPV Challenge Program by

sponsored comapnise

Collection through international cooperation through the OECD

HPV program and US Challenge Program etc 645 chemicals

126 chemicals

532 chemicals

(Japan contributes to OECD program as well)

(Core Target)

Japan HPV Challenge ProgramJapan HPV Challenge Program� Organic chemicals (except for Polymers)� Identify chemical substances based on the CAS number. � HPV : over total 1,000 tons 

per year (in Japan)(Based on METI’s “survey of import/manufacturing volume of chemical substances in 

2001”)

About 650 substances selected as target chemicals

25

Interim assessment report & Current Interim assessment report & Current situation of Japan Challenge Programsituation of Japan Challenge Program

<Current Situation>• Sponsors have been registered for 89 chemicals (all listed

materials*:126 materials) by June 2008.• 105 privates and 3 groups (including 27 consortia) join in the

program• Collection of safety information on 2 chemicals were finished

� In June 2008, Interim assessment report of Japan Challenge Program was conducted

� Summary:Although there were some points which need more

considerations, the program was evaluated mostly well along the object, that is “the Government will disseminate the information to the public in the form that can be easily understood.”

26

GLP Requirements• In principle, test data submitted for pre-manufacture/import evaluation of

new chemicals must comply with Good Laboratory Principles (GLP) (Tests conducted by facilities in other countries complying with OECD-GLP

principles are accepted)• Tests of existing chemicals by government (or sometimes voluntarily by

manufacturer/ importer) are also conducted at GLP test facilities• MOE, MHLW, METI set up a common operating procedure to certify

conformity to GLP principles (documents required, study audits, inspection, etc.)

27

Ministry Role under CSCL

GLP tests (example)

MOE Ecotoxicity alga, growth inhibition test, daphniaacute immobilization test, and fish, acute toxicity test, etc.

MHLW Toxicity repeated dose 28-day toxicity study in rodents, and in vitro mammalian chromosomal aberration test, etc.

METI Bioconc./ Biodegr.

biodegradability test and bioconcentration

Review of Chemical Management PolicySchedule of legislative review• PRTR Law： To be reviewed 7 years after the entry into

force (in 2007）• CSCL： To be reviewed 5 years after the entry into force of

the 2003 Amendment of CSCLNov. 2006, Consult the Central Environment Council on

the future policy for the environmental chemicals management

-> Joint deliberation with the Industrial Structure Council

Aug. 2007, Interim report on the review of PRTR Law

Jan. 2008, Started the deliberation for CSCL-> Joint deliberation with the Health Science Council and

Industrial Structure Council

Toward the end of 2008: Council report expected

Envisaged points for CSCL review• WSSD 2020 Goal recognized as the fundamental goal

– Management system based on scientific risk assessment for all chemicals

<Specific features>• Establish risk assessment system and strengthen

information collection on exposure and hazard– Obligatory reporting of production volume– Request for hazard information for priority chemicals– Retain the pre-marketing evaluation of new chemicals– Screening and risk assessments to be done by the government

• Strengthen the management of SVHC– Information requirements for persistent and bioaccumulative

substances etc.• International harmonization

– Essential uses for POPs, Polymer exemption etc

Conclusions<Company responses to REACH>• Companies feel some uncertainties in responses

to REACH• Big companies are largely OK, but smaller

companies will need to accelerate their responses

<Chemical management policy aspect>• REACH has much to learn from to move toward

the common goal: WSSD 2020 target.• Efforts for greater international harmonisation

needed.