REACH

10th Annual Chemicals Management Services Workshop,Hilton San Francisco, (CA)

October 25-27, 2006 Robert Donkers, Environment Counselor at the Delegation of

the European Commission to the U.S.

What does it mean and how can you prepare?

European Commission

TYPES OF LEGISLATIVE MEASURES USED IN EU ENVIRONMENT POLICY

Directives: indirectly legally binding for Member States, setting objectives, to be transposed in national law (because ofmixed competence, most used instrument for EU environment policy)Regulations: directly legally binding for Member states in all its details, no need to transpose (in EU environment policy mainly used for transposition of international treaties, but …REACH)Decisions: directly legally binding to the addressee (s) (used for ozone depletion substances allocations for critical uses)Recommendations, guidance documents: not legally binding (used for agreements on car emissions with Korean, Japanese car manufacturers)

European Commission

The Current EU Chemicals Policy

Distinction between new and existing substances, September 1981

New substances heavily regulated, 0.01 % of marketed volume

Existing substances virtually not regulated, 99.9 % of marketed volume

ProblemsProblems

Burden of the PastBurden of the Past

European Commission

The Current EU Chemicals Policy

Existing substances can be used without testing (100,106 existing substances registered in EINECS)30,000 to 70,000 on the marketBurden of proof on public authoritiesNo efficient instrument to ensure safe use of the most problematic substancesRisk assessments too slow: few substances assessedInsufficient resources on the part of Member States: heavy delays (4 to 6 years for some substances)

Existing substancesExisting substances

Lack of Confidence in Chemicals

European Commission New substances - Knowledge of dangerous properties

3.500new substances

70% dangerous

100% tested

European Commission

30,000 existing substances

?

2600 HPV substances *:3 % … tested

11 % … Base Set15 % … almost Base Set15 % … no data56 % … often data for

acute toxicity

N

*… Evaluation by the ECB.HPV = high production volume(>= 1000 tonnes/year/manufacturer). These substances cover over 95% of thechemicals on the market.

Existing substancesExisting substancesKnowledge of dangerous propertiesKnowledge of dangerous properties

European Commission

A careful approach

Example: Phthalates in baby toysPrecaution appliedElements:

Risk assessment was on its way but not ready: alarming interim resultsPreliminary evaluation by Scientific CommitteeIn view of potential irreversible effects: Temporary restriction to be reviewed every 6 months on basis of state of the art on scienceFinally: Commission proposal for permanent banAdoption by Council and European Parliament

European Commission

Objectives of REACHObjectives of REACH

Substitution and precaution underpin system

A New EU Chemicals Policy

Sustainable DevelopmentProtection of human health and the environmentMaintain/enhance innovation/competitivenessMaintain the Internal MarketIncreased transparency and consumer awarenessIntegration with international effortsPromotion of non-animal testingConformity to WTO obligations

European Commission

WHY do we need REACH?Current chemicals management system is inefficient

Difficult to identify risks + difficult to address risks:Lack of information about most chemicals on the marketBurden of proof lies on public authoritiesNo efficient instrument is in place to deal with problematic substances

Lack of incentives for innovationLack of confidence in chemicals and the chemicals industry.

European Commission

WHAT is REACH? (1)

Proposal for a Regulation on the Registration, Evaluation and the Authorisation of CHemicalsScope:manufacture, import, placing on market and use of substances (ontheir own, in preparations or in articles)

Goals: Improving health and safety of workers and the general public.Environmental protection – avoiding chemical contamination of air, water, soil and damage to biodiversityMaintaining a competitive/innovative chemicals industry

European Commission

Registration of substances ≥ 1 metric tonne/yrIncreased information and communication throughout the supply chainEvaluation of some substances: testing proposalsAuthorization only for substances of very high concernRestrictions - the safety net (Community wide action)Agency to efficiently manage system

Focus on priorities:Substances with high volumes and those of greatest concern!

WHAT is REACH? (2)

European Commission

Objective: Ensure industry adequately manages risks from substances

REACH: Registration

Method:Manufacturer/Importer obtains/generates adequate informationElectronic dossier submitted to AgencyNon-confidential information to central (largely public) database.

ScopeSubstances Manufactured/Imported ≥ 1 metric tonne/year; no threshold for authorization substancesExemptions: other law, Annex II/III; polymers (review); PPORDAs registered: biocides, pesticides, notified substances.

Consortia encouraged

Industry’s responsibility

European Commission

Registration (3): OSOR

ONE SUBSTANCE ONE REGISTRATIONPre-registration of all substances18 (12?) months after Entry into Force

Data sharingAnimal data always sharedNon animal data shared on request

Joint data submission: mandatory with opt outs:Disproportionate costCommercial secretsDisagreement on selecting data

European Commission

REACH: Registration (2)

EIF 12 months

Pre-registration

3 years 6 years 11 years

•1000+ tonnes•CMRs 1+ tonne• PBTs/vPvBs (R50-53) 100+ tonnes

Agency start up 100-1000 tonnes 1-100 tonnes

[6 months]

18 months

Notification of SVHC in SIA

Non-phase-in substances

European Commission

Registration:Substances in articles (SIA) (1)

Registration of substances intentionally released (Art. 6.1)

applies to all SIA (i.e. no requirement to meet criteria for classification as dangerous)deadlines as other substances

European Commission

Registration:Substances in articles (SIA) (2)

Notification of substances of very high concern (Art. 6.2) if:

present above a concentration limit of 0,1%,exposure of the public or the environment during the full life cycle cannot be excluded,it is present above 1 tonne

applies 6 months after substance listed on authorization candidate list – i.e. only commences 3 years and 6 months after EIF

European Commission

Registration:Substances in articles (SIA) (3)

Agency can request registration of any notified substance contained in articles, when:

Substance is present over 1t; AND Suspects that the substance is released and that release presents a risk to human health or the environment; ANDSubstance is not subject to Art. 6.1

European Commission

REACH: Authorization

Applies toSVHC (CMR, PBT, vPvB, ‘serious and irreversible effects’)Substance, substance in mixture (unless below concentration limit), substance incorporated into an article

Substance cannot be used unless authorizedPrioritized - Substances progressively authorized (as resources allow)Downstream Users can use suppliers authorization.Commission grants authorizations on proposal of Chemicals Agency

Objective: Ensure risks from substances of very high concern (SVHC) are properly controlled and eventually substituted.

European Commission

Authorization (2)

Criteria for granting authorizations:Authorization granted if adequate control

Not available for PBT, vPvBs or CMRs/substances of equivalent concern if not possible to determine a threshold.

Still possible to grant authorization if socio-economic benefits outweigh the costsAnalysis of substitutes in all cases.

Public list of substances to be authorized (eventually):Published by AgencyCandidate list: substances meeting criteriaAnnex XIII (substances prioritized and picked for authorization within set timeframe)

European Commission

Provide confidence that industry is meeting obligationsPrevent unnecessary testing

Evaluation

Dossier evaluation Substance evaluation

Check test proposalsCompliance

Output:

• Further information decisions

• Info to other parts of REACH/other legislation

Examine any information on a substance on CRP

European Commission

Objective: act as safety net

REACH: Restrictions

Community wide concernMember States/Commission initiated

Fast track possible e.g. CMR substances for consumers.

Agency Committees examine:The risk, andThe socio-economic aspects involved.

Commission - final decision through comitologyCarry-over of existing restrictions (76/769/EEC).

European Commission’s responsibility

European Commission

European Chemicals Agency

Day to day management of REACHTechnical, scientific and administrative aspects

Responsibilities:Registration - reject or require completion of registrationEvaluation - ensure a harmonised approach; take decisionsAuthorisation/restrictions - facilitate process; suggest prioritiesSecretariat for Forum and CommitteesDeal with appeals - registration, R&D, evaluation, confidentiality.

European Commission

Progress in co-decisionParliament: First reading: 17 November 2005Council: Common Position by unanimity: 27 June 2006

In 20062nd reading in Parliament (End of November 2006)

Authorization regimeSubstitution

Council of Ministers Meeting (11-12 December 2006)Council and Parliament Agreement end of 2006?

2007 Entry into force (estimated April/May 2007)2008 Agency commences2010 First Registration deadline (1000 tonnes +)

European Commission

REACH and GHSCurrently, EU classification and labelling requirements includedin the Dangerous Substances Directive, the Dangerous Preparations Directive and the Safety Data Sheet DirectiveAugust 21, 2006, the European Commission launched a 2 month internet consultation on a draft legislative proposal to introduce GHSFinal Commission proposal by end of 2006/beginning of 2007 will include transitional arrangementsEntry into force around the same time as entry into force of REACH

European Commission

- Re-focus Current Activities- Preparing for REACH- Strategic Partnerships

- Setting up the Agency“Working together, preparing for REACH”

Aligning Dir. 67/548 and Reg. 793/93 with REACH

Developing Guidance Documents and Software Tools for efficient, transparent and consistent implementation

Finland: Practical aspectsCOM: Organisation

The interim strategy has 4 basic work elements:

The Interim Strategy

The Interim Strategy prepares ALL stakeholders for a Sustainable REACH

Implementation

European Commission

Preparing for REACH

REACH Implementation Projects (RIPs):RIP 1: Process descriptionsRIP 2: Development of IT systems (IUCLID database and REACH-IT)RIP 3/4: Guidance Documents industry/authoritiesRIP 5/6: Setting up the (pre-) Agency

Objective: In close collaboration with all stakeholders develop guidance to help fulfil the obligations under

REACH

European Commission

RIP-2: REACH-IT and IUCLID-52 main systems, “talking to each other”

IUCLID 5:

Industry: tool for capturing data on chemicals, preparing and submitting dossiersAgency and Member States: central data repository for all dossiers submitted and tool for preparing different kinds of evaluation dossiers

REACH-IT: Support for managing the complete systemAgency web portalWorkflow systemDissemination

European Commission

3.1: Preparing theregistration dossier3.1: Preparing the

registration dossier

3.2: Preparing the CSR

3.2: Preparing the CSR

3.3: Information requirements

3.3: Information requirements

3.10: Guidance on checking

substance ID

3.10: Guidance on checking

substance ID

3.5: Guidance for downstream users3.5: Guidance for downstream users

3.8: Requirementsfor articles

3.8: Requirementsfor articles

3.6: Guidance onC&L

under GHS

3.6: Guidance onC&L

under GHS

3.7: Guidance on applications for

authorization

3.7: Guidance on applications for

authorization

3.9: Guidance on SEA

3.9: Guidance on SEA

3.4: Guidance on data-sharing

3.4: Guidance on data-sharing

RIP-3

European Commission

4.1: Guidance on dossier evaluation4.1: Guidance on dossier evaluation

4.2: Guidance on substance evaluation4.2: Guidance on

substance evaluation

4.3: Inclusion of substances in

Annex XIII

4.3: Inclusion of substances in

Annex XIII

4.4: Preparation of Annex XIV dossiers4.4: Preparation of Annex XIV dossiers

4.5: Priority settingfor evaluation

4.5: Priority settingfor evaluation

RIP-4Guidance for

Authorities

European Commission

Stakeholder Expert Groups

Discuss the project implementation, including work plan, deliverables and timing Discuss progress and advise on consequent adjustments needed to the work planProvide comments on draft guidance documentsWhere relevant, and a mandate has been given by the Commission, carry out parts of the RIP work.

European Commission

SEG Representation

Approximately 200 experts follow the process!19 Member States or accession countriesIndustry organisations:

CEFIC, CEPE, CEPI, CONCAWE, DUCC, ESIA, Euratex, ReachAlliance, EuPC, BLIC, EDANA, Eurocommerce, AISE, ASD, FECC, UNICE, ESBA, CIA, EPIA

NGO’s:ETUC, FoE, WWF, ECEAE, EEB, Greenpeace

Others:OECD secretariat, Health Canada, Japan Business Council in Europe

European Commission

Example: Exposure Scenarios in RIP 3.2

Exposure Scenarios represent a new element of “risk assessment” and is central to REACH implementation;Industry, in particular sector / branch organisations should provide support by gathering best practice Risk Management Measures and developing generic but sector-specific Exposure Scenarios

European Commission

The ‘Arona network’Main conclusions

1. A manageable number of ES is needed to cover standard processes within an industrial sector

2. Bottom-up approach is a way forward in developing ES3. Use standard descriptions of current practice within

industrial sectors as a starting point

Report and presentations at: http://ecb.jrc.it/REACH→ documents →Arona network

European Commission

Preparation: U.S. exportersREACH may have implications for your business - costs, professional resources, R&D, portfolios of chemicals, procurement, relations up and down the supply chain, management systems etc. It is important to have a clear and realistic understanding of the implications of REACHMake an Inventory of substances to be exportedStudy obligations of your EU importer

REACH registration requirementsGuidance developed: http://ecb.jrc.it/REACH

Actively communicate with your EU clients to see how their needs can be met and

Provide adequate information on the substancesDevelop and provide exposure scenarios

Plan for the futureDon’t leave data generation and assessment too late

European Commission

Conclusions

REACH is on the horizon and expect agreement by the end of the year.REACH Implementation Projects being prepared and ready by mid-2007. Consult drafts and give input!REACH opportunity to rebuild confidence in chemicals Start preparing your company now and understand the implications of REACH for your business

European Commission

Further information on RIPshttp://ecb.jrc.it/REACH/

European Commission

Information

http://europa.eu.int/comm/enterprise/chemicals/index.htm

http://europa.eu.int/comm/environment/chemicals/index.htm