European Commission

REACH

European Chemicals Policy Experts Tour USA, 20-28 October 2003

Robert Donkers, Delegation of the European Commission to the U.S.

European Commission, DG Environment

Unit C.3: Chemicals

ProblemsProblems

Burden of the Past

The Current EU Chemicals Policy

Existing substances can be used without testingBurden of proof on public authoritiesNo efficient instrument to deal with problematic

substancesLack of incentives for innovation, in particular of

less hazardous substitutes

European Commission, DG Environment

Unit C.3: Chemicals

ObjectivesObjectives

Guiding Principles - substitution and precaution

Solution: A New EU Chemicals Policy

Sustainable Development Protection of human health and the environment Maintain/enhance innovation/competitiveness Maintain the Internal Market Increased transparency and consumer awareness Integration with international efforts Promotion of non-animal testing

European Commission, DG Environment

Unit C.3: Chemicals

Development of the new legislation:REACH

White Paper (Feb 2001) Reactions: Council (Jun 2001) and Parliament (Oct 2001) Reactions: stakeholders - very varied

Fact-finding (Sep 2001 - Mar 2002): Technical consultation (Working Groups), Studies

Drafting stage (Mar 2002 - May 2003) Internet Consultation (15 May 2003 to 10 July 2003)

6400 consultation responses Review of replies & re-drafting (Jul - Aug 2003)2nd inter-service consultation (Sept - Oct 2003)

European Commission, DG Environment

Unit C.3: Chemicals

One SystemOne System

A Tiered Approach

REACH

Single, coherent system for new/existing chemicals Elements:

Duty of Care for all manufacturers and importers Registration of substances above 1 tonne Evaluation by the Member States Authorisation for substances of very high concern Restrictions - the safety net Agency to manage system

Focus on: high volumes greatest concern.

European Commission, DG Environment

Unit C.3: Chemicals

Information through the supply chain

What?SDSs based on Chemical Safety Reports Information on authorisations, restrictions, registration

number etc.

Result?more information on risksdownstream users brought into the systemdialogue up/down the supply chain-encouraged/stimulated

Improve risk management

European Commission, DG Environment

Unit C.3: Chemicals

Ensure industry adequately manages the risk from its substances

Registration (1)

Method: manufacturer/importer obtains adequate data > 10 tonnes/year: performs chemicals safety reports (inc RRM) Electronic submission to authorities (enforcement, transparency) Info in central, largely public, database.

Substances produced/imported > 1 tonne/year Information requirements increase according to tonnage > 100 tonnes/year: testing proposals Reduced requirements - Intermediates

Deadlines for phase in substances

No formal acceptance necessary - industry retain responsibility

European Commission, DG Environment

Unit C.3: Chemicals

Yr 0 Yr 0 +3 Yr 0 + 6 Yr 0 + 11

>1000 t + CMR 100 - 1000 t 10 - 100t

1 - 10 t

Registration (2): DeadlinesA Phased Approach

European Commission, DG Environment

Unit C.3: Chemicals

Data sharing

Non-phase-in substances (= new): potential registrant checks if already registered CA responds:

previous registration older than 10 years: give data previous registration less than 10 years: enable contact with previous registrant

Phase-in substances (= existing): potential registrants (before deadline) submit lists of available data all potential registrants = a ‘SIEF’ (Substance Info Exchange Forum) internal communication in SIEF:

If a study is not available, participants agree who performs it; If a study is available, participants agree on sharing cost and performing study;

Sharing mandatory, if company refuse => sanctions (but testing allowed).

Avoidance of unnecessary animal testing + save costs

European Commission, DG Environment

Unit C.3: Chemicals

Confidence that industry is meeting obligations

Prevent unnecessary testing

Evaluation

Dossier evaluation: Competent authorities review certain registrations check testing proposals

CAs assess test proposals (allocation criterion) CAs prepare draft decisions requiring tests Decision

check compliance with registration requirements

Substance evaluation CAs look at any information on a substance (allocation criterion) CAs may require further information on suspected hazardous properties CAs prepare draft decisions (deadlines and agreement procedure) Decision

European Commission, DG Environment

Unit C.3: Chemicals

Agency

Development of ‘central entity’. Feasibility study - Agency advantages:

better long term continuity financial (fees, staff) consistent with Governance WP (role of COM)

Structure: Committees - RA, SE, MS Forum for exchange of info on enforcement Secretariat Management Board Executive Director

European Commission, DG Environment

Unit C.3: Chemicals

Control uses of very high concern substances

Authorisation

Substances (+ in preps + in articles) Very high concern: CMR, PBT, vPvB, ‘equivalent concern’ Authorisation of use or several uses

may include a review period. some uses or categories of use may be exempted

Prioritised (progressively authorised as resources allow) Application date and sunset date

Applicant to show: adequate control of risks, or social and economic benefits outweigh the risks - substitution considered

Commission takes final decision via comitology: Letter of access/downstream user access

European Commission, DG Environment

Unit C.3: Chemicals

Safety net

Restrictions

Community wide concernAgency Committees examine:

the risk and the socio-economic aspects involved

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

European Commission, DG Environment

Unit C.3: Chemicals

Substances in articles

Producers/importers of articles have obligation to register substances in them if: substance present > 1 tonne per article type/year; and intended to be released under normal use; and substance has not already been registered for that use

Producers/importers notify substances in articles if: substance present > 1 tonne per article type/year; and likely to be released under normal use; and substance has not already been registered for that use, and release may affect human health or the environment Agency may request registration on basis of notification

European Commission, DG Environment

Unit C.3: Chemicals

Who does what?Industry Agency Member States Commission

Registration Submitdossier toAgency.

RA and RMM

Decision ondossier

Data basemaintenance

Public info

Follow up/enforcement.

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Evaluation Testingproposal

Furthertesting ifrequired

Co-ordination. Ensure

consistentdecision-making

Review ofdossiers orsubstances

Decisions onfurthertesting.

Decisiononly if MSdisagree

Authorisation Submitsapplicationdossier

Supportdecision-making,

Recommendpriorities

Member Stateauthorisationfor strictlylocal uses

Decisionon prioritysetting andauthorisation

Restriction Provide socio-economicassessments.

Provideopinions andcomments.

Submitproposals

Decisiononrestrictions.

European Commission, DG Environment

Unit C.3: Chemicals

C and L Inventory

Inventory:managed by Agency contains C and L info for all marketed substances:

no tonnage limit

industry co-operate to resolve differences in C&LEU harmonisation:

CMRs respiratory sensitisers

European Commission, DG Environment

Unit C.3: Chemicals

Downstream Users (DU) Manufacturer/importer registration to cover all uses identified by

downstream users DU must

implement supplier’s RRM for identified uses perform chemical safety assessments for unidentified uses inform Agency of unidentified uses > 1 tonne

DU need to: enter into dialogue with their suppliers consider consortia building and/or cost sharing

DU may need to apply for authorisation

European Commission, DG Environment

Unit C.3: Chemicals

Stakeholder concerns raised

High costsIncreased animal testingImpact on downstream usersProduction moving outside the EUEU industry disadvantaged internationallyLoss of marketed substances

European Commission, DG Environment

Unit C.3: Chemicals

The knowledge gap REACH is designed to fill

Costs

Impact Assessment:Direct costs: €2 billion(range €1.6 - 2.9 billion).

less than 0.1 % of yearly turnover over 11 years

Agency: one off cost €0.4 billion Indirect costs (downstream users): €2.8 - 3.6 billion

60 % of direct costs from testingAn indication of the amount of information industry has about its chemicals?

European Commission, DG Environment

Unit C.3: Chemicals

Benefits (1)For new and existing substances, equivalent:

levels of protection competitive advantages

(Existing: hazardous v New: non-hazardous)

> 30,000 existing substances investigatedAcute (and long-term) toxicity

Improved innovationmore R&D flexibilityno significant loss of protection

Testing: 1-10 tonnes generally in-vitro

European Commission, DG Environment

Unit C.3: Chemicals

Benefits (2)Occupational Health:

increase the effectiveness of existing law esp. for DUPublic health:

substantial benefits Difficult to assess financially but total health benefits

estimated €50 billion (over 30 yrs). Environmental benefits hard to express in cash terms

reduced pollution of air, water, soil, reduced pressure on biodiversity.

Conclusion: benefits significant

European Commission, DG Environment

Unit C.3: Chemicals

REACH = large-scale information collection, = large-scale testing.

Limit animal testing

Information requirements - smart/targeted: exposure often taken into account. not always necessarily to do new testing (eg (Q)SAR).

Low volume chemicals (1-10 tonnes/year): as far as possible no animal testing.

Higher volume chemicals: testing only if existing information/validated alternative methods

not sufficient. Testing programmes - decided by the competent authorities

Data sharing compulsory; fair cost sharing.

European Commission, DG Environment

Unit C.3: Chemicals

Timing

End Oct 2003: Adoption of proposals by Commission and start of

co- decision procedure Nov 2003: Submission proposal to EP and

Council

Decision making in EP and Council: 2003-2006?

European Commission, DG Environment

Unit C.3: Chemicals

Benefits

significantly

outweigh

costs

Conclusion - REACH will ensure:

High level of protection Burden of proof on those creating risks Improved knowledge Improved innovation Substitution of dangerous substances

particularly through authorisation

Better: use of resources reaction to emerging risks information for downstream users consumer confidence