twinning project ro2004/ib/en-09 implementation and enforcement of the environmental acquis at...

20 July 2006

Component 1 - Activity 1.3 training in EU co-ordination

Twinning Project RO2004/IB/EN-09 Implementation and Enforcement of the Environmental Acquis at National Level and Coordination of the 8 Regional Twinning Projects

Twinning Project RO2004/IB/EN-09

Implementation and enforcement of the environmental acquis at national level and coordination of the other 8 regional twinning

projects

Training

REACH REACH AT THE EDGE OF THE SECOND READINGAT THE EDGE OF THE SECOND READING

Karel BláhaDepartment of Environmental Risks

20 July 2006



SCOPE OF THE PRESENTATIONSCOPE OF THE PRESENTATION

What is REACH ?Introduction, current state of artWorkplan in 2006

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A Tiered Approach

What is REACH?What is REACH?

Single, coherent system for new (non phase-in) and existing (phase–in) chemicals

Elements:

• Registration of substances ≥ 1 tonne/yr (staggered deadlines)

• Evaluation of some substances by Member States• Authorisation only for substances of very high concern• Restrictions - the safety net• Agency to manage system

Focus on priorities:• high volumes (early deadline)• greatest concern (CMRs early)

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Substitution and precaution underpin system

OBJECTIVES OF REACHOBJECTIVES OF REACHSustainable Development

Protection of human health and the environment Maintain/enhance innovation/competitiveness Maintain the internal market Increase transparency and consumer awareness Integration with international efforts Promotion of non-animal testing Conformity to WTO obligations

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REGISTRATION: GENERALREGISTRATION: GENERAL Scope

• substances produced/imported ≥ 1 tonne/year• Isolated intermediates: reduced requirements.• Exemptions e.g. PPORD, polymers

Tasks of the registrant (manufacturer/importer only): • obtain adequate information (inc (Q)SAR and existing data)• perform CSR for substances > 10 tonnes/year (prove safety of

uses)• send information to Agency by deadline (and to clients)

Joint submission encouraged (OSOR)

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CHEMICAL SAFETY ASSESSMENTCHEMICAL SAFETY ASSESSMENT Scope: Substances subject to registration > 10 t/year

Preparations:for substances above certain concentration limits,

No health consideration needed for:• cosmetic end uses• food contact material end uses

Process description in Annex I: Physicochemical and human health hazard assessment Environmental hazard assessment PBT and vPvB assessment Exposure scenario generation

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DATA SHARINGDATA SHARING Information > 10 years – freely availableInformation > 10 years – freely available At registration – registrants indicate if share non-animal dataAt registration – registrants indicate if share non-animal data Non-phase-in substances:Non-phase-in substances:

• Agency enables contact with previous, or potential, registrants – share costs

• Studies involving vertebrate animals not repeated Phase-in substances:Phase-in substances:

• Potential registrants of substance: ‘SIEF’ (Substance Info Exchange Forum)

• Share data (inc new tests) and costs;• Sharing mandatory (vertebrate animals)

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EVALUATIONEVALUATION: AGENCY: AGENCY

DOSSIER EVALUATION

SUBSTANCE EVALUATION

Check test proposals Compliance

Output:

• Further information decisions

• Info to other parts of REACH/other legislation

Examine any information on a substance

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AUTHORISATION (1)AUTHORISATION (1)

Which substances require authorisation? Substances of very high concern:

• CMR• PBT, vPvB, ‘serious and irreversible effects’: identified on basis of

Dossier prepared by Agency or MS (agreement procedure) Recommendation on priority substances

• Agency recommendation• PBT/vPvB; wide dispersive uses; high volumes

Inclusion into Annex XIII:• Commission decision (comitology)• application date and sunset date (18 months later)

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AUTHORISATION (2)AUTHORISATION (2)

How to obtain authorisation?

Application to Agency• Broad info on uses applied for is published

(comments) Agency Committees deliver opinions

• Risk Assessment Committee• Socio-economic Analysis Committee• Sent to applicant for comments which are

taken into account for final opinion Commission decision (comitology)

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Safety netRESTRICTIONSRESTRICTIONS

MS or COM initiated (Annex XIV dossier) Community wide concern Agency Committees examine:

• the risk, and• the socio-economic aspects involved• 3rd part comments

Consumer use CMR substances - fast track possible. Commission - final decision through comitology Carry-over of existing restrictions (76/769/EEC)

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AgencyComposed of:

• Executive Director

• Management Board (25 nominated by Council; 3 nominated by Commission; 3 non-voting members from stakeholders)

• Committee for risk assessment (authorisations and restrictions)

• Committee for socio-economic analysis (authorisations and restrictions)

• Member State Committee (evaluation, C&L and identification of SVHC)

• Forum (enforcement)

• Technical and scientific Secretariat (registration, C&L, Agency decisions, management of committees)

• Board of Appeal

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Pre-registration and phase-in

EIF 12 months

Pre

-reg

istra

tion

3 years 6 years 11 years

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

Ag

en

cy sta

rt up

100-1000 tonnes

1-100 tonnes

[6 months]

18 months

Notification of SVHCs in SIA

Non-phase-in substances

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REACH – brief history Feb 2001 White Paper published

May 2003 Internet consultation launched: 6000+ comments received

Aug/Sep 2003 Proposals substantially amended as result of comments

29 Oct 2003 Draft REACH regulation adopted by Commission

20 Nov 2003 Ad-hoc Working Party established

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EU Chemicals Policy Review Co-decision process & timing

New Chemical Policy in Force: 2007?

Opinion Commission

Final Legislative

Acts

Conciliation

Development of the White Paper

1999 - Feb 2001

White Paper

Feb. 2001Stakeholder Consultation

2 April 2001

Council Common

Position

2005/6

Parliament’s 1st Reading

NOV 2005

Parliament’s 2nd Reading

2006

Directly applicable in

Member States

Council Conclusions

Parliament’s Opinion

April –Nov. 2001

Legislative ProposalsOctober 2003

Proposal DG ENVDG ENTApril 2003

Internet ConsultationMay-July 2003

Proposal DG ENVDG ENT

September 2003

Interservice Process

Commission

InterserviceProcess

Commission

20 July 2006



REACH Voting Calendar

AM tabled

Comments Consideration of AM

Votes Plenary

ENVI 1185 All AM available

Evaluation done

Sacconi

15 SEP 4 OCT 14/17 NOV

ITRE 1301 All AM available

Evaluation done

Ek

30 AUG 13 SEP

IMCO 895 All AM available

Evaluation done

Nassauer

5 SEP 13 SEP

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Council meetings - 2005Council meetings - 2005

11 OCT: Competitiveness Council – Policy Debate

17 OCT: Environment Council – Policy Debate

13 DEC: Competitiveness Council – Extraordinary Meeting

Political agreement achieved

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Council ACouncil AHHWWPP Meetings Meetings

13-14 FEB: RecitalsConsolidated text of the Regulationdocument 15921/05 REV 1 (March 9, 2006)

16 MAY: Technical amendments

27 JUNE: Common position adopted by the Council

Council - Council - ATAT Presidency 200 Presidency 20066

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COMMON POSITITIONCOMMON POSITITION

7524/06 COMPET 72 ENV 189 CHIMIE 12

CODEC 252 OC 224(June 27, 2006)

Common position adopted by the Council with a view to adopting a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants} and a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals

20 July 2006



Council ACouncil AHHWWPP Meetings Meetings 3-4 JULY: Discussion of EP amendments

WD 31/06 (March 9, 2006)

17-18 JULY: Discussion of EP amendments continues

4 AHWP meetings scheduled in September

Adoption of the Regulation in the second reading by the end of 2006

Finish should finish !Finish should finish !

Council - Council - FIFI Presidency 200 Presidency 20066

20 July 2006



WD 31/06 Rev 1 (June 22, 2006)

The groups of amendments:- Duty of care - Animal testing - The Agency and the involvement of the European Parliament therein- Communication of Information- SMEs- Other amendments

20 July 2006



European Commission Working GroupEuropean Commission Working Groupon the Practical Preparations on REACHon the Practical Preparations on REACH

11 OCT: CWG/15/2005 – Preparation for the European Chemicals Agency

25 OCT: AHWP Meeting – Cion presents WD 255/05

2 NOV: CZ sends the Letter of Commitment to Cion

28 NOV: CWG Meeting (London) back-to-back with the CA meeting

13 MAR: 13 MAR: subgroup for REACH enforcement subgroup for REACH enforcement establishedestablished

22 MAY22 MAY Preparations for the Agency establishmentPreparations for the Agency establishment

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20 July 2006



ENVI June 21: first exchange of views on amendments

June 30: Draft Recommendation published (inet) by Mr. Sacconi (out of 230 amds., 49 retabled) and taken by Presidency in WD 31/06

Oct. 10: VotingPLENARY Sept. 6: Common Position to be delivered to the Chair

3 (+ 1) months for 2nd reading !!! Nov. 16

or Dec. 14: Voting

European ParliamentEuropean Parliament

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WHAT CAN HAPPEN on Nov 16 or Dec 14??

1. EP approves the Common Position – proposal adopted

2. EP approves the amendments to the Common Position – proposal goes back to the Council

CONCILIATION STARTS (6 WEEKS)

European ParliamentEuropean Parliament

20 July 2006



WHAT CAN HAPPEN within 6 weeks ??

1. COUNCIL can by qualified majority revert the EP amendments, provided that Cion agrees (if it is not the case, COUNCIL must be unanimous)

2. If the step 1 fails, a Conciliation Committe must prepare the COMPROMISED TEXT

3. COMPROMISED TEXT submitted to COUNCIL and EP

CONCILIATIONCONCILIATION

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WHAT CAN HAPPEN ??EITHER

COUNCIL (by qualified majority) and

EP (by absolute majority) approves the compromised text

PROPOSAL ADOPTED

OREither COUNCIL or EP disagree

PROPOSAL REJECTED

END OF THE GAMEEND OF THE GAME

20 July 2006



20 July 2006



Thank you for your attention [email protected]

twinning project ro2004/ib/en-09 implementation and enforcement of the environmental acquis at...

Documents

registration of substances

substances subject

information decisions

safety of usessend information

high concernrestrictions

adequate information

health consideration

safety netagency