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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
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
SCOPE OF THE PRESENTATIONSCOPE OF THE PRESENTATION
What is REACH ?Introduction, current state of artWorkplan in 2006
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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)
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Thank you for your attention !karel_blaha@env.cz
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