REACH State of Play & Cefic activities REACH Workshop, Prague, Dr. Thomas Jostmann

2 Prague conference Talking points  Actual state of play in the political process  REACH implementation  Commission / MS activities  Industry / Cefic activities  Service providers  How to get prepared for REACH

CO-DECISION PROCESS & TIMING REACH comes into force: mid 2007 Communication from the COM on common position Council political agreement DEC 2005 EP first reading NOV 2005 COM proposal 29 October 2003 Council Common Position May/June 2006 EP second reading (absolute majority) EP proposes amendments to Council common position Commission’s opinion on EPs amendments Second reading by the Council Council does not approve the amendments to the common position (3 + 1 months) months Conciliation weeks

4 COUNCILEP Registration/pre -registration  Duty of Care  Evaluation Role of Agency  Authorisation  CBI/Access to Information  5 Key Priorities of Cefic Additional topics under discussion which created already some turbulences but will not be picked up by Cefic’s advocacy:  Imported polymers  Fee structure (free-ride for SME in small tonnage band)

5 Prague conference Position of the main actors in the debate (1) General rule for the European Parliament:  Only those amendments can be re-tabled in the second reading of the EP which have been adopted during the first reading!  Compromise amendments jointly supported by several political groups can be introduced as new amendments Sacconi:  Re-tabled his amendments on authorization, duty of care, animal testing and CSA obligation for substances > 1 t/a EPP:  No compromise found with SPE, therefore re-tabling of all amendments supported in the first plenary vote  In total roughly 300 AM have now been re-tabled

6 Prague conference State of play So far, no agreement in sight between EPP and PES Sacconi – Oomen discussions deadlocked Possible scenario Sacconi keeps hard line till the vote in ENVI, then seeks compromise with Council (Co-legislators want to avoid conciliation) In plenary  Sacconi must get a majority (367 MEPs),  If no compromise possible, EPP retables all AMs  EPP could constitute blocking minority  Risk of split in EPP (260)?  What about PES (200), ALDE (88), UEN (27), IND/DEM (33)?

7 Prague conference Position of the main actors in the debate (2) European Council:  Presidency did not signal any willingness so far to the EP to discuss compromises on the common position  creates some resistance in EP  Has unofficially approached MS representatives to evaluate various features of the common position Duty of care, Animal testing, The Agency and the involvement of the EP, Communication of Information, Small and Medium sized Enterprises, Other amendments. Aims at facilitating a discussion that seeks solutions on these issues before the vote in the EP Environment Committee, scheduled for 10 October.

8  Presidency considers these issues as “potentially less controversial” and tries is to seek solutions in the 2nd reading at an early stage thereby allowing more time for negotiations on more critical issues later in the process, i.e. between the vote of the Environment Committee and the European Parliament's Plenary Session.  Presidency considers Council's Common Position on registration and authorisation as well balanced.  “There will be little or no room for manoeuvre for the Council in these areas”  “At the end of the process a package solution (including registration, authorisation and other elements) has to be found between the Parliament and the Council. This means that nothing is agreed until everything is agreed” Council Finnish Presidency – next steps

9 Substance authorised under adequate controls THE COUNCIL AND EP APPROACH COMPARED Substitute No safe use or no threshold limit Safe use No benefitsBenefits Chemicals of High Concern Use substitute No authorisation Substance authorised use controls No substitute Periodic review No substitute Benefits Chemicals of High Concern No authorisation Safe use Benefits Substance authorised under adequate controls No benefits No authorisation Use substitute Substitute Time limited (5 yrs) No safe use or no threshold limit Authorization can become critical for more than substances PBT, CMR, vPvB

10 Prague conference EP second reading Timetable CouncilEP JUNCommon Position adopted Environment Council (27) ENVI: informal discussions SEP Sacconi - Shadow Rapporteurs (7) Deadline for AMs (11) Consideration of AMs (13-14) OCTThe rest of the timetable will depend on the number of AM tabled and the time needed for compromises. The options are the following Vote ENVI (3/4) Vote ENVI (10/11) Vote Plenary (29-30) NOVVote Plenary (13-16) Vote ENVI (20/21) DEC Vote Plenary (11-14)

11 Prague conference Cefic’s key advocacy activities 1. Targeted advocacy interventions as only few people from the EP, Council and Commission are involved – Avoid massive over lobbying.  EP: - Meetings with key MEPs  Council: - Meetings held with Austrian Presidency and Secretariat - Finnish presidency (2 nd half 06) planned - German presidency (1 st half 07) likely to adopt REACH  Commission: - Regular contact with the relevant Commission services 2. Alliances and dialogue with other interest groups  Close co-operation with Downstream Users & with UNICE, especially on authorisation  Dialogue with EMCEF and other trade unions in downstream industries

12 Prague conference Talking points  Actual state of play in the political process  REACH implementation  Commission / MS activities  Industry / Cefic activities  Service providers  How to get prepared for REACH

13 Prague conference Guidance to help industry and authorities will not be ready in due time  RIP projects are partly delayed and will not be ready before Q3/2007  Guidance will be not easy to apply and needs some navigation tools to be applicable  Level of preparedness at MS level varies tremendously  IT tool to submit pre-registration dossier to ECA will be delayed and reduce effective time to submit dossier by 12 months  Beta version of IUCLID V is now available  MS and Agency help desk are actually under development  Industry resources running short in RIP projects

14 Prague conference Industry engagement in RIPs is pivotal for achieving practical guidance Cefic is participating in the RIP projects of the Commission by  Representing industry positions in major parts of RIP 3 and RIP 4 via nominated representatives for the SEGs (stakeholder expert groups).  Active participation in RIP 2 (REACH IT)  Leading role in „consortium“ on RIP – task 4 (exposure scenario & risk management measures for CSA/CSR)  Leading role in „partnership“ on RIP (data requirements & endpoints)  Partner in tender for RIP 3.4 (industry cooperation/ consortia)

15 Prague conference Timetable RIP projects RIP N°NameStarting date TGD on preparing the CSR (Guidance Development) Start April 2006 (12 months) TGD on Information Requirements (Guidance Development) Start Dec 05 (12 months) 3.4 Guidance document on data sharing (pre- registation) Start Sept 06 (9 months) TGD on Downstream User Requirements (Guidance Development) Start June/ July 06 (10 months) 3.6Guidance on C&L under GHSStart Oct 06 (8 months) 3.7Guidance on application for authorizationStart Sept 06 (8 months) 3.8Guidance on fulfilling requirements for articlesFinal comments April Guidance on carrying out a SEA (Phase 2 Guidance Development) Start June/ July 2006 (12 months) 3.10Guidance on performing substance ID checkFinal comments sent March 2006

16 Prague conference Although guidance is not yet finalized there are already many offers to help!  REACH services seems to be a huge market attracting a lot of commercial service providers with different expertise and service offerings  no accreditation scheme foreseen at EU level  no quality check available  usefulness needs to be assessed by the client himself  network of trade associations establishing a coherent platform to provide necessary support for companies

17 Prague conference A natural logical split National Associations Front line help desk National language Link to MSCAs Tools and guidance Cefic Consortia management and registration service Provision of standard tools/formats Consistency “custodian” Training of other service providers Help desk (for smaller MSs, non-EU companies, affiliated organisations)

18 Prague conference Creation of ReachCentrum ReachCentrum is being established as an independent service body, which will be part of consistent service network provided by Cefic, national associations and Member State authorities Clear distinction between regular trade association offering (covered by regular membership fee) and tailor-made services to companies (invoiced separately) Potential customers include members, companies throughout the value chain, and non-EU chemical manufacturers

19 Want to learn more? Welcome to

20 Tailor-made to your company’s needs Help desk – advice and guidance on how to prepare for REACH Consortia management Registration service Submission of authorisation applications Archiving and data management AVAILABLE NOW! AVAILABLE FROM LATE 2006 ONWARDS

21 Prague conference Talking points  Actual state of play in the political process  REACH implementation  Commission / MS activities  Industry / Cefic activities  Service providers  How to get prepared for REACH

22 Prague conference Industry Preparations REACH Industry preparation letter n°4 issued  Interest from Companies and Federations  Positive feedback 3 rd REACH awareness workshop on 20. September with more than 120 participants 1 st REACH IT workshop on 21. September on support tools (e.g. IUCLID V)

23 Prague conference Recommendations to companies: List of all substances produced and used in the manufacturing of substances (incl. critical auxiliaries)  Which substances need to be pre-registered (phase-in status)?  Any intermediates / polymers which need notification?  Any imported preparation containing substances which need to be registered?  List of suppliers (substance identification (CAS/EINECS, quantity..) Next steps:  Potential SIEF / consortia partners  Cost calculation for registration efforts  Use & exposure information available?  Substances falling under authorization? REACH will be with us from mid 2007 onwards – you better get prepared!