REACH State of Play & Cefic activities

REACH Workshop, Prague, 5.10.2006

Dr. Thomas Jostmann

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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)

3 + 1 months

Conciliation

6 + 2 weeks

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COUNCIL EP

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)

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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/aEPP: 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

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State of play

So far, no agreement in sight between EPP and PESSacconi – Oomen discussions deadlocked

Possible scenario Sacconi keeps hard line till the vote in ENVI, then seekscompromise 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)?

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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.

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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

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Substance authorised

under adequatecontrols

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

Noauthorisation

Safe use

Benefits

Substance authorised

under adequatecontrols

No benefits

No authorisation

Use substitute

Substitute

Tim

e li

mite

d (

5 y

rs)

No safe use or no threshold limit

Authorization can become critical for more than 3.000 substances

PBT, CMR, vPvB

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EP second reading 2006 - Timetable

Council EP

JUN Common Position adopted

Environment Council (27)

ENVI: informal discussions

SEP Sacconi - Shadow Rapporteurs (7)

Deadline for AMs (11)Consideration of AMs (13-14)

OCT The 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)

NOV Vote Plenary (13-16)

Vote ENVI (20/21)

DEC

Vote Plenary (11-14)

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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 (2nd half 06) planned- German presidency (1st 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

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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

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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

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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 3.2.2 – task 4 (exposure scenario & risk management measures for CSA/CSR) Leading role in „partnership“ on RIP 3.3.2 (data requirements & endpoints) Partner in tender for RIP 3.4 (industry cooperation/ consortia)

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Timetable RIP projects

RIP N° Name Starting date

3.2-2TGD on preparing the CSR (Guidance Development)

Start April 2006 (12 months)

3.3-2TGD on Information Requirements (Guidance Development)

Start Dec 05 (12 months)

3.4Guidance document on data sharing (pre-registation)

Start Sept 06 (9 months)

3.5-2TGD on Downstream User Requirements (Guidance Development)

Start June/ July 06 (10 months)

3.6 Guidance on C&L under GHS Start Oct 06 (8 months)

3.7 Guidance on application for authorization Start Sept 06 (8 months)

3.8 Guidance on fulfilling requirements for articles Final comments April 2006

3.9-2Guidance on carrying out a SEA (Phase 2 Guidance Development)

Start June/ July 2006 (12 months)

3.10 Guidance on performing substance ID check Final comments sent March 2006

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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

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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)

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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

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Want to learn more?

• Welcome to

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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

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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

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Industry Preparations

REACH Industry preparation letter n°4 issued

Interest from Companies and FederationsPositive 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)

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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!