Giuseppe Malinverno

1
REACH RUSH FINALE

• Giuseppe Malinverno
• Presidente Comitato Sicurezza Prodotti -
  Federchimica

IT FORUM LInnovazione dellInformation
Technology al servizio di Sicurezza, Salute e
Ambiente per una Chimica sempre più
responsabile Bollate, 23 novembre 2006
2
Co-decision process timing
Council political agreement DEC 2005
COM proposal 29 October 2003
Council Common Position to be adopted in the
ENVI Committee on 27/06/06
EP first reading NOV 2005
Transmission of common position
4/09/06-September part-session
EP second reading ENVI Committee (10.10.)
Plenary (11-14.12) (absolute majority)
(3 1 months it means within December 2006)
We are here
Commissions opinion on EPs amendments
Draft amendments to Council common position
Second reading Council
3 1 months
Council does not approve the amendments to the
common position
Conciliation
6 2 weeks
REACH comes into force April or July 2007
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EP Environment Committee

• The Environment, Public Health and Food Safety
  Committee has 63 members, its chairmen is
  Karl-Heinz Florenz (EPP) . The committee voted on
  the rapporteurs (Sacconi/PES) report. The
  Sacconi-report contains mostly industry
  critical amendments.
• Political composition of the committee
• European People's Party (EPP) 22
• Party of European Socialists (PES) 16
• Alliance of Liberals and Democrats for Europe
  (ALDE) 8
• Greens/Free European Alliance (Greens) 5
• European United Left / Nordic Green Left
  4
• Independence / Democracy Group 4
• Union for Europe of Nations Group 3
• Non-attached 1

Result of the vote on October 10th 42 votes in
favour, 12 against, 6 abstentions
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Environment committee Analysis of the Vote

• EPs 1st reading position on Authorisation,
  Substitution and Duty of care reinstalled
• European Peoples Party was split
• UK-Tories pro Sacconi, EPP-SWE voted green
• Liberals voted mostly Green
• Hardly any abstentions

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ENVI-vote in Detail (I)

• Duty of Care (principle)
• Origin in Anglo-Saxon legal system, introduces
  new (extra) obligations for industry interfering
  with national liability systems and lead to legal
  uncertainties
• Agency
• Many technical decisions are replaced by
  political ones. Art. 272 gives power of veto to
  the European Parliament concerning commission
  decisions on authorisation. No right to appeal
  against agency decisions regarding confidential
  business information
• Registration
• Chemical Safety Assessment and Report starting
  from 1 t (before 10 t)
• Polymers
• Earlier revision after 6 years (instead of 10
  before)
• Scope
• Nanoparticles now fall under REACH and are
  considered substances of very high concern.
  but tight vote (29/28)

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ENVI-Vote in Detail (II)

• Authorisation Procedure (41 /17) concerns ?
  1.500 substances high-risk substances
• The Authorisation will be granted under
  strict conditions only, namely if
• 1. Suitable alternatives or technologies do not
  exist measures to minimise exposure
• AND
• 2. It is demonstrated that the social and
  economical advantages outweigh the risks to human
  health or the environment
• AND
• 3. The risk to human health/environment are
  adequately controlled as documented in the
  applicants chemical safety report.
• The Authorisation will only be valid for a period
  of max 5 years (35/23)
• Substitution (38/19)
• Mandatory substitution, even when no
  alternative exists.
• Substitution plan is always requested
  when applying for an authorisation
• Precautionary principle mentioned in
  the general provisions of REACH and in the
  provisions on authorisation

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Authorisation Council vs. Parliament
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Major players reactions to the vote

• Finnish presidency (before and after the vote)
• Environment Minister Enestam governments
  should seek some adjustments to REACHs
  authorizations and compromise with MEPs
  substitution views.
• CEFIC The stricter criteria for granting
  authorisation and mandatory substitution, even
  when there is no alternative, will lead to the
  banning of certain substances even though there
  are clear socio-economic benefits and no
  alternative is available. This situation could
  encourage a lot of producers to move out of
  Europe.
• UNICE The outcome in the Parliaments
  Environment Committee is disappointing as it does
  not take into account the Councils proposals
  towards a workable and smart approach based on
  the concept of adequate control of risk. The
  European Parliament, Council and Commission must
  continue their efforts to achieve a
  cost-effective and workable REACH before the
  plenary.
• ETUC (EU Trade Unions Confederation) wants
  Council to follow the MEPs' lead on the
  substitution principle in the second reading
  negotiations on REACH.

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REACH timing
SVHC Substances of very high concern SIA
Substances in articles EIF Entry into force
Notification of SVHC in SIA If gt1t/year and the
substance is present in those articles above a
concentration of 0,1 weight by weight (w/w)
Agency start up
1-100 tonnes
?1000tonnes ?CMRs 1tonne ?PBTs/vPvBs
(R50-53) 100tonnes
Pre-registration
100-1000 tonnes
Non-phase-in substances
6 months
11 years (April 2018?)
3 years
6 years
EIF (April 2007?) 12 months
18 months
Source DG-JRC Mr. Jack de Bruijn
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News from COREPER

• On 15th November, during the meeting of the
  COREPER, the Presidency invited and pushed the
  delegation to do the maximum efforts to reach the
  compromise.
• Many delegations agreed (Italy included) but
  Germany, Malta, Hungary, Poland and Czech
  Republic stayed firmly on the Common Position.

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News from COREPER

• There are currently 2 proposals floating
• The UK proposal only regards authorisation for
  non-threshold substances under article 59.4 (not
  59.2). This means the UK is not proposing any
  mandatory substitution plan for substances
  authorised on the basis of adequate control, but
  rather for those on basis of socio-economic need.
  This plan would only be required
• a) if a safer alternative has been identified
• b) if it is technically and economically
  feasible
• c) only at time of any review to the original
  authorisation.
• There is strong support in Council to
  maintain the common position for
• authorisation on basis of adequate
• The Finnish Proposal would mean substitution
  plans would have to be submitted as part of the
  application for authorisation where the
  assessment of alternatives has identified that a
  safer alternative (which is technically and
  economically feasible) for the use of that
  substance exists.

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News from COREPER

• The following member states argued in favour of
  the UK proposal over the Finnish one UK, DE,
  POL, ES, IRE, PORT, MT, CZ (i.e. a blocking
  minority).
• DK, SWE and FR were more supportive of the
  Finnish Presidency.
• Despite the opposition, the Finns insisted on
  presenting their proposal to Sacconi in the next
  Trialogue. Several member states are angry that
  the Finns are trying to go beyond their official
  mandate. It is expected that Sacconi will not
  accept the UK proposal as he will be aware of the
  Finnish desire.

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Trilogue meetings

• Trilogue meeting of 20th November the
  compromise on authorization should/shall be
  reached ??
• On 22th November the different COREPER will get
  the possible agreement. Within few hours they
  must give their opinion (!!!??) on the whole
  package (which probably include besides the
  authorization, duty of care, confidentiality of
  data etc.)
• On 24th November the COREPER will decide
• The next Trilogue is scheduled for 27th November
• The vote is still foreseen for the 13th of
  December in plenary 
•  

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WHY RIPs

• REACH is a comprehensive piece of legislation
  covering a wide range of aspects of chemical
  management
• Guidance and support tools are essential to help
  stakeholders understand their tasks and fulfil
  their obligations
• Successful implementation needs proper and timely
  preparation

Source DG-JRC Mr. Jack de Bruijn
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Preparations for REACH Commission interim
strategy

• REACH Implementation Projects (RIPs)
• RIP 1 Process descriptions
• RIP 2 Development of IT systems (IUCLID database
  and REACH-IT)
• RIP 3 Guidance Documents for industry
• RIP 4 Guidance Documents for authorities
• RIP 5/6 Setting up the (pre)-Agency
• AIM In close collaboration with all stakeholders
  develop guidance to help fulfil the obligations
  under REACH

Source DG-JRC Mr. Jack de Bruijn
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RIPs
3.1 Preparing the registration dossier
3.2 Preparing the CSR
3.10 Guidance on checking substance ID
RIP-3 Guidance for Industry
3.4 Guidance on data-sharing
3.3 Information requirements
3.7 Guidance on applications for authorisation
3.5 Guidance for downstream users
3.9 Guidance on SEA
3.8 Requirements for articles
3.6 Guidance on CL under GHS
Source DG-JRC Mr. Jack de Bruijn
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RIPs
4.3 Inclusion of Substances in Annex XIII
4.1 Guidance on dossier evaluation
4.2 Guidance on substance evaluation
RIP-4 Guidance for Authorities
4.4 Preparation of Annex XIV dossiers
4.5 Priority setting for evaluation
Source DG-JRC Mr. Jack de Bruijn
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Timelines for RIP 3 projects
Source DG-JRC Mr. Jack de Bruijn
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General management of the RIPs

• Overall process coordinated by the European
  Chemicals Bureau (ECB) of the JRC
• Most projects are tendered out via open call for
  tendersA number of projects have started with
  scoping studies
• Working papers and draft final reports are being
  discussed in Stakeholder Expert Group (SEG)
  meetings
• Industry, Member States, NGOs and the Commission
  take part in the SEG meetings and provide input
  and written comments
• Final reports are being discussed and commented
  by the Technical Committees following todays
  chemicals legislation
• Under REACH, the Agency will be responsible for
  the guidance !

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Stakeholder Expert Group participation

• Nomination of experts via Commission Working
  Group on REACH (Members Observers)
• More than 200 experts follow the process!
• 19 MS or accession countries
• Many Industry organisations
• CEFIC, CEPE, CEPI, CONCAWE, DUCC, ESIA, Euratex,
  Reach Alliance, EuPC, BLIC, EDANA, Eurocommerce,
  AISE, ASD, FECC, UNICE, ESBA, CIA, EPIA, VCH, 3M
• Many NGOs
• ETUC, FoE, WWF, ECEAE, BUAV, EEB, Greenpeace
• Others
• OECD, US-EPA, Health Canada, Japan Business
  Council in Europe

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(No Transcript)
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Conclusions

• Absolute majority (367 MEPs) required for the
  Vote in Plenary in Dec. 2006, Absenteeism
  determinant
• Uncertainty How will the Finnish Presidency and
  the Member States react, now that the Parliament
  has a strong political mandate
• European Advocacy Strategy needed for Parliament
  and
• Council

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Thanks for your attention