CPR

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REACH Key issues and co-operation with Member
States in Central Europe Prague - 6 October
2004 Dr Uta Jensen-Korte, Director Chemicals
Policy/Regulatory Affairs
European Chemicals Policy Review

Chemistry making a world of difference
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Chemicals Policy - REACH

• Background
• Challenges
• Suggestions for improvement
• Collaboration with the CEEC
• Practical preparation for working
• under REACH

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EU Chemicals Policy Review Co-decision process
timing
Proposal DG ENV DG ENT April 2003
Interservice Process Commission
Development of the White Paper
Internet Consultation May-July 2003
White Paper
Proposal DG ENV DG ENT September 2003
Opinion Commission
Interservice Process Commission
ConciliationProcess
Directly applicable in Member States
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Main Features of REACH

• A single system for new (non-phase-in) and
  existing (phase-in) manufactured/ imported
  substances
• on their own, in preparations or in articles
• Legal basis Article 95 ensures single EU market
• Pre-registration data sharing and avoidance of
  unnecessary testing
• Registration of substances of 1 ton or more per
  M/I/year
• Information in the supply chain downstream users
• Evaluation of dossiers by Member States
• Authorisation for substances of very high concern
• Restrictions the safety net
• Agency to manage the system

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Selected features of todays and the future
framework )
in future
today

• responsibility mainly the regulator
  mainly industry

• scope pre-market
  pre-manufacturing

• registration testing
• requirements
• new substances 10 kg/a ) 1
  t/a for all substances
• existing subst. none )
  tailored for higher volumes
• new existing subst. C L (mktg.)
  C L all

• exemptions new substances for flexibility
  for RD subst.
• R D intermediates, polymers

• restriction mktg. use (76/769) manuf.,
  mktg. use, POPs

• authorisation none for CMRs cat 12, PBT,
  vPvB

) according to the COM proposal
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Chemicals Policy - REACH

• Background
• Challenges
• Suggestions for improvement
• Collaboration with the CEEC
• Practical preparation for working
• under REACH

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Chemical industry view on CP

• The chemical industry continues to support the
  aim of developing a new chemicals regulatory
  system.
• We support
• the overall political objective
• the importance to ensure the protection of human
  health and environment
• However, even with the improvements, the system
  will not achieve its goals. It will have a
  negative impact on the competitiveness of the
  European chemical industry in the global market,
  its contribution to the economic wellbeing of the
  EU and its ability to finance innovation.

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Chemical industry what is at stake

• The Chemical Industry
• employs 1.7 million people directly, several
  millions more
• indirectly
• EUs economy is heavily reliant on the health
  and vitality of
• the chemical industry
• but EU share of global output reduced from 32
  to 28 in a
• decade success cannot be taken for granted
• Need for coherent industrial policy to remain
  competitive
• and innovative
• A workable and efficient chemicals management
  system
• is one of the essential pre-conditions for
  maintaining the competitiveness of the EU
  chemical industry and for ensuring a high level
  of protection of human health and the environment

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REACH - challenges

• Present achievements existing law
• Classification and Labelling (approx. 7000 in 30
  years)
• New Substances Notification (approx. 3700 in 20
  years)
• Existing Substances Reg. (approx. 80 RA in 10
  years)
• ICCA HPV (210 since 2000)

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REACH - challenges

• The challenge for chemical industry
• assess (including data generation)
• document (Chemical Safety Report)
• register (together with other
• producers and downstream users)
• communicate (via Safety Data Sheet)
• 30.000 substances in 11 years

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Chemicals Policy - REACH

• Background
• Challenges
• Suggestions for improvement
• Collaboration with the CEEC
• Practical preparation for working
• under REACH

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Key elements to improve REACH

• Rationalise the Scope of REACH
• Prioritisation of substances to be based on risk
  (including use exposure) and requirements to be
  proportionate
• Authorisation - Decisions must be based on sound
  science
• Central Agency
• Efficiency a straight forward approach is
  needed, not ping-pong between different
  authorities
• Must have full responsibility for all aspects of
  the management of the system

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Interim period - REACH
Opportunity to identify workability problems
A WORKABLE REACH
IMPACT ASSESSMENTS
Strategic Partnership on REACH Testing (SPORT)
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Chemicals Policy - REACH

• Background
• Challenges
• Suggestions for improvement
• Collaboration with the CEEC
• Practical preparation for working
• under REACH

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Collaboration with the CEEC ChemFed/ChemLeg 2

• ChemFed/ChemLeg 2 Joint
• training programme of the
• Commission, Cefic and
• CEEC federations
• A follow-up to ChemFed and ChemLeg projects
• Objectives
• Implementation of Federation acquis ChemFed
  (organisation, governance, competition law
  compliance, best practice and voluntary
  initiatives)
• Implementation of the Community acquis on
  chemicals - ChemLeg

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Collaboration with the CEEC ChemFed/ChemLeg 2

• Workshop on collaborative assessment of chemicals
  (HPV, HERA)
• Workshop on REACH legislative proposals and
  internet consultation
• Workshop on relations with new EP, Council and
  Commission (4 March 2004, Brussels, Belgium)
  contribution to public hearing
• Workshop on Impact of New Chemicals Legislation
  (27 May 2004, Prague, Czech Republic)
• Networking with Cefic chemicals policy review
  team
• Training on assessment of the impact of new
  regulatory requirements REACH as case study
• Training of trainers on REACH (17 trainers)

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ChemFed/ChemLeg 2 Future activities

• Support networking with Cefic groups
• Training sessions in the CEECs
• Workshops Cefic LT/Boards of CEEC Federations
• Contributing to the Cefic/UNICE/Commission impact
  assessment
• REACH cluster in Responsible Care to assist
  companies in implementing interim strategy

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Chemicals Policy - REACH

• Background
• Challenges
• Suggestions for improvement
• Collaboration with the CEEC
• Practical preparation for working
• under REACH

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Start preparing for REACH

• Although REACH is not final yet, you can start
• Produce a substance inventory
• Substance identity, CAS number etc
• Tonnages produced/imported and marketed?
• Would your substance require registration?
• Which legal entity of your group of companies
  manufacturers or imports?
• Who are your competitors/suppliers?
• Who are your customers and what are their main
  uses?
• Do you use distributors?

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Start preparing for REACH

• Assess your vulnerability
• Hazard Data available
• In-house data, vertebrate animal studies, other
  type of hazard information e.g. human data
  ,(Q)SAR, literature
• Classification labelling information
• Safety Data Sheet
• Other regulatory registrations/assessments
• Exposure Data
• Human environmental
• Throughout your products life cycle
• Would the substances require an authorisation?
• CMR Cat 1 or 2, PBT, vPvB

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Conclusion
REACH must be improved to make it work!