FUTURE EU CHEMICALS POLICY: The View of the American Chamber of Commerce Jonathan Kapstein Director Corporate Communications, International Lyondell Europe Warsaw, November 26th 2004

REACH in a nutshell  REGISTRATION: For any substance above 1 ton: Producers / Importers to notify authorities of intention to produce / import substances. o Information dossier to contain: Identities + properties, Intended uses, Estimated human + environmental exposures, Production quantity, Proposal for classification + labeling, Preliminary risk- assessment covering intended uses, Proposed risk assessment measures  EVALUATION of Registration dossier for completeness check + Evaluation of substances. Producers / importers may have to propose a strategy for further testing  AUTHORIZATION for substances that are Carcinogenic, Mutagenic, or Toxic to reproduction (CMR’s) & Persistent Organic Pollutants (POP’s). General prohibition applies, unless specific exemption is delivered.

Key elements of REACH Registration information and timetable

Übersicht (5) Source:

Future EU Chemicals Policy Industry comments  Fully supports sound scientific, practical policies to promote the safe management of chemicals on a global basis uFully supports the objectives of REACH and its underlining principles uWe see improvements in the scope but the proposal should substantially be improved to be workable for industry and authorities

Future EU Chemicals Policy Main concerns uHazard-based legislation uBurdensome & disproportionate requirements (Excessive data requirements = unnecessary animal testing + higher costs + need to develop new testing methods) uNo coordination with programs developed in other trading blocks uRisk of disruption with EU single market (no central decision-making role for the chemicals agency) uConfidential business information not protected

Future EU Chemicals Policy Areas for substantial improvements  Central responsibility of the European Chemicals Agency uPrioritization of substances ( substances in 11 years!) uShift focus from hazard to risk-based decisions uRealistic timelines and simplified testing obligations uTransparent and simplified decision-making process uProportionate requirements uProtection of confidential business information uMutual recognition between global chemical management schemes uClarification scope versus other regulatory schemes (avoid overlap & duplication) uAuthorization/Restriction as a follow-on step to registration + evaluation uFurther assessments of the impact on industrial competitiveness

Commission’s Proposal (Oct.03) European ParliamentCouncil of Ministers  Competitiveness Council leads  Ad Hoc Working group on Chemicals – High level reading  New EP  Environment committee likely to lead  Enhanced collaboration procedure (‘Hughes’) would apply 1. Vote in Plenary on Report & Amendments = 1 st Reading (2005) 2. Council develops a Common Position ( ??) Legislative process & timing (estimation) 3. EP reviews Common Position = 2nd reading 4. Council rejects some Amendments Conciliation leading to Adoption ( 2006/2007??) UK (2/05) IRL (1/04) NL (2/04) L (1/05) A (1/06) F (2/06)

Fundamental themes raised  Prioritisation  “One substance – One registration”  Data sharing – avoid unnecessary animal testing, further analysis required regarding consortia, confidentiality, costs, information to others  Role of Agency  Authorisation- extension of scope, substitution, inter- relationship authorisation and restriction  Necessity of adequate impact assessments  Duty of Care (liability) Council Ad hoc Working Group

EP (Results elections June 10-13) IND/DEM, 36 Greens/ EFA, 42 PES, 200 ALDE, 87 EPP-ED, 268 GUE/NGL, 41 UEN, 27 Others, 30 GUE/NGL PES Greens/EFA IND/DEM ALDE EPP-ED UEN Others France: 31 seats Spain: 24 seats UK: 13 seats Germany: 49 seats Germany: 13 seats

Polish MEPs by Political Groups EPP-ED Group of the European People’s Party (Christian Democrats) and European Democrats IND/DEM Independence/Democracy Group PES Socialist Group in the European Parliament UEN Union for Europe of the Nations Group NI Non-attached Members ALDE Group of the Alliance of Liberals and Democrats for Europe

 WTO process follow-up  Continue to advocate fundamental changes  Continue to advocate for an extended impact assessment  Conduct impact assessment on bilateral trade and investment flows  Continue to promote regulatory and convergence /harmonization of chemical regimes  Continue dialogue with DG Trade & DG External relations  Open dialogue with Parliamentary Inter-groups The way forward