Chemicals Policy in Europe: New Directions

1. Chemicals Policy in Europe: New Directions Rachel Massey Policy Analyst April 2006

2. REACH Registration Evaluation and Authorization of Chemicals

3. REACH: The Basics • New regulatory structure for chemicals • Replaces or incorporates about 40 pieces of existing legislation • Creates a centralized European Chemicals Agency

4. What Problems does REACH Solve? • Lack of data on health and environmental effects of chemicals • Artificial historical distinction between “new” and “existing” chemicals • Incentives against testing chemicals

5. REACH: Who is Regulated? • European chemical manufacturers • Some European downstream users of chemicals • Importers of chemicals and some products containing chemicals

6. REACH vs. EU Baseline How does REACH compare with the baseline of current EU legislation? • More stringent for “existing” (pre-1981) chemicals • Less stringent for “new” (post-1981) chemicals • Fewer tests required at low volume tiers • Requirements start at 1 ton per year

7. Legislative Process in the EU • European Commission: the executive branch, responsible for proposing and implementing legislation. • European Parliament: elected by EU citizens • Council of the European Union, or Council of Ministers: includes ministers of the governments of each EU member state

8. Stakeholder consultation Council Conclusions WHITE PAPER Cardiff Council meeting Proposal DG Env DG ENT Parliament’s Opinion We are here 2001 1998 Internet consultation Council Common Position July 2003 COMMISSION PROPOSAL Opinion Commission Parliament’s 1st reading Oct 03 Parliament’s 2nd reading FINAL LEGISLATIVE ACTS Member state implementation New Chemical Policy Consiliation process 2007 Source: International Chemical Secretariat

9. REACH Registration Evaluation and Authorization of Chemicals

10. REGISTRATION • Manufacturers and importers must submit information on health and environmental effects of the chemicals they sell. • Companies can form consortia to share testing costs. • Testing requirements depend on annual production volume per company.

11. REGISTRATION: Time Line Source: International Chemical Secretariat

12. National authorities evaluate registration data on selected chemicals, and may ask for data gaps to be filled. Dossier evaluation: applies > 100 tons per year. Substance evaluation: applies when there is reason to believe a substances presents a risk to health or the environment. EVALUATION

13. AUTHORIZATION • Substances of Very High Concern (SVHC) cannot be sold without an authorization. • Applicant must show “adequate control,” or • Socioeconomic value that outweighs the risks. • An authorization applies to specific uses.

14. AUTHORIZATION Substances of Very High Concern include: • Carcinogenic, Mutagenic, Reproductive toxicity (CMR) 1 & 2 • Persistent, Bioaccumulative, and Toxic (PBT) • Very Persistent, very Bioaccumulative (vPvB) • Substances of “equivalent concern,” e.g. endocrine disrupting chemicals

15. RESTRICTION • Safety net • Incorporates current restrictions • Can include conditions for use, or prohibition • Dossier must show risk to health or the environment that needs to be addressed at the European Community level, and explore options for managing risk.

16. Substances in Articles – Still Subject to Debate • For substances present at more than 1 tpa per producer or importer, the Council version requires registration for substances that are intended to be released, plus • “notification” of substances that constitute more than 0.1% of the article by weight. Does not apply if company can exclude exposure.

17. REACH Exemptions • Radioactive materials • Pharmaceuticals • Polymers • Pesticides • Some byproducts • Some minerals, ores, and fuels • Some familiar, commonly used substances

18. Costs of REACH • Testing • Registration • Withdrawals • Authorization

19. Costs of REACH • Extended Impact Assessment by the European Commission: REACH will cost companies €2.3 billion over 11 years. • Cost of chemicals will increase 1/50 of 1%, or at most 1/10 of 1%. (Joan Canton and Ch. Allen, “A Microeconomic Model to Assess the Economic Impacts of the EU’s New Chemicals Policy,” DG Enterprise, November 2003, pp. 27-31.) • Commission partnership with industry groups: • Registration requirements will not lead to significant withdrawal of low-volume chemicals • REACH will have limited impacts on downstream users (Source: KPMG study, summarized in ChemSec, Surviving REACH.)

20. Benefits of REACH • Access to information • Less risk of future liability • Lower worker protection and compensation costs • Cleanup costs avoided • Innovation encouraged

21. Benefits of REACH • Health benefits over 30 years estimated at €50 billion (European Commission - order of magnitude estimate) (Commission’s Extended Impact Assessment (October 2003). • Estimated savings of €3.5 billion over ten years from occupational skin and respiratory diseases avoided (Simon Pickvance et al., “The Impact of REACH on Occupational Health with a Focus on Skin and Respiratory Diseases,” September 2005, http://hesa.etui-rehs.org/uk/newsevents/files/reach-sheffield-complet.pdf.)

22. RESOURCES • Lowell Center for Sustainable Production • Chemicals Policy Initiative: • http://chemicalspolicy.org • International Chemical Secretariat • http://www.chemsec.org/ * Interactive walk-through of REACH * Publications Surviving REACH