1. The European Parliament and chemicals policy Axel Singhofen Adviser for Public Health and Consumer Policy

2. EC legislative process European Commission (COM)  right of initiative = only body that can make a legisl. proposal  > 90% of all COM proposals will become law  ± 80% of final content determined by COM proposal European Parliament (EP) and enviro legislation  co-legislator = equal power to all 15 Member States (=Council)  no fixed majorities, no “governing” party 8 political groups: –2 big groups: Conservatives 37%, Socialists 28% –3 small groups: Liberals 8%, United Left 8%, Greens/EFA 7% –3 very small groups: UEN 4%, EDD 3%, non-attached 5%)  EP generally the “greenest” of all three institutions

3. Substitution in general Workers’ health  Carcinogens at work (90/394/EEC): carcinogens to be replaced by a substance, preparation or process which is not dangerous or less dangerous  Chemical agents at work (98/24/EC): substitution first to eliminate/ reduce risks to a minimum Environment  Biocides (98/8/EC) no positive listing may if there is an alternative which presents significantly less risk to health or to the environment  Haz substances in electrical/electronic equipment (2002/95/EC) EP broadened approach on substitution: from substance-based to overall approach, incl. changes of design, materials or components

4. Concrete examples of Substitution Hazardous substances  ban of sale of substances that are carcinogenic, mutagenic or reprotox to general public as such or in preparations (76/769/EEC)  EP achieved phase-out of discharges of persistent, bio- accumulative and toxic substances to water (2000/60/EC)  EP achieved broader scope of ban on polybrominated diphenylethers (added octa, action on deca) (2003/11/EC)  EP achieved ban of substances that are carcinogenic, muta- genic or toxic to reproduction in cosmetics (2003/15/EC)  EP achieved broader scope of neutralisation of Cr-VI in cement (only closed processes) (2003/53/EC)

5. Substitution in REACH Commission’s White Paper (Feb 2001)  Substitution of hazardous chemicals important objective Council conclusions (June 2001)  Chemicals that are dangerous should be substituted with safer chemicals or with safer technologies European Parliament resolution (Nov 2001)  Substitution principle to be fully applied to all chemicals of concern/ broad concept/ duty for manufacturers to substitute  no authorisation of substances of very high concern if alternatives exist  no authorisations for substances of very high concern in consumer products after 2012; zero discharges after 2020 Commission’s latest draft (September 2003)  objective to encourage substitution  if “adequate control”, no need to consider alternatives

6. Transparency Access to documents in general (EC) 1049/2001)  EP increased scope (EU agencies to be included)  EP reduced derogations (confidentiality challengeable by overriding) Access to environmental information (2003/04/EC)  EP increased scope (nat. persons performing admin. tasks)  EP reduced derogations (confidentiality case by case, to be weighed against public interest) Revision of Pharmaceuticals Legislation (ongoing)  EP eliminated attempt to introduce advertisement by industry for certain prescription-only medicines  EP inserted more transparency (i.a. access to database; withdrawals or refusals of authorisations to be made public)

7. Transparency in REACH Commission’s White Paper (Feb 2001)  Stakeholder access to non-confidential info in the database Council conclusions (June 2001)  Information for safe use of chemicals/products to all users  Access to non-confidential info important but not sufficient  Duty on manufacturers to provide comprehensive info on content of chemicals in products and label products appropriately (CHK) European Parliament resolution (Nov 2001)  As Council + volume, uses, sources of exposure NOT confidential Commission’s latest draft (September 2003)  always confidential: name of registrant, volume, use  additional confidentiality upon request, agency or Member States decides on request, if accepted => to be treated as confidential by all

8. Summary Provisions on substitution and transparency in various fields of EC enviro legislation This EP clear track record in strengthening substitution and transparency requirements Council asked for strengthening of REACH......EP asked for even further strengthening of REACH......but in latest draft, Commission weakened its proposal

9. Outlook  Council/EP able to strengthen COM proposal?  Competences for file not clarified yet in Council/EP Enviro vs. Competetiveness Council/ Enviro vs. Industry committee  New key persons in current Parliament  Enlargement May 2004 Council increases from 15 to 25 Member States EP increases from 626 to 732 Members þ new countries lagging behind on environmental protection  EP elections June 2004 (likely to strengthen the Conservatives)  Key decisions to be made by new Council/EP  Very heavy industry pressure, trend towards industry interests  Pressure from Heads of State D, F, UK in favour of industry þMost parameters make it unlikely that Council/EP will be able to strengthen COM proposal (significantly), but there is reason for optimism on substitution and transparency