The European Parliament and chemicals policy

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 comprehensiveinfo 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 • 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 • Most 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