EUROPEAN COMMISSION The History of REACH The European

EUROPEAN COMMISSION The History of REACH The European Union Proposal for Chemicals Management Framing a Future Chemicals Policy Boston (MA), April 27, 2005 Robert Donkers, Environment Counselor Delegation of the European Commission to the US

EUROPEAN COMMISSION REACH – an overview of its history q Informal Environment Council at Chester (UK) in Spring 1998 q November 1998: Commission Report on performance of the existing legislation followed by Council Conclusions requesting new EU policy q February 2001: White Paper published q June/November 2001: Conclusions Environment Council/Resolution EP q September 2001 - March 2002: Technical Working Groups + studies q May - July 2003: Internet consultation on internal draft q 20 May 2003, early notice to WTO Members q 29 October 2003: Draft REACH regulation adopted by Commission q 21 January 2004: Proposal notified under the TBT Agreement q Today: under discussion in European Parliament and Council of Ministers (still subject to modification).

EUROPEAN COMMISSION WHY do we need REACH? Current system for chemicals management is inefficient q Difficult to identify risks – difficult to address risks: Ø Lack of information about most substances on the market q Lack of incentives for innovation, in particular of less hazardous substitutes. US rate of new notifications 3 to 4 times higher

EUROPEAN COMMISSION The Current EU Chemicals Policy Problems q Distinction between new and existing substances, September 1981 q New substances heavily regulated, 0. 01 % of marketed volume q Existing substances virtually not regulated, 99. 9 % of marketed volume Burden of the Past

EUROPEAN COMMISSION The Current EU Chemicals Policy Existing substances q q q Existing substances can be used without testing (100, 106 existing substances registered in EINECS) 30, 000 to 70, 000 on the market Burden of proof on public authorities No efficient instrument to ensure safe use of the most problematic substances Risk assessments too slow: few substances assessed Insufficient resources on the part of Member States: heavy delays (4 to 6 years for some substances) Lack of Confidence in Chemicals

New substances – EUROPEAN COMMISSION Knowledge of dangerous properties 70% dangerous 3. 500 new substances 100% tested

Existing substances EUROPEAN COMMISSION Knowledge of dangerous properties ? 30, 000 existing substances *… Evaluation by the ECB. HPV = high production volume(>= 1000 tonnes/year/ manufacturer). These substances make out over 95% of the chemicals on the market. 2600 HPV substances *: 3 % … tested 11 % … Base Set 15 % … almost Base Set 15 % … no data 56 % … often data for acute toxicity

EUROPEAN COMMISSION Knowledge about chemicals is needed for q Classification and labeling Self-responsibility of industry does not work (see Commission Report, November 1998) q Producer liability For long-term effects it will never work, because-effect relationships difficult to demonstrate q Safety at work legislation Occupational limit values, etc. q Consumer Protection and Product Safety q Local production permits For installation permits, etc. q Environment legislation (waste, water, air, IPPC)

EUROPEAN COMMISSION Costs to address Asbestos q Removal from buildings Ø Berlaymont (Commission HQ): € 0. 12 billion Ø Public buildings in Berlin (West), Cologne, Bremen: € 1. 63 billion q Liability claims Ø US: (Re-) insurance companies pay billions of $. Halberton “settles” for $ 5 billion Ø UK: Lloyds in difficulties some years ago

EUROPEAN COMMISSION A New EU Chemicals Policy Objectives of REACH q Sustainable Development Ø Protection of human health and the environment Ø Maintain/enhance innovation/competitiveness Ø Maintain the Internal Market Ø Increased transparency and consumer awareness Ø Integration with international efforts Ø Promotion of non-animal testing Ø Conformity to WTO obligations Substitution and precaution underpin system

EUROPEAN COMMISSION International initiatives on “existing” substances Current state of play H US EPA started programmes to assess 2, 800 HPV. Further action will follow as necessary. to assess 23 chemicals relevant for children H Canada launched a programme covering 23, 000 DSL chemicals H Japan has also started action H OECD has started a hazard assessment programme on 4, 100 HPV H ICCA established in Oct. 1999 a voluntary global programme of accelerated testing and hazard assessments by 2004 of around 1, 000 of the 4, 100 HPV. CEFIC is responsible for 40 % of these

EUROPEAN COMMISSION Commission Working Groups q Testing, Registration and Evaluation q Risk Assessment q Accelerated Risk Management and Authorisation q Substances of very high concern: PBT and VPVB q Substances in products q Classification and Labelling, including GHS q Information through the supply chain, including safety data sheets

EUROPEAN COMMISSION Council and European Parliament Strong support for White Paper Council q PBT and v. Pv. B substances under Authorization scheme q Secure workers’ protection q Supportive measures for in particular SMEs European Parliament q Only time-limited authorizations and when applicant is developing alternative q Yearly report on volumes q No substances of very high concern in consumer products from 2012 and no authorisations after 2020

EUROPEAN COMMISSION Impact on US Suppliers? q Alleged discrimination Ø Substances in articles (Article 6) Ø Application of REACH to EU and non-EU manufacturers q The principle of least trade restrictiveness q Other concerns Ø Ø Inconsistent application by EU Member States Compatibility with international efforts Effects on innovation Protection of confidential information

EUROPEAN COMMISSION Substances in articles q Concern: Alleged discrimination against non-EU producers of articles that are imported into the European Union. q Response: Article 6 is not discriminatory against articles imported into the European Union: Ø EU producers and importers have the same duties – otherwise major loophole in protection. Ø Scope limited to dangerous substances that are released (intended or non intended). Ø Proposal to limit provisions to a substance list inconsistent with the principle of industry responsibility and difficult to identify the substances in advance.

EUROPEAN COMMISSION The principle of least trade restrictiveness q Concern: REACH is more trade restrictive than necessary: Ø potential for duplication of testing and risk assessments. Ø authorisation is disproportionate and unworkable; decisions are based on hazard Ø General concerns about workability and burden on industry but no clear examples given q Response: Ø individual registrations necessary (but co-operation encouraged and generation of new data is last resort) Ø authorisation is limited in scope, workable and decisions are taken based on risk Ø impact assessment indicates: benefits outweigh costs Ø Interim strategy to prepare for the introduction of REACH

EUROPEAN COMMISSION Compatibility of REACH with international efforts to control chemicals q Concern: REACH is incompatible with international and other initiatives, such as the US, OECD, ICCA HPV programmes, Canadian PBT scanning and the GHS q Response: Ø REACH is complementary to such programmes and starts later Ø REACH uses OECD test guidelines incl. in vitro, MAD Ø Information generated under the HPV programmes may be used for REACH, as long as registrants can demonstrate they have a right to use the studies and the studies are of good quality via IUCLID Ø Any information generated under other programmes can be used if appropriate (see REACH annex IX), including non-GLP data, (Q) SARs etc. Ø The EU is planning to implement GHS by law. Proposal expected in course of 2005

EUROPEAN COMMISSION Summary - Current & New Policy Current Burden of proof Mainly regulator Registration and testing requirements Exemptions Risk management Database 10 kg for new substances None for existing substances For R&D new substances Limitation or ban (Dir. 76/769/EWG) IUCLID New Mainly industry 1 t for all substances Tailor-made for higher tonnages. Authorisation for CMR, PBTs, v. Pv. Bs More flexibility for R&D and intermediates Accelerated risk management on the basis of targeted risk assessment and application of precaution Central database (ECB) Access for the public