The Substitution Approach in the “White Paper on the Future EU Chemicals Policy” European Conference on Substitution of Hazardous Chemicals Hamburg, 13 and 14 June 2002 Robert Donkers Deputy Head of the Chemicals Unit Directorate-General Environment, European Commission, Brussels

The Current EU Chemicals Policy  Distinction between new and existing substances, 1981  New substances heavily regulated, 0.01 % of marketed volume  Existing substances virtually not regulated, 99.9 % of marketed volume  Lack of incentives for innovation, in particular of less hazardous substitutes  US rate of new notifications 3 to 4 times higher Problems Innovation gap

The Current EU Chemicals Policy  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) Existing substances Burden of the Past

New substances - Knowledge of dangerous props new substances 70% dangerous 100% tested

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

A Sustainable EU Chemicals Policy  S u s t a i n a b l e D e v e l o p m e n t  Protection of human health and the environment  Innovation & Competitiveness of EU Chemical industry  Prevention of fragmentation of the Internal Market  Increased Transparency and consumer awareness  Integration with international efforts  Promotion of non-animal testing General Objectives Guiding “Principles” Precaution Substitution

The REACH System One System Tiered Approach  A single, coherent system for new and existing chemicals with the following three new elements:  Registration  Evaluation (+ Accelerated Risk Management)  Authorisation  Chemical substances  A tiered approach to chemicals with a focus on chemicals in high volumes or of great concern.

REACH > 1 tonne > 100 tonnes and lower in cases of concern CMR & POPs RegistrationEvaluationAuthorisation

Registration of Chemicals: A Phased Approach , t + CMR... 2, t 4, t 20, t Number of substances (not to scale)

Registration Requirements  Data/information on identity and properties of substances (including data on toxicological and eco- toxicological properties)  Intended uses, estimated human and environmental exposure  Production quantity envisaged  Proposal for the classification and labelling of the substance  Safety Data Sheet  Preliminary risk assessment covering the intended uses  Proposed risk management measures

Testing, Evaluation + Accelerated Risk Management  Flexible testing of substances according to exposure and use (‘tailor-made testing)  Development of ‘decision trees’ determining test requirements  Exemptions for substances in R&D to be extended  Risk Management: ban or restriction of uses

Authorisation Procedure  Ban of CMRs and POPs with the possibility of authorisation  Industry to demonstrate societal need of use and negligible risk  ‘Group exemptions’ for substances used in controlled ‘low risk’ industrial applications or research laboratories  ‘Group applications’ by several manufacturers and/or for several substances

Rights and Obligations of Industry  General duty of care irrespective volume placed on the market, including substitution  Obligation on producers/importers to deliver data on substances, where necessary after testing  Downstream users to inform authorities where use differs from that envisaged by manufacturer  Risk assessments to be performed by manufacturers (and downstream users in case no sharing of data with producers)  Avoid duplication of animal tests  Property rights for test data  Market driven substitution or legal requirement?

Reduction and replacement of animal testing  Make testing requirements more tailor-made (cf. intermediates)  Take account of available knowledge  Use test data generated under other initiatives (ICCA, EPA-HPV)  Use predictive techniques (QSAR, etc)  Use in vitro tests

Innovation and competitiveness of chemicals industry HMore flexibility for R & D HReduced testing when rigorous containment HBetween 1 and 10 tonnes: Generally in vitro methods HBetween 10 kg and 1 tonne: Industry presents evidence on request HEqual treatment of existing and new substances HNew markets for subsitutes Elements of support

COUNCIL CONCLUSIONS JUNE 2001  Simple register for substances produced/imported below 1 t  PBT and VPVB substances under Authorisation scheme  Minimization of animal tests  Secure workers’ protection  Inclusion of sanctions  Legislation on chemicals in products  Supportive measures for European chemicals industry, in particular SMEs Strong support for White Paper More stringent elements

And the European Parliament  Requests Commission to study whether PBT/VPVB substances, endocrine disrupters, sensitisers should be included in Authorization scheme  Only time-limited authorizations and when applicant is developing an alternative/substitute  Registration of chemicals above 1 tonne  Yearly report on volumes  No substances of very high concern in consumer products from 2012  No Authorisations after 2020  Strong control of chemicals in products  Inclusion of pesticides Schörling Report Plenary November 2001

Outstanding Issues  Test data between 1 and 10 tonnes?  PBT and VPVB substances  Property rights for test data?  Sustitutes?  Sanctions?  Substances in products, in particular when imported?  Central entity? Further consideration is needed for...

Next steps –Outcome Commission Technical Working Groups –Business Impact Study and Central Entity Study Draft legislation Autumn 2002 ?