EPA essential principles for reform of chemicals management legislation – lessons from REACH Dr Veerle Heyvaert London School of Economics Chemical Regulation: REACHing for TSCA Reform 38 th National Spring Conference on the Environment 11 June 2010 University of Maryland School of Law

Basics What is a chemical? Any substance used in or resulting from a reaction involving changes to atoms or molecules Chemical substances Chemical preparations / mixtures Chemicals in articles

REACH core features Regulation: does not call for implementing legislation at State level Requires registration for all substances produced or imported in volumes of + 1 tonne/pm/py Substance evaluation resulting in an EU- wide programme for chemicals control Authorisation & substitution Scope for marketing and use restrictions Should be fully effective by 2018

EPA Principle 1 Chemicals should be reviewed against safety standards that are based on sound science and reflect risk-based criteria protective of human health and the environment

Principle 1 – REACH version REACH: a flagship for the precautionary principle (exemplified in authorisation & substitution requirements) EU interpretation of precaution: prioritises risk-based decision-making where possible; insists on use of best available scientific information; incorporates the proportionality principle is aimed at problem-solving in case of scientific conflict Moreover, REACH prescribes intense data production and science-based risk assessment

EPA Principle 2 Manufacturers should provide EPA with the necessary information to conclude that new and existing chemicals are safe and do not endanger public health or the environment

Principle 2 – REACH version REACH incorporates the polluter pays principle and demands substantial contributions from the chemicals sector: Involvement of manufacturers and importers; Registration required for chemical substances, preparations (mixtures) and chemicals in articles; Involvement of downstream users; Risk assessment as part of registration duties for high volume chemicals Enforcement formula: no data, no market Actual policing and enforcement happens at Member State level

EPA Principle 3 Risk management decisions should take into account sensitive subpopulations, cost, availability of substitutes and other relevant considerations

Principle 3 – REACH version Proportionality as general principle of EU law Decision-making standards in Article 191 TFEU Socio-economic considerations listed in the CSR (risk assessment) ECHA Socio-Economic Committee Formal substitution requirement for most SVHCs Scope for public participation Contestability of REACH decisions

EPA Principle 4 Manufacturers and EPA should assess and act on priority chemicals, both existing and new, in a timely manner

Principle 4 – REACH version Chemicals assessment as a shared responsibility between private sector & public authorities Priority-setting features of REACH: Volume-based registration duties Cascading registration deadlines Priority-setting through substance evaluation programme

Cont’d ‘Both existing and new’: REACH does not distinguish between existing and new substances (exception for notified substances) Timeliness concerns reflected in REACH: Timeframes and deadlines; Sunset clauses; Safeguard clauses for emergency intervention; ‘No data, no market’ seeks to incentivise timely cooperation Procedural complexity could get in the way of timely decision-making

EPA Principle 5 Green Chemistry should be encouraged and provisions assuring transparency and public access to information should be strengthened

Principle 5 – REACH version R&D registration exemptions High level of transparency mandated by EU Law & Aarhus Convention Serious attempts at inclusive governance

EPA Principle 6 EPA should be given a sustained source of funding for implementation

Principle 6 – REACH version REACH operates through a regulatory network Advantage: risk of underfunding is spread Disadvantage: weakest link threat Registration fees are major contributor to ECHA funding Potential problem area

Early experiences Pre-registration completed; registration ongoing Development of guidance documents ongoing Fewer international trade tensions than feared But unusually high level of litigation within the EU SIEFs: early experiences with the joys and the woes of private networking Some indications that chemical industry is adapting its production and marketing strategies to stay under REACH thresholds