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Making norms work for the environment. Best practices and lessons learned. IFRI, 29 March 2010. Session 2 Chemical safety: An emerging environmental norm?. REACH. Regulation n°1907/2006 (18 December 2006) of the European Parliament and the Council,
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Making norms work for the environment.Best practices and lessons learned.IFRI, 29 March 2010 Session 2 Chemical safety: An emerging environmental norm?
REACH Regulation n°1907/2006 (18 December 2006) of the European Parliament and the Council, concerning the Registration, Evaluation, Authorization and Restriction of Chemicals
Somefacts and figures - More than 100.000 different substances on the EU market, 10.000 of which are marketed in volumes of more than 1000 tons per year. Before REACH: a vastmajority of substances was not subject to testing and assessment. Toxic ignorance (lack of knowledge about the properties and uses of chemicals as well as about the management of the risksresultingfromthese uses).
A paradigmatic shift in chemicals policy A comprehensive system, which intends to place the legal burden of ensuring the safety of chemicals on the industry. • REACH relies on a “no data, no market” principle • REACH reverses the burden of proof • REACH creates a single and wide-reaching system for all substances • Registration is the cornerstone of the new regime • A special transitional regime is created for substances already placed on the market • Authorization and restriction processes should ensure an efficient management of chemicals risks
Making the norm work (1)Modern regulatory principles - Preventive approach - Self-responsibility - Inclusiveness - Transparency
Making the norm work (2)Organizational structure 1) Governing REACH • ECHA • European Commission • Member States 2) Coping with REACH from the industry’s point of view
Major concerns (1) • Legal uncertainty Substance in article Concentration threshold of 0,1%. ECHA = applies to the article as produced or imported. Interpretation not endorsed by 6 MS. Mind the gap: REACH and other legal instruments
Major concerns (2) • Operational difficulties in day-to-day practice Substance information exchange forums (SIEF) The aim of a SIEF is to a) Facilitate, for the purpose of registration, the exchange of information between potential registrants, thereby avoiding the duplication of studies b) Agree classification and labeling Around 2.400 SIEF formed (around 9.000 expected) IT Issues
Major concerns (3) • Workability Time-consuming Deadlines • Economic issues Costs Particular burden in times of economic crisis Competitiveness
Raising the standards? (1) At the European level • Better self-management of risks • The authorization and restriction processes Authorization • SVHC cannot be placed on the market after a sunset date without authorization • aim: substitution / phase-out of SVHC by regulatory intervention Restriction Community-wide unacceptable risks – aim is to reduce this risk. Not based on a substance intrinsic properties but on exposure. Annex XIV: a drop in the ocean?
Raising the standards? (2) Non EU-States and REACH • REACH reaches beyond EU borders • Towards an upgrade of domestic chemical standards US Japan, Korea and Taiwan • Not good enough? The Russian and Chinese examples