|EU Chemicals management legislation and HERA
|In Europe, risk assessment legislation has emerged within the last decade to address potential risks for both man and the environment from newly notified chemicals and from existing chemicals.
Commission Directive 93/67/EEC (EC, 1993a) covers risk assessment of New Substances while Commission Regulation (EC) No. 1488/94 (EC, 1994), required under Council Regulation 793/93 (EC, 1993b), lays down the risk assessment principles for Existing Substances.
However, the process of assessing risk from chemical substances and products is not new.
For decades, scientists in industry, academia and governmental bodies have assessed such risks for human health and the environment.
The HERA project was developed a few months before EU Authorities announced the revision of the Chemicals Policy, though a 'White Paper' presented in February 2001.
The basic concept of the new EU proposed policy lies in the full responsibility of industry to establish the safety of their product through risk assessment.
The proposed "REACH" system (Registration, Evaluation, Authorisation of chemicals) foresees comprehensive risk assessment procedures for all chemicals above 1 ton/year/manufacturer in the EU, as well as a thorough evaluation and specific authorisation procedures for the most concerning chemicals (see http://europa.eu.int/comm/environment/chemicals/0188_en.pdf)
A.I.S.E. and Cefic believe that HERA is compatible with the aspirations of this proposal given the following key common elements :
- Industry takes responsibility for safety
- Information and collaboration between manufacturers and downstream-users
- Risk-based approach (hazard and exposure)
- Grouping of substances
- Responds to challenges on existing substances
- International integration.