On 27 February 2001 the European Commission issued a White Paper outlining the future strategy for a European Chemicals Policy. Following discussions with major stakeholders, the European Commission released a proposal on 29 October 2003 for implementing the new European Union (EU) chemicals policy known as REACH (Registration, Evaluation and Authorization of CHemicals). REACH is currently being negotiated by the European Council of Ministers and the European Parliament and is expected to be finalized and enter into force in April 2007.

Since 1981, notifications for an estimated 3,000 new chemical substances have been filed and placed on the EU market. While new chemicals require extensive testing, there are no such provisions for the 100,106 existing chemicals on the EINECS (European Inventory of Existing Chemical Substances) list that was closed and published in Sept 1981. As a result of grandfathering, there is currently a large deficit of available public information to identify risks and to develop risk mitigation and risk management programs to effectively control these substances in work places and in commerce. In the current regulatory environment, public authorities of Member States have the responsibility for completing risk assessments of chemical substances rather than the manufacturer importer who places chemicals into the EU market or the downstream user of these same chemical substances. Since 1993, Member States have identified only 141 high-volume chemicals for detailed risk assessments and follow up recommendations to reduce risks. To date, only 27 of these 141 chemical substances have been adequately assessed. EU Member States are lacking technical resources and adequate funding to complete these assessments.

Since 1976, the EU has restricted the marketing or use of approximately 100 substances (e.g., asbestos, certain azo-dyes, and POPs - persistent organic pollutants), including the use of some of these in commercial articles and the EU has restricted the marketing of an additional 900 chemical substances to the general public that are classified as being carcinogenic, mutagenic or toxic to reproduction. It is anticipated under REACH that many more chemical substances will face restrictions once data is generated and made available for regulatory review.

The new regulatory system proposed in REACH consists of four processes:

  • Registration of chemicals - documenting that risks are identified and adequately controlled

  • Evaluation of registration dossiers - mainly considering animal testing proposals to address concerns identified in the registration process

  • Authorization of chemical substances - managing chemicals with identified concerns

  • Restriction of chemical substances at the European Community level - when industry measures are not sufficient to manage identified risks

REACH has the overriding goal to support sustainable development while achieving the following high level objectives:

  • Protect human health and the environment

  • Maintain and enhance the competitiveness of the EU chemical industry

  • Prevent fragmentation of the internal market

  • Increase transparency

  • Integrate with international efforts

  • Promote non-animal testing

  • Conform with EU international obligations under the World Trade Organization

Keywords:
technical guidance document, assessment, Authorization, risk management, testing requirement, downstream user, responsibility, Member State, requirement, classification
Subjects:
Health, Safety, Risk Management and Decision-Making
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2006. American Society of Safety Engineers
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