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Institutional framework

EU strategy on endocrine disruption

Environment DG


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REACH (Registration, Evaluation and Authorisation of Chemicals) is a proposal for a new EU regulatory framework for chemicals, launched by the European Commission in October 2003, which is currently under legislative review in the European Parliament. Under the proposed new system, enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. The aims of the proposed new Regulation are to improve the protection of human health and the environment, while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. Furthermore, REACH would give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances.

An authorisation system for uses of substances and the placing on the market of substances for such uses is established for the substances of very high concern. Substances of very high concern are defined as: substances that are category 1 and 2 carcinogens or mutagens; substances that are toxic to the reproductive system of category 1 and 2; substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative; and substances such as endocrine disrupters, which are demonstrated to be of equivalent concern. The authorisation provisions require those using or making available substances with properties of very high concern to apply for an authorisation of each use within deadlines set by the Commission. The burden of proof is placed on the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks. Downstream users may use a substance for an authorised use provided they obtain the substance from a company for whom an authorisation has been granted and that they keep within the conditions of that authorisation.

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