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The risk assessment of notified substances

A Commission Directive of 20.7.1993 lays down the principles for assessment of the risks of notified substances to man and the environment.

The Directive (93/67/EEC) concerns substances notified in accordance with Council Directive 67/548/EEC relating to the classification, p...
A Commission Directive of 20.7.1993 lays down the principles for assessment of the risks of notified substances to man and the environment.

The Directive (93/67/EEC) concerns substances notified in accordance with Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances. It notes that the responsibility for risk assessment lies with the Member States. However, it is appropriate that general principles are adopted at Community level to avoid disparities which may affect the functioning of the internal market and also do not guarantee the same level of protection of man and the environment throughout the Community.

In general, risk assessment should be based on a comparison of the potential adverse effects of a substance with the reasonably foreseeable exposure of man and the environment. The assessment of risks to man should take account of the psycho-chemical (explosivity, flammability and oxidizing potential) and toxicological properties of the substance (acute toxicity, irritation, corrosivity, sensitization, repeated dose toxicity, mutagenicity, carcinogenicity, toxicity for reproduction). Similarly, risks to the environment should take account of potential environmental effects of the substance (indications of bioaccumulation potential, the shape of the toxicity/time curve in ecotoxicity testing, indications of other adverse effects, consideration of data on structurally analogous substances).

Risk assessment, to be undertaken by the competent authorities in the Member States, includes hazard identification addressing properties and potential adverse effects as defined in an Annex to the Directive. This assessment shall be followed by a series of tests to establish a number of specific attributes of the substance with regard to dose-response, exposure assessment and risk characterization.

Member States shall adopt and publish the provisions necessary to comply with the Directive by 31 October 1993.

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