Directive 1993/67 - Principles for assessment of risks to man and the environment of subtances notified in accordance with Council Directive 67/548/EEC - Main contents

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Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of subtances notified in accordance with Council Directive 67/548/EEC

Official Journal L 227 , 08/09/1993 P. 0009 - 0018

Finnish special edition: Chapter 13 Volume 25 P. 0003

Swedish special edition: Chapter 13 Volume 25 P. 0003

COMMISSION DIRECTIVE 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of subtances notified in accordance with Council Directive 67/548/EEC

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 67/548/EEC of 27 June 1967, on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as amended by Directive 93/21/EEC (2) and, in particular, Article 3 thereof,

Whereas, in accordance with the provisions of Directive 67/548/EEC, any new substance placed on the market should be notified to the competent authorities to Member States by means of a notification containing certain information;

Whereas Article 16 of Directive 67/548/EEC requires the competent authorities receiving notification of a new substance to carry out an assessment of its risks to man and the environment in accordance with general principles;

Whereas, given that the responsibility for risk assessment lies with the Member States, it is, however, appropriate that general principles be adopted at Community level to avoid disparities between Member States which not only affect the functioning of the internal market but also do not guarantee the same level of protection of man and the environment thorughout the Community and whereas, therefore, Article 3 of Council Directive 67/548/EEC provides that the Commission shall lay down the general principles;

Whereas the assessment of risks should be based on a comparison of the potential adverse effects of a substance with the reasonably foreseeable exposure of man and the environment to that substance;

Whereas, having regard to its classification in accordance with Directive 67/548/EEC, the assessment of risks to man should take account of the physico-chemical and toxicological properties of a substance;

Whereas, having regard to its classification in accordance with Directive 67/548/EEC, the assessment of risks to the environment should take account of the environmental effects of a substance;

Whereas, where the assessment of risks indicates that a substance is of concern, the competent authority may acquire further information including the results of further tests to determine the substance's intrinsic hazardous properties in accordance with Council Directive 67/548/EEC;

Whereas the results of a risk assessment should be the principal basis of decisions under appropriate legislation to reduce the risks arising from the placing of substances on the market;

Whereas it is appropriate that, having carried out an assessment of risks, the competent authority may inform the notifier of a dangerous substance of its conclusions and that, further, the competent authority should forward a written report thereon to the Commission;

Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (3);

Whereas the provisions of this Directive shall be without prejudice to specific Community legislation concerning the safety and protection of health of workers at work, in particular Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage...

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