5.6.92 Official Journal of the European Communities No L 154/1 (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3}, Whereas disparity between the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and to the notification of new substances in the Member States may lead to barriers to trade between Member States and create unequal conditions of competition; whereas the disparity between these measures in the Member States has a direct impact on the functioning of the internal market and does not guarantee the same level of protection of public health and the environment; Whereas measures for the approximation of the provisions of the Member States which have as their object the establishment and functioning of the internal market shall, inasmuch as they concern health, safety and the protection of man and the environment, take as their basis a high level of protection; Whereas, in order to protect man-and the environment from potential risks which could arise from the placing on the market of new substances, it is necessary to lay down appropriate measures and in particular to amend and (1) O] No C 33, 13. 2. 1990, p. 3. (2) OJNoC 284,12.11.1990, p. 85 and O] No C 13,20.1. 1992, p. 82. (3) O] No C 332, 31. 12. 1990, p. 9. reinforce the provisions of Council Directive 67/548/ EEC (%), as last amended by Directive 90/517/EEC (5); Whereas any new substance placed on the market should be notified to the competent authorities by means of a notification containing certain information; whereas, in the case of substances placed on the market in quantities of less than one tonne per year per manufacturer, the notification requirements may be reduced; whereas, however, where the quantity of a substance placed on the market exceeds certain limits, provision should be made for additional studies; Whereas it is necessary to lay down measures to make it possible to introduce a notification procedure under which a notification made in one Member State is then valid for the Community; whereas it may be worthwhile, in the case of substances manufactured outside the Community, for the manufacturer to appoint an exclusive representative in the Community for the purpose of notification; Whereas, in order to forecast the effects on man and the environment, it is advisible that any new substance that is notified be the subject of an assessment of the risks, and whereas uniform principles for risk assessment should be laid down; Whereas it is, moreover, important to follow closely the evolution and use of new substances placed on the market and whereas it is therefore necessary to institute a system which allows all new substances to be listed; Whereas the Commission, pursuant to Article 13 (1) of Directive 67/548/EEC (¢), drew up, in accordance with the guidelines laid down in Commission Decision 81/437/EEC, (*) OJ No 196, 16. 8. 1967, p. 1. (’) O] No L 287, 19. 10. 1990, p. 37. (¢) O] No L 167, 24. 6. 1981, p. 31.