Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances
Modified by
Regulation (EC) No 1882/2003 of the European Parliament and of the Councilof 29 September 2003adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty, 32003R1882, October 31, 2003
Regulation (EC) No 1907/2006 of the European Parliament and of the Councilof 18 December 2006concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(Text with EEA relevance)Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(Official Journal of the European Union L 396 of 30 December 2006), 32006R190732006R1907R(01), December 30, 2006
Corrected by
Corrigendum to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances, 31993R0793R(01), September 3, 1993
Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, 32006R1907R(01), May 29, 2007
Council Regulation (EEC) No 793/93of 23 March 1993on the evaluation and control of the risks of existing substancesTHE 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 CommissionOJ No C 276, 5. 11. 1990, p. 1.,In cooperation with the European ParliamentOJ No C 280, 28. 10. 1991, p. 65 andOJ No C 337, 21. 12. 1992.,Having regard to the opinion of the Economic and Social CommitteeOJ No C 102, 18. 4. 1991, p. 42.,Whereas disparities between the laws, regulations and administrative provisions relating to the risk evaluation of existing substances which are in effect or in preparation in the Member States are liable to hinder trade between Member States and create unequal conditions of competition;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 must, in so far as they concern health, safety, environmental and consumer protection, take a high level of protection as a basis;Whereas, in order to ensure the protection of man, including workers and consumers, and of the environment, it is necessary to carry out at Community level a systematic evaluation of the risks involving existing substances appearing in the Einecs (European Inventory of Existing Commercial Substances)OJ No C 146, 15. 6. 1990, p. 1.;Whereas, in the interests of efficiency and economy, it is necessary to establish a Community policy which will ensure a sharing and coordination of responsibilities between Member States, the Commission and industrialists;Whereas a Regulation is the appropriate legal instrument as it imposes directly on manufacturers and importers precise requirements to be implemented at the same time and in the same manner throughout the Community;Whereas, in order to undertake a preliminary risk evaluation of existing substances and to identify priority substances requiring immediate attention, it is necessary to collect certain information and test data on existing substances;Whereas the requirement to provide such information should not apply to certain substances which, on the basis of their intrinsic properties, involve only risks generally recognized as minimal;Whereas the information should be submitted by manufacturers and importers to the Commission, which will send copies to all Member States; whereas, however, it should be possible for a Member State to ask manufacturers and importers established in its territory to submit the same information at the same time to its competent authorities;Whereas, for the purpose of the risk evaluation of certain existing substances, it is necessary, in certain cases, to require manufacturers or importers to submit further data or to carry out further testing on given existing substances;Whereas it is necessary to draw up, at Community level, lists of priority substances which require special attention; whereas the Commission should submit not later than one year after the entry into force of this Regulation an initial priority list;Whereas the risk evaluation of substances on the priority lists should be carried out by the Member States; whereas the latter should be designated at Community level on the basis of a distribution of responsibilities taking account of the situation of the Member States; whereas risk evaluation principles should also be established at Community level;Whereas, in the priority-setting process and risk evaluation of existing substances, it is necessary to take into account, in particular, the lack of data on the effects of the substance, the work already carried out in other international organizations, such as the Organization for Economic Cooperation and Development, and other legislation and/or Community programmes concerning dangerous substances;Whereas it is necessary to adopt at Community level the results of the risk evaluation and the recommended strategy for limiting risks in respect of substances on the priority lists;Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes in accordance with the provisions of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposesOJ No L 358, 18. 12. 1986, p. 1.; whereas, wherever possible and in consultation, in particular, with the European Centre for Alternative Testing Methods, the use of animals must be avoided by recourse to validated alternative procedures;Whereas for tests on chemical substances to be carried out in the context of this Regulation it is necessary to follow the good laboratory practices set out in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substancesOJ No L 15, 17. 1. 1987, p. 29.;Whereas the Commission, assisted by a committee made up of representatives of the Member States, should be given the necessary powers to adapt certain Annexes to technical progress and to adopt certain implementing measures in respect of the Regulation;Whereas the confidential nature of certain information covered by industrial or commercial secrecy should be guaranteed,HAS ADOPTED THIS REGULATION: