14. 2. 97 Official Journal of the European Communities No L 43/1 (Acts whose publication is obligatory) REGULATION (EC) No 258/97 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 1997 concerning novel foods and novel food ingredients THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission ('), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty () in the light of the joint text approved by the Conciliation Committee on 9 December 1996, (1) Whereas differences between national laws relating to novel foods or food ingredients may hinder the free movement of foodstuffs; whereas they may create conditions of unfair competition, thereby directly affecting the functioning of the internal market; (2) Whereas, in order to protect public health, it is necessary to ensure that novel foods and novel food ingredients are subject to a single safety assessment through a Community procedure before they are placed on the market within the Community; whereas in the case of novel foods and novel food ingredients which are substantially equivalent to () ©OJ No C 190, 29. 7. 1992, p. 3 and OJ No C 16, 19. 1. 1994, p. 10. (» OJ No C 108, 19. 4. 1993, p. 8. (*) Opinion of the European Parliament of 27 October 1993 (O] No C 315, 22. 11. 1993, p. 139). Council Common Position of 23 October 1995 (O] No C 320, 30. 11. 1995, p. 1) and De- cision of the European Parliament of 12 March 1996 (O] No C 96, 1. 4. 1996, p. 26). Decision of the Council of 19 Decem- ber 1996 and Decision of the European Parliament of 16 January 1997. existing foods or food ingredients a simplified proce- dure should be provided for; (3) Whereas food additives, flavourings for use in food- stuffs and extraction solvents are covered by other Community legislation and should therefore be excluded from the scope of this Regulation; (4) Whereas appropriate arrangements should be made for the placing on the market of novel foods and novel food ingredients derived from plant varieties subject to Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of vari- eties of agricultural plant species () and Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (°); (5) Whereas risks to the environment may be associated with novel foods or novel food ingredients which contain or consist of genetically modified organisms; whereas Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (¥) stipulates that, for such products, an environmental risk assessment must always be undertaken to ensure environmental safety; whereas, in order to establish a unified Community system for assessment of such products, provision must be made under this Regulation for a specific environmental risk assessment, which in accordance with the procedure provided for in Article 10 of Directive 90/220/EEC must be similar to that laid down in that Directive, but must also include the assessment of the suitability of the product to be used as a food or food ingredient; () OJ No L 225, 12.10. 1970, p. 1. Directive as last amended by Ditective 90/654/EEC (OJ No L 3§3, 17. 12. 1990, p. 48). () OJ No L 225, 12. 10. 1970, p. 7. Directive as last amended by Directive 90/654/EEC (OJ No L 353, 17. 12. 1990, p. 48). () OJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/15/EC (O] No L 103, 22. 4. 1994, p. 20).