Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 22. 07. 1996 COM(96)375 final 96/0195 (COD) Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (presented by the Commission) EXPLANATORY MEMORANDUM In 1981 the Scientific Committee for Food (SCF) delivered an opinion on 48 extraction solvents1 and issued provisional ADIs for a large number of them. Directive 88/344/EEC,2 which authorized some of these substances in foodstuffs, called upon the Commission to review the provisions relating to the solvents two years after adoption and to make amendments as necessary. In May 1990 the SCF reviewed all the solvents once more with a view to establishing a definitive evaluation. The information the Commission had at that time was not enough for the Committee to complete this task, and thus additional information was requested. Since the information received concerned certain specific substances only, a new deadline was set for April 1991. Acting on the generally insufficient information provided, the SCF decided to confirm its agreement on a number of solvents already approved in the past and to withdraw provisional agreement for others for lack of the information requested. Furthermore, its decision : to maintain its provisional agreement for butyl acetate and hexane, and not to oppose continued use of methyl-propanol-1, which had not been evaluated up to that point, was accompanied by a request to receive all the information needed to establish permanent agreement within two years. In June 1993 the SCF issued definitive agreement for hexane only. For the two other substances it repeated its request for the information needed to make a complete evaluation within two years. The industry has never supplied the information requested and one of the sectors contacted (European Flavour and Fragrance Association) replied that it had no interest in these two substances. The Commission has, however, received a request for the use of a^new substance, 1,1,1,2-tetrafluoroethane, as an extraction solvent in the preparation of flavours. The Scientific Committee gave its agreement in December 1995. This proposal takes account of all these developments. 1 2 SCF reports - 11th edition, 1981. OJL 157, 24. 6. 1988. Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and 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,3 Having regard to the opinion of the Economic and Social Committee,4 Acting in accordance with the procedure set out in Article 189b of the Treaty,5 Whereas the Scientific Committee for Food has reexamined all the extraction solvents listed in the Directive with a view to replacing the provisional acceptable daily intakes (ADIs) set in 1981 by definitive figures; whereas this has not always been possible because the information needed, although requested from the industry, has not been communicated; whereas, with the information received, the Scientific Committee for Food has been able to confirm its agreement for the majority of the solvents; whereas the maximum residues of the solvents in certain foodstuffs can be reduced; Whereas some solvents are no longer used and should thus be taken off the list; Whereas scientific progress has made for other substances which can be added to the Directive; Whereas a new solvent which has received a favourable opinion from the Scientific Committee should be authorized; Whereas, in view of technical and scientific progress, the amendments needed amount to measures of a technical nature; whereas to simplify and accelerate the procedure adoption of these measures should be entrusted to the Commission; OJNoC. OJ No C. OJNoC. Whereas a procedure of this kind makes for quicker placing on the market of innovations, which is to the benefit of both the industry and the consumer, HAVE ADOPTED THIS DIRECTIVE: Artickl Directive 88/344/EEC is hereby amended as follows: 1. The following new paragraph (a) is added to Article 4: "(a) In view of the scientific and technical progress in the field of solvents, their conditions of use and maximum residue limits the requisite amendments to the Annex; The old paragraphs (a), (b) and (c) become paragraphs (b), (c) and (d) respectively. " 2. The Annex to the Directive is amended as follows: (a) (b) Part I The substance butyl acetate is deleted. Part II The entry for hexane is amended as follows: — —- I ' i i i i - i l l. » Name (1) Conditions of use (Summary description of extraction) "Hexane Production or fractionation of fats and oils and production of cocoa butter II - ^ ^ —. in i, • i i ^ — —— Maximum residue limits in the extracted foodstuff or food ingredient 1 mg/kg in the fat or oil or cocoa butter Preparation of defatted protein products 10 mg/kg in the food containing and defatted flours the defatted protein products and the defatted flours Preparation of defatted cereal germs The two footnotes remain unchanged. 30 mg/kg in the defatted soya proudcts as sold to the final consumer 5 mg/kg in the defatted cereal germs". (c) Part III The substance methyl-propanol-1 is deleted The following substance is added: | Name 1,1,1,2-tetrafluoroethane Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials 0. 02 mg/kg I Artkkl 1. The Member States shall amend their laws, regulations and administrative provisions so as to: authorize trade in products complying with this Directive by 1 July 1997 at the latest; and ban trade in products not complying with this Directive as from 1 January 1998. They shall forthwith inform the Commission thereof. 2. Where the Member States adopt these provisions the latter shall contain a reference to this Directive or be accompanied by such a reference on official publication. How this reference is made shall be determined by the Member States. Artkki This Directive shall enter into force on the twenty-first day following its oublication in the Official Journal of the European Communities. This Directive is addressed to the Member States. Article 4 Done at Brussels, For the Parliament The President For the Council The President ISSN 0254-1475 COM(96) 375 final DOCUMENTS EN 06 15 Catalogue number : CB-CO-96-376-EN-C ISBN 92-78-07303-2 Office for Official Publications of the European Communities L-2985 Luxembourg 6