L 20836 Official Journal of the European Communities 1.8.2001 COMMISSION DIRECTIVE 2001/57/EC of 25 July 2001 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals ('), as last amended by Commission Directive 2001/48/EC (3), and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (*), as last amended by Commission Directive 2001/39/EC (%), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (°), as last amended by Directive 2001/ 48[EC, and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (°), as last amended by Commission Directive 2001/ 49[EC (), and in particular Article 4(1)(f) thereof, Whereas: (1)  The existing active substance, fluroxypyr, was included in Annex I to Directive 91/414/EEC by Commission Directive 2000/10/EC (}). No harmonised maximum residue levels for this active substance have yet been set by the Commission. The harmonisation of maximum residue levels is desirable both from the public health and from the trade point of view. (2)  Following inclusion of the substance in Annex I, Member States authorised a number of plant protection products containing it in accordance with Article 4 of Directive 91/414/EEC, and established provisional maximum residue levels as required by Article 4(1)(f) thereof. These authorisations concern uses as a herbicide in orchards or as a post emergence herbicide on apples, olives, onions, cereals, meadows and pastures. As required by that Directive, those levels, and the informa- tion on which they were based, have been notified to the 221, 7.8.1986, p. 37. 180, 3.7.2001, p. 26. 221, 7.8.1986, p. 43. 148, 1.6.2001, p. 70. 350, 14.12.1990, p. 71. 230, 19.8.1991, p. 1. 176, 29.6.2001, p. 61. 57, 2.3.2000, p. 28. V@bww LLeeeerece |l onill onlll anll el anll el o ) Commission. This information together with data avail- able from other sources has been reviewed and is suffi- cient to provisionally fix certain maximum residue levels. (3)  Article 5 of Directive 86/363/EEC requires that provi- sional maximum residue levels for animal products established pursuant to Article 4(1)(f) of Directive 91/ 414[EEC be indicated in Annex I to Directive 86/ 363 [EEC. (4) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of fluroxypyr was finalised on 30 November 1999 in the format of the Commission review report for fluroxypyr. In this review report the acceptable daily intake (ADI) for fluroxypyr was set at 0,8 mg/kg bw/day. The lifetime exposure of consumers of food products treated with fluroxypyr has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation (°) and it has been calcu- lated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of this ADL (5)  Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of fluroxypyr in Annex I to Directive 91/414/EEC. (6)  To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set maximum residue levels at the lower limit of analytical determination for all such products covered by Direct- ives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of provisional maximum residue levels does not prevent Member States from establishing provisional maximum residue levels for flur- oxypyr in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. (7)  Four years is considered a sufficient period of time during which to establish most further uses of flurox- ypyr. After that period, provisional maximum residue levels should become definitive. (®) Guidelines for é)redlctmg dietary intake of pesticide residues (revised), preapare by the GEMS[Food Programme in collaboration thh the Codex Committee on Pest1c1de Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97 7).