L 148/70 Official Journal of the European Communities 1.6.2001 COMMISSION DIRECTIVE 2001/39/EC of 23 May 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 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 2000/82[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 Directive 2000/82/EC, and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (), as last amended by Directive 2000/ 82[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/ 21/EC (), and in particular Article 4(1)(f) thereof, Whereas: (1) The new active substances, azimsulfuron, and prohexa- dione calcium were included in Annex I to Directive 91/414/EEC by Commission Directives 1999/80/EC () and 2000/50/EC (%), respectively, for use as a pre-emer- gence herbicide on rice, and as a plant growth regulator respectively. (2)  The substances were included in Annex I to Directive 91/414[EEC based on assessment of the information submitted concerning the proposed uses. (3)  Prior to the inclusion of the substances in Annex I to Directive 91/414/EEC, their use had been provisionally authorised in certain Member States in accordance with Article 8(1) of the Directive. Following inclusion of the substances in Annex I, those Member States authorised a number of plant protection products containing them in 221, 7.8.1986, p. 37. 3, 6.1.2001, p. 18. 221, 7.8.1986, p. 43. 350, 14.12.1990, p. 71. 230, 19.8.1991, p. 1. 69, 10.3.2001, p. 17. 210, 10.8.1999, p. 13. 198, 4.8.2000, p. 39. V@bww LLeeeeece |l onill onlll anll el anll el o ) accordance with Article 4 of the Directive, and estab- lished provisional maximum residue levels as required by Article 4(1)(f). As required by the Directive, those levels, and the information on which they were based, have been notified to the Commission. This information together with data available from other sources has been reviewed and is sufficient to fix certain maximum residue levels (MRLS). Where no Community maximum residue level or provisional MRL exists, Member States must establish a national provisional maximum residue level in accordance with Article 4(1)(f) of the Directive before the authorisation may be granted. In view of Article 5 of Directive 86/363/EEC, this also applies for provisional MRLs for animal products where commodi- ties containing residues of an active substance may be expected to be used as animal feeds. (4) At their inclusion in Annex I to Directive 91/414/EEC, the technical and scientific evaluations of azimsulfuron, and prohexadione calcium were finalised on 2 July 1999, and 16 June 2000, respectively in the Commis- sion review reports for azimsulfuron and prohexadione calcium. In these review reports the acceptable daily intake (ADI) for azimsulfuron was set at 0,1 mg/kg bw/day, and for prohexadione calcium at 0,2 mg/kg bw/day. The lifetime exposure of consumers of food products treated with azimsulfuron, and prohexadione calcium has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (°) and the opinion of the Scientific Committee for Plants (%) on this methodology. It has been calculated that the maximum residue levels provided for in this Directive do not result in these ADIs being exceeded. (5)  Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluations and discussions that preceded the inclusion of azimsul- furon, and prohexadione calcium in Annex I to Directive 91/414/EEC. (®) Guidelines for é)redlctmg dietary intake of pesticide residues (revised), prepared by the GEMS[Food Programme in collaboration thh the Codpex Committee on Pest1c1de Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97 7). (1) Opinion of the Scientific Committee on Plants regarding questions relating to amending the annexes to Counc1fg Directives 86/ 362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the Scientific =~ Committee  on  Plants, 14 July  1998) (http://europa.eu. 1nt/comm/dg24/health/sc/scp/out21 en.html).