L 136[42 Official Journal of the European Communities 18.5.2001 COMMISSION DIRECTIVE 2001/35/EC of 11 May 2001 amending the Annexes to Council Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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 Commission Directive 2000/82/EC (?), and in particular Article 7 thereof, Whereas: 1) 2 e m = sUltlllluoell = =TT S ollerrrerces Commission Directive 2000/42[EC (*) fixed maximum residue levels (MRLs) in relation to pesticide/food combi- nations that were left open in Council Directives 94/29/ C (%, 94/30/EC (%), 95/38EC (%), 95/39/EC (), 96/32/ C(®), 96/33/EC () and Commission Directive 98/82/ EC (19). The above entries in the Annexes to the Direct- ives were left ‘open’, or were fixed on a temporary basis, because there was insufficient data available, at the dates of their adoption, to justify the fixing of maximum residue limits at Community level by 1 July 2000. The objective of fixing the said deadline was to provide interested parties with sufficient time to provide the necessary data enabling, where appropriate and justified, the adoption of maximum residue levels at Community level above the lower limit of analytical determination. In the period preceding the expiry of the deadline, the available data was evaluated and in some cases not considered adequate to justify fixing maximum residue levels higher than the limit of analytical determination. Following publication of Directive 2000/42/EC, the Commission received requests, supported by further data, to review the levels at which MRLs for certain pesticide/food combinations had been fixed by virtue of Directive 2000/42/EC. The applications and data were reviewed, and for some combinations, the data was suffi- cient to justify the fixing of an MRL above the lower limit of analytical determination. For other combinations the information available remains inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other combinations L 350, 14.12.1990, p. 71. L 3, 6.1.2001, p. 18. L 158, 30.6.2000, p. 51. L 189, 23.7.1994, p. 67. L 189, 23.7.1994, p. 70. L 197, 22.8.1995, p. 14. L 197, 22.8.1995, p. 29. L 144, 18.6.1996, p. 12. L 144, 18.6.1996, p. 35. J L 290, 29.10.1998, p. 25. the information now available is sufficient to demon- strate that the setting of a maximum residue level above the lower limit of analytical determination may give rise to an unacceptable acute or chronic exposure of the consumer to the residues. In such cases, the maximum residue levels should remain fixed at the lower limit of analytical determination. The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides arising from their uses in plant protection and, where applicable, in veterinary medicine has been assessed and evaluated in accordance with the proced- ures and practices used within the European Community taking account of guidelines published by the World Health Organisation (1) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of the acceptable daily intakes. The acute exposure of consumers to these pesticides via each of the food products that may contain residues of these pesticides 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. It has been calculated that the maximum residue levels fixed for open positions in the present Directive do not give rise to acute toxic effects. The Community's trading partners will be consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels will be considered. The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. The methodo- logy described by the World Health Organisation, referred to above, as applied by rapporteur Member States, checked and evaluated by the Commission in the framework of the Standing Committee on Plant Health, is in agreement with the guidance given by the Scientifc Committee of Plants (12). (")) Guidelines for predicting dietary intake of pesticide residues (revised), pre areg with the Codex Committee on Pest1c1de Residues, published by the World Health Organisation 1997 (WHO/FSF[FOS/97.7). by the GEMS[Food Programme in collaboration (') SCP/RESI[021; SCP/RESI/024.