Commission Directive 2006/60/CE
of 7 July 2006
amending Annexes to Council Directive 90/642/EEC as regards the maximum residue levels of trifloxystrobin, thiabendazole, abamectin, benomyl, carbendazim, thiophanate-methyl, myclobutanyl, glyphosate, trimethylsulfonium, fenpropimorph and chlormequat
(Text with EEA relevance)
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(1), 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(2), and in particular Article 4(1)(f) thereof
Whereas:
(1) In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations have to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops.
(2) Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake.
(3) MRLs for pesticides covered by Directive 90/642/EEC are to be kept under review and may be modified to take account of new or changed uses. Information about new or changed uses has been communicated to the Commission which will lead to changes in the residue levels of trifloxystrobin, thiabendazole, abamectin, the benomyl group (benomyl, carbendazim, and thiophanate-methyl), myclobutanyl, glyphosate, trimethylsulfonium and fenpropimorph.
(4) For chlormequat information has been communicated to the Commission that justifies the adoption of a temporary MRL on pears for three years.
(5) The lifetime exposure of consumers to those pesticides via food products that may contain residues of those pesticides, 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 Organization(3). In this evaluation it was taken into account that abamectin and thiabendazole are also used as veterinary medicines intended for food producing animals and that Maximum Residues Limits have been establishment for those two substances in accordance with the provisions of Council Regulation (EEC) No 2377/90(4). Based on that assessment and evaluations, the MRLs for those pesticides should be set so as to ensure that the acceptable daily intake is not exceeded.
(6) In the case of benomyl, carbendazim, thiophanate-methyl, fenpropimorph and chlormequat for which an acute reference dose (ARfD) exists, the acute exposure of consumers 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 currently used within the Community, taking account of guidelines published by the World Health Organization. The opinions of the Scientific Committee on Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides(5), have been taken into account. Based on the dietary intake assessment, the MRLs for those pesticides should be fixed so as to ensure that the ARfD will not be exceeded. In the case of the other substances, an assessment of the available information has shown that no ARfD is required and that therefore a short term assessment is not needed.
(7) Where authorised uses of plant protection products do not result in detectable levels of pesticide residues in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data, MRLs should be fixed at the lower limit of analytical determination.
(8) Therefore it is appropriate to fix new MRLs for those pesticides.
(9) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for glyphosate, trimethylsulfonium and trifloxistrobin in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of these substances. The provisional Community MRL should then become definitive.
(10) Lupines are consumed as food in several Member States. On lupines the use of glyphosate is authorised. The insertion of the entry ‘lupines’ and setting of MRLs for lupines is therefore necessary to protect consumers from excess pesticide residues used on lupines.
(11) Directive 90/642/EEC should therefore be amended accordingly.
(12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/53/EC (OJ L 154, 8.6.2006, p. 11).
OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/45/EC (OJ L 130, 18.5.2006, p. 27).
Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).
OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC No 205/2006 (OJ L 34, 7.2.2006, p. 21).
Opinion regarding questions relating to amending the annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the SCP, 14 July 1998); Opinion regarding variable pesticide residues in fruit and vegetables (Opinion expressed by SCP on 14 July 1998) http://europa.eu.int/comm/food/fs/sc/scp/outcome_ppp_en.html