EN Official Journal of the European Union L 154/11

COMMISSION DIRECTIVE 2006/53/EC

of 7 June 2006

amending Council Directive 90/642/EEC as regards the maximum residue levels of fenbutatin-oxide, fenhexamid, cyazofamid, linuron, triadimephon/triadimenol, pymetrozine, and pyraclostrobin

(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) Maximum residue levels (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 with respect to fenbutatin oxide, fenhexamid, cyazofamid, linuron, triadimephon/triadimenol, pymetrozine, and pyraclostrobin.

(4) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these 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 Organisation (3). Based on those assessment and evaluations, the MRLs for those pesticides should be set so as to ensure that the acceptable daily intake is not exceeded.

(5) In the case of pymetrozine, linuron, triadimenol, pyraclostrobine and fenbutatin oxide 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 Organisation. The opinions of the Scientific Committee on Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides (4), have been taken into account. Based on the intake assessment of pymetrozine, linuron, triadimenol, pyraclostrobine and fenbutatin oxide, the MRLs for those five 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.

(6) 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.

(7) Therefore it is appropriate to fix new MRLs for those pesticides.

(8) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for fenhexamid, cyazofamid, linuron, pymetrozine, and pyraclostrobin 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.

(9) Directive 90/642/EEC should therefore be amended accordingly.

(10) 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:

Article 1

In Annex I to Directive 90/642/EEC in the category ‘2. Vegetables, fresh or uncooked, frozen or dry, (v) Leaf vegetables and fresh herbs, (a) Lettuce and similar’, the entries ‘leaves and stems of brassica’ and ‘ruccola’ are added between the entries ‘Scarole’ and ‘others’.

Article 2

Part A of Annex II to Directive 90/642/EEC is amended in accordance with the Annex to this Directive.

Article 3

1. Member States shall adopt and publish, by 8 December 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 9 December 2006 except for pyraclostrobine where they shall apply the provisions from 21 April 2007.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 7 June 2006. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/30/EC (OJ L 75, 14.3.2006, p. 7).

(2) 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).

(3) 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).

(4) 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