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(1), as last amended by Commission Directive 2000/82/EC(2), and in particular Article 7 thereof,

Whereas:

(1) Commission Directive 2000/42/EC(3) fixed maximum residue levels (MRLs) in relation to pesticide/food combinations that were left open in Council Directives 94/29/EC(4), 94/30/EC(5), 95/38/EC(6), 95/39/EC(7), 96/32/EC(8), 96/33/EC(9) and Commission Directive 98/82/EC(10). The above entries in the Annexes to the Directives 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.

(2) 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 sufficient 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 the information now available is sufficient to demonstrate 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.

(3) 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 procedures and practices used within the European Community taking account of guidelines published by the World Health Organisation(11) 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.

(4) 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.

(5) 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.

(6) 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 methodology 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).

(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The maximum levels for residues listed in the Annex to this Directive shall replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2001 at the latest. They shall forthwith inform the Commission thereof.

They shall apply these measures as of 1 July 2001.

Article 3

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.

Article 4

This Directive shall enter into force on the first day following its publication in the Official Journal of the European Communities.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 11 May 2001.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 350, 14.12.1990, p. 71.

(2) OJ L 3, 6.1.2001, p. 18.

(3) OJ L 158, 30.6.2000, p. 51.

(4) OJ L 189, 23.7.1994, p. 67.

(5) OJ L 189, 23.7.1994, p. 70.

(6) OJ L 197, 22.8.1995, p. 14.

(7) OJ L 197, 22.8.1995, p. 29.

(8) OJ L 144, 18.6.1996, p. 12.

(9) OJ L 144, 18.6.1996, p. 35.

(10) OJ L 290, 29.10.1998, p. 25.

(11) 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).

(12) SCP/RESI/021; SCP/RESI/024.

ANNEX

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Note:

For the convenience of the reader, MRLs are indicated in bold type character when they reflect changes relative to MRLs in Annexes of Directives earlier than Directive 2000/42/EC, when indicated in normal type characters, they are reiterations of existing MRLs.