COMMISSION DIRECTIVE 1999/71/EC

of 14 July 1999

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

(Text with EEA relevance)

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(1), as last amended by Commission Directive 1999/65/EC(2), 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(3), as last amended by Comission Directive 98/82/EC(4), and in particular Article 10 thereof,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(5), as last amended by Directive 1999/65/EC, and in particular Article 7 thereof,

Having regard to Council Directive 91/414/EEC concerning the placing of plant protection products on the market(6), as last amended by Directive 99/1/EC(7), and in particular Article 4(1) (f) thereof,

(1) Whereas the new active substance, azoxystrobin, was included in Annex I to Directive 91/414/EEC by Commission Directive 98/47/EC(8) for use as fungicide only, but without specifying particular conditions having an impact on crops which may be treated with plant protection products containing azoxystrobin;

(2) Whereas the said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals and vines; whereas information relating to uses on cereals, vines and bananas has been submitted by certain Member States in accordance with the requirements of Article 4(1) (f) of Directive 91/414/EEC; whereas the information available has been reviewed and is sufficient to fix certain maximum residue levels;

(3) Whereas where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1) (f) of Directive 91/414/EEC before the authorisation may be granted;

(4) Whereas at the inclusion in Annex I to Directive 91 /414/EEC the technical and scientific evaluation of azoxystrobin was finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin; whereas in this review report the acceptable daily intake (ADI) for azoxystrobin was set at 0.1 mg/kg bw/day; whereas the lifetime exposure of consumers of food products treated with azoxystrobin 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(9) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI;

(5) Whereas acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion which preceded the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC;

(6) Whereas for certain agricultural products the use conditions for azoxystrobin have already been defined in a manner which permits the establishing of definitive maximum residue levels;

(7) Whereas to ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC; whereas the setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for azoxystrobin in accordance with Article 4(1) (f) of Directive 91/414/EEC and in accordance with Annex VI to Directive 91/414/EEC in particular part B, Section 2.4.2.3 to this Annex; whereas four years is considered a sufficient period of time during which to establish most further uses of azoxystrobin; whereas after that period these provisional maximum residue levels should become definitive;

(8) Whereas the Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered; whereas the possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data;

(9) Whereas the opinion 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;

(10) Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The following pesticide residues shall be added to part A of Annex II to Directive 86/362/EEC:

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Article 2

The following pesticide residues shall be added to part B of Annex II to Directive 86/363/EEC:

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Article 3

The following pesticide residues shall be added to Annex II to Directive 90/642/EEC:

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Article 4

1. For those agricultural products listed in part A of Annex II to Directive 86/362/EEC, and in Annex II to Directive 90/642/EEC where the maximum residue levels for azoxystrobin are indicated as "(p)", this shall mean that they are provisional (p) in accordance with the provisions of Article 4(1) (f) of Directive 91/414/EEC.

2. Four years after the entry into force of this Directive, provisional maximum residue levels for azoxystrobin in the Annexes shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.

Article 5

1. This Directive shall enter into force on 1 August 1999.

2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 January 2000. They shall immediately inform the Commission thereof. These measures shall apply as from 1 February 2000.

3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 14 July 1999.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ L 221, 7.8.1986, p. 37.

(2) OJ L 172, 8.7.1999, p. 40.

(3) OJ L 221, 7.8.1986, p. 43.

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

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

(6) OJ L 230, 19.8.1991, p. 1.

(7) OJ L 21, 21.1.1999, p. 21.

(8) OJ L 191, 7.7.1998, p. 50.

(9) 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).