Avis juridique important

Commission Directive 2000/58/EC of 22 September 2000 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) Official Journal L 244 , 29/09/2000 P. 0078 - 0083

Commission Directive 2000/58/EC of 22 September 2000 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 2000/48/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 Commission Directive 2000/42/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 certain products of plant origin including fruit and vegetables(5), as last amended by Directive 2000/57/EC(6), 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(7), as last amended by Commission Directive 2000/10/EC(8), and in particular Article 4(1)(f) thereof, Whereas: (1) The new active substance, kresoxim-methyl, was included in Annex I to Directive 91/414/EEC by Commission Directive 1999/1/EC(9) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing kresoxim methyl. (2) The said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals, pome fruit and vines. Information relating to other uses has been submitted by certain Member States in accordance with the requirements of Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels. (3) 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. The information available has been reviewed and is sufficient to fix certain maximum residue levels. (4) At the inclusion in Annex I to Directive 91/414/EEC, the technical and scientific evaluation of kresoxim methyl was finalised on 16 October 1998 in the format of the Commission review report for kresoxim methyl. In this review report the acceptable daily intake (ADI) for kresoxim methyl was set at 0,4 mg/kg of body weight. The lifetime exposure of consumers of food products treated with kresoxim methyl 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(10) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of this ADI. (5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of kresoxim methyl in Annex I to Directive 91/414/EEC. (6) For certain agricultural products the use conditions for kresoxim methyl were already defined in a manner which permits the establishing of definitive maximum residue levels. (7) 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 Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for kresoxim methyl 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. Four years is considered a sufficient period of time during which to establish most further uses of kresoxim methyl. After that period these provisional maximum residue levels should become definitive; (8) The Community's trading partners have been consulted aobut the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. 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) 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. (10) This Directive is in accordance with the opinion of the Standing Committee on Plant Health, HAS ADOPTED THIS DIRECTIVE: Article 1 The following is added to Part A of Annex II to Directive 86/362/EEC: ">TABLE>" Article 2 The following is added to Part of Annex II to Directive 86/363/EEC: ">TABLE>" Article 3 The maximum residue levels for kresoxim methyl in the Annex to this Directive are added to Annex II to Directive 90/642/EEC. Article 4 1. Where the maximum residue levels for kresoxim methyl are indicated as "(p)", this means 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 kresoxim methyl in the Annexes cease to be provisional and 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 This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions as of 1 April 2001. 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 6 This Directive is addressed to the Member States. Done at Brussels, 22 September 2000. For the Commission David Byrne Member of the Commission (1) OJ L 221, 7.8.1986, p. 37. (2) OJ L 197, 3.8.2000, p. 26. (3) OJ L 221, 7.8.1986, p. 43. (4) OJ L 158, 30.6.2000, p. 51. (5) OJ L 350, 14.12.1990, p. 71. (6) See page 76 of this Official Journal. (7) OJ L 230, 19.8.1991, p. 1. (8) OJ L 57, 2.3.2000, p. 28. (9) OJ L 21, 28.1.1999, p. 21. (10) 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 Organsiation 1997 (WHO/FSF/FOS/97.7). ANNEX >TABLE>

Commission Directive 2000/58/EC

of 22 September 2000

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 2000/48/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 Commission Directive 2000/42/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 certain products of plant origin including fruit and vegetables(5), as last amended by Directive 2000/57/EC(6), 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(7), as last amended by Commission Directive 2000/10/EC(8), and in particular Article 4(1)(f) thereof,

Whereas:

(1) The new active substance, kresoxim-methyl, was included in Annex I to Directive 91/414/EEC by Commission Directive 1999/1/EC(9) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing kresoxim methyl.

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

(3) 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. The information available has been reviewed and is sufficient to fix certain maximum residue levels.

(4) At the inclusion in Annex I to Directive 91/414/EEC, the technical and scientific evaluation of kresoxim methyl was finalised on 16 October 1998 in the format of the Commission review report for kresoxim methyl. In this review report the acceptable daily intake (ADI) for kresoxim methyl was set at 0,4 mg/kg of body weight. The lifetime exposure of consumers of food products treated with kresoxim methyl 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(10) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of this ADI.

(5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of kresoxim methyl in Annex I to Directive 91/414/EEC.

(6) For certain agricultural products the use conditions for kresoxim methyl were already defined in a manner which permits the establishing of definitive maximum residue levels.

(7) 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 Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for kresoxim methyl 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. Four years is considered a sufficient period of time during which to establish most further uses of kresoxim methyl. After that period these provisional maximum residue levels should become definitive;

(8) The Community's trading partners have been consulted aobut the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. 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) 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.

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

The following is added to Part A of Annex II to Directive 86/362/EEC:

">TABLE>"

Article 2

The following is added to Part of Annex II to Directive 86/363/EEC:

">TABLE>"

Article 3

The maximum residue levels for kresoxim methyl in the Annex to this Directive are added to Annex II to Directive 90/642/EEC.

1. Where the maximum residue levels for kresoxim methyl are indicated as "(p)", this means 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 kresoxim methyl in the Annexes cease to be provisional and 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

This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.

They shall apply these provisions as of 1 April 2001.

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 6

This Directive is addressed to the Member States.

Done at Brussels, 22 September 2000.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 197, 3.8.2000, p. 26.

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

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

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

(6) See page 76 of this Official Journal.

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

(8) OJ L 57, 2.3.2000, p. 28.

(9) OJ L 21, 28.1.1999, p. 21.

(10) 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 Organsiation 1997 (WHO/FSF/FOS/97.7).

ANNEX

>TABLE>