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Commission Directive 2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance.) Official Journal L 291 , 28/10/2002 P. 0001 - 0019

Commission Directive 2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2002/71/EC(2), and in particular Article 5 thereof, 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(3), as last amended by Commission Directive 2002/76/EC(4), 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(5), as last amended by Directive 2002/71/EC, 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(6), as last amended by Directive 2002/76/EC, and in particular Article 7 thereof, Whereas: (1) The Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC, consist of lists of pesticide residues and their maximum levels. (2) On re-examination of the available data it has been determined that sufficient information exists to permit maximum levels be fixed for certain pesticide residues, namely abamectin, azocyclotin, bioresmethrin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, cyhexatin, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin, tridemorph, triadimefon and triadimenol. (3) Pesticide residues may arise in food of animal origin as a result of agricultural practices. It is necessary to take into account relevant data obtained both from authorised pesticide use and from supervised trials and animal feeding studies. (4) The information available has been reviewed. For many pesticide/agricultural product combinations the data is sufficient to allow the calculation of a maximum residue level at which residues of the pesticide concerned may be considered safe for human health. Where this level exceeds the lower limit of analytical determination it is appropriate to fix the maximum residue level at the level calculated. For some combinations the information available is inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other positions the information is adequate but demonstrates 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, it is appropriate to fix maximum residue levels at the lower limit of analytical determination. (5) The lifetime exposure and the acute 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 Community procedures and practices taking account of guidelines published by the World Health Organisation(7). For abamectin, maximum residue limits have been established in accordance with Council Regulation (EEC) No 2377/90(8), as last amended by Commission Regulation (EC) No 1752/2002(9) resulting from the use of veterinary medicinal products containing the same substance for the treatment of food-producing animal species (Commission Regulation (EC) No 3425/93(10). These uses and the evaluation of the acceptable daily intake provided by the Committee for Veterinary Medicinal Products on which these maximum residue limits were based were taken into account. It has been concluded that the maximum residue levels proposed in this Directive do not lead to the acceptable daily intakes being exceeded or to acute toxic effects. (6) 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 maximum residue levels at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. (7) Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (8) The Community's trading partners have been consulted about the levels proposed in this Directive through the World Trade Organisation, and their comments on these levels have been considered. (9) The opinions of the Scientific Committee for Plants, and in particular advice and recommendations concerning the protection of consumers of food crops treated with plant protection products, have been taken into account(11). (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 II to Directive 76/895/EEC, the entry relating to "bromopropylate" is deleted. Article 2 In part A of Annex II to Directive 86/362/EEC the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazole, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol listed in Annex I to the present Directive are added. Article 3 Annex II to Directive 86/363/EEC is amended as follows: (a) in part A maximum pesticide residue levels for abamectin, bifenthrin, bitertanol, bromopropylate, cyromazine, flucytrinate, metacrifos, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex II to the present Directive are added; (b) in part B the maximum pesticide residue levels for azocyclotin and cyhexatin, fenpropimorph, clofentezine and myclobutanil, listed in Annex III to the present Directive are added. Article 4 Annex II to Directive 90/642/EEC is amended as follows: (a) the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex IV to the present Directive are added; (b) the maximum pesticide residue level for ethion in tea is replaced by 3 mg/kg. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 4(b) of the present Directive by 31 December 2002. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 January 2003. 2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with of Articles 1, 2 and 3 and Article 4(a) by 31 May 2003. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 August 2003. 3. When Member States adopt the provisions provided for in paragraphs 1 and 2, 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 shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States. Done at Brussels, 2 October 2002. For the Commission David Byrne Member of the Commission (1) OJ L 340, 9.12.1976, p. 26. (2) OJ L 225, 22.8.2002, p. 21. (3) OJ L 221, 7.8.1986, p. 37. (4) OJ L 240, 7.9.2002, p. 45. (5) OJ L 221, 7.8.1986, p. 43. (6) OJ L 350, 14.12.1990, p. 71. (7) 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). (8) OJ L 224, 18.8.1990, p. 1. (9) OJ L 264, 2.10.2002, p. 18. (10) OJ L 312, 15.12.1993, p. 12. (11) SCP/RESI/021; SCP/RESI/024 ANNEX I >TABLE> ANNEX II >TABLE> ANNEX III >TABLE> ANNEX IV PESTICIDE RESIDUES AND MRLs (mg/kg) >TABLE>

Commission Directive 2002/79/EC

of 2 October 2002

amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2002/71/EC(2), and in particular Article 5 thereof,

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(3), as last amended by Commission Directive 2002/76/EC(4), 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(5), as last amended by Directive 2002/71/EC, 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(6), as last amended by Directive 2002/76/EC, and in particular Article 7 thereof,

Whereas:

(1) The Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC, consist of lists of pesticide residues and their maximum levels.

(2) On re-examination of the available data it has been determined that sufficient information exists to permit maximum levels be fixed for certain pesticide residues, namely abamectin, azocyclotin, bioresmethrin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, cyhexatin, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin, tridemorph, triadimefon and triadimenol.

(3) Pesticide residues may arise in food of animal origin as a result of agricultural practices. It is necessary to take into account relevant data obtained both from authorised pesticide use and from supervised trials and animal feeding studies.

(4) The information available has been reviewed. For many pesticide/agricultural product combinations the data is sufficient to allow the calculation of a maximum residue level at which residues of the pesticide concerned may be considered safe for human health. Where this level exceeds the lower limit of analytical determination it is appropriate to fix the maximum residue level at the level calculated. For some combinations the information available is inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other positions the information is adequate but demonstrates 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, it is appropriate to fix maximum residue levels at the lower limit of analytical determination.

(5) The lifetime exposure and the acute 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 Community procedures and practices taking account of guidelines published by the World Health Organisation(7). For abamectin, maximum residue limits have been established in accordance with Council Regulation (EEC) No 2377/90(8), as last amended by Commission Regulation (EC) No 1752/2002(9) resulting from the use of veterinary medicinal products containing the same substance for the treatment of food-producing animal species (Commission Regulation (EC) No 3425/93(10). These uses and the evaluation of the acceptable daily intake provided by the Committee for Veterinary Medicinal Products on which these maximum residue limits were based were taken into account. It has been concluded that the maximum residue levels proposed in this Directive do not lead to the acceptable daily intakes being exceeded or to acute toxic effects.

(6) 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 maximum residue levels at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC.

(7) Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

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

(9) The opinions of the Scientific Committee for Plants, and in particular advice and recommendations concerning the protection of consumers of food crops treated with plant protection products, have been taken into account(11).

(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:

In Annex II to Directive 76/895/EEC, the entry relating to "bromopropylate" is deleted.

Article 2

In part A of Annex II to Directive 86/362/EEC the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazole, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol listed in Annex I to the present Directive are added.

Article 3

Annex II to Directive 86/363/EEC is amended as follows:

(a) in part A maximum pesticide residue levels for abamectin, bifenthrin, bitertanol, bromopropylate, cyromazine, flucytrinate, metacrifos, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex II to the present Directive are added;

(b) in part B the maximum pesticide residue levels for azocyclotin and cyhexatin, fenpropimorph, clofentezine and myclobutanil, listed in Annex III to the present Directive are added.

Article 4

Annex II to Directive 90/642/EEC is amended as follows:

(a) the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex IV to the present Directive are added;

(b) the maximum pesticide residue level for ethion in tea is replaced by 3 mg/kg.

Article 5

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 4(b) of the present Directive by 31 December 2002. They shall forthwith inform the Commission thereof.

They shall apply these provisions with effect from 1 January 2003.

2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with of Articles 1, 2 and 3 and Article 4(a) by 31 May 2003. They shall forthwith inform the Commission thereof.

They shall apply these provisions with effect from 1 August 2003.

3. When Member States adopt the provisions provided for in paragraphs 1 and 2, 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 shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities.

Article 7

This Directive is addressed to the Member States.

Done at Brussels, 2 October 2002.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 340, 9.12.1976, p. 26.

(2) OJ L 225, 22.8.2002, p. 21.

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

(4) OJ L 240, 7.9.2002, p. 45.

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

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

(7) 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).

(8) OJ L 224, 18.8.1990, p. 1.

(9) OJ L 264, 2.10.2002, p. 18.

(10) OJ L 312, 15.12.1993, p. 12.

(11) SCP/RESI/021; SCP/RESI/024

ANNEX I

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ANNEX II

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ANNEX III

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ANNEX IV

PESTICIDE RESIDUES AND MRLs (mg/kg)

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