Avis juridique important

Commission Directive 2000/42/EC of 22 June 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 158 , 30/06/2000 P. 0051 - 0075

Commission Directive 2000/42/EC of 22 June 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 2000/24/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 Directive 2000/24/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(4), as last amended by Directive 2000/24/EC, and in particular Article 7 thereof, Whereas: (1) Council Directives 94/29/EC(5) and 94/30/EC(6), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for benalaxyl, benfuracarb, carbofuran, carbosulfan, cyfluthrin, ethephon, fenarimol, furathiocarb, lambda-cyhalothrin, metalaxyl and propiconazole provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 30 June 1999. This deadline was amended to read "at the latest by 1 July 2000" by Commission Directive 97/71/EC(7). (2) Council Directives 95/38/EC(8) and 95/39/EC(9), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for aldicarb, amitraz, methidathion, methomyl, thiodicarb, pirimiphos-methyl and thiabendazole provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 1 July 2000. (3) Council Directives 96/32/EC(10) and 96/33/EC(11), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for chlormequat, diazonon, dicofol, disulfoton, endosulfan, fenbutatin oxide, mecarbam, phorate, propoxur, propyzamide, triazophos, and triforine provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 30 April 2000. This deadline was amended to read "at the latest by 1 July 2000" by Directive 97/71/EC. (4) Commission Directive 98/82/EC(12) in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for benomyl, carbendazim, thiophanate methyl, chlorothalonil, fenvalerate (including other mixtures of constituents), acephate and quinalphos provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 1 July 2000. (5) The above positions 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. 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. Interested parties were notified of the deadline. For many open positions additional data has been provided permitting the fixing of maximum residue levels. Where no additional data has been provided, it is appropriate to fix maximum residue levels at the lower limit of analytical determination. (6) Requests, supported by further data, were received from Community trading partners to grant greater tolerances for some of these pesticides for positions where Community maximum residue levels had already been fixed in the Annexes to the base Directives. (7) The information available has been reviewed. For many positions the data is sufficient to fix residue level above the lower limit of analytical determination and it is appropriate to do so. For some positions 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. (8) Commission Decision 98/270/EC of 7 April 1998 concerning the withdrawal of authorisations of plant protection products containing fenvalerate as an active substance(13) obliged Member States to withdraw authorisations of fenvalerate as a plant protection product by 7 April 1999. The use of esfenvalerate remains authorised. Since the current description "Fenvalerate including other mixtures of constituents" of the residue in the Annexes to Directives 86/362/EEC, 86/363/EEC, and 90/642/EEC does not distinguish between residues arising from the use of fenvalerate and those arising from the use of esfenvalerate, it is appropriate to modify the residue definition and the maximum level to reflect the permitted continued use of esfenvalerate and the prohibition on the use of fenvalerate. (9) 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 European Community taking account of guidelines published by the World Health Organisation(14) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of the acceptable daily intakes. (10) 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. (11) 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. (12) 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. (13) 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 Scientific Committee of Plants(15). (14) 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 Annex I to this Directive shall replace those listed in Part A of Annex II to Directive 86/362/EEC for the pesticides in question. Article 2 1. The maximum levels for residues listed in Annex II to this Directive shall replace those listed in Part A of Annex II to Directive 86/363/EEC for the pesticides in question. 2. The maximum levels for residues listed in Annex III to this Directive shall replace those listed in Part B of Annex II to Directive 86/363/EEC for the pesticides in question. Article 3 1. The maximum levels for residues listed in Annex IV to this Directive shall replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question. 2. The maximum level for residues for acephate on peaches shall be fixed at 0,02(16) mg/kg. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2001 at the latest. They shall forthwith inform the Commission thereof. They shall apply these measures as of 1 July 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 5 This Directive shall enter into force on the first day following that of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States. Done at Brussels, 22 June 2000. For the Commission David Byrne Member of the Commission (1) OJ L 221, 7.8.1986, p. 37. (2) OJ L 107, 4.5.2000, p. 28. (3) OJ L 221, 7.8.1986, p. 43. (4) OJ L 350, 14.12.1990, p. 71. (5) OJ L 189, 23.7.1994, p. 67. (6) OJ L 189, 23.7.1994, p. 70. (7) OJ L 347, 18.12.1997, p. 42. (8) OJ L 197, 22.8.1995, p. 14. (9) OJ L 197, 22.8.1995, p. 29. (10) OJ L 144, 18.6.1996, p. 12. (11) OJ L 144, 18.6.1996, p. 35. (12) OJ L 290, 29.10.1998, p. 25. (13) OJ L 117, 21.4.1998, p. 15. (14) 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). (15) SCP/RESI/021; SCP/RESI/024. (16) Indicates lower limit of analytical determination. ANNEX I >TABLE> ANNEX II >TABLE> ANNEX III >TABLE> ANNEX IV >TABLE> >TABLE>

Commission Directive 2000/42/EC

of 22 June 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 2000/24/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 Directive 2000/24/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(4), as last amended by Directive 2000/24/EC, and in particular Article 7 thereof,

Whereas:

(1) Council Directives 94/29/EC(5) and 94/30/EC(6), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for benalaxyl, benfuracarb, carbofuran, carbosulfan, cyfluthrin, ethephon, fenarimol, furathiocarb, lambda-cyhalothrin, metalaxyl and propiconazole provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 30 June 1999. This deadline was amended to read "at the latest by 1 July 2000" by Commission Directive 97/71/EC(7).

(2) Council Directives 95/38/EC(8) and 95/39/EC(9), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for aldicarb, amitraz, methidathion, methomyl, thiodicarb, pirimiphos-methyl and thiabendazole provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 1 July 2000.

(3) Council Directives 96/32/EC(10) and 96/33/EC(11), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for chlormequat, diazonon, dicofol, disulfoton, endosulfan, fenbutatin oxide, mecarbam, phorate, propoxur, propyzamide, triazophos, and triforine provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 30 April 2000. This deadline was amended to read "at the latest by 1 July 2000" by Directive 97/71/EC.

(4) Commission Directive 98/82/EC(12) in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for benomyl, carbendazim, thiophanate methyl, chlorothalonil, fenvalerate (including other mixtures of constituents), acephate and quinalphos provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 1 July 2000.

(5) The above positions 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. 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. Interested parties were notified of the deadline. For many open positions additional data has been provided permitting the fixing of maximum residue levels. Where no additional data has been provided, it is appropriate to fix maximum residue levels at the lower limit of analytical determination.

(6) Requests, supported by further data, were received from Community trading partners to grant greater tolerances for some of these pesticides for positions where Community maximum residue levels had already been fixed in the Annexes to the base Directives.

(7) The information available has been reviewed. For many positions the data is sufficient to fix residue level above the lower limit of analytical determination and it is appropriate to do so. For some positions 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.

(8) Commission Decision 98/270/EC of 7 April 1998 concerning the withdrawal of authorisations of plant protection products containing fenvalerate as an active substance(13) obliged Member States to withdraw authorisations of fenvalerate as a plant protection product by 7 April 1999. The use of esfenvalerate remains authorised. Since the current description "Fenvalerate including other mixtures of constituents" of the residue in the Annexes to Directives 86/362/EEC, 86/363/EEC, and 90/642/EEC does not distinguish between residues arising from the use of fenvalerate and those arising from the use of esfenvalerate, it is appropriate to modify the residue definition and the maximum level to reflect the permitted continued use of esfenvalerate and the prohibition on the use of fenvalerate.

(9) 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 European Community taking account of guidelines published by the World Health Organisation(14) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of the acceptable daily intakes.

(10) 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.

(11) 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.

(12) 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.

(13) 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 Scientific Committee of Plants(15).

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

HAS ADOPTED THIS DIRECTIVE:

The maximum levels for residues listed in Annex I to this Directive shall replace those listed in Part A of Annex II to Directive 86/362/EEC for the pesticides in question.

Article 2

1. The maximum levels for residues listed in Annex II to this Directive shall replace those listed in Part A of Annex II to Directive 86/363/EEC for the pesticides in question.

2. The maximum levels for residues listed in Annex III to this Directive shall replace those listed in Part B of Annex II to Directive 86/363/EEC for the pesticides in question.

Article 3

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

2. The maximum level for residues for acephate on peaches shall be fixed at 0,02(16) mg/kg.

Article 4

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2001 at the latest. They shall forthwith inform the Commission thereof.

They shall apply these measures as of 1 July 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 5

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

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 22 June 2000.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 107, 4.5.2000, p. 28.

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

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

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

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

(7) OJ L 347, 18.12.1997, p. 42.

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

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

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

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

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

(13) OJ L 117, 21.4.1998, p. 15.

(14) 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).

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

(16) Indicates lower limit of analytical determination.

ANNEX I

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ANNEX II

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ANNEX III

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ANNEX IV

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