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Commission Directive 2002/71/EC of 19 August 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 pesticide residues (formothion, dimethoate and oxydemeton-methyl) 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 225 , 22/08/2002 P. 0021 - 0028

Commission Directive 2002/71/EC of 19 August 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 pesticide residues (formothion, dimethoate and oxydemeton-methyl) 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 2002/66/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 Directive 2002/66/EC, 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(4), as last amended by Directive 2002/66/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(5), as last amended by Directive 2002/66/EC, and in particular Article 7 thereof, Whereas: (1) In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is both as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides, and where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected. (2) MRLs for pesticides should be kept under review and may be changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data. (3) In the case of dimethoate and oxydemeton-methyl some Member States informed the Commission of their desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC, in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission. The Commission concluded that it is prudent to modify some of the MRLs in view of the possible risks to consumers. It is important that additional risk management measures should be taken by the Member States to adequately protect the consumer. For dimethoate and oxydemeton-methyl Member States shall have to review existing authorisations in accordance with Article 4 of Directive 91/414/EEC(6), as last amended by Commission Directive 2002/64/EC(7) in order that authorised uses do not lead to MRLs being exceeded. (4) The lifetime exposure of consumers to these pesticides in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation(8). It is calculated that the MRLs fixed in this Directive will not lead to the acceptable daily intakes being exceeded. The ADI for oxydemeton-methyl is 0,0003 mg/kg bw (JMPR 1989), the ARfD is 0,005 mg/kg bw, the ADI for dimethoate is 0,002 mg/kg bw (JMPR 1996), the ARfD is 0,03 mg/kg bw. (5) Where relevant, 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 Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the MRLs proposed in this Directive will not cause acute toxic effects. (6) For formothion no uses are reported worldwide. In the absence of sufficient data on residues and toxicology it is appropriate to set Maximum Residue Levels for formothion for all products at the Lower Limit of Analytical Determination. (7) Through the World Trade Organisation, the Community's trading partners were consulted about the levels for formothion, dimethoate and oxydemeton-methyl proposed in this Directive and their comments on these levels were taken into account. (8) The opinions of the Scientific Committee for Plants have been taken into account, in particular its advice and recommendations concerning the methodology to be followed for the protection of consumers of agricultural products treated with pesticides. (9) Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended. (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 entries relating to "dimethoate", "omethoate", "formothion", "oxydemeton-methyl", "demeton-S-methyl", and "demeton-S-methylsulfone" are deleted. Article 2 In part A of Annex II to Directive 86/362/EEC the following rows are added: "" Article 3 In part B of Annex II to Directive 86/363/EEC the following rows are added: "" Article 4 The maximum residue levels listed in the Annex to this Directive are added or replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply those provisions with effect from 1 January 2003. 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 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, 19 August 2002. For the Commission David Byrne Member of the Commission (1) OJ L 340, 9.12.1976, p. 26. (2) OJ L 192, 20.7.2002, p. 47. (3) OJ L 221, 7.8.1986, p. 37. (4) OJ L 221, 7.8.1986, p. 43. (5) OJ L 350, 14.12.1990, p. 71. (6) OJ L 230, 19.8.1991, p. 1. (7) OJ L 189, 18.7.2002, p. 27. (8) 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). (9) Indicates lower limit of analytical determination. (10) Indicates lower limit of analytical determination. ANNEX >TABLE>

Commission Directive 2002/71/EC

of 19 August 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 pesticide residues (formothion, dimethoate and oxydemeton-methyl) 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 2002/66/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 Directive 2002/66/EC, 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(4), as last amended by Directive 2002/66/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(5), as last amended by Directive 2002/66/EC, and in particular Article 7 thereof,

Whereas:

(1) In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is both as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides, and where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected.

(2) MRLs for pesticides should be kept under review and may be changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data.

(3) In the case of dimethoate and oxydemeton-methyl some Member States informed the Commission of their desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC, in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission. The Commission concluded that it is prudent to modify some of the MRLs in view of the possible risks to consumers. It is important that additional risk management measures should be taken by the Member States to adequately protect the consumer. For dimethoate and oxydemeton-methyl Member States shall have to review existing authorisations in accordance with Article 4 of Directive 91/414/EEC(6), as last amended by Commission Directive 2002/64/EC(7) in order that authorised uses do not lead to MRLs being exceeded.

(4) The lifetime exposure of consumers to these pesticides in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation(8). It is calculated that the MRLs fixed in this Directive will not lead to the acceptable daily intakes being exceeded. The ADI for oxydemeton-methyl is 0,0003 mg/kg bw (JMPR 1989), the ARfD is 0,005 mg/kg bw, the ADI for dimethoate is 0,002 mg/kg bw (JMPR 1996), the ARfD is 0,03 mg/kg bw.

(5) Where relevant, 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 Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the MRLs proposed in this Directive will not cause acute toxic effects.

(6) For formothion no uses are reported worldwide. In the absence of sufficient data on residues and toxicology it is appropriate to set Maximum Residue Levels for formothion for all products at the Lower Limit of Analytical Determination.

(7) Through the World Trade Organisation, the Community's trading partners were consulted about the levels for formothion, dimethoate and oxydemeton-methyl proposed in this Directive and their comments on these levels were taken into account.

(8) The opinions of the Scientific Committee for Plants have been taken into account, in particular its advice and recommendations concerning the methodology to be followed for the protection of consumers of agricultural products treated with pesticides.

(9) Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended.

(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 entries relating to "dimethoate", "omethoate", "formothion", "oxydemeton-methyl", "demeton-S-methyl", and "demeton-S-methylsulfone" are deleted.

Article 2

In part A of Annex II to Directive 86/362/EEC the following rows are added: ""

Article 3

In part B of Annex II to Directive 86/363/EEC the following rows are added: ""

Article 4

The maximum residue levels listed in the Annex to this Directive are added or replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commission thereof.

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

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

This Directive is addressed to the Member States.

Done at Brussels, 19 August 2002.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 192, 20.7.2002, p. 47.

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

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

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

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

(7) OJ L 189, 18.7.2002, p. 27.

(8) 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).

(9) Indicates lower limit of analytical determination.

(10) Indicates lower limit of analytical determination.

ANNEX

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