Avis juridique important

Commission Directive 2002/66/EC of 16 July 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 in and on fruit and vegetables, cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance) Official Journal L 192 , 20/07/2002 P. 0047 - 0053

Commission Directive 2002/66/EC of 16 July 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 in and on fruit and vegetables, 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 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 2000/82/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 2002/42/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 2002/42/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 2002/42/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 should 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 practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the protection of the health of consumers in terms of estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels should 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 to the amounts of such residues that might be found in commodities when good agricultural practices have been respected by producers. (2) MRLs for pesticides should be kept under review and the levels may be changed to take account of new information and data. MRLs should be fixed at the lower limit of analytical determination where there are no authorised uses. (3) Commission Decisions have been taken not to include active substances in Annex I to Council Directive 91/414/EEC of 15 June 1991 on the placing of plant protection products on the market(7), as last amended by Commission Directive 2002/48/EC(8) for: lindane (Commission Decision 2000/801/EC)(9), quintozene (Commission Decision 2000/816/EC)(10), permethrin (Commission Decision 2000/817/EC)(11), zineb (Commission Decision 2001/245/EC)(12) and parathion (Commission Decision 2001/520/EC)(13). These Decisions provided that plant protection products containing these active substances shall no longer be authorised for use in the Community. It is therefore necessary to add all of the pesticide residues arising from use of these plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Since it is not possible to discriminate in routine monitoring between zineb and other dithiocarbamates, it is not possible to set MRLs for zineb. In order to allow legitimate expectations to be fulfilled for existing stocks of pesticides to be used, the Commission non-inclusion Decisions allowed a phasing out period, and it is appropriate that MRLs premised on the notion that use of the substance concerned is not authorised in the Community, should not apply until the end of the phasing out period applying to that substance. (4) Maximum residue levels have previously been fixed in relation to lindane and parathion for some commodities, in Annex II to Directive 76/895/EEC (as amended by Commission Directive 82/528/EEC)(14), but this Directive allows Member States to establish higher MRLs. To establish harmonised maximum levels of pesticide residues for lindane and parathion in and on fruit and vegetables at Community level it is necessary to include these MRLs instead in Directive 90/642/EEC. Further, the MRLs should be amended to reflect the withdrawal of authorisations at Community level. (5) Community maximum residue levels and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex maximum residue limits for lindane, quintozene, permethrin and parathion. These have been considered in the setting of the maximum residue levels fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The Codex MRLs for lindane 0,1 mg/kg (eggs) and 0,7 mg/kg (poultry meat) are EMRLs (extraneous residue limits). These MRLs are not set at the level which would result from current use of plant protection products, but take account of the fact that uses of the substances in the past have left residues which can be considered as contaminants. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers, no risk was established when using the toxicological end points based on the studies available to the Commission. The ADI for lindane is 0,001 mg/kg bw/day (JMPR 1997), no acute reference dose being considered necessary, the ADI for parathion is 0,004 mg/kg bw/day (JMPR 1995), the ARfD being 0,01 mg/kg bw/day (JMPR 1995), the ADI for permethrin is 0,05 mg/kg bw/day (JMPR 1999), no ARfD being considered necessary, the ADI for quintozene is 0,01 mg/kg bw/day (JMPR 1995), no ARfD being considered necessary. (6) The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. MRLs for specific pesticide/crop combinations used in third countries could be examined by the Commission on the basis of the acceptable data submitted(15). (7) 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 lindane and parathion shall be deleted. Article 2 In the table in Part A of Annex II to Directive 86/362/EEC entries in respect of the following pesticide residues shall be added: "" Article 3 Entries in respect of the following pesticide residues shall be added to the table in part A of Annex II to Directive 86/363/EEC: "" Article 4 In the table in Annex II to Directive 90/642/EEC, the entries for pesticide residues as set out in the Annex to this Directive shall be added or modified. Article 5 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 November 2002 at the latest. They shall forthwith inform the Commission thereof. 2. They shall apply these provisions as of 1 December 2002 for lindane, quintozene and permethrin and as of 1 May 2003 for parathion. 3. 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, 16 July 2002. For the Commission David Byrne Member of the Commission (1) OJ L 340, 9.12.1976, p. 26. (2) OJ L 3, 6.1.2001, p. 18. (3) OJ L 221, 7.8.1986, p. 37. (4) OJ L 134, 22.5.2002, p. 29. (5) OJ L 221, 7.8.1986, p. 43. (6) OJ L 350, 14.12.1990, p. 71. (7) OJ L 230, 19.8.1991, p. 1. (8) OJ L 148, 6.6.2002, p. 19. (9) OJ L 324, 21.12.2000, p. 42. (10) OJ L 332, 28.12.2000, p. 112. (11) OJ L 332, 28.12.2000, p. 114. (12) OJ L 88, 28.3.2001, p. 19. (13) OJ L 187, 10.7.2001, p. 47. (14) OJ L 234, 9.8.1982, p. 1. (15) Guidance notes on import tolerances - Document 7169/VI/99 rev. 1. (16) Indicates lower limit of analytical determination. (17) These MRLs are based on Codex MRLs (extraneous residue limits) and do not result from the use of plant protection products. (18) Based on monitoring data. (19) Indicates lower limit of analytical determination. ANNEX >TABLE>

Commission Directive 2002/66/EC

of 16 July 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 in and on fruit and vegetables, 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 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 2000/82/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 2002/42/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 2002/42/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 2002/42/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 should 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 practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the protection of the health of consumers in terms of estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels should 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 to the amounts of such residues that might be found in commodities when good agricultural practices have been respected by producers.

(2) MRLs for pesticides should be kept under review and the levels may be changed to take account of new information and data. MRLs should be fixed at the lower limit of analytical determination where there are no authorised uses.

(3) Commission Decisions have been taken not to include active substances in Annex I to Council Directive 91/414/EEC of 15 June 1991 on the placing of plant protection products on the market(7), as last amended by Commission Directive 2002/48/EC(8) for: lindane (Commission Decision 2000/801/EC)(9), quintozene (Commission Decision 2000/816/EC)(10), permethrin (Commission Decision 2000/817/EC)(11), zineb (Commission Decision 2001/245/EC)(12) and parathion (Commission Decision 2001/520/EC)(13). These Decisions provided that plant protection products containing these active substances shall no longer be authorised for use in the Community. It is therefore necessary to add all of the pesticide residues arising from use of these plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Since it is not possible to discriminate in routine monitoring between zineb and other dithiocarbamates, it is not possible to set MRLs for zineb. In order to allow legitimate expectations to be fulfilled for existing stocks of pesticides to be used, the Commission non-inclusion Decisions allowed a phasing out period, and it is appropriate that MRLs premised on the notion that use of the substance concerned is not authorised in the Community, should not apply until the end of the phasing out period applying to that substance.

(4) Maximum residue levels have previously been fixed in relation to lindane and parathion for some commodities, in Annex II to Directive 76/895/EEC (as amended by Commission Directive 82/528/EEC)(14), but this Directive allows Member States to establish higher MRLs. To establish harmonised maximum levels of pesticide residues for lindane and parathion in and on fruit and vegetables at Community level it is necessary to include these MRLs instead in Directive 90/642/EEC. Further, the MRLs should be amended to reflect the withdrawal of authorisations at Community level.

(5) Community maximum residue levels and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex maximum residue limits for lindane, quintozene, permethrin and parathion. These have been considered in the setting of the maximum residue levels fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The Codex MRLs for lindane 0,1 mg/kg (eggs) and 0,7 mg/kg (poultry meat) are EMRLs (extraneous residue limits). These MRLs are not set at the level which would result from current use of plant protection products, but take account of the fact that uses of the substances in the past have left residues which can be considered as contaminants. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers, no risk was established when using the toxicological end points based on the studies available to the Commission. The ADI for lindane is 0,001 mg/kg bw/day (JMPR 1997), no acute reference dose being considered necessary, the ADI for parathion is 0,004 mg/kg bw/day (JMPR 1995), the ARfD being 0,01 mg/kg bw/day (JMPR 1995), the ADI for permethrin is 0,05 mg/kg bw/day (JMPR 1999), no ARfD being considered necessary, the ADI for quintozene is 0,01 mg/kg bw/day (JMPR 1995), no ARfD being considered necessary.

(6) The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. MRLs for specific pesticide/crop combinations used in third countries could be examined by the Commission on the basis of the acceptable data submitted(15).

(7) 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 lindane and parathion shall be deleted.

Article 2

In the table in Part A of Annex II to Directive 86/362/EEC entries in respect of the following pesticide residues shall be added: ""

Article 3

Entries in respect of the following pesticide residues shall be added to the table in part A of Annex II to Directive 86/363/EEC:

""

Article 4

In the table in Annex II to Directive 90/642/EEC, the entries for pesticide residues as set out in the Annex to this Directive shall be added or modified.

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

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 November 2002 at the latest. They shall forthwith inform the Commission thereof.

2. They shall apply these provisions as of 1 December 2002 for lindane, quintozene and permethrin and as of 1 May 2003 for parathion.

3. 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, 16 July 2002.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 3, 6.1.2001, p. 18.

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

(4) OJ L 134, 22.5.2002, p. 29.

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

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

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

(8) OJ L 148, 6.6.2002, p. 19.

(9) OJ L 324, 21.12.2000, p. 42.

(10) OJ L 332, 28.12.2000, p. 112.

(11) OJ L 332, 28.12.2000, p. 114.

(12) OJ L 88, 28.3.2001, p. 19.

(13) OJ L 187, 10.7.2001, p. 47.

(14) OJ L 234, 9.8.1982, p. 1.

(15) Guidance notes on import tolerances - Document 7169/VI/99 rev. 1.

(16) Indicates lower limit of analytical determination.

(17) These MRLs are based on Codex MRLs (extraneous residue limits) and do not result from the use of plant protection products.

(18) Based on monitoring data.

(19) Indicates lower limit of analytical determination.

ANNEX

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