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Commission Directive 98/82/EC of 27 October 1998 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 290 , 29/10/1998 P. 0025 - 0054

COMMISSION DIRECTIVE 98/82/EC of 27 October 1998 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 97/71/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 97/71/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 of pesticide residues in and on products of plant origin, including fruit and vegetables (4), as last amended by Directive 97/71/EC, 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 (5), as last amended by Commission Directive 98/47/EC (6), Whereas Council Directives 93/57/EEC (7) and 93/58/EEC (8) amended the Annexes II to Directives 86/362/EEC and 86/363/EEC and 90/642/EEC to establish maximum residue levels for a first list of pesticides for cereals and products of animal origin and for products of plant origin, including fruit and vegetables, respectively; whereas, however, certain positions were left open where available data were insufficient to establish maximum levels and interested parties were given the opportunity to generate the missing data within a specified timetable; whereas, if maximum levels are not adopted by 31 October 1998 the appropriate lower limit of analytical determination will apply; Whereas, in accordance with the provisions of Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States; whereas such authorisations are required to be based on the evaluation of effects on human and animal health and influence on the environment; whereas elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops; Whereas, for cereals and products of plant origin, including fruit and vegetables, maximum residue levels reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake; whereas, for foodstuffs of animal origin, maximum residue levels reflect the consumption of cereals and products of plant origin treated with pesticides resulting in residues in animals and animal products, as well as taking into account the direct consequences of the use of veterinary medicines where appropriate; Whereas maximum residue levels are fixed at the lower limit of analytical determination where authorised uses of plant protection 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 with such necessary data; Whereas the lifetime exposure of consumers of food products treated with the pesticides covered by this Directive have 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 (9); Whereas the scientific approach and procedures for calculating acute reference doses (ARfDs) and estimating short-term acute dietary exposure have not yet been agreed at European Community level; whereas the Scientific Committee on Plants, considering that the scientific approach and procedures developed in the 1997 FAO/WHO consultation (10) is appropriate pending agreement at Community level, has calculated the maximum toxicologically acceptable residue levels for pome fruit, peaches, apricots and peppers (11) with regard to methamidophos; whereas on the basis of information on GAP and supervised field trials MRLs for methamidophos can be fixed at the levels indicated to be toxicologically acceptable for peaches and apricots; whereas in the absence of such information for pome fruit, in order to accommodate the residues of methamidophos arising from the use of acephate, the MRL for methamidophos should also be fixed at the toxicologically acceptable level; whereas Member States have to review, in particular for the abovementioned agricultural products, existing good agricultural practices to ensure that the established MRLs for acephate and methamidophos are satisfied; Whereas maximum residue levels for pesticides should be kept under review; whereas the levels may be changed to take account of new information and data and, in particular, should be urgently reconsidered with a view to reduction if concerns about dietary exposure of consumers, based on new or reviewed information, are brought to the attention of the Commission, in particular in implementation of Article 9 of Directive 86/362/EEC, Article 9 of Directive 86/363/EEC or Article 8 of Directive 90/642/EEC; whereas, in particular, the MRLs fixed for acephate, metamidophos and vinclozolin in this Directive should be urgently reviewed together with the MRLs for these pesticides fixed by Directives 93/57/EEC and 93/58/EEC based on the evaluation work on these active substances under the provisions of Article 8(2) of Directive 91/414/EEC; Whereas Community maximum residue levels and levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures; whereas however the information in the relevant evaluations of the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) concerning the pesticides covered by this Directive have been presented in a way which over-summarises authorised uses/good agricultural practices and supervised residue trials and does not indicate a clear basis for the recommended maximum level; whereas authorisations of plant protection products in third countries may require the use of greater quantities of pesticides or shorter pre-harvest intervals than are authorised in the Community and consequently may require higher residue levels; whereas 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 and discussed by the Standing Committee on Plant Health; whereas the possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the programme of work established in Article 8(2) of Directive 91/414/EEC; Whereas the opinion of the Scientific Committee on Plants, in particular concerning the protection of consumers of food products treated with pesticides, has been taken into account; Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health, HAS ADOPTED THIS DIRECTIVE: Article 1 In Annex II of Directive 86/362/EEC in the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon are replaced by the lists set out in Annex A to this Directive. Article 2 In Annex II of Directive 86/363/EEC the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon are replaced by the lists set out in Annex B to this Directive. Article 3 In Annex II of Directive 90/642/EEC the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon and the maximum levels specifically fixed for tea are replaced by the lists set out in Annex C to this Directive. Article 4 The maximum residue levels set out in Annex D to this Directive are fixed on a temporary basis for acephate, methamidophos and vinclozolin, in advance of the adoption for all agricultural products of reviewed maximum residue levels for these three pesticides on the basis of the evaluation works on these active substances under the provisions of Article 8(2) of Directive 91/414/EEC, and before 30 April 2001 at the latest, for acephate and methamidophos and before 31 December 1999 at the latest for vinclozolin. Article 5 1. This Directive will enter into force on 1 November 1998. 2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 30 April 1999. They shall immediately inform the Commission thereof. They shall apply these measures as from 1 August 1999. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 6 This Directive is addressed to the Member States. Done at Brussels, 27 October 1998. For the Commission Franz FISCHLER Member of the Commission (1) OJ L 221, 7. 8. 1986, p. 37. (2) OJ L 347, 18. 12. 1997, p. 42. (3) OJ L 221, 7. 8. 1986, p. 43. (4) OJ L 350, 14. 12. 1990, p. 71. (5) OJ L 230, 10. 8. 1991, p. 1. (6) OJ L 191, 7. 7. 1998, p. 50. (7) OJ L 211, 23. 8. 1993, p. 1. (8) OJ L 211, 23. 8. 1993, p. 6. (9) 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. (10) Consultation on food consumption and intake assessment of chemicals, Geneva, Switzerland, 10 to 14 February 1997: Food Safety Unit, Programme of Food Safety and Food Aid, World Health Organisation 1997; WHO/FSF/FOS.97.5. (11) Opinion of the Scientific Committee on Plants regarding questions relating to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC: SCP/RESI/024 Final: 4 August 1998. ANNEX A >TABLE> >TABLE> ANNEX B >TABLE> >TABLE> ANNEX C >TABLE> >TABLE> >TABLE> ANNEX D >TABLE> >TABLE> >TABLE>

COMMISSION DIRECTIVE 98/82/EC of 27 October 1998 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 97/71/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 97/71/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 of pesticide residues in and on products of plant origin, including fruit and vegetables (4), as last amended by Directive 97/71/EC, 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 (5), as last amended by Commission Directive 98/47/EC (6),

Whereas Council Directives 93/57/EEC (7) and 93/58/EEC (8) amended the Annexes II to Directives 86/362/EEC and 86/363/EEC and 90/642/EEC to establish maximum residue levels for a first list of pesticides for cereals and products of animal origin and for products of plant origin, including fruit and vegetables, respectively; whereas, however, certain positions were left open where available data were insufficient to establish maximum levels and interested parties were given the opportunity to generate the missing data within a specified timetable; whereas, if maximum levels are not adopted by 31 October 1998 the appropriate lower limit of analytical determination will apply;

Whereas, in accordance with the provisions of Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States; whereas such authorisations are required to be based on the evaluation of effects on human and animal health and influence on the environment; whereas elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops;

Whereas, for cereals and products of plant origin, including fruit and vegetables, maximum residue levels reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake; whereas, for foodstuffs of animal origin, maximum residue levels reflect the consumption of cereals and products of plant origin treated with pesticides resulting in residues in animals and animal products, as well as taking into account the direct consequences of the use of veterinary medicines where appropriate;

Whereas maximum residue levels are fixed at the lower limit of analytical determination where authorised uses of plant protection 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 with such necessary data;

Whereas the lifetime exposure of consumers of food products treated with the pesticides covered by this Directive have 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 (9);

Whereas the scientific approach and procedures for calculating acute reference doses (ARfDs) and estimating short-term acute dietary exposure have not yet been agreed at European Community level; whereas the Scientific Committee on Plants, considering that the scientific approach and procedures developed in the 1997 FAO/WHO consultation (10) is appropriate pending agreement at Community level, has calculated the maximum toxicologically acceptable residue levels for pome fruit, peaches, apricots and peppers (11) with regard to methamidophos; whereas on the basis of information on GAP and supervised field trials MRLs for methamidophos can be fixed at the levels indicated to be toxicologically acceptable for peaches and apricots; whereas in the absence of such information for pome fruit, in order to accommodate the residues of methamidophos arising from the use of acephate, the MRL for methamidophos should also be fixed at the toxicologically acceptable level; whereas Member States have to review, in particular for the abovementioned agricultural products, existing good agricultural practices to ensure that the established MRLs for acephate and methamidophos are satisfied;

Whereas maximum residue levels for pesticides should be kept under review; whereas the levels may be changed to take account of new information and data and, in particular, should be urgently reconsidered with a view to reduction if concerns about dietary exposure of consumers, based on new or reviewed information, are brought to the attention of the Commission, in particular in implementation of Article 9 of Directive 86/362/EEC, Article 9 of Directive 86/363/EEC or Article 8 of Directive 90/642/EEC; whereas, in particular, the MRLs fixed for acephate, metamidophos and vinclozolin in this Directive should be urgently reviewed together with the MRLs for these pesticides fixed by Directives 93/57/EEC and 93/58/EEC based on the evaluation work on these active substances under the provisions of Article 8(2) of Directive 91/414/EEC;

Whereas Community maximum residue levels and levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures; whereas however the information in the relevant evaluations of the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) concerning the pesticides covered by this Directive have been presented in a way which over-summarises authorised uses/good agricultural practices and supervised residue trials and does not indicate a clear basis for the recommended maximum level; whereas authorisations of plant protection products in third countries may require the use of greater quantities of pesticides or shorter pre-harvest intervals than are authorised in the Community and consequently may require higher residue levels; whereas 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 and discussed by the Standing Committee on Plant Health; whereas the possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data;

Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the programme of work established in Article 8(2) of Directive 91/414/EEC;

Whereas the opinion of the Scientific Committee on Plants, in particular concerning the protection of consumers of food products treated with pesticides, has been taken into account;

Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

In Annex II of Directive 86/362/EEC in the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon are replaced by the lists set out in Annex A to this Directive.

Article 2

In Annex II of Directive 86/363/EEC the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon are replaced by the lists set out in Annex B to this Directive.

Article 3

In Annex II of Directive 90/642/EEC the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon and the maximum levels specifically fixed for tea are replaced by the lists set out in Annex C to this Directive.

The maximum residue levels set out in Annex D to this Directive are fixed on a temporary basis for acephate, methamidophos and vinclozolin, in advance of the adoption for all agricultural products of reviewed maximum residue levels for these three pesticides on the basis of the evaluation works on these active substances under the provisions of Article 8(2) of Directive 91/414/EEC, and before 30 April 2001 at the latest, for acephate and methamidophos and before 31 December 1999 at the latest for vinclozolin.

Article 5

1. This Directive will enter into force on 1 November 1998.

2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 30 April 1999. They shall immediately inform the Commission thereof.

They shall apply these measures as from 1 August 1999.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 27 October 1998.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ L 221, 7. 8. 1986, p. 37.

(2) OJ L 347, 18. 12. 1997, p. 42.

(3) OJ L 221, 7. 8. 1986, p. 43.

(4) OJ L 350, 14. 12. 1990, p. 71.

(5) OJ L 230, 10. 8. 1991, p. 1.

(6) OJ L 191, 7. 7. 1998, p. 50.

(7) OJ L 211, 23. 8. 1993, p. 1.

(8) OJ L 211, 23. 8. 1993, p. 6.

(9) 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.

(10) Consultation on food consumption and intake assessment of chemicals, Geneva, Switzerland, 10 to 14 February 1997: Food Safety Unit, Programme of Food Safety and Food Aid, World Health Organisation 1997; WHO/FSF/FOS.97.5.

(11) Opinion of the Scientific Committee on Plants regarding questions relating to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC: SCP/RESI/024 Final: 4 August 1998.

ANNEX A

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ANNEX B

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ANNEX C

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ANNEX D

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