Important legal notice

Commission Directive 2003/60/EC of 18 June 2003 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 155 , 24/06/2003 P. 0015 - 0034

Commission Directive 2003/60/EC of 18 June 2003 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 2002/79/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 2002/79/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 2002/79/EC, and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(5), as last amended by Commission Directive 2002/100/EC(6), 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(7), as last amended by Commission Directive 2003/39/EC(8), and in particular Article 4(1)(f) thereof, Whereas: (1) The existing active substances amitrole, diquat, isoproturon and ethofumesate, were included in Annex I to Council Directive 91/414/EEC by Commission Directives 2001/21/EC(9), 2002/18/EC(10) and 2002/37/EC(11), respectively. (2) The new active substances fenhexamid, acibenzolar-S-methyl, cyclanilide, pyraflufen-ethyl, iprovalicarb, prosulfuron, sulfosulfuron, cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M, picolinafen and flumioxazine were included in Annex I to Council Directive 91/414/EEC by Commission Directives 2001/28/EC(12), 2001/87/EC(13), 2002/48/EC(14), 2002/64/EC(15) and 2002/81/EC(16). (3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed. (4) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised. (5) For the active substances chlorfenapyr, fentin acetate and fentin hydroxide decisions were taken not to include them in Annex I to Directive 91/414/EEC by Commission Decision 2001/697/EC(17), 2002/478/EC(18) and 2002/479/EC(19), respectively. 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. (6) 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. (7) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for diquat and fentin (-acetate or -hydroxide). These have been considered in the setting of the MRLs fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. 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. (8) With respect to the inclusion in or exclusion from Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The assessment reports for the substances mentioned were finalised on the dates as mentioned in the Commission Directives cited under (1) and (2) and in the Commission Decisions cited under (5). These reports fixed the acceptable daily intake (ADI) and, if necessary, the acute reference dose (ARfD) for the substances concerned. The lifetime exposure of consumers to food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation(20) and the opinion of the Scientific Committee for Plants(21) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded. (9) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination. (10) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances in this Directive in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (11) 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. The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (12) To establish maximum levels of pesticide residues for diquat at Community level it is necessary to transfer provisions from Directive 76/895/EEC to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, delete these provisions in Directive 76/895/EEC and amend some of these provisions in the light of technical and scientific progress as well as changes in uses and authorisations at national and Community level. (13) This Directive is 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 diquat shall be deleted. Article 2 The maximum pesticide residue levels as shown in Annex I to this Directive are added to Part A of Annex II to Directive 86/362/EEC: Article 3 The maximum pesticide residue levels as shown in Annex II and III to this Directive are added to Annex II A and B to Directive 86/363/EEC. Article 4 The maximum pesticide residue levels as shown in Annex IV to this Directive are added to Annex II to Directive 90/642/EEC. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2003 at the latest except for the provisions for fentin hydroxide, fentin acetate and chlorfenapyr, which shall be brought into force by 30 June 2004. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 July 2003, except for the provisions for fentin hydroxide, fentin acetate and chlorfenapyr, which they shall apply by 1 July 2004. 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 20th day following that of its publication in the Official Journal of the European Union. Article 7 This Directive is addressed to the Member States. Done at Brussels, 18 June 2003. For the Commission David Byrne Member of the Commission (1) OJ L 340, 9.12.1976, p. 26. (2) OJ L 291, 28.10.2002, p. 1. (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 2, 7.1.2003, p. 33. (7) OJ L 230, 19.8.1991, p. 1. (8) OJ L 124, 20.5.2003, p. 30. (9) OJ L 69, 10.3.2001, p. 17. (10) OJ L 55, 26.2.2002, p. 29. (11) OJ L 117, 4.5.2002, p. 10. (12) OJ L 113, 24.4.2001, p. 5. (13) OJ L 276, 19.10.2001, p. 17. (14) OJ L 148, 6.6.2002, p. 19. (15) OJ L 189, 18.7.2002, p. 27. (16) OJ L 276, 12.10.2002, p. 28. (17) OJ L 249, 19.9.2001, p. 19. (18) OJ L 164, 22.6.2002, p. 41. (19) OJ L 164, 22.6.2002, p. 43. (20) 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). (21) Opinion of the Scientific Committee on Plants regarding questions relating to amending the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (opinion expressed by the Scientific Committee on Plants, 14 July 1998) (http://europa.eu.int/comm/ food/fs/sc/index_en.html). ANNEX I >TABLE> >TABLE> >TABLE> ANNEX II >TABLE> ANNEX III >TABLE> ANNEX IV >TABLE>

Commission Directive 2003/60/EC

of 18 June 2003

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 2002/79/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 2002/79/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 2002/79/EC, and in particular Article 10 thereof,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(5), as last amended by Commission Directive 2002/100/EC(6), 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(7), as last amended by Commission Directive 2003/39/EC(8), and in particular Article 4(1)(f) thereof,

Whereas:

(1) The existing active substances amitrole, diquat, isoproturon and ethofumesate, were included in Annex I to Council Directive 91/414/EEC by Commission Directives 2001/21/EC(9), 2002/18/EC(10) and 2002/37/EC(11), respectively.

(2) The new active substances fenhexamid, acibenzolar-S-methyl, cyclanilide, pyraflufen-ethyl, iprovalicarb, prosulfuron, sulfosulfuron, cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M, picolinafen and flumioxazine were included in Annex I to Council Directive 91/414/EEC by Commission Directives 2001/28/EC(12), 2001/87/EC(13), 2002/48/EC(14), 2002/64/EC(15) and 2002/81/EC(16).

(3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed.

(4) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised.

(5) For the active substances chlorfenapyr, fentin acetate and fentin hydroxide decisions were taken not to include them in Annex I to Directive 91/414/EEC by Commission Decision 2001/697/EC(17), 2002/478/EC(18) and 2002/479/EC(19), respectively. 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.

(6) 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.

(7) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for diquat and fentin (-acetate or -hydroxide). These have been considered in the setting of the MRLs fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. 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.

(8) With respect to the inclusion in or exclusion from Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The assessment reports for the substances mentioned were finalised on the dates as mentioned in the Commission Directives cited under (1) and (2) and in the Commission Decisions cited under (5). These reports fixed the acceptable daily intake (ADI) and, if necessary, the acute reference dose (ARfD) for the substances concerned. The lifetime exposure of consumers to food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation(20) and the opinion of the Scientific Committee for Plants(21) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded.

(9) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination.

(10) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances in this Directive in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive.

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

(12) To establish maximum levels of pesticide residues for diquat at Community level it is necessary to transfer provisions from Directive 76/895/EEC to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, delete these provisions in Directive 76/895/EEC and amend some of these provisions in the light of technical and scientific progress as well as changes in uses and authorisations at national and Community level.

(13) This Directive is 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 diquat shall be deleted.

Article 2

The maximum pesticide residue levels as shown in Annex I to this Directive are added to Part A of Annex II to Directive 86/362/EEC:

Article 3

The maximum pesticide residue levels as shown in Annex II and III to this Directive are added to Annex II A and B to Directive 86/363/EEC.

Article 4

The maximum pesticide residue levels as shown in Annex IV to this Directive are added to Annex II to Directive 90/642/EEC.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2003 at the latest except for the provisions for fentin hydroxide, fentin acetate and chlorfenapyr, which shall be brought into force by 30 June 2004. They shall forthwith inform the Commission thereof.

They shall apply these provisions with effect from 1 July 2003, except for the provisions for fentin hydroxide, fentin acetate and chlorfenapyr, which they shall apply by 1 July 2004.

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 20th day following that of its publication in the Official Journal of the European Union.

Article 7

This Directive is addressed to the Member States.

Done at Brussels, 18 June 2003.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 291, 28.10.2002, p. 1.

(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 2, 7.1.2003, p. 33.

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

(8) OJ L 124, 20.5.2003, p. 30.

(9) OJ L 69, 10.3.2001, p. 17.

(10) OJ L 55, 26.2.2002, p. 29.

(11) OJ L 117, 4.5.2002, p. 10.

(12) OJ L 113, 24.4.2001, p. 5.

(13) OJ L 276, 19.10.2001, p. 17.

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

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

(16) OJ L 276, 12.10.2002, p. 28.

(17) OJ L 249, 19.9.2001, p. 19.

(18) OJ L 164, 22.6.2002, p. 41.

(19) OJ L 164, 22.6.2002, p. 43.

(20) 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).

(21) Opinion of the Scientific Committee on Plants regarding questions relating to amending the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (opinion expressed by the Scientific Committee on Plants, 14 July 1998) (http://europa.eu.int/comm/ food/fs/sc/index_en.html).

ANNEX I

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ANNEX II

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ANNEX III

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ANNEX IV

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