Commission Directive 2002/42/EC

of 17 May 2002

amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues (bentazone and pyridate) 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 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 2002/23/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 2002/23/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(4), as last amended by Directive 2002/23/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 2002/37/EC(6), and in particular Article 4(1)(f) thereof,

Whereas:

(1) The existing active substances bentazone and pyridate were included in Annex I to Directive 91/414/EEC by Commission Directives 2000/68/EC(7) and 2001/21/EC(8), for use as a herbicide on cereals, vegetables and forage.

(2) 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 uses. Information relating to these uses 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.

(3) 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.

(4) With respect to the inclusion in 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 reports were finalised on 13 July 2000, in the case of bentazone and on 12 December 2000 in the case of pyridate. They fixed the acceptable daily intake (ADI) for bentazone at 0,1 mg/kg bw/day and for pyridate at 0,036 mg/kg bw/day. The lifetime exposure of consumers of food products treated with the active substances concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation(9) and the opinion of the Scientific Committee for Plants(10) on the methodology employed. It is concluded that the MRLs proposed will not lead to those ADIs being exceeded.

(5) No acute toxic effects requiring the setting of an acute reference dose were noted during the evaluations and discussions preceding the inclusion of pyridate in Annex I to Directive 91/414/EEC. The acute reference dose for bentazone was established at 0,25 mg/kg bw/day. According to the exposure assessment the MRLs proposed will not lead to an unacceptable acute exposure of consumers.

(6) In order to ensure that the consumer is adequately protected from exposure to residues in or on products, for which no authorisation has been granted, it is prudent to set provisional MRLs at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC.

(7) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for bentazone and pyridate 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 most further uses of the active substances concerned. The provisional MRL should then become definitive.

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

(9) The Commission notified this Directive in draft form to the World Trade Organisation and no comments have been received. The possibility of fixing import tolerance MRLs for specific pesticide/crop combinations will be examined by the Commission on the basis of the acceptable data submitted.

(10) 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

The following maximum pesticide residue levels are added to Part A of Annex II to Directive 86/362/EEC: ""

Article 2

The following maximum pesticide residue levels are added to Part B of Annex II to Directive 86/363/EEC: ""

Article 3

The maximum pesticide residue levels for bentazone and pyridate as shown in the Annex to this Directive are added to Annex II to Directive 90/642/EEC.

Article 4

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 these 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 5

This Directive shall enter into force on the 20th 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, 17 May 2002.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 64, 7.3.2002, p. 13.

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

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

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

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

(7) OJ L 276, 28.10.2000, p. 41.

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

(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 (WHO/FSF/FOS/97.7).

(10) 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 (Opinion expressed by the Scientific Committee on Plants, 14 July 1998) (http.//europa.eu.int/comm/food/fs/sc/out21_en.html).

(11) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 4 years from date of coming into force of the Directive introducing this amendment.

(12) Indicates lower limit of analytical determination.

(13) Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 4 years from date of coming into force of the Directive introducing this amendment.

(14) Indicates lower limit of analytical determination.

ANNEX

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