EN Official Journal of the European Union L 243/61

COMMISSION DIRECTIVE 2007/57/EC

of 17 September 2007

amending certain Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for dithiocarbamates

(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), 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 (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), 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 certain products of plant origin, including fruit and vegetables (4), and in particular Article 7 thereof,

Whereas:

(1) Maximum residue levels (MRLs) 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 terms of estimated dietary intake.

(2) MRLs for pesticides are kept under review and changed to take account of new information, including new or changed uses. Information about new or changed uses has been communicated to the Commission, which should lead to changes in the residue levels of maneb, mancozeb, metiram, propineb and thiram.

(3) The active substance ziram has been included in Annex I to Council Directive 91/414/EEC (5) by Commission Directive 2003/81/EC (6). The inclusion in Annex I to Directive 91/414/EEC was based on the assessment of the information submitted concerning the proposed use. The information available has been reviewed and is sufficient to allow certain MRLs to be fixed.

(4) There are already Community MRLs in Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC for maneb, mancozeb, metiram, propineb and thiram. Those levels have been taken into consideration when adapting the MRLs concerned by this Directive. In particular, as in routine monitoring the residues of maneb, mancozeb, metiram, propineb, thiram and ziram cannot be individually identified, MRLs are set for the whole group of those pesticides which are also known as dithiocarbamates. However, for propineb, thiram and ziram single methods exist, although not on a routine basis. Those methods should be used on a case-by-case basis, when the specific quantification of propineb, ziram and/or thiram is required.

(5) The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, fix the Acceptable Daily Intake (ADI) and, if necessary, the Acute Reference Dose (ARfD) for those substances. The exposure of consumers of 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 (7) and the opinion of the Scientific Committee for Plants (8) on the methodology employed. It has been concluded that the MRLs proposed will not lead to those ADI or ARfD being exceeded.

(6) Where authorised uses of plant protection products do not result in detectable levels of pesticide residues 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, MRLs should be fixed at the lower limit of analytical determination.

(7) It is therefore necessary to modify the MRLs set out in the Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC to allow proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the Annexes to those Directives, it is appropriate to amend them. Where MRLs have not already been defined, it is appropriate to set them for the first time.

(8) Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

(9) 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 entry relating to thiram is deleted.

Article 2

Directive 86/362/EEC is amended in accordance with Annex I to this Directive.

Article 3

Directive 86/363/EEC is amended in accordance with Annex II to this Directive.

Article 4

Directive 90/642/EEC is amended in accordance with Annex III to this Directive.

Article 5

Member States shall adopt and publish, by 18 March 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 19 March 2008.

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 its publication in the Official Journal of the European Union.

Article 7

This Directive is addressed to the Member States.

Done at Brussels, 17 September 2007. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2007/8/EC (OJ L 63, 1.3.2007, p. 9).

(2) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2007/27/EC (OJ L 128, 16.5.2007, p. 31).

(3) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2007/28/EC (OJ L 135, 26.5.2007, p. 6).

(4) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2007/39/EC (OJ L 165, 27.6.2007, p. 25).

(5) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).

(6) OJ L 224, 6.9.2003, p. 29.

(7) 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).

(8) 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/index_en.html).

ANNEX I In Part A of Annex II to Directive 86/362/EEC, the lines for ‘Mancozeb, maneb, metiram, propineb, zineb (expressed as CS2)’ are replaced by the following: ‘Pesticide residues Maximum levels in mg/kg Dithiocarbamates, expressed as CS2, including mancozeb, maneb, metiram, propineb, thiram and ziram (1), (2) 1 Wheat, Rye, Triticale, Spelt (ma, mz) 2 Barley, Oats (ma, mz) 0,05 (4) Other cereals Propineb (expressed as propilendiammine) (3) 0,05 (4) CEREALS Thiram (expressed as Thiram) (3) 0,1 (4) CEREALS Ziram (expressed as Ziram) (3) 0,1 (4) CEREALS (1) The MRLs expressed as CS2 can arise from different dithiocarbamates and therefore they do not reflect a single Good Agricultural Practice (GAP). It is therefore not appropriate to use these MRLs to check compliance with a GAP. (2) In brackets the origin of the residue (ma: maneb; me: metiram; mz: mancozeb; pr: propineb; t: thiram; z: ziram). (3) As all dithiocarbamates result in the final CS2 residue, discrimination among them is generally not possible. However single residue methods are available for propineb, ziram and thiram. These methods should be implemented on a case by case basis when the specific quantification of propineb, ziram and/or thiram is required. (4) Indicates lower limit of analytical determination.’

ANNEX II In Part B of Annex II to Directive 86/363/EEC, the lines for ‘Mancozeb, maneb, metiram, propineb, zineb (expressed as CS2)’ are replaced by the following: Maximum levels in mg/kg Pesticide residues of meat, including fat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602 for milk and milk products listed in Annex I under headings Nos 0401, 0402, 0405 00 and 0406 of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408 ‘Dithiocarbamates, expressed as CS2, including mancozeb, maneb, metiram, propineb, thiram and ziram 0,05 (1) 0,05 (1) 0,05 (1) (1) Indicates lower limit of analytical determination.’