EN Official Journal of the European Union L 63/26

COMMISSION DIRECTIVE 2007/11/EC

of 21 February 2007

amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for acetamiprid, thiacloprid, imazosulfuron, methoxyfenozide, S-metholachlor, milbemectin and tribenuron

(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), 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 (2), 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 (3), 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 (4), and in particular Article 4(1)(f) thereof,

Whereas:

(1) The existing active substance tribenuron has been included in Annex I to Directive 91/414/EEC by Commission Directive 2005/54/EC (5).

(2) The following new active substances have been included in Annex I to Directive 91/414/EEC: acetamiprid and thiacloprid by Commission Directive 2004/99/EC (6), imazosulfuron, methoxyfenozide, and S-metholachlor by Commission Directive 2005/3/EC (7), and milbemectin by Commission Directive 2005/58/EC (8).

(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 that Directive. 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) The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, fixed 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 (9) and the opinion of the Scientific Committee for Plants (10) on the methodology employed. It has been concluded that the MRLs proposed will not lead to those ADIs or ARfD being exceeded.

(6) 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.

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

(8) It is therefore necessary to modify the MRLs set out in 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. 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.

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

(10) 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

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

Article 2

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

Article 3

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

Article 4

1. Member States shall adopt and publish, by 1 September 2007 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 2 September 2007.

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.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 5

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

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 21 February 2007. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2006/92/EC (OJ L 311, 10.11.2006, p. 31).

(2) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2006/62/EC (OJ L 206, 27.7.2006, p. 27).

(3) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/92/EC.

(4) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).

(5) JO L 244, 20.9.2005, p. 21.

(6) OJ L 309, 6.10.2004, p. 6.

(7) OJ L 20, 22.1.2005, p. 19.

(8) OJ L 246, 22.9.2005, 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/index_en.html).

ANNEX I In Part A of Annex II to Directive 86/362/EEC, the following lines for acetamiprid, thiacloprid, imazosulfuron, methoxyfenozide, S-metholachlor, milbemectin, thiacloprid and tribenuron are added: Pesticide residues Maximum levels in mg/kg ‘Acetamiprid 0,01 (1) (2) Cereals Imazosulfuron 0,01 (1) (2) Cereals Methoxyfenozide 0,05 (1) (2) Cereals Metholachlor including other mixtures of constituent isomers including S-metolachlor (Sum of isomers) 0,05 (1) (2) Cereals Milbemectin 0,05 (1) (2) Cereals Thiacloprid 0,02 (1) (2) Cereals Tribenuron — methyl 0,01 (1) (2) Cereals (1) Indicates lower limit of analytical determination. (2) (p) 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 21 March 2011.’

ANNEX II In Part A of Annex II to Directive 86/363/EEC, the following lines for acetamiprid, methoxyfenozide and thiachloprid are added: 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 ‘Acetamiprid and IM-2-1 metabolite meat 0,05 (1) (2); liver 0,1 (2); kidney 0,2 (2); fat 0,05 (1) (2); others 0,05 (1) (2) 0,05 (1) (2) 0,05 (1) (2) Methoxyfenoxide 0,01 (1) (2) 0,01 (1) (2) 0,01 (1) (2) Thiacloprid meat 0,05 (2); liver 0,3 (2); kidney 0,3 (2); fat 0,05 (2); others 0,01 (1) (2) 0,03 (2) 0,01 (1) (2) (1) Indicates lower limit of analytical determination. (2) (p) 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 21 March 2011.’