EN Official Journal of the European Union L 128/31

COMMISSION DIRECTIVE 2007/27/EC

of 15 May 2007

amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for etoxazole, indoxacarb, mesosulfuron, 1-methylcyclopropene, MCPA and MCPB, tolylfluanid and triticonazole

(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 following existing active substances have been included in Annex I to Directive 91/414/EEC: MCPA and MCPB by Commission Directive 2005/57/EC (5), tolylfluanid by Commission Directive 2006/6/EC (6), triticonazole by Commission Directive 2006/39/EC (7).

(2) The following new active substances have been included in Annex I to Directive 91/414/EEC: etoxazole by Commission Directive 2005/34/EC (8), mesosulfuron by Commission Directive 2003/119/EC (9), indoxacarb by Commission Directive 2006/10/EC (10) and 1-methylcyclopropene by Commission Directive 2006/19/EC (11).

(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 that 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) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a number of Codex MRLs for tolylfluanid and they were taken into account. The MRLs based on Codex MRLs have been evaluated in the light of the risks for the consumers. No unacceptable risk was identified when using the toxicological end points based on the studies available to the Commission.

(6) 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 in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (12) and the opinion of the Scientific Committee for Plants (13) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded.

(7) 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.

(8) 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 further uses of the active substance concerned. The provisional MRL should then become definitive.

(9) 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.

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

(11) 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 16 November 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 17 November 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, 15 May 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 2007/11/EC (OJ L 63, 1.3.2007, p. 26).

(2) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2007/11/EC.

(3) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2007/12/EC (OJ L 59, 27.2.2007, p. 75).

(4) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).

(5) OJ L 246, 22.9.2005, p. 14.

(6) OJ L 12, 18.1.2006, p. 21.

(7) OJ L 104, 13.4.2006, p. 30.

(8) OJ L 125, 18.5.2005, p. 5.

(9) OJ L 325, 12.12.2003, p. 41.

(10) OJ L 25, 28.5.2006, p. 24.

(11) OJ L 44, 15.2.2006, p. 15.

(12) 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).

(13) 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 are added: ‘Pesticide residues Maximum levels in mg/kg Etoxazole 0,02 (1) (2) cereals Indoxacarb as sum of the isomers S and R 0,02 (1) (2) cereals MCPA, MCPB including their salts, esters and conjugates expressed as MCPA 0,05 (1) (2) cereals Tolylfluanid (Sum of tolylfluanid and dimethylaminosulfotoluidide expressed as tolylfluanid) 0,05 (1) (2) cereals Mesosulfuron-methyl expresssed as mesosulfuron 0,01 (1) (2) cereals Triticonazole 0,01 (1) (2) cereals 1-methylcyclopropene 0,01 (1) (2) cereals (1) Indicates lower limit of analytical determination. (2) 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 5 June 2011.’

ANNEX II In Part A of Annex II to Directive 86/363/EEC, the following lines 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, 0206, 0207, ex 0208, 0209, 0210, 1601 and 1602 for milk and milk products listed in Annex I under headings Nos 0401, 0402, 0405 and 0406 of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 and 0408 ‘Indoxacarb as sum of the isomers S and R meat and edible offals: 0,01 (1) (2); fat: 0,3 (2) milk: 0,02 (2); cream of milk 0,3 (2) 0,01 (1) (2) MCPA, MCPB and MCPA thioethyl expressed as MCPA 0,1 (1) (2); edible offals: 0,5 (1) (2) 0,05 (1) (2) 0,05 (1) (2) Tolylfluanid (tolylfluanid analysed as dimethylaminosulfotoluidide and expressed as tolylfluanid) 0,1 (1) (2) 0,02 (1) (2) 0,1 (1) (2) (1) Indicates lower limit of analytical determination. (2) 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 5 June 2011.’