Commission Directive 2005/48/ECShow full title

Commission Directive 2005/48/EC

of 23 August 2005

amending Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for certain pesticides in and on cereals and certain products of animal and plant origin

(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: iprodione by Commission Directive 2003/31/EC(5); propiconazole by Commission Directive 2003/70/EC(6) and molinate by Commission Directive 2003/81/EC(7).

(2) The following new active substances have been included in Annex I to Directive 91/414/EEC: mesotrione by Commission Directive 2003/68/EC(8) and silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium and fosthiazate by Commission Directive 2003/84/EC(9).

(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) 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 iprodione and propiconazole. There are already Community MRLs set out in 86/362/EEC, 86/363/EEC and 90/642/EEC for: iprodione (Council Directive 93/58/EEC)(10) and propiconazole (Council Directive 94/30/EC)(11). These have been taken into account 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.

(6) 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 assessment reports for those substances mentioned were finalised on the dates as mentioned in the Commission Directives cited in Recitals 1 and 2. These reports fixed the Acceptable Daily Intake (ADI) and if necessary, the Acute Reference Dose (ARfD) for the substances concerned. 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(12) and the opinion of the Scientific Committee for Plants(13) on the methodology employed. It has been 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 the development of 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. 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.

(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:

(1)

OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2005/46/EC (OJ L 177, 9.7.2005, p. 35).

(2)

OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2005/46/EC.

(3)

OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2005/46/EC.

(4)

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).

(5)

OJ L 101, 23.4.2003, p. 3.

(6)

OJ L 184, 23.7.2003, p. 9.

(7)

OJ L 224, 6.9.2003, p. 29.

(8)

OJ L 177, 16.7.2003, p. 12.

(9)

OJ L 247, 30.9.2003, p. 20.

(10)

OJ L 211, 23.8.1993, p. 6.

(11)

OJ L 189, 23.7.1994, p. 70.

(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).