EN Official Journal of the European Union L 137/3

COMMISSION REGULATION (EU) No 508/2011

of 24 May 2011

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin, acetamiprid, cyprodinil, difenoconazole, dimethomorph, fenhexamid, proquinazid, prothioconazole, pyraclostrobin, spirotetramat, thiacloprid, thiamethoxam and trifloxystrobin in or on certain products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) thereof,

Whereas:

(1) For abamectin, acetamiprid, fenhexamid, pyraclostrobin, thiacloprid and trifloxystrobin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For cyprodinil, difenoconazole, dimethomorph, proquinazid, prothioconazole, spirotetramat, and thiamethoxam, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005.

(2) In the context of a procedure, in accordance with Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), for the authorisation of the use of a plant protection product containing the active substance fenhexamid on onions an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.

(3) As regards abamectin, such an application was made for the use on apricots and peaches. As regards acetamiprid, such an application was made for the use on land cress and red mustard. As regards cyprodinil, such application was made for the use in fresh lentils. As regards difenoconazole, such an application was made for the use on peppers and aubergines. As regards dimethomorph, such an application was made for the use in garlic, onions, shallots, aubergines and globe artichokes. As regards proquinazid, such an application was made for the use on strawberries. As regards prothioconazole, such an application was made for the use on various root vegetables As regards pyraclostrobin, such an application was made for the use on tomatoes, aubergines, globe artichokes and celeriac. As regards spirotetramat, such an application was made for the use in various crops outside the European Union. As regards thiacloprid, such an application was made for the use on cotton seed and figs. As regards thiamethoxam, such an application was made for the use in strawberries and beans (with pods). As regards trifloxystrobin, such an application was made for the use on leafy brassica.

(4) Regarding trifloxystrobin, the European Food Safety Authority, hereinafter ‘the Authority’ has reviewed not only the use on leafy brassica but also the animal feeding studies and has concluded that it is necessary to set MRLs for products of animal origin with an amended residue definition at the limit of determination for enforcement purposes.

(5) In accordance with Article 8 of Regulation (EC) No 396/2005, these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.

(6) The Authority, assessed the applications and the evaluation reports, examining in particular the risks to the consumer and where relevant to animals and gave reasoned opinions on the proposed MRLs (3). It forwarded these opinions to the Commission and the Member States and made them available to the public.

(7) The Authority concluded in its reasoned opinions that all requirements with respect to data were met and that the modifications to the MRLs as recommended by the Authority were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.

(8) Based on the reasoned opinions and statement of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2)(a) of Regulation (EC) No 396/2005.

(9) Annex II and III to Regulation (EC) No 396/2005 should therefore be amended accordingly.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 May 2011. For the Commission The President José Manuel BARROSO

(1) OJ L 70, 16.3.2005, p. 1.

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

(3) EFSA scientific reports available on http://www.efsa.europa.eu:

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for abamectin in apricots and peaches (including nectarines), EFSA Journal 2010; 8(7):1683. Published: 13 July 2010 Adopted: 12 July 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for acetamiprid in land cress and red mustard , EFSA Journal 2010; 8(6):1643. Published: 7 June 2010 Adopted: 3 June 2010.

Reasoned opinion of EFSA: Modification of the existing MRL for cyprodinil in fresh lentils EFSA Journal 2010; 8(3):1529. Published: 10 March 2010 Adopted: 8 March 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for difenoconazole in peppers and aubergines, EFSA Journal 2010; 8(6):1651. Published: 25 June 2010 Adopted: 24 June 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for dimethomorph in various crops, EFSA Journal 2010; 8(5):1622. Published: 21 May 2010 Adopted: 20 May 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for fenhexamid in onions, EFSA Journal 2010; 8(7):1696. Published: 13 July 2010 Adopted: 12 July 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for proquinazid in strawberries , EFSA Journal 2010; 8(8):1712. Published: 26 July 2010 Adopted: 20 July 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for prothioconazole in various root vegetables, EFSA Journal 2010; 8(7):1675. Published: 8 July 2010 Adopted: 7 July 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for pyraclostrobin in tomatoes, aubergines, globe artichokes and celeriac EFSA Journal 2010; 8(6):1630. Published: 7 June 2010 Adopted: 28 May 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for spirotetramat in various crops, EFSA Journal 2010; 8(7):1665. Published: 1 July 2010 Adopted: 29 June 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for thiacloprid in figs and various crops, EFSA Journal 2010; 8(7):1668. Published: 1 July 2010 Adopted: 29 June 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for thiacloprid in cotton seed, EFSA Journal 2010; 8(8):1713. Published: 27 August 2010 Adopted: 26 August 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for thiamethoxam in strawberries and beans (with pods), EFSA Journal 2010; 8(6):1647. Published: 24 June 2010 Adopted: 22 June 2010.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of existing MRL for trifloxystrobin in leafy brassica, EFSA Journal 2010; 8(6):1648. Published: 28 June 2010 Adopted: 23 June 2010.