EN Official Journal of the European Union L 290/7

COMMISSION REGULATION (EC) No 1050/2009

of 28 October 2009

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 azoxystrobin, acetamiprid, clomazone, cyflufenamid, emamectin benzoate, famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and trifloxystrobin in or on certain products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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) thereof,

Whereas:

(1) For azoxystrobin, acetamiprid, famoxadone, fenbutatin oxide, indoxacarb, ioxynil, mepanipyrim, thiacloprid and trifloxystrobin maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005. For clomazone, cyflufenamid, flufenoxuron, fluopicolide and prothioconazole, MRLs were set in Annex III to Regulation (EC) No 396/2005. For emamectin benzoate and pyridalyl no specific MRLs were set nor were the substances included in Annex IV 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 azoxystrobin on beet leaves and broccoli an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modifications of the existing MRLs.

(3) As regards acetamiprid, such an application was made for the use on cress, spinach and herbs, except parsley. As regards clomazone, such an application was made for the use on herbs. As regards cyflufenamid, such an application was made for the use on oats. In view of that application, it is also necessary to modify the existing MRLs for animal products, since this cereal is used as feed. As regards emamectin benzoate, such an application was made for the use on pome fruit, peaches and nectarines, table and wine grapes, strawberries, tomatoes, aubergines, pepper, cucurbits (edible and inedible peel), cauliflower, broccoli, head cabbage, lettuce and other salad plants, scarole, herbs, fresh beans (with and without pods), peas with pods and artichokes. As regards famoxadone, such an application was made for the use on flowers of herbal infusions. As regards fenbutatin oxide, such an application was made for the use on tomatoes. As regards indoxacarb, such an application was made for the use on small fruits and berries except gooseberries and currants. As regards ioxynil, such an application was made for the use on rye and triticale. In view of that application, it is also necessary to modify the existing MRLs for meat, liver, kidney and fat from bovines, sheep and goats, since those cereals are used in feed for these animals. As regards mepanipyrim, such an application was made for the use on courgette. As regards prothioconazole, such an application was made for the use on head cabbage and Brussels sprouts. As regards pyridalyl, such an application was made for the use on tomatoes, aubergines, peppers, cucurbits (inedible peel), lettuce and cotton seed. As regards thiacloprid, such an application was made for the use on leeks and spring onions. As regards trifloxystrobin, such an application was made for the use on head cabbage, celery, blue berries, lettuce, herbs, scarole and Brussels sprouts.

(4) In accordance with Article 6(2) of Regulation (EC) No 396/2005 applications were made for flufenoxuron on tea, fluopicolide on peppers and for trifloxystrobin on passion fruit. The authorised use of flufenoxuron on tea shrubs in Japan leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of Japanese tea, a higher MRL is necessary. The authorised use of fluopicolide on pepper plants in the USA leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of American peppers, a higher MRL is necessary. The authorised use of trifloxystrobin on passion fruit in Kenya leads to higher residues than the present MRL in Annex III. To avoid trade barriers for the importation of Kenyan passion fruits, a higher MRL is necessary.

(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 European Food Safety Authority, hereinafter ‘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 requested by the applicants 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. Where the Authority recommended two MRL values for the same pesticide-product combination as two different ‘risk management options’, the Commission always opted for the lowest MRL in line with recital 5 of Regulation (EC) No 396/2005. In the case of flufenoxuron and tea, additional information provided by France about registered uses made it possible to conclude that the new MRL does not lead to a chronic health risk.

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

(9) 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, 28 October 2009. For the Commission Androulla VASSILIOU Member of the Commission

(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 MRLs for azoxystrobin. EFSA Scientific Report (2009) 283.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for acetamiprid. EFSA Scientific Report (2009) 247.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for clomazone. EFSA Scientific Report (2009) 265.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for cyflufenamid in oats. EFSA Scientific Report (2009) 291.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for emamectin benzoate in various crops. EFSA Scientific Report (2009) 290.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for famoxadone. EFSA Scientific Report (2009) 274.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for fenbutatin oxide. EFSA Scientific Report (2009) 268.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for flufenoxuron. EFSA Scientific Report (2009) 267.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the setting of an import tolerance for fluopicolide on peppers. EFSA Scientific Report (2009) 292.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for indoxacarb. EFSA Scientific Report (2009) 275.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for ioxynil in several food commodities of animal origin. EFSA Scientific Report (2009) 288.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for mepanipyrim. EFSA Scientific Report (2009) 266.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for prothioconazole. EFSA Scientific Report (2009) 261.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for pyridalyl. EFSA Scientific Report (2009) 270.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for thiacloprid. EFSA Scientific Report (2009) 256.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for trifloxystrobin. EFSA Scientific Report (2008) 212.

Reasoned opinion of EFSA prepared by the Pesticides Unit (PRAPeR) on the modification of the existing MRLs for trifloxystrobin. EFSA Scientific Report (2009) 273.