EN Official Journal of the European Union L 151/1

COMMISSION REGULATION (EU) No 500/2013

of 30 May 2013

amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, Adoxophyes orana granulovirus strain BV-0001, azoxystrobin, clothianidin, fenpyrazamine, heptamaloxyloglucan, metrafenone, Paecilomyces lilacinus strain 251, propiconazole, quizalofop-P, spiromesifen, tebuconazole, thiamethoxam and zucchini yellow mosaik virus - weak strain 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 Articles 5(1) and 14(1)(a) thereof,

Whereas:

(1) For acetamiprid, azoxystrobin and propiconazole maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For clothianidin, fenpyrazamine, metrafenone, quizalofop-P, spiromesifen, tebuconazole and thiamethoxam MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For Adoxophyes orana granulovirus strain BV-0001, heptamaloxyloglucan, Paecilomyces lilacinus strain 251 and zucchini yellow mosaik virus - weak strain, no specific MRLs were set in Annex II and III nor were the substances included in Annex IV to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applies.

(2) In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance acetamiprid on purslane, legume vegetables and pulses (beans and peas), an application was made in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.

(3) As regards azoxystrobin, such an application was made for lettuce and other salad plants, spinach and similar, celery, cardoon, spices (seeds, fruits and berries) and rhubarb. As regards clothianidin, such an application was made for fresh herbs (except chervil). As regards fenpyrazamine, such an application was made for peaches, apricots and strawberries. As regards metrafenone, such an application was made for strawberries, tomatoes, peppers, aubergines, cucurbits and cultivated fungi. As regards propiconazole, such an application was made for citrus fruits. As regards quizalofop-P, such an application was made for rape seed, sunflower seed, soya bean and cotton seed. As regards tebuconazole, such an application was made for citrus fruits (except orange), lettuce and other salad plants, parsley, chives and pulses. As regards thiamethoxam, such an application was made for table olives, olives for oil production, cauliflower and globe artichokes.

(4) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for fenpyrazamine on almonds, grapes and strawberries. The applicant claims that the authorised use of fenpyrazamine on such crops in the United States leads to residues exceeding the MRLs authorised under Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of these crops.

(5) As regards spiromesifen, such an application was made for tea. The applicant claims that the authorised use of spiromesifen on such crop in Japan, India and Indonesia leads to residues exceeding the MRL authorised under Regulation (EC) No 396/2005 and that a higher MRL is necessary to avoid trade barriers for the importation of tea.

(6) 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.

(7) 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 (2). It forwarded these opinions to the Commission and the Member States and made them available to the public.

(8) The Authority concluded in its reasoned opinions that, as regards the use of acetamiprid on legume vegetables (beans and peas with pods) and pulses (beans and peas), the number of trials is insufficient to set new MRLs for northern EU. As regards the use of fenpyrazamine on apricots and the use of quizalofop-P on soya bean, it concluded that the submitted data are not sufficient to set a new MRL. As regards the use of fenpyrazamine on strawberries, the Authority concluded that the submitted data are not sufficient to set a new MRL for the outdoor use.

(9) As regards all other applications, the Authority concluded 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 and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.

(10) As regards Adoxophyes orana granulovirus strain BV-0001, Paecilomyces lilacinus strain 251 and zucchini yellow mosaik virus - weak strain the Authority concluded (3) that these substances are not pathogenic to humans and will not produce any toxins. In view of that conclusion, the Commission considers that the inclusion of such substances in Annex IV to Regulation (EC) No 396/2005 is appropriate. As regards heptamaloxyloglucan, the Authority concluded (4) that its inclusion in Annex IV to Regulation (EC) No 396/2005 is appropriate.

(11) On 7 July 2012 the Codex Alimentarius Commission (CAC) (5) adopted Codex maximum residue limits (CXLs) for acetamiprid, clothianidin, tebuconazole and thiamethoxam. These CXLs should be included in Regulation (EC) No 396/2005 as MRLs, with the exception of those CXLs which are not safe for a European consumer group and for which the Union presented a reservation to the CAC (6).

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

(13) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(14) 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, III and IV 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, 30 May 2013. For the Commission The President José Manuel BARROSO

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

(2) EFSA scientific reports available online: http://www.efsa.europa.eu:

Reasoned opinion on the modification of the existing MRLs for acetamiprid in purslane, legume vegetables and pulses (beans and peas). EFSA Journal 2012; 10(12):3051 [28 pp.]. doi:10.2903/j.efsa.2012.3051.

Reasoned opinion on the modification of the existing MRLs for azoxystrobin in lettuce, spinach, celery, cardoon, spices and rhubarb. EFSA Journal 2012; 10(11):2991 [27 pp.]. doi:10.2903/j.efsa.2012.2991.

Reasoned opinion on the modification of the existing MRLs for fenpyrazamine in almonds, grapes, apricots, peaches and strawberries. EFSA Journal 2012; 10(11):2989 [32 pp.]. doi:10.2903/j.efsa.2012.2989.

Reasoned opinion on the modification of the existing MRLs for metrafenone in various crops. EFSA Journal 2013; 11(1):3075 [30 pp.]. doi:10.2903/j.efsa.2013.3075.

Reasoned opinion on the modification of the existing MRLs for propiconazole in citrus fruits. EFSA Journal 2012; 10(12):3049 [35 pp.]. doi:10.2903/j.efsa.2012.3049.

Reasoned opinion of EFSA: Modification of the existing MRLs for quizalofop-P in sunflower seed and cotton seed. EFSA Journal 2010; 8(3):1532 [29 pp.]. doi:10.2903/j.efsa.2010.1532.

Reasoned opinion on the modification of the existing MRLs for quizalofop-P in oilseed rape, sunflower, cotton and soybean. EFSA Journal 2012; 10(12):3008 [28 pp.]. doi:10.2903/j.efsa.2012.3008.

Reasoned opinion on the modification of the existing MRL for spiromesifen in tea. EFSA Journal 2012; 10(12):3050 [27 pp.]. doi:10.2903/j.efsa.2012.3050.

Reasoned opinion on the modification of the existing MRLs for tebuconazole in citrus (except oranges), lettuce and other salad plants, parsley and chives. EFSA Journal 2012; 10(9):2898 [37 pp.]. doi:10.2903/j.efsa.2012.2898.

Reasoned opinion of EFSA: Modification of the existing MRLs for tebuconazole in pulses. EFSA Journal 2011; 9(6):2282 [30 pp.]. doi:10.2903/j.efsa.2011.2282.

Reasoned opinion on the modification of the existing MRLs for thiamethoxam and clothianidin in various crops. EFSA Journal 2012; 10(11):2990 [44 pp.]. doi:10.2903/j.efsa.2012.2990.

(3) Conclusion on the peer review of the pesticide risk assessment of the active substance Adoxophyes orana granulovirus. EFSA Journal 2012; 10(4):2654 [32 pp.]. doi:10.2903/j.efsa.2012.2654.

Conclusion regarding the peer review of the pesticide risk assessment of the active substance Paecilomyces lilacinus. doi:10.2903/j.efsa.2007.103r.

Conclusion on the peer review of the pesticide risk assessment of the active substance zucchini yellow mosaic virus - weak strain. EFSA Journal 2012; 10(6):2754 [30 pp.]. doi:10.2903/j.efsa.2012.2754.

(4) Conclusion regarding the peer review of the pesticide risk assessment of the active substance heptamaloxyloglucan. doi:10.2903/j.efsa.2009.334r.

(5) Codex Committee on Pesticide Residues reports available on:

http://www.codexalimentarius.org/download/report/777/REP12_PRe.pdf

Joint FAO/WHO food standards programme Codex Alimentarius Commission. Appendix II and III. Thirty-Fifth Session. Rome, Italy, 2 - 7 July 2012.

(6) Scientific support for preparing an EU position in the 44th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2012; 10(7):2859 [155 pp.]. doi:10.2903/j.efsa.2012.2859.