Commission Regulation （EU） No 813/2011
of 11 August 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 acequinocyl, emamectin benzoate, ethametsulfuron-methyl, flubendiamide, fludioxonil, kresoxim-methyl, methoxyfenozide, novaluron, thiacloprid 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 kresoxim-methyl, methoxyfenozide, 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 acequinocyl, emamectin benzoate, flubendiamide, fludioxonil and novaluron, MRLs were set in Part A of Annex III to Regulation （EC） No 396/2005. For ethametsulfuron-methyl no MRLs were set before in any of the Annexes to Regulation （EC） No 396/2005, so the default value of 0,01 mg/kg applied.
（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 thiacloprid on peas （with pods） an application was made under Article 6（1） of Regulation （EC） No 396/2005 for modification of the existing MRL.
（3） As regards acequinocyl, such an application was made for use on hops. As regards emamectin benzoate, such an application was made for use оn citrus fruit, plums and apricots. As regards fludioxonil, such an application was made for use on table and wine grapes. As regards kresoxim-methyl, such an application was made for use on blueberries and cranberries. As regards methoxyfenozide, such an application was made for use on plums. As regards trifloxystrobin, such an application was made for use on aubergines and cranberries.
（4） In accordance with Article 6（2） and （4） of Regulation （EC） No 396/2005 an application was made for ethametsulfuron-methyl for use on rape seed. The authorised use of ethametsulfuron-methyl on rape seed in Canada leads to higher residues than the MRL fixed at the default value in Regulation （EC） No 396/2005. To avoid trade barriers for the importation of rape seed, a higher MRL is necessary.
（5） As regards flubendiamide, such an application was made to raise the current MRLs for tree nuts, apples, pears, cherries, peaches, table and wine grapes, lettuce, spinach, celery, soya bean, cotton seed, maize and plums in order to avoid trade barriers for the importation of these products from the United States. Concerning the same active substance, such an application was made to raise the current MRL for rice in order to avoid trade barriers for the importation of rice from India. As regards fludioxonil, such an application was made to raise the current MRLs for sweet potatoes and yams in order avoid trade barriers for the importation of these products from the United States. As regards novaluron, such an application was made to raise the current MRL for cranberries in order to avoid trade barriers for the importation of cranberries from the United States. As regards methoxyfenozide, such an application was made to raise the current MRLs for avocados and pomegranates in order to avoid trade barriers for the importation of these products from the United States.
（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 [3]. 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 use of trifloxystrobin on cranberries and flubendiamide on soya bean, cotton seed, maize and plums, residue data were not adequate to support the MRLs requested. For tomatoes, peppers and sweet corn the Authority concluded that the MRLs were already fixed at the levels corresponding to the current authorised use. As regards emamectin benzoate on citrus the Authority concluded that the MRLs were already fixed at the levels corresponding to the current authorised use. 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 showed that there is a risk that the acceptable daily intake （ADI） or the acute reference dose （ARfD） is exceeded.
（9） 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 requirements of Article 14（2） of Regulation （EC） No 396/2005.
（10） Regulation （EC） No 396/2005 should therefore be amended accordingly.
（11） 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, 11 August 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: Modification of the existing MRL for acequinocyl in hops. EFSA Journal 2010;8（12）:1937 [25 pp.].Reasoned opinion of EFSA: Modification of the existing MRLs for emamectin benzoate in plums, apricots and citrus fruit. EFSA Journal 2011;9（1）:1974 [37 pp.]. Published: 12 January 2010. Approved: 10 January 2011.Reasoned opinion of EFSA: Setting of an MRL for ethametsulfuron-methyl in rape seed. EFSA Journal 2010;8（12）:1959 [25 pp.]. Published: 17 December 2010. Adopted: 15 December 2010.Reasoned opinion of EFSA: Modification of the existing MRLs for flubendiamide in various food commodities. EFSA Journal 2010;8（12）:1960 [45 pp.]. Published: 17 December 2010. Adopted: 16 December 2010.Reasoned opinion of EFSA: Modification of the existing MRLs for fludioxonil in sweet potatoes, yams and grapes. EFSA Journal 2010;8（11）:1912 [25 pp.]. Published: 22 November 2010. Adopted: 19 November 2010.Reasoned opinion of EFSA: Modification of the existing MRLs for kresoxim-methyl in blueberries and cranberries. EFSA Journal 2010;8（12）:1933 [25 pp.]. Published: 1 December 2010. Adopted: 30 November 2010.Reasoned opinion of EFSA: Modification of the existing MRLs for methoxyfenozide in various fruits. EFSA Journal 2010;8（11）:1902 [25 pp.]. Published: 15 November 2010. Adopted: 15 November 2010.Reasoned opinion of EFSA: Modification of the existing MRL for novaluron in cranberries. EFSA Journal 2010;8（12）:1963 [24 pp.]. Published: 21 December 2010. Adopted: 16 December 2010.Reasoned opinion of EFSA: Modification of the existing MRLs for thiacloprid in peas （with pods）. EFSA Journal 2010;8（12）:1939 [27 pp.]. Published: 9 December 2010. Adopted: 7 December 2010.Reasoned opinion of EFSA: Modification of the existing MRLs for trifloxystrobin in cranberries and aubergines. EFSA Journal 2011;9（1）:1973 [26 pp.]. Published: 12 January 2011. Adopted: 7 January 2011.
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ANNEX
Annexes II and III to Regulation （EC） No 396/2005 are amended as follows:
（1） In Annex II, the columns for kresoxim-methyl, methoxyfenozide, thiacloprid and trifloxystrobin are replaced by the following:
"Pesticide residues and maximum residue levels （mg/kg）
具体表格请见附件 
欧洲国会和议会关于(EC) No 396/2005附件II 和 III中灭螨醌、甲胺基阿维菌素、胺苯磺隆、氟虫酰胺、咯菌腈、醚菌酯、甲氧虫酰肼、敌草胺、噻虫啉、肟菌酯在特定产品中的最大残留量的修正