COMMISSION REGULATION (EU) No 364/2014 of 4 April 2014

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Logo Eur LExThe official journal of April 15 2014 published the COMMISSION REGULATION (EU) No 364/2014 of 4 April 2014 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 fenpyroximate, flubendiamide, isopyrazam, kresoxim-methyl, spirotetramat and thiacloprid in or on certain products. the regulation enters into force 20 days after publishing date.



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,



For kresoxim-methyl and thiacloprid maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For fenpyroximate, flubendiamide, isopyrazam and spirotetramat MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005.


In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance fenpyroximate on blackberries, raspberries, peppers and beans (with pods), an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.


As regards flubendiamide, such an application was made for strawberries. As regards isopyrazam, such an application was made for root and tuber vegetables (except sugar beet, potatoes and tropical root and tuber vegetables), peppers and cucurbits. As regards kresoxim-methyl, such an application was made for azaroles. As regards spirotetramat, such an application was made for strawberries, bananas, table olives and shallots. As regards thiacloprid, such an application was made for spinach and similar leaves.


In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for spirotetramat on pineapples. The applicant claims that the authorised use of that substance on such crop in the United States leads to residues exceeding the MRL in Regulation (EC) No 396/2005 and that a higher MRL is necessary to avoid trade barriers for the importation of that crop.


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.


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.


The Authority concluded in its reasoned opinion that, as regards the use of kresoxim-methyl on azaroles, the submitted data are sufficient to set a new MRL based on the northern EU outdoor use. As regards the use of thiacloprid in spinach and similar leaves, the submitted data are sufficient to set a new MRL based on the northern EU outdoor use for spinach and beet leaves only.


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 them, nor the short-term exposure due to high 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.


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.


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


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

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