BAKGRUNN (fra kommisjonsforordningen)

(1) For 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. 

(2) During the review of those MRLs pursuant to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (‘the Authority’) identified some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers. Data gaps were indicated in Annex II to that Regulation specifying the date by which the missing information was to be submitted to the Authority by the applicant in support of the proposed MRLs. 

(3) For 2,4-DB, the missing information concerning its metabolism and analytical methods for barley, oats, rye and wheat was submitted by the applicant and the Authority concluded that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was sufficiently addressed. Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be maintained, and the footnote requiring the submission of additional information should be deleted from that Annex. For swine (muscle, fat, liver, kidney), bovine (muscle, fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat, liver, kidney, edible offals), equine (muscle, fat, liver, kidney, edible offals), other farmed terrestrial animals (muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, goat, horse), although information on analytical methods was submitted by the applicant, a feeding study for ruminants is still missing. The Authority concluded that this information was not sufficient to address the data gap previously identified and recommended that risk managers consider lowering the MRLs for those products to the limit of determination (‘LOD’). Therefore, it is appropriate to set the MRLs for those products in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the footnote indicating a request for a submission additional information from that Annex. 

(4) For iodosulfuron-methyl, the missing information concerning storage stability, crop metabolism and residue trials for linseeds and residue trials for maize/corn was not submitted by the applicant. The Authority therefore concluded that the data gap previously identified was not addressed, and recommended that risk managers consider lowering those MRLs to the LOD. Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the [footnote indicating a] request for the submission of additional information from that Annex. 

(5) For mesotrione, the missing information on residue trials investigating residue levels of that substance and its metabolite AMBA (free and conjugate) for sugar canes was not submitted by the applicant. The Authority therefore concluded that the data gap previously identified was not addressed4 , and recommended that risk managers consider lowering that MRL to the LOD. Therefore, for sugar canes, it is appropriate to set the MRL in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the requirement to submit additional information from that Annex. 

(6) For pyraflufen-ethyl, the missing information concerning analytical methods for hops was not submitted by the applicant. The Authority therefore concluded that the data gap previously identified was not addressed5 , and recommended that risk managers consider lowering that MRL to the LOD. Therefore, for hops, it is appropriate to set the MRL in Annex II to Regulation (EC) No 396/2005 at the product-specific LOD, and to delete the requirement to submit additional information from that Annex. 

(7) The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain products technical developments permit the setting of lower LODs. 

(8) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. 

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

(10) In order to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products, which have been placed on the market before the new MRLs become applicable and for which a high level of consumer protection is maintained. 

(11) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,