Reasoned opinion on the setting of new MRLs for penthiopyrad in various crops
30 October 2012
In accordance with Article 6 of Regulation (EC) No 396/2005, The United Kingdom, herewith referred to as the rapporteur Member State (RMS), received an application from the company LKC UK Ltd. to set MRLs for penthiopyrad in a wide range of plant commodities in order to accommodate intended European uses and uses authorized in the United States and Canada. Resulting from the use of penthiopyrad on plants, a need to set MRLs in animal commodities was also identified by the RMS. The RMS drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals for most of the pesticide uses notified to EFSA. EFSA notes that residue trials on maize, oilseed rape, cotton, sunflower and soya have been performed with a genetically modified crop. The applicant has to confirm that the metabolism of penthiopyrad in genetically modified crop proceeds in the same way as in its conventional counterpart. Adequate enforcement methods are available to control the residues of parent penthiopyrad. For the calculated dietary burdens no residues of penthiopyrad would occur in commodities of animal origin above the analytically achievable LOQ. An adequate analytical method is available for the determination of penthiopyrad in milk, eggs, bovine meat and liver at the LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that for the notified uses of penthiopyrad on scarole and Chinese cabbage (mustard greens), a potential acute consumer intake concerns cannot be excluded for penthiopyrad residues. Thus the derived MRL proposals are not recommended to be taken over in EU legislation. The penthiopyrad residues expected on the remaining crops under consideration will not result in a consumer exposure exceeding the toxicological reference values for penthiopyrad and therefore is unlikely to pose a public health concern. The risk assessment for the metabolite PAM could not be finalised lacking toxicological data which are required to conclude on the toxicological profile of the metabolite. Since the peer review according to Commission Regulation (EU) No 188/2011 is not yet finalised, the conclusions reached in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the peer review.
© European Food Safety Authority, 2012
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