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Reasoned opinion on the setting of new MRLs for tembotrione in kidney and liver of bovine and swine

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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Austria, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer Austria GmbH to set MRLs for the active substance tembotrione in bovine kidney, bovine liver and swine liver. In order to accommodate the intended use of tembotrione on maize in Austria and as a result of using maize products as livestock feed, the EMS proposed to set the MRLs of 0.05 mg/kg in bovine kidney, 0.1 mg/kg in bovine liver and 0.02 mg/kg in swine liver. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. The calculated dietary burdens and the results of livestock feeding studies indicate that from the intake of maize silage and grain no residues above the LOQ are expected in milk, fat, muscle of bovine and swine. Residues above the LOQ are expected in bovine liver and kidney and, swine kidney and liver and MRLs for these commodities are therefore proposed. Based on the risk assessment results, EFSA concludes thatthe intended use of tembotrione on maize and the proposed MRLs for the commodities of animal origin will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. Since the peer review according to Commission Regulation (EU) No 188/2011 is not yet finalised, the conclusions reported 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.