Reasoned opinion on the modification of MRLs for spirodiclofen in strawberries bananas, avocado, mango and papaya


European Food Safety Authority
EFSA Journal
EFSA Journal 2012;10(7):2821 [30 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
6 juillet 2012
Published in the EFSA Journal
9 juillet 2012
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, herewith referred as the evaluating Member State (EMS), received an application from Bayer S.A.S-Bayer CropScience to modify the existing MRLs for spirodiclofen in strawberries and bananas and set import tolerances for papaya, avocado and mango. The Netherlands proposed to decrease the existing MRL for strawberries from 2 mg/kg to 0.02 mg/kg and to increase the MRL for banana from the limit of quantification 0.02* mg/kg to 0.3mg/kg. In order to accommodate the import of produce, the Netherlands proposed to set the MRL for papaya, mangos and avocados at 1.0 mg/kg. The Netherlands 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 of 0.3 mg/kg for the proposed use in banana and 1.5 mg/kg to accommodate the reported use in the USA on avocado, noting that the MRL in the country of origin is set at the level of 1 mg/kg. EFSA has some reservations regarding the proposal that the residue trial results for avocado might be extrapolated to propose MRLs on papaya and mango. The intended use on strawberries is not adequately supported by residue data. Based on the risk assessment results, EFSA concludes that the proposed use of spirodiclofen on strawberry, banana, avocado, mango and papaya will not result in consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Spirodiclofen, strawberries, bananas, avocado, papaya, mango, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, tetronic acids
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