Modification of the existing MRLs for dodine in pome fruit, apricots and olives


Dodine, various crops, MRL application, lowering of MRLs, Regulation (EC) No 396/2005, consumer risk assessment, guanidine fungicide.
First published in the EFSA Journal
15 February 2013
8 February 2013
Reasoned Opinion

In accordance with Article 6 of Regulation (EC) No 396/2005, Portugal, herewith referred to as the evaluating Member State (EMS), received an application from the company Agriphar to lower the existing MRL for dodine in apricots to reflect a less critical European use. The applicant also submitted additional residue trials on apples and a new freezer storage stability study in high oil content matrices to confirm the MRLs derived for pome fruit and olives in the previously issued EFSA reasoned opinion. The lowering of the MRL for apricots is justified as for the existing MRL acute consumer intake concerns cannot be excluded. According to EFSA, the submitted data are sufficient to confirm the MRL proposal of 0.9 mg/kg for pome fruits as derived in the previous EFSA reasoned opinion. The MRL proposal of 0.09 mg/kg for apricots has been derived, in accordance with the provisions of the EU guidance document on extrapolation from residue trials on peaches and apples. Although the data are compliant with the data requirements, EFSA recommends performing additional trials on apricots to confirm that the MRL is sufficient to cover the use on apricots. The new freezer storage stability study submitted for dodine in high oil content matrices confirms the validity of the residue trials on olives. Thus, the data gap identified in the previous opinion with regard to the MRL for olives (20 mg/kg) is sufficiently addressed. Based on the risk assessment results, EFSA concludes that the new intended less critical uses on pome fruit and apricots which result in lower MRL proposals compared to the existing MRLs, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.

pesticides.mrl [at]
EFSA Journal 2013;11(2):3112 [25 pp.].
European Food Safety Authority
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