Reasoned opinion on the modification of the existing MRLs for captan in pome fruits and commodities of animal origin

captan, tetrahydrophthalimide (THPI), pome fruit, animal commodities, MRL application, Regulation (EC) No 396/2005, consumer risk assessment.
First published in the EFSA Journal
24 July 2013
22 July 2013
Reasoned Opinion


In accordance with Article 6 of Regulation (EC) No 396/2005, France received an application to modify the existing MRLs for captan in pome fruits and in commodities of animal origin. In order to accommodate the intended use, France proposed raising the existing MRLs for pome fruit, ruminant tissues and milk. According to EFSA, the data are sufficient to derive a MRL proposal for the SEU and the NEU use on pome fruit, according to the residue definition “sum of captan and THPI, expressed as captan” and for the residue definition “sum of captan and folpet”. The nature of captan residues in livestock is sufficiently elucidated and EFSA proposes to modify the existing residue definitions in animal commodities according to the conclusions of the peer review. The results of the feeding study indicate that in order to accommodate the SEU use of captan on pome fruit, the MRLs for ruminant meat, liver and kidney would have to be amended. For the less critical NEU use on pome fruit, MRLs at the LOQ are sufficient for commodities of animal origin. Based on the results of the consumer risk assessment EFSA concludes that the NEU use of captan on pome fruit and resulting residues in commodities of animal origin will not pose a public health concern. No consumer health risk was identified also for the MRL proposals derived for the more critical SEU use. However, in case apples and pears contain residues at the level of the MRL proposal for the SEU use, the safety margin for acute exposure was found to be very narrow. Therefore EFSA would recommend setting the MRLs for apple and pear on the basis of the NEU data set.

European Food Safety Authority
pesticides.mrl [at]
EFSA Journal 2013;11(7):3337
Question Number
On request from
European Commission

Background documents