Reasoned opinion of EFSA: Modification of the existing MRLs for fenhexamid in various leafy vegetables

摘要

According to Article 6 of the Regulation (EC) No 396/2005, Belgium compiled an application tomodify the existing MRLs for the active substance fenhexamid in lettuce and other salad plants. Inorder to accommodate for the intended use of fenhexamid, it is proposed to raise the existing MRLs inlettuce and other salad plants from 30 to 40 mg/kg. Belgium drafted an evaluation report according toArticle 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission andforwarded to EFSA on 3 September 2009.EFSA derived the following conclusions based on the submitted evaluation report prepared byBelgium, the Draft Assessment Report (DAR) prepared under the Directive 91/414/EEC by the UnitedKingdom, the Review Report on fenhexamid (including the list of end points) and the Germanproposal to amend MRL for fenhexamid in fresh beans.The toxicological profile of fenhexamid was investigated in the peer review and the data weresufficient to conclude on an ADI value of 0.2 mg/kg bw/d. Due to the low acute toxicity of the activesubstance, no ARfD was established.Metabolism of fenhexamid in plants has been investigated in three crop categories (fruit, leafyvegetables and root group) and a general residue definition for risk assessment and monitoring wasproposed as fenhexamid. Sufficiently validated analytical enforcement methods are available tocontrol the compliance of the proposed MRL for fenhexamid in the crops under consideration.The submitted supervised residue field trials indicate that a higher EC MRL of 50 mg/kg for lettucewould be necessary to accommodate the intended use of fenhexamid.The applicant proposed the extrapolation from lettuce to the whole group of salad plants. A generalextrapolation is possible from lettuce to the whole group of lettuce and other salad plants in case theactive substance is used up to or close to harvest and the GAPs are comparable, but possible residuesin lamb’s lettuce and cress should be considered. Supervised residues trials were not appropriate tosupport this extrapolation since no data regarding the residues in lamb’s lettuce and cress wereprovided.The occurrence of fenhexamid or its metabolites in rotational crops was also investigated. Theoccurrence of fenhexamid residues in rotational crops is not expected due to the rapid degradation ofthe parent compound in soil.Residues in commodities of animal origin were not assessed in the framework of this application sincethe crops under consideration are not livestock feeding items.The effect of processing on the nature of fenhexamid has been evaluated under the framework of thepeer review. A study on the hydrolytic degradation of radiolabel fenhexamid under representativeconditions of processing showed it to be resistant to hydrolysis. It is therefore unlikely that processingwill affect the nature of the fenhexamid residue.Specific studies investigating the effect of processing on the magnitude of fenhexamid in lettuce arenot necessary considering the low individual contribution of this crop to the total dietary intake.Moreover, lettuce is not generally processed before consumption.The consumer risk assessment was performed with revision 2 of the EFSA PRIMo Pesticides ResidueIntake Model. For the chronic intake assessment EFSA used the existing MRLs as established inAnnex II and III of Regulation EC No 396/2005. Acute risk assessment was not performed since noARfD is established for fenhexamid.No long-term intake concerns were identified for any of the European diets incorporated in the EFSAPRIMo. The total calculated dietary intake ranged from 1.6 to 16.2% of the ADI. The contribution oflettuce to the total consumer exposure to fenhexamid accounted for a maximum of 3.25 % of the ADI(ES adult diet).