Modification of the existing MRL for acetamiprid in cherries European Food Safety Authority

According to Article 6 of the Regulation (EC) No 396/2005, Germany received an application from the Landwirtschaftliches Technologiezentrum Augustenberg to modify the existing MRL for the active substance acetamiprid in cherries. In order to accommodate for the intended use of acetamiprid, it is proposed to raise the existing MRL in cherries from 0.2 to 0.5 mg/kg. Germany 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 on 27 October 2009. EFSA derived the following conclusions based on the submitted evaluation report prepared by Germany, the Draft Assessment Report (DAR) prepared under the Directive 91/414/EEC by Greece as well as the list of end points included in the Review Report on acetamiprid. The toxicological profile of acetamiprid was investigated in the peer review and the data were sufficient to conclude on an ADI value of 0.07 mg/kg bw/d and an ARfD value of 0.1 mg/kg bw. Metabolism of acetamiprid in plants has been investigated in three crop categories (fruit, leafy vegetables and root group) and a general residue definition for risk assessment and monitoring was proposed by the peer review as acetamiprid. Sufficiently validated analytical enforcement methods are available to control the compliance of the proposed MRL for acetamiprid in the crop under consideration. A sufficient number of supervised residue trials on sweet and sour cherries has been submitted. EFSA concludes that a higher EC MRL of 0.5 mg/kg for cherries would be necessary to accommodate the intended use of acetamiprid. Since cherry trees are perennial crops, the occurrence of acetamiprid or its metabolites in rotational crops was not investigated. Residues in commodities of animal origin were not assessed in the framework of this application since the crop under consideration is not a livestock feeding item. Effects of processing on the nature of acetamiprid were assessed in the peer review. Buffer solutions spiked with radio labeled acetamiprid were subjected to conditions simulating sterilization, baking and boiling and pasteurization. In all cases, acetamiprid accounted for the majority of the radioactivity (9398%). A change in the nature of residues after industrial or household processing is therefore not expected. Thus, for processed commodities the same residue definition as for raw agricultural commodities is applicable. No studies have been submitted to assess the magnitude of acetamiprid residues during the processing of cherries. Such studies however are not necessary considering the low individual contribution of this crop to the total dietary intake. The consumer risk assessment regarding the parent compound acetamiprid was performed with revision 2 of the EFSA PRIMo (Pesticide Residue Intake Model). For the chronic intake assessment, EFSA used the existing MRLs as established in Annex II and in Annex IIIB of the Regulation (EC) 396/2005 as well as the STMR value derived for the intended use of acetamiprid on cherries. The STMR values derived on lettuce, lamb's lettuce, scarole, rocket, spinach, herbs and beet leaves (chard) in the previously issued EFSA opinions on the modification of the existing MRLs for acetamiprid, were also considered. The acute intake assessment was performed only with regard to the crop under consideration. The relevant HR value for cherries as derived from the intended GAPs was used as input value in the acute intake calculation. No long-term intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated dietary intake ranged from 0.9 to 10.8% of the ADI. The contribution of cherries to the total consumer exposure to acetamiprid accounted for a maximum of 0.056% of the ADI (DE child diet). No acute intake concerns were identified in relation to the MRL proposal for acetamiprid in cherries. The acute intake of acetamiprid residues via cherries is calculated to be 3.5% or 1.2% of the ARfD for children and adults, respectively. Consequently EFSA concludes that residues resulting from the use of acetamiprid on cherries are acceptable as they will not lead to an exceedance of the toxicology reference values. EFSA derived the following recommendations: [GRAPHICS]