According to Article 6 of the Regulation (EC) No 396/2005, Germany, herewith referred as the evaluating Member State (EMS), received from the company Stahler International GmbH & Co. KG an application to modify the existing MRL for the active substance acequinocyl in hops. In order to accommodate for the intended use of acequinocyl, it is proposed to raise the existing MRL from the limit of quantification of 0.02 mg/kg to 15 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 20 July 2010. EFSA bases its assessment on the evaluation report, the Draft Assessment Report and the addendum prepared under Council Directive 91/414/EEC, the conclusions on the peer review of the pesticide risk assessment of the active substance acequinocyl as well as the conclusion from a previous EFSA opinion on acequinocyl. The toxicological profile of acequinocyl was assessed in the framework of the peer review and the data were sufficient to derive an ADI of 0.023 mg/kg body weight/day and an ARfD of 0.08 mg/kg body weight. The plant metabolism of acequinocyl was investigated in apples, eggplants and oranges. From these studies the peer review experts concluded to establish the residue definition for risk assessment and enforcement as acequinocyl. For the use on hops, EFSA concluded that the metabolism of acequinocyl is sufficiently elucidated and no additional investigations are necessary. Adequate analytical methods are available to enforce the proposed MRL on the crop under consideration. The supervised residue trials are sufficient and adequate to derive an MRL proposal for the intended use on hops. The studies indicate that a MRL of 15 mg/kg would be required for the intended use. Specific studies investigating the magnitude of acequinocyl residues in processed commodities are not required, as the total theoretical maximum daily intake (TMDI) is below the trigger value of 10% of the ADI. Since the use of acequinocyl in the framework of this application is on semi-permanent crops, the possible occurrence of residues in rotational crops is not required to be assessed. The nature and magnitude of acequinocyl residues in commodities of animal origin is not relevant in the framework of this application, as hops are not fed to livestock. The consumer exposure assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model. For the calculation of the chronic exposure, EFSA used the STMR values as derived from the residue trials on hops. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. To refine the calculations, EFSA used the STMR values reported in the previously issued EFSA reasoned opinion. The acute exposure assessment was performed only with regard to the crop under consideration using the HR value as derived from the submitted supervised residue field trials. Since no processing factors are available EFSA assumed a complete transfer of unchanged acequinocyl residues from hops to beer. The calculated exposure was then compared with the toxicological reference values derived for acequinocyl. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 1 to 8 % of the ADI (maximum for DE child diet). The contribution of residues in hops to the total consumer exposure accounted for a maximum of 0.07% of the ADI (UK adult diet). No acute consumer risk was identified in relation to the MRL proposal for hops. No short-term intake concerns were identified regarding the intake of hops (2.2% of the ARfD). Consequently EFSA concludes that the intended use of acequinocyl on hops will not result in an exceedance of the toxicological reference values and derived the following recommendations: [GRAPHICS]
