EFSA Finds Insufficient Evidence to Modify Existing MRL for Quinoxyfen in Hops

According to the EU legislation for hops at least eight trials representative for the GAP authorised in the country of origin have to be submitted by an applicant to substantiate a MRL request.

3 May 2010 --- According to Article 6 of the Regulation (EC) No 396/2005, the United Kingdom, as designated Rapporteur Member State (RMS), received an application from the US Hop Industry Plant Protection Committee to set an import tolerance value for the active substance quinoxyfen in hops. It is proposed to raise the existing MRL from 0.5 mg/kg to 3.0 mg/kg in order to meet the need of an international trade for hop produced in the United States of America. The United Kingdom 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 7 December 2009.

On 12 January 2010 data gaps were identified, which prevented EFSA to conclude on an MRL proposal and to carry out the risk assessment for the consumer. Supervised field residue trials on hops reflecting the authorized GAP in the importing country were requested. A reply letter was submitted from United Kingdom on 16 February 2010 and taken into consideration by EFSA for the finalization of this reasoned opinion.

EFSA derived the following conclusions based on the Evaluation Report drawn up by the United Kingdom, the Draft Assessment Report and the addendum report prepared in the framework of the peer review under the Directive 91/414/EEC, and the JMPR report on quinoxyfen.

The toxicological profile of quinoxyfen was assessed by the RMS in the framework of the peer review and the data were sufficient to derive an ADI of 0.2 mg/kg bw/day. Due to the low acute toxicity of the compound, an ARfD value was not necessary.

The metabolism of quinoxyfen in plants was evaluated on wheat under the peer review. Additional metabolism studies on grapes and sugar beets were evaluated by JMPR and are mentioned in the evaluation report. The parent compound quinoxyfen was proposed as residue definition for both enforcement and risk assessment purposes.

The residues of quinoxyfen in rotational crops are of no relevance for the given import tolerance application, as well as those in livestock as hop is usually not fed to animals. According to the EU legislation for hops at least eight trials representative for the GAP authorised in the country of origin have to be submitted by an applicant to substantiate a MRL request. In support of the import tolerance request submitted by the applicant, in total four supervised field trials on hops were submitted, none of them was exactly reflecting the authorised US Good Agricultural Practice (GAP).

Due to this deficiency it was therefore not possible to obtain an estimation of the residues of quinoxyfen in hops at harvest and to calculate a reliable STMR value necessary to perform a reliable consumer risk assessment. EFSA concludes that, according to the EU legislation, the available information and studies are not sufficient to derive a MRL proposal (import tolerance) for the US GAP for quinoxyfen on hops.