In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Spain, received an application from Cheminova Agro S.A. to modify the existing maximum residue level (MRL) for the active substance pyriproxyfen in bananas. In order to accommodate for the intended use of pyriproxyfen, Spain proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.5 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 27 July 2015.
EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Directive 91/414/EEC, the Commission review report on pyriproxyfen, the conclusion on the peer review of the pesticide risk assessment of the active substance, the JMPR Evaluation report as well as the conclusion from previous EFSA opinion.
The toxicological profile of pyriproxyfen was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.1 mg/kg bw per day. No acute reference dose (ARfD) was deemed necessary.
The metabolism of pyriproxyfen in primary crops was investigated in the fruit, pulses/oilseeds crop groups following foliar application. From these studies the peer review established the residue definition as pyriproxyfen for enforcement and risk assessment. For the use on banana, EFSA concludes that the metabolism of pyriproxyfen in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.
EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.7 mg/kg on banana.
Adequate analytical enforcement methods are available to monitor the residues of pyriproxyfen in plant matrices/on the commodity under consideration at the validated LOQ of 0.01 mg/kg.
Studies investigating the nature of pyriproxyfen residues under standard hydrolysis conditions were assessed during peer review and showed the active substance to be hydrolytically stable under standard hydrolysis conditions. Therefore for processed commodities the same residue definition as for raw commodities (RAC) is applicable. Based on the four supervised residues trials where samples were analysed for residues in peel and pulp respectively, a processing factor (peeling factor) of 0.05 was derived for banana pulp. EFSA recommends the inclusion of this processing factor in Annex VI of Regulation (EC) No 396/2005.
As the proposed use of pyriproxyfen is on permanent crops and since banana are normally not fed to livestock, investigations of residues in rotational crops and in commodities of animal origin were not assessed and are not required.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo model. The maximum chronic intake was calculated to be 8 % of the ADI (DE, children). An acute consumer risk assessment was not performed since the setting of and ARfD was concluded to be unnecessary for the active substance. EFSA concludes that the proposed use of pyriproxyfen on banana will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a health risk to consumers.