In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Greece, received two applications from the company Nisso Chemical Europe to modify the existing maximum residue levels (MRL) for the active substance acetamiprid in various crops. In order to accommodate the intended European uses of acetamiprid, Greece proposed to raise existing MRLs for all crops, except apricots, where a modification was not proposed. Greece drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 28 January 2015 and on 9 November 2015. For reasons of efficiency EFSA assessed both applications in one reasoned opinion.
EFSA bases its assessment on the evaluation reports submitted by the EMS, the draft assessment report (DAR) prepared under Directive 91/414/EEC, the Commission review report on acetamiprid, the JMPR evaluation report, the scientific opinion of the EFSA PPR Panel as well as the conclusions from previous EFSA opinions on acetamiprid, including the opinion on the review of acetamiprid MRLs according to Article 12 of Regulation (EC) No 396/2005 (hereafter Article 12 MRL review).
The toxicological profile of acetamiprid 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 0.07 mg/kg bw per day and an acute reference dose (ARfD) of 0.1 mg/kg bw. However, in 2013, based on additional information on the developmental neurotoxicity potential, the EFSA PPR Panel recommended to lower the ADI and ARfD to a value of 0.025 mg/kg bw per day.
The metabolism of acetamiprid in the fruit, root and leafy crop groups was evaluated in the framework of the peer review; additional study on pulses/oilseeds crop group was assessed by the Article 12 MRL review. The residue definition for monitoring and for risk assessment was proposed as acetamiprid by the peer review and confirmed during the Article 12 MRL review. For the uses on the crops under consideration, EFSA concludes that the metabolism of acetamiprid is sufficiently addressed. Adequate analytical enforcement methods are available.
EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals for all crops under consideration. For apricots the submitted trials indicate no need to modify the existing MRL.
Acetamiprid is hydrolytically stable under standard hydrolysis conditions and the residue definitions proposed for primary crops are also applicable for processed commodities. The applicant submitted results of the processing studies where the magnitude of acetamiprid was investigated in the processing of olives and gherkins. Results indicate a reduction of residues in canned olives, raw olive oil and canned gherkins. Processing factors were derived but are not proposed for the inclusion in Annex VI of Regulation (EC) No 396/2005 as no details of processing conditions were provided.
The occurrence of acetamiprid residues in rotational crops was investigated in the framework of the peer review. During Article 12 MRL review due to insufficient information on the persistent soil metabolite IM-1-5, EFSA recommended for Member States granting an authorisation for acetamiprid to take the necessary risk mitigation measures in order to avoid residues in rotational crops.
Rape seeds, wheat grain, pulses and their by-products can be fed to livestock and therefore a potential carry-over of residues into food of animal origin was assessed. The dietary burdens for livestock were recently calculated under Article 12 MRL review and were now updated with residues in the feed crops under consideration from the intended uses. As residues in oilseed rape, wheat and pulses do not affect the calculated dietary burdens, a modification of the MRLs proposed for animal commodities under Article 12 MRL review is not necessary.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). A comprehensive long-term exposure assessment which was performed under Article 12 MRL review was now updated with the MRL proposals that have entered into force after the finalisation of the Article 12 MRL review and with the median residue values derived from the residue trials conducted on the crops under consideration in this MRL application. For commodities of animal origin, the existing MRLs as established in Regulation (EU) 2015/846 were used as input values. The acute exposure assessment was performed only with regard to the crops under consideration.
The consumer risk assessment calculations were performed considering the current and the new recommended toxicological reference values. No long-term consumer intake risks were identified for any of the European diets incorporated in the EFSA PRIMo. No exceedance of ARfD was identified in relation to the MRL proposals for the crops under consideration.
EFSA concludes that the intended use of acetamiprid on apricots, olives, tomatoes, gherkins, beans and peas (with pods), pulses, rapeseeds and wheat will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers.