Modification of the existing maximum residue levels for beta-cyfluthrin in various cereals

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(3):4417 [23 pp.].
doi
10.2903/j.efsa.2016.4417
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00501
Approved
16 February 2016
Published
4 March 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany received an application from ADAMA Deutschland GmbH to modify the existing maximum residue levels (MRLs) for the active substance beta-cyfluthrin in barley, oat, rye and wheat. Germany 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 EFSA. According to EFSA, the data are sufficient to derive MRL proposals of 0.3 mg/kg for barely and oat and 0.04 mg/kg for rye and wheat. Adequate analytical enforcement methods are available to control the residues of beta-cyfluthrin in cereals. Based on the risk assessment results, EFSA concludes that the proposed uses of beta-cyfluthrin on barley, oat, rye and wheat will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany received an application from ADAMA Deutschland GmbH to modify the existing maximum residue levels (MRLs) for the active substance beta-cyfluthrin in various cereals. In order to accommodate for the intended uses of beta-cyfluthrin, Germany proposed to raise the existing MRLs to 0.3 mg/kg in barley and oat and 0.04 mg/kg in rye and wheat. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and formally forwarded to the European Food Safety Authority (EFSA).

EFSA bases its assessment on the revised evaluation report, the draft assessment report (DAR) prepared under Council Directive 91/414/EEC, the Commission review reports on beta-cyfluthrin and cyfluthrin, the JMPR evaluation reports and previously issued EFSA opinions.

The toxicological profile of beta-cyfluthrin was assessed in the framework of the peer review under Directive 91/414/EEC and an acceptable daily intake (ADI) of 0.003 mg/kg bw per day and an acute reference dose (ARfD) of 0.02 mg/kg bw were proposed.

The metabolism of beta-cyfluthrin in primary crops was investigated with the structurally related active substance cyfluthrin in four crop groups following foliar applications. From these studies the peer review under Directive 91/414/EEC proposed the residue definition for enforcement and risk assessment as “cyfluthrin, including other mixtures of constituent isomers (sum of isomers)” for all crops, including cereals.

EFSA concludes that the submitted supervised residue trials support MRL proposals of 0.3 mg/kg on barley and oat and 0.04 mg/kg on rye and wheat. Adequate analytical enforcement methods are available to monitor the residues on cereals at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of beta-cyfluthrin residues under standard hydrolysis conditions were assessed in the framework of this MRL application and showed the active substance to be hydrolytically stable under processing conditions representing pasteurisation and boiling. Under sterilisation conditions, the active substance was largely degraded to metabolites FPB acid, FPB aldehyde and an unidentified polar fraction. EFSA concludes that for cereals, which are not expected to undergo sterilisation process, the residue definition in processed products can be provisionally proposed as for raw commodities but will need to be reconsidered for other crop commodities. Specific studies investigating the magnitude of beta-cyfluthrin in processed commodities were not submitted and are not required.

The occurrence of beta-cyfluthrin residues in rotational crops was investigated in the framework of the peer review under Directive 91/414/EEC. Based on the available information, EFSA concludes that residues are not expected to be present provided that the active substance is applied according to the proposed good agricultural practice (GAP).

As cereals are used as feed products, the potential carry-over of residues into food of animal origin was assessed. However, the intended uses of beta-cyfluthrin on the cereals under consideration are not expected to significantly affect the previously estimated maximum dietary burden in livestock and a change of the existing MRLs for commodities of animal origin is not necessary.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the most recent long-term consumer exposure assessment with the supervised trials median residues (STMRs) for the crops under concern as derived from the submitted trials and the STMR values related to certain Codex limits assessed in the framework of the 45th sessions of the Codex Committee on Pesticide Residues. Short-term consumer risk assessment was performed with the cereals under consideration only. The highest calculated long-term intake accounted for 97% of the ADI (Dutch child). The contribution of residues in the crops under consideration to the total consumer exposure was less than 3% of the ADI. An acute consumer risk was not identified in relation to the MRL proposals (maximum 2% of ARfD for barley).

EFSA concludes that the proposed uses of beta-cyfluthrin on barley, oat, rye and wheat will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk

Keywords
beta-cyfluthrin, cyfluthrin, cereals, MRL application, consumer risk assessment
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Number of Pages
23