Modification of the existing maximum residue level (MRL) for trifloxystrobin in celeriacs

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(1):4383 [17 pp.].
doi
10.2903/j.efsa.2016.4383
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00495
Approved
14 December 2015
Published
26 January 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) the Netherlands received an application from Bayer CropScience to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in celeriacs. The Netherlands 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 intended use on celeriacs assessed in the framework of this MRL application is covered by the use assessed under the Article 12 MRL review, for which however, a change of the existing MRL to 0.03 mg/kg is proposed. Adequate analytical enforcement methods are available to control the residues of trifloxystrobin in celeriacs. EFSA confirms that the proposed MRL for trifloxystrobin on celeriacs will not result in an exceedance of the toxicological reference value and therefore is unlikely to pose a health risk to consumers.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the Netherlands received an application from Bayer CropScience to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in celeriacs. In order to accommodate for the intended use of trifloxystrobin, the Netherlands proposed to raise the existing MRL from 0.02 to 0.04 mg/kg. The Netherlands 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) for an opinion on 2 September 2015.

EFSA bases its assessment on the evaluation report, the draft assessment report (DAR) prepared under Directive 91/414/EEC, the Commission review report on trifloxystrobin, the JMPR Evaluation reports as well as the conclusions from previous EFSA opinions, including the reasoned opinion on the review of the existing MRLs for trifloxystrobin according to Article 12 of Regulation (EC) No 396/2005 (Article 12 MRL review).

The toxicological profile of trifloxystrobin 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 trifloxystrobin in primary crops was investigated in three crop groups following foliar applications. The Article 12 MRL review concluded on a residue definition for enforcement as parent trifloxystrobin and for risk assessment as sum of trifloxystrobin and CGA321113, expressed as trifloxystrobin in all plant commodities.

The applicant and the EMS proposed to set an MRL of 0.04 mg/kg on celeriacs derived by extrapolation from residue trials conducted on celeriacs (two trials) and carrots (four trials) according to a good agricultural practice (GAP) defined as three applications at 100 g/ha with a pre-harvest interval (PHI) of 21 days. EFSA is of the opinion that the MRL on celeriacs should be set at 0.03 mg/kg based on the more critical GAP (3 × 130 g/ha, PHI 14 days) already assessed during the Article 12 MRL review and considering the corrected residue levels of the four trials on celeriacs presented in this MRL application. Adequate analytical enforcement methods are available to monitor the residues in celeriacs at the validated LOQ of 0.01 mg/kg.

Specific studies investigating the magnitude of trifloxystrobin residues in processed celeriac products are not required. Conclusions drawn during the Article 12 MRL reviews that residues exceeding 0.01 mg/kg in rotational crops are not expected when the active substance is used according to the proposed GAP are valid. Residues of trifloxystrobin in commodities of animal origin do not need to be assessed, since celeriacs are normally not fed to livestock.

EFSA confirms that the proposed MRL for trifloxystrobin on celeriacs will not result in an exceedance of the toxicological reference value and therefore is unlikely to pose a health risk to consumers.

Keywords
trifloxystrobin, celeriacs, MRL application, consumer risk assessment
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Number of Pages
17