Reasoned opinion on the setting of a new MRL for imazapic in genetically modified soya bean

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(10):3426 [26 pp.].
doi
10.2903/j.efsa.2013.3426
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2013-00004
Approved
14 October 2013
Published in the EFSA Journal
18 October 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from Exponent International Ltd. on behalf of BASF Corporation to set an import tolerance for the active substance imazapic in genetically modified (GM) soya bean BPS-CV127-9 grown in Brazil at the level of 0.4 mg/kg. The United Kingdom 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 a MRL proposal of 0.5 mg/kg for the use of imazapic on imidazolinone-tolerant soya bean imported from Brazil. As alternative option, risk manager may consider the MRL of 0.3 mg/kg, which is derived based on a previous calculation methodology and corresponds to the MRL value established in Brazil. An adequate analytical enforcement method is available to control the residues of imazapic in the crop under consideration. Based on the risk assessment results, EFSA concludes that the reported use of imazapic on soya bean BPS-CV127-9 will not result in a consumer exposure exceeding the toxicological reference value for imazapic and therefore is unlikely to pose a consumer health risk.

Keywords
imazapic, soya bean, BPS-CV127-9, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, imidazolinone herbicide
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Number of Pages
26