Modification of the existing maximum residue levels for bentazone in soyabeans and poppy seeds

bentazone, soyabeans, poppy seeds, pesticide, MRL, consumer risk assessment
First published in the EFSA Journal
2 August 2019
Approved
8 July 2019
Type
Reasoned Opinion

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both commodities. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in plant matrices under consideration. The studies requested by EFSA in the framework of the peer review to address the toxicological properties of metabolite 6‐hydroxy‐bentazone were only partially provided. Instead of studies investigating the general toxicity of this metabolite, the applicant provided an argumentation to justify read‐across from the available information on parent bentazone and 8‐hydroxy‐bentazone. EFSA did not agree with the provided reasoning for read‐across. Therefore, the EMS asked EFSA to continue the assessment despite the data gap. EFSA performed an indicative short‐term and long‐term dietary risk assessment; the calculated dietary exposure was well below the toxicological reference values. The risk assessment however is affected by additional, non‐standard uncertainties resulting from data gap related to the toxicological properties for 6‐hydroxy‐bentazone.

European Food Safety Authority
Contact
pesticides.mrl [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5798
EFSA Journal 2019;17(7):5798
Question Number
On request from
European Commission

Background documents