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EFSA reviews

23 May 2019

Evaluation of confirmatory data following the Article 12 MRL review for bentazone

The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available.

To address the data gaps, a new livestock feeding study and storage stability data for bentazone and 6‐hydroxy bentazone in animal matrices were submitted.

To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review.

The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions.

Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk.

The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified.

For more information see the EFSA report.


Review of the existing maximum residue levels for clethodim

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance clethodim.

To assess the occurrence of clethodim residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and European authorisations reported by Member States (including the supporting residues data).

Based on the assessment of the available data, MRL could not be proposed because an overall consumer risk assessment could not be finalised. Risk managers should be made aware that the genotoxic potential of the clethodim metabolite 3‐chloroallyl alcohol, the aglycon of 3‐chlorolallyl alcohol glucoside (M14A/M15A) could not be concluded and no toxicological reference values could be derived for this metabolite.

Until a conclusion on the toxicological properties of the metabolite is reached, a decision on the residue definition for risk assessment cannot be made which is a prerequisite to perform a reliable dietary risk assessment.

For more information see the EFSA report.

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