Reasoned opinion on the review of the existing maximum residue levels (MRLs) for benalaxyl according to Article 12 of Regulation (EC) No 396/2005


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(10):3405 [43 pp.].

EFSA wishes to thank the rapporteur Member State Portugal for the preparatory work on this scientific output.

Reasoned Opinion
On request from
Question Number
7 October 2013
Published in the EFSA Journal
8 October 2013
European Food Safety Authority (EFSA), Parma, Italy

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance benalaxyl. In order to assess the occurrence of benalaxyl 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 as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing and the consumer risk assessment for benalaxyl is considered indicative only. Moreover, residues of benalaxyl may also be generated by the use of benalaxyl-M, which is the purified R-enantiomer of benalaxyl and which is currently stioll under assessment at EU level. Considering that EFSA was not yet in a position to include the use of benalaxyl-M in the above assessment and that most of the uses of benalaxyl evaluated in the framework of this review do not seem to require the setting of MRLs higher than those currently listed in Annexes II and III of Regulation (EC) No 396/2005 EFSA recommends that the existing EU MRLs for benalaxyl (benalaxyl including other mixtures of constituent isomers including benalaxyl-M (sum of isomers)), except for table grapes, are maintained until the review of MRLs for benalaxyl-M can be finalised. For table grapes, EFSA recommends to increase the existing EU MRL of 0.3 mg/kg to 0.6 mg/kg to cover the authorised use of benalaxyl on table grapes which is adequately supported by data and for which no risk to consumers was identified.

benalaxyl, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, phenylamide, fungicide, benalaxyl M
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