Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

imazalil, MRL review, Regulation (EC) No 396/2005, consumer risk assessment,imidazole, pesticide, fungicide
First published in the EFSA Journal
30 October 2018
28 September 2018
Reasoned Opinion


In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fruits, apples, pears, potatoes, bananas and melons because the assessment of the toxicological properties of the metabolite R014821 (expected to occur following post‐harvest application of imazalil) could not be finalised. Risk managers should be made aware that the genotoxic potential of the metabolite R014821 could not be ruled out. For all these commodities, a decision on the residue definition for risk assessment could not be taken, which is a perquisite to perform a reliable dietary risk assessment. For the other commodities and considering fall‐back Good Agricultural Practices (GAPs) when possible, some information required by the regulatory framework was missing. Hence, although no apparent risk to consumers was identified, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. It is noted that MRL proposals in commodities of animal origin were not derived because, provided that GAPs with post‐harvest applications would be withdrawn, the livestock exposure is not expected to exceed the trigger value. Nevertheless, it is noted that lacking of information/data (in particular on the toxicity of metabolites FK‐772 ad FK‐284) was also identified, which prevent from proposing residue definition for enforcement and risk assessment in livestock commodities.

European Food Safety Authority
pesticides.mrl [at] efsa.europa.eu
EFSA Journal 2018;16(10):5453
Question Number
On request from
European Commission

Background documents