Reasoned Opinion on the modification of the existing MRLs for malathion in various crops


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(2):3588 [56 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
14 February 2014
21 February 2014
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy (evaluating Member State (EMS)), received an application from the company Cheminova to modify the existing MRLs for malathion in citrus and pome fruits, plum, strawberry and lettuce. In order to accommodate intended Southern European Union uses on lettuce, strawberries and citrus fruits and the authorized use on apples, pears and plums in the third countries, the EMS proposed to raise the existing MRLs for malathion in all crops under consideration, including other salad plants. According to EFSA, the submitted residue data are sufficient to derive MRL proposals for citrus fruit, strawberries, apples, plums and lettuce. Residue data were not sufficient to derive a MRL proposal for pears. An extrapolation of residue data from lettuce to the whole group of salad plants is not supported by residue data. EFSA notes that for the MRL proposals on apples, plums, strawberries and lettuce additional data gaps were identified during the assessment. Based on the combined risk assessment, which was performed for malathion and its metabolites with similar toxicity (DMM desmethyl-malathion, MMCA malathion monocarboxylic acid and MDCA malathion dicarboxylic acid) and separately for malaoxon and taking into account the currently available information for the crops under consideration, the existing MRLs and the lack of detailed information on the actual approved uses of malathion, a potential long-term consumer health risk cannot be excluded. Setting a MRL on provisional basis might be acceptable by risk managers for citrus fruits, strawberries and lettuce, taking into account the low contribution of these crops to the overall long-term exposure and high level of uncertainties of the risk assessment which were compensated by using conservative assumptions leading to an overestimation of the calculated dietary exposure.

malathion, fruits, MRL application, Regulation (EC) No 396/2005, organothiophosphate insecticide, malaoxon
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