Modification of the existing maximum residue level for pendimethalin in lettuce

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(9):4249 [18 pp.].
doi
10.2903/j.efsa.2015.4249
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00789
Approved
14 September 2015
Published
25 September 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State, the United Kingdom, received an application from UK Horticultural Development Company to modify the existing maximum residue level (MRL) for the active substance pendimethalin in lettuce. In order to accommodate for the intended use of pendimethalin, UK proposed to raise the existing MRL from the limit of quantification to 0.15 mg/kg. According to EFSA, data are sufficient to derive an MRL proposal of 0.1 mg/kg to support the use of pendimethalin on lettuce. Adequate analytical enforcement methods are available to control the residues of pendimethalin in lettuce at the validated LOQ of 0.05 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed use of pendimethalin on lettuce will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) the United Kingdom, received an application from the UK Horticultural Development Company to modify the existing maximum residue level (MRL) for the active substance pendimethalin in lettuce. In order to accommodate for the intended use of pendimethalin, the United Kingdom proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.15 mg/kg. The United Kingdom drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 31 October 2014.

EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Directive 91/414/EEC, the Commission review report on pendimethalin as well as the conclusions from previous EFSA opinions on pendimethalin, including the review of all existing MRLs according to Article 12 of Regulation (EC) No 396/2005.

The toxicological profile of pendimethalin was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.125 mg/kg bw per day. No acute reference dose (ARfD) was deemed necessary.

The metabolism of pendimethalin in primary crops was investigated in the root, cereal and pulses/oilseeds crop groups following foliar and soil applications. From these studies the peer review established the residue definition for enforcement and for risk assessment as pendimethalin. For the use on lettuce, EFSA concludes that the metabolism of pendimethalin in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.

EFSA concludes, based on the supervised residue trials submitted by the applicant, the MRL of 0.1 mg/kg is sufficient to support the use of pendimethalin on lettuce. Adequate analytical enforcement methods are available to monitor the residues of pendimethalin on the commodity under consideration at the validated LOQ of 0.05 mg/kg.

Specific studies investigating the magnitude of pendimethalin residues in processed commodities are not required, as lettuce is consumed as fresh product.

The occurrence of pendimethalin residues in rotational crops was investigated in the framework of the peer review and during the MRL review under Article 12 of Regulation (EC) No 396/2005, where the same residue definition as for raw agricultural commodity (RAC) was proposed. Pendimethalin residues are not expected in rotational crops for applications with a plant back interval (PBI) of more than 180 days.

Residues of pendimethalin in commodities of animal origin were not assessed, since lettuce is normally not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the long-term consumer exposure assessment conducted in the framework of the Article 12 MRL review, taking into account the short-term median residue (STMR) derived for lettuce and considering the STMR values derived for some commodities assessed in previous MRL applications under Article 10 of Regulation (EU) 396/2005. The highest chronic consumer exposure was calculated to be 1.4% of the ADI (NL, Child).

EFSA concludes that the proposed use of pendimethalin on lettuce will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers. EFSA proposes to amend the existing MRL as reported in the summary table below.

Keywords
pendimethalin, lettuce, MRL application, consumer risk assessment
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Number of Pages
18