Reasoned opinion on the modification of the existing maximum residue level maximum residue level (MRL) for pyridaben in cucurbits – edible peel

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(3):4041 [21 pp.].
doi
10.2903/j.efsa.2015.4041
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00708
Approved
3 March 2015
Published
10 March 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (505.63 KB)
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Nissan Chemical Europe S.A.R.L. to modify the existing maximum residue level (MRL) for the active substance pyridaben in cucurbits – edible peel. In order to accommodate for the intended uses of pyridaben, the Netherlands proposed to raise the existing MRL from 0.1 mg/kg to a MRL of 0.15 mg/kg. the Netherlands 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 EFSA. According to EFSA the data are sufficient to derive a MRL proposal of 0.15 mg/kg for the proposed use on cucurbits – edible peel. A fully validated analytical enforcement method is available to control the residues of pyridaben in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of pyridaben on cucurbits – edible peel will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Nissan Chemical Europe S.A.R.L. to modify the existing maximum residue level (MRL) for the active substance pyridaben in cucurbits – edible peel. In order to accommodate for the intended uses of pyridaben, the Netherlands proposed to raise the existing MRL from 0.1 mg/kg to a MRL of 0.15 mg/kg. the Netherlands 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 EFSA on 1 October 2014. 

EFSA bases its assessment on the evaluation report submitted by the EMS (Netherlands, 2014), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (Netherlands, 2007), the addendum to the DAR and the revised DAR (Netherlands, 2009), the Commission Review Report on pyridaben (EC, 2010) and the conclusion on the peer review of the pesticide risk assessment of the active substance pyridaben (EFSA, 2010). 

The toxicological profile of pyridaben 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 0.01 mg/kg bw per day and an acute reference does (ARfD) of 0.05 mg/kg bw.

The metabolism of pyridaben in primary crops was investigated in the fruit crop group only (citrus, apple, tomato) following paint and spray applications. From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as pyridaben only. 

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.15 mg/kg for the proposed use on cucurbits – edible peel. A fully validated analytical enforcement method is available to control the residues of pyridaben in the commodities under consideration at the validated LOQ of 0.05 mg/kg.

Studies investigating the nature of pyridaben residues in processed commodities were assessed in the framework of the peer review and showed that the compound is hydrolytically stable under standard hydrolysis conditions. Specific studies to assess the magnitude of pyridaben residues during the processing of cucurbits – edible peel are not required since cucumbers and gherkins are mostly eaten raw. For courgettes, since the highest residue levels in the raw agricultural commodity (RAC) do not exceed the trigger value of 0.1 mg/kg and the contribution of this crop to the TMDI/IESTI is less than 10 % of the ADI/ARfD, processing studies on courgettes (cooked) are considered as not triggered. 

The occurrence of pyridaben residues in rotational crops was investigated in the framework of the peer review. Based on the available information, it is concluded that significant residue levels are unlikely to occur in rotational crops provided that the active substance is used on cucurbits – edible peel according to the proposed GAP (Good Agricultural Practice).

Residues of pyridaben in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The total calculated chronic intake accounted for up to 78 % of the ADI (German child). The contribution of residues in the cucurbits – edible peel crop group to the total consumer exposure accounted for less than 1 % of the ADI. 

No acute consumer risk was identified in relation to the MRL proposal for cucurbits – edible peel. The calculated maximum exposure in percentage of the ARfD was 11 % for cucumbers (Dutch, child).

EFSA concludes that the intended use of pyridaben on cucurbits – edible peel will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.

It is, however, highlighted that the consumer risk assessment has to be considered provisional since the revision of the existing EU MRLs under Article 12 of Regulation (EC) No 396/2005 is not yet finalised and might need to be reconsidered in the light of the outcome of this assessment.

Thus EFSA proposes to amend the existing MRL as reported in the summary table.

 

Keywords
pyridaben, cucurbits – edible peel, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, insecticide, acaricide
Print on demand
Number of Pages
21