Reasoned opinion on the modification of the existing MRLs for cyromazine in various leaf vegetables and fresh herbs

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(1):4004 [22 pp.].
doi
10.2903/j.efsa.2015.4004
Type
Reasoned Opinion
On request from
European Commission
Question Number
No EFSA-Q-2014-00600
Approved
22 January 2015
Published
30 January 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, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for cyromazine in leaves and sprouts of brassica spp, spinach and similar leaves from the limit of quantification (LOQ) of 0.05mg/kg to 3 mg/kg and to confirm the provisional MRLs of 3 mg/kg in lettuce and rocket and to conclude on a MRL of 3 or 15 mg/kg in lamb lettuce and herbs. According to EFSA the data are sufficient to derive an MRL proposal of 3 mg/kg for lettuce, extrapolated to the crop groups ‘lettuce and other salad plants including brassicacea’ (except scarole), ‘spinach and similar (leaves)’ and ‘herbs’. The assessment covers the indoor uses of cyromazine only. Adequate analytical enforcement methods are available to control the residues of cyromazine and melamine in plant matrices. Based on the risk assessment results, EFSA concludes that the proposed use of cyromazine on the crops under consideration 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, Belgium, hereafter referred to as the EMS, compiled an application to modify the existing maximum residue levels (MRL) for cyromazine in leaves and sprouts of brassica spp, spinach and similar (leaves), from the LOQ of 0.05mg/kg to 3 mg/kg, to confirm the provisional MRL of 3 mg/kg in lettuce and rocket proposed during the Article 12 MRL review and to conclude on a MRL of 3 mg/kg or 15 mg/kg in lamb’s lettuce and herbs. In order to accommodate for the uses of cyromazine, Belgium drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission (EC) and forwarded to EFSA on 1 September 2014.

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance cyromazine, the JMPR Evaluation report, the scientific opinion of EFSA on melamine in food and feed, as well as the conclusion from the EFSA opinion on the review of the existing MRLs of cyromazine under the Article 12. The toxicological profile of cyromazine 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 0.06 mg/kg bw per day and an Acute Reference Dose (ARfD) of 0.1 mg/kg bw. These toxicological reference values were concluded to be applicable to melamine, its main plant metabolite. In 2010, the toxicity of melamine was reviewed by the EFSA’s CONTAM and CEF panels, where a Tolerable Daily Intake (TDI) of 0.2 mg/kg bw was derived. To perform the chronic and acute consumer risk assessment related to melamine, EFSA will therefore consider this value of 0.2 mg/kg bw.

The metabolism of cyromazine in primary crops was investigated using foliar and soil applications in the leafy crop group (lettuce and celery) and by foliar applications in the fruit crop group. From these studies the peer review established the residue definition for enforcement as cyromazine and as, sum of cyromazine and melamine expressed as cyromazine, for risk assessment. Having regard to the different toxicological endpoints set for cyromazine and melamine, two separate residue definitions, as cyromazine and melamine respectively, were proposed for risk assessment in the course of the Article 12 MRL review. These separate residue definitions will be considered by EFSA in the framework of this MRL application. For the intended uses on leafy vegetables, EFSA considers that the metabolism of cyromazine in primary crops is sufficiently addressed and the proposed residue definitions applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive an MRL proposal of 3 mg/kg for lettuce, extrapolated to the crop groups ‘lettuce and other salad plants including brassicacea’ (except scarole), ‘spinach and similar (leaves)’ and ‘herbs’. The assessment covers the indoor uses of cyromazine only. Adequate analytical enforcement methods are available to control the residues of cyromazine and melamine in plant matrices at the validated LOQ of 0.05 mg/kg.

Cyromazine residues are stable under standard hydrolysis conditions and therefore, for processed commodities the same residue definitions as for raw agricultural commodities (RAC) are applicable.

Based on rotational crop studies conducted at exaggerated application rates, the peer review concluded that residues of cyromazine and melamine are not expected in rotational crops. Considering the total application rate of 130 g/ha envisaged for the crops under consideration, EFSA concludes that significant residue of cyromazine and melamine are unlikely to occur in rotational crops when the active substance is used according to the proposed GAPs.

Residues of cyromazine in commodities of animal origin were not assessed since the crops under consideration are not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). During the MRL review according to Article 12 of Regulation (EC) No 396/2005, a comprehensive chronic and acute exposure calculation was performed considering the existing uses of cyromazine at the EU level. Now, EFSA updates the model calculations with the STMR and HR values derived from the residue trials conducted on lettuce. No long-term consumer intake concerns were identified for any of the European diets incorporated in the model. The total calculated chronic intake accounted for up to 4 % of the ADI (FR toddler) for cyromazine and 0.3 % of the ADI (WHO cluster B) for melamine. No acute consumer risk was identified for cyromazine and melamine, the maximum chronic exposure was calculated to be 45 % of the ARfD for cyromazine and 1 % of the ARfD for melamine (lettuce, DE diet).

EFSA concludes that cyromazine on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. Thus EFSA proposes to amend the existing MRLs as reported in the summary table.

Keywords
cyromazine, leaf vegetables and fresh herbs, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazine, melamine
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Number of Pages
22