Setting of a temporary maximum residue level for mepiquat in cultivated fungi

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(2):4315 [25 pp.].
doi
10.2903/j.efsa.2016.4315
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00074
Approved
18 November 2015
Published
18 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 16 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from the company BASF SE to set a temporary maximum residue level (MRL) for the active substance mepiquat in cultivated fungi, based on monitoring data. This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA. Mepiquat residues in cultivated mushrooms do not result from the use of the active substance on mushrooms, but from the uptake from the growth substrate composed of straw from cereals that have been previously treated with mepiquat. The monitoring dataset submitted by the United Kingdom was completed by additional data from national control programmes. Based on a total of 545 samples and on the Food and Agriculture Organization of the United Nations (FAO) approaches recommended for the setting of MRLs in spices and for the setting of extraneous MRLs (EMRL), EFSA derived three optional MRL proposals of 0.05, 0.07 and 0.09 mg/kg. It is proposed to risk managers to decide which value is the more appropriate to cover the presence of mepiquat residue in cultivated fungi. EFSA concludes that the highest MRL proposal for mepiquat will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health.

Summary

In accordance with Article 16 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from the company BASF SE to set a temporary maximum residue level (MRL) for the active substance mepiquat in cultivated fungi, based on monitoring data. Mepiquat residues in mushrooms do not result from the use of the active substance on mushrooms, but from the uptake of residues from the growth substrate composed of straw from cereals that have been previously treated with mepiquat. The EMS proposes to set a temporary MRL for mepiquat in cultivated fungi at 0.2 mg/kg (0.3 mg/kg expressed as mepiquat chloride). This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of the Regulation.

EFSA bases its assessment on the evaluation report and monitoring data submitted by the EMS the United Kingdom, the draft assessment report (DAR prepared under Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance mepiquat, conclusions on the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 and additional national monitoring data which have been made available to EFSA.

The toxicological profile of mepiquat chloride 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 0.2 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.3 mg/kg bw.

The metabolism of mepiquat chloride was evaluated in the framework of the peer review under Directive 91/414/EEC and in the Article 12 MRL review in the cereal/grass, pulses/oilseeds and fruit crop groups. Based on available metabolism studies, the residue definition for both enforcement and risk assessment was agreed as the ‘sum of mepiquat and its salts, expressed as mepiquat chloride’. The current residue definition set in Regulation (EC) No 396/2005 is ‘mepiquat’. Specific studies on metabolism of mepiquat in mushrooms are not available. However, since the metabolic profile of mepiquat was seen to be similar in the three crop groups investigated, with the active substance mostly un-metabolised, EFSA concludes that the residue definitions for enforcement and risk assessment as agreed during the peer review are applicable to mushrooms and additional information is not requested. Sufficiently validated analytical methods are available to control mepiquat residues in cultivated fungi.

In addition to the monitoring data submitted by the United Kingdom, EFSA took into account data from national control programmes conducted in 2012 and 2013 by national laboratories in Germany, Poland, Belgium, Denmark, Slovakia, Ireland and the Netherlands and resulting in a total of 545 samples originated from 12 different European Member States. Based on the Food and Agriculture Organization of the United Nations (FAO) approaches recommended for the setting of MRLs in spices and for the setting of extraneous MRLs (EMRLs) considering different violation rate options, EFSA derived three optional MRL proposals of 0.05, 0.07 and 0.09 mg/kg. It is proposed to risk managers to finally conclude which value is the more appropriate to cover the presence of mepiquat residue levels in cultivated fungi.

Studies investigating the nature of mepiquat residues under standard hydrolysis conditions were assessed during the peer review and showed the active substance to be hydrolytically stable. Processing studies on mushrooms have not been submitted and are not required.

The residues of mepiquat in rotational crops and livestock are not of relevance for the current assessment of mepiquat in cultivated fungi.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the estimation of the chronic consumer exposure, EFSA used the median residue as derived from the monitoring data on mushrooms. For the remaining commodities of plant and animal origin, the existing MRLs or the risk assessment values, where available, were used as input values. For the acute exposure calculation, the highest derived MRL proposal was used as an input value.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated chronic intake accounted for up to 13% of the ADI (WHO Cluster B). The contribution of residues in cultivated fungi to the total consumer exposure accounted for less than 0.1% of the ADI (IE adult).

No acute consumer risk was identified in relation to the MRL proposal for cultivated fungi (0.3% of the ARfD).

EFSA concludes that the highest MRL estimate of 0.09 mg/kg of mepiquat in cultivated fungi will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health. 

Keywords
mepiquat, cultivated fungi, MRL application, consumer risk assessment
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Number of Pages
25