Review of the existing maximum residue levels (MRLs) for mepiquat according to Article 12 of Regulation (EC) No 396/2005


European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(8):4214 [35 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
17 August 2015
24 August 2015
European Food Safety Authority (EFSA), Parma, Italy
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According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance

mepiquat . In order to assess the occurrence of mepiquat residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. 

Mepiquat was included in Annex I to Directive 91/414/EEC on 1 March 2009 by Commission Directive 2008/108/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked United Kingdom, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 21 January 2015 and finalised on 17 March 2015. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 20 April 2015.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS and Member States, EFSA prepared in June 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 9 July 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The metabolism of mepiquat has been investigated in three different crop groups as well as in rotational crops. The only relevant compound found in these studies was mepiquat. The metabolic pattern depicted in rotational crops was found to be more extensive than in primary crops but, as no relevant residues were found in the succeeding crops, a specific residue definition was not deemed necessary. Hydrolysis studies demonstrated that mepiquat is stable under processing by pasteurisation, baking/brewing/boiling and sterilisation. Therefore, a general residue definition for both monitoring and risk assessment in all plant commodities was proposed as the sum of mepiquat and its salts, expressed as mepiquat chloride. A validated analytical method for this residue definition in all commodities of plant origin is available.

The available residue trials allowed EFSA assessing the magnitude of residues resulting from the authorised GAPs reported in this review. MRL proposals as well as risk assessment values were derived for all commodities under evaluation, except for linseed and sunflower seed. For rape seed, where additional trials are still required for the most critical GAPs, only a tentative MRL is derived. In addition, studies investigating the magnitude of residues in processed commodities of rapeseed and cereals allowed EFSA to derive robust processing factors for enforcement and risk assessment in crude oil, refined oil, meal/press cake, brewing malt, beer, pot/pearl, bran, whole-meal flour, whole-meal bread and white flour.

Mepiquat is authorised for use in oilseeds and cereals which might be fed to livestock. The metabolism of mepiquat was investigated in lactating goats and laying hens. As metabolic pathways are expected to be similar in ruminants and pigs, the results of the goat metabolism study could be extrapolated to swine. From these studies, EFSA proposed a general residue definition for monitoring of livestock commodities as the sum of mepiquat and its salts, expressed as mepiquat chloride. A validated analytical method for enforcement of the proposed residue definition in commodities of animal origin is available. For risk assessment, the residue definition was set as the sum of mepiquat, 4‑hydroxy‑mepiquat and their salts, expressed as mepiquat chloride. EFSA was able to derive a conversion factor for monitoring to risk assessment in ruminant liver (1.7) but it was not deemed necessary in all other animal commodities. Based on the ruminant feeding study, MRLs and risk assessment values were derived in ruminants and swine products. For poultry products, the metabolism study was sufficient to conclude that MRLs and risk assessment values could be established at the limit of quantification (LOQ).

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure represented 6.6% of the acceptable daily intake (ADI) (WHO Cluster diet B) and the highest acute exposure amounted to 10.3% of the acute reference dose ARfD (sunflower seed).

mepiquat, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, quaternary ammonium compound, plant growth regulator, mepiquat chloride
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