Modification of the existing maximum residue levels for proquinazid in apples, pears and animal commodities

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(3):4428 [24 pp.].
doi
10.2903/j.efsa.2016.4428
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00813
Approved
7 March 2016
Published
17 March 2016
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 (EMS) Germany received an application from DuPont de Nemours (Deutschland) GmbH to modify the existing maximum residue levels (MRLs) for the active substance proquinazid in apples and pears. In order to accommodate for the intended uses, Germany proposed to raise the existing MRLs in apples and pears and to set MRLs in ruminant tissues and milk. According to EFSA the data are sufficient to derive a MRL proposal of 0.08 mg/kg in apples and pears. For animal products, EFSA derived two different sets of MRLs considering the residue definition for enforcement established in the conclusion of the peer review (option 1) and according to the EMS proposal, where the residue definition is limited to the metabolite IN-MU210 (option 2). EFSA proposes to risk managers to decide which option should be applied for the setting of MRLs in animal products. Adequate analytical enforcement methods are available to control the residues of proquinazid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of proquinazid on apples and pears will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany received an application from DuPont de Nemours (Deutschland) GmbH to modify the existing maximum residue levels (MRLs) for the active substance proquinazid in apples and pears. In order to accommodate for the intended use of proquinazid, Germany proposed to raise the MRL in apples and pears from the limit of quantification (LOQ) of 0.02 mg/kg to 0.06 mg/kg and to set MRLs in ruminant tissues and milk. Germany 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).

EFSA bases its assessment on the evaluation report, the draft assessment report (DAR) and its addendum prepared under Directive 91/414/EEC, the Commission review report, the conclusions on the peer review of the pesticide risk assessment and previous EFSA opinions on proquinazid.

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

The metabolism of proquinazid in primary crops was investigated under Directive 91/414/EEC in the fruit (grape) and cereals (wheat) crop groups following foliar applications. The residue definition for enforcement was established as proquinazid. For risk assessment the definition was proposed as ’sum proquinazid and metabolite IN-MW977 and its isomer expressed as proquinazid'’ and considering that IN-MW977 is not relevant for grape as observed in the metabolism study on cereal only. Since the absence of IN-MW977 was confirmed in an additional metabolism study on apples, EFSA concludes that for the fruit crop group, the residue definition for risk assessment can be limited to proquinazid only. For the use on pome fruits, EFSA concludes that the metabolism of proquinazid in primary crops is sufficiently addressed.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.08 mg/kg on apples and pears. Adequate analytical enforcement methods are available to monitor residues of proquinazid on pome fruits at the validated LOQ of 0.01 mg/kg.

The effect of processing on the nature of proquinazid residues was investigated in the framework of the peer review, which concluded that proquinazid is hydrolytically stable. Specific studies to assess the magnitude of residues during the processing were not provided and are not requested.

As the proposed use of proquinazid is on permanent crop, investigations of residues in rotational crops are not required.

Considering that proquinazid is the marker of the residues in poultry matrices while metabolite IN‑MU210 is the marker in ruminant matrices, the enforcement residue definition for animal commodities was proposed as ‘sum proquinazid and metabolite IN-MU210 expressed as proquinazid’ in the conclusion of the peer review. Based on the submitted cow feeding study, the EMS proposes to establish MRLs for ruminant products limited to the metabolite IN-MU210 only. Therefore, EFSA has derived two different sets of MRLs considering the two possible residue definitions and proposes to risk managers to decide which of these two options should be considered for the setting of MRLs in animal products.

The consumer risk assessment was performed with the revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). To calculate the chronic exposure, EFSA used median residue values (STMR) derived from the residue trials conducted on apples, the STMRs derived for animal products and the STMR values reported in a previous EFSA reasoned opinion. For the remaining commodities, the MRLs listed in the EU legislation were used as input values. The acute exposure assessment was performed only with regard to apples, pears and ruminant products.

The highest calculated chronic intake accounted for 14% of the ADI (Dutch child). An acute consumer risk was not identified in relation to the MRL proposals for apples, pears and animal products, the highest calculated acute intake being 2% of the ARfD for pome fruits.

EFSA concludes that the proposed uses of proquinazid on apples and pears will not result in a consumer exposure exceeding the toxicological reference values and are unlikely to pose a health risk to consumers.

Therefore, it is proposed to amend the MRLs as reported in the summary table below. For animal products, EFSA proposes to risks managers to decide which residue definition for enforcement should be applied to animal commodities, bearing in mind that a residue definition limited to the metabolite IN-MU210 (option 2), would be not appropriate to monitor residues in poultry products since this metabolite was not observed in the poultry metabolism.

Keywords
proquinazid, pome fruits, animal commodities, MRL application, consumer risk assessment
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Number of Pages
24