Reasoned opinion on setting of an MRL for copper compounds in wild game

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(10):3870 [15 pp.].
doi
10.2903/j.efsa.2014.3870
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2014-00394
Approved
3 October 2014
Published
9 October 2014
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, Germany, hereafter referred to as the evaluating Member State (EMS), compiled an application to set an MRL for copper compounds in wild game. Since the default MRL of 0.01 × mg/kg would not be sufficient to cover the natural background level of copper compounds in wild game, Germany proposed to set an MRL of 4 mg/kg. 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 EFSA. According to EFSA the data sufficient to derive an MRL proposal of 4 mg/kg for copper in order to cover the natural background levels of copper in wild game. Adequate analytical enforcement methods are available to control the residues of total copper on the wild game. Since the contribution of the proposed MRL to the total consumer exposure to copper is negligible (0.7 % of the ADI, IE adult), EFSA recommends the setting of an MRL of 4 mg/kg for copper compounds in wild game.

Summary

In accordance with Article 16 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), compiled an application to set an MRL for copper compounds in wild game. Since the default MRL of 0.01 × mg/kg would not be sufficient to cover the natural background level of copper compounds in wild game, Germany proposed to set an MRL of 4 mg/kg. 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 EFSA on 27 May 2014.

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC, the conclusions on the peer review of the pesticide risk assessment of the active substance copper compounds.

The toxicological profile of copper compounds was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.15 mg/kg bw per day. No ARfD was deemed necessary.

Since this application refers to the natural background levels of copper compounds in wild game, residues in primary crops, rotational crops and under processing were not investigated.

Since copper is an element not degraded or metabolized by animal it was concluded that the residue definition proposed during the peer review for plant as "total copper", is also applicable for animal origin products.

The data from the monitoring programme conducted on wild game in Germany in 2012 (mostly deer and stag meat), are sufficient to derive an MRL proposal of 4 mg/kg for copper in order to cover the natural background levels of copper in wild game. Adequate analytical enforcement methods are available to control the residues of total copper on the wild game at different LOQs ranged from 0.05 mg/kg to 1 mg/kg.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). Considering the MRL value of 4 mg/kg proposed for wild game and the existing MRLs set for copper in products of plant and animal origin, the Theoretical Maximum Daly Intake (TMDI) was calculated to be up to 351 % of the ADI (WHO cluster B). This TMDI should be considered as a large overestimate of the chronic consumer exposure to copper. A refined calculation to estimate the actual consumer exposure to copper compounds will be performed at a later stage, during the review of the existing MRLs under Article 12 of the Regulation (EC) No 396/2005, when all necessary information will be collected by EFSA.

Since the contribution of the proposed MRL to the total consumer exposure to copper is negligible (0.7 % of the ADI, IE adult), EFSA recommends the setting of the MRL of 4 mg/kg for copper compounds in wild game, in order to cover the natural background level of copper observed in the survey conducted in Germany in 2012.

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

Keywords
Copper compounds, wild game, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, fungicide, bactericide
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Number of Pages
15