Scientific Opinion on Chloramphenicol in food and feed

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Article
Panel on Contaminants in the Food Chain
EFSA Journal
EFSA Journal 2014;12(11):3907 [145 pp.].
doi
10.2903/j.efsa.2014.3907
Panel members at the time of adoption
Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael DiNovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Anne-Katrine Lundebye, Manfred Metzler, Antonio Mutti (from 6 October 2014), Carlo Stefano Nebbia, Michael O’Keeffe, Annette Petersen (from 6 October 2014), Ivonne Rietjens (until 2 May 2014), Dieter Schrenk, Vittorio Silano (until 15 July 2014), Hendrik van Loveren, Christiane Vleminckx, and Pieter Wester.
Acknowledgements

The Panel wishes to thank the members of the Standing Working Group on non-allowed pharmacologically active substances in food and feed and their reference points for action: Bitte Aspenström-Fagerlund, Metka Filipič (from 18 September 2014), Peter Fürst, Laurentius (Ron) Hoogenboom, Anne-Katrine Lundebye, Marcel Mengelers (from 8 August 2014), Carlo Stefano Nebbia, Michael O’Keeffe, Ivonne Rietjens (until 2 May 2014), Vittorio Silano (until 22 July 2014), Rolaf Van Leeuwen and Pieter Wester for the preparatory work on this scientific opinion, and the hearing experts: Noël Dierick, Klaus-Dieter Jany and Noel Joseph, and EFSA staff Davide Arcella, Katleen Baert, Gina Cioacata, Athanasios Gkrillas, Sofia Ioannidou and Hans Steinkellner for the support provided to this scientific opinion. The CONTAM Panel acknowledges all European competent institutions that provided occurrence data on chloramphenicol in food and feed, and supported the data collection for the Comprehensive European Food Consumption Database.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2013-00925
Adopted
5 November 2014
Published in the EFSA Journal
26 November 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Chloramphenicol is an antibiotic not authorised for use in food-producing animals in the European Union (EU). However, being produced by soil bacteria, it may occur in plants. The European Commission asked EFSA for a scientific opinion on the risks to human and animal health related to the presence of chloramphenicol in food and feed and whether a reference point for action (RPA) of 0.3 μg/kg is adequate to protect public and animal health. Data on occurrence of chloramphenicol in food extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF) were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which chloramphenicol is present at 0.3 μg/kg in all foods of animal origin, foods containing enzyme preparations and foods which may be contaminated naturally. The mean chronic dietary exposure for this worst-case scenario would range from 11 to 17 and 2.2 to 4.0 ng/kg b.w. per day for toddlers and adults, respectively. The potential dietary exposure of livestock to chloramphenicol was estimated to be below 1 μg/kg b.w. per day. Chloramphenicol is implicated in the generation of aplastic anaemia in humans and causes reproductive/hepatotoxic effects in animals. Margins of exposure for these effects were calculated at 2.7 ✕ 105 or greater and the CONTAM Panel concluded that it is unlikely that exposure to food contaminated with chloramphenicol at or below 0.3 μg/kg is a health concern for aplastic anaemia or reproductive/hepatotoxic effects. Chloramphenicol exhibits genotoxicity but, owing to the lack of data, the risk of carcinogenicity cannot be assessed. The CONTAM Panel concluded that, when applied to feed, the current RPA is also sufficiently protective for animal health and for public health, arising from residues in animal derived products.

Keywords
chloramphenicol, food, feed, reference point for action, aplastic anaemia, natural occurrence, risk assessment
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Number of Pages
145