Scientific Opinion on Chloramphenicol in food and feed


chloramphenicol, food, feed, reference point for action, aplastic anaemia, natural occurrence, risk assessment
First published in the EFSA Journal
26 November 2014
5 November 2014
Opinion of the Scientific Committee/Scientific Panel

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.

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.
Panel on Contaminants in the Food Chain
EFSA Journal 2014;12(11):3907 [145 pp.].
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