Scientific Opinion on nitrofurans and their metabolites in food

Abstract

Nitrofurans are antimicrobial agents not authorised for use in food-producing animals in the European Union. Nitrofurans are rapidly metabolised, occurring in animal tissues as protein-bound metabolites. The European Commission requested EFSA to provide a scientific opinion on the risks to human health related to the presence of nitrofurans in food and whether a reference point for action (RPA) of 1.0 µg/kg for the marker metabolites is adequate to protect public health. Data on occurrence of nitrofuran marker metabolites in food were extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF). The CONTAM Panel concluded that these data were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which a single nitrofuran marker metabolite is present at 1.0 µg/kg in foods of animal origin, excluding milk and dairy products. The mean chronic dietary exposure for this worst-case scenario would range from 3.3 to 8.0 and 1.9 to 4.3 ng/kg b.w. per day for toddlers and adults, respectively. Nitrofurans and their marker metabolites, generally, are genotoxic and carcinogenic and, also, have non-neoplastic effects in animals. Margins of exposure (MOEs) were calculated at 2.0 × 10 5 or greater for carcinogenicity and at 2.5 × 10 3 or greater for non-neoplastic effects. The CONTAM Panel concluded that it is unlikely that exposure to food contaminated with nitrofuran marker metabolites at or below 1.0 µg/kg is a health concern. A scenario in which foods are considered to be contaminated with semicarbazide, from use of carrageenan as a food additive, at 1 µg/kg was used to assess whether it is appropriate to apply the RPA to foods of non-animal origin; MOEs of greater than 10 4 calculated for nonneoplastic effects do not indicate a health concern.© European Food Safety Authority, 2015 However, the opinion also identified certain categories of non-allowed pharmacologically active substances that are considered to be outside the scope of the procedure, including substances that are high potency carcinogens, such as nitrofurans. As nitrofurans are excluded from that opinion, and taking into account that the presence of SEM in food may be from sources other than use of nitrofurazone, the European Commission (EC) requested the European Food Safety Authority (EFSA) for a scientific opinion on the risks to human health related to the presence of nitrofurans and their metabolites in food. The opinion should include (a) an evaluation of the toxicity of nitrofurans and their metabolites for humans, considering all relevant toxicological endpoints and identification of the toxicological relevance of nitrofurans and their metabolites present in food, and (b) an exposure assessment of the EU population to nitrofurans and their metabolites from food, including the consumption patterns of specific (vulnerable) groups of the population. In addition, the opinion should assess the appropriateness of...

Evaluation of public and animal health risks in case of a delayed post‐mortem inspection in ungulates

“…furazolidone, furaltadone, nitrofurantoin, nitrofurazone and nifursol) are broadspectrum antibiotics that are not authorised for use in food-producing animals in the EU. EFSA assessed the risk related to the presence of nitrofurans and their metabolites in food in 2015 (EFSA CONTAM Panel, 2015). The current assessment is based on that opinion.…”

Development of Antibodies and Immunoassays for Monitoring of Nitrofuran Antibiotics in the Food Chain

“…Major advances in rapid and robust "green chemistry" sample preparation methods are required to enable portable multiplex detection platforms suitable for novice ends users outside the laboratory and to improve sample turnaround times at inspection points. (v) There have recently been calls for a modern toxicological risk assessment of nitrofurans in food to be carried out [2] and, in particular, a comprehensive carcinogenicity study of SEM [3]. (vi) There remains a need to identify an alternative to SEM as the marker residue for nitrofurazone abuse due to potential other sources of SEM in food.…”

“…They were used previously in livestock production for prevention and treatment of gastrointestinal infections and as growth promoters. Current evidence of the health risks posed by nitrofuran residues in our food has been thoroughly assessed in a recent Scientific Opinion published by the European Food Safety Authority [3]. EU Member States are required to test for the presence of nitrofurans in foodstuffs as part of their National Residues Monitoring Schemes and 3 rd countries exporting relevant foods to the EU are required to implement analogous control systems.…”

Synthesis and retention properties of molecularly imprinted polymers for antibiotics containing a 5-nitrofuran ring

“…6 European Food Safety Agency (EFSA), has recently provided a scientic opinion on the risks to human health related to the presence of nitrofurans in food by taking 1.0 mg kg À1 as possible concentration in which a single nitrofuran marker metabolite is present in foods of animal origin due to insufficient data from monitoring. 7 An indication of the continuous violations is provided by the European Rapid Alert System for Food and Feed (RASFF) 8 online database that contains more than 800 notications since 2002. 7 The interest in researching the accumulation of these drugs or their metabolites in different animal tissues as well as on the analytical methods for their identication and determination is still actual concern.…”

“…7 An indication of the continuous violations is provided by the European Rapid Alert System for Food and Feed (RASFF) 8 online database that contains more than 800 notications since 2002. 7 The interest in researching the accumulation of these drugs or their metabolites in different animal tissues as well as on the analytical methods for their identication and determination is still actual concern. 9,10 Comparative new studies focused on the interaction of some nitrofuran antibiotics with bovine serum albumin by means of uorescence and FT-IR spectroscopy, circular dichroism, atomic force microscopy and molecular docking investigation showed that the conformation of bovine serum albumin can be changed and unfolded in the presence of nitrofurans.…”