Panel members at the time of adoption
Nivalenol is a mycotoxin produced by various Fusarium species. The European Commission (EC) asked the European Food Safety Authority (EFSA) for a scientific opinion on the risk to human and animal health related to the presence of nivalenol in food and feed. A total of 13 164 results for nivalenol in food, feed and unprocessed grains, collected in 2001-2011 from 18 European countries, were available for the evaluation. The highest mean concentrations for nivalenol were observed in oats, maize, barley and wheat and products thereof. Grains and grain-based foods, in particular bread and rolls, grain milling products, pasta, fine bakery wares and breakfast cereals, made the largest contribution to nivalenol exposure for humans. Animal exposure to nivalenol is primarily from consuming cereal grains and cereal by-products. The available information on the toxicokinetics of nivalenol is incomplete. Evidence exists for metabolic de-epoxidation in some species. Based on the data available, the Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that the overall weight of evidence is that nivalenol is unlikely to be genotoxic. Toxic effects of nivalenol include immunotoxicity and haematotoxicity. A reduction in white blood cell (WBC) counts in a 90-day rat study was identified as the critical effect for human risk assessment. Using these data and a benchmark dose analysis the CONTAM Panel established a tolerable daily intake (TDI) of 1.2 µg/kg b.w. per day. All chronic human dietary exposures to nivalenol estimated, based on the available occurrence data in food, are below the TDI, and are therefore not a health concern. No toxicity data were identified for ruminants, rabbits, fish and companion animals but lowest-observed-adverse-effect levels were identified in pigs and poultry. Based on estimates of exposure the risk of adverse health effects of feed containing nivalenol is low for both these species.