Ethyl carbamate and hydrocyanic acid in food and beverages Scientific Opinion of the Panel on Contaminants

Ethyl carbamate occurs naturally in fermented foods and alcoholic beverages such as bread, soy sauce, yoghurt, wine, beer, and spirits, particularly in stone-fruit brandies. A number of precursors present in food and beverages such as hydrocyanic acid, urea and ethanol can lead to the formation of ethyl carbamate during food processing and storage. Ethyl carbamate is genotoxic and a multisite carcinogen in animals and probably carcinogenic in man. The European Commission asked the CONTAM Panel for a scientific opinion on the risks to human health related to the presence of ethyl carbamate and hydrocyanic acid in food and alcoholic beverages, in particular stone-fruit brandies. In response, EFSA in late September 2006 issued a call for submission of data on levels of ethyl carbamate and hydrocyanic acid in food and beverages. Seven EU Member States, the Liquor Control Board of Ontario and the Wine Institute of California responded to EFSA's call for data on ethyl carbamate and submitted results covering analyses from 1998 to 2006. Three Member States submitted data on hydrocyanic acid in alcoholic beverages. Only very few food (excluding alcoholic beverages) results for ethyl carbamate were reported to EFSA and of the results 41% were below the limit of detection. In the 2005 the Joint FAO/WHO Expert Committee on Food Additives (JECFA) review it was concluded that food products in general would contribute less than 1 mu g/person per day and this figure was used in exposure assessment calculations. In contrast to the few food results, EFSA received over 33,000 testing results of alcoholic beverages. For almost 93% of the beer samples, 42% of the wine samples, but fewer than 15% of the spirit samples, the results were below the limit of detection. Median levels of ethyl carbamate in alcoholic beverages of up to 5 mu g/L for beer and wine, 21 mu g/L for spirits other than fruit brandy and 260 mu g/L for fruit brandy were calculated. From these data, a dietary exposure of 17 ng/kg b.w. per day3 was estimated from food for an average 60 kg person who does not consume alcohol, whereas this would increase up to 65 ng/kg b.w. for consumers of a variety of different alcoholic beverages. The highest exposure to ethyl carbamate can be expected for persons exclusively consuming fruit brandy with exposure at a 95th percentile consumption level of 558 ng/kg b.w. per day. The estimated dietary exposure to hydrocyanic acid was about 1.6 mu g/kg b.w. per day for a 60 kg person. The main contributor to hydrocyanic acid exposure in average consumers was food products, with alcoholic beverages contributing only minor amounts. At the 95th percentile consumption level of fruit brandy and the 95th percentile concentration level for hydrocyanic acid a peak dietary exposure of 24 mu g/kg b.w. per day would be possible, which is undesirable. A risk characterisation was performed using the Margin of Exposure (MOE) approach comparing a BMDL104 derived from animal cancer data with scenarios for exposure to ethyl carbamate. A value of 10,000 and above was considered to be of low concern for public health. The MOEs were calculated using the estimated intake of ethyl carbamate at the median levels in alcoholic beverages and the BMDL10 value of 0.3 mg/kg b.w per day (10% incidence of alveolar and bronchiolar neoplasms in male and female mice). The Panel concluded that the MOE of almost 18,000 calculated for exposure to ethyl carbamate in food excluding alcoholic beverages indicates a low concern for human health. However, the MOE was in the region of 5,000 for food consumed together with a variety of alcoholic beverages, and for high consumers of fruit brandy the MOE was less than 600. Based on these MOEs the Panel concluded that ethyl carbamate in alcoholic beverages indicates a health concern, particularly with respect to stone fruit brandies. The Panel noted that for consumers of particular brands of stone fruit brandy, with higher than average levels of ethyl carbamate, the MOEs could be even lower. Mitigation measures should be taken to reduce the levels of ethyl carbamate in certain alcoholic beverages such as fruit brandies. Such measures should include focus on hydrocyanic acid and other precursors of ethyl carbamate to prevent the formation of ethyl carbamate during shelf-life of these products.