Scientific Opinion on risk based control of biogenic amine formation in fermented foods

Biogenic amines, histamine, tyramine, fermented food, formation, criteria
First published in the EFSA Journal
11 October 2011
21 September 2011
Scientific Opinion


A qualitative risk assessment of biogenic amines (BA) in fermented foods was conducted, using data from the scientific literature, as well as from European Union-related surveys, reports and consumption data. Histamine and tyramine are considered as the most toxic and food safety relevant, and fermented foods are of particular BA concern due to associated intensive microbial activity and potential for BA formation. Based on mean content in foods and consumer exposure data, fermented food categories were ranked in respect to histamine and tyramine, but presently available information was insufficient to conduct quantitative risk assessment of BA, individually and in combination(s). Regarding BA risk mitigation options, particularly relevant are hygienic measures to minimize the occurrence of BA-producing microorganisms in raw material, additional microbial controls and use of BA-nonproducing starter cultures. Based on limited published information, no adverse health effects were observed after exposure to following BA levels in food (per person per meal): a) 50 mg histamine for healthy individuals, but below detectable limits for those with histamine intolerance; b) 600 mg tyramine for healthy individuals not taking monoamino oxidase inhibitor (MAOI) drugs, but 50 mg for those taking third generation MAOI drugs or 6 mg for those taking classical MAOI drugs; and c) for putrescine and cadaverine, the information was insufficient in that respect. Presently, only high-performance liquid chromatography (HPLC)-based methods enable simultaneous and high sensitivity quantification of all BA in foods, hence are best suited for monitoring and control purposes. Monitoring of BA concentrations in fermented foods during the production process and along the food chain would be beneficial for controls and further knowledge. Further research on BA in fermented foods is needed; particularly on toxicity and associated concentrations, production process-based control measures, further process hygiene and/or food safety criteria development, and validation of analysis methods.

Panel members at the time of adoption

John Daniel Collins, Birgit Noerrung, Herbert Budka, Olivier Andreoletti, Sava Buncic, John Griffin, Tine Hald, Arie Havelaar, James Hope, Günter Klein, Kostas Koutsoumanis, James McLauchlin, Christine Müller-Graf, Christophe Nguyen-The, Luisa Peixe, Miguel Prieto Maradona, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm and Emmanuel Vanopdenbosch
Panel on Biological Hazards
biohaz [at]
EFSA Journal 2011;9(10):2393
Question Number
On request from