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European Regulatory Framework and Safety Assessment of Food-Related Bioactive Compounds

European Union

Apr 01, 2020

A great variety of functional foods, nutraceuticals, or foods with bioactive compounds are
provided nowadays to consumers. Aware of the importance of the safety aspects, the food industry
has to comply with different legal requirements around the world. In this review, the European
regulatory framework for food-related bioactive compounds is summarized. The term bioactive
compound is not defined in the European regulations, however, since they can be part of food
supplements, fortified foods, or novel food, they are included within the legal requirements of those
corresponding types of foods or supplements. Lists of authorized compounds/foods appear in the
correspondent regulations, however, when a new compound/food is going to be launched into the
market, its safety assessment is essential. Although the responsibility for the safety of these
compounds/foods lies with the food business operator placing the product on the market, the
European Food Safety Authority (EFSA) carries out scientific evaluations to assess the risks for
human health. To facilitate this procedure, different guidelines exist at the European level to explain
the tier toxicity testing approach to be considered. This approach divides the evaluation into four
areas: (a) toxicokinetics; (b) genotoxicity; (c) subchronic and chronic toxicity and carcinogenicity;
and (d) reproductive and developmental toxicity.


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