Scientific Opinion on the safety of a ‘fermented black bean extract (Touchi extract)’ as a Novel Food ingredient

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for "fermented black bean extract (Touchi extract)" as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections of a scientific nature raised by Member States. Touchi extract is obtained by hot water extraction of small soybeans (Glycine max) fermented with Aspergillus oryzae. Hot water extraction of 15 g of fermented black beans yields 4.5 g of Touchi extract. The Panel considers that data on the composition, production process and stability do not raise concerns. The applicant intends to market Touchi extract in food supplements to adults and proposes one dose of 0.3 g Touchi extract to be consumed with every meal of the day. The applicant anticipates an average intake of 0.9 -1.2 g Touchi extract per day and proposes a maximum intake level of 4.5 g per day. The applicant provided data that indicate that the typical serving size of traditional fermented black bean products contains approximately 15 g of fermented black beans. The documentation on the safety of Touchi extract is based mainly on the history of the source of the novel food, on the significant human consumption of traditional fermented black bean products in and outside of Europe, data on the production process and on the compositional similarity between fermented black beans and Touchi extract. Toxicological and clinical data provide limited evidence for the safety of Touchi extract and do not raise concerns. The Panel concludes that the "fermented black bean extract (Touchi extract)" is safe at the proposed conditions of use.