Safety of synthetic l‐ergothioneine (Ergoneine®) as a novel food pursuant to Regulation (EC) No 258/97

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on synthetic l-ergothioneine, marketed as Ergoneine®, as a novel food submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The novel food, synthetic l-ergothioneine, is produced by a one-pot patented manufacturing process. Chemically, l-ergothioneine is a derivative of thiolhistidine, and it is naturally present in a number of foodstuffs such as mushrooms, some varieties of black and red beans, offal and cereals. The production process for the novel food is sufficiently described and does not raise concerns about the safety of the novel food. The information on the composition, specifications, batch-to-batch variability and stability of the novel food is sufficient and does not raise safety concerns. The applicant intends to use the novel food in quantities of up to 5 mg per serving in alcohol-free beverages, cereal bars, milk, fresh dairy products and chocolate. The applicant also proposes to provide the novel food as a food supplement, with a daily dose of up to 30 mg/day for adults and 20 mg/day for children. The target population is children above 3 years of age and the general adult population, except pregnant and breastfeeding women. Considering the NOAEL of 800 mg/kg bw per day, which was based on two subchronic toxicity studies in rats, and the maximum estimated intake levels for l-ergothioneine from all sources, the Panel concludes that the margins of safety of 470 for adults (except pregnant and breastfeeding women) and of 216 for children above 3 years of age are sufficient. The Panel concludes that the novel food, synthetic l-ergothioneine (marketed as Ergoneine®), is safe under the intended conditions of use as specified by the applicant.