Scientific Opinion on Rooster Combs Extract

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 ‘Rooster Combs Extract’ (RCE) 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. Rooster combs extract results from a production process involving enzymatic hydrolysis of rooster combs and subsequent filtration, concentration and precipitation steps. The principle constituents of RCE are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate. The applicant intends to add RCE to a number of dairy products with a recommended maximum intake of 80 mg RCE per portion and per day. The target population is the general population, with the exception of pregnant women, children and people with adverse reactions to sodium hyaluronate and/or avian protein. In the high intake scenario for “consumers only”, the highest daily intake would occur in adults in Belgium (0.788 g). The highest intake scenario for “all subjects” was estimated for adolescents in Denmark (0.427 g/day). The Panel notes that no adverse effects were observed at the highest tested dose of 600 mg/kg bw per day in a 90-day oral toxicity study in rats. Considering the nature, the natural occurrence and previous consumption of RCE constituents, the Panel is of the opinion that the margin between the intended as well as the estimated maximum possible intake of RCE in relation to the highest dose administered to rats without adverse effects in a subchronic oral toxicity study is sufficient. The Panel concludes that the novel food ingredient, Rooster Comb Extract, is safe under the proposed uses and use levels.