Safety of nonapeptide-pentapeptide mixture as a novel food pursuant to regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on a nonapeptide-pentapeptide mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture composed of a 1:1 combination of nonapeptide and pentapeptide. These two peptides are independently produced by solid-phase chemical synthesis and have a defined amino acid sequence. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The NF is proposed to be used as a food supplement intended for adults, excluding pregnant and lactating women, at a maximum dose of 30 mg NF/day. Effects on the liver were observed in the two subchronic toxicity studies performed in rats and dogs. The lowest no observed adverse effect level (NOAEL) was identified in a 90-day study in dogs (40 mg NF/kg body weight (bw) per day). Applying the standard uncertainty factor of 200, the resulting safe dose is 0.2 mg/kg bw per day. This corresponds to a safe level of 14 mg NF/day for 70-kg adults. Regarding the human intervention study provided by the applicant, uncertainties related to whether or not the test substance used corresponds to the NF do not allow to draw conclusions regarding the safety of the NF. The Panel concludes that the NF is safe when consumed at intake levels up to 14 mg NF/day by adults, excluding pregnant and lactating women.