EFSA Establishes Safe Intake Level for Nonapeptide–Pentapeptide Mixture as a Novel Food in food supplements

The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) assessed the safety of a nonapeptide–pentapeptide mixture submitted as a novel food under Regulation (EU) 2015/2283. The novel food consists of a 1:1 combination of two chemically synthesized peptides with defined amino acid sequences and is intended for use in food supplements for adults, excluding pregnant and lactating women. While the production process, composition, and specifications did not raise safety concerns, sub chronic toxicity studies in rats and dogs identified effects on the liver, with the lowest NOAEL established at 40 mg/kg body weight per day in dogs.
Based on the toxicological data and application of an uncertainty factor of 200, EFSA determined a safe intake level of 14 mg/day for a 70-kg adult. Due to uncertainties regarding the identity of the test substance used in the human intervention study, the study could not be used to support safety conclusions. EFSA concluded that the novel food is safe for adults at intake levels up to 14 mg/day.