Scientific Opinion on the safety of 'Sardine Peptide Product'

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 "Sardine Peptide Product" Valtyron (R) as a food ingredient in the context of Regulation (EC) No 258/97. The "Sardine Peptide Product" is a peptide mixture obtained by an alkaline protease-catalysed hydrolysis of the muscle of sardine (Sardinops sagax) and by chromatographic separation of the desired fraction. The applicant provided sufficient information regarding the production, the composition, the stability, and the estimated intake of the "Sardine Peptide Product". According to the information provided, several products containing sardine peptides are currently on the market in Japan as supplements. "Sardine Peptide Product" is proposed for use in milk and dairy products, soups, stews and soup powders, beverages and breakfast cereals. The maximum intake of "Sardine Peptide Product" proposed by the applicant is 0.6 g/serving. The daily intake based on a conservative estimate, was calculated to occur in male teenagers with a mean of 0.89 g/person and 2.4 g/person for the 97.5th percentile. The animal studies did not provide reasons for concern, but were of limited value in assuring the safety of "Sardine Peptide Product". The Panel has no concerns related to genotoxicity. It is considered that a large portion of the "Sardine Peptide Product" would be hydrolysed in the small intestine to the individual constituent amino acids prior to absorption and only a small fraction would be available for systemic uptake. No adverse effects were observed in human studies. The Panel concludes that the "Sardine Peptide Product" is safe as a food ingredient at the proposed conditions of use and the proposed intake levels.