Following an application submitted by Arla Foods Ingredient Group, EFSA has published a scientific opinion on the safety of beta-lactoglobulin as novel food. The ingredient contains at least 90% of protein on dry matter basis, and is equivalent to the beta-lactoglobulin present in milk and whey protein isolate.
The applicant requested the use of the novel food in isotonic and sport drinks (25 g/100 g), whey powder and milk-based drinks and similar products (8-12 g/100 g), and in food for special medical purposes (in accordance with the specific requirements of the target population). The application provided a full analysis of 5 batches of the products, and EFSA did not raise any safety concern associated with this composition.
The safety of the novel food has been substantiated by the required toxicity studies: a bacterial reverse mutation test, one in vitro mammalian micronucleus test in human lymphocytes, a 14-day oral toxicity study and a 90-day oral toxicity study. These studies demonstrated the safety of the novel food. EFSA only notes the risk of allergic reaction in subjects with known allergy to milk and dairy products.
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ,Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, HeinonenM, Marchelli R, Neuhauser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Fernandez Dumont A, Noriega Fernandez E and Knutsen HK, 2022. Scientific Opinion on the safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022;20(4):7204.