RT info:eu-repo/semantics/article T1 Safety of Beta‐lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283 A1 Turck, Dominique A1 Bohn, Torsten A1 Castenmiller, Jacqueline A1 De Henauw, Stefaan A1 Hirsch‐Ernst, Karen Ildico A1 Maciuk, Alexandre A1 Mangelsdorf, Inge A1 McArdle, Harry J A1 Naska, Androniki A1 Peláez, Carmen A1 Pentieva, Kristina A1 Siani, Alfonso A1 Thies, Frank A1 Tsabouri, Sophia A1 Vinceti, Marco A1 Cubadda, Francesco A1 Frenzel, Thomas A1 Heinonen, Marina A1 Marchelli, Rosangela A1 Neuhäuser‐Berthold, Monika A1 Poulsen, Morten A1 Prieto Maradona, Miguel A1 Schlatter, Josef Rudolf A1 van Loveren, Henk A1 Fernández Dumont, Antonio A1 Noriega Fernández, Estefanía A1 Knutsen, Helle Katrine A2 Nutricion y Bromatologia K1 Tecnología de los alimentos K1 Beta-lactoglobulin K1 Novel food K1 Whey protein isolate K1 3206 Ciencias de la Nutrición K1 3309 Tecnología de Los Alimentos AB [EN] 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 beta-lactoglobulin (BLG) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF (≥ 90% w/w dry matter protein) consists of BLG as primary component (≥ 90% of total protein), which is equivalent to BLG present in bovine milk and whey protein isolate (WPI). The NF is produced from bovine whey by crystallisation under acidic or neutral conditions. The NF is proposed to be used as a food ingredient in isotonic and sport drinks, whey powder and milk-based drinks and similar products, and in food for special medical purposes as defined in Regulation (EU) No 609/2013. The target population is the general population. The highest daily intake of the NF was estimated for children of 3 to < 10 years of age as 667 mg/kg body weight (bw) per day. The NF presents proximate composition and content of essential amino acids similar to those in WPI. The Panel notes that the highest mean and highest 95th percentile daily protein intakes from the NF are below the protein population reference intakes for all population groups. Although a tolerable upper intake level has not been derived for protein, the protein intake from the NF may nevertheless further contribute to an already high dietary protein intake in Europe. The exposure to the reported minerals does not raise concerns. The Panel considers that the consumption of the NF is not nutritionally disadvantageous. No genotoxic concerns were identified from the standard in vitro test battery. No adverse effects were observed in the subchronic toxicity study, up to the highest dose tested, i.e. 1,000 mg NF/kg bw per day. The Panel concludes that the NF is safe under the proposed conditions of use. PB Wiley Open Access SN 1831-4732 LK https://hdl.handle.net/10612/20485 UL https://hdl.handle.net/10612/20485 NO Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Peláez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., et al. (2022). Safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 20(4), Article e7204. https://doi.org/10.2903/J.EFSA.2022.7204 DS BULERIA. Repositorio Institucional de la Universidad de León RD Jul 6, 2024