Safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood 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 asprimary component (≥90% of total protein), which is equivalent to BLG present in bovine milk andwhey protein isolate (WPI). The NF is produced from bovine whey by crystallisation under acidic orneutral 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 asdefined in Regulation (EU) No 609/2013. The target population is the general population. The highestdaily 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 tothose in WPI. The Panel notes that the highest mean and highest 95th percentile daily protein intakesfrom the NF are below the protein population reference intakes for all population groups. Although atolerable upper intake level has not been derived for protein, the protein intake from the NF maynevertheless further contribute to an already high dietary protein intake in Europe. The exposure tothe reported minerals does not raise concerns. The Panel considers that the consumption of the NF isnot nutritionally disadvantageous. No genotoxic concerns were identified from the standardin vitrotest battery. No adverse effects were observed in the subchronic toxicity study, up to the highest dosetested, i.e. 1,000 mg NF/kg bw per day. The Panel concludes that the NF is safe under the proposedconditions of use.
Domaines
Sciences du Vivant [q-bio]
Fichier principal
EFSA Journal - 2022 - - Safety of Beta‐lactoglobulin as a Novel food pursuant to Regulation EU 2015 2283.pdf (2.52 Mo)
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