Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283

摘要

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies ( ) was asked to deliver an opinion on whey basic protein isolate as a novel food ( ) pursuant to Regulation ( ) 2015/2283. The is obtained by ion exchange chromatography of skimmed cow's milk. The applicant intends to market the in infant and follow‐on formulae and meal replacement beverages, dietary foods for special medical purposes and as food supplements. The highest estimated intake of the based on the proposed uses and use levels would be 24.8 mg/kg body weight (bw) per day in infants and 27.8 in toddlers. The information provided on composition, specifications, production process and stability of the do not raise safety concerns. Taking into account the composition of the and the intended use levels, the Panel considers that the consumption of the is not nutritionally disadvantageous. The Panel considers that there is no concern with respect to genotoxicity. The no observed adverse effect level ( ) of a subchronic 13‐week rat study was 2000 mg/kg bw per day. Considering the source, the production process and nature of the , the Panel considers the margin of exposure ( ) of 154 to be sufficient for the adult population (on a high‐estimated intake of 13 mg/kg bw). For infants and toddlers, the would be at least 81 and 72, respectively. Taking into account the composition of the , its source, the history of consumption of the main components of the , the production process and that the in a subchronic rat study was the highest dose tested the Panel considers that also the for infants and toddlers are sufficient. The Panel concludes that the novel food ingredient, whey basic protein isolate, is safe under the proposed uses and use levels.