Whey basic protein isolate safe for use in infant nutrition, EFSA rules

01 Aug 2018 --- Whey basic protein isolate is safe for use in infant and follow‐on formula and meal replacement beverages, dietary foods for special medical purposes and as food supplements, the European Food Safety Authority (EFSA) has concluded. The application for EFSA’s scientific opinion was submitted by French dairy ingedients company Armor Protéines. 

EFSA was asked to deliver an opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Whey basic protein isolate is obtained by ion exchange chromatography of skimmed cow's milk. Taking into account the composition of the NF and the intended use levels, the panel considers that the consumption of the NF is not nutritionally disadvantageous. 

The highest estimated intake of the NF based on Armor Protéines’ 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 NF do not raise safety concerns, EFSA reports. 

The panel considers that there is no concern with respect to genotoxicity. The no observed adverse effect level (NOAEL) of a subchronic 13‐week rat study was 2000 mg/kg bw per day. 

Considering the source, the production process and nature of the NF, the panel reports it considers the margin of exposure (MOE) of 154 to be sufficient for the adult population (on a high‐estimated intake of 13 mg/kg bw). For infants and toddlers, the MOE would be at least 81 and 72, respectively. 

Taking into account the composition of the NF, its source, the history of consumption of the main components of the NF, the production process and that the NOAEL in a subchronic rat study was the highest dose tested the panel considers that also the MOE for infants and toddlers are sufficient.