News

EFSA delivers positive verdict on whey basic protein

2 Aug 2018

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that whey basic protein isolate is safe.

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283.

The NF is obtained by ion exchange chromatography of skimmed cow's milk. The applicant intends to market the NF 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 NF 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 NF did not raise safety concerns.

Taking into account the composition of the NF and the intended use levels, the Panel considered that the consumption of the NF was not nutritionally disadvantageous. The Panel considered that there was 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 considered 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 considered that also the MOE for infants and toddlers are sufficient.

The Panel concluded that the novel food ingredient, whey basic protein isolate, is safe under the proposed uses and use levels.