Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The assessment of the safety of this NF, which follows the methodology set out in the EFSA Guidance on the preparation and presentation of an application for authorisation of a novel food Regulation (EU) 2015/2283 and in the Commission Implementing Regulation (EU) 2017/2469, is based on the data supplied in the application, the initial assessment by the competent authority of Ireland, the concerns and objections of a scientific nature raised by the other Member States and the responses of the applicant, the information submitted by the applicant following EFSA requests for supplementary information and additional data identified by the Panel.
The NF in subject of the application is a whey basic protein isolate, 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 NF is a mixture of basic whey proteins obtained by ion exchange chromatography from skimmed cow’s milk. The main constituents are bovine lactoferrin (bLF), lactoperoxidase (bLP) and transforming growth factor β2 (TGF β2), which share an amino acid sequence homology of approximately 70, 83 and 99%, respectively, with their analogues present in human milk. The highest estimated intake of the NF based on the proposed uses and use levels would be 24.8 mg/kg 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. 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 Panel considers that there is no concern with respect to genotoxicity of the NF. The no observed adverse effect level (NOAEL) of a subchronic 13‐week rat study was 2000 mg/kg bw per day (the highest dose tested). The human studies did not raise safety concerns.
Considering the source, the production process and the nature of the NF, the Panel 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.
The Panel concludes that the NF ingredient, whey basic protein isolate, is safe under the proposed uses and use levels.
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