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

Abstract

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

Food Safety Assessment and Nutraceutical Outcomes of Dairy By-Products: Ovine Milk Whey as Wound Repair Enhancer on Injured Human Primary Gingival Fibroblasts

“…In 2017, the International Dairy Federation (IDF) partnered with Codex Alimentarius in the development, identification, elaboration, and dissemination of a science-based international standard. This standard aims to foster the clarity, composition, safety, and quality of powdered dairy permeates when used as ingredients in food [ 37 ]. Then, in 2020, the Panel of the EFSA expressed a scientific opinion on whey basic protein isolate as a novel food ingredient obtained from bovine skimmed milk, concluding that the consumption of the bovine milk whey is not nutritionally disadvantageous and is safe when the composition is known and the proposed levels of use are taken into consideration [ 38 ].…”

Dairy, Plant, and Novel Proteins: Scientific and Technological Aspects

“…Once a novel food has been authorized, anyone can market food products that have the same specifications and use [63]. Dairy protein ingredients usually receive novel-food authorizations, such as whey protein isolates and bovine milk-derived casein hydrolysate [64][65][66]. In general, the global dairy protein market is growing.…”

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

“…According to the EFSA NDA Panel, NF derived from allergenic foods, including processing aids, listed in Annex II of Regulation (EU) No 1169/2011, 28 should be labeled, as they are assumed to retain the allergenicity potential of the source, regardless of the amounts of final protein content in the NF. This rationale was applied for the safety evaluation of shrimp peptide concentrate ( 34 ), spent grains from barley ( Hordeum vulgare ) and rice ( Oryza sativa ) ( 28 ), bovine milk basic whey protein isolate ( 37 ), and beta-lactoglobulin (BLG) ( 36 ). For example, the NDA Panel considered the egg membrane hydrolysate to be potentially allergenic due to its egg origin, despite the negative results when testing the hydrolysates in a radio-allergo-sorbent-inhibition assay and an in-vivo sensitization assay on guinea pigs ( 35 ).…”