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

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Dominique Turck, Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Marco VincetiPeter Willatts, Karl–Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Josef Rudolf Schlatter, Mathias Amundsen, Henk van Loveren

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)
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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.

Original languageEnglish
Article numbere05360
Pages (from-to)1-18
Number of pages18
JournalEFSA Journal
Issue number7
Publication statusPublished - Jul 2018


  • basic whey protein isolate
  • ingredient
  • novel food
  • safety

ASJC Scopus subject areas

  • Food Science
  • veterinary (miscalleneous)
  • Animal Science and Zoology
  • Microbiology
  • Parasitology
  • Plant Science


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