Safety of β-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Miguel Prieto Maradona, Rosangela MarchelliMonika Neuhäuser-Berthold, Morten Poulsen, Josef Rudolf Schlatter, Henk van Loveren, Océane Albert, Tilemachos Goumperis, Helle Katrine Knutsen, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

Research output: Contribution to journalArticlepeer-review


Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on β-hydroxybutyrate (BHB) salts as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of sodium, magnesium and calcium BHB salts, and is proposed to be used by adults as a food ingredient in a number of food categories and as food supplement. The data provided by the applicant about the identity, the production process and the compositional data of the NF over the course of the risk assessment period were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the test item used in the subchronic toxicity study and human studies provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.

Original languageEnglish
Article numbere07449
Number of pages11
JournalEFSA Journal
Issue number10
Early online date13 Oct 2022
Publication statusPublished - 13 Oct 2022


  • novel food
  • β-hydroxybutyrate
  • calcium
  • magnesium
  • sodium
  • chemical synthesis
  • food supplements


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