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

Published:
Adopted:
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Wiley Online Library

Meta data

DOI
https://doi.org/10.2903/j.efsa.2022.7449
Keywords
novel food, β‐hydroxybutyrate, calcium, magnesium, sodium, chemical synthesis, food supplements
On request from
European Commission
Question Number
EFSA‐Q‐2018‐00343
Panels
Nutrition, Novel Foods and Food Allergens
Panel members at the time of adoption
Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti.

Abstract

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.

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