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 Marchelli; Monika 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)

doi:10.2903/j.efsa.2022.7449

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)

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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.

Original language	English
Article number	e07449
Journal	EFSA Journal
Volume	20
Issue number	10
DOIs	https://doi.org/10.2903/j.efsa.2022.7449
Publication status	Published - 13 Oct 2022

Keywords

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

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10.2903/j.efsa.2022.7449Licence: CC BY-ND

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Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Frenzel, T., Heinonen, M., Prieto Maradona, M., ... EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2022). Safety of β-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 20(10), Article e07449. https://doi.org/10.2903/j.efsa.2022.7449

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

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.",

keywords = "calcium, chemical synthesis, food supplements, magnesium, novel food, sodium, β-hydroxybutyrate",

author = "Dominique Turck and Torsten Bohn and Jacqueline Castenmiller and {De Henauw}, Stefaan and Hirsch-Ernst, {Karen Ildico} and Alexandre Maciuk and Inge Mangelsdorf and McArdle, {Harry J.} and Androniki Naska and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Francesco Cubadda and Thomas Frenzel and Marina Heinonen and {Prieto Maradona}, Miguel and Rosangela Marchelli and Monika Neuh{\"a}user-Berthold and Morten Poulsen and Schlatter, {Josef Rudolf} and {van Loveren}, Henk and Oc{\'e}ane Albert and Tilemachos Goumperis and Knutsen, {Helle Katrine} and {EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)}",

note = "Publisher Copyright: {\textcopyright} 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.",

year = "2022",

month = oct,

day = "13",

doi = "10.2903/j.efsa.2022.7449",

language = "English",

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Turck, D, Bohn, T, Castenmiller, J, De Henauw, S, Hirsch-Ernst, KI, Maciuk, A, Mangelsdorf, I, McArdle, HJ, Naska, A, Pelaez, C, Pentieva, K, Siani, A, Thies, F, Tsabouri, S, Vinceti, M, Cubadda, F, Frenzel, T, Heinonen, M, Prieto Maradona, M, Marchelli, R, Neuhäuser-Berthold, M, Poulsen, M, Schlatter, JR, van Loveren, H, Albert, O, Goumperis, T, Knutsen, HK & EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) 2022, 'Safety of β-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283', EFSA Journal, vol. 20, no. 10, e07449. https://doi.org/10.2903/j.efsa.2022.7449

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T1 - Safety of β-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283

AU - Turck, Dominique

AU - Bohn, Torsten

AU - Castenmiller, Jacqueline

AU - De Henauw, Stefaan

AU - Hirsch-Ernst, Karen Ildico

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Pelaez, Carmen

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Tsabouri, Sophia

AU - Vinceti, Marco

AU - Cubadda, Francesco

AU - Frenzel, Thomas

AU - Heinonen, Marina

AU - Prieto Maradona, Miguel

AU - Marchelli, Rosangela

AU - Neuhäuser-Berthold, Monika

AU - Poulsen, Morten

AU - Schlatter, Josef Rudolf

AU - van Loveren, Henk

AU - Albert, Océane

AU - Goumperis, Tilemachos

AU - Knutsen, Helle Katrine

AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

PY - 2022/10/13

Y1 - 2022/10/13

N2 - 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.

AB - 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.

KW - calcium

KW - chemical synthesis

KW - food supplements

KW - magnesium

KW - novel food

KW - sodium

KW - β-hydroxybutyrate

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UR - https://pubmed.ncbi.nlm.nih.gov/36254193

U2 - 10.2903/j.efsa.2022.7449

DO - 10.2903/j.efsa.2022.7449

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SN - 1831-4732

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JO - EFSA Journal

JF - EFSA Journal

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M1 - e07449

ER -

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

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