Title :

Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283

Author(s) :

Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Castenmiller, J. [Auteur]
European Food Safety Authority [EFSA]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [Auteur]
Kearney, J. [Auteur]
Maciuk, A. [Auteur]
Mangelsdorf, I. [Auteur]
Mcardle, H. J. [Auteur]
Naska, A. [Auteur]
Pelaez, C. [Auteur]
Pentieva, K. [Auteur]
Siani, A. [Auteur]
Thies, F. [Auteur]
Tsabouri, S. [Auteur]
Vinceti, M. [Auteur]
Cubadda, F. [Auteur]
Frenzel, T. [Auteur]
Heinonen, M. [Auteur]
Marchelli, R. [Auteur]
Neuhauser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Maradona, M. P. [Auteur]
Schlatter, J. R. [Auteur]
Van Loveren, H. [Auteur]
Dumas, C. [Auteur]
Roldan-Torres, R. [Auteur]
Steinkellner, H. [Auteur]
Knutsen, H. K. [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J.

Volume number :

19

Pages :

-

Publication date :

2021-07-21

ISSN :

1831-4732

English keyword(s) :

Novel Foods
calcidiol monohydrate
food supplement
safety
bioavailability
vitamin D

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on the safety of calcidiol monohydrate as anovel food (NF) pursuant to ...
Show more >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on the safety of calcidiol monohydrate as anovel food (NF) pursuant to Regulation (EU) 2015/2283, including its bioavailability as a metabolite ofvitamin D3when added for nutritional purposes to food supplements. The NF is produced chemically.It is proposed in food supplements up to 10lg/day for individuals≥11 years of age, includingpregnant and lactating women and up to 5lg/day in 3- to 10-year-old children. The productionprocess, composition, specifications and stability of the NF do not raise safety concerns. Animal andhuman data indicate efficient absorption. The NF contains a fraction of nanoparticles, which are fatsoluble and unlikely to reach systemic distribution. There are no concerns regarding genotoxicity.Human adult studies do not raise safety concerns. Combined intake estimates of calcidiol from the NFand calcidiol and vitamin D from the diet were below the tolerable upper intake level (UL) for vitaminD for subjects above 11 years of age. The achieved mean serum 25(OH)D concentration in adultssupplemented with 10lg NF per day remained below 200 nmol/L. The Panel concludes that the NF issafe under the proposed conditions of use and use levels for individuals≥11 years old, includingpregnant and lactating women. The applicant did not provide data on the bioavailability and safety ofthe NF in children. The combined intake estimation in children (3–10 years) is close to the UL forvitamin D. Therefore, the Panel could not conclude on the safety of consumption of the NF in children(3–10 years) at the proposed daily intake. The NF is a bioavailable source of the biologically activemetabolite of vitamin D, i.e. 1,25-dihydroxyvitamin DShow less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-12T06:28:05Z
2024-02-28T10:58:25Z