Title :

Safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to Regulation (EU) 2015/2283.

Author(s) :

Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bohn, T. [Auteur]
Castenmiller, J. [Auteur]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [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]
Maradona, M. P. [Auteur]
Marchelli, R. [Auteur]
Neuhäuser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Schlatter, J. R. [Auteur]
Albert, O. [Auteur]
Matijević, L. [Auteur]
Knutsen, H. K. [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J

Volume number :

20

Pages :

e07611

Publication date :

2022-11-18

ISSN :

1831-4732

English keyword(s) :

aqueous ethanolic extract of Labisia pumila
novel food
safety
food supplement

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 and Food Allergens (NDA) was asked to deliver an opinion on aqueous extract of Labisia pumila as a novel food (NF) pursuant to ...
Show more >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 aqueous extract of Labisia pumila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a standardised hydroalcoholic extract from a dried whole plant (including roots) of L. pumila, mixed with maltodextrin (as a drying aid), and proposed by the applicant to be used as a food supplement in amounts up to 750 mg/day. The target population is the general adult population, except pregnant and lactating women. The major constituents of this NF are carbohydrates (up to 85.5%), with a smaller amount of proteins (up to 6.5%), gallic acid (up to 3.7%) and fats (up to 1.6%). The Panel considers that taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. The provided genotoxicity studies do not raise concerns about the genotoxicity of the NF. Based on the available toxicological data, the Panel considers an intake of up to 5 mg/kg body weight per day as safe. For the target population, this level corresponds to 350 mg/day, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population up to 350 mg/day.Show 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 :

2024-01-12T00:03:57Z
2024-03-22T10:36:20Z