Title :

Safety of a botanical extract derived from panax notoginseng and astragalus membranaceus (astragin (tm)) 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, Jacqueline [Auteur]
European Food Safety Authority [EFSA]
De Henauw, Stefaan [Auteur]
Hirsch-Ernst, Karen Ildico [Auteur]
Kearney, John [Auteur]
Maciuk, Alexandre [Auteur]
Mangelsdorf, Inge [Auteur]
Mcardle, Harry J. [Auteur]
Naska, Androniki [Auteur]
Pelaez, Carmen [Auteur]
Pentieva, Kristina [Auteur]
Siani, Alfonso [Auteur]
Thies, Frank [Auteur]
Tsabouri, Sophia [Auteur]
Vinceti, Marco [Auteur]
Cubadda, Francesco [Auteur]
Engel, Karl-Heinz [Auteur]
Frenzel, Thomas [Auteur]
Heinonen, Marina [Auteur]
Marchelli, Rosangela [Auteur]
Neuhauser-Berthold, Monika [Auteur]
Poulsen, Morten [Auteur]
Schlatter, Josef Rudolf [Auteur]
van Loveren, Henk [Auteur]
Ackerl, Reinhard [Auteur]
Knutsen, Helle Katrine [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J.

Volume number :

18

Publication date :

2020-05-01

ISSN :

1831-4732

Keyword(s) :

novel food
extract
Panax notoginseng
Astragalus propinquus
Astragalus membranaceus
safety

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 a scientific opinion on a botanical extract derived from bothPanax notoginsengandAstragalus ...
Show more >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver a scientific opinion on a botanical extract derived from bothPanax notoginsengandAstragalus membranaceus(AstraGinTM) as a novel food (NF) pursuant toRegulation (EU) 2015/2283. The NF is a combination of an ethanol extract of the roots ofA. membranaceusand a hot water extract of the roots ofP. notoginseng. The NF contains 1.5–5%total saponins, 0.1–0.5% ginsenoside Rb1 and 0.01–0.1% astragaloside I. Both plants that are used toproduce the NF have a long history of use, especially in traditional Chinese medicine. Information onthe production process and the composition of the NF is sufficient and does not raise safety concerns.The applicant proposed to use the NF as a food supplement for the general adult population, excludingpregnant women, at a maximum daily amount of 350 mg. Taking into account these conditions of use,the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The providedgenotoxicity studies do not raise concerns for genotoxicity of the NF. Based on thefindings of asubchronic toxicity study, supported by a subacute toxicity study, the Panel identified the overall noobserved adverse effect level (NOAEL) of the NF at 100 mg/kg body weight (bw) per day. By applyingan uncertainty factor of 200, the Panel concludes that the NF is safe at an intake level of 0.5 mg/kgbw per day, corresponding to a maximum daily intake of 35 mg of the NF for the target population,i.e. adults excluding pregnant women.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Inserm
Université de Lille

Collections :

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

Submission date :

2021-07-06T12:47:16Z
2024-03-28T10:56:26Z