Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus (AstraGin (TM)) as a novel food pursuant to Regulation (EU) 2015/2283

Show full item record



Permalink

http://hdl.handle.net/10138/325754

Citation

EFSA Panel Nutr Novel Foods Food , Turck , D & Heinonen , M 2020 , ' Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus (AstraGin (TM)) as a novel food pursuant to Regulation (EU) 2015/2283 ' , EFSA Journal , vol. 18 , no. 5 , 6099 . https://doi.org/10.2903/j.efsa.2020.6099

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: EFSA Panel Nutr Novel Foods Food; Turck, Dominique; Heinonen, Marina
Other contributor: University of Helsinki, Department of Food and Nutrition


Date: 2020-05
Language: eng
Number of pages: 16
Belongs to series: EFSA Journal
ISSN: 2314-9396
DOI: https://doi.org/10.2903/j.efsa.2020.6099
URI: http://hdl.handle.net/10138/325754
Abstract: Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on a botanical extract derived from both Panax notoginseng and Astragalus membranaceus (AstraGin (TM)) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a combination of an ethanol extract of the roots of A. membranaceus and a hot water extract of the roots of P 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 to produce the NF have a long history of use, especially in traditional Chinese medicine. Information on the 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, excluding pregnant 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 provided genotoxicity studies do not raise concerns for genotoxicity of the NF. Based on the findings of a subchronic toxicity study, supported by a subacute toxicity study, the Panel identified the overall no observed adverse effect level (NOAEL) of the NF at 100 mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the Panel concludes that the NF is safe at an intake level of 0.5 mg/kg bw per day, corresponding to a maximum daily intake of 35 mg of the NF for the target population, i.e. adults excluding pregnant women. (C) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Subject: Panax notoginseng
Astragalus membranaceus
Astragalus propinquus
extract
novel food
safety
SYSTEMIC-LUPUS-ERYTHEMATOSUS
L-CANAVANINE
T-CELLS
PHYTOCHEMISTRY
PHARMACOLOGY
416 Food Science
Rights:


Files in this item

Total number of downloads: Loading...

Files Size Format View
j.efsa.2020.6099.pdf 1.674Mb PDF View/Open

This item appears in the following Collection(s)

Show full item record