Writing in the EFSA journal, the Authority’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) deems the botanical extract AstraGin as safe at 0.5 milligrams per kilogram (mg/kg bw) bodyweight per day.
This value corresponds to a maximum daily intake of 35 mg of this Novel Food (NF) for adults excluding pregnant women.
AstraGin is a botanical extract of Panax notoginseng and Astragalus membranaceus roots standardised to contain a minimum of 1.5% total saponins, 0.01% astragaloside I, and 0.1% ginsenoside Rb1.
Its makers NuLiv Sciences market the product as a proprietary food and dietary ingredient that enhances the absorption of nutrients such as amino acids and folate, among others in the intestinal lumen.
In 2012, the Californian-based firm received GRAS approval for AstraGin with a Natural Product Number (NPN) granted by Health Canada in 2017 to expand the ingredient into the Canadian Market.
In another ruling the Panel also considers that the dried whole cell of the Euglena gracilis, is safe up to the highest dose tested - 3,300 mg/kg bw, which the Panel considers as the no-observed-adverse-effect-level (NOAEL) of the study.
The values correspond to the general population, except for food supplements and for foods for total diet replacement. Here, the target is the general population from 12 months of age onwards.
Here, the applicant Kemin Foods, proposes the ingredient be used as a food supplement, in foods for total diet replacement for weight control and as a food ingredient in a number of foods.
"EFSA conducted an extremely rigorous evaluation of the safety data on BetaVia Complete, and this tremendous achievement demonstrates the strength of the novel food dossier Kemin Human Nutrition and Health submitted to EFSA," says Pedro Vieira, vice president – Europe and Latin America, Kemin Human Nutrition and Health.
"We are extremely excited to receive EFSA's positive opinion for our ingredient, BetaVia Complete, as Europe is a key market in terms of growth for both BetaVia and Kemin Human Nutrition and Health."
The NF is essentially the dried biomass of the microalga Euglena gracilis, that is produced by fermentation of which its major constituent (over 50%) is a β‐glucan polysaccharide.
Further nutritional analysis of the NF foud that along with the high content of β‐1,3‐glucan the NF contains protein (about 20%), fat (about 8%), ash (about 4%) and moisture (about 4%)
The applicant also provided information on sugar profiles and concentrations of vitamins (C, E, D2, D3, K) and minerals, fatty acids, carotenoids and amino acids.
The Panel considers that taking into account the composition of the NF and the proposed conditions of use the consumption of the NF is not ‘nutritionally disadvantageous.’
"With increasing consumer demand for products that offer immune support, we are very excited to be one step closer to making BetaVia Complete available to European consumers who seek solutions to live a healthier life," adds Miguel Martinho, marketing manager for Europe, Kemin Human Nutrition and Health.