First company to receive authorization to market this pure synthetic micronutrient in the European Union
First company to receive authorization to market this pure synthetic micronutrient in the European Union
Ergoneine also has GRAS designation in the US
Paris, France, March 5, 2019 – Tetrahedron, a research and innovation company specialized in developing innovative ingredients for the nutraceutical, pharmaceutical and personal care industries, today announces that the European Commission has given ‘Novel Food’ status to, and approved the launch of, Tetrahedron’s pure nature-identical L-ergothioneine (brand name Ergoneine™) for the general population. Tetrahedron is the first company in Europe to receive such authorization to supply L-ergothioneine for incorporation into nutritional products for European consumers.
The ‘Novel Food’ designation refers to food that before May 15, 1997, had not been consumed to a significant degree by humans in the EU, when the first regulation on novel food came into force. ‘Novel Food’ can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU.
In January 2015 Ergoneine also gained GRAS (Generally Recognized As Safe) designation for this micronutrient.
Numerous studies have shown that L-ergothioneine can protect human cells and tissues from pro-inflammatory conditions that lead to oxidative damage. Micronutrient deficiencies may increase the risk of developing age-related disorders, including immune dysfunction, cognitive decline, skin photo-ageing and vision deterioration. The development of these disorders is correlated with a mild pro-inflammatory state, which is induced by chronic exposure to stress factors such as UV radiation, pathogens and pollutants, and in which oxidative stress plays a major role. Oxidative stress in combination with micronutrient deficiency results in the loss of functional and structural integrity of cells. In this regard, balancing the diet with L-ergothioneine may contribute to cell protection against oxidative stress for healthy aging.
Following the EC official publication, Tetrahedron is now the only company authorized to sell a highly pure and safe source of GMP-level synthetic L-ergothioneine for incorporation into a wide range of nutritional products on the European market. The company has already started to market the ingredient to the functional food and nutraceutical industries. It is now looking for industrial customers to include this unique micronutrient in their dietary supplements.
“We are very excited to bring this new source of L-ergothioneine to the market,” said Jean-Claude Yadan, Ph.D., president of Tetrahedron and recognized world expert on L-ergothioneine. “Over 100 years of research has shown the potential health benefits of L-ergothioneine. Until now, that potential has gone unrealized due to the unavailability of L-ergothioneine at a cost and quality that make it fully marketable. Our new Ergoneine ingredient, now authorized as ‘Novel Food’, will fulfill the unmet need for this unique antioxidant L-ergothioneine in human health nutrition.”
L-ergothioneine is produced in nature only by microorganisms and fungi, and naturally absorbed by humans through their diet. The main sources are mushrooms, black and red beans, oat bran, garlic and certain meat products (liver and kidney). The human genome includes a genetic code for a specific transporter of L-ergothioneine, allowing the absorption of this nutrient into all essential tissues (liver, kidney, heart, skin, lung, intestine, central nervous system etc). For several reasons, including the depleted soil in ergothioneine-producing microorganisms, or certain cooking conditions, the human diet can potentially lack this micronutrient. In such cases, as a supplement, L-ergothioneine contributes to a more balanced diet.
About Tetrahedron
Tetrahedron SAS, based in Paris, France, is a privately held company and has been a leading innovator in nature-inspired ingredients for the nutraceutical, pharmaceutical and cosmetics industries since 2003. The company was founded by Jean-Claude Yadan, PhD, Irene Erdelmeier, PhD and Marc Moutet, PhD.
Tetrahedron’s mission is to help maintain or restore a healthy life by developing unique active ingredients for various applications. The management team has over 25 years combined experience in designing and managing R&D in cosmetics, diagnostics, nutrition and therapeutics, especially in the research and development of new active compounds and patents. Its expertise lies at the interface of chemistry and biology, in free radical biology, enzymology, sulphur and selenium chemistry, as well as in the development of sustainable processes.
www.tetrahedron.fr
