Gnosis by Lesaffre submitted the application with the aim of launching its branded SAG, marketed at Emothion, on the European market.
Astrid Douchin, brand manager of Emothion, said subsequent authorization from the European Commission would unlock a validated, high-efficacy tool for the pursuit of cellular longevity.
“EU authorization would be a transformative regulatory milestone, not just for Emothion, but for the entire European glutathione category,” she said. “It would create the first fully compliant, novel food-authorized S-acetyl glutathione in the EU. This instantly establishes a new, premium segment within the cellular health and longevity market.”
What is S-acetyl glutathione and what are its potential supplement applications?
Glutathione is an antioxidant which is naturally made by the body. It consists of three amino acids—glutamate, cysteine and glycine—and helps to protect cells from damage, fight free radicals and eliminate toxins from the liver.
While glutathione has long been available on the European market due to its non-novel food status, SAG is a chemically modified derivative and therefore considered novel.
Douchin said the key differentiator between glutathione and SAG is the addition of an acetyl group, a small chemical building block.
“This modification acts as a protective shuttle, allowing the glutathione molecule to resist degradation in the digestive tract,” she said. “In contrast, standard reduced glutathione (GSH) is largely broken down into its constituent amino acids during digestion, with only a fraction available for the body.”
Gnosis’ Emothion is a patent-protected form of SAG. Research published by the company shows that Emothion enables the direct intracellular delivery of the active glutathione molecule, providing enhanced bioavailability. The research also showed that SAG substantially increases plasma glutathione levels compared to standard reduced glutathione, and this increase is sustained over time.
With the delivery mechanism validated, Douchin said that Gnosis is currently pursuing investigations into the ingredient’s health benefits.
“Gnosis is actively investing in targeted clinical research to explore specific health endpoints,” she said. “We have advanced studies underway in the realm of ‘cellular beauty’ and skin health.”
EFSA’s proposed conditions of use
When evaluating the safety of SAG, the panel used liver weight as a benchmark to calculate safe intakes for human consumption. This is because a 90-day study in rats showed very high doses of SAG caused an increase in liver weight relative to overall body weight.
However, these changes were not accompanied by tissue damage or cellular abnormalities under microscopic examination, nor were there any harmful changes in blood markers of liver function.
EFSA therefore used a 200-fold safety buffer to establish a safe maximum dose, concluding that SAG is safe at the proposed conditions of use of 300 mg/day for adults, excluding pregnant and lactating women.
For children and adolescents, the proposed conditions of use are different. EFSA recommends a safe intake level of 190 mg/day for young adolescents and 269 mg/day for older adolescents. Douchin described the outcome as “positive and expected.”
“EFSA’s approach establishes clear, science-based guidelines for all populations, which is fundamental for responsible innovation,” she said. “Crucially, for our partners, this has no impact on the adult market. Emothion is specifically developed for healthy adults, and our pharmacokinetic research and comprehensive safety data fully support our recommended dosage. For brands and formulators, dosage will depend on their marketing strategies, but we remain focused on developing effective products for adults.”
