On May 14, 2026, following an inquiry initiated by Lithuania, European authorities officially determined that SAMe disulfate tosylate falls within the scope of the EU Novel Food Regulation and is therefore classified as a Novel Food.
As a natural substance found in our bodies, SAMe (S-adenosyl-methionine) is widely known and heavily used in food supplements. However, in its pure form, it is very “fragile.” To ensure chemical stability and long shelf life, manufacturers convert it into a more stable salt form known as SAMe disulfate tosylate.
SAMe works mainly as the body’s universal methyl donor: it donates methyl groups to many molecules involved in DNA and histone methylation, neurotransmitter metabolism, phospholipid synthesis, and other cellular processes. As the body’s primary methyl donor, SAMe supports healthy serotonergic and dopaminergic functions, which contribute to emotional well-being, motivation, focus, and overall cognitive performance.
So, what’s the problem? In Europe, there is a very strict rule designed to protect consumers: if an ingredient was not regularly consumed as food or as a supplement before May 15, 1997, it gets labelled as a “Novel Food.” An ingredient with this status must first pass lengthy and expensive safety tests to get authorized for selling.
Koncentra, proven by one preliminary and one clinical study, has shown, even in low dosage, similar effects to SAMe’s mechanism of action, delivering significant positive impacts on sustained energy levels, improved mood and boosted cognition, focus and memory.
Moreover, Koncentra can be freely sold on the European market as it is a compound of botanical extracts compliant with European regulations, allowing manufacturers to implement it in several market products, such as food supplements, nutraceuticals and food & bavarage items.
In conclusion, if SAMe poses a problem for industries, Koncentra is the solution for all companies caring for functional, well-being, innovative ingredients.
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