EU reverses novel food decision on healthy aging ingredient SAMe

Under EU rules, an ingredient requires novel food authorization if it was not consumed to a significant degree in the EU before May 15, 1997, with the original assessment of SAMe concluding there was insufficient evidence of historical consumption of this specific salt form.

However, the status of SAMe disulfate tosylate has now been reassessed following an Article 4 consultation submitted to the Lithuanian authorities, deeming it non-novel.

“This evaluation is really interesting because initially, the opinion was negative and Lithuania proposed firstly to consider this ingredient as novel,” explained Jerome Le Bloch, PhD, head of scientific affairs at FoodChain ID. “However, thanks to feedback from the industry and some authorities, mainly Italy, the decision has been changed, and SAMe remains usable in food supplements.

“This is not so common to have this kind of decision, with an EU Member State challenging the decision from another Member State.”

SAMe disulfate tosylate benefits and uses

SAMe is made naturally by the body from the amino acid methionine and ATP, supporting essential biochemical processes involved in DNA regulation, cell membrane function and neurotransmitter metabolism. It also contributes to glutathione synthesis, helping protect cells against oxidative stress.

SAMe disulfate tosylate is a stabilized form of SAMe, commonly used by manufacturers in food supplements because it helps address SAMe’s chemical instability, making it more suitable for tablet and capsule formulations.

Supplements containing SAMe are primarily marketed to support mood, joint health and liver function.

SAMe EU novel food status timeline

In February 2016, Italy officially stated that it considered SAMe disulfate tosylate to be an established ingredient in food supplements, rather than a novel food, and subsequently provided technical and historical documents to support this position.

Although most commercial documents dated from after May 15, 1997, they helped to explain how earlier references to SAMe might relate to this more stable form.

After reviewing the evidence and considering the views of other EU Member States, a meeting was held on Sept. 17, 2026. Lithuania reconsidered its original assessment and concluded that SAMe disulfate tosylate is not novel when used in food supplements.

The decision changed because the evidence supporting its history of use improved, Le Bloch explained, with Italy playing a central role in advocating for a non-novel classification.

“Italy has been the key factor in this evaluation,” he said. “This is not the first time. Another example is Maqui berries (Aristotelia chilensis), which have also been considered not novel in supplements thanks to Italian data.”

Market impact

Le Bloch noted that the decision provides regulatory clarity for companies developing food supplements containing SAMe disulfate tosylate, confirming that the ingredient can be used in food supplements without novel food authorization, subject to other requirements.

Companies must still comply with national legislation, however, including daily intake limits of 200 mg in Croatia and 250 mg in Italy.

While the clarified status could encourage more SAMe-based supplements to enter the EU market in the coming months, the overall market impact may be limited as the ingredient was already legally available. Instead, the change is likely to benefit companies that had previously heald back on launching SAMe products due to regulatory uncertainty.

EU decisions and the UK Market

The conclusion applies across all 27 EU Member States and may also be relevant in other markets, such as Switzerland, Le Bloch noted.

The UK does not automatically recognize EU-level novel food assessments, therefore the change in the regulaotry status of SAMe disulfate tosylate may not apply directly to the UK market. Companies seeking to market supplements containing the ingredient in the UK may therefore need to determine its status under the relevant UK regulatory framework.

“Technically, this decision does not apply in UK,” Le Bloch said. “However, I would not be surprised by an informal recognition of this decision by the UK’s Food Standards Agency (FSA); that means a tolerance and no questions on this ingredient in the UK until the validation of the SPS agreement.”

Potential knock-on impact

As Le Bloch noted, the reassessment could set a precedent for other ingredients classified as novel foods, although its impact is more likely to be felt in the form of continued discrepancies in how Member States interpret and apply regulatory requirements.

“For example, mung bean proteins have been considered novel due to a three-fold enrichment in proteins, while lentil protein, with a 2.5-4-fold enrichment, is not novel,” he said. “Another example is that iron-enriched Saccharomyces cerevisiae [brewer’s yeast] or silicon-enriched spirulina are novel foods, while mineral-enriched Aspergillus oryzae [kōji mold] is not novel, even if the process —enrichment of the growth media—is similar.”

He emphasized that authorities can only reassess these classifications following the submission of a new Article 4 consultation.

Although Article 4 is necessary to clarify regulatory status, a lack of transparency and consistency can leave established ingredients vulnerable to challenges that disrupt market access and distort competition.

Luca Bucchini, managing director of Hylobates Consulting, recently called for greater transparency and centralized decision-making under the European Commission to ensure consistency and fairness.

“One wants to make sure [a novel food application] is necessary—the substance really is novel and requires an application whereas competitors with similar substances are also held to the same standard,” he said.