Produced naturally by the body from the amino acid methionine and ATP, SAMe plays a role in DNA regulation, cell membrane function and neurotransmitter metabolism and is marketed as supplement to support mood, joint health and liver function. SAMe disulfate tosylate is a stabilized form, commonly used to address SAMe’s chemical instability, making it better suited to tablet and capsule formulations.
Until recently, SAMe was classified as a novel food because under EU rules, ingredients that were not consumed to a significant degree in the EU before May 15, 1997 are generally classified as novel foods and require authorization before being placed on the market.
Applying this criterion to an Article 4 consultation request submitted in Lithuania earlier this year, the European Commission published the decision that there was insufficient evidence of SAMe disulfate tosylate specifically as a food or food supplement in the EU before the cut-off date.
In September, however, EU Member States met to revisit the ingredient’s status, taking into account an earlier Italian assessment from 2016, prompting a reclassification of the ingredient as “not novel in food supplements.”
“This evaluation is really interesting because initially, the opinion was negative, and Lithuania proposed firstly to consider this ingredient as novel,” said Jerome Le Bloch, PhD, head of scientific affairs at food safety and quality solutions firm 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.”
The conclusion applies across all 27 EU Member States and may also be relevant in other markets.
Clarifying earlier evidence
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be an established ingredient in food supplements, rather than a novel food—a determination supported by technical and historical documents.
Although most of evidence of commercial use dated from after May 15, 1997, it helped clarify how earlier references to SAMe might relate to the more stable disulfate tosylate form.
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.”
He 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 held back on launching SAMe products due to regulatory uncertainty.
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 the interpretation and application of 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-to-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, as was the case with SAMe disulfate tosylate.
While Article 4 provides a mechanism for clarifying regulatory status, a lack of transparency and consistency in how classifications are applied can leave established ingredients open to regulatory challenges, potentially disrupting market access and distorting 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.