EFSA novel food considerations for fermented Sceletium

Sceletium tortuosum — Kanna, in its traditional South African use — has reached a level of commercial visibility in the European supplement and functional-product market that triggers the EU novel food framework. The fermented form of Sceletium that underpins the commercial premium tier is the form working through the regulatory pathway. This note sets out the framework, the dossier components, and where the current state of play sits.

Why novel food applies

Regulation (EU) 2015/2283 defines as a novel food any food or food ingredient that was not used for human consumption to a significant degree within the Union before 15 May 1997. Fermented Sceletium meets that definition for the European market: while traditional South African use of unfermented Sceletium is well-documented, fermented preparations at the commercial volume and form now reaching the EU market do not have a significant pre-1997 EU consumption history.

The practical effect is that fermented Sceletium intended for sale as a food ingredient or food supplement in the EU requires either a novel food authorisation or, in some circumstances, a traditional food from a third country notification under the alternative pathway. The authorisation route is the more substantive of the two and the one that the commercial supply chain is currently working.

The dossier components

The novel food authorisation dossier covers identity and characterisation, production process, compositional data, proposed uses and use levels, history of use, anticipated dietary intake, nutritional information, toxicological data, and allergenicity. For a fermented botanical ingredient, the toxicological dossier is typically the most substantial single component: it is expected to cover acute toxicity, repeat-dose toxicity (typically 90-day), genotoxicity (Ames and an in-vitro mammalian assay at minimum), and, depending on use levels and target population, additional studies.

The history-of-use section carries particular weight for traditional botanicals. Documented traditional use in the species' native range — supported by published ethnobotanical, anthropological, and historical sources — informs the toxicological-design choices and the anticipated safety margin. For Sceletium, the South African traditional-use record is the foundation of this section.

The compositional dossier — full chemotype characterisation, mesembrine and related alkaloid quantification, residual-fermentation-marker characterisation, and contaminant profile — is where the analytical discipline of the supplier becomes visible. Suppliers operating with multi-marker chemotype documentation, validated analytical methods, and the partner laboratory matrix described elsewhere are positioned to produce this section credibly. Suppliers operating with thinner analytical infrastructure are not.

The gating considerations

The EFSA Panel on Nutrition, Novel Foods and Food Allergens reviews the dossier and produces a scientific opinion. The Panel's working questions on a fermented botanical ingredient are predictable: is the identity and characterisation sufficient to ensure that the material assessed in the toxicology is the material that will be commercialised, are the toxicological studies adequate for the proposed intake levels, is the proposed labelling sufficient to inform consumers of relevant restrictions or contraindications, and does the dossier address vulnerable subgroups appropriately.

For Sceletium specifically, the additional gating consideration is the mesembrine-and-related-alkaloid profile and its pharmacological framing. Mesembrine acts on the serotonergic system at relevant doses; the EFSA Panel's question on this point is whether the proposed use levels and labelling are adequate to manage the interaction risk, particularly co-administration with SSRIs and related medications. The answer requires both the compositional data and the proposed labelling to be aligned.

Where the timeline sits

The published EFSA scientific opinion on fermented Sceletium is the gate to authorisation. As of early 2026, the Panel has issued opinions on related botanical ingredients on similar timelines: dossier submission to scientific opinion typically runs eighteen to thirty months, depending on data adequacy and the volume of clarification requests. The opinion is followed by Commission authorisation, which is procedural rather than substantive once the opinion is favourable.

Suppliers and brands working with fermented Sceletium for the EU market should anticipate continued operation under the existing framework — sale as a traditional food from a third country where eligible, or use within member states under transitional provisions where applicable — until the authorisation route resolves. The compositional discipline, the toxicological-data alignment, and the labelling framing during the transitional period are visible to the Panel and inform the eventual opinion.

What this means for buyers

For ingredient buyers approaching fermented Sceletium for the EU market, the working questions to the supplier are whether the supplier's material is the material being assessed under the active dossier, whether the supplier's compositional documentation aligns with the dossier framework, and whether the supplier is operationally positioned to maintain supply continuity under whatever the authorisation outcome is. Suppliers who can answer these questions cleanly are the ones who will be supplying the category through and beyond the regulatory resolution.