The European Commission updates the Novel Food Catalogue: 8 new ingredients under regulatory review

The European Commission has recently added eight new entries to the Novel Food Catalogue , an update that may have a direct impact on the development and marketing of food supplements in the European Union.

Although the Novel Food Catalogue is not legally binding, it is a key reference tool for interpreting the application of Regulation (EU) 2015/2283 on novel foods. Therefore, any changes to this catalogue must be carefully analyzed from a regulatory perspective.

La Comisión Europea actualiza el Catálogo Novel Food: 8 nuevos ingredientes bajo revisión regulatoria

Which ingredients have been updated?

Among the new entries, two different regulatory situations stand out:

Isolated substances classified as Novel Food

Three plant-based compounds have been identified as Novel Foods , which means they require prior authorization before being marketed in the EU:

• Apigenin (isolated, for example, from chamomile)

• Cycloastragenol (derived from the root of astragalus)

• Pterostilbene (present in certain plant species)

The key here is not the traditional use of the plant itself, but the fact that these are isolated and concentrated substances , for which there is insufficient evidence of significant consumption before May 15, 1997 (the cut-off date established by European regulations).

In these cases, marketing in food supplements will require the submission and approval of a Novel Food authorization dossier , including toxicological and safety data.

Botanicals with "non-novel" status limited to food supplements

Five plant species have been classified as non-Novel Food for their specific use in food supplements , but not necessarily for other food categories (e.g., infusions or conventional foods).

This distinction is especially relevant from a regulatory point of view: an ingredient may be acceptable in supplements, but not in other food formats.

Relevant case: confirmation of the status of Chelidonium majus

The update also reaffirms that Chelidonium majus (greater celandine), a plant that has been under scrutiny for potential liver risks, maintains its status as a Novel Food not authorized in food supplements.

This confirms that its use is still not permitted in the EU under the current framework.

The European regulatory environment for food supplements continues to evolve, particularly regarding concentrated botanicals and phytochemicals. Anticipating these changes is key to avoiding trade barriers or subsequent product recalls.