The latest update to the EU Novel Food Catalog confirms that traditional preparations of Echinacea herbs and roots are considered non-novel when used in food supplements, providing greater regulatory clarity for industry.
The notable change in the update is the recognition of non-concentrated aqueous infusions, such as traditional teas, as non-novel foods. This means they can be used across food categories, including food supplements.
However, questions remain around the status of Echinacea flowers, whole-plant preparations and the species Echinacea pallida, according to Jerome Le Bloch, head of scientific affairs at FoodChain ID.
“The update raises questions regarding the regulatory status of flowers, which are not specifically covered in the Catalog entry,” Le Bloch said, adding that further questions remain over whole-plant preparations and the species Echinacea pallida.
Echinacea’s regulatory history
Echinacea is a group of flowering plants widely utilized in supplements to support immune health, with the most studied species being Echinacea purpurea, E. angustifolia and E. pallida.
Because there was evidence of consumption of Echinacea before the Novel Food Regulation came into force, regulators have traditionally considered Echinacea ingredients to be “non-novel”, although administration of regulations was not always a harmonized view across Member States.
In contrast, cell-culture extracts from E. angustifolia and E. purpurea are on the EU’s list of authorized novel foods.
Le Bloch noted the main change is the recognition of ‘non-concentrated aqueous infusions’ as non-novel.
He noted that Member States such as Germany and Austria have traditionally recognized the use of echinacea species in teas and tea-like products, and the new wording preserves these traditional uses.
However, Le Bloch noted that there could be a possible problem with the new wording, potentially making the rules ‘slightly more restrictive’ because it recognizes the herb and root as non-novel only when used in food supplements, rather than in all types of food as it was previously written.
“I assume that the addition of ‘non-concentrated aqueous infusions’ was intended to cover these traditional uses and align the Catalog with the German BVL plant list (the official Lists of Substances managed by the German Government),” he said. “Nevertheless, this could be interpreted as a slight narrowing of the recognized food uses, from herbs and roots in general to only non-concentrated aqueous infusions.”
He also noted that some EU countries already allow Echinacea flowers and the whole plant in food products, but the updated EU Catalog does not specifically mention them, so it is unclear whether these uses are still recognized as non-novel at EU level.
He also noted that E. pallida, which appears in the positive lists for several EU Member States, has not been included in the Novel Food Catalog update.
Its absence does not necessarily mean that the species is considered novel at EU level, but it leaves uncertainty over how its established national food uses should be interpreted under the EU framework, he told NI.
Le Bloch said companies can seek Article 4 clarification to determine whether specific Echinacea products can be considered non-novel at EU level. However, the potential for an unfavorable determination may make businesses reluctant.
“For this reason, I do not anticipate a substantial increase in Article 4 consultations as a result of this update,” Le Bloch said.
NutraIngredients contacted the European Commission for clarification on the uncertainties raised and was awaiting a response at the time of publication.
