Why regulatory status matters
For any business bringing guayusa to the European market, regulatory classification is the first gate. Under EU law, foods not consumed to a significant degree in the Union before 15 May 1997 are treated as “novel” and require authorization before they can be sold. Ilex guayusa falls into this framework.
What is authorized today
Since December 2017, the EU Union List of authorized novel foods includes the aqueous (water) extract of dried leaves of Ilex guayusa, intended for use as a herbal infusion. This is set out in Commission Implementing Regulation (EU) 2017/2470, which established the Union List, with subsequent updates including Regulation (EU) 2018/1023. In practice, this gives the aqueous leaf extract a defined, legal route to market as an infusion.
Where the whole leaf stands
The authorization is specific. The whole dried leaf and other preparations do not share the same clear-cut status as the authorized aqueous extract, and their use can be more restricted or require separate assessment. Manufacturers should not assume that approval of the extract automatically extends to every form of the plant.
What this means for manufacturers
European brands should match their intended product format to the authorized use, confirm specifications against the Union List entry, and document their supply chain accordingly. Getting this right early avoids costly reformulation and market-access delays later.
How Waykana supports the process
As a vertically integrated grower and processor, Waykana can supply guayusa with the documentation and traceability that regulatory diligence demands, and works alongside European partners to align product formats with current Novel Food requirements. From certificates of analysis to species identity and processing records, that paper trail is often what turns a promising ingredient into an approvable one. This does not replace a manufacturer’s own regulatory assessment, but it makes that assessment far easier to complete.
This article is for informational purposes only. These statements have not been evaluated by the FDA.