A critical issue has emerged for the food supplement industry following the May 7, 2025 meeting of EFSA’s NDA expert panel. Under scrutiny are the fruits of sweet and bitter fennel (Foeniculum vulgare and Foeniculum piperitum), which may soon face exclusion from food supplements due to the presence of estragole, a compound considered genotoxic and carcinogenic.
EFSA’s Opinion
EFSA stated:
Estragole is genotoxic and capable of damaging DNA, with no identifiable safe threshold.
Therefore, the intentional use of fennel in supplements is no longer justifiable.
The evaluation has been extended to structurally similar compounds, such as methyl eugenol and safrole, which are also found in common herbs (basil, thyme, rosemary, etc.).
Effects may also concern pregnant women and children, with recommendations to avoid teas and supplements containing these substances.
Industry Concerns
SISTE and several stakeholders have raised serious concerns:
EFSA’s methodology focuses on isolated molecules, ignoring the “matrix effect”—the complex interaction of natural components in plants.
Traditional usage of these botanicals is well-documented and has never shown large-scale risks.
Other regulatory bodies, such as ECHA, use different approaches and recognize safe thresholds for these substances.
What Comes Next
EFSA’s official opinion is expected by mid-June 2025, followed by a public consultation phase.
This could go well beyond fennel: EFSA’s extended review may lead to bans on several other aromatic plants, impacting well-established supply chains and biodiversity.
Industry Response
To address the situation, the sector is reacting:
A call for constructive dialogue between authorities, scientific institutions, and companies.
A push for realistic assessment criteria grounded in evidence and regulatory coherence.
The Botanicals Research Foundation is currently being established to promote authoritative, multidisciplinary studies supporting the field.
Contacts and Information
For further technical or strategic information, please contact our staff
