Updated Public Statement of the HMPC on HMPs containing Estragole

Recommendation

5/6 October 2023

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In 2005, the HMPC prepared the "Public statement on the use of herbal medicinal products containing estragole". There are many plants (including their preparations) which contain estragole, sometimes in particurlarly high amounts, like, for example, Foeniculum vulgare Mill. (Fennel) and Pimpinella anisum L. (Anise).

Now, several footnotes were added in Table 1 (Section 1.1) of the document regarding the provided examples of estragole-containing plants, stating the following:

• "Compilation originating mainly from the food sector, that is partially based on older publications whose cited original data are not (completely) publicly available anymore. The list not exhaustive."
• "The actual relevance for medicinal products should be cross-checked with the data provided in respective assessment reports for EU herbal monographs and/or recent scientific literature relevant for specific substances/preparations in question."
• "Plant with currently known use as active substance or excipient in medicinal products and relevant amount of estragole in the essential oil." (related to bitter fennel, sweet fennel, star anise and aniseed)

More information is available in HMPCs Public statement on the use of herbal medicinal products containing estragole.