Updated Public Statement of the HMPC on HMPs containing Estragole
![Serialization/Aggregation - Live Online Training](files/eca/userImages/training.img/Z-ECA-Serialization-Live-Online-Training.jpg)
Recommendation
23/24 October 2024
Requirements, Challenges & Solutions
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.
Related GMP News
28.05.2024New USP Proposal for CBD Monograph
28.05.2024Revised German Cannabis Monograph
25.04.2024German Federal Council approves Cannabis Law
25.04.2024Revised GACP Guideline
12.03.2024How does GMP apply for Herbal Medicinal Products?
12.03.2024Is it Acceptable to Mix Extract-Batches in order to Improve Batch-to-Batch Consistency?