New Ph. Eur. Chapter for Estragole Determination

A new European Pharmacopoeia (Ph. Eur.) chapter 2.8.27. Determination of Estragole has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.

Background

Estragole is a natural organic compound and a constituent of several essential oils. It is suspected to be carcinogenic and genotoxic, as is indicated by a report of EMA's Committee on Herbal Medicinal Products (HMPC) on the use of herbal medicinal products (HMPs) containing estragole. The HMPC document provides information on the natural occurrence, toxicity and pharmacokinetics of estragole.

Because of the generally accepted evidence of genotoxic carcinogenicity, exposure to estragole should be kept as low as practically achievable. In the evaluation of HMPs containing estragole EU Member States should take steps to ensure that the public is protected from exposure.

The new Ph. Eur. general chapter is intended for the quantitative estragole determination in herbal drugs and herbal drug preparations. The proposed method (gas chromatography) has been validated for aniseed, anise oil, star anise, star anise oil, sweet fennel, bitter fennel, cut bitter fennel, bitter-fennel fruit oil and bitter-fennel herb oil. However, its suitability for other herbal drugs or herbal drug preparations must be demonstrated or another validated method used.

For more information please go to Pharmeuropa online.