Medicinal products containing estragole 

Since 2005, several significant publications on estragole have appeared in the scientific literature. The new data raised concerns from a toxicological point of view, and this prompted the HMPC to reassess all available data regarding their relevance for the safe human use of herbal medicinal products containing estragole, therefore HMPC recently published a new revision of the public statement on the use of herbal products containing estragole.

Estragole is a major or minor component of a large number of plants or plant parts used for herbal medicinal products, botanicals and flavourings. From the European perspective, the most interesting plants are Foeniculum vulgare Mill. (both fruit and essential oil) and Pimpinella anisum L. (fruit).

According to the public statement, the use of estragole containing excipients should be avoided as much as possible in (traditional) herbal medicinal products and exposure to estragole should be kept as low as practically achievable, because of its generally accepted evidence of genotoxic carcinogenicity. The content of estragole should be reduced by appropriate measures to a content below the guidance value of 0.05 mg per person per day for adults and adolescents and 1.0 μg/kg bw for children, respectively.

MAHs/RHs of medicinal products containing plants or their preparations which contain estragole, either as active substance or excipient, should check whether their medicinal products comply with above-mentioned guidance value. If necessary, appropriate regulatory action should be undertaken to ensure compliance.

References:

EMEA (European Agency for the Evaluation of Medicinal Products). Committee on Herbal Medicinal Products (HMPC). Final. Public statement on the use of herbal medicinal products containing estragole. (EMA/HMPC/137212/2005 Rev 1) 

CMDh (Co-ordination group for mutual regodnition and decentralised procedures – Human). Report from the CMDh meeting held on 22-23 February 2022. (EMA/CMDh/78976/2022)