Use of herbal medicinal products containing estragole - Scientific guideline

This document provides information on the natural occurence, toxicity and pharmacokinetics of estragole. It gives recommendation on the safety of herbal medicinal products containing this substance.

Keywords: Herbal medicinal products; HMPC; estragole; fennel; fennel oil; anise, anise oil

Revision 1

Public statement on the use of herbal medicinal products containing estragole - Revision 1

Consultation dates: 15/02/2020 to 15/05/2020Draft: consultation closedReference Number: EMA/HMPC/137212/2005 Rev. 1 Corr.

Overview of comments received on the draft revised Public statement on the use of herbal medicinal products containing estragole (EMA/HMPC/137212/2005 Rev 1 – 2nd Draft)

Reference Number: EMA/HMPC/482974/2020

Overview of comments received on the draft revised Public statement on the use of herbal medicinal products containing estragole (EMA/HMPC/137212/2005 Rev 1)

Reference Number: EMA/HMPC/278706/2015

Document history

Public Statement on the use of herbal medicinal products containing estragole

AdoptedReference Number: EMEA/HMPC/137212/2005

Public statement on the use of herbal medicinal products containing estragole

Consultation dates: 22/12/2014 to 31/03/2015Draft: consultation closedReference Number: EMA/HMPC/137212/2005 Rev. 1Summary:

In 2005 the HMPC prepared the ‘Public statement on the use of herbal medicinal products containing estragole’. There is a number of plants and their preparations which contain estragole, sometimes in very high amounts. Since 2005, a number of significant publications on estragole (and of various alkenylbenzenes) have appeared in the scientific literature and prompted HMPC to reassess the toxicology of estragole and of preparations containing these constituents.

An overview of available data and ‘weight of evidence toxicity risk assessment’ is presented. It is recommended that because of the generally accepted evidence of genotoxic carcinogenicity, exposure to estragole should be kept as low as practically achievable. In the evaluation of herbal medicinal products containing estragole Member States should take steps to ensure that the public are protected from exposure and follow thresholds both for the oral and the cutaneous use of herbal medicinal products.

Overview of Comments received on Public Statement on the use of herbal medicinal products containing estragole and on Public Statement on the use of herbal medicinal products containing methyleugenol

Reference Number: EMEA/381090/2005