Page 68 - 2025中醫藥與天然藥物聯合學術研討會-中醫藥與天然藥物的挑戰Ｘ機遇與未來大會手冊

Upcoming Tests of Toxic Constituents of Herbal Drugs in the European

Pharmacopoeia

,1
Bauer Rudolf *

1 Institute of Pharmaceutical Sciences, Pharmacognosy; Beethovenstrasse 8, 8010 Graz,
Austria

* E-mail: rudolf.bauer@uni-graz.at

Abstract
Recently, there have been safety concerns about alkenylbenzenes, like estragole and
methyleugenol, and monoterpenes, like a-/b- thujone, pulegone and menthofuran, because of

their mutagenic and possibly carcinogenic potential. These are secondary plant metabolites,
which are contained in essential oils of many medicinal plants.
EMA/HMPC concluded in a ‘Public statement on the use of herbal medicinal products
containing estragole’ (EMA/HMPC/137212/2005 Rev 1) that the intake of estragole from
(Traditional) Herbal Medicinal Products in the general population should be as low as

possible, which includes a short-time duration of use (maximum 14 days) and a guidance
value of max. 0.05 mg/person per day. For children, the daily intake of estragole should not be
more than 1.0 µg/kg bw. Since estragole is very common in fennel (Foeniculum vulgare

Mill.), this herbal drug is mainly affected. However, since also several Chinese herbs contain
estragole, this will become relevant also for the use of TCM at least in Europe. Similar
EMA/HMPC statements exist for a-/b- thujone, as well as for pulegone and menthofuran.
In the future, it will be necessary to know the content of these potentially carcinogenic
compounds in the herbal raw material and in the herbal preparations. The European

Pharmacopoeia therefore is in progress to elaborate tests for the determination.

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