Assessment of genotoxicity of herbal medicinal preparations according to the guideline EMEA/HMPC/107079/2007: A model project of Kooperation Phytopharmaka, Bonn, Germany

Guidance for the assessment of genotoxicity of herbal medicinal substances (preparations) is given by a recent guideline of the Committee on Herbal Medicinal Products (HMPC) of the European regulatory agency EMEA [1]. A draft concept paper of the HMPC [2] recommends a bracketing and matrixing approach, thus offering an alternative to testing each individual preparation (extract) from a certain herbal drug by a joint conduction of tests.

In accordance to these documents, Kooperation Phytopharmaka, a German scientific organisation in the field of HMPs, has started a model project for the screening of herbal preparations, including extracts produced with polar to unpolar extraction solvents to cover the whole spectrum of constituents of the herbal drug. This even allows an assessment for powdered herbal drugs otherwise not accessible to in vitro methods.

Until now the project has produced data on 24 of the most important herbal drugs used in Europe, including e.g. St. John's wort, caraway, lemon balm, garlic, ginkgo and hawthorn. The project was conducted in accordance with all modern guidelines including those of OECD, ICH and EMEA in cooperation with renowned laboratories, starting with the first step of the test strategy, the Ames test. The project has not only broadened the knowledge about the safety of important herbal drugs used in Europe and beyond and allowed to meet current regulatory requirements, but has turned out to be an important step in the continuous process of updating the safety profile of modern phytotherapy, which is already now documented excellently. For expanding the project to further herbal drugs, cooperation partners are welcome.

References: [1] Guideline on the assessment of genotoxicity of herbal medicinal substances/preparations, Doc. Ref. EMEA/HMPC/107079/2007, in effect since 1 December 2008.

[2] Draft concept paper on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products, Doc. Ref. EMEA/HMPC/315413/2008.