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DAB -- European Regulatory Literature





"DAB 10" is considered the highest measurable standard in the world, as it is applied to the purity and quality control of herbs. A "10" rating means the herbs in question are of a sufficient quality to be used in a medicinal product.

herbs In 1975, the European Economic Community (EEC) published Directive 75/318/EEC dealing with the special problems associated with herbal medicines (e.g., multiple chemical compounds and the variability of these compounds). In particular, the directive attempts to clarify distinctions between herbs and conventional drugs ("chemically defined active ingredients"). The directive notes, "Consistent quality for products of vegetable origin can only be assured if the starting materials are defined in a rigorous and detailed manner, including the specific botanical identification of the plant material used. It is also important to know the geographical source and conditions under which the vegetable drug is obtained in order to ensure material of a consistent quality." (EEC, 1975.)

The German Pharmacopoiea (Deutsches Arzneibuch, or DAB) contains monographs on the quality and standards of many herbal drugs, medicinal plant preparations, and natural substances (e.g., essential oils) sold in Germany. As is customary in pharmacopoeial standards monographs, the approved medicinal uses of the herb are not listed, but instead they contain the standards for assuring the proper identity and purity of the herbal drug.

Monographs are available online from the American Botanical Council as examples of the level of quality control measures required for manufacturers of phytomedicines in Germany at www.herbalgram.org. Included are monographs taken from DAB 8, DAB 9, and DAB 10: Hawthorn fluidextract DAB 10 (Crataegi extractum fluidum), Hawthorn leaf with flower (Crataegi folium cum flore), Horse Chestnut seed (Hippocastani semen), Standardized Horse Chestnut seed extract (Hippocastani semen extractum siccum normatum), Lemon Balm DAB 10 (Melissae folium), and Milk Thistle fruit (Cardui mariae fructus). When the work of Commission E was terminated in 1994, DAB 10 was valid; currently DAB 1997 is valid (Schilcher, 1997b). ABC received permission to reprint translations of these monographs from the publisher, Deutscher Apotheker Verlag in Stuttgart, Germany. Consistent with European harmonization efforts, current work on updating the monographs for the DAB is being conducted in concert with the European Pharmacopoeia (Koerner, 1997).

Read other Garber Gastro Glossary entries on evalu8.org.

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