Traditional Knowledge for the Assessment oh Health Effects for Botanicals- A Framework for data Collection

In the European Union (EU), botanicals have a long tradition of use for their health effects. Their medicinal use has evolved more recently. Medicinal products containing botanicals can be registered as traditional herbal medicinal products in the EU if bibliographical or expert evidence is available that the product has been in medicinal use throughout a period of at least 30 years. For food use however, the effects observed must be proven under the new health claims rules. The substantiation required relies mainly on the availability of randomised controlled trials. Evidence from traditional use is not considered. This is bound to lead to the loss of an important heritage. The consideration of traditional evidence from various sources is a valid scientific discipline. This paper is aimed at providing a framework for data collection in support of traditional use for botanicals. It provides guidance on how traditional use can be incorporated into the totality of the evidence and can be used as a basis for the assessment leading to the acceptance of health effects for botanicals

The european role on traditional herbal medicinal products and traditional plant food supplements

Herbs are used in Europe as medicinal products, food, food supplemets and related products. This paper will discuss the concepts of traditional herbal medicines and traditional plant food supplements, defined in Europea legislation under differing legal frameworks, regarding traditional plant food supplements ( including Claims regulation) and the role of the european food safety autorithy in health claims

Levels of Genotoxic and Carcinogenic Compounds in Plant food Supplements and Associated Risk Assessment

The present study describes the selection, analysis and risk assessment of genotoxic and carcinogenic compounds of botanicals and botanical preparations which can be found in plant food supplements (PFS). First an inventory was made of botanical compounds that are of possible concern for human health because of their genotoxic and/or car- cinogenic properties. In total, 30 botanical compounds were selected and subsequently judged for their actual genotoxic and/or carcinogenic potential. Among the 30 compounds considered, 18 compounds were judged to be both genotoxic and carcinogenic. Interestingly, the majority of these compounds belong to the group of alkenylbenzenes or unsaturated pyrrolizidine alkaloids. Subsequently, based on available carcinogenicity data and estimated daily human exposure that was determined focusing on the intake from PFS, the Margin of Exposure (MOE) was calculated for the alkenylbenzenes estragole, methyleugenol, safrole and ß-asarone. Calculating the MOEs for intake estimates of these alkenylbenzenes from PFS resulted in MOE values that were generally lower than 10,000 and often lower than 100. In some cases the MOE was even below 10 meaning that the estimated daily intake is in the range of dose levels causing malignant tumors in experimental animals. This result indicates that the use of PFS containing the genotoxic carcino-gens estragole, methyleugenol, safrole or ß-asarone might raise a potential concern for human health and would be of high priority for risk managemen

Anti-proliferative properties of prenylated flavonoids from hops (Humulus lupulus L.) in human prostate cancer cell lines

Chalcones xanthohumol (X) and desmethylxanthohumol (DMX), present in hops (Humulus lupulus L.), and the corresponding flavanones isoxanthohumol (IX, from X), 8-prenylnaringenin (8-PN, from DMX), and 6-prenylnaringenin (6-PN, from DMX), have been examined in vitro for their anti-proliferative activity on human prostate cancer cells PC-3 and DU145. X proved to be the most active compound in inhibiting the growth of the cell lines with IC50 values of 12.3 +/- 1.1 mu M for DU145 and 13.2 +/- 1.1 mu M for PC-3. 6-PN was the second most active growth inhibitor, particularly in PC-3 cells (IC50 of 18.4 +/- 1.2 mu M). 8-PN, a highly potent phytoestrogen, exhibited pronounced anti-proliferative effects on PC-3 and DU145 (IC50 of 33.5 +/- 1.0 and 43.1 +/- 1.2 mu M, respectively), and IX gave comparable activities (IC50 of 45.2 +/- 1.1 mu M for PC-3 and 47.4 +/- 1.1 mu M for DU145). DMX was the least active compound. It was evidenced for the first time that this family of prenylated flavonoids from hops effectively inhibits proliferation of prostate cancer cells in vitro. (c) 2006 Elsevier GmbH. All rights reserved