The toxicity of plants containing certain pyrrolizidine alkaloids has long been recognized in grazing animals and humans. Genotoxicity and carcinogenicity data from in vitro and in vivo (animal) studies were published over the last few decades for some of the 1,2-unsaturated pyrrolizidine alkaloids, leading to regulatory action on herbal medicinal products with pyrrolizidine alkaloid-containing plants more than 30 years ago. In recent years, it has become evident that in addition to herbal medicinal products containing pyrrolizidine alkaloid-containing plants, these products may also contain pyrrolizidine alkaloids without actually including pyrrolizidine alkaloid-containing plants. This is explained by contamination by accessory herbs (weeds). The national competent authorities of the European member states and the European Medicines Agency, in this case, the Committee on Herbal Medicinal Products, reacted to these findings by setting limits for all herbal medicinal products. This review article will briefly discuss the data leading to the establishment of thresholds and the regulatory developments and consequences, as well as the current discussions and research in this area.

中文翻译：

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草药产品中吡咯里西啶生物碱污染的监管前景

含有某些吡咯里西啶生物碱的植物的毒性早已在放牧动物和人类中得到认可。在过去的几十年中，一些 1,2-不饱和吡咯里西啶生物碱的体外和体内（动物）研究的基因毒性和致癌性数据发表，导致对含有吡咯里西啶生物碱植物的草药产品采取监管行动 30几年前。近年来，很明显，除了含有吡咯里西啶生物碱植物的草药产品外，这些产品也可能含有吡咯里西啶生物碱，但实际上并不包括含有吡咯里西啶生物碱的植物。这可以通过附属药草（杂草）的污染来解释。欧洲成员国的国家主管部门和欧洲药品管理局，在这种情况下，草药产品委员会通过对所有草药产品设定限制来对这些发现做出反应。这篇综述文章将简要讨论导致阈值建立的数据以及监管发展和后果，以及该领域目前的讨论和研究。