Within the group of botanical products there is a large range of variation with regard to their properties. Some products are identical to foods while others come close to or are medicines. Botanical products are regulated differently within the different member states of the European Union (EU) and globally. They are regulated either as food or as medicinal products, and in the latter case often with simplified registration procedures. These differences are caused by differences in traditional use, in cultural and historical background, in scientific substantiation and in enforcement of current legislation. One may expect that in the future differences will remain, unless EU legislation is enacted with sufficient room for different approaches. The strengths and weaknesses of the different regulatory procedures have been reviewed and evaluated as well as the current methods for quality, efficacy and safety evaluation. Criteria to categorize botanical products have been defined, such that botanical products can be regulated under the current food and medicinal regulations. Furthermore, a decision tree has been developed as a tool to distinguish herbal medicinal products from botanical health products and vice versa, and to provide a stepwise framework for the assessment of safety and efficacy.

中文翻译：

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植物保健产品的位置和有效安全使用的要求。

在植物产品类别中，就其性质而言，变化范围很大。有些产品与食品相同，而另一些则接近或属于药品。在欧盟（EU）的不同成员国以及全球范围内，对植物产品的监管不同。它们被监管为食品或医药产品，在后一种情况下，通常采用简化的注册程序。这些差异是由于传统用途，文化和历史背景，科学依据和现行立法的执行方面的差异引起的。有人可能会希望，除非欧盟立法颁布后，有足够的空间采取不同的方法，否则将来还会存在分歧。审查和评估了不同监管程序的优缺点，以及当前的质量，功效和安全性评估方法。已经定义了对植物产品进行分类的标准，以便可以根据当前的食品和药品法规对植物产品进行监管。此外，已经开发出决策树作为一种工具，以区分草药产品和植物保健产品，反之亦然，并为评估安全性和有效性提供逐步的框架。