Dept. Veterinary Public Health and Food Safety, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.
Food Funct. 2011 Dec;2(12):740-6. doi: 10.1039/c1fo10112a. Epub 2011 Aug 17.
It is essential to guarantee the safety of unprocessed plants and food supplements if consumers' health is to be protected. Although botanicals and their preparations are regulated at EU level, at least in part, there is still considerable discretion at national level, and Member States may choose to classify a product either as a food supplement or as a drug. Accurate data concerning the finished products and the plant used as the starting point are of major importance if risks and safety are to be properly assessed, but in addition standardized criteria for herbal preparation must be laid down and respected by researchers and manufacturers. Physiologically active as well as potentially toxic constituents need to be identified, and suitable analytical methods for their measurement specified, particularly in view of the increasing incidence of economically motivated adulteration of herbal raw materials and extracts. It remains the duty of food operators to keep up with the scientific literature and to provide sufficient information to enable the adaptation of specifications, sampling schemes and analytical methods to a fast-changing environment.
如果要保护消费者的健康,就必须保证未加工植物和食品补充剂的安全。尽管植物药及其制剂在欧盟层面受到一定程度的监管,但在国家层面仍有相当大的酌处权,成员国可能会选择将产品归类为食品补充剂或药物。如果要对风险和安全性进行正确评估,那么关于成品和起始植物的准确数据非常重要,但此外,还必须为草药制剂制定标准化标准,并得到研究人员和制造商的遵守。需要识别具有生理活性和潜在毒性的成分,并指定其测量的合适分析方法,特别是考虑到出于经济动机对草药原料和提取物进行掺假的情况日益增多。食品经营者有责任关注科学文献,并提供足够的信息,以便使规范、抽样计划和分析方法适应快速变化的环境。