European regulations on nutraceuticals, dietary supplements and functional foods: A framework based on safety
European regulations on nutraceuticals, dietary supplements and functional foods: A framework based on safety
复制标题
DOI：
10.1016/j.tox.2005.12.022
复制
发表时间：
2006-04-03
期刊：
影响因子：
4.5
通讯作者：
Pettman, S
中科院分区：
文献类型：
--
作者：
Coppens, P;da Silva, MF;Pettman, S
本文介绍了欧盟（EU）功能性食品营销相关的立法，该立法是如何制定的，以及对制造商，营销商和消费者的一些实际影响。它还讨论了一些具体的例子，说明欧盟对食品的安全要求如何影响了一系列产品类别。在九十年代后期，对功能性成分的研究显示出在食品中使用这些成分的良好前景。主要出于安全考虑，这些新的科学发展伴随着对立法的紧急呼吁。欧洲委员会2000年关于食品安全的白色文件宣布了大约80项关于这一领域新的和改进的立法的建议。其中包括制定《食品法通则》，规定食品法的原则，并设立一个独立的食品管理局，负责根据科学风险评估就问题提供科学建议，明确划分风险评估、风险管理和风险沟通的职责。然而，在欧盟食品法中，没有针对“功能性食品”或“营养保健品”的监管框架。适用的规则有很多，取决于食品的性质。一般食品法规的规则适用于所有食品。此外，关于油营养食品、食品补充剂或新型食品的立法也可能适用于功能性食品，这取决于产品的性质和用途。最后，目前正在立法过程中的关于营养和健康声称以及关于在食品中添加维生素、矿物质和其他物质的两项提案，也将成为未来欧洲“营养保健品”销售的重要因素。欧盟食品立法的基石，包括功能食品和营养保健品，都是“安全”。关于立法安全基础的决定是基于风险分析，其中科学风险评估由欧洲食品安全局进行，风险管理由欧盟委员会、成员国进行，如果是立法，则与欧洲议会一起进行。在风险管理阶段，我们会考虑预防原则及其他合理因素，以选择最佳的处理方法。由于适用的法例繁多，所须遵循的程序亦各不相同，因此，将“功能食品”推出市场的过程，肯定是一项既费钱又费时的工作。然而，从市场成功和改善消费者健康方面来看，这显然也是值得的。(c)2006爱思唯尔爱尔兰有限公司保留所有权利。
This article describes the legislation that is relevant in the marketing Of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication.Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation oil dietetic foods, on food Supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'neutraceuticals' in Europe.The cornerstone of EU legislation on food products, including functional foods and nutraceuticals is 'safety'. Decisions on the safety-basis of legislation are based on risk analysis, in which scientific risk assessment is performed by the European Food Safety Authority and risk management is performed by the European Commission, the Member States, and in case of legislation, together with the European Parliament. In the risk management phase, both the precautionary principle and other legitimate factors may be considered in choosing the best way of dealing with an issue.Due to the numerous pieces of legislation applying and to the different procedures to be followed, the process or having 'functional foods' ready for the market is certainly a costly and time-consuming task. However, it may also be clearly worth it in terms of market success and improved Consumer health. (c) 2006 Elsevier Ireland Ltd. All rights reserved.