Coppens Patrick, da Silva Miguel Fernandes, Pettman Simon
European Advisory Services (EAS)--Strategic Advice on Nutritional Products, Rue de l'Association 50, 1000 Brussels, Belgium.
Toxicology. 2006 Apr 3;221(1):59-74. doi: 10.1016/j.tox.2005.12.022. Epub 2006 Feb 15.
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 on 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 'nutraceuticals' 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 of 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.
本文介绍了欧盟（EU）功能性食品营销方面的相关立法，该立法的制定过程以及对制造商、营销商和消费者的一些实际影响。它还列举了一些具体事例，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此类成分在食品中应用的广阔前景。主要出于安全考虑，这些新的科学进展引发了对立法的迫切需求。欧盟委员会2000年的《食品安全白皮书》宣布了约80项关于该领域新的和改进的立法提案。其中，它预见将制定一项《通用食品法条例》，规定食品法的原则，并设立一个独立的食品管理局，赋予其根据科学风险评估就相关问题提供科学建议的任务，对风险评估、风险管理和风险沟通的职责进行明确划分。从那时起，超过90%的白皮书提案已得到实施。然而，欧盟食品法中并没有专门针对“功能性食品”或“营养保健品”的监管框架。适用的规则众多，且取决于食品的性质。《通用食品法条例》的规则适用于所有食品。此外，根据产品的性质及其用途，关于特殊膳食用食品、食品补充剂或新型食品的立法也可能适用于功能性食品。最后，目前正在立法过程中的关于营养与健康声称以及在食品中添加维生素、矿物质和其他物质的两项提案，也将是未来欧洲“营养保健品”营销中的一个重要因素。欧盟关于食品（包括功能性食品和营养保健品）的立法基石是“安全”。基于安全的立法决策基于风险分析，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、成员国执行，在立法情况下，还需与欧洲议会共同执行。在风险管理阶段，在选择处理问题的最佳方式时，可考虑预防原则和其他合法因素。由于适用的立法众多且需遵循不同程序，让“功能性食品”进入市场的过程无疑是一项成本高昂且耗时的任务。然而，就市场成功和改善消费者健康而言，这也可能显然是值得的。
