European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

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.