During the last 6 y, the European Union has undergone a profound qualitative change in the focus on food safety problems. In 1997, nine new scientific committees were created, including the Scientific Committee on Food (SCF) and the Scientific Steering Committee (SSC), and were put under the auspices of the Directorate General in charge of defending consumer interests and health. The process is foreseen to be completed by the incorporation in 2003 of all food safety activities of these committees into the European Food Safety Authority (EFSA). Among the immediate challenges in the near future are the scientific and technological developments and the regulatory measures for the so-called ‘functional foods’, which can positively affect the health and well-being of consumers. Functional foods are a recent phenomenon in Europe and are, as yet, not covered by any specific legislation. The two key aspects in the evaluation of functional foods are safety and efficacy. Whereas safety can be covered under different legislative umbrellas such as novel foods (NFs), foods for particular nutritional purposes, supplements, additives and others, the issue of evaluation of their efficacy is only at a very early stage since the criteria to establish the validity of ‘health claims’ has not been clearly addressed at a European level.