ORIGINAL COMMUNICATION General aspects on the assessment of functional foods in the European Union A Palou 1 *, F Serra 1 and C Pico 1 Laboratori de Biologia Molecular, Nutricio´i Biotecnologia, Departament de Biologia Fonamental i Cie  ncies de la Salut, Universitat de les Illes Balears, Palma de Mallorca, Spain 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. European Journal of Clinical Nutrition (2003) 57, Suppl 1, S12–S17. doi:10.1038/sj.ejcn.1601822 Keywords: functional foods; novel foods; food safety; food efficacy; PARNUTS; supplements; European Union Introduction The traditional idea of an adequate diet, in the mere sense of providing enough nutrients to ensure the survival of an individual, to satisfy metabolic needs and to pleasantly gratify the sensation of hunger, has become insufficient to cover the present situation (Bellisle et al, 1998). Nowadays, including this and everything related to food safety, the emphasis is on food potential to promote health, improve well-being and reduce the risk of illnesses (Bellisle, 2002; Palou et al., 2002). Thus, the concept of ‘adequate nutrition’ is tending to be replaced by ‘optimal nutrition’. The notion of ‘Functional Foods’, ‘Foods for Specified Health Use’, ‘Health Promoting Foods’ or ‘Foods for particular nutritional uses’ appears to indicate that some foods may have a beneficial action on body functions that goes beyond their basic nutritional effects (Contor, 2001; Eckhardt, 2001; Arai et al, 2002). Functional foods have no universally accepted definition. They are foods in which one of their components, whether it is a nutrient or not, or the particular combination of ingredients, affects target functions of the organism in a specific, positive way, producing a physiological effect beyond its traditional nutritional value. The positive effect of a functional ingredient, or the elimination of an adverse one, may be both its contribution to maintain and promote a healthy state and/or to reduce the risk of suffering a certain illness or disorders (Diplock et al, 1999; Roberfroid, 2000). The concept of functional foods includes foods that are usual components of the diet and exert their beneficial effects in quantities that are normally consumed in a balanced diet, and excludes pills, capsules and tablets as such (Hasler, 2002). A functional foodstuff should continue being food and its effects should be produced in the usual quantities present in the diet. Therefore, the development of *Correspondence: Palou, Departament de Biologia Fonamental i Cie `ncies de la Salut, Universitat de les Illes Balears, Cra. Valldemossa Km 7.5, 07122 Palma de Mallorca, Spain. E-mail: andreu.palou@uib.es Contributors: The order in which the contributors are listed is agreed among the investigators, and indicates that the first author (A Palou) has made the greatest contribution, consisting of designing the schedule of the publication and writing the preliminary version, and the second and third authors (F Serra and C Pico) have equally contributed to the work in writing the definitive version. European Journal of Clinical Nutrition (2003) 57, Suppl 1, S12–S17 & 2003 Nature Publishing Group All rights reserved 0954-3007/03 $25.00 www.nature.com/ejcn