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The functional foods concept started in Japan in the early 1980s with the launch of three large-scale government-funded research programs on systematic analyses and development of functional foods, analyses of physiological regulation of the functional food and analyses of functional foods and molecular design (Ashwell 2002; Pravst et al. 2010). In 1991, in an effort to reduce the escalating cost of health care, a category of foods with potential benefits was established (Foods for Specified Health Use – FOSHU) (Ashwell 2002). In the USA, evidence-based health or disease prevention claims have been allowed since 1990, when the Nutrition Labelling and Education Act was adopted; claims have to be approved by the Food and Drug Administration (FDA) (Arvanitoyannis and Houwelingen-Koukaliaroglou 2005). Codex Alimentarius Guidelines for the use of nutrition and health claims were accepted in 2004, and amended in 2008 and 2009, followed by Recommendations on the scientific basis of health claims (Grossklaus 2009). In the European Union, harmonisation was achieved in 2006 with Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, which requires authorization of all health claims before entering the market. The definition of functional foods is an ongoing issue and many variations have been suggested (Arvanitoyannis and Houwelingen-Koukaliaroglou 2005). A consensus on the functional foods concept was reached in the European Union in 1999, when a working definition was established whereby a food can be regarded as functional if it is satisfactorily demonstrated to beneficially affect one or more target functions in the body beyond adequate nutritional effects in a way that is relevant to either an improved state of health and well-being or a reduction of disease risk. Functional foods must remain foods and demonstrate their effects when consumed in daily amounts that can be normally expected (Ashwell 2002). In practice, a functional food can be: an unmodified natural food; a food in which a component has been enhanced through special growing conditions, breeding or biotechnological means; a food to which a component has been added to provide benefits; a food from which a component has been removed by technological or biotechnological means so that the food provides benefits not otherwise available; a food in which a component has been replaced by an alternative component with favourable properties; a food in which a component has been modified by enzymatic, chemical or technological means to provide a benefit; a food in which the bioavailability of a component has been modified; or a combination of any of the above (Ashwell 2002). Regardless of the various definitions, the main purpose of functional food should be clear – to improve human health

Functional Foods in Europe: A Focus on Health Claims