Health claims for probiotics: substantiating claims according to European regulation

At the end of 2006, the European Union approved a regulation allowing the use of nutritional and health claims for food and food supplements. Approval is restricted to food with a 'healthy' nutritional profile and after a scientific assessment provided by the European Food Safety Authority (EFSA). Two kinds of health claims have been allowed: the first ones referring to the functions of the body, including psychological, behavioural functions and weight control. These claims are also called 'generic claims', as it is assumed that these functional properties could be shared by all food containing the selected active ingredient(s). The second group of allowed claims will refer to reduction of risk disease; in this case, the authorisation will be specific for each food product applying for the claim. Probiotics are among the active ingredients most present in foods applying for the first kind of claims, and the substantiation of the scientific background supporting the request of claims is the challenge for 2009 of the scientists providing advice to EFSA. It is easy to predict that this assessment will be challenging for applicants, including the definition itself of 'probiotics', which implies beneficial effects on health and could be, therefore, considered as a health claim per se. The International Dairy Federation has recently issued a document providing guidelines for establishing the physiological and functional properties of probiotics; this paper is aimed to review the state of the art of efficacy assessment of probiotics in this particular moment, at least in Europe, when science is crossing the road of regulatory affairs