Probiotics and European Food Safety Authority Health Claims

"Probiotic” is a generic term that includes a large number of species of microorganisms, specifically lactobacilli and bifidobacteria. Probiotics are among the most active ingredients present in foods; the definition of “probiotics,” which implies beneficial effects on health, is therefore considered by the European Union as a health claim per se. Adequately characterising the probiotic bacteria tested in a study is mandatory for them to be subject to a consumer health claim, as stipulated by the European Food Safety Authority (EFSA). Probiotics cannot be properly evaluated as a class, but rather need to be judged on a single-strain basis. This characterization should be performed at the strain level, a rule that is not always adhered to in scientific publications. Indeed, the clinical effects of probiotics, in treatment or prevention, depend on the specific bacteria, which should be defined not only by their genus and species, but also at the strain level. At the end of 2006, the European Union approved a Regulation allowing the use of nutritional and health claims for food and food supplements. Two types of health claim have been allowed. The first type of claim refers to the functions of the body, including psychological and behavioral 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 refers to reduction of disease risk; in this case the authorization will be specific for each food product applying for the claim. The substantiation of the scientific background supporting the request of claims is the challenge for 2009 for the scientists providing advice to the EFSA. Opinions voiced by the EFSA in July 2009 with regard to probiotic claims were all negative. A clinical effect of probiotic bacteria should be attributed only to those strains that have demonstrated one. Conversely, when a strain does not elicit a given clinical effect, this does not mean that no other strain can produce it. A comparison was made with vitamins, as, for example, not all prevent scurvy or increase calcium absorption but this does not imply that they are ineffective in health maintenance. For supplements of vitamins and minerals, Regulation 2002/46/ specifies that only nutrient sources whose safety and bioavailability have been assessed by the EFSA and listed in the relevant Annex of the Directive can continue to be used in food supplements from 1 January 2010. These are the items largely discussed during the 5th Congress on “Probiotics Prebiotics and New Foods” in Rome from 13 to 15 September 2009 and in part reported in this issue of Journal of Clinical Gastroenterology.