by-case basis. Furthermore, the guidance is a living document and will be updated as appropriate.
Types of Nutrition and Health Claims That Can Be Made About Probiotic and Prebiotic Food Products
As in the United States, three types of nutrition and health claims are allowed in the European Union: (1) nutrition claims based on scientific assessment of a benefit, (2) function claims about the maintenance or improvement of a function, and (3) disease risk reduction claims about the reduction of a risk factor for a human disease and claims concerning children. With respect to disease risk reduction claims, disease risk reduction must be demonstrated using a commonly accepted risk factor and changes in relevant biomarkers that relate to the risk of the particular disease. These categories of claims were not decided by EFSA, but rather by “word of law.”
Examples of function claims are claims about bowel function and constipation, gastrointestinal discomfort, and defense against pathogens. In order to make a function claim about bowel function and constipation, for example, one would define an average healthy consumer and then show that the probiotic or prebiotic in question can reduce or somehow improve bowel function. Salminen commented on the availability of validated questionnaires for use in assessing GI discomfort and the ways to gather these data in a scientifically acceptable manner. Making a function claim about pathogen defense requires demonstrating a reduction in numbers of specific pathogens (i.e., “real” pathogens associated with the particular risk, not opportunistic pathogens). An example of a disease risk reduction claim is a claim about LDL (low-density lipoprotein) cholesterol as a recognized risk factor for heart disease. As required by the regulation, the risk factors must be physiologically relevant. Salminen emphasized that there is no exhaustive list of recognized risk factors, reiterating that EFSA conducts assessments on a case-by-case basis.
Characterizing and Evaluating Probiotic and Prebiotic Products in the European Union
There is no legal EU definition of either “probiotic” or “prebiotic.” According to the Food and Agriculture Organization-World Health Organization (FAO-WHO, 2002) definition, probiotics are defined as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” A prebiotic was defined by FAO as “a non-viable food component that confers a health benefit on the host associated with modulation of the microbiota” (Pineiro et al., 2008). On the basis of these definitions and other parameters laid out by FAO and WHO, Salminen explained