ABSTRACT

To better understand the regional or country-speciic regulations, this chapter will irst provide a broad overview of the global legal framework concerning probiotics. There is no universal deinition of probiotics that can be considered generically either as a food (including food additives and dietary supplements) or as a drug (medicines). Nevertheless, the deinition of probiotics by a joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) expert consultation in October of 2001 (already mentioned in Chapter 1) has been widely used. These experts produced a report on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. This report,

together with another on Drafting Guidelines for the Evaluation of Probiotics in Food developed by a joint FAO/WHO expert working group in 2002, provides scientiic advice on the methodology for evaluation of probiotics in food, addressing methods for strain identiication, safety assessment and functional characterization as well indication of what data are required to accurately substantiate health claims. The problems associated with probiotic product selection also become more understandable by application of guidelines established by the International Scientiic Association for Probiotics and Prebiotics (ISAPP, 2009). These guidelines will be detailed in Section 7.2.