FAO/WHO guidelines on probiotics: 10 years later.

October 1 to 4, 2001, Cordoba, Argentina: on this date (and not in 2006, as incorrectly reported in several documents!) a group of experts convened in that beautiful town for an Expert Consultation held jointly by the FAO and WHO to provide a scientific opinion on the matter of “probiotics.”1 The FAO/WHO collaboration stemmed from a request made by the Argentinian Government to solve an international trade litigation on a powdered milk containing lactic acid bacteria defined as “probiotics.” The term “probiotic,” a curious mix of Latin (pro=for, in favor of) and Greek (bios= life) was coined, as opposite to “antibiotic,” in the 1960s to define substances produced from protozoa and able to support the growth of other microorganisms.2 After 20 years, Fuller3 refocused the definition on bacteria and used this term to mean “a live microbial feed supplement which beneficially affects the host animal by improving its intestinal balance.” Clearly, the definition was intended to be used for animal feeding, and it should be kept in mind that research on biological additives to replace auxinic antibiotics was booming at that time. The use of specifically selected and characterized beneficial bacteria in humans was referred to in the Havenaar et al’s4 definition; “a viable mono or mixed culture of bacteria which, when applied to animal or man, beneficially affects the host by improving the properties of the indigenous flora.” The term was further refined by Guarner and Schaafsma,5: “live microorganisms which, when consumed in adequate amounts, confer a health effect on the host.” The use of this word in scientific literature was negligible until the 1990s (fewer than a dozen of times per year up to 1993), but reached 100 papers/y at the turn of the millennium and is present today in about 900 papers/y. In 2001, the year of the FAO/WHO Expert Consultation, there were 274 papers listed in PubMed under the keyword “probiotics,” whereas in 2011 this number was as high as 975 (data from http://www.gopubmed.org). The Expert Consultation was held in a period that marked the rise of interest in probiotics for the clinical and scientific communities. The framework of the consultation was provided in 3 papers as follows. (1) Technological & commercial applications of lactic acid bacteria; health & nutritional benefits in dairy products by S. Gilliland (USA). (2) Taxonomy and physiology of lactic acid bacteria, effects and function on nutrition by L Morelli (Italy). (3) Regulatory and clinical aspects of dairy probiotics by G. Reid (Canada). In addition to the 3 aforementioned authors, the full panel of experts included 8 scientists from all over the world. M. Araya, Chile P. Gopal, New Zealand S. Lindgren, Sweden R. Lodi, Italy G. Oliver, Argentina M. Saxelin, Finland A. Servin, France C. Stanton, Ireland M. Pineiro (FAO) and J. Schlundt (WHO) were in charge of coordinating the consultation. The experts were asked to: examine scientific information in relation to the dietary impact of the introduction of live lactic acid bacteria in milk for human consumption; evaluate the properties, benefits, safety, and nutritional features, as well as the potential adverse effects of powder milk with added live lactic acid bacteria on the basis of available scientific data, taking into consideration the work done by national authorities, FAO, WHO, other international organizations and other relevant international bodies; review the scientific basis for the health claims and legislative/regulatory needs; discuss existing strategies for the safety and nutritional assessment of this type of probiotic, taking into account the ever increasing public concerns and experiences accumulated in food safety evaluation; make recommendations on further research needs, priorities for the evaluation of safety, and nutritional aspects of probiotics as well as regulatory actions if required. Two specific major outcomes were obtained during the 4 days of exciting and challenging discussion: a definition for probiotics was established and it was recognized that the properties, function, and benefits of selected probiotics are unique to each single strain and that the benefits obtained by ingesting a specific strain must be extrapolated from other strains, even within the same species. The definition “Live microorganisms which, when administered in adequate amounts, confer a health benefit on the host” is now the term of reference for both science and regulations after 10 years. The first Regulatory Authority to use the FAO/WHO definition of probiotics was the Italian Ministry of Health From the *Istituto di Microbiologia, U.C.S.C, Piacenza; and wRetired Emeritus Head of the Department of Gastroenterology, AO “S. Filippo Neri” Rome, Italy (e-mail: lcapurso@libero.it). The authors declare that they have nothing to disclose. Reprints: Lorenzo Morelli, PhD, Istituto di Microbiologia, U.C.S.C, Via Emilia Parmense 84, Piacenza 29122, Italy (e-mail: lorenzo.morelli@unicatt.it). Copyright r 2012 by Lippincott Williams & Wilkins FOREWORD