ISSN 0254-4725 FAO Probiotics In Food FOOD AND NUTRITION .

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ISSN 0254-4725Probiotics in foodHealth and nutritional propertiesand guidelines for evaluationThis paper includes joint FAO and WHO work to evaluate the latest information and scientificevidence available on the functional and safety aspects of food probiotics, as well as themethodology to assess such aspects, by bringing together worldwide scientific experts in thefield. It includes the reports of the expert consultation and of the working group. These reportsprovide scientific advice in relation to the safety assessment of probiotics, general guidancefor their evaluation and on specific questions in relation to their pathogenicity, toxigenicity,allergenicity, as well as to their functional and nutritional properties. The guidelines for theevaluation of probiotics in foods were developed as part of this joint effort, providing criteriaand methodology to assess the efficacy and the safety of these productsISBN 92-5-105513-09789251ISSN 0254-4725055137TC/M/A0512E/1/05.06/800FAOFOOD ANDNUTRITIONPAPER85

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ForewordThe beneficial effects of probiotic foods on human health and nutrition are increasinglyrecognized by health professionals. Recent scientific work on the properties andfunctionality of living micro-organisms in food have suggested that probiotics play animportant role in immunological, digestive and respiratory functions, and that they couldhave a significant effect on the alleviation of infectious diseases in children and otherhigh-risk groups. In parallel, the number and type of probiotic foods and drinks that areavailable to consumers, and marketed as having health benefits, has increasedconsiderably.In view of this growing popularity of probiotic foods, and the lack of internationalconsensus on the methodology to assess their efficacy and the safety, FAO and WHOinitiated work to examine the scientific evidence on the functional and safety aspects ofprobiotics in food. In particular, an expert consultation on the health and nutritionalproperties of powder milk with live lactic acid bacteria was convened by FAO and WHOin Cordoba, Argentina in 2001, and an expert working group organized in 2002 todevelop guidelines for the evaluation of probiotics in food.The FAO/WHO consultation in 2001 brought together international scientific experts toevaluate available information on the functional and safety aspects of probiotics inpowder milk. The consultation examined available scientific information on the dietaryimpact of probiotics, evaluated their properties, benefits, safety and nutritional features,and considered their potential adverse effects, taking into consideration work done bynational authorities, FAO, WHO and other international organizations and relevant globalfora. It reviewed the scientific basis for health claims linked to probiotic foods,considered regulatory needs and discussed strategies for the safety and nutritionalassessment of probiotics, taking into account public concerns and food safety evaluationfindings. The consultation generated a number of recommendations for further research,as well as priorities for the evaluation of safety and nutritional aspects of probiotics andregulatory requirements.In follow-up to this consultation, FAO and WHO convened an expert working group todevelop Guidelines for the Evaluation of Probiotics in Food. The resulting Guidelinesprovide a methodology for use in the evaluation of probiotics, and define the criteria andspecific levels of scientific evidence needed to make health claims for probiotic foods.By supporting the development of scientific knowledge on the functional and safetyaspects of probiotics, FAO and WHO hope to enhance the overall safety and quality offood for consumers. In particular, it is hoped that the outputs of the FAO/WHO expertconsultation and working group on probiotics will be used as a science-based assessmentprocess for managerial decisions on probiotics, and that the Guidelines for the Evaluationof Probiotics in Food will provide a practical model to scientifically evaluate probioticsand be adopted by industry. It is also expected that these outputs will be useful fornational work on health and nutrition claims, and as a scientific assessment of a novelfood.

Health and Nutrition Properties of Probiotics in Foodincluding Powder Milk with Live Lactic Acid BacteriaReport of a Joint FAO/WHO Expert Consultation onEvaluation of Health and NutritionalProperties of Probiotics in Food including Powder Milk with LiveLactic Acid BacteriaCordoba, Argentina1-4 October 2001The opinions expressed in this report are those of the participants of the Working Group and donot imply any opinion on the part of FAO and WHO

Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics inFood including Powder Milk with Live Lactic Acid Bacteria, 1-4 October 2001CONTENTS1.Introduction. 12.Background. 13.Scope. 14.History of Probiotics. 25.Guidelines for the Assessment ofProbiotic Microorganisms. 45.15.25.3Selection of probiotic strains for human use. 4Classification and identification of individual strains. 5Defining and measuring the health benefits of probiotics. 56.Testing methods for establishing health benefits conferredby probiotic microorganisms. 127.Safety considerations. 137.17.28.Antimicrobial resistance profiles of probiotics. 13Safety of probiotics in humans. 14Probiotic product specifications, quality assurance andregulatory issues . 158.18.28.38.4Regulatory issues . 15Appropriate labeling . 16Manufacturing and handling procedures. 16Prebiotics. 179.Post market surveillance. 1710.Conclusions. 1811.Recommendations. 1812.List of abbreviations. 2013.References. 21v

Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics inFood including Powder Milk with Live Lactic Acid Bacteria, 1-4 October 2001Annex 1: List of ParticipantsExperts. 28Authors of working papers. 29FAO/WHO Secretariat. 30vi

Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics inFood including Powder Milk with Live Lactic Acid Bacteria, 1-4 October 20011.IntroductionA joint Food and Agriculture Organization of the United Nations/World HealthOrganization (FAO/WHO) Expert Consultation on Health and Nutritional Properties ofPowder Milk with Live Lactic Acid Bacteria was held in the Amerian Cordoba ParkHotel, Cordoba, Argentina from 1 to 4 October 2001. The Consultation, which was thefirst meeting of this group, focused on the evaluation of the scientific evidence availableon the properties, functionality, benefits, safety, and nutritional features of probioticfoods. A total of 11 experts from 10 countries participated in the Consultation. Thecomplete list of participants is given in Annex 1.Mr Juan Schiaretti, Minister of Production of the Province of Cordoba, opened theConsultation. He acknowledged the need for sound scientific evidence to substantiatehealth benefits associated with probiotic foods. Mr Victor Faraudo, Secretary ofAgriculture of the Province of Cordoba; Mr Carlos Debandi, President of the CordobaScience Agency, and Mr Eduardo Echaniz, Coordinator of the National CodexCommittee also gave welcome addresses. Dr Jorgen Schlundt and Dr Maya Pineiro spokeon behalf of the World Health Organization and the Food and Agriculture Organization ofthe United Nations. In their statements, the importance of probiotics to the health of thehuman population was indicated, with particular reference to their potential in developingcountries.The Consultation elected Dr Gregor Reid as Chairperson and Dr CatherineStanton as Rapporteur.2.BackgroundThe beneficial effects of food with added live microbes (probiotics) on humanhealth, and in particular of milk products on children and other high-risk populations, arebeing increasingly promoted by health professionals. It has been reported that theseprobiotics can play an important role in immunological, digestive and respiratoryfunctions and could have a significant effect in alleviating infectious disease in children.As there are no international consensus on the methodology to assess the efficacyand the safety of these products, at present, it was considered necessary to convene anExpert Consultation to evaluate and suggest general guidelines for such assessments.The Consultation evaluated the latest information and scientific evidence availableon the functional and safety aspects of probiotics, as well as the methodology to assesssuch aspects, by bringing together worldwide scientific experts in the field.1

Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics inFood including Powder Milk with Live Lactic Acid Bacteria, 1-4 October 20013.ScopeThe Consultation agreed that the scope of the meeting would include probioticsand prebiotics in food, and exclude reference to the term biotherapeutic agents, andbeneficial microorganisms not used in food. The Consultation has redefined probiotics forthe purpose of this meeting as ‘Live microorganisms which when administered inadequate amounts confer a health benefit on the host’, but restricted its scope todiscussion of ‘Live microorganisms which when consumed in adequate amounts as partof food1 confer a health benefit on the host’. The Consultation agreed that the specificissues related to powder milk could not be discussed without a more generalconsideration of probiotics in food.The Consultation agreed to confine its discussion to the following:a) Properties of probiotic strains and their assessmentb) Probiotic product specifications, quality assurance and regulatory issuesc) Safety and beneficial human health effectsAs background to these discussions, the Consultation received background papers andpresentations on: Taxonomy and physiology of lactic acid bacteria, effects and function on nutrition(Morelli L); Technological and commercial applications of lactic acid bacteria; Health andNutritional Benefits in Dairy Products (Gilliland S); Regulatory and clinical aspects of dairy probiotics (Reid G).The Consultation focused on strains available as probiotics in food. Although theConsultation did not specifically address issues related to genetically modified organisms,the concepts and principles are equally applicable to all probiotics. The potentialimportance of probiotic strains used in animal feeds as they pertain to human health wasrecognized.4.History of ProbioticsThe term probiotic is a relatively new word meaning “for life” and it is currentlyused to name bacteria associated with beneficial effects for humans and animals. Theoriginal observation of the positive role played by some selected bacteria is attributed toEli Metchnikoff, the Russian born Nobel Prize winner working at the Pasteur Institute atthe beginning of the last century, who suggested that "The dependence of the intestinal1Water is included as a food2

Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics inFood including Powder Milk with Live Lactic Acid Bacteria, 1-4 October 2001microbes on the food makes it possible to adopt measures to modify the flora in ourbodies and to replace the harmful microbes by useful microbes" (Metchnikoff, 1907).At this time Henry Tissier, a French paediatrician, observed that children withdiarrhea had in their stools a low number of bacteria characterized by a peculiar, Yshaped morphology. These “bifid” bacteria were, on the contrary, abundant in healthychildren (Tissier, 1906). He suggested that these bacteria could be administered topatients with diarrhea to help restore a healthy gut flora.The works of Metchnikoff and Tissier were the first to make scientific suggestionsconcerning the probiotic use of bacteria, even if the word "probiotic" was not coined until1960, to name substances produced by microorganisms which promoted the growth ofother microorganisms (Lilly and Stillwell, 1965). Fuller (1989), in order to point out themicrobial nature of probiotics, redefined the word as "A live microbial feed supplementwhich beneficially affects the host animal by improving its intestinal balance". A similardefinition was proposed by Havenaar and Huis in 't Veld (1992), “a viable mono or mixedculture of bacteria which, when applied to animal or man, beneficially affects the host byimproving the properties of the indigenous flora”. A more recent, but probably not the lastdefinition is "live microorganisms, which when consumed in adequate amounts, confer ahealth effect on the host" (Guarner and Schaafsma, 1998).It is clear that these definitions have:1) restricted the use of the word probiotic to products which contain livemicroorganisms;2) pointed out the need for providing an adequate dose of probiotic bacteria in order toexert the desirable effects.The observations of Metchnikoff and Tissier were so appealing that commercialexploitation immediately followed their scientific works. Unfortunately, results were notalways positive and most of these observations were anecdotal. The probiotic conceptwas therefore regarded as scientifically unproven and it received minor interest fordecades, with some research involving animal feeding, in order to find healthysubstitutes for growth promoting agents. In the last 20 years however, research in theprobiotic area has progressed considerably and significant advances have been made inthe selection and characterization of specific probiotic cultures and substantiation ofhealth claims relating to their consumption.Members of the genera Lactobacillus and Bifidobacterium are mainly used, butnot exclusively, as probiotic microorganisms and a growing number of probiotic foodsare available to the consumer. Some ecological considerations on the gut flora arenecessary to understand the relevance, for human health, of the probiotic food concept.Bacteria are normal inhabitants of humans (as well as the bodies of upper animalsand insects) including the gastrointestinal tract, where more than 400 bacterial species are3

Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics inFood including Powder Milk with Live Lactic Acid Bacteria, 1-4 October 2001found (reviewed by Tannock, 1999): half of the wet weight of colonic material is due tobacterial cells whose numbers exceed by 10-fold the number of tissue cells forming thehuman body. Normally the stomach contains few bacteria (103 colony forming units perml of gastric juice) whereas the bacterial concentration increases throughout the gutresulting in a final concentration in the colon of 1012 bacteria/g. Bacterial colonization ofthe gut begins at birth, as new-borns are maintained in a sterile status until the deliverybegins, and continues throughout life, with notable age-specific changes (Mitsuoka,1992). Bacteria, forming the so-called resident intestinal microflora, do not normally haveany acute adverse effects and some of them have been shown to be necessary formaintaining the well being of their host.As an example of the beneficial role of intestinal microflora, it is possible to citewhat has been referred to as "colonization resistance" or “barrier effect” (van der Waaij etal., 1971; Vollaard and Clasener, 1994) meaning the mechanism used by bacteria alreadypresent in the gut to maintain their presence in this environment and to avoid colonizationof the same intestinal sites by freshly ingested microorganisms, including pathogens.Therefore, it could be assumed that dietary manipulation of gut microflora, in order toincrease the relative numbers of "beneficial bacteria" could contribute to the well being ofthe host. This was also the original assumption of Metchnikoff who however, cautionedthat:"Systematic investigations should be made on the relation of gut microbes to precociousold age, and on the influence of diets which prevent intestinal putrefaction in prolonginglife and maintaining the forces of the body."This prudent statement can still be regarde

for their evaluation and on specific questions in relation to their pathogenicity, toxigenicity, allergenicity, as well as to their functional and nutritional properties. The guidelines for the evaluation of probiotics in foods were developed as part of this joint effort, providing criteria

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