In a push toward harmonizing the regulation of the global probiotic category, members of the International Probiotics Association (IPA) are working toward the creation of new guidelines within the food and dietary supplement markets. The new guidelines were proposed at the 39th session of the CCNFSDU (Codex Committee on Nutrition and Foods for Special Dietary Uses) meeting in Berlin, Dec. 4-8, 2017.
 
IPA requested a review the current probiotics industry climate with Codex, with the main goal of establishing a more consistent framework for the category. The organization aims to create eligibility criteria and guidelines for the production of probiotic products, with the intention of helping global regulatory agencies construct their own methods of oversight.
 
Defining ‘Probiotic’
An essential step in this process includes redefining the generally accepted definition of “probiotic.” The definition—which was established in a joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria in 2001, (and revised by Hill et al. in 2014)—refers to probiotics as “Live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.” However, IPA recognized the global problem of products being sold as probiotics that do not meet this definition.
 
According to IPA Executive Director George Paraskevakos, this FAO/WHO definition is “well respected from not only the probiotic community, but also the scientific and regulatory communities since its inception.” However, he said, this definition “only provides a very general guidance for the recognition of the health benefit and consumer demand for probiotic foods, in a world where a global regulatory landscape is not harmonized. Due to the technological and scientific advances within the probiotic industry since the FAO/WHO work, we are now at a crossroads and a broader scope is required to include these advancements into new guidelines.”
 
Guidelines & Standards
The FAO/WHO Consultation in 2001, and the subsequent Expert Working Group, created a methodology for evaluating probiotics and criteria for substantiating health claims for probiotic foods (but not bio therapeutic agents or probiotics not included in food). These guidelines helped lay the groundwork for the initial oversight of the emerging probiotic category, despite the lack of international consensus.
 
Yet, as more probiotic products have made their way to the international marketplace, and as the science supporting the health benefits of probiotics has evolved with time, IPA recognized the need for revisiting this initial framework.
 
Discussing the need for a more unified probiotic industry, Mr. Paraskevakos expressed that, “The lack of harmonization in industry practice and legislation remains and often leads to serious issues and concerns for the probiotics industry, regulators, and even consumers in regard of quality, safety, and labeling.”
 
IPA believes that an organized framework for probiotic products will provide a guideline for global regulatory agencies to build probiotics-focused regulations, he explained. “The establishment of global requirements will satisfy the triumvirate of authorities, consumers and industry, and will certainly lead to better consumer satisfaction, health, and well-being. Moreover, the development of guidelines and a harmonized framework for probiotics, including general specifications and considerations is necessary to ensure and sustain quality probiotic products on a global scale.”
 
To encourage the same level of quality and manufacturing requirements across all probiotic products in the international marketplace, IPA called for the development of an Alimentarius guidance or standard to more clearly define what constitutes a safe and effective probiotic supplement of food.
 
Proposing to initiate a dedicated “New Work on Harmonized Probiotic Guidelines for Use in Foods and Dietary Supplements,” the IPA delegation was met with support for its suggested endeavor. With approval from many national delegations, Argentina’s delegation requested to take the lead in this task, and committed to preparing a document on the content and scope of the new work at next year’s CCNFSDU meeting.
 
In addition to redefining probiotics and building upon the criteria introduced by FAO/WHO, the new work will look to establish safety criteria, manufacturing standards, and determining effective dosage thresholds.
 
Next Steps
The plan set into action at the CCNFSDU meeting is the start of a lengthy, highly regimented process, Mr. Paraskevakos explained. “As the activities within Codex are strictly regulated and protocol-oriented, we expect this work will be long term. But the IPA considers it an essential part of the process for the harmonization of the probiotic framework.”
 
Looking ahead, Mr. Paraskevakos said Argentina will begin working on a discussion paper, which will form the basis for the project document for new work on probiotics. This, he said, will be submitted at the next CCNFSDU meeting in November 2018, “where an electronic Working Group of interested countries will be established and the process for establishing a new framework begins.”