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WASHINGTON — The Council for Responsible Nutrition (CRN), the leading trade association for the U.S. dietary supplement and functional food industry, announced Monday the favorable outcome from consideration of proposed international regulatory guidelines on probiotics at the recent Codex Alimentarius committee meeting.
Following hours of deliberation where some countries pushed for the global organization to begin new work on a Probiotics Guideline, the Codex Committee on Nutrition and Foods for Special Dietary Uses, 44th session (CCNFSDU44), held in Dresden, Germany, on September 30-October 5, 2024, agreed to reject the proposal for new work. Instead, CCNFSDU44 requested the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) to conduct a review of their previous documents, incorporating a new review of scientific evidence on probiotics. CRN has advocated continually since 2017, when this proposal was first brought to Codex, that the WHO and FAO documents are the global reference point and progressing this new work could have unnecessary implications on trade.
The proposal from Argentina, Malaysia and China contained a scope of work that was still unclear to the Committee and included a definition of probiotics that required such products to demonstrate the ability to “confer a health benefit on their host.” The proposal as presented would likely have resulted in opening up debates around the standard of evidence for demonstrating a clear and beneficial effect on human health, referred to as a “host-benefit.”
CRN’s long-term strategic advocacy, working with its colleagues at its member companies, contributed to the favorable outcome to reject the prioritization of new work on the proposal contained in the “Discussion Paper on Harmonized Probiotic Guidelines.” CRN appreciates the CCNFSDU44 decision to not start work that was going to replicate what already exists in FAO/WHO documents and is widely used (and would have been redundant), or would modify the definition which is already a reference point across the world.
This conclusion signals that it will likely be several years before the proposed probiotic guidelines will be reconsidered. Codex member states were encouraged to provide resources for FAO/WHO to initiate such work, but it is uncertain when sufficient resources could be secured for the work to review FAO/WHO’s “Health and Nutrition Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria” (2001) and “Guidelines for the Evaluation of Probiotics in Food” (2002).
“We are pleased with the outcome of these discussions at CCNFSDU44, which validates CRN’s proactive and balanced approach to probiotic regulation,” said CRN’s James Griffiths, Senior Vice President, International & Scientific Affairs. “Our goal is to ensure that safe and high-quality probiotic products remain accessible to consumers, while avoiding regulatory measures that do not enhance product safety or efficacy. All other dietary supplement ingredients are accommodated in current Codex standards, which focus on safety, efficacy, labeling, etc., without the need for a de novo vertical standard just for probiotic ingredients.”
CRN's sustained efforts have emphasized the importance of preserving a science-based, global regulatory environment that recognizes the proven safety profile and value of probiotics. This positive decision at Codex reinforces CRN’s ongoing commitment to advocating for policies that allow companies to bring trusted products to consumers worldwide.
As an internationally recognized leader in the field of dietary supplements and functional foods, CRN continues to engage actively at Codex and other regulatory bodies to ensure that global standards reflect the most current science and support a thriving health and wellness industry. CRN was the first U.S.-based non-government organization (NGO) to receive Observer status at Codex to advocate on behalf of dietary supplements. CRN annually hosts a scientific symposium in conjunction with the CCNFSDU meeting to educate regulators and other stakeholders on the latest in nutrition science.
