Market Updates, Regulations

New Codex Guidelines on Probiotics Rejected at 44th Committee

New guidelines would incorporate emerging science on probiotics and provide a definition that was met with mixed reactions from the industry.

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By: Mike Montemarano

At the 44th Session of the Codex Committee on Nutrition and Foods for Special Dietary uses (CCNFSDU44), the committee failed to agree to create new guidelines for probiotics, which among other things would establish a new regulatory definition and incorporate emerging science. The final proposal was developed by Argentina, Malaysia, and China.
 
The new guidelines would rely upon the Food and Agriculture Organization (FAO) and World Health Organization (WHO) to conduct a scientific review and systematic analysis to develop proposed Codex-owned guidelines on probiotics.
 
Instead, CCNFSDU44 agreed to keep the status quo with no Codex guides on probiotics for what will likely be at least several years. Instead, the committee requested that FAO and WHO conduct a review of their previous documents, and incorporate a new review of the scientific evidence on probiotics. Codex member states were encouraged to provide FAO and WHO with resources to initiate the work to review the jointly-created “Heatlh and Nutrition Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria” and “Guidelines for the Evaluation of Probiotics in Food.”
 
The International Probiotics Association (IPA) first proposed that Codex Alimentarius consider the topic of globally harmonized guidelines for probiotics in 2017, with the support of other industry organizations such as the International Scientific Association for Probiotics and Prebiotics (ISAPP).
 
The U.S. reported that while it would not oppose CCNFSDU undertaking new work on probiotics if supported by consensus, it didn’t consider it to be a priority at the time.
 
The Council for Responsible Nutrition (CRN), the first U.S.-based non-government organization (NGO) to receive observer status at Codex to advocate on behalf of dietary supplements, commended the decision. Since 2017, they’ve held the position that the new work would have unnecessary implications on trade, and the WHO and FAO’s current documents serve as a global reference point.
 
The key sticking points? The scope of the work wasn’t clear to the committee, and included a definition of probiotics that required products to demonstrate the ability to “confer a health benefit on their host,” which could have opened up debates around the standard of evidence needed to demonstrate a clear and beneficial effect on human health, CRN reported.
 
CRN also considered the proposed work replicative of what already exists and is widely used in FAO/WHO documents, and that it would modify the definition of probiotics which is already a reference point across the world.
 
“We are pleased with the outcome of these discussions at CCNFSDU44, which validates CRN’s proactive and balanced approach to probiotic regulation,” said James Griffiths, senior vice president of international and scientific affairs at CRN. “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, et cetera, without the need for a de novo vertical standard just for probiotic ingredients.”
 

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