The 44th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU44) convened in Dresden from October 2 to 6, 2024, marking a significant yet inconclusive step in the global discussion on harmonized probiotic guidelines. A key agenda item was the “Discussion Paper on Harmonized Probiotic Guidelines for Use in Foods and Food Supplements,” prepared by an Electronic Working Group chaired by Argentina with co-chairs from Malaysia and China.
The session witnessed polarized responses to the proposal. While many member countries backed the initiative, others argued it was premature or lacked sufficient focus. FAO/WTO representatives noted that “there is potential for a review, but financial resources should be provided by the countries.” This statement underscored the practical and financial considerations affecting the proposal’s progress.
Rosanna Pecere, representing the International Probiotics Association (IPA), voiced her disappointment at the session’s outcome. “Thirteen Codex members, representing nearly 75% of the global population, supported dedicated Codex guidelines for probiotics. Codex appears to have missed a unique opportunity to offer clarity for consumers worldwide. The scientific foundation on probiotics’ safety and functionality was established by FAO/WHO over two decades ago. Does CCNFSDU’s stance imply an outdated definition?”
The proposal by Malaysia and China received support from several national delegations, particularly in Asia, the African Union, and Saudi Arabia. In a notable shift, the European Commission moved from opposition to a position of “no objection, but with concerns.” This shift may have been influenced by an ongoing Ombudsman inquiry into the European Commission’s approach to probiotics, reflecting the EU’s own evolving stance on the topic.
Delegates from various regions stressed that while many probiotic products have a robust scientific foundation for health benefits, the market also contains products that either do not meet established definitions or pose potential safety risks. Guidelines, they argued, would empower countries to develop legislation that ensures probiotic products meet safety and labeling standards, supporting consumer trust and informed decision-making.
As Malaysia, co-chair of the EWG, highlighted, members emphasized the need for harmonized guidelines encompassing definitions, characterization, safety, and labeling specific to probiotics. Malaysia also clarified that there was no expectation for CCNFSDU to review the safety or efficacy of specific strains or to create approved or banned lists.
China, also co-chair, underscored that the proposed guidelines would align with FAO and WHO recommendations, enabling members to incorporate these standards into national regulations. This alignment, China argued, would promote human health, food safety, consumer protection, and trade consistency worldwide.
In the session’s conclusion, CCNFSDU agreed to maintain the status quo for the next three to five years rather than start to work on new guidelines. The committee requested FAO and WHO to review their existing documents, FAO’s FNP 85, developed after expert consultations in 2001 (Argentina) and 2002 (Canada), which currently guide probiotic evaluation. FAO and WHO committed to updating these documents with new scientific evidence, including systematic reviews, as part of their review process.
Once the review of the two documents will be completed, a new work proposal on probiotics could be reconsidered.
