FAO/WHO Experts Recommend Updating Codex Powdered Infant Formula Guidance to Consider Clostridia, B. cereus
The Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Meetings on Microbiological Risk Assessment (JEMRA) has recommended updates to the Codex Alimentarius guidance, Code of Hygienic Practice for Powdered Formula for Infants and Young Children (CXC 66-2008), following a review of emerging microbiological hazards associated with powdered formulas. The meeting, held in Rome, Italy, on June 15–19, 2026, was convened at the request of the Codex Committee on Food Hygiene (CCFH) in response to continued outbreaks and recalls linked to powdered formula.
The expert group reviewed the latest scientific evidence on Cronobacter, Salmonella, botulinum neurotoxin (BoNT)-producing clostridia like Clostridium botulinum, and cereulide toxin produced by Bacillus cereus, all of which have been associated with contamination of powdered infant formula or its ingredients. Within just the last year, the U.S. experienced two infant botulism outbreaks linked to infant formula, and the rest of the world experienced extensive formula recalls due to cereulide contamination.
The latest review expanded JEMRA's previous priority hazards to include BoNT-producing clostridia and B. cereus/cereulide, while also recommending continued monitoring of other microorganisms—including Enterococcus, Pseudomonas, and Candida species—for their potential risk in powdered formula.
Among its recommendations, JEMRA called for stronger supplier risk management programs, enhanced environmental monitoring that includes pathogen-specific testing, improved hygienic practices in manufacturing, and additional on-farm measures to reduce spore contamination of dairy ingredients. The experts also recommended updating consumer guidance on powdered formula preparation, handling, and storage, noting that current preparation recommendations developed for Cronobacter and Salmonella may not adequately address the risks posed by BoNT-producing clostridia or cereulide-producing B. cereus.
The group also identified significant knowledge gaps, including limited surveillance data on illnesses associated with powdered formula and challenges in assessing risks posed by toxin-producing microorganisms. The recommendations will inform a future revision of the Codex Code of Hygienic Practice.
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