Prompted by a global food safety incident and infant formula recalls spanning 99 countries, the European Commission has drafted a regulation that would set a limit of 1 µg/kg cereulide toxin in dried formula products. The draft regulation is open for public feedback.
Considering the unprecedented ByHeart and Nara Organics infant botulism outbreak and with a focus on dairy ingredients, participants emphasized the need for prevalence research, more sensitive and standardized testing, data-sharing, validated preventive controls, and coordinated industry action.
Regulation (EU) 2026/1825 expands MLs for 3-monochloropropanediol (3-MCPD) and glycidyl fatty acid esters, and Regulation (EU) 2026/1890 establishes new MLs for furan, 2-methylfuran, and 3-methylfuran.
The Nara Organics infant botulism outbreak has ended, with four sick in three states. Whole genome sequencing (WGS) findings and a shared powdered milk supplier/processor indicate a common source of contamination with the 2025 outbreak linked to ByHeart infant formula.
Following the global infant formula recall linked to cereulide contamination, Elena Medo discusses vulnerabilities in infant formula supply chains, infant-specific food safety risks, surveillance gaps, donor milk safety, and the lessons regulators and manufacturers can take away from this unprecedented event.
JEMRA convened in June to review the latest scientific evidence on microbiological hazards that have recently been associated with public health events due to the contamination of powdered infant formula or its ingredients.
The letter to industry was issued in response to the botulism outbreaks linked to Nara Organics and ByHeart formulas, which identified Clostridia in the whole milk powder ingredient supply chain, as well as the global formula recall due to cereulide-contaminated arachidonic acid oil.
Four infants in three states have been hospitalized with botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula. California public health officials have detected Clostridium botulinum in an open can of Nara Organics formula collected from the home of an outbreak patient.
This episode of Food Safety Five covers a novel detection method for Clostridium botulinum and a potential new processing approach to mitigate contamination, as well as growing discussion around how C. botulinum should be handled in infant formula manufacturing, spurred by recent botulism outbreaks.
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