A new review warns that cereulide can survive processing and reach powdered infant formula through microbially derived lipid ingredients, prompting calls for toxin testing across the supply chain.
Powdered infant formula has long been treated as a low-risk product for microbial growth because it contains very little water, but recent assessments have sharpened concern around a different hazard: a toxin that can survive heat, drying and storage. A review published in the Journal of Food Safety says cereulide, the emetic toxin made by certain strains of Bacillus cereus, can be produced earlier in the supply chain and persist into finished formula even when live bacteria are not detectable. That makes the issue less about contamination after opening and more about what happens during ingredient manufacture, blending and processing.
The review places particular emphasis on fermentation-derived lipid ingredients, especially arachidonic acid and docosahexaenoic acid concentrates made with microbes, which it describes as the main upstream route by which cereulide risk can enter powder formula production. It also explains that the toxin is linked to a gene cluster on a large plasmid carried by emetic B cereus strains, and that ordinary microbiological checks may miss the problem if they do not also look for the toxin itself. According to the paper, the most useful monitoring approach combines microbial counts, screening for the ces gene cluster and direct measurement of cereulide in ingredients and finished products.
That message has gained urgency this year. In February 2026, the European Food Safety Authority set an acute reference dose for cereulide in infants of 0.014 micrograms per kilogram of body weight, using vomiting as the key short-term harmful effect. EFSA said the figure was intended to help risk managers decide when precautionary market withdrawals may be needed. In January 2026, the World Health Organisation also reported a global recall of infant nutrition products after cereulide was detected, underscoring how rapidly the toxin can become a public health concern. Food testing specialists, including the US Food and Drug Administration, have likewise highlighted the need for direct analytical methods such as liquid chromatography-tandem mass spectrometry, or LC-MS/MS, because heat stability and resistance to digestion make the toxin difficult to assess through routine bacterial testing alone.
Taken together, the new review and recent regulatory assessments point to a more supply-chain-focused approach to infant formula safety. Rather than relying only on checks at the end of production, the paper argues that manufacturers should target higher-risk ingredients first, particularly microbially derived lipid concentrates, and build surveillance around both the organism and the toxin it produces. The overall aim, the authors say, is to reduce the chance that a biologically active toxin reaches a product designed for one of the most vulnerable groups of consumers.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
