Recent recalls of infant formulas from leading brands have shaken lawmakers and the industry and alerted parents.

• In January 2026, Nestlé initiated a global recall of specific batches of infant formula (SMA, BEBA, NAN, Alfamino) due to potential contamination with cereulide, a toxin from Bacillus cereus.
• In January 2026, Danone recalls batches of Aptamil baby formula due to a scare of potential contamination with cereulide, a toxin from Bacillus cereus.
• Now Lactalis blocks and recalls formula batches due to cerulide concerns.
• Now Sanulac Nutritionals Australia (a Danone-related entity) infant formula products are under recall in Australia due to potential contamination with Bacillus cereus bacteria.

Cereulide is a toxin produced by certain strains of Bacillus cereus during germination. It produces fast vomiting and nausea, as well as more serious illnesses such liver failure and NEC. French officials are investigating the deaths of two babies in France who reportedly consumed contaminated Nestlé newborn formula.

Cereulide cannot be inactivated or removed in food by the normal processes like pasteurisation, as it is extremely heat stable.

The contamination is suspected to come from arachidonic acid oil (ARA), which is a special oil used in infant formula. A Chinese supplier is under investigation. 

The safety of the infants is the first priority of public health authorities and the industry. 

The public health authorities need to respond to these contaminations. To inform risk management decisions, EFSA has been requested by the European Commission to provide scientific advice on the contamination threshold above which products should be recalled. The request includes two specific questions:

• Establish an Acute Reference Dose (ARfD) for cereulide in infants.
• Provide information on typical and higher-end consumption levels of infant formula. 

The advice will be published on EFSA’s website at the beginning of the week starting 2 February 2026.

However, we believe that this is insufficient. Norms for Bacillus cereus and maximum amounts of the cereulide toxin in newborn formula need to be established quickly. 

Every infant formula manufacturer will need to move rapidly to reduce the risk. So what could be done?

The focus should be on risk prevention:

• Prevent access by establishing precise ingredient specifications, procuring COAs, and implementing an analytical procedure for all key ingredients. Milk and milk derivatives may present a unique challenge in this regard. Be extremely picky in your supplier selection, and approve only after an audit that focuses on Bacillus cereus access and growth risk, as well as toxin formation. To prevent access to the industrial environment, implement stringent zoning and change areas. 
• Prevent growth and toxin generation by assessing sanitary equipment design, validating CIP and cleaning methods, and including Bacillus cereus in the environmental monitoring plan. Ensure quick cooling and heating. Special attention should be paid to operations that take products across the mesophilic temperature range. 
• Prevent cross-contamination. Ensure all barriers to prevent cross-contamination are in place.

It is recommended to analyse and release the finished products based on both Bacillus cereus and cereulide latest when norms have been established by the public health authorities.