Food safety

Infant milk at risk of toxins, new limits from the European Authority

Efsa ruling on effects and doses of cereulide after infant formula recalls in 65 countries

by Silvia Marzialetti

2 February 2026

2' min read

Translated by AI

Versione italiana

Key points

The black list
Dose not to exceed
December alarm
Chinese track

2' min read

Translated by AI

Versione italiana

Code of Conduct and new risk assessment limits. While the recalls of nursable infant formulabrands Nestlé, Danone, Lactalis due to the presence of the cereulide toxin are being investigated in 65 countries, the EU Food Safety Authority (EFSA) is intervening with a new regulation. The aim is to guide EU risk managers with regard to possible further recalls in line with precautionary public health measures.

The black list

Meanwhile, according to Efsa, blacklisted products should not be given to infants, or young children, and those who develop vomiting or diarrhoea after consuming infant formula included in the recalled batches should consult a paediatrician. If severe symptoms such as dehydration or persistent vomiting occur, they should go to the emergency room immediately.

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The dose not to be exceeded

In the newly released document, Efsa scientists set an ARfD of 0.014 μg/kg body weight . The ARfd - writes the Authority - is a new term in the glossary for "acute reference dose" and corresponds to an estimate of the amount of a substance present in food, normally expressed on a body weight basis (mg/kg or μg/kg body weight), that can be ingested in a period of 24 hours or less without appreciable health risk to the consumer.

Since very young infants (below 16 weeks of age) metabolise substances differently from adults, Efsa took a cautious approach and added an additional safety factor when defining this threshold. The report sets a value of 260 ml per kilogram of body weight as the value above which short-term (24-hour) exposure is triggered in infant formula. For follow-on formula, the value is 140 ml per kilogram of body weight. Safety levels are exceeded at a concentration of 0.054 μg/L for infant formula and 0.1 μg/L for follow-on formula.

December alarm

The recalls of several batches and brands (in Italy, Granarolo has also recalled as a precautionary measure Granarolo Bimbi follow-on milk 2 Uht from the Granarolo Bimbi line) for the presence of a toxin produced by the bacterium Bacillus cereus, which causes vomiting and diarrhoea, began in December 2025 .

The Ecdc (European Centre for Disease Prevention and Control) was the first to intervene, providing advice and scientific guidelines to support national investigations and facilitating a timely exchange of information between countries. Parma's intervention responds to the request - forwarded by Brussels - to ensure a coordinated and effective response.

The Chinese track

Recent recounts in the Financial Times attribute the matrix of the infection to arachidonic acid (ARA)-rich oil supplied by a single producer in China. The substance, contaminated with the cereulide toxin at a laboratory in Wuhan, was allegedly added to hundreds of product lines distributed in more than 65 countries. In France, meanwhile, the suspicious death of two infants who had consumed the incriminated batches is being investigated. Although the direct causal link has not yet been confirmed by the public prosecutors' offices of Bordeaux and Angers.