There have been recalls of infant formula from various manufacturers worldwide in recent weeks. These recalls are mainly precautionary measures due to the possible presence of cereulide in one of the ingredients of a supplier (this is the so-called ARA oil). Cereulide is a heat-stable toxin produced by Bacillus cereus bacteria. Investigations by AGES and the competent food authorities since December 2025 have shown that some of the affected products were also on the market in Austria. The concentrations of cereulide detected at that time were so low that there was no health risk.
However, in a recent sample from last week, a cereulide concentration was detected that is likely to be harmful to health. This product has already been recalled by the manufacturer.
In the current EFSA risk assessment of 2 February 2026, the available scientific basis for the effects of cereulide was re-evaluated. Taking into account a safety factor of 100 and an additional safety factor of 3 for infants, an ARfD of 0.014 µg/kg bw/d (acute reference dose) has now been set for the first time. AGES used the manufacturer's dosage and consumption recommendations on the packaging to assess cereulide exposure for infants of different ages and compared the calculated daily intake with the new ARfD of 0.014 µg/kg body weight. In the product now tested, a cereulide concentration was found that must be assessed as harmful to health under food law, as the ARfD was exceeded several times.
There are still no health concerns for the products that tested positive in December.
The Ministry of Health has commissioned a prioritised campaign in which infant formula from various manufacturers is also being tested for cereulide. The provincial food authorities are taking samples in all provinces and the laboratory tests are being carried out by AGES.