BuRO risk assessment on cereulide in instant noodles with flavouring substance

Reason for the assessment

On 5 January 2026, Nestlé recalled a number of batches of infant formula from the market due to the presence of the bacterial toxin cereulide. Cereulide can cause symptoms such as vomiting and diarrhoea.

Cereulide is produced by strains of the bacterium Bacillus cereus. The cereulide in Nestlé's infant formula was found to originate from the raw material arachidonic acid oil. Arachidonic acid oil is used not only in infant formulas, but also in flavouring substances for instant noodles and possibly also in other foods, including food supplements.

On 8 January 2026, Directorate Enforcement of NVWA asked BuRO for a risk assessment of cereulide in food.

Approach

The risk assessment is based on the acute reference dose (ARfD: maximum intake during 24 hours) for cereulide in infant formula. This ARfD was published by the European Food Safety Authority (EFSA) on 2 February 2026. In addition, BuRO has conducted a literature search. Long-term effects of cereulide intake have not been assessed.

BuRO did not carry out chemical analyses of its own. For the risk assessment, BuRO used data from other parties: Nestlé provided cereulide concentration data in arachidonic acid oil and noodle producers shared recipe data.

Questions and answers

These are the questions posed and the answers.

What level of cereulide (bacterial toxin) is harmful when consumed?

The harmfulness of cereulide intake depends on the following aspects:

• the food in which cereulide is present
• the quantity of consumption (portion size)
• the population group

Infants are very vulnerable. The ARfD for infant formulae and follow-on formulae was recently set by EFSA at 0.014 μg/kg body weight. For less vulnerable population groups, the ARfD is higher. The ARfD of cereulide for food not intended for infants is 0.042 μg/kg body weight.

Is harmfulness dependent on other factors such as the food in which the cereulide occurs (e.g. moisture versus solid, fat content, acidity, temperature or other aspects) or age at consumption (especially infants, young people in growth versus adults)?

Properties such as moisture content, fat content or acidity have no effect on the harmfulness (health effects) of cereulide. However, there are several factors that influence the growth of bacteria that can produce cereulide in a food. Examples of these types of factors are storage and process temperature.

Infants may be more sensitive to the effects of cereulide. Infants are less able to metabolise and excrete certain substances. In addition, infants are completely dependent on infant formula.

The ARfD is determined per kg body weight. This means that the ARfD is exceeded earlier in children: they have a lower body weight than adults.

Is it possible to inactivate cereulide (since it is a polypeptide, perhaps better: irreversibly denature)?

Cereulide cannot be inactivated or denatured. Cereulide is heat- and pH-resistant and cannot be filtered out of a food.

Cereulide in flavour instant noodles

When consuming a 250 g serving of instant noodles with flavouring substance, the exposure to cereulide is 0.0033 μg/kg body weight for a 60-kg adult. Children weighing 12 kg, who eat half a serving (125 g) are exposed to 0.0033 μg cereulide/kg body weight. This is well below the ARfD of 0.042 μg/kg body weight.

Cereulide in other foods and food supplements

• The maximum amount of cereulide that can be present in a food in order not to exceed the ARfD depends on the portion size of a food. Children (12 kg) may be exposed to up to 0.504 μg cereulide, and adults (60 kg) to up to 2.52 μg.
• A food supplement containing 1800 mg arachidonic acid oil may contain up to 1.8 mg cereulide/kg arachidonic acid oil.