EFSA provides rapid risk assessment on cereulide in infant formula

Multi-country recalls of several infant formula products are ongoing following the detection of cereulide – a toxin produced by the bacterium Bacillus cereus. The European Commission asked EFSA to deliver urgent scientific advice to support risk management The management of risks which have been identified by risk assessment. It includes the planning, implementation and evaluation of any resulting actions taken to protect consumers, animals and the environment decisions across the EU.

In their rapid risk assessment, EFSA’s scientists established an acute reference dose (ARfD) for cereulide in infants and established cereulide concentrations in infant formula of potential safety concern. This advice is intended to help EU risk managers determine when products should be withdrawn from the market as a precautionary public health measure.

Key scientific findings

A health-based guidance value Guidance on safe consumption of substances that takes into account current safety data, uncertainties in these data, and the likely duration of consumption for infants

EFSA’s scientists proposed an ARfD An acute reference dose (ARfD) is the estimate of the amount of a substance in food – normally expressed on a body-weight basis (mg/kg or μg/kg of body weight) – that can be ingested in a period of 24 hours or less without appreciable health risk to the consumer. of 0.014 μg/kg body weight for cereulide in infants. Emesis (vomiting) is the critical acute adverse effect A change in the health, growth, behaviour or development of an organism that impairs its ability to develop or survive used to set the ARfD, which was derived using benchmark dose The minimum dose of a substance that produces a clear, low level health risk, usually in the range of a 1-10% change in a specific toxic effect such as cancer induction modelling. Because very young infants (below 16 weeks) metabolise substances differently from adults, EFSA took a cautious approach and added an extra safety factor when setting an ARfD.

Consumption values used to estimate acute exposure A one-off or very short term exposure to a substance, usually less than 24 hours

For infant formula, EFSA confirmed that a value of 260 mL per kilogram of body weight remains appropriate for estimating short-term (24-hour) exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. For follow-on formula Breast milk substitute aimed at infants who have commenced complementary feeding (i.e. the introduction of solid foods at or around 6 months of age) – which is generally not consumed by infants younger than 16 weeks – EFSA confirmed a value of 140 mL per kilogram of body weight for the same purpose. These values are based on the higher end of what infants typically drink, so that the assessment stays conservative.

Concentrations that may lead to exceedance of the ARfD

By comparing the ARfD with these high consumption values, EFSA concluded that cereulide concentrations in reconstituted (liquid) infant formula above:

• 0.054 μg/L for infant formula, and
• 0.1 μg/L for follow-on formula,

may lead to safe levels being exceeded.

Public health advice and recommendations

Recalled products should not be given to infants or young children. Consumers are advised to follow the instructions and guidance issued by national food safety authorities.

For infants who develop vomiting or diarrhoea after consuming infant formula included in the recall, the European Centre for Disease Prevention and Control (ECDC) recommends seeking medical advice from a healthcare professional, such as a paediatrician, or, if the symptoms are severe (e.g., dehydration or persistent vomiting), at an emergency department. Gastrointestinal symptoms in infants can rapidly lead to complications, regardless of the underlying cause.

More information

• Background on the ongoing recalls: Precautionary global recall of infant nutrition products following detection of Bacillus cereus toxin
• EFSA’s rapid risk assessment (scientific advice): Rapid risk assessment on acute reference dose (ARfD) of cereulide in infants and information on acute consumption of infant formulae