Considering multi-country recalls of infant formula products following the detection of cereulide, a toxin produced by some strains of Bacillus cereus, the European Food Safety Authority (EFSA) established the acute reference dose for cereulide in infants. On the basis of infant formula consumption, the EFSA also defined the cereulide concentrations in infant formula of potential safety concern. These data will help EU risk managers determine when products should be withdrawn from the market as precautionary health measure.
Background:
Infant preparations sold in Europe and outside of Europe were recalled and withdrawn in December 2023 and Janauary 2024, following the detection of cereulide, a thermostable toxin produced by some strains of Bacillus cereus. This toxin can cause sudden nausea, vomiting and diarrhea 30 minutes to 6 hours after consumption. The European Centre for Disease Prevention and Control has received reports of diarrhoea in infants following consumption of recalled products. National investigations are ongoing.
In this context, the European Commission requested the EFSA an urgent scientific advice for assessing the risk linked to cereulide ingestion in infants.
Risk assessment on cereulide in infants:
The European Commission asked the EFSA to provide a rapid risk assessment on cereulide in infants based on the available toxicological data. Vomiting was considered as the critical endpoint for the acute effects of cereulide in infants. On the basis of outcomes from toxicological studies performed on relevant animal models, the EFDA established the acute reference dose of cereulide in infants by applying a default uncertainty factor and taking into account reduced metabolism and renal excretion in infants. The acute reference dose of cereulide is 0,014µg/kg of body weight. In addition, when considering the acute infant formulae consumption data, the EFSA determined that the cereulide concentrations in reconstituted liquid infant preparations above:
- 0,054 µg/L in infant formulae and foods for special medical purposes targeted for infants below 16 weeks
- 0,1 µg/L in follow up formulae and foods for special medical purposes targeted for infants ≥ 16 weeks to < 12months of age may lead to safe levels being exceeded.
Application in public health concern:
These maximal levels help the national authoritative bodies in the EU to determine when the infant preparations should be withdrawn from the market as a precautionary measure.
To know the details of the rapid risk assessment of cereulide in infants, consult the EFSA scientific advice here.
Orchidali can help you to follow the EU regulatory updates.
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EFSA definition of the acute reference dose for cereulide in infants
Considering multi-country recalls of infant formula products following the detection of cereulide, a toxin produced by some strains of Bacillus cereus, the European Food Safety Authority (EFSA) established the acute reference dose for cereulide in infants. On the basis of infant formula consumption, the EFSA also defined the cereulide concentrations in infant formula of potential safety concern. These data will help EU risk managers determine when products should be withdrawn from the market as precautionary health measure.
Background:
Infant preparations sold in Europe and outside of Europe were recalled and withdrawn in December 2023 and Janauary 2024, following the detection of cereulide, a thermostable toxin produced by some strains of Bacillus cereus. This toxin can cause sudden nausea, vomiting and diarrhea 30 minutes to 6 hours after consumption. The European Centre for Disease Prevention and Control has received reports of diarrhoea in infants following consumption of recalled products. National investigations are ongoing.
In this context, the European Commission requested the EFSA an urgent scientific advice for assessing the risk linked to cereulide ingestion in infants.
Risk assessment on cereulide in infants:
The European Commission asked the EFSA to provide a rapid risk assessment on cereulide in infants based on the available toxicological data. Vomiting was considered as the critical endpoint for the acute effects of cereulide in infants. On the basis of outcomes from toxicological studies performed on relevant animal models, the EFDA established the acute reference dose of cereulide in infants by applying a default uncertainty factor and taking into account reduced metabolism and renal excretion in infants. The acute reference dose of cereulide is 0,014µg/kg of body weight. In addition, when considering the acute infant formulae consumption data, the EFSA determined that the cereulide concentrations in reconstituted liquid infant preparations above:
Application in public health concern:
These maximal levels help the national authoritative bodies in the EU to determine when the infant preparations should be withdrawn from the market as a precautionary measure.
To know the details of the rapid risk assessment of cereulide in infants, consult the EFSA scientific advice here.
Orchidali can help you to follow the EU regulatory updates.
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