Europe’s food-safety regulator has set a limit for cereulide before the toxin linked to a global infant-formula recall poses a health risk.
Following a “rapid risk assessment” after a request from the European Commission, the European Food Safety Authority (EFSA) today (2 February) published its advice, setting a threshold for cereulide at the same level laid down by France last week of 0.014 micrograms per kg of body mass.
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By setting a maximum acute reference dose (ARfD) for the toxin in infants, the EFSA seeks to “help EU risk managers determine when products should be withdrawn from the market as a precautionary public health measure”.
Cereulide is connected to the Bacillus cereus bacterium and can trigger vomiting, abdominal cramps and diarrhoea in infants.
The detection of the toxin in Nestlé formula in December prompted a European recall that went global in January. French peers Lactalis and Danone also recalled products last month, along with a host of smaller baby formula producers.
The source of the cereulide toxin concerned has been linked to a supplier in China of arachidonic acid (ARA) oil.
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By GlobalDataExplaining its decision, the EFSA said today: “Emesis (vomiting) is the critical acute adverse effect used to set the ARfD, which was derived using benchmark dose 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.”
On Friday, France lowered its own ARfD following investigations at the Europe-wide level. The Ministry of Agriculture and Food Sovereignty cut its reference rate from 0.03 micrograms per kg.
In so doing, the Ministry said further recalls could be expected.
Meanwhile, the EFSA detailed the conditions for its assessment based on “consumption values used to estimate acute exposure” to cereulide.
The regulator explained: “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.
“For follow-on formula – 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.”
EFSA also provided guidance on consumption levels that could risk the exceedance of the newly defined ARfD based on reconstituted infant formula.
It said 0.054 micrograms per litre or infant formula and 0.1 micrograms per litre for follow-on formula “may lead to safe levels being exceeded”.
French prosecutors in Angers and Bordeaux have launched investigations after receiving reports that two infants had died from the consumption of the Nestlé formulas in question.
France’s Ministry of Health, Families, Autonomy and Persons with Disabilities, through its Health Crisis Centre, has previously confirmed the investigations but said there was no evidence of a link between the formula eaten by the babies and their symptoms.
Nestlé has also insisted it is not aware of any deaths but admitted last week it had detected “very low levels” of the toxin cereulide in formula samples at the end of November – ten days before informing local authorities.
