EU Body Recommends Toxin Limits in Baby Formula, Leading to Increased Recalls
On Monday, the European food safety authority issued a recommendation regarding a maximum threshold for cereulide toxin in infant formula. This announcement has prompted several French producers to withdraw additional products from the market.
Cereulide is a toxin known to cause nausea and vomiting, and it has been detected in ingredients sourced from a Chinese factory that supplies major formula manufacturers, including Nestle, Danone, and Lactalis. The contamination has led to recalls of infant formula across numerous countries, raising significant concerns among parents.
Read more: Europe to Decide How Much Toxin in Baby Formula Is Too Much
In response to the situation, the European Commission requested the European Food Safety Authority (EFSA) to urgently establish a scientific safety threshold, known as an acute reference dose (ARfD). This threshold is intended to guide governments and producers on when products should be removed from shelves.
EFSA’s assessment proposed a new limit of 0.014 micrograms per kilogram of body weight for infants. The agency emphasized that very young babies metabolize substances differently and require additional protection. Vomiting was identified as the primary short-term symptom used to determine this threshold.
The French farm ministry, which had anticipated EFSA’s advice over the weekend, noted that the new level is more than half lower than the previous one. They warned that this would likely lead to further precautionary recalls.
In light of the new threshold recommendation, French manufacturers Vitagermine and Popote announced on Monday that they would be withdrawing batches of infant milk from the market.
Danone and Nestle Welcome Threshold
Both Danone and Nestle have expressed their support for the EFSA guidance. However, Lactalis stated that the new threshold would not alter the scope of its existing recall.
Analysts from Barclays indicated that neither Danone nor Nestle should face additional product recalls. Jefferies also noted that the new thresholds “suggest that further recall risks for Danone & Nestle are limited.” Following this news, Danone’s shares closed 4.7% higher, while Nestle’s rose by 2.8%. (Editor’s note: This article was published by Reuters on February 2).
The French agriculture ministry identified Cabio Biotech, a Chinese producer, as the source of the arachidonic acid (ARA) oil linked to the contamination. Cabio Biotech could not be reached for comment outside of working hours.
While EFSA’s recommendations are not legally binding, EU countries typically adhere to them when deciding whether to recall food products or impose sales restrictions. The agency also estimated the amount of formula that infants are likely to consume in a 24-hour period, allowing scientists to calculate when the new limit might be exceeded.
Based on these consumption levels, EFSA determined that cereulide concentrations exceeding 0.054 micrograms per liter in infant formula and 0.1 micrograms per liter in follow-on formula could pose safety concerns.
Additionally, French investigators are currently examining whether there is a connection between the deaths of two infants and the recalled formula products. The health ministry has stated that there is no evidence linking the two at this time, with results expected in the coming days.
(Reporting by Sybille de La Hamaide, additional reporting by Alexander Marrow; editing by Ros Russell)
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On Monday, the European food safety authority issued a recommendation regarding a maximum threshold for cereulide toxin in infant formula. This announcement has prompted several French producers to withdraw additional products from the market.
Cereulide is a toxin known to cause nausea and vomiting, and it has been detected in ingredients sourced from a Chinese factory that supplies major formula manufacturers, including Nestle, Danone, and Lactalis. The contamination has led to recalls of infant formula across numerous countries, raising significant concerns among parents.
Read more: Europe to Decide How Much Toxin in Baby Formula Is Too Much
In response to the situation, the European Commission requested the European Food Safety Authority (EFSA) to urgently establish a scientific safety threshold, known as an acute reference dose (ARfD). This threshold is intended to guide governments and producers on when products should be removed from shelves.
EFSA’s assessment proposed a new limit of 0.014 micrograms per kilogram of body weight for infants. The agency emphasized that very young babies metabolize substances differently and require additional protection. Vomiting was identified as the primary short-term symptom used to determine this threshold.
The French farm ministry, which had anticipated EFSA’s advice over the weekend, noted that the new level is more than half lower than the previous one. They warned that this would likely lead to further precautionary recalls.
In light of the new threshold recommendation, French manufacturers Vitagermine and Popote announced on Monday that they would be withdrawing batches of infant milk from the market.
Danone and Nestle Welcome Threshold
Both Danone and Nestle have expressed their support for the EFSA guidance. However, Lactalis stated that the new threshold would not alter the scope of its existing recall.
Analysts from Barclays indicated that neither Danone nor Nestle should face additional product recalls. Jefferies also noted that the new thresholds “suggest that further recall risks for Danone & Nestle are limited.” Following this news, Danone’s shares closed 4.7% higher, while Nestle’s rose by 2.8%. (Editor’s note: This article was published by Reuters on February 2).
The French agriculture ministry identified Cabio Biotech, a Chinese producer, as the source of the arachidonic acid (ARA) oil linked to the contamination. Cabio Biotech could not be reached for comment outside of working hours.
While EFSA’s recommendations are not legally binding, EU countries typically adhere to them when deciding whether to recall food products or impose sales restrictions. The agency also estimated the amount of formula that infants are likely to consume in a 24-hour period, allowing scientists to calculate when the new limit might be exceeded.
Based on these consumption levels, EFSA determined that cereulide concentrations exceeding 0.054 micrograms per liter in infant formula and 0.1 micrograms per liter in follow-on formula could pose safety concerns.
Additionally, French investigators are currently examining whether there is a connection between the deaths of two infants and the recalled formula products. The health ministry has stated that there is no evidence linking the two at this time, with results expected in the coming days.
(Reporting by Sybille de La Hamaide, additional reporting by Alexander Marrow; editing by Ros Russell)
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