EU Body’s Advice on Toxin Limit in Baby Formula Prompts More Recalls

The European food safety body on Monday advised a maximum threshold for the cereulide toxin used in infant formula, prompting some French producers to withdraw additional products from the market.

Cereulide, a toxin that can cause nausea and vomiting, has been detected in ingredients from a Chinese factory supplying major formula makers including Nestle, Danone and Lactalis.

The contamination triggered infant formula recalls in dozens of countries and heightened concerns among parents.

The European Commission asked the European Food Safety Authority to urgently establish a scientific safety threshold, known as an acute reference dose (ARfD), to guide governments and producers on when products should be pulled from shelves.

In its assessment, EFSA proposed a new limit of 0.014 micrograms per kilogram of body weight for infants. The agency said very young babies process substances differently and require extra protection. Vomiting was identified as the key short-term symptom used to determine the threshold.

The French farm ministry, which had anticipated EFSA’s advice over the weekend, said the level was more than half lower than the previous one and warned that it would likely lead to additional precautionary recalls.

French manufacturers Vitagermine and Popote said on Monday they were withdrawing batches of infant milk following the new threshold recommendation.

Danone and Nestle Welcome Threshold

Danone and Nestle welcomed the EFSA guidance. Lactalis said it did not change the scope of a recall it had in place.

Barclays analysts said neither Danone nor Nestle should have to make further product recalls. Jefferies said in a note that the new thresholds “suggest that further recall risks for Danone & Nestle are limited”

Danone’s shares closed 4.7% higher while Nestle’s rose 2.8%. (Editor’s note: This article was published by Reuters on February 2).

The French agriculture ministry said that Chinese producer Cabio Biotech was the producer of the arachidonic acid (ARA) oil at the source of the contamination.

Cabio Biotech could not immediately be reached outside of working hours.

EFSA’s recommendations are not legally binding, but EU countries typically follow them when deciding whether to recall food products or restrict sales.

The agency also estimated how much formula infants are likely to drink in a 24-hour period, allowing scientists to calculate when the new limit would be exceeded.

Based on those consumption levels, EFSA said that cereulide concentrations above 0.054 micrograms per liter in infant formula and 0.1 micrograms per liter in follow-on formula could pose a safety concern.

French investigators are looking into whether there is a link between the death of two infants and recalled formula products, the health ministry said, adding that there was no such evidence at this point. Results were expected in the coming days.

(Reporting by Sybille de La Hamaide, additional reporting by Alexander Marrow; editing by Ros Russell)

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