More Baby Formula Recalls Likely After EU Advises Strict Toxin Limit

(Bloomberg) — The European Union’s food safety regulator said almost no amount of the toxin cereulide is considered safe in infant formula, guidance that could prompt further product recalls.

The little-known toxin has become the focus of a global infant formula safety scare that has engulfed food giants like Nestlé SA, Danone SA and Groupe Lactalis.

The reference dose for cereulide in infant formula should be set at 0.014 micrograms per kilogram, the European Food Safety Authority said Monday in what it called “a cautious approach.” It’s effectively a no-tolerance policy, as anything that low is considered too small to detect.

“This advice is intended to help EU risk managers determine when products should be withdrawn from the market as a precautionary public-health measure,” the agency said.

It’s the first time the agency has set a threshold for cereulide and the decision — if adopted by the European Commission and EU member states — may lead to fresh recalls.

Danone previously followed guidance from countries like Ireland that set the toxin’s limit at 0.4 micrograms.

Nestlé, which is most affected by the contamination, used a threshold of 0.2 micrograms. The Swiss company welcomed the guidance, which it said “provides further clarity on the food safety framework for cereulide in infant formula.” Switzerland will align with the EU, a government spokesperson said by phone.

The toxin can cause sudden nausea, vomiting and stomach pain for babies, and in some case lead to complications such as dehydration. Very young infants metabolize substances differently from adults and gastrointestinal symptoms can rapidly lead to complications, according to EFSA.

Infant Deaths

The proposed limit comes after Nestlé, the world’s largest infant-formula producer, recalled hundreds of products potentially contaminated in more than 60 countries. French authorities are currently investigating whether two infant deaths are linked to consumption of Nestlé’s Guigoz formula.

Rivals Danone, Lactalis and other smaller producers have also since recalled some products. Nestlé traced the contamination to arachidonic acid oil obtained from a single supplier, whom it declined to name publicly. The supplier has since been identified as China’s Cabio Biotech Wuhan Co.

Although the infant formula industry is highly regulated it still struggles to balance infant nutrition and safety, especially as companies lengthen the supply chain by adding ingredients to make their formulas more closely resemble breast milk.

The industry, including Nestlé, have long been calling for nations to harmonize their policies and testing procedures.

–With assistance from Fabienne Kinzelmann.

(Updates with Nestle comment from seventh paragraph)

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