More baby formula recalls likely after EU caution on toxin limit

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 Nestle, 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 on 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.


The decision-if adopted by the European Commission and EU member states-could prompt additional recalls from producers.

It's the first time EFSA has set a threshold for cereulide. Danone previously followed guidance from countries like Ireland that set the limit at 0.4 micrograms. Nestle, the company most affected by the contamination, used 0.2 micrograms per kilogram as its limit. The toxin can cause sudden nausea, vomiting and stomach pain for babies, and in some case lead to complications such as dehydration.

The proposed limit comes after Nestle, 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 Nestle's Guigoz formula.

Rivals Danone, Lactalis and other smaller producers have also since recalled some products. Nestle 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.

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.