Testing Blind Spot in Infant Formula: Toxin Levels Can Jump up to 75× After Reconstitution

Belgium’s Sciensano found that cereulide toxin levels can be up to 75 times higher after infant formula is reconstituted than when measured in powder, a discrepancy linked to microencapsulated arachidonic acid (ARA). The discovery has triggered method revisions, industry recalls, and an EFSA proposal for a strict infant exposure limit, exposing gaps in testing standards and supply‑chain controls.

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Key Takeaways

  • 1Sciensano discovered current testing can understate cereulide because microencapsulated ARA can trap toxin in powder form and release it after mixing.
  • 2Measured cereulide concentrations in reconstituted formula were up to 75 times higher than in powder samples.
  • 3Several major manufacturers have recalled infant formula; the suspected contamination points to a shared ARA ingredient supplier.
  • 4EFSA proposed an acute reference dose for cereulide in infants (0.014 μg/kg), a move that could prompt stricter screening and more recalls.
  • 5The incident underscores the need for harmonised detection methods, testing in the consumed state, and tighter raw‑material traceability.

Editor's
Desk

Strategic Analysis

This episode is a textbook case of a modern supply‑chain vulnerability: concentrated ingredient suppliers plus innovation in ingredient formulation (microencapsulation) can create unintended testing blind spots. Regulators and labs will now need to pivot from legacy protocols that focus on dry goods to methods that replicate the consumer’s experience — testing reconstituted formula under realistic conditions. Expect a wave of policy responses: harmonised cereulide assays, mandatory liquid‑state testing for powdered foods intended to be reconstituted, and stricter audit requirements for specialty ingredient suppliers. For industry, short‑term costs will include expanded testing, possible reformulation away from microencapsulated ARA or stricter supplier qualification, and higher recall risk. Longer term, firms that invest in transparent traceability and conservative testing regimes will gain a competitive trust advantage, while those that resist methodological updates risk repeated public‑health incidents and regulatory sanctions.

China Daily Brief Editorial
Strategic Insight
China Daily Brief

Belgium’s federal public‑health institute Sciensano has identified a critical gap in how infant formula is tested: standard laboratory methods that analyse powdered formula can dramatically understate levels of a heat‑stable bacterial toxin once the powder is mixed into liquid. Measurements run by Sciensano found that cereulide, the toxin produced by Bacillus cereus, can appear at concentrations as much as 75 times higher in reconstituted formula than in the dry powder.

Scientists at Sciensano say the discrepancy stems from the way certain formula ingredients — in particular preparations of arachidonic acid (ARA) — are physically formulated. Some ARA preparations are microencapsulated, effectively enclosing oil droplets in a protective coating. In dry powder form those capsules can “lock” cereulide inside and prevent it from being released during routine testing, but they dissolve when the powder is mixed with water, releasing the toxin into the liquid consumers actually ingest.

The finding has immediate consequences for the recent wave of global recalls by major dairy groups including Nestlé, Danone and Lactalis, many of which trace the suspected contamination to a common ARA supplier. Nestlé has pushed back, saying the ARA used in its recalled products was supplied as a pure oil rather than microencapsulated material and that over 400 ARA oil samples it tested in the last three years contained no cereulide. The company also cautioned that cereulide contamination is uncommon and that testing every conceivable risk in perpetuity is not feasible.

Regulators are already responding. The discovery has prompted Sciensano to revise its laboratory methods and to call on European laboratories to do the same. At the same time the European Food Safety Authority has, for the first time, proposed an acute reference dose for cereulide in infants — 0.014 micrograms per kilogram of body weight — a threshold that, if widely adopted, would tighten acceptable exposure limits and likely accelerate regulatory screening and product withdrawals.

The episode exposes broader weaknesses in food‑safety regimes: many countries still lack harmonised standards for cereulide detection and firms commonly rely on internal test protocols. The supply‑chain dimension — a single ARA supplier serving multiple global brands — highlights how contamination at the ingredient level can cascade into multinational recalls and reputational damage.

For consumers and policymakers the practical lesson is straightforward. Safety assessments must evaluate products in the state in which they are consumed, not only as manufactured. That will require updating laboratory protocols, rethinking the use and formulation of functional ingredients such as microencapsulated oils, and strengthening supplier audits and traceability. The costs of more stringent testing and tighter raw‑material controls will be borne by manufacturers and, ultimately, consumers, but the alternative is persistent blind spots that undermine confidence in a market where the stakes — infant health — are exceptionally high.

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