Nutriswiss trial removes 99.99% of cereulide from contaminated ARA oil in infant formula

Oil refining specialist Nutriswiss says its trials are showing “highly promising results” on eliminating cereulide toxins from arachidonic acid (ARA) oil, used in infant formula. Detection of this bacterial toxin in products triggered a wave of voluntary global recalls earlier this year. 

The source of contamination was traced to ARA oils containing the cereulide-producing Bacillus cereus strain. The toxin can cause sudden nausea, vomiting, and stomach pain 30 minutes to six hours after ingestion. 

Nutriswiss notes that cereulide is generally considered “impossible to remove” by conventional refining steps, such as deodorization, acid or alkali treatment, washing, or filtration. This has resulted in enforced destruction of contaminated batches.

The company has conducted a short-term study on a contaminated ARA oil sample to determine how cereulide could be removed through technological measures, with further trials underway to optimize the process.

“Through a specific combination of process steps, process conditions, and various processing aids, we have so far managed to slash the original cereulide content of the sample from 200 ppb to below 0.3 ppb during refining. This corresponds to a reduction of approximately 99.99%,” says Frank Möllering, head of R&D at Nutriswiss.

The team hopes to achieve the analytical limit of quantification for cereulide of 0.1 ppb in the near future. Nutriswiss says that such a “near-complete” removal of the contaminant would mean that affected ARA oils could be purified and put back on the market.

Cereulide contamination

The voluntary global infant formula recalls started in December 2025 and expanded in January this year, affecting nutrition companies such as Nestlé, Danone, Lactalis Nutrition Santé, and Hochdorf.

The source of contaminated ARA oil has not been confirmed, but safety authorities reported that the recalls were associated with ingredients manufactured in China.

In February, the European Food Safety Authority (EFSA) developed scientific advice on a contamination threshold to support risk management, setting an acute reference dose of 0.014 μg/kg body weight for cereulide in infants.

EFSA also confirmed that the appropriate value for estimating short-term exposure to infant formula is 260 mL/kg of body weight. While in liquid infant and follow-on formula, exceeding cereulide concentrations of 0.054 μg/L and 0.1 μg/L, respectively, may pose a safety risk.

On February 24, the European Commission implemented legislation noting that ARA oil from China may only be imported into the EU if there is no cereulide toxin present, meaning that the analytical result does not exceed the limit of quantification of 0.1 μg/kg.

Although Nutriswiss says it is not affected by cereulide contamination, the company refines customer-supplied oils from fermentation processes for infant formula.

ARA for infant development

ARA and docosahexaenoic acid (DHA) are microbial nutritional lipids found in breast milk, the “gold standard” for infant nutrition. Nutrition Insight recently spoke with dsm-firmenich’s VP of Early Life Nutrition, James Young, who highlighted scientific research supporting the ARA and DHA’s critical roles in supporting proper growth and development.

“Given this robust evidence, most national, regional, and international regulations have been updated to include ARA and DHA at specific levels and ratios,” he told us. “Infant nutrition brands must therefore meet these regulations and standards, which ensure consistent safety and quality.”

The company’s senior director of Scientific Engagement, Jim Richards, Ph.D., also told us that ARA and DHA should be considered jointly, as they work cooperatively to support infant development. He noted that DHA is key for brain and visual development, while ARA is also a major component of cell membranes throughout the body.

Richards noted that the ratio of ARA and DHA is key as well for neurodevelopmental outcomes during infancy and beyond, highlighting benefits when ARA meets or exceeds DHA, typically at an ARA:DHA ratio of 1:1 to 2:1.