dsm-firmenich on how brands can inspect ARA suppliers amid global infant formula recalls

Infant formula manufacturers are facing a growing international backlash linked to arachidonic acid (ARA) oil contaminated with the toxin cereulide. Companies are expanding product recalls to over 65 countries to ensure babies’ health. 

Amid this crisis, Nutrition Insight speaks with dsm-firmenich about safe ARA alternatives, how brands can find the right supplier, and how to build long-term trust by verifying ingredient manufacturing processes.

James Young, VP of Early Life Nutrition, explains that at the start of the year, manufacturers across several regions recalled batches of infant formula due to cereulide-contaminated ARA oil. The omega-6 fatty acid is naturally found in breast milk and commonly added to infant formula.

This toxin is produced by the microorganism Bacillus cereus. “If consumed, the toxin can cause nausea, vomiting, and abdominal cramps,” says Young. “As such, the industry-wide recall of these contaminated batches was paramount to protect the health of formula-fed babies.”

Dutch consumer watchdog Foodwatch recently filed a criminal complaint in France, naming seven infant formula manufacturers — Nestlé, Lactalis, Danone, Vitagermine (Babybio), Hochdorf, La marque en moins, and Granarolo — over their handling of the global contamination crisis.

Although the source of the contaminated ARA oil has not been confirmed, safety authorities such as the Food Safety Authority of Ireland and news agencies such as Reuters report that the recalls are linked to a Chinese supplier of the ingredient.

New standards

Young draws attention to dsm-firmenich’s microbial Arasco and Life’sARA as examples from its wider portfolio of microbial nutritional lipids, which are not associated with the ongoing product recalls. He underscores that the company meets the highest quality industry standards for safety and quality.

Young says full control over microbial lipid production — from fermentation to finished oil — is key to rebuilding trust in infant nutrition supply chains.Furthermore, he says that the role of nutritional lipids in infant nutrition is evolving with new consumer expectations.

“ARA and docosahexaenoic acid (DHA) are key microbial nutritional lipids found in breast milk, the ‘gold standard’ for infant nutrition. Scientific research into these nutrients has revealed their critical roles in supporting proper growth and development in early life.” 

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

Meanwhile, he adds that parents are expecting the highest standards from infant nutrition brands, elevating expectations across ingredient suppliers to demonstrate quality systems and transparency while maintaining total control over ingredient manufacturing.

In light of the crisis, the European Food Safety Authority (EFSA) recently issued scientific advice to the European Commission to support risk management. The organization sets an acute reference dose (ARfD) of 0.014 μg/kg body weight for cereulide in infants. 

EFSA 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.

In response to the new ARfD, Nestlé France has expanded product recalls for two brands. The company also states that it is working with new suppliers that have enhanced control procedures and no longer purchase ARA oil from the company that is “responsible for the problem.” 

Young underscores that quality assurance is especially critical for nutritional lipids used in infant formula when breastfeeding is not an option. Infants are especially vulnerable, therefore, microbial nutritional lipids are produced under tightly controlled conditions.

Finding the right partner

Since there are varied suppliers offering nutritional lipids, Young advises that brands select the right partner based on their rigorous risk assessments and strict production protocols and control mechanisms. This should carry through the entire production process, from fermentation through finished oil.

“Equally important are long-standing regulatory compliance, comprehensive monitoring and testing, certified food safety systems in accordance with the Global Food Safety Initiative (GFSI) standards, and a track record of supplying ingredients for infant nutrition at scale.” 

“Manufacturers who can deliver science-backed, clean label ARA and DHA solutions are well-positioned to meet the latest regulatory standards and growing consumer demand for transparency and purity in infant nutrition,” he suggests.

Young adds that dsm-firmenich’s food safety management systems are regularly audited according to GFSI principles and certified by accredited external certification bodies. “On top of this, we also own and control the entire production chain of our ARA products — from fermentation through to the finished oil.” 

Full control over production

Young details what distinguishes dsm-firmenich’s microbials. For instance, Arasco and life’sARA are made through a fully integrated, US-based production chain. 

Infant formula recalls linked to cereulide-contaminated ARA oil have affected products shipped to over 65 countries, prompting renewed focus on safety and transparency.“As the only end-to-end western-based provider of ARA, we do not rely on fermentation, crude oil, or intermediate materials from third-party suppliers. Nor do we outsource any steps of the production or processing to external parties for Arasco.” 

“We fully own and control every step of the process. This end-to-end control, combined with stringent microbiological criteria and regular external audits, allows us to deliver ARA ingredients that meet the highest safety and quality standards for infant nutrition,” he explains.

Pointing to the ongoing infant formula recalls, Young stresses the need for continuous strengthening and enforcing industry standards, especially regarding microbiological testing and preventive controls for microbial nutritional lipids.

“While current regulations mandate food safety controls and microbiological testing throughout production to avoid contamination, suppliers have a responsibility to carry out these tests to ensure consistently safe ingredients.”

“dsm-firmenich monitors emerging regulatory topics and works closely with customers to ensure we deliver high-quality and safe products,” he says.

Long-term trust 

To build trust between ingredient suppliers and infant nutrition brands, transparency and consistency must be built over time, underscores Young.

“This includes aligned specifications and thorough Hazard Analysis and Critical Control Point (HACCP) plans for products — a preventive approach to food safety, designed to identify, evaluate, and control biological, chemical, and physical hazards.”

“Additionally, continuous microbiological monitoring is paramount, and if any risks are identified, suppliers need clear policies for immediate action. Taking such actions helps to prevent contaminated batches from reaching the shelves. Regular audits and validation from accredited external certification bodies can also help infant nutrition brands build trust with suppliers,” he concludes.