Summary
- Recall hit nearly 60 countries, exposing fragile, trade-dependent supply chains.
- Contamination in a low-risk ingredient implies the need for tighter controls.
- Swapping ARA oil is complex due to strict nutritional and regulatory specifications.
- Manufacturers hold ultimate responsibility for compliance and transparency.
- A tougher testing and process reviews under HACCP could be rolled out in the future.
Nestlé recalled infant formula products from nearly 60 countries globally over contamination fears.
Batches from brands including SMA, Alfamino and Beba were pulled after cereulide, a toxin that can cause nausea and vomiting, was discovered in the ARA oil ingredient used in the formulations.
All recalls have now been announced according to Nestlé and no illnesses have been reported to date.
But the Swiss major has faced scrutiny over the speed and transparency of its response, with nonprofit Foodwatch International criticizing the company for not informing consumers of the issue earlier in the recall process.
Nestlé CEO Philipp Navratil defended the company’s actions, stating: “As soon as we confirmed the issue, we engaged proactively with the respective health and food safety authorities in each country that received the affected products. We collaborated closely with the authorities and followed their guidance. This meant that the recalls were announced locally one by one as planned.”
In the aftermath of the recall, many questions remain.
An industry insider who spoke on condition of anonymity to protect relationships shed light on the key implications for infant formula supply, vulnerabilities in supplier oversight, and what manufacturers can learn from the high-profile recall.
How does the recall impact global infant formula supply?
Nestlé has pulled products from nearly 60 countries globally; so how serious could that be for the global supply of specialized nutrition products?
According to our source, the global infant formula supply is trade-dependent and vulnerable to disruptions, particularly when it comes to very niche products. But when it comes to recalls of widely-available product categories, the impact on supply is more limited.
“The real question is how ‘global’ this [problem] actually is,” the source said. “In our sector, it’s quite specific because we don’t have manufacturing facilities in every country. We rely heavily on trade, so an issue at one production site can affect multiple markets.
“It also depends on the type of product. If it’s very niche, the impact might spread globally, but in terms of volume, it won’t be significant.”
Nestlé has said that the product batches it recalled formed less than 0.5% of its annual group sales.
Are there similarities with the 2022 US infant formula shortage?
The infant formula market’s vulnerability to supply chain disruptions became clear during the 2022 US infant formula shortage, when pandemic supply shortages were exacerbated by Abbott Nutrition’s plant shutdown and recall.
Can parallels be drawn between the 2022 crisis and the 2026 Nestlé recall in terms of its potential for disruption?
“At this stage, I don’t see a similar situation happening,” the source said.
“The US market is quite unique because of the WIC program, which is government-funded and very specific to the US.
“This creates a strong dependency on certain manufacturers to supply a set amount of formula. If one of those manufacturers can’t deliver, shortages happen much faster than in a typical market.
“I don’t think you can draw direct parallels here, because this situation involves a single company.”
How long does it take for contamination events to be resolved?
When it comes to ingredient contamination, how long does it typically take manufacturers and ingredient suppliers to resolve quality control issues and restore production back to its usual levels? That depends, the source said.
“It’s really case-by-case and depends on the source of contamination,” we were told. “Identifying that source can take time, and once you do, you need to assess the risk and decide what actions to take to contain it.
“Some contamination issues are easy to resolve, while others are much more complex. Is it from a raw ingredient? How far is the impact in the facility affected? [It’s] all of that – there are so many parameters that can play there.”
How is QC managed by infant formula manufacturers?
Typically, quality and risk control practices are based on the HACCP (hazard analysis critical control points) rules, with ingredients categorized by risk (low to high) and tested accordingly.
In Nestlé’s case, the contaminated ingredient was ARA oil, which is classes as ‘low-risk’: meaning that it was routinely tested but not as rigorously as ‘high-risk’ ingredients such as raw milk.
“Normally, low-risk ingredients aren’t monitored as closely – you just have your routine checks,” the source told us. “From what I understand, this contamination was discovered during one of those routine controls.
“So, the main way to mitigate this is through strict controls, keeping your specifications up to date, and making sure they’re followed.”
Manufacturers or regulators: Who is responsible?
When it comes to informing the public and managing recalls, both regulators and product manufacturers come under scrutiny. But who is ultimately responsible – and did Nestlé do everything by the book?
“I would say yes,” the source said, adding: “Regulations generally require all food business operators to ensure that everything they supply, manufacture, or sell complies with the rules. So responsibility is shared across the production chain, even though each operator has individual accountability. At least in the EU that’s how it works; globally, it can vary.
“That said, the manufacturer putting the product on the market is ultimately responsible from the regulators’ perspective. That’s why the manufacturer’s address is always on the label.”
Can ARA oil be easily swapped in infant nutrition products?
The contamination was traced back to an ARA oil ingredient supplied to Nestlé by a third-party. This could lead to the company having to seek an alternative to resume production – but how easy would it be to replace ARA oil?
Similarly to how tricky it can be to swap ingredients in commercial food processing for formulation reasons, substituting ingredients used in specialized nutrition products is far from straightforward.
“You can’t just swap one ingredient for another because we’re dealing with precise formulations,” the source said. “You need the exact amount and the same specifications, and that’s often the biggest challenge – finding a substitute that matches perfectly.
“If the issue is with ARA, for example, you need another ARA with identical specifications. And ‘specifications’ cover a lot: food safety, manufacturing process, and even whether it performs the same way in the formulation.
“Manufacturers set precise specifications for each ingredient to deliver the intended health and nutritional benefits. That’s what formulations are all about – every component serves a very specific purpose.
“So finding a substitute isn’t easy – you need something that matches those specifications exactly to achieve the same effect.”
What can the industry learn from Nestlé’s infant formula recall?
Nestlé’s product recall isn’t unique to the company or the industry – but lessons should be learned from it.
“You always learn from every incident,” the source said. “[As an industry], we’ll need to evaluate, and I’m sure certification bodies will also review it and take their own lessons to improve processes in the future.”
The source suggested that testing on ARA oil is also likely to intensify. “Of course, everyone will now test ARA. If nothing happens for 10 years, then in risk management it will probably be downgraded back to a lower risk. That’s just how the system works – the HACCP approach adjusts risk levels over time based on experience.”
Key takeaways
Nestlé’s infant formula recall has highlighted several pain points for the global specialized nutrition industry.
The sector remains highly dependent on trade, with major recalls, particularly on more niche products, still having the potential to disrupt supply chains and ultimately, product availability.
While Nestlé’s recall is unlikely to lead to widespread shortages in infant formula globally, the event is a timely reminder of how critical risk mitigation remains.
The event has also flagged potential QC gaps - with a low-risk ingredient like ARA oil being up for potentially more stringent testing in the future.
Ingredient supply diversification also remains crucial. While ARA oil supplies are not believed to be considerably affected by this recall event, difficulty in swapping ingredients in specialized nutrition products highlights the need for manufacturers to have alternatives on hand.
Finally, while the entire supply chain has risk-management responsibilities, manufacturers hold ultimate responsibility for compliance and transparency.
