Why nutritional lipid quality is under the microscope—and what infant nutrition brands should do about it

• Recent arachidonic acid (ARA) contamination recalls have put the quality of nutritional lipids in infant formula under scrutiny, raising fundamental questions about what robust quality assurance actually looks like across the supply chain.
• To find out more, we asked James Young, Vice President of Early Life Nutrition at dsm-firmenich, to share his expert perspective.
• Keep reading to discover why quality assurance in nutritional lipids has become a pressing issue, what infant nutrition brands should look for in a supplier, and what to expect from regulators and the industry going forward.

Nutritional lipids are critical building blocks in early life nutrition. Breast milk, the ‘gold standard’ for infant nutrition, naturally contains a number of key lipids, including arachidonic acid (ARA) and docosahexaenoic acid (DHA). A robust and growing body of scientific evidence shows that both ARA and DHA play important roles in supporting proper growth and development in infants. When exclusive breastfeeding isn’t an option, formula milk supplemented with ARA and DHA is the best possible alternative. This is why ARA and DHA are allowed as optional inclusions in infant formula globally. In fact, when DHA is added, almost all markets mandate the inclusion of ARA at no less than the same level. The European Commission is the exception, mandating the inclusion of DHA, but without any stipulations for including ARA, which is still classified as an optional extra. As a result, infant nutrition brands must navigate this regulatory landscape while ensuring consistent safety and quality.

Given that the first year of life is one of the most critical in terms of health and development, parents expect the highest safety and quality standards from infant nutrition brands. This, in turn, raises expectations across the industry for ingredient suppliers to demonstrate robust quality systems, transparency, and full control over how their ingredients are made.

Notably, the ARA contamination recalls earlier this year put ingredient quality and safety under a spotlight the industry cannot ignore, raising fundamental questions about what robust quality assurance looks like. To unpack what this means for infant nutrition brands and the wider industry, we spoke with James Young, Vice President of Early Life Nutrition, dsm-firmenich. In this interview, he shares what the recent events revealed about risk in the lipid supply chain and the practical questions brands should be asking right now about supplier controls, microbiological testing, traceability, and regulatory readiness.

1. Why has quality assurance in nutritional lipids become such a pressing issue?
 

Quality assurance is non-negotiable across all consumer categories, but when it comes to infants, it’s a particularly high-stakes issue. This is because infants are among the most vulnerable consumer groups, making the safety and quality of all ingredients in infant formula, including nutritional lipids, especially critical. As such, ingredients must meet stringent food safety criteria and be produced under tightly controlled conditions. Yet, earlier this year, standards in infant nutrition were compromised and several infant formula brands issued recalls across more than 65 countries after a quality issue was traced to a single ingredient supplier. 

This issue was specifically related to the omega-6 fatty acid, ARA. The recalled batches identified the presence of cereulide, a toxin produced by the micro-organism Bacillus cereus, in the ARA oil. When consumed, this toxin can cause nausea, vomiting, and abdominal cramps, making the industry-wide recall of these contaminated batches paramount to protect the health of formula-fed babies.

2. What should infant nutrition brands consider when choosing the right partner for nutritional lipids?

Brands should look for suppliers that have rigorous risk assessments as well as stringent protocols and control mechanisms throughout the entire production process. Equally important is 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. 

In addition, today’s families want their nutritional choices to reflect their values and therefore seek products that are not only beneficial for their child’s health but also kind to the planet; and some parents are therefore questioning the sustainability of ingredients. This expectation is accelerating demand for nutritional lipids that are both high quality and environmentally responsible. For brands looking to innovate more sustainably and meet the needs of eco-conscious families, partnering with a supplier that offers pure, traceable, and sustainable ARA and DHA is a strategic advantage.

3. How does dsm-firmenich build long-term trust with its infant nutrition partners?
 

To help build a legacy of trust with our partners, we develop infant nutrition solutions that meet the highest industry standards for safety and quality. But we know that customers can’t just take our word for it—they need proof. That’s why we comply with stringent microbiological criteria and have a thorough Hazard Analysis and Critical Control Point (HACCP) plan, as well as microbiological monitoring and policies in place. Furthermore, our 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. We do not outsource any steps of production or processing to external parties or rely on fermentation, crude oil, or intermediate materials from third-party suppliers. Thanks to these stringent standards, our microbial ARASCO® and life’s®ARA products, as well as our wider portfolio of nutritional lipids, were not involved in any of the recent quality issues.

4. What do you expect from regulators and the industry going forward?
 

The recent quality events in the infant nutrition market highlight the importance of continuously strengthening and upholding industry standards, particularly around microbiological testing and preventive controls for nutritional lipids like ARA. Raising the bar in infant nutrition doesn’t sit on the shoulders of regulators alone though, suppliers have a fundamental role to play too. While current regulations mandate food safety controls and microbiological testing throughout production to avoid contamination, suppliers have a responsibility to carry out these tests regularly to ensure consistently safe ingredients. 

Regulatory progress in this space is a more varied picture. The European Commission previously allowed for the optional inclusion of ARA and DHA in infant formula. However, a new regulation published in 2016 and made applicable in 2020, mandates the inclusion of DHA without the need for ARA, which remains as an optional nutrient in Europe. In contrast, many other national and international regulations have been updated in recent years and mandate the inclusion of ARA when DHA is added, at equal or greater levels. This reflects expert guidance that infant formulas should be modelled on human milk and thus provide DHA to at least global human milk mean levels, with ARA content at least equalling DHA content. Indeed, breastmilk typically contains an average global ARA:DHA ratio of approximately 1.5:1. Similarly, at dsm-firmenich, we recommend that infant formulas should provide ARA and DHA at a ratio of 1:1 to 2:1 (each at 20–50 mg per 100 kcal).^1,2,3 

While current regulations allow for the inclusion of ARA and DHA at appropriate levels and ratios in infant formula, this is not a mandated requirement. We therefore believe more progress is needed to bring regulation in line with the latest science, ensuring that both ARA and DHA are added together in infant formula at levels and ratios reflecting the composition of breast milk. Until then, we hope to see regulators continue to strengthen requirements in line with the evidence, while brands take proactive steps to formulate with both fatty acids to help support optimal infant development. We continue to monitor this evolving landscape and provide updates to our customers as they emerge.

Support pure beginnings with dsm-firmenich
 

For over 25 years, our DHA and ARA oils have been used in commercial infant formulas worldwide, safely supporting more than 250 million infants. As one of the purest portfolios on the market, our life’sDHA® omega-3 and life’s®ARA omega-6 oils are naturally free from ocean borne contaminants like heavy metals, pesticides, brominated flame retardants, as well as PFAS, BPA, BPS, and phthalates. They are also the most extensively studied, single-cell long chain polyunsaturated fatty acids (LCPUFAs) in the field of infant nutrition. With these high-quality, science-backed solutions, early life formula manufacturers can formulate with confidence.