Fit for purpose: How analytical methods keep nutrition products safe

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"The formula industry is constantly striving to replicate breast milk as closely as possible. One key area of development is human milk oligosaccharides (HMOs), which is still relatively new." Image: Getty Images (Getty Images/iStockphoto)

Retired Nestlé specialist Erik Konings explains how global collaboration through Codex, ISO, IDF, and SPIFAN is advancing validated testing methods to ensure safety and compliance in specialized nutrition

Erik Konings spent nearly 15 years at Nestlé where he played a pivotal role in driving global standardization of analytical methods, particularly for infant formula and adult nutritionals.

Now an independent consultant for bodies including the International Special Dietary Foods Industries association, Konings is a key figure at SPIFAN*, a global science-based initiative that helps make sure specialized nutrition products such as infant formula and adult nutritional products are safe, consistent, and accurately labeled.

As part of the initiative, he collaborates with international bodies like Codex, ISO, and the International Dairy Federations (IDF) to promote standardized analytical methods for infant formula and adult nutritionals. In turn, this collaboration enables fair trade, supports public health, and provides dispute-resolution methods by developing validated, fit-for-purpose testing protocols adopted by global bodies like FAO and WHO.

We spoke to Konings about the importance of product safety, what regulatory gaps still exist, and how rapid methods for the analysis of specialized nutrition products are evolving.

Why standardization matters

“It was important for Nestlé as a global company, to have harmonized analytical methods,” he opened. “They cannot work if somebody in the US tests a product with method A, and in Europe with method B, and in China with method C, and these all deliver different results.

“At the time one of the major topics was standardization in methods for infant formula and adult nutritionals, dairy-based, because these products serve a very sensitive population, which is why they are the most strictly regulated and rigorously tested for compliance in the world. This category of products needs methods which are validated through a rigorous scientific process, ensuring accuracy and reliability.”

This mission is also key to SPIFAN, which recently marked its 15-year anniversary, a period during which it helped with the development of nearly 50 standards and over 60 validated methods for infant formula and adult nutritionals.

“Products for infant and medical nutrition are a difficult matrix, which needs accurate validation and the rigorous scientific projects to ensure that the method delivers the correct results.”

Erik Konings, independent consultant

“We started it with Nestlé as one of the companies to drive standardization of methods of analysis in this category, because the existing methods were not fit for purpose anymore.

“Most of them were developed in the early 1980s when the Infant Formula Act was enabled in the US. But products evolved: there were new ingredients, and these analytical methods were no longer fit for purpose.”

Changes to analytical techniques

So how have analytical techniques evolved since? “In the 1980s, they used microbiological methods to determine the amount of vitamins [in foods including infant formula and adult nutritionals].”

But microbiological methods used to measure vitamins aren’t very selective – microbes can respond to various nutrients in the product, not just the target vitamin – and this lack of specificity has driven a shift toward more precise techniques, he explained.

“In recent years, this evolved to techniques as liquid chromatography and mass spectrometry-based methods, which are more selective, faster and robust, compared to the techniques used in the in the 1980s.”

Are there major gaps between regulatory requirements and analytical capabilities? “One gap that still exists is around vitamin D in infant formula. Recent European regulations have significantly narrowed the allowable range, which means analytical methods now need much greater reproducibility to confirm compliance. That’s a challenge for current reference methods – they often lack the precision needed to meet these stricter requirements.”

Definitions, definitions

“There’s a lack of harmonization in how nutrients are defined,” Konings continued.

“Take vitamin A, for example. It includes several compounds with vitamin A activity, and unless analytical methods account for all of them, the results won’t be accurate. Without harmonized definitions, results can vary, leading to uncertainty. That’s why global alignment is essential – not just in definitions, but also in the methods themselves.

“In practice, manufacturers sometimes have to use multiple methods to meet different national standards. In China, for instance, companies must apply the local GB method alongside international ones.”

“Harmonization is key. We’re constantly in dialogue with organizations like AOAC and with governments to align standards.”

Erik Konings

“It’s a scientific process, and perspectives differ across regions, so it takes time and ongoing collaboration.

“Through joint development, the same method can be published as an AOAC, ISO, and IDF standard – ensuring consistency no matter which framework is used."

This harmonization also helps pave the way for Codex adoption, he added. “Codex, a joint FAO and WHO body, is the backbone of food safety and trade facilitation worldwide.”

Why should methods be referenced?

When it comes to analytical methods, why should Codex reference these? “We believe methods should be referenced to support accurate labelling,” Konings explained.

“You need to measure all nutrients accurately: not just the ones added, but also those naturally present in ingredients, like milk or soy. That requires specific sample preparations to ensure everything is captured in the analysis. Without that, results can be misleading.

“The second reason is the rigorous process behind standard development. From initial validation to Codex adoption, it takes about five years. Methods must prove reproducibility across multiple labs worldwide, ensuring accuracy and reliability.

“Finally, while Codex prefers flexibility in method use, for complex products like infant formula and adult nutritionals, we need fully described, step-by-step methods – not just performance criteria. This ensures consistency, supports dispute resolution, and upholds regulatory compliance.”

Dairy: An evolving landscape

In the dairy sector, manufacturers rely heavily on validated methods, and that’s where the International Dairy Federation (IDF) plays a key role.

“IDF is closely aligned with the processes I mentioned earlier to ensure that accurate and reliable methods are used: methods that are validated through the same procedures adopted at the Codex level,” Konings told us.

“In Codex, the dairy sector is also well represented through its own provisions and methods in Codex Standard 234-1999 on recommended methods of analysis and sampling. For each provision –whether it concerns heavy metals, moisture content, or other parameters – IDF has developed and validated specific methods.

“In fact, IDF was one of the first international organizations to collaborate with ISO to ensure that all provisions relevant to the dairy sector have validated methods integrated into the system.”

When it comes to challenges, IDF is also actively working to ensure that methods are fit for purpose, especially with the adoption of new technologies. “Accuracy is key, and there’s growing interest in rapid methods,” he added.

For manufacturers of dairy-based specialized nutrition products, challenges continue to emerge daily. “We’ve recently seen increased attention on PFAS – this is just one area where new topics are constantly arising and require updated methods and approaches.”

Adult nutrition: A challenging matrix

Besides infant nutrition, adult nutritional products are increasingly growing in importance for manufacturers, particularly those who play in the medical nutrition field. Enteral nutrition is widespread in China’s top-tier hospitals according to Danone, but there’s runway for category growth in the wider industry.

“Tube feeding products present a challenging matrix for analysis, much like infant formula,” Konings told us. “These formulas – whether for infants or for special medical purposes – often share similar compositions and must be validated accordingly.

“However, when it comes to other specialized nutrition formats like gels or puddings, their unique compositions require tailored validation processes. Each matrix must be carefully assessed to ensure analytical methods are fit for purpose and deliver accurate results.”

How would analytical methods evolve?

Looking ahead, Konings thinks analytical sciences will evolve significantly over the next few years, especially in terms of method availability to support new ingredients.

“The formula industry is constantly striving to replicate breast milk as closely as possible. One key area of development is human milk oligosaccharides (HMOs), which is still relatively new. HMOs represent a large family – over 200 compounds – and the challenge lies not only in producing them for inclusion in formula, but also in developing analytical methods to accurately identify and quantify these compounds. This will become increasingly important in the future.”

Another area of progress is in multi-method approaches, he told us.

“For instance, we’re seeing advancements in multi-vitamin analysis – such as methods that can simultaneously measure several B vitamins (B1, B2, B3, B6), which previously had to be analyzed individually using older microbiological techniques. Now, the trend is toward fast and accurate multi-methods.

“This also applies to fat-soluble vitamins like A, D, E, and K.

“I expect these multi-methods to continue evolving in the coming years, improving both speed and precision in nutritional analysis.”

SPIFAN stands for AOAC’s Stakeholder Program on Infant Formula and Adult Nutritionals. Erik supports ISDI in its role as the official coordinator of manufacturers contributing to the SPIFAN programme. Up-to-date methods for specialized nutrition can be found on the website Test Methods for Special Dietary Foods, developed by ISDI in collaboration with AOAC INTERNATIONAL and the International Dairy Federation. The website also references methods developed by ISO.