From Lab to Bottle: Standards for Testing Infant Formula
Testing standards for infant formula is critical to the success of manufacturing quality infant formula products. Infant formula is often the sole source of nutrition for many infants, so it must be perfect. There needs to be 100% of every nutrient in each product. These standards can ensure that the nutrients in infant formula products are exactly at the level they are supposed to be and have become the guideline for measuring the quality of infant formulas.
The Association of Official Analytical Collaboration (AOAC) is an international organization that initially started creating standards to resolve disputes between laboratories. The Eurofins network of laboratories was the leading contract research organization (CRO) involved in the creation of the AOAC International Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN). The challenge the industry was facing was different laboratories getting different results on the same study because they were using different testing methods. This led to problems and questionable quality, so AOAC started validating and publishing testing standards that could be used across the board.
About 14 years ago, AOAC brought together major manufacturers of infant formulas because there was a need for improved testing methods. At the time, there were disputes because some government agencies rejected products that used inferior testing methods. The creation of the SPIFAN stakeholder panel worked to prioritize the different testing methods and develop standard method performance requirements (SMPRs). The group created over 50 official standards that are now used around the world. Today, AOAC-SPIFAN is the leading standards organization in the world for infant formula test methods.
New methods for testing infant formula
Over the years, many new methods of testing infant formulas have been developed. The driving forces for these new methods are primarily automation, specificity, sensitivity, precision, and accuracy. Methods must be more precise than they were 15 to 20 years ago.
For example, in the past, sensitivity with test methods looked at parts per million. Today, those test methods look at subparts per billion levels. Significant changes are evolving every day and every year. New standards drive the need for new testing methods, and those methods need to be validated.
Regulatory agencies like the Food and Drug Administration (FDA) require the use of a fully validated method to test infant formula. This means test methods must be statistically evaluated for precision and accuracy.
Other standard organizations that work with AOAC on infant formula testing include Europe’s International Standards Organization (ISO) and the International Dairy Federation (IDF).
Codex standards for infant formula
Codex Alimentarius is a collection of internationally recognized standards created by the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO). Codex standards on infant formulas are recognized in 180 countries.
Codex identifies infant formula testing methods as Codex Type II methods, which are dispute resolution methods. Codex is recognized by the judiciary as the method that will give a correct answer. Therefore, when there is a dispute between two countries or between a regulatory agency and a manufacturer, they must agree that they will use the Codex Type II method for dispute resolution.
Trends in infant formula
There’s been an ongoing initiative in infant formulas to mimic a mother’s milk as much as possible. Although it cannot be replicated exactly, research continues to uncover new carbohydrates and diverse protein components in human milk. These can then be isolated and submitted for approval by regulatory agencies to add them to infant formula. These new components added to infant formula make them better and more like human milk.
Another trend in infant formula is the evolution of organic, all-natural, locally sourced products. A significant portion of the population wants to buy products locally and know where milk and other ingredients are sourced. This trend started in Europe 10 to 15 years ago and is more recent in the U.S. Many of these products are subscription-based products that get delivered right to the consumer’s home.
Conclusion
Ensuring infant formula is safe and nutritious is extremely important because it’s often a baby’s only source of food. Over the years, testing methods have improved to be more precise and reliable, helping manufacturers meet safety regulations and avoid disputes. With ongoing improvements in testing and product development, parents can feel more confident that the formula they choose is safe, nutritious, and high quality.
Start the Conversation
Have additional questions? Ready to get started? We can help.
