Safeguarding Infant Formula: The Importance of Analytical Testing in Infant Formula
The safety of infant formula has been a major topic in the news this year, highlighting the critical need for the highest quality standards. As one of the most essential sources of nutrition for vulnerable individuals, ensuring safety and regulatory compliance is paramount. This editorial by Eurofins Food Chemistry Testing CSO, Darryl Sullivan, explores the rigorous analytical testing and regulatory requirements that companies must meet to bring infant formula to market, shedding light on the complexities of this highly regulated industry.
Modern infant formula is a remarkable achievement in nutritional science, meticulously designed to meet or exceed all essential dietary needs for infants. Formulated with precision, these products contain 32 or more vital nutrients in carefully balanced concentrations to support healthy growth and development. From proteins, carbohydrates, and fats to essential vitamins and minerals, infant formula provides comprehensive nutrition, ensuring infants receive the nourishment they need to thrive.
Since infant formula is the sole source of nutrition for an infant, the products must contain all the required nutrients and should be free from any harmful levels of contaminants. Most infant formula companies assure these requirements are met through very robust quality control and verification programs. These programs rely very heavily on accurate test data.
Analytical testing of infant formula is very challenging and cannot be performed by just any testing lab. This is particularly true when testing for contaminants, since these concentrations are extremely low. There are very high standards that need to be met for a company to manufacture infant formula and even higher standards that need to be met for a laboratory to be qualified to test these products.
Laboratories conducting infant formula testing must meet stringent accreditation requirements to ensure the highest standards of quality, accuracy, and reliability. The minimum expectation is compliance with a recognized accreditation, with most contract testing facilities holding ISO 17025 certification. ISO 17025 is an internationally recognized standard that establishes the competence of testing and calibration laboratories, ensuring they operate with technical expertise, validated methodologies, and rigorous quality control measures.
The next requirement to consider is the analytical test method. Regulatory agencies require that infant formula be tested using fully validated methods. To comply with this expectation, you would expect a lab to use methods that are approved standards from standards development organizations. Most frequently these are Official Methods of Analysis from AOAC INTERNATIONAL, or something equivalent. The laboratory must have complete documentation of the test method used, and how it was qualified in the testing facility.
In addition to documenting the scientifically validated test method, laboratories must maintain comprehensive quality control records. These should include, but are not limited to:
- Training records for all analysts
- Test method qualification data
- Scientist qualification for conducting the test
- Documentation of quality control standards utilized
- Reference materials used in testing
Analytical data from infant formula testing is only considered valid when these requirements are met. Any published data must, at a minimum, cite the specific test methods used, along with references to the testing facility and the expertise of the researchers involved.
When evaluating the safety of infant formula, it’s essential to rely on verified facts rather than assumptions. Numerous factors influence the final reported results, and not all analytical test methods or laboratories are created equal. Choosing an ISO 17025-accredited lab that meets the highest standards for infant formula testing is the key to ensuring accuracy, reliability, and confidence in a product’s safety and quality.
Reach out to Eurofins Food Chemistry Testing Madison, Inc today to discover how our testing processes ensure confidence in your infant formula product.
Meet the Expert
Darryl Sullivan
Chief Science Officer
Eurofins Food Chemistry Testing
Mr. Sullivan acts as a consultant for companies who need help meeting scientific and regulatory requirements. In this role, he is often called upon as an expert witness for litigation and dispute resolution. He is considered an international expert in the analysis of infant formula and dietary supplements and represents Eurofins in many areas of the scientific and regulatory communities. Mr. Sullivan is a delegate to Codex Alimentarius and actively participates in the Codex Nutrition Committee (CCNFSDU) and the Methods Committee (CCMAS).
Mr. Sullivan has over 40 years of experience in laboratory testing. He is an expert in the field of validation of analytical methods, having served for three years as Chair of the AOAC INTERNATIONAL Official Methods Board. He is the past President and Secretary of the AOAC INTERNATIONAL Board of Directors. Mr. Sullivan was most recently a Director on the IFT Board. He is also a past member of the USP Expert Committee for Dietary Supplements. Mr. Sullivan is currently the Chair of the ACIL Dietary Supplement Working Group and Vice-Chair of the Food Science Section. Mr. Sullivan has developed and validated hundreds of analytical methods in the areas of nutrient and residue analysis and is the author of over 75 publications and hundreds of scientific presentations.
Additional Resources
How to Ensure the Chemical Safety of Infant Formula and Baby Foods
