Infant Formula Testing - Poolside Chat with Darryl Sullivan
Below is an email exchange between Keren Breiterman and Darryl Sullivan about trends in the Infant Formula Testing space.
Infant Formula General Industry Questions
How long have you been working with the infant formula (IF) industry?
40+ years. The first samples I learned how to test for vitamins were infant formulas.
What would you say has been the top 3 biggest evolutions in the Infant Formula industry in that time?
1. Creation of AOAC-SPIFAN (Stakeholder Panel on Infant Formula and Adult Nutritionals) which lead to the global harmonization of test methods. Covance / Eurofins was the leading CRO (contract research organization) in this activity.
2. The FDA Infant Formula Act of 1980– the first law that regulated the safety and nutrition of infant formula.
3. The FDA Guidance on the Labeling of Infant formula – 2016. This rule created the requirements for testing infant formula.
What are the biggest challenges facing the industry in today’s environment?
New ingredients and new formulas e.g. Lactoferrin, HMOs (human milk oligosaccharides). The biggest challenge with these new ingredients is sourcing from reputable suppliers and having analytical testing methods to be able to assess their quality both as a raw material and as an ingredient in the final product.
What’s the hottest trend(s) in the IF industry today?
Trying to make infant formula even closer in composition to human breast milk. The components of infant formula that companies are focused on include the fat, carbohydrates, and protein. The protein and carbohydrates are the greatest challenges since there are 100’s of these unique compounds in human breast milk.
What role do you think start-ups play in this industry?
Moving the market towards organic/all-natural/locally sourced infant formulas. These new products do not contain any synthetic ingredients.
Infant Formula Technical Questions
What would be the top 3 attributes you would recommend a manufacturer to look for in choosing a third party lab (TPL)?
1. Experience & expertise – many third-party labs can claim they can perform infant formula testing however it’s the small nuances that are associated with infant formula testing that differentiate the experienced labs. Whether it’s from sample prep knowing how to correctly sample an infant formula to ensure a homogenous representative sample is being analyzed by the lab, to questioning a vitamin result when it’s behaving differently from other vitamins added together in the same premix. These small differences can make a huge impact when reporting results out to a client.
2. Use of AOAC SPIFAN test methods – the goal of SPIFAN methods is to become Codex Type II methods i.e. dispute resolution methods. By having your third-party lab use these methods you are ensuring your products are in the best position when going to market. Any government or regulatory body with default to Codex Type II methods as being the most accurate methods so by having these methods run on your products from the get-go will save you time and money (and the headache!) from retesting further down the road should a dispute with another lab’s results arise.
3. Accreditation – ISO 17025. This is the global standard for testing labs and should be a minimum requirement when searching for a third-party lab. Having this accreditation means the lab is running correct procedures to ensure the results are reliable giving you confidence in your CoA (certificate of analysis.
What are Eurofins’ top qualities that position us as being the best choice for manufacturers to partner up with?
1. Long-standing reputation in the infant formula third-party testing space.
2. Many of our scientists have had their work on infant formula published in peer-reviewed scientific literature.
3. Dedicated commercial support team for infant formula manufacturers.
4. Laboratories that operate 24 hours a day / seven days a week.
What would you see as the biggest challenges facing third-party labs in today’s environment?
Changing ingredient sources away from the traditional dairy powders and premixes to plant-based novel ingredients which can be more difficult to test using traditional methods. Turnaround time (TAT) – huge pressure on manufacturers to get their product out the door. Top-notch infant formula third-party testing labs should be running 24/7 to keep up.
How can Eurofins support manufacturers when new emerging nutrients/bio-additives come onto the market?
By staying ahead of the curve with methods and testing protocols e.g. having methods ready to go as new ingredients are being qualified by the FDA.
What are the advantages of using a third-party testing lab vs an in-house lab? Or when should you consider using a third-party lab over an in house lab?
Third-party testing labs can take care of all of the testing that doesn’t require the manufacturer’s in-house expertise e.g. stability, routine label claim testing, etc. The manufacture’s experts can then spend their time on researching new ingredients and new product development.
How can Eurofins help start-ups navigate through testing challenges?
By having a group of subject matter experts on standby ready to help mediate any testing challenges – there isn’t a challenge we haven’t seen before.
