Cronobacter in Infant Formula: How Testing Protects Consumers and You
The United States has one of the largest infant formula markets in the world, with an estimated 58 billion dollars in
20211. With a market this large, there is a clear need for high quality, reliable products. The dedication (and requirements) needed for the manufacturing of quality infant formula becomes even more important as consequences for infants, who are considered a high-risk population, can be devastating.
Recent media has shed light on the dangers of Cronobacter contamination in infant formula, highlighting the absolute necessity of Cronobacter, and pathogen testing in general, for all infant formula products.
The basics: What is Cronobacter?
Cronobacter is a gram-negative bacterial genus found in most environments. There are a few species of this pathogen, but the general term Cronobacter is used to refer to any that can cause harmful infections. This microbe thrives in dry powders, like infant formula, dried dairy products, and other ingredients such as herbs and spices2. Cronobacter can survive on abiotic surfaces, like stainless steel, that have direct contact with food ingredients during product processing and production. This is dangerous because while Cronobacter infections are rare, they can be deadly for infants. Infection can start with a fever and poor feeding and lead to seizures, sepsis, and death3.
How common are Cronobacter infections?
The CDC receives 2-4 reports of Cronobacter infection in infants a year and rarely do these reports include death2. After an infection occurs, there is almost no way to know if a bacterial infection was a result of contaminated materials, processing procedures or equipment, or accidental mishandling at home while preparing formula for feeding. However, any illness in an infant can be extremely harmful to a brand or business. This bacteria can grow in most environments including produce, packaged foods, and water, therefore it is necessary to test infant formula products produced near potential contamination sources4. In addition, further investigation into raw materials from unknown production facilities may be necessary.
How does Cronobacter contamination occur in products?
Cronobacter can get into products in a variety of ways. For instance, it can survive in dirty water and on contaminated surfaces, meaning a breakout can occur from improper equipment sterilization and improperly cleaned work spaces4. Cronobacter can be present in raw materials or products can become contaminated after being opened.
Typically, infant formula processing includes a pasteurization step that kills bacteria in the materials, which is why the type of contamination is very rare.
When should testing occur?
- Best practices includes testing all raw materials before used in the production of a product
- Finished products should complete releasing testing, either by lot or batch, prior to distribution
- Our experts can help determine the best approach to sample and batch testing to ensure thorough and reliable safety measures are in place
- Avoid costly lawsuits, recalls, and harming consumers by testing early and often
Testing and detection techniques at Eurofins:
Culture based:
Culture based methods involve isolating bacteria from a sample, growing it on or in media, and identifying the species. Samples can be screened for a specific pathogen, like Cronobacter, or a panel of potential contaminants using selective media. Different methods have different processing times, but growing microbes takes up to a week. Usually, bacterial identification is confirmed with a PCR based method.
PCR based:
Polymerase Chain Reaction (PCR), is a method that amplifies specific regions of DNA to determine the identity of a pathogen. Some methods include a DNA extraction of any microbe present in a product, followed by identification to a genus or species level. More specific methods couple culture growth to PCR by isolating specific classes of bacteria that can grow on certain media, then isolating DNA and confirming the bacterial identity. PCR can detect very low levels of pathogens and is a quick method optimized for infant formula.
Immunological:
Immunological assays use probes, like antibodies or florescent tags to target proteins. These can be extremely specific and target proteins found only in certain species of bacteria. However, immunological assays are more labor intensive and less common than PCR and culture based approaches.
Chemistry based:
LC-MS is a technique that separates and quantifies chemical compounds in a sample. LC-MS can be used to determine the presence, ratio, and quantity of compounds that are known to be present in Cronobacter but not in any raw materials. This provides a specific, high-throughput approach to Cronobacter testing with a fast turn-around-time and simple results.
Contact us today to learn more about our complete package of infant formula tests and develop a testing plan that is right for you!
