• EU Regulation (EC) No 2073/2005 mandates absence of Cronobacter and Enterobacteriaceae in 10g and Salmonella in 25g of dried infant formula and dietary foods for special medical purposes.
• In the US, all finished dried product infant formula samples must be tested for Salmonella and Cronobacter.
• R-Biopharm offers solutions for infant formula testing, including a multiplex qPCR kit for microbial safety and advanced vitamin testing kits.
• The Lactoferrin FAST ELISA test is developed for use in baby milk powder, ensuring accurate levels of added bovine lactoferrin.

Infant formula provides essential nutrients for a baby's growth and development, so it is paramount to ensure its safety and quality.

Since 2022, there have been 14 recalls (source: RASFF & FDA) of infant formula products due to microbial contamination, mainly because of Cronobacter sakazakii. Another recall was related to high levels of Vitamin A and D, for instance.

Regulatory Testing Requirements
Compliance with regulatory standards is important in infant formula production. Rigorous testing for contaminants, nutritional content, and hygiene factors ensures that every product meets the highest safety and quality standards.

In the EU, Commission Regulation (EC) No 2073/2005 requires the absence of Cronobacter and Enterobacteriaceae in 10 g and of Salmonella in 25 g, respectively, in dried infant formula and dried dietary foods for special medical purposes intended for infants below six months of age. Moreover, this food has to be tested for presumptive Bacillus cereus.

In the US, all finished dried product infant formula samples (domestic or imported) selected for microbiological analysis must be tested for Salmonella and Cronobacter. For Salmonella analysis, a portion must be 25 g or larger, and for Cronobacter testing, it must be 10 grams or larger.

Added Vitamins: What's Allowed?
Among the requirements for infant formulas, the FDA for instance, specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients. Read more here.

Lactoferrin
A natural improvement of the baby’s immune system is mediated by the protein Lactoferrin in the mother’s milk. There, it plays an important role in the innate immune system and represents the first anti-microbial and anti-viral defense system. The anti-microbial effect is mainly caused by the chelation of iron-ions, which are important for bacterial growth. Besides that, lactoferrin is reported to be an antioxidant that may strengthen the immune response by supporting the proliferation, differentiation and activation of immune cells. Lactoferrin is found in mucosal secretions, urine, and plasma. The highest concentration of lactoferrin is found in milk and colostrum.

After the European Food Safety Authority approved bovine lactoferrin (bLF) as a novel food ingredient in 2012, the demand for this substance has exploded due to its application in baby powder milk, especially in China.

Our solutions for infant formula testing

Microbial Safety - A Non-Negotiable Priority
Microbial safety is of utmost importance in infant formula production. Our new multiplex qPCR kit was specifically designed for the detection of Enterobacteriaceae, Cronobacter and Salmonella in infant formula products:

SureFast® Enterobacteriaceae 4plex (F5180)
The intuitive workflow ensures a hassle-free experience, from sample preparation to result interpretation:

• One enrichment
• One DNA preparation
• One master-mix

Vitamin Testing Kits:
Our advanced kits provide precise analysis, ensuring accurate levels of added vitamins in infant formula.

Lactoferrin testing
Adding Lactoferrin not only improves the value of the milk powder but also makes it more expensive. The EuroProxima brand of R-Biopharm presents the Lactoferrin FAST ELISA to monitor the concentration of added bovine lactoferrin. This ELISA test is specifically developed for use in baby milk powder. It is a fast screening test with an easy sample preparation without the use of any organic solvent.

From vitamin transparency to microbial safety, our testing solutions allow producers to meet and exceed regulatory requirements. As we collectively strive for the highest standards, we contribute to the well-being of the little ones who rely on these essential products for a healthy start in life

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