Sourced from bovine milk, the MFGM approved is produced by Arla Foods Ingredients and is commercially available under the name “Lacprodan MFGM-10″.
According to Arla Foods Ingredients, the company will enjoy 15 months of exclusivity in supplying MFGM for use in infant formula products in Australia.
The ingredient can be used in infant formula products at a concentration of 0.14 g/100 kJ to 0.28 g/100 kJ, and be labelled as “milk fat globule membrane-enriched whey protein concentrate (MFGM-WPC)” in products.
Naturally occurring in human milk, MFGM contains phospholipids, sphingolipids and gangliosides.
The associated health benefits that it could provide when added to infant formulas include 1) anti-pathogenic effect, 2) immunomodulation, and 3) development of the gut microbiome through increased Bifidobacterium expression, said FSANZ.
For example, findings of a clinical trial published in The Journal of Pediatrics reported that infants receiving formula with added bovine MFGM and bovine lactoferrin had significantly fewer diarrhoea and respiratory-associated adverse events.
“FSANZ’s safety assessment concluded that MFGM-WPC is an appropriate source of phospholipids for inclusion in infant formula products and does not pose a safety risk to infants.
“While more data is needed to substantiate improved mental development compared to standard infant formula products, there is evidence MFGM-WPC may be beneficial for infant gut microbiota development,” said FSANZ.
This approval, however, is not applicable in the New Zealand market, which has opted out of the Australia-New Zealand joint infant formula products standard recently.
Elsewhere, the ingredient has been used in infant formula products sold in the European Union for 15 years. In Canada, the ingredient is approved for use as a bioactive nutrient in infant formula as well.
In fact, the ingredient is increasingly used in infant formulas and kids nutrition products across Asia-Pacific as well.
Notable products containing MFGM include Mead Johnson’s Enfamil Enspire 1 infant formula and Interbos Hoff milk pudding in Vietnam.
“We’re proud to have pioneered the use of MFGM in infant nutrition, which has allowed significant improvements in the creation of scientifically backed formula products.
“Following the recent positive decision about Lacprodan MFGM-10 in the EU, this is another highly welcome regulatory development. We’re delighted that its many clinically supported benefits for infants are now also available in Australia,” said Jakob Madsen Pedersen, senior director, specialised nutrition at Arla Foods Ingredients.
