Arla Foods Ingredients has obtained Generally Recognized as Safe (GRAS) approval relating to its use of alpha-lactalbumin in infant formula.

The US Food & Drug Administration (FDA) issued the company with a GRAS Notice known as a ‘no objection letter’. It states that it has no questions regarding the safety of fractionated whey protein concentrate containing 41% alpha-lactalbumin – marketed by Arla Foods Ingredients as Lacprodan ALPHA-10 – when used in infant formula.

Arla gets GRAS approval for Lacprodan ALPHA-10

The FDA’s decision means Lacprodan ALPHA-10 is permitted as an ingredient in cows’ milk-based non-exempt formula for term infants at levels of to 8.3g per litre. It will also allow Arla Foods Ingredients to supply fractionated whey protein concentrate containing 41% alpha-lactalbumin to the US infant formula market.

Alpha-lactalbumin is rich in essential amino acids and the most abundant protein in human milk, comprising about 25% of total protein content. Arla says that adding an alpha-lactalbumin ingredient such as Lacprodan ALPHA-10 to an infant formula means it can emulate human milk more closely in terms of protein concentration and composition.

It also makes it possible to reduce overall protein levels in a formula, the company says. This is widely considered desirable because, while more research is needed, reducing the protein concentration of formula has been suggested as a preventive strategy for cutting the risk of overweight and obesity in children. Other benefits aid to be associated with alpha-lactalbumin include a reduction in feeding-related gastrointestinal events, protection against intestinal infections and support for a healthy gut microbiota.

Kal Ramanujam, Senior Scientific Advisor, Pediatric, at Arla Foods Ingredientssaid: “Lacprodan ALPHA-10 delivers safe and documented benefits when used in infant formula. This approval is a regulatory milestone in the U.S. It will benefit millions of babies by allowing them to consume clinically documented levels of bovine alpha lactalbumin.”

Lacprodan ALPHA-10 is a whey protein fraction with 41% alpha-lactalbumin and a high content of tryptophan, cysteine and 88% protein concentrate in dry matter.