Arla Foods Ingredients has received Generally Recognized as Safe (GRAS) approval from the US Food & Drug Administration (FDA) for its use of alpha-lactalbumin in infant formula.

The USFDA has issued a ‘no objection letter’ GRAS Notice to the company.

The letter implies that the FDA has no questions regarding the safety of fractionated whey protein concentrate that contains 41% alpha-lactalbumin.

The company markets the product alpha-lactalbumin as Lacprodan ALPHA-10.

Arla Foods Ingredients pediatric senior scientific advisor Kal Ramanujam said: “Lacprodan ALPHA-10 delivers safe and documented benefits when used in infant formula.

“This approval is a regulatory milestone in the US. It will benefit millions of babies by allowing them to consume clinically documented levels of bovine alpha-lactalbumin.”

The company added that its Lacprodan ALPHA-10 includes high contents of tryptophan, cysteine and 88% protein concentrate in dry form.

Arla Foods will now include 8.3g per litre of Lacprodan ALPHA-10 as an ingredient in cows’ milk-based non-exempt formula for term infants.

Alpha-lactalbumin is claimed to be rich in essential amino acids, the most abundant protein in human milk.

The company further noted that the addition of Lacprodan ALPHA-10 could match human milk more closely in terms of protein concentration and composition.

Additionally, the FDA’s letter will allow the company to distribute fractionated whey protein concentrate containing 41% alpha-lactalbumin to the US infant formula market.

In January, Arla Foods Ingredients developed a new whey protein-based concept for infant formula.

The company said that its new formula contains alpha-lactalbumin and whey protein hydrolysates, broken down by enzymes.