Arla obtains GRAS approval for alpha-lactalbumin in infant formula

Adding an alpha-lactalbumin ingredient means can emulate human milk more closely in terms of protein concentration and composition

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

The US FDA issued the Danish 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 as Lacprodan ALPHA-10 – when used in infant formula.

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 8.3 g per litre. It will also allow Arla 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. 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. 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 associated with alpha-lactalbumin include a reduction in feeding-related gastrointestinal events, protection against intestinal infections and support for healthy gut microbiota.

Kal Ramanujam, Senior Scientific Advisor of Pediatric, at Arla, 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.”

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.

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