Arla Foods’ Peptigen IF-3080 protein hydrolysate officially approved for infant formula in the EU


Last year, the EU introduced new regulations for infant and follow-on formulas manufactured with protein hydrolysates.

Photo from Arla Foods Ingredients

Photo from Arla Foods Ingredients

This year, the European Union rolled out new regulations for infant and follow-on formulas manufactured with protein hydrolysates. The regulations cover specific compositional requirements for these products, including for protein content, protein source, protein processing, and key amino acids and L-carnitine. The European Food Safety Authority (EFSA) has stated that “the safety and suitability of each specific formula containing protein hydrolysates has to be established by clinical evaluation in the target population.”

Whey-ingredients supplier Arla Foods Ingredients (Viby J, Denmark) had submitted its protein hydrolysate ingredient Peptigen IF-3080 for review, with EFSA publishing an opinion that the ingredient is safe for use in infant formulas and follow-on formulas. According to Arla, the company was “one of only a few milk protein hydrolysates” to achieve this status.

Now, Arla says, Peptigen IF-3080 is covered under European Commission Delegated Regulation 2023/589—which establishes the new protein hydrolysate rules, amending Delegation Regulation 2016/127 and published this January—cementing Peptigen IF-3080's authorized use in the EU in these products.

Anders Steen Jørgensen, head of Arla Foods Ingredients’ pediatric business unit, said in a press release, “It’s great news that Peptigen IF-3080 has completed its journey to market in the EU. Safety and quality are of course paramount in infant nutrition, and this decision reflects our absolute commitment to the highest possible standards. We believe it will benefit manufacturers developing innovative products, as well as increasing the choice of high-quality formula available to parents.”

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