Arla Foods Ingredients’ new infant formula classified as novel food by EFSA

12 May 2022 --- Arla Foods Ingredients has obtained a positive opinion from the European Food and Safety Authority (EFSA) on their new infant formula. The statement declares that the formula would be classified as a novel food concerning osteopontin derived from bovine whey.

The innovation will become Arla Foods Ingredients’ first infant nutrition approved product under the novel food regulation in the EU, available to purchase in Europe at the end of 2022 or early 2023.

“This decision is a significant step toward achieving Novel Food approval. It’s a strong signal of trustworthiness in this new ingredient for infant milk formula and opens up new opportunities for formula manufacturers,” says Anders Steen Jørgensen, director of pediatric at Arla Foods Ingredients.

The product aims to provide higher protein levels to bovine milk. (Credit: Arla Foods Ingredients)Benefits of osteopontin
Lacprodan OPN-10 is a whey protein, heavily phosphorylated and contains strong calcium-binding properties from acidic glycoprotein. 

The product aims to provide more protein to bovine milk, as human milk contains significantly higher amounts of protein. Thus, infant formulas have provided lower protein levels than human breast milk.

“This results from more than five years of hard work from our R&D department, Early Life Nutrition Science teams and regulatory teams. Lacprodan OPN-10 is a fantastic addition to our infant nutrition portfolio and continues our record of being first to market with products in this sector,” Jørgensen notes.

The production and application of osteopontin are protected by several patterns Arla Foods Ingredients holds. The primary purpose of the Lacprodan OPN-10 is to help infant formula manufacturers develop pure forms of osteopontin in their products. 

The product will be available for infants up to 35 months old, with a maximum of 151 mg per liter in infant formula, follow-on formula and ready-eat dairy-based meals for children. The product will provide a ten times higher bovine milk osteopontin (bmOPN) concentration than natural cow’s milk and other available infant formulas.

Thus, the product aims to provide the same amount of bmOPN as human breast milk. Previous studies have shown the benefits of using osteopontin in infant formulas due to the high protein levels, as it already exists highly in human breast milk. It protects against infections and helps the maturation of the immune system. 

Novel food classifiedArla Foods Ingredients has received positive feedback from the EFSA for this novel food. (Credit: Arla Foods Ingredients)
Defined as food not consumed significantly by humans, Novel food received its first regulation by the European Commission in 1997. For food to be classified as novel, it must be newly developed and innovative. Additionally, new technologies are used in the production process.

If food has been significantly consumed outside the EU, it can also be classified as novel when first brought into the region.

During a six-month study, there were limitations and inconsistencies in the study report on the novel food. However, no safety concerns were raised by the EFSA, and the conclusion is that it is safe to use within the proposed conditions.

Edited by Beatrice Wihlander