The European Food Safety Authority (EFSA) has published an opinion that OPN is safe for use in infant formula, follow-on formula and ready-to-eat dairy-based meals for children.
When the full Novel Foods process is complete, Lacprodan OPN-10 will be Arla Foods Ingredients’ first infant nutrition product approved under the Novel Food Regulation. Products containing Lacprodan OPN-10 will be authorised for sale in Europe towards the end of 2022 or by early 2023, the company predicted.
“We’re delighted by this decision, which is a significant step towards 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,” Anders Steen Jørgensen, Director Paediatric at Arla Foods Ingredients said.
Osteopontin is a whey protein, which is a heavily phosphorylated, acidic glycoprotein with strong calcium-binding properties. Significant amounts of this protein have been identified in human milk, while smaller quantities are present in bovine milk. This means that – to date – infant formulas have had lower osteopontin content than human breast milk.
The EFSA opinion considered the use of OPN in infant formula, follow-on-formula and ready to eat children's meals at a maximum concentration of 151mg/l. This is around a ten-fold higher concentration than OPN naturally found in cow’s milk and infant formula already on the market, the food safety authority noted. The intended use levels of the Novel Food would provide OPN at a concentration ‘within the range of human milk’ OPN.
“The Panel concludes that the NF is safe under the proposed conditions of use,” EFSA stated.
EFSA approval is an important milestone within the Novel Foods regulation as it helps inform the final decision which is issued by the European Commission.
With regulatory approval on the horizon, Arla Food Ingredients said it will be able to help infant formula manufacturers to develop products containing osteopontin in its ‘purest form to date’. Arla Foods Ingredients already holds several patents for the production and application of osteopontin.
“This is the result of 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 added.