Arla Foods Ingredients can safely add Bovine Milk Osteopontin ingredient Lacprodan OPN-10 to ready-to-eat, dairy-based, follow-on meals for children as well as the formula.
The European Food Safety Authority (EFSA) has just recently published the opinion.
When this process is complete, Lacprodan OPN-10 will become Arla Foods Ingredients’ first product for infant nutrition approved under the new Novel Food Regulation (EU) 2015/2283.
Products containing Lacprodan OPN-10 will be authorised for sale in Europe towards the end of 2022 or early 2023.
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.
Anders Steen Jørgensen, Director Pediatric at Arla Foods Ingredients said: “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.
"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.
Anders added that with Lacprodan OPN-10, Arla Foods Ingredients can now help infant formula manufacturers to develop products containing osteopontin in its purest form to date. Arla Foods Ingredients holds several patents for the production and application of osteopontin.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) said: "The intended use levels of the novel food would provide bmOPN at a concentration within the range of human milk (hm) OPN.
In a 6‐month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) infant formula were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns."
EFSA said that considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure is sufficient. The Panel concluded that the novel food is safe under the proposed conditions of use.