Bovine ingredient safe to be added to infant formula EFSA says

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Infant formula Breastfeeding China Nutrition European union

A novel food application for a whey protein to be used safely in infant formula has secured a positive opinion.

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 secto​r.

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.

Related news

Show more

Related products

4 reasons children need MFGM, according to science

4 reasons children need MFGM, according to science

Content provided by Valio | 29-Sep-2023 | White Paper

In this white paper, Dr Anu Turpeinen discusses the ample scientific evidence showing why milk fat globule membrane (MFGM) is essential for children’s...

Introducing a new era in infant nutrition

Introducing a new era in infant nutrition

Content provided by dsm-firmenich | 01-Sep-2023 | Research Study

Omega-3s are critical to infant health and development – but conventional omega-3 ingredients are impacting the planet.

Solutions of Amino Acids-Based Infant Formula

Solutions of Amino Acids-Based Infant Formula

Content provided by INNOBIO Corporation Limited | 22-Jun-2023 | White Paper

Many infants who are born with nutritional defects often need specifically developed infant formulas to maintain their growth and development. Amino acids-based...

LIPOFER™: a bioavailable and stable source of iron

LIPOFER™: a bioavailable and stable source of iron

Content provided by Lipofoods, a Lubrizol Company | 26-Apr-2023 | White Paper

Maintaining adequate iron levels is critical to maintaining a healthy body, with deficiencies being the cause of several health issues including anemia...

Follow us

Products

View more

Webinars