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FrieslandCampina lactoferrin ingredient granted EC novel foods approval

By Mark Astley , 05-Dec-2012
Last updated the 11-Dec-2012 at 09:13 GMT

The European Commission (EC) has given Dutch dairy giant FrieslandCampina the go-ahead to market bovine lactoferrin as a novel food ingredient.

Last week, the EC published its decision to approve lactoferrin produced by FrieslandCampina as a novel food - meaning it can now be used across the European Union (EU) in a variety of foods, including infant, medical and sports nutrition products.

Bovine lactoferrin (bLF) is a protein that occurs naturally in cow’s milk. It is also found naturally in human breast milk, but at much higher levels.

FrieslandCampina’s bovine lactoferrin product, which is marketed as Vivinal LF, is concentrated from cow's milk to mimic the lactoferrin present in breast milk.

It is already available as an ingredient and in FrieslandCampina infant formula products in parts of Asia and the US – where it has regulatory approval.

Speaking with DairyReporter.com, FrieslandCampina spokesperson Jan Willem ter Avest revealed that the ingredient will be available immediately. It may also be added to its European infant formula range in future.

No health risks

The EC announcement represents the end of a long, scientific process, said ter Avest.

“We started the process in 2009. It has taken three years. First it was assessed by the Dutch government, then by each of the European Union Member States, then finally by EFSA. None of them discovered any health risks.”

“The European Commission publication was the final step in this procedure.”

“We have been given this novel food approval, but it is important to reiterate that this is not the same as a health claim,” ter Avest added.

FrieslandCampina Ingredients chief operating officer (COO) Roelof Joosten welcomed the EC decision.

“Lactoferrin is directly derived from cow’s milk, one of the most nutritious foods there is. New ingredients do not often get approval from the European Commission, and particularly not for infant nutrition. This new authorisation will enable us and our customers to use our lactoferrin in various foods throughout Europe,” said Joosten.

EFSA approval

The EC based its decision on an assessment by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). The assessment, which was carried out following a request from the EC, concluded that bovine lactoferrin was safe for human consumption.

The Panel noted that lactoferrin is a normal constituent of human milk, and that the intended consumption of bovine lactoferrin – as specified by FrieslandCampina – was well within the levels of breast milk.

“The Panel considers that bLF up to the highest dose (2,000mg/kg bw per day) tested in this subchronic rat study did not show adverse effects which could be attributed to the test substance,” said the EFSA opinion.

“The Panel concludes that the novel food ingredient bLF is safe under the proposed uses and use levels.”

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