Bovine lactoferrin: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink): 100 mg/100 ml
• Foods on dairy basis intended for young children (ready to eat/drink): 200 mg/100 g
• Processed cereal food (solid): 670 mg/100 g
• Foods for special medical purposes as defined in Regulation (EU) No 609/2013: Depending on the needs of the individual up to 3 g/day
• Beverages based on milk: 200 mg/100 g
• Powdered drink mixes based on milk (ready to drink): 330 mg/100 g
• Beverages based on fermented milk (including yoghurt drinks): 50 mg/100 g
• Non-alcoholic drinks: 120 mg/100 g
• Products based on yoghurt: 80 mg/100 g
• Products based on cheese: 2 000 mg/100 g
• Ice cream: 130 mg/100 g
• Cakes and pastries: 1 000 mg/100 g
• Candies: 750 mg/100 g
• Chewing gum: 3 000 mg/100 g

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

Bovine lactoferrin is a protein that occurs naturally in cows’ milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.

Production process: Bovine lactoferrin is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtration steps. Finally, it is dried by freeze drying or spraying and the large particles are sieved out. It is a virtually odourless, light pinkish powder.

Physical-Chemical properties of Bovine lactoferrin:

Moisture: < 4,5 %

Ash: < 1,5 %

Arsenic: < 2,0 mg/kg

Iron: < 350 mg/kg

Protein: > 93 %

of which bovine lactoferrin: > 95 %

of which other proteins: < 5,0 %

pH (2 % solution, 20 °C): 5,2-7,2

Solubility (2 % solution, 20 °C): complete

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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