2012/725/EU: Commission Implementing Decision of 22 November 2012 authorising the placing on the market of bovine lactoferrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (Morinaga) (notified under document C(2012) 8390)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Bovine lactoferrin as specified in Annex I may be placed on the market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II, and without prejudice to the provisions of Regulation (EC) No 1925/2006 of the European Parliament and of the Council ( 4 ) and Directive 2009/39/EC of the European Parliament and of the Council ( 5 ) .
The designation of bovine lactoferrin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cow’s milk’.
This Decision is addressed to Morinaga Milk Industry Co., Ltd, 33-1, Shiba 3-chome, Minato-ku, Tokyo 108-8384, Japan.
ANNEX I SPECIFICATIONS OF BOVINE LACTOFERRIN Definition Bovine lactoferrin (bLF) is a protein that occurs naturally in cow’s milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids. bLF is isolated from skimmed milk via ion exchange and subsequent ultra-filtration steps. Finally it is dried by spraying and large particles are sieved out. Description : Virtually odorless, light pinkish powder Physical-chemical properties of bovine lactoferrin Moisture less than 4,5 % Ash less than 1,5 % Arsenic less than 2 mg/kg Iron less than 350 mg/kg Protein more than 93,0 % of which bovine lactoferrin more than 95,0 % of which other proteins less than 5,0 % pH (2 % solution, 20 °C) 5,2 to 7,2 Solubility (2 % solution, 20 °C) complete
ANNEX II USES OF BOVINE LACTOFERRIN (bLF) Food category Maximum use levels of bLF Infant formulae and follow on formulae (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 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.