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)

• CELEX: Regulation (EC) No 258/97
• Articles: 5

Article 1

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 ) .

Article 2

The designation of bovine lactoferrin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cow’s milk’.

Article 3

This Decision is addressed to Morinaga Milk Industry Co., Ltd, 33-1, Shiba 3-chome, Minato-ku, Tokyo 108-8384, Japan.

Schedules & Appendices

ANNEX I

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

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