02012D0725 — EN — 09.04.2015 — 001.001
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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) (Only the English text is authentic) (OJ L 327 27.11.2012, p. 46) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING DECISION (EU) 2015/568 of 7 April 2015 |
L 93 |
71 |
9.4.2015 |
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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)
(Only the English text is authentic)
(2012/725/EU)
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.
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 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.
Description: Virtually odorless, light pinkish powder
Physical-chemical properties of bovine lactoferrin
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Moisture |
less than 4,5 % |
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Ash |
less than 1,5 % |
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Arsenic |
less than 2 mg/kg |
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Iron |
less than 350 mg/kg |
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Protein |
more than 93,0 % |
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of which bovine lactoferrin |
more than 95,0 % |
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of which other proteins |
less than 5,0 % |
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pH (2 % solution, 20 °C) |
5,2 to 7,2 |
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Solubility (2 % solution, 20 °C) |
complete |
ANNEX II
USES OF BOVINE LACTOFERRIN (bLF)
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Food category |
Maximum use levels of bLF |
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Infant formulae and follow on formulae (ready to drink) |
100 mg/100 ml |
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Foods on dairy basis intended for young children (ready to eat/drink) |
200 mg/100 g |
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Processed cereal food (solid) |
670 mg/100 g |
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Foods for special medical purposes |
Depending on the needs of the individual up to 3 g/day |
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Beverages based on milk |
200 mg/100 g |
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Powdered drink mixes based on milk (ready to drink) |
330 mg/100 g |
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Beverages based on fermented milk (including yoghurt drinks) |
50 mg/100 g |
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Non-alcoholic drinks |
120 mg/100 g |
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Products based on yoghurt |
80 mg/100 g |
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Products based on cheese |
2 000 mg/100 g |
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Ice cream |
130 mg/100 g |
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Cakes and pastries |
1 000 mg/100 g |
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Candies |
750 mg/100 g |
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Chewing gum |
3 000 mg/100 g |
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 2 ) EFSA Journal 2012; 10(7): 2811.
( 3 ) EFSA Journal 2012; 10(5): 2701.
( 4 ) OJ L 404, 30.12.2006, p. 26.
( 5 ) OJ L 124, 20.5.2009, p. 21.