Document ID: 02012D0725-20150409
Language: ENG

02012D0725 — EN — 09.04.2015 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING DECISION</p><p>of 22 November 2012</p><p>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)</p><p>(notified under document C(2012) 8390)</p><p>(Only the English text is authentic)</p><p><a>(2012/725/EU)</a></p><p>(OJ L 327 27.11.2012, p. 46)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING DECISION (EU) 2015/568&#160;of 7 April 2015</a></p></td><td><p>&#160;&#160;L&#160;93</p></td><td><p>71</p></td><td><p>9.4.2015</p></td></tr></table>
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
<table><col/><col/><tbody><tr><td><p>Moisture</p></td><td><p>less than 4,5&#160;%</p></td></tr><tr><td><p>Ash</p></td><td><p>less than 1,5&#160;%</p></td></tr><tr><td><p>Arsenic</p></td><td><p>less than 2&#160;mg/kg</p></td></tr><tr><td><p>Iron</p></td><td><p>less than 350&#160;mg/kg</p></td></tr><tr><td><p>Protein</p></td><td><p>more than 93,0&#160;%</p></td></tr><tr><td><p>of which bovine lactoferrin</p></td><td><p>more than 95,0&#160;%</p></td></tr><tr><td><p>of which other proteins</p></td><td><p>less than 5,0&#160;%</p></td></tr><tr><td><p>pH (2&#160;% solution, 20&#160;&#176;C)</p></td><td><p>5,2 to 7,2</p></td></tr><tr><td><p>Solubility (2&#160;% solution, 20&#160;&#176;C)</p></td><td><p>complete</p></td></tr></tbody></table>
ANNEX II
USES OF BOVINE LACTOFERRIN (bLF)
<table><col/><col/><tbody><tr><td><p>Food category</p></td><td><p>Maximum use levels of bLF</p></td></tr><tr><td><p>Infant formulae and follow on formulae (ready to drink)</p></td><td><p>100&#160;mg/100&#160;ml</p></td></tr><tr><td><p>Foods on dairy basis intended for young children (ready to eat/drink)</p></td><td><p>200&#160;mg/100&#160;g</p></td></tr><tr><td><p>Processed cereal food (solid)</p></td><td><p>670&#160;mg/100&#160;g</p></td></tr><tr><td><p>Foods for special medical purposes</p></td><td><p>Depending on the needs of the individual up to 3&#160;g/day</p></td></tr><tr><td><p>Beverages based on milk</p></td><td><p>200&#160;mg/100&#160;g</p></td></tr><tr><td><p>Powdered drink mixes based on milk (ready to drink)</p></td><td><p>330&#160;mg/100&#160;g</p></td></tr><tr><td><p>Beverages based on fermented milk (including yoghurt drinks)</p></td><td><p>50&#160;mg/100&#160;g</p></td></tr><tr><td><p>Non-alcoholic drinks</p></td><td><p>120&#160;mg/100&#160;g</p></td></tr><tr><td><p>Products based on yoghurt</p></td><td><p>80&#160;mg/100&#160;g</p></td></tr><tr><td><p>Products based on cheese</p></td><td><p>2&#160;000 &#160;mg/100&#160;g</p></td></tr><tr><td><p>Ice cream</p></td><td><p>130&#160;mg/100&#160;g</p></td></tr><tr><td><p>Cakes and pastries</p></td><td><p>1&#160;000 &#160;mg/100&#160;g</p></td></tr><tr><td><p>Candies</p></td><td><p>750&#160;mg/100&#160;g</p></td></tr><tr><td><p>Chewing gum</p></td><td><p>3&#160;000 &#160;mg/100&#160;g</p></td></tr></tbody></table>
<note>
( 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.
</note>