HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 327/46
EN
Official Journal of the European Union
27.11.2012
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)
THE EUROPEAN COMMISSION,
(6) On
27
April
2012
in
another
‘Scientific
opinion
on
bovine lactoferrin’
( 3 ) EFSA already came to the
conclusion that lactoferrin was safe under the proposed
Having regard to the Treaty on the Functioning of the European
uses and use levels. Therefore it appears appropriate to
Union,
authorise the same uses for both applications.
(7) Bovine
lactoferrin
complies
with
the
criteria
laid
down
in
Having regard to Regulation (EC) No 258/97 of the European
Article 3(1) of Regulation (EC) No 258/97.
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients ( 1 ), and in particular
(8) The
measures
provided
for
in
this
Decision
are
in
Article 7 thereof,
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Whereas:
HAS ADOPTED THIS DECISION:
Article 1
(1) On
2
March
2011
the
company
Morinaga
Milk
Industry Bovine lactoferrin as specified in Annex I may be placed on the
Co. Ltd made a request to the competent authorities of
market as a novel food ingredient for the uses defined and at
Ireland to place bovine lactoferrin on the market as novel
the maximum levels established in Annex II, and without
food ingredient. Bovine lactoferrin is an iron binding
prejudice to the provisions of Regulation (EC) No 1925/2006
protein from milk to be added to foods.
of the European Parliament and of the Council ( 4 ) and Directive
2009/39/EC of the European Parliament and of the Council ( 5 ).
(2) On
22
June
2011
the
competent
food
assessment
body
Article 2
of Ireland issued its initial assessment report. In this
report they recommended that instead of carrying out
The designation of bovine lactoferrin authorised by this
an initial assessment an additional assessment was
Decision on the labelling of the foodstuffs containing it shall
required, because another application concerning bovine
be ‘Lactoferrin from cow’s milk’.
lactoferrin was already referred to EFSA.
Article 3
This Decision is addressed to Morinaga Milk Industry Co., Ltd,
(3) The
Commission
forwarded
the
initial
assessment
report
to all Member States on 20 July 2011.
33-1, Shiba 3-chome, Minato-ku, Tokyo 108-8384, Japan.

(4) The
European
Food
Safety
Authority
(EFSA)
was Done at Brussels, 22 November 2012.
consulted on 22 August 2011.
For the Commission
(5) On
28
June
2012
in
their
‘Scientific
opinion
on
bovine
lactoferrin’ (
Maro EFOVI

2 ) EFSA came to the conclusion that bovine
lactoferrin is safe under the proposed uses and use levels.
Vice-President
( 3 ) EFSA Journal 2012; 10(5): 2701.
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 4 ) OJ L 404, 30.12.2006, p. 26.
( 2 ) EFSA Journal 2012; 10(7): 2811.
( 5 ) OJ L 124, 20.5.2009, p. 21.

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EN
27.11.2012 Official
Journal
of
the
European
Union L
327/47
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 approxi
mately 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

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L 327/48
EN
Official Journal of the European Union
27.11.2012
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

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