HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 327/52
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 (FrieslandCampina)
(notified under document C(2012) 8404)
(Only the Dutch text is authentic)
(2012/727/EU)
THE EUROPEAN COMMISSION,
that bovine lactoferrin is safe under the proposed uses
and use levels. Therefore it appears appropriate to
Having regard to the Treaty on the Functioning of the European
authorise the same uses for both applications.
Union,
(8) 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
Article 7 thereof,
(9) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Whereas:
(1) On
2
March
2009
the
company
FrieslandCampina HAS ADOPTED THIS DECISION:
(formerly DMV International) made a request to the
competent authorities of the Netherlands to place lacto
Article 1
ferrin on the market as novel food ingredient. Lactoferrin
is an iron-binding protein from milk to be added to
Bovine lactoferrin as specified in Annex I may be placed on the
foods.
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
(2) On
31
March
2010
the
competent
food
assessment
body
of the Netherlands issued its initial assessment report. In
of the European Parliament and of the Council ( 4 ) and Directive
this report it came to the conclusion that there was no
2009/39/EC of the European Parliament and of the Council ( 5 ).
reason for concern thus lactoferrin may be placed on the
market as a novel food ingredient.
Article 2
The designation of bovine lactoferrin authorised by this
(3) The
Commission
forwarded
the
initial
assessment
report Decision on the labelling of the foodstuffs containing it shall
to all Member States on 13 April 2010.
be ‘Lactoferrin from cows’ milk’.
(4) Within
the
60-day
period
laid
down
in
Article
6(4)
of
Regulation (EC) No 258/97 reasoned objections were
Article 3
raised in accordance with that provision.
This Decision is addressed to FrieslandCampina, Nieuwe Kanaal
7R, 6709 PA Wageningen, The Netherlands.
(5) Therefore
the
European
Food
Safety
Authority
(EFSA)
was consulted on 9 November 2010.
Done at Brussels, 22 November 2012.
(6) On
27
April
2012
in
their
‘Scientific
opinion
on
bovine
lactoferrin’ ( 2 ) EFSA came to the conclusion that bovine
lactoferrin is safe under the proposed uses and use levels.
For the Commission
(7) On
28
June
2012
in
another
‘Scientific
opinion
on
Maro EFOVI
bovine lactoferrin’ ( 3 ) EFSA also came to the conclusion
Vice-President
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 2 ) EFSA Journal 2012;(5):2701.
( 4 ) OJ L 404, 30.12.2006, p. 26.
( 3 ) 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
327/53
ANNEX I
SPECIFICATIONS OF BOVINE LACTOFERRIN
Definition
Bovine lactoferrin (bLF) is a protein that occurs naturally in cows’ 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 odourless, 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 %
of which bovine lactoferrin more
than
95
%
of which other proteins less
than
5
%
pH (2 % solution, 20 °C) 5,2
to
7,2
Solubility (2 % solution, 20 °C) complete

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L 327/54
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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