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5.6.2012 Official
Journal
of
the
European
Union L
144/19
COMMISSION REGULATION (EU) No 471/2012
of 4 June 2012
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the
Council as regards the use of lysozyme (E 1105) in beer
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
at the levels necessary to achieve the desired tech
nological effect. It is therefore appropriate to allow the
use of lysozyme (E 1105) for the preservation of beers
Having regard to the Treaty on the Functioning of the European
that will not receive either pasteurisation or sterile
Union,
filtration.
Having regard to Regulation (EC) No 1333/2008 of the
European Parliament and of the Council of 16 December
(7) According
to
Commission
Directive
2008/84/EC
of
27 August 2008 laying down specific purity criteria on
2008 on food additives ( 1 ), and in particular Article 10(3) and
food additives other than colours and sweeteners (
Article 30(5) thereof,

4 ),
lysozyme (E 1105) is obtained from hen’s eggs whites.
Eggs and products thereof are listed in Annex IIIa to
Whereas:
Directive 2000/13/EC of the European Parliament and
of the Council of 20 March 2000 on the approximation
of the laws of the Member States relating to the labelling,
(1) Annex
II
to
Regulation
(EC)
No
1333/2008
lays
down
a
presentation and advertising of foodstuffs
( 5 ). The
Union list of food additives approved for use in foods
presence of this enzyme in beers needs to be indicated
and their conditions of use.
on the labelling in accordance with the requirements of
the said Directive.
(2) That
list
may
be
amended
in
accordance
with
the
procedure referred to in Regulation (EC) No
(8) Pursuant
to
Article
3(2)
of
Regulation
(EC)
No
1331/2008 of the European Parliament and of the
1331/2008, the Commission is to seek the opinion of
Council of 16 December 2008 establishing a common
the European Food Safety Authority in order to update
authorisation procedure for food additives, food enzymes
the Union list of food additives set out in Annex II to
and food flavourings ( 2 ).
Regulation (EC) No 1333/2008, except where the update
in question is not liable to have an effect on human
health. Since the authorisation of use of lysozyme (E
(3) Pursuant
to
Article
3(1)
of
Regulation
(EC)
No
1331/2008, the Union list of food additives may be
1105) as a preservative in beer constitutes an update
updated either on the initiative of the Commission or
of that list which is not liable to have an effect on
following an application.
human health, it is not necessary to seek the opinion

of the European Food Safety Authority.
(4) An
application
for
authorisation
of
the
use
of
lysozyme
(E 1105) as a preservative in beer was submitted and has
(9) Pursuant
to
the
transitional
provisions
of
Commission
been made available to the Member States.
Regulation (EU) No 1129/2011 of 11 November 2011
amending Annex II to Regulation (EC) No 1333/2008 of
the European Parliament and of the Council by estab
(5) Most
breweries
use
sterile
filtration
or
pasteurisation
of
lishing a Union list of food additives ( 6 ), Annex II estab
their beers to prevent bacterial spoilage during storage of
lishing the Union list of food additives approved for use
the beer before consumption. For some specialty beers,
in foods and conditions of use applies from 1 June 2013.
like the top-fermenting beers with re-fermentation, for
In order to allow the use of lysozyme (E 1105) in beers
instance cask-conditioned beer and bottle-conditioned
before that date, it is necessary to specify an earlier date
beer, such treatments are not possible because the
of application with regard to that food additive.
present viable micro-organisms are part of the
production process of those beers. Lysozyme (E 1105)
has been proven to be a suitable antibacterial agent for
(10) Therefore,
Annex
II
to
Regulation
(EC)
No
1333/2008
brewing purposes and it is effective in inhibiting lactic
should be amended accordingly.
acid bacteria added to finished beers.
(11) The
measures
provided
for
in
this
Regulation
are
in
(6) Lysozyme
(E
1105)
belongs
to
the
group
of
additives
for
accordance with the opinion of the Standing
which no acceptable daily intake has been specified ( 3 ).
Committee on the Food Chain and Animal Health and
This implies that it does not represent a hazard to health
neither the European Parliament nor the Council has
opposed them,
( 1 ) OJ L 354, 31.12.2008, p. 16.
( 2 ) OJ L 354, 31.12.2008, p. 1.
( 4 ) OJ L 253, 20.9.2008, p. 1.
( 3 ) Report from the Commission on Dietary Food Additive Intake in the
( 5 ) OJ L 109, 6.5.2000, p. 29.
European Union, COM(2001) 542 final.
( 6 ) OJ L 295, 12.11.2011, p. 1.

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L 144/20
EN
Official Journal of the European Union
5.6.2012
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 June 2012.
For the Commission
The President
José Manuel BARROSO

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5.6.2012 Off
ANNEX
In Part E of Annex II to Regulation (EC) No 1333/2008 the following entry is inserted in the food category 14.2.1 ‘beer and malt beverages’ after the entry for E 962:
‘E 1105 Lysozyme quantum
satis only
in
beers
that
will
not
receive
either
pasteurisation
or
Period of application:
sterile filtration
From 25 June 2012’
EN

icial
Jour
nal
of
the
European
Union
L
144/21

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Document Outline

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