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19.9.2012 Official
Journal
of
the
European
Union L
252/11
COMMISSION IMPLEMENTING REGULATION (EU) No 839/2012
of 18 September 2012
concerning the authorisation of urea as a feed additive for ruminants
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
that substance should be authorised as specified in the
Annex to this Regulation.
Having regard to the Treaty on the Functioning of the European
Union,
(6) Since
modifications
to
the
conditions
of
authorisation
of
urea are introduced and as there are no direct immediate
effects on safety, a reasonable period should be allowed
Having regard to Regulation (EC) No 1831/2003 of the
to elapse before authorisation in order to allow the
European Parliament and of the Council of 22 September
interested parties to prepare themselves to meet the
2003 on additives for use in animal nutrition ( 1 ), and in
new requirements resulting from the authorisation. In
particular Article 9(2) thereof,
addition, it is appropriate to allow a transitional period
for the disposal of existing stocks of urea, as authorised
Whereas:
by Directive 82/471/EEC, and of feed containing urea.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
(7) It
is
disproportionately
complex
for
operators
to
adapt
orisation of additives for use in animal nutrition and
repeatedly and from one day to the other labels of feed
for the grounds and procedures for granting such auth
containing different additives which have been
orisation. Article 10 of that Regulation provides for the
successively authorised according to the procedure laid
re-evaluation of products authorised pursuant to Council
down in Article 10(2) of Regulation (EC) No 1831/2003
Directive 82/471/EEC of 30 June 1982 concerning
and for which new labelling rules are to be complied
certain products used in animal nutrition (
with. It is therefore appropriate to reduce the adminis

2 ).
trative burden on the operators by providing a period of
time allowing a smooth conversion of labelling.
(2) Urea
was
authorised
without
a
time
limit
by
Directive
82/471/EEC. That product was subsequently entered in
(8) The
measures
provided
for
in
this
Regulation
are
in
the Community Register of feed additives as an existing
accordance with the opinion of the Standing
product, in accordance with Article 10(1) of Regulation
Committee on the Food Chain and Animal Health,
(EC) No 1831/2003.
HAS ADOPTED THIS REGULATION:
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, an
Article 1
application was submitted for the re-evaluation of urea
as a feed additive for ruminants, requesting that additive
Authorisation
to be classified in the additive category ‘nutritional
additives’. That application was accompanied by the
The preparation specified in the Annex, belonging to the
particulars and documents required under Article 7(3)
additive category ‘nutritional additives’ and to the functional
of Regulation (EC) No 1831/2003.
group ‘urea and its derivatives’ is authorised as an additive in
animal nutrition subject to the conditions laid down in that
Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 7 March 2012 ( 3 ) that,
Article 2
under the proposed conditions of use, urea does not
have an adverse effect on animal health, human health
Labelling requirements
or the environment, and that it provides non-protein
nitrogen for microbial protein synthesis in the rumen.
Feed containing urea shall be labelled in accordance with this
The Authority does not consider that there is a need
Regulation at the latest by 19 May 2013.
for specific requirements of post-market monitoring. It
also verified the report on the method of analysis of the
However, feed containing urea which has been labelled in
feed additive in feed submitted by the Community
accordance with Directive 82/471/EEC before 19 May 2013
Reference Laboratory set up by Regulation (EC) No
may continue to be placed on the market until stocks are
1831/2003.
exhausted.
(5) The
assessment
of
urea
shows
that
the
conditions
for
Article 3
authorisation, as provided for in Article 5 of Regulation
Transitional measures
(EC) No 1831/2003, are satisfied. Accordingly, the use of
Existing stocks of urea and of feed containing urea at the date
of entry into force of this Regulation may continue to be placed
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 213, 21.7.1982, p. 8.
on the market and used under the conditions of Directive
( 3 ) EFSA Journal 2012; 10(3):2624.
82/471/EEC until they are exhausted.

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L 252/12
EN
Official Journal of the European Union
19.9.2012
Article 4
Entry into force
This Regulation shall enter into force on 19 November 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 September 2012.
For the Commission
The President
José Manuel BARROSO

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19.9.2012 Off
ANNEX
Minimum
Maximum
Identification Name of the
Species or
content
content
number of
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
the additive
authori
analytical method
age
authorisation
sation
animal
mg/kg of complete feed with
a moisture content of 12 %
EN

Category of nutritional additives. Functional group: Urea and its derivatives
3d1
— Urea Additive
composition:
Ruminants
— 8
800 The
directions
for
use
of
the
feed
19 November 2022
Urea content: minimum 97 %
with a
additive and feed containing urea
Nitrogen content: 46 %
functional
shall include the following:
rumen
‘Urea shall only be fed to animals
Characterisation of the active substance:
with a functional rumen. Feeding
Diaminomethanone, CAS number 58069-82-2,
urea to the maximum level dose
chemical formula: (NH
should be done gradually. The

2) 2CO
maximum content of urea
icial
should be only fed as part of
Analytical methods (1 ):
diets rich in easily digestible
Jour
For the determination of the total nitrogen in the
carbohydrates and low in
additive: Titrimetry (method 2.3.3 in Annex IV to
soluble nitrogen.
nal
Regulation (EC) No 2003/2003)
of
A maximum 30
% of total
the
For the determination of the biuret contribution to
nitrogen in the daily ration
the total nitrogen in the additive: Spectropho
should come from urea-N.’
European
tometry (method 2.5 in Annex IV to Regulation
(EC) No 2003/2003)
For the determination of urea in premixtures,
Union
compound feed and feed materials: Spectropho
tometry (Annex III.D to Regulation (EC)
No 152/2009)
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx
L
252/13

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Document Outline

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