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8.2.2014 Official
Journal
of
the
European
Union L
39/53
COMMISSION IMPLEMENTING REGULATION (EU) No 121/2014
of 7 February 2014
concerning the authorisation of L-selenomethionine as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No
1831/2003.
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
assessment
of
L-selenomethionine
shows
that
the
conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of that preparation should be auth
Having regard to Regulation (EC) No 1831/2003 of the
orised as specified in the Annex to this Regulation.
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(6) The
Authority
concluded
that
the
limitation
of
the
supplementation with organic selenium established for
other organic compounds of selenium should also
Whereas:
apply to L-selenomethionine. Furthermore, in case
different compounds of selenium are added to the feed,
the supplementation with organic selenium should not
exceed 0,2 mg per kg complete feed.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation.
(7) The
applicant
delivered
supplementary
data
consequently
to the abovementioned opinion of the Authority to
prove the stability of the additive once it is incorporated
in premixtures containing compounds of trace elements.
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003, an application was submitted for the auth
orisation of L-selenomethionine. That application was
accompanied by the particulars and documents required
(8) The
measures
provided
for
in
this
Regulation
are
in
under Article 7(3) of Regulation (EC) No 1831/2003.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) That
application
concerns
the
authorisation
of
L-sele
nomethionine, an organic compound of selenium, as a
HAS ADOPTED THIS REGULATION:
feed additive for all animal species, to be classified in the
additive category ‘nutritional additives’.
Article 1
The preparation specified in the Annex, belonging to the
(4) The
European
Food
Safety
Authority
(‘the
Authority’) additive category ‘nutritional additives’ and to the functional
concluded in its opinion of 2 May 2013 ( 2 ) that, under
group ‘compounds of trace elements’, is authorised as an
the proposed conditions of use, L-selenomethionine does
additive in animal nutrition, subject to the conditions laid
not have an adverse effect on animal health, human
down in that Annex.
health or the environment and that its use may be
considered as an efficient source of selenium for all
animal species. The Authority does not consider that
there is a need for specific requirements of post-market
Article 2
monitoring. It also verified the report on the method of
This Regulation shall enter into force on the twentieth day
( 1 ) OJ L 268, 18.10.2003, p. 29.
following that of its publication in the Official Journal of the
( 2 ) EFSA Journal 2013; 11(5):3219.
European Union.

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L 39/54
EN
Official Journal of the European Union
8.2.2014
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 February 2014.
For the Commission
The President
José Manuel BARROSO

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8.2.2014 Off
ANNEX
Minimum
Maximum
Identifi
Name of
content
content
cation
the
Species or
number of holder of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the
authori
analytical method
animal
age
Selenium in mg/kg of
authorisation
additive
sation
complete feed with a
EN
moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements
3b815
— L-selenomethionine Characterisation
of
the
additive
All species
— 0,50
(total) 1.
The additive shall be incorporated into 28 February 2024
feed in the form of a premixture.
Solid preparation of L-selenomethionine
with a selenium content < 40 g/kg
2. For user safety: breathing protection,
safety glasses and gloves shall be worn
Characterisation of the active substance
during handling.
Organic selenium in form of L-selenome
3. Technological additives or feed materials
thionine (2-amino-4-methylselanyl-butanoic
included in the preparation of the
icial
acid) from chemical synthesis
additive shall ensure a dusting potential
< 0,2 mg selenium/m3 air.
Jour
Chemical formula: C 5H 11NO 2Se
nal
4. In the directions for use of the additive
CAS number: 3211-76-5
and premixtures, indicate the storage and
of
stability conditions.
the
Crystalline powder with L-selenomethionine
> 97 % and
5. Maximum supplementation with organic
European
selenium:
Selenium > 39 %
0,20 mg Se/kg of complete feed with a
Analytical method (1 )
moisture content of 12 %.
Union
For the determination of L-selenomethionine
6. If the preparation contains a tech
in the feed additive: high performance liquid
nological additive or feed materials for
chromatography and inductively coupled
which a maximum content is set or
plasma mass spectrometry (HPLC-ICPMS)
which is subject to other restrictions,
after triple proteolytic digestion.
the feed additive manufacturer shall
provide this information to the
For the determination of total selenium in
customers.
the feed additive: inductively coupled
plasma mass spectrometry (ICPMS), or
inductively coupled plasma atomic emission
spectrometry (ICP-AES).
For the determination of total selenium in
premixtures, compound feed and feed
materials: hydride generation atomic
absorption spectrometry (HGAAS) after
microwave digestion (EN 16159:2012).
L
39/55
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory:
http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx

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