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15.5.2013 Official
Journal
of
the
European
Union L
130/21
COMMISSION IMPLEMENTING REGULATION (EU) No 445/2013
of 14 May 2013
concerning the authorisation of hydroxy-analogue of selenomethionine as a feed additive for all
animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
post-market monitoring. It also verified the report on the
method of analysis of the feed additive in feed submitted
Having regard to the Treaty on the Functioning of the European
by the Reference Laboratory set up by Regulation (EC)
Union,
No 1831/2003.
(5) The
assessment
of
hydroxy-analogue
of
selenomethionine
Having regard to Regulation (EC) No 1831/2003 of the
shows that the conditions for authorisation, as provided
European Parliament and of the Council of 22 September
for in Article 5 of Regulation (EC) No 1831/2003, are
2003 on additives for use in animal nutrition ( 1 ), and in
satisfied. Accordingly, the use of this preparation should
particular Article 9(2) thereof,
be authorised as specified in the Annex to this Regu
lation.
Whereas:
(6) The
Authority
concluded
that
the
limitation
of
the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
supplementation with organic selenium should apply to
orisation of additives for use in animal nutrition and
the already authorised organic selenium compounds, the
for the grounds and procedures for granting such auth
selenised yeasts, and hydroxy-analogue of selenome
orisation.
thionine. Thus, in case inorganic compounds of
selenium are also added to the feed, the supplementation
with organic selenium should not exceed 0,2 mg per kg
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
complete feed.
1831/2003, an application was submitted for the auth

orisation of hydroxy-analogue of selenomethionine. The
application was accompanied by the particulars and
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
documents required under Article 7(3) of Regulation
Committee on the Food Chain and Animal Health,
(EC) No 1831/2003.


HAS ADOPTED THIS REGULATION:
(3) The
application
concerns
the
authorisation
of
hydroxy-
analogue of selenomethionine, an organic compound of
Article 1
selenium, as a feed additive for all animal species, to be
classified in the additive category ‘nutritional additives’.
The preparation specified in the Annex, belonging to the
additive category ‘nutritional additives’ and to the functional
group ‘compounds of trace elements’, is authorised as an
(4) The
European
Food
Safety
Authority
(‘the
Authority’) additive in animal nutrition, subject to the conditions laid
concluded in its opinion of 11 December 2012 ( 2 ) that,
down in that Annex.
under the proposed conditions of use, hydroxy-analogue
of selenomethionine does not have an adverse effect on
Article 2
animal health, human health or the environment and
that its use may be considered as an effective source of
This Regulation shall enter into force on the twentieth day
selenium for all animal species. The Authority does not
following that of its publication in the Official Journal of the
consider that there is a need for specific requirements of
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 May 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2013; 11(1):3046.

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L 130/22
ANNEX
Minimum
Maximum
Identifi
content
content
cation
Name of
Species or
End of period
number of the holder
Additive Composition,
chemical
formula,
description,
analytical
method
category of
Maximum
Other provisions
of authori
the
of authori
animal
age
Content of element (Se) in
sation
additive
sation
mg/kg of complete feed with a
EN
moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements
3b814
— Hydroxy-
Characterisation of the additive
All species
— 0,50
(total) 1.
The additive shall be 4 June 2023
analogue of sele
incorporated into feed in
nomethionine
Solid and liquid preparation of Hydroxy-analogue of selenome
the form of a premixture.
thionine
2. For user safety: breathing
Content of selenium: 18 000 to 24 000 mg Se/kg
protection, safety glasses
and gloves should be
Off
Organic selenium > 99 % of total Se
worn during handling.
icial
Hydroxy-analogue of selenomethionine > 98 % of total Se
3. Maximum
supplemen
Jour
tation with organic
Solid preparation: 5 % Hydroxy-analogue of selenomethionine
selenium:
nal
and 95 % carrier
0,20 mg
Se/kg
of
of
Liquid preparation: 5 % Hydroxy-analogue of selenomethionine
complete feed with a
the
and 95 % distilled water
moisture content of
European
12 %.
Characterisation of the active substance
Organic selenium from hydroxy-analogue of selenomethionine
Union
(R,S-2-hydroxy-4-methylselenobutanoic acid)
Chemical formula: C 5H 10O 3Se
CAS number 873660-49-2
Analytical method (1 )
For the determination of hydroxy analogue of methionine in
the feed additive:
— High performance liquid chromatography coupled to UV
detection at 220 nm (HPLC-UV)
For the determination of total selenium in the feed additive:
— Inductively coupled plasma mass spectrometry (ICPMS) after
microwave digestion with HNO
15.5.2013
3/H 2O 2, or
— Inductively coupled plasma atomic emission spectrometry
(ICPAES) after digestion with HNO 3/HCl

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15.5.2013 Off
Minimum
Maximum
Identifi
content
content
cation
Name of
Species or
End of period
number of the holder
Additive Composition,
chemical
formula,
description,
analytical
method
category of
Maximum
Other provisions
of authori
the
of authori
animal
age
Content of element (Se) in
sation
additive
sation
mg/kg of complete feed with a
moisture content of 12 %
For the determination of total selenium in premixtures and
EN
feed:

— Hydride generation atomic absorption spectrometry
(HGAAS) after microwave digestion with HNO 3/H 2O 2 (EN
16159:2012)
(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
icial
Jour
nal
of
the
European
Union
L
130/23

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Document Outline

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