HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 127/20
EN
Official Journal of the European Union
9.5.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 427/2013
of 8 May 2013
concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC
R646 as a feed additive for all animal species and amending Regulations (EC) No 1750/2006,
(EC) No 634/2007 and (EC) No 900/2009 as regards the maximum supplementation with
selenised yeast
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Accordingly, the use of this preparation should be auth
orised as specified in the Annex to this Regulation.
Having regard to the Treaty on the Functioning of the European
Union,
(6)
The Authority reiterated in its opinion mentioned above
the recommendation from its opinion of 15 March
2011 ( 3 ) to limit the maximum supplementation with
Having regard to Regulation (EC) No 1831/2003 of the
selenised yeast, an organic selenium compound, to
European Parliament and of the Council of 22 September
0,2 mg Se/kg complete feed for reasons of consumer
2003 on additives for use in animal nutrition ( 1 ), and in
safety. Selenised yeasts are already authorised by
particular Article 9(2) thereof,
Commission Regulations (EC) No 1750/2006 ( 4 ), (EC)
No 634/2007
( 5 ) and (EC) No 900/2009
( 6 ).
Whereas:
Consequently, these authorisations should be amended

in consistency with the Annex to this Regulation. In
case inorganic compounds of selenium are also added
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
to the feed, the supplementation with organic Selenium
orisation of additives for use in animal nutrition and
should not exceed 0,2 mg per kg complete feed.
for the grounds and procedures for granting such auth
orisation.
(7) Since
further
use
of
selenised
yeasts
as
a
feed
additive
at
incorporation rates higher than 0,20 mg Se/kg complete
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
feed may cause a risk to human health, feed materials
1831/2003, an application was submitted for the auth
and compound feed with higher levels of selenised yeasts
orisation of selenomethionine produced by Saccharomyces
should be phased out. For practical reasons however, a
cerevisiae NCYC R646. That application was accompanied
limited transitional period should be allowed for
by the particulars and documents required under
interested parties to prepare themselves to meet the
Article 7(3) of Regulation (EC) No 1831/2003.
new requirements.
(3) The
application
concerns
the
authorisation
of
selenome
(8) The
measures
provided
for
in
this
Regulation
are
in
thionine, an organic compound of selenium, produced by
accordance with the opinion of the Standing
Saccharomyces cerevisiae NCYC R646 as a feed additive for
Committee on the Food Chain and Animal Health,
all animal species, to be classified in the additive category
‘nutritional additives’.
HAS ADOPTED THIS REGULATION:
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 1
concluded in its opinion of 15 June 2012 ( 2 ) that,
under the proposed conditions of use, selenomethionine
The preparation specified in the Annex, belonging to the
produced by Saccharomyces cerevisiae NCYC R646 does not
additive category ‘nutritional additives’ and to the functional
have an adverse effect on animal health, human health or
group ‘compounds of trace elements’, is authorised as an
the environment and that its use may be considered as
additive in animal nutrition, subject to the conditions laid
an effective source of selenium for all animal species. The
down in that Annex.
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
verified the report on the method of analysis of the feed
Article 2
additive in feed submitted by the Reference Laboratory
In column 9 in the Annex to Regulation (EC) No 1750/2006,
set up by Regulation (EC) No 1831/2003.
the text in the line ‘3b8.10’ shall be replaced by the following:
(5) The
assessment
of
selenomethionine
produced
by
‘1. The additive shall be incorporated in feed in the form of
Saccharomyces cerevisiae NCYC R646 shows that the
a premixture.
conditions for authorisation, as provided for in
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
( 3 ) EFSA Journal 2011; 9(4):2110.
( 4 ) OJ L 330, 28.11.2006, p. 9.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 5 ) OJ L 146, 8.6.2007, p. 14.
( 2 ) EFSA Journal 2012; 10(7):2778.
( 6 ) OJ L 256, 29.9.2009, p. 12.

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EN
9.5.2013 Official
Journal
of
the
European
Union L
127/21
2. For user safety: breathing protection, safety glasses and
‘1. The additive shall be incorporated in feed in the form of
gloves should be worn during handling.
a premixture.
3. Maximum supplementation with organic selenium:
2. For user safety: breathing protection, safety glasses and
0,20 mg Se/kg of complete feed with a moisture
gloves should be worn during handling.
content of 12 %.’.
3. Maximum supplementation with organic selenium:
Article 3
0,20 mg Se/kg of complete feed with a moisture
content of 12 %.’.
In column 9 in the Annex to Regulation (EC) No 634/2007, the
text in the line ‘3b8.11’ shall be replaced by the following:
Article 5
‘1. The additive shall be incorporated in feed in the form of
The manufacturing of feed containing selenised yeast according
a premixture.
to the existing maximum contents in Regulations (EC) No
1750/2006, (EC) No 634/2007 and (EC) No 900/2009 shall
be brought in compliance with the new maximum contents as
2. For user safety: breathing protection, safety glasses and
soon as possible and at the latest by 28 July 2013. Feed
gloves should be worn during handling.
containing selenised yeast according to the existing maximum
contents in Regulations (EC) No 1750/2006, (EC) No 634/2007
3. Maximum supplementation with organic selenium:
and (EC) No 900/2009 may be used up until stocks are
0,20 mg Se/kg of complete feed with a moisture
exhausted.
content of 12 %.’.
Article 6
Article 4
This Regulation shall enter into force on the twentieth day
In column 9 in the Annex to Regulation (EC) No 900/2009, the
following that of its publication in the Official Journal of the
text in the line ‘3b8.12’ shall be replaced by the following:
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 May 2013.
For the Commission
The President
José Manuel BARROSO

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L 127/22
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum age
Other provisions
End of period of
additive
authorisation
method
animal
Maximum content of element (Se)
authorisation
in mg/kg of complete feed with a
EN
moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements
3b813
— Selenome
Characterisation of the additive
All species
— 0,50
(total) 1.
The
additive
shall
be
incor 29 May 2023
thionine
porated into feed in the
produced by Preparation of organic selenium:
form of a premixture.
Saccharomyces Content of selenium: 1 000 to 2 650 mg Se/kg
cerevisiae
2. For user safety: breathing
NCYC R646 Organic selenium > 98 % of total selenium
protection, safety glasses
and gloves should be
Off
(Selenised
Selenomethionine > 70 % of total selenium
worn during handling.
icial
yeast inacti
vated)
3. Maximum
supplemen
Characterisation of the active substance
Jour
tation with organic
Selenomethionine produced by Saccharomyces
selenium:
nal
cerevisiae NCYC R646
0,20 mg Se/kg of complete
of
feed with a moisture
the
Analytical method (1 )
content of 12 %.
European
For the determination of selenomethionine in
the feed additive:
High performance liquid chromatography and
Union
inductively coupled plasma mass spectrometry
(HPLC-ICPMS) after triple proteolytic digestion.
For the determination of total selenium in the
feed additive:
Inductively coupled plasma mass spectrometry
(ICPMS) after microwave digestion with
HNO 3/H 2O 2.
For the determination of total selenium in
premixtures and feed:
Hydride generation atomic absorption spec
trometry (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
9.5.2013

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Document Outline

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