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19.10.2013 Official
Journal
of
the
European
Union L
279/59
COMMISSION IMPLEMENTING REGULATION (EU) No 1006/2013
of 18 October 2013
concerning the authorisation of L-cystine as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
efficacious to contribute to the requirements for sulphur-
containing amino acids in all animal species. The
Having regard to the Treaty on the Functioning of the European
Authority does not consider that there is a need for
Union,
specific requirements of post-market monitoring. It also
verified the report on the method of analysis of the feed
Having regard to Regulation (EC) No 1831/2003 of the
additive in feed submitted by the Reference Laboratory
European Parliament and of the Council of 22 September
set up by Regulation (EC) No 1831/2003.
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) The
assessment
of
that
substance
shows
that
the
conditions for authorisation, provided for in Article 5
Whereas:
of Regulation (EC) No 1831/2003, are satisfied. Accord
ingly, the use of that substance should be authorised, as
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
specified in the Annex to this Regulation.
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation.
(6) The
measures
provided
for
in
this
Regulation
are
in

accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
1831/2003 an application was submitted for the auth
orisation of L-cystine as a feed additive in the functional
HAS ADOPTED THIS REGULATION:
group ‘amino acids, their salts and analogues’. That appli
cation was accompanied by the particulars and
documents required under Article 7(3) of Regulation
Article 1
(EC) No 1831/2003.
The substance specified in the Annex, belonging to the additive
category ‘nutritional additives’ and to the functional group
(3) That
application
concerns
the
authorisation
of
L-cystine ‘amino acids, their salts and analogues’, is authorised as an
as a feed additive for all animal species, to be classified in
additive in animal nutrition subject to the conditions laid
the additive category ‘nutritional additives’.
down in that Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Article 2
concluded in its opinion of 13 March 2013 ( 2 ) that,
under the proposed conditions of use, L-cystine does
This Regulation shall enter into force on the twentieth day
not have an adverse effect on animal health, human
following that of its publication in the Official Journal of the
health or the environment and that it may be considered
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) EFSA Journal 2013; 11(4):3173.

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L 279/60
ANNEX
Minimum content Maximum content
Identification
Name of the
number of the
holder of
Additive
Composition, chemical formula,
Species or category of
Other provisions
End of period of
additive
authorisation
description, analytical method
animal
Maximum age
mg/kg of complete feed with a
authorisation
moisture content of 12 %
EN
Category of nutritional additives. Functional group: amino acids, their salts and analogues

3c391
— L-cystine Additive
composition
All animal species
—
—
— 1.
For
user
safety:
Breathing
8 November
protection, safety glasses and
2023
Crystalline powder produced by

gloves should be worn during
hydrolysis of natural keratin from
handling.
poultry feathers with a minimum
L-cystine content of 98,5 %
2. Indicate in the directions for
use of the additive and
Characterisation of the active substance
premixtures:
IUPAC name: (2R)-2-amino-3-
— Processing stability and
Off
[(2R)-2-amino-3-hydroxy-3-
storage conditions.
icial
oxopropyl] disulfanyl-propanoic
acid
— Supplementation with
Jour
L-cystine shall depend on
CAS number: 56-89-3
the requirements of the
nal
Chemical formula: C
target animals for sulphur-
6H 12N 2O 4S 2
of
containing amino acids
Analytical methods (1 )
the
and the level of other
For the determination of L-cystine
sulphur-containing amino
European
in the feed additive:
acids in the ration.
Titrimetry, European Phar
macopoeia (Ph. Eur. 6.0, method
Union
01/2008-0998).
For the determination of cystine in
premixtures, compound feed and
feed materials:
Ion exchange chromatography
method with post-column deri
vatisation and photometric
detection: Commission Regulation
(EC) No 152/2009 (2 ) (Annex III,
F).
(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
(2 ) OJ L 54, 26.2.2009, p. 1.
19.10.2013

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Document Outline

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