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22.8.2013 Official
Journal
of
the
European
Union L
224/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 795/2013
of 21 August 2013
concerning the authorisation of choline chloride as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
consumer health, and it is not expected to pose
additional risk for the environment. The Authority also
Having regard to the Treaty on the Functioning of the European
concluded that no safety concerns would arise for users
Union,
provided that appropriate protective measures are taken.
The Authority does not consider that there is a need for
Having regard to Regulation (EC) No 1831/2003 of the
specific requirements of post-market monitoring. It also
European Parliament and of the Council of 22 September
verified the report on the method of analysis of the feed
2003 on additives for use in animal nutrition (
additive in feed submitted by the Reference Laboratory

1 ), and in
particular Article 9(2) thereof,
set up by Regulation (EC) No 1831/2003.
Whereas:
(5) The
assessment
of
choline
chloride
shows
that
the
conditions for authorisation, as provided for in
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
orisation of additives for use in animal nutrition and
Accordingly, the use of that substance should be auth
for the grounds and procedures for granting such auth
orised as specified in the Annex to this Regulation.
orisation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council
(6)
Since safety reasons do not require the immediate appli
Directive 70/524/EEC ( 2 ).
cation of the modifications to the conditions of auth
orisation, it is appropriate to allow a transitional period
(2)
Choline chloride was authorised without a time limit in
for the disposal of existing stocks of the additive,
accordance with Directive 70/524/EEC as a feed additive
premixtures and compound feed containing it, as auth
for use on all animal species as part of the group ‘Vit
orised by Directive 70/524/EEC.
amins, pro-vitamins and chemically well-defined
substances having similar effect’. That product was
subsequently entered in the European Union Register of
(7) The
measures
provided
for
in
this
Regulation
are
in
Feed Additives as an existing product, in accordance with
accordance with the opinion of the Standing
Article 10(1) of Regulation (EC) No 1831/2003.
Committee on the Food Chain and Animal Health,


(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the re-evaluation of
Article 1
choline chloride, as a feed additive for all animal
species, requesting that additive to be classified in the
The preparation specified in the Annex, belonging to the
additive category ‘nutritional additives’. That application
additive category ‘nutritional additives’ and to the functional
was accompanied by the particulars and documents
group ‘vitamins, pro-vitamins and chemically well-defined
required under Article 7(3) of Regulation (EC) No
substances having similar effect’, is authorised as an additive
1831/2003.
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 6 September 2011 ( 3 ) that,
Article 2
under the proposed conditions of use in feed, choline
chloride does not have an adverse effect on animal and
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before 11 March
2014 in accordance with the rules applicable before
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
11 September 2013, may continue to be placed on the
( 3 ) EFSA Journal 2011; 9(9):2353.
market and used until the existing stocks are exhausted.

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L 224/2
EN
Official Journal of the European Union
22.8.2013
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 August 2013.
For the Commission
The President
José Manuel BARROSO

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22.8.2013 Off
ANNEX
Minimum content Maximum content
Identification
Species or
number of the Name of the holder of
category of
Maximum age
Other provisions
End of period of
additive
authorisation
Additive
Composition, chemical formula,
description, analytical method
animal
mg/kg of complete feedingstuff with a
authorisation
moisture content of 12 %
EN
Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

3a890
— Choline
Additive composition
All animal
—
—
— 1.
If
the
preparation
contains
a
tech 11 September
chloride
species
nological additive or feed materials
2023
Preparation of choline chloride, solid

for which a maximum content is
and liquid forms
set or which is subject to other
restrictions, the feed additive
Characterisation of the active substance
manufacturer shall provide this
Name: choline chloride
information to the customers.
Chemical formula: C
2. In the directions for use of the

5H 14ClNO
additives and premixture indicate
CAS No: 67-48-1
the storage and stability
icial
conditions.
Produced by chemical synthesis
Jour
3. Choline chloride may be used via
Purity criteria: min. 99 %, anhydrous
nal
water for drinking.
basis
of
4. The labelling of feed for poultry
the
Method of Analysis (1 )
and pigs containing choline
chloride should indicate in the
European
For the determination of choline
instructions of use: ‘simultaneous
chloride in the feed additive,
use with water for drinking in
premixtures, feedingstuffs and water:
which choline chloride has been
ion chromatography with conduc
added should be avoided’.
Union
tivity detection (IC-CD)
5. Recommended not to exceed
supplemental levels of 1 000 mg
of choline chloride/kg of complete
feed for poultry and pigs.
6. For safety: breathing, eye and skin
protection shall be used during
handling.
(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/Pages/index.aspx
L
224/3

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Document Outline

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