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23.8.2013 Official
Journal
of
the
European
Union L
225/17
COMMISSION IMPLEMENTING REGULATION (EU) No 803/2013
of 22 August 2013
concerning the authorisation of folic acid as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
health, and it is not expected to pose additional risk for
the environment. The Authority also concluded that no
safety concerns would arise for users provided that
appropriate protective measures are taken. It also
Having regard to the Treaty on the Functioning of the European
verified the report on the method of analysis of the
Union,
feed additive in feed submitted by the Reference
Laboratory set up by Regulation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition ( 1 ), and in
(5) The
assessment
of
folic
acid
shows
that
the
conditions
particular Article 9(2) thereof,
for authorisation, as provided for in Article 5 of Regu
lation (EC) No 1831/2003, are satisfied. Accordingly, the
use of that substance should be authorised as specified in
the Annex to this Regulation.
Whereas:
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
(6)
Since safety reasons do not require the immediate appli
orisation of additives for use in animal nutrition and
cation of the modifications to the conditions of auth
for the grounds and procedures for granting such auth
orisation, it is appropriate to allow a transitional period
orisation. Article 10 of that Regulation provides for the
for the disposal of existing stocks of the additive,
re-evaluation of additives authorised pursuant to Council
premixtures and compound feed containing it, as auth
Directive 70/524/EEC ( 2 ).
orised by Directive 70/524/EEC.
(2) Folic
acid
was
authorised
without
a
time
limit
in
accordance with Directive 70/524/EEC as a feed
(7) The
measures
provided
for
in
this
Regulation
are
in
additive for use on all animal species as part of the
accordance with the opinion of the Standing
group ‘Vitamins, pro-vitamins and chemically well-
Committee on the Food Chain and Animal Health,
defined substances having similar effect’. That product
was subsequently entered in the European Union
Register of Feed Additives as an existing product, in
accordance with Article 10(1) of Regulation (EC) No
1831/2003.
HAS ADOPTED THIS REGULATION:
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, an
Article 1
application was submitted for the re-evaluation of folic
The preparation specified in the Annex, belonging to the
acid, as a feed additive for all animal species, requesting
additive category ‘nutritional additives’ and to the functional
that additive to be classified in the additive category
group ‘vitamins, pro-vitamins and chemically well-defined
‘nutritional additives’. That application was accompanied
substances having similar effect’, is authorised as an additive
by the particulars and documents required under
in animal nutrition subject to the conditions laid down in
Article 7(3) of Regulation (EC) No 1831/2003.
that Annex.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 24 April 2012 ( 3 ) that,
Article 2
under the proposed conditions of use in feed, folic acid
does not have an adverse effect on animal and consumer
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before 12 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.
12 September 2013 may continue to be placed on the
( 3 ) EFSA Journal 2012; 10(5):2674.
market and used until the existing stocks are exhausted.

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L 225/18
EN
Official Journal of the European Union
23.8.2013
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, 22 August 2013.
For the Commission
The President
José Manuel BARROSO

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23.8.2013 Off
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 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

3a316
— Folic
acid Additive
composition
All animal species
—
—
— 1.
If
the
preparation
contains
a
12 September
technological additive or feed
2023
Preparation of folic acid, solid form

materials for which a
Characterisation of the active substance
maximum content is set or
which is subject to other
Name: folic acid
restrictions, the feed additive
Chemical formula: C
manufacturer shall provide this
19H 19N 7O 6
information to the customers.
CAS No: 59-30-3
2. In the directions for use of the
Produced by chemical synthesis
additive and premixture,
icial
Purity: not less than 96 % folic
indicate the storage and
Jour
acid, anhydrous basis
stability conditions.
nal
Purity criteria: as laid down by
3. Folic acid may be used also via
European Pharmacopeia 6th
water for drinking.
of
edition 01/2008/0067
the
4. For safety: breathing, eye and
Method of Analysis (
European
1 )
skin protection shall be used
during handling.
— For the quantification of folic
acid in feed additive and
premixtures: Reverse Phase
Union
High-Performance Liquid Chro
matography coupled to UV
detection (RP-HPLC-UV).
— For the quantification of total
folates (including added folic
acid) in feedingstuffs and water:
microbiological assay — based
on CEN-ring trial validated
method EN 14131.
(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
225/19

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Document Outline

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