HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"EN
25.9.2012 Official
Journal
of
the
European
Union L
257/3
COMMISSION IMPLEMENTING REGULATION (EU) No 868/2012
of 24 September 2012
concerning the authorisation of azorubine as a feed additive for cats and dogs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
assessment
of
azorubine
shows
that
the
conditions
for authorisation, as provided for in Article 5 of Regu
lation (EC) No 1831/2003, are satisfied. Accordingly, the
Having regard to the Treaty on the Functioning of the European
use of that substance should be authorised as specified in
Union,
the Annex to this Regulation.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(6) Since
modifications
to
the
conditions
of
authorisation
of
2003 on additives for use in animal nutrition ( 1 ), and in
azorubine are introduced and as there are no direct
particular Article 9(2) thereof,
immediate effects on safety, a reasonable period should
be allowed to elapse before authorisation in order to
allow the interested parties to prepare themselves to
Whereas:
meet the new requirements resulting from the authori
sation. In addition, it is appropriate to allow a transi
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
tional period for the disposal of existing stocks of
orisation of additives for use in animal nutrition and
azorubine, as authorised in accordance with Directive
for the grounds and procedures for granting such auth
70/524/EEC and of feed containing azorubine.
orisation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council
Directive 70/524/EEC (
(7) It
is
disproportionately
complex
for
operators
to
adapt

2 ).
repeatedly and from one day to the other labels of feed
containing different additives which have been
(2) Azorubine
(synonym
carmoisine)
was
authorised
without
successively authorised according to the procedure laid
a time limit in accordance with Directive 70/524/EEC as
down in Article 10(2) of Regulation (EC) No 1831/2003
a feed additive for use on feed for cats and dogs falling
and for which new labelling rules are to be complied
under the category ‘colouring agents’ under the heading
with. It is therefore appropriate to reduce the adminis
‘colouring agents authorised for colouring foodstuffs by
trative burden on the operators by providing a period of
Community rules, other than patent blue V, acid brilliant
time allowing a smooth conversion of labelling.
green BS and canthaxanthin’. That use was subsequently
entered in the Community Register of feed additives as
an existing product, in accordance with Article 10(1) of
(8) The
measures
provided
for
in
this
Regulation
are
in
Regulation (EC) No 1831/2003.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003, an application was submitted for the re-
HAS ADOPTED THIS REGULATION:
evaluation of azorubine as a feed additive for cats and
dogs, requesting that additive to be classified in the
additive category ‘sensory additives’. That application
Article 1
was accompanied by the particulars and documents
required under Article 7(3) of Regulation (EC) No
Authorisation
1831/2003.
The substance azorubine specified in the Annex, belonging to
the additive category ‘sensory additives’ and to the functional
(4) The
European
Food
Safety
Authority
(‘the
Authority’) group ‘colourants’, (i) substances that add or restore colour in
concluded in its opinion of 31 January 2012 ( 3 ) that,
feedingstuffs, is authorised as an additive in animal nutrition
under the proposed conditions of use, azorubine does
subject to the conditions laid down in that Annex.
not have an adverse effect on animal health, or the
environment, and that it is effective as colourant. It
concluded that no safety concerns would arise for users
Article 2
provided that appropriate protective measures are taken..
Labelling requirements
The Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
Feed containing azorubine shall be labelled in accordance with
verified the report on the method of analysis of the feed
this Regulation at the latest by 25 May 2013.
additive in feed submitted by the Community Reference
Laboratory set up by Regulation (EC) No 1831/2003.
However, feed containing azorubine which has been labelled in
accordance with Directive 70/524/EEC before 25 May 2013
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
may continue to be placed on the market until stocks are
( 3 ) EFSA Journal 2012; 10(2):2570.
exhausted.

---

L 257/4
EN
Official Journal of the European Union
25.9.2012
Article 3
Transitional measures
Existing stocks of azorubine and of feed containing azorubine at the date of entry into force of this
Regulation may continue to be placed on the market and used under the conditions of Directive
70/524/EEC until they are exhausted.
Article 4
Entry into force
This Regulation shall enter into force 25 November 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 September 2012.
For the Commission
The President
José Manuel BARROSO

---

25.9.2012 Off
ANNEX
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
mg of active substance/kg of
authorisation
complete feedingstuff with a
EN
moisture content of 12 %

Category of sensory additives. Functional group: colourants
2a122
— Azorubine
or
Additive composition
Cats and dogs
—
— 176 1.
In
the
directions
for
use
of
the
25 November
carmoisine
additive and premixture, indicate
2022
Azorubine
the storage temperature, storage
life, and stability to pelleting.
Characterisation of the active substance
2. For safety: breathing, eye and skin
1. Chemical
name:
Disodium
4-hydroxy-3-
protection shall be used during
(4-sulfonato-1-naphthylazo)
handling.
icial
naphthalene-1-sulfonate
Jour
2. Synonyms:
carmoisine,
CI
Food
Red
3
nal
of
3. Einecs:
222-657-4
the
4. Chemical
formula:
C
European
20H 12N 2Na 2O 7S 2
5. Purity:
Union
5.1. Assay: minimum contents of 85 %
colouring matters calculated as the
sodium salt
5.2. 4-aminonaphthalene-1-sulfonic acid and
4-hydroxynaphthalene-1-sulfonic acid:
not more than 0,5 %
5.3. Subsidiary colouring matters: not more
than 2,0 %
5.4. Water insoluble matter: not more than
0,2 %
5.5. Unsulfonated primary aromatic amines):
not more than 0,01 % (calculated as
aniline)
L
5.6. Ether extractable matter: not more than
257/5
0,2 % under neutral conditions

---

L 257/6
Minimum
Maximum
content
content
Identification
Name of the
Species or
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
mg of active substance/kg of
authorisation
complete feedingstuff with a
moisture content of 12 %
Method of Analysis (1 )
EN

For the identification of azorubine in the feed
additive: spectrophotometry at 516 nm in
water and Thin Layer Chromatography
(TLC) (FAO JECFA monographs No 1 (Vol.
4) Combined compendium for food additive
specifications).
For the determination of azorubine in the
feed additive: spectrophotometry at 516 nm
in aqueous solution Commission Directive
Off
2008/128/EC (2 ).
icial
(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
Jour
(2 ) OJ L 6, 10.1.2009, p. 20.
nal
of
the
European
Union
25.9.2012

---

Document Outline

• �

---