
Article 1 
The substance azorubine specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, (i) substances that add or restore colour in feedingstuffs, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2 
Feed containing azorubine shall be labelled in accordance with this Regulation at the latest by 25 May 2013.
However, feed containing azorubine which has been labelled in accordance with Directive 70/524/EEC before 25 May 2013 may continue to be placed on the market until stocks are exhausted.
Article 3 
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 
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
ANNEX

Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Category of sensory additives. Functional group: colourants
2a122 — Azorubine or carmoisine 
 Additive composition
Azorubine
 Characterisation of the active substance
1.. Chemical name: Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate
2.. Synonyms: carmoisine, CI Food Red 3
3.. Einecs: 222-657-4
4.. Chemical formula: C20H12N2Na2O7S2
5.. Purity:

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)
5.6. Ether extractable matter: not more than 0,2 % under neutral conditions
 Method of Analysis
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 2008/128/EC. Cats and dogs — — 176 
1.. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
2.. For safety: breathing, eye and skin protection shall be used during handling. 25 November 2022

