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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Authorisation
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.
Labelling requirements
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.
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.
Entry into force
This Regulation shall enter into force 25 November 2012.
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: C 20 H 12 N 2 Na 2 O 7 S 2 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 ( 1 ) 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 ( 2 ) . 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 ( 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 ( 2 ) OJ L 6, 10.1.2009, p. 20 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.