Authorisation
The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and in 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.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
ANNEX
Identification number of the feed additive
Name of the 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 complementary feed with a moisture content of 12 %
Category: Sensory additives. Functional group: Colourants: (i) substances that add or restore colour in feedingstuffs
2a102
Tartrazine
Additive composition
Tartrazine
Solid form
———————————————
Characterisation of the active substance as the sodium salt
Tartrazine, described as the sodium salt, consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
Calcium and potassium salts are also allowed with the same characterisation as sodium salt.
Chemical formula: C 16 H 9 N 4 Na 3 O 9 S 2
CAS number 1934-21-0
Produced by chemical synthesis
Purity criteria:
Colouring matter calculated as the sodium salt: ≥ 85 % (assay)
Subsidiary colouring matter: ≤ 1 %
Organic compounds other than colouring matters ≤ 0,5 %:
—
4-hydrazinobenzene sulfonic acid,
—
4-aminobenzene-1-sulfonic acid,
—
5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid,
—
4,4′-diazoaminodi(benzene sulfonic acid),
—
Tetrahydroxysuccinic acid
Unsulfonated primary aromatic amines: ≤ 0,01 %
Ether extractable matter ≤ 0,2 % under neutral conditions.
———————————————
Analytical method
( 1 )
For the quantification of total colouring matters content of tartrazine in the feed additive:
—
Spectrophotometry at 426 nm (FAO JECFA monographs No 1, Vol. 4 and Commission Regulation (EU) No 231/2012 ( 2 ) ).
For the quantification of tartrazine in compound feed:
—
High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).
Freshwater food-producing finfish
-
-
30
1.
In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.
2.
The additive shall only be used in fishing baits. The additive shall not be used in aquaculture feed.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.
4 February 2036
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .
( 2 ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( OJ L 83, 22.3.2012, p. 1 , ELI: http://data.europa.eu/eli/reg/2012/231/oj ).