Commission Implementing Regulation (EU) 2022/1247 of 19 July 2022 concerning the authorisation of Allura Red AC as a feed additive for small non-food producing mammals and ornamental birds (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1247
• Articles: 3

Article 1

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

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 active substance/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Colourants . (i) substances that add or restore colour in feedingstuffs

2a129

Allura Red AC

Additive composition:

Allura Red AC described as the sodium salt as the principal component.

Solid form (powder or granules)

Guinea pig

Chinchilla

Degu

Hamster

Gerbil

Chipmunk

-

-

500

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

9 August 2032

Characterisation of the active substance:

Allura Red AC consists essentially of disodium 2-hydroxy- 1-(2- methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

The calcium and the potassium salts are also permitted.

Produced by chemical synthesis

Purity criteria: content not less than 85 % total colouring matters, calculated as the sodium salt (assay)

Water insoluble matter: ≤ 0,2 % Subsidiary colouring matters: ≤ 3 % Organic compounds other than colouring matters:

—

6-hydroxy-2-naphthalene sulfonic acid, sodium salt: ≤ 0,3 %

—

4-amino-5-methoxy-2- methylbenezene sulfonic acid:

≤ 0,2%

—

6,6-oxybis (2-naphthalene sulfonic acid) disodium salt: ≤ 1 %

Unsulfonated primary aromatic amines: ≤ 0,01 % (calculated as aniline)

Ether extractable matter: ≤ 0,2 % from a solution of pH 7

Chemical formula: C 18 H 14 N 2 Na 2 O 8 S 2

CAS number: 25956-17-6

EINECS number: 247-368-0

Ferrets

Other small non-food producing mammals, except dogs and cats

-

-

99

Canaries

Budgerigars

Mynahs

Toucans

-

-

45

Lovebirds

-

-

51

Cockatiels

-

-

79

Cockatoos

-

-

115

Amazons

-

-

145

Parrots

-

-

147

Yellow breast macaws

-

-

150

Blue-throated macaws

-

-

173

Hyacinth macaws

-

-

214

Other ornamental birds

-

-

45

Analytical method

( 1 )

For the quantification of Allura Red AC in the feed additive:

—

spectrophotometry at 504 nm (Commission Regulation (EU) No 231/2012 referring to FAO JECFA monographs n. 1 (Vol. 4))

For the quantification of Allura Red AC in feedingstuffs:

—

high performance liquid chromatography coupled to tandem mass spectrometry (LC- MS/MS)

( 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