Commission Implementing Regulation (EU) 2023/1712 of 7 September 2023 concerning the authorisation of Sunset Yellow FCF as a feed additive for cats, dogs, ornamental fish, grain-eating ornamental birds and small rodents (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1712
• Articles: 4

Article 1 Authorisation

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 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 28 March 2024, in accordance with the rules applicable before 28 September 2023, may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex, which are produced and labelled before 28 September 2025, in accordance with the rules applicable before 28 September 2023, may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3 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.

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

2a110

Sunset Yellow FCF

Additive composition

Sunset Yellow FCF

Solid form (powder or granules)

Cats

-

-

165

1.

In the directions for use of the additive and premixtures, the storage conditions 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 by such procedures and measures, the additive and premixtures shall be used with personal eyes, skin and breathing protective equipment.

28 September 2033

Dogs

-

-

198

Characterisation of the active substance

Sunset Yellow FCF, described as the sodium salt, consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Calcium and potassium salts are also allowed with the same characterisation as sodium salt.

Produced by chemical synthesis

Purity criteria: content not less than 90 % total colouring matters, calculated as the sodium salt (assay)

Water insoluble matter: ≤ 0,2 %

Subsidiary colouring matters: ≤ 5 %

1-(Phenylazo)-2-naphthalenol (Sudan I): ≤ 0,5 mg/kg)

Organic compounds other than colouring matters: ≤ 0,5 %

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

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

Chemical formula: C 16 H 10 N 2 Na 2 O 7 S 2

CAS number: 2783-94-0

Ornamental fish

-

-

733

Grain-eating ornamental birds

-

-

24

Small rodents

-

-

750

Analytical method

( 1 )

For the determination of the total colouring matters content of Sunset Yellow FCF in the feed additive:

—

spectrophotometry at 485 nm and titration with titanic chloride as specified and described in Commission Regulation (EU) No 231/2012  ( 2 ) which refers to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4) and the Monograph No 11 (2011) ‘Sunset Yellow FCF’

For the determination of Sunset Yellow FCF in compound feed:

—

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.

( 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 ).