Commission Implementing Regulation (EU) 2025/714 of 10 April 2025 concerning the authorisation of indigo carmine as a feed additive for cats, dogs and ornamental fish

• CELEX: Implementing Regulation (EU) 2025/714
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants: 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 Transitional measures

1.   The feed additive indigotine as authorised pursuant to Directive 70/524/EEC, and premixtures containing this additive, which are intended for cats, dogs and ornamental fish, and which are produced and labelled before 1 November 2025 in accordance with the rules applicable before 1 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 1 May 2027 in accordance with the rules applicable before 1 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for cats, dogs and ornamental fish.

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 feed 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 additive/kg complete feedingstuff with 12 % moisture content

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

2a132

Indigo carmine

Additive composition:

Indigo carmine

Solid form

Characterisation of the active substance:

Indigo carmine, described as the sodium salt, consists essentially in a mixture of disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate

Calcium and potassium salts are also allowed with the same characterisation as sodium salt.

Produced by chemical synthesis

Chemical formula: C 16 H 8 N 2 Na 2 O 8 S 2

CAS No: 860-22-0 / 54947-75-0

Total colouring matter ≥ 85 %

Disodium 3,3'-dioxo-2,2'-bi-indolylidene-5,7'-disulphonate ≤ 18 %

Subsidiary colouring matter ≤ 1 %

Organic compounds other than colouring matters (isatin-5-sulphonic acid, 5-sulphoanthranilic acid and anthranilic acid) ≤ 0,5 %

Unsulphonated primary aromatic amines ≤ 0,01 %

Ether extractable matter ≤ 0,2 % under neutral conditions

Lead ≤ 2 mg/kg

Analytical method

For the quantification of total colouring matters content of indigo carmine in the feed additive:

—

Spectrophotometry at 610 nm (FAO JECFA monographs n. 1, Vol. 4 and Commission Regulation (EU) No 231/2012)  ( 1 ) for indigo carmine

For the quantification of indigo carmine in compound feed:

—

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

Cats

Dogs

250

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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment.

1.5.2035

Ornamental fish

1 000

( 1 )   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 ).