Date: 2025-04-11Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Health and Food Safety
## Policy Analysis Report: Commission Implementing Regulation (EU) 2025/714 regarding Indigo Carmine as a Feed Additive
**1. Executive Summary:**
This report analyzes Commission Implementing Regulation (EU) 2025/714, which authorizes indigo carmine as a feed additive for cats, dogs, and ornamental fish. The core purpose, based on the regulation's text, is to authorize the use of indigo carmine under specific conditions and limitations, ensuring both the safety of the animals consuming the additive and the safety of the individuals handling it. Key findings highlight the permitted levels of indigo carmine, the requirement for user safety measures, and transitional periods for implementation.
**2. Introduction:**
This report aims to provide an informative overview of Commission Implementing Regulation (EU) 2025/714 concerning the authorization of indigo carmine as a feed additive for cats, dogs, and ornamental fish. The analysis is based solely on the information provided within the text of the regulation.
**3. Policy Overview:**
This is a *New Policy* authorizing the use of a substance.
* **Core Objective(s):** The primary objective, inferred from the text, is to authorize the use of indigo carmine as a feed additive for cats, dogs, and ornamental fish, contingent upon ensuring animal safety and minimizing potential health risks to users handling the additive. This objective is supported by the establishment of maximum content levels, safety conditions, and transitional measures within the regulation.
**4. Background and Rationale:**
As a *New Policy*, the regulation likely addresses the need for a standardized framework governing the use of indigo carmine as a feed additive within the EU. The text suggests that indigo carmine was previously authorized under different directives and needed re-evaluation under Regulation (EC) No 1831/2003. The rationale also stems from the European Food Safety Authority (EFSA) assessment, which provides scientific justification for the authorized levels and necessary safety precautions. The policy seeks to consolidate existing authorisations under a single, updated regulatory framework.
**5. Key Provisions:**
The regulation establishes the following key provisions:
* **Authorization:** Authorizes indigo carmine as a feed additive for cats, dogs, and ornamental fish, classified as a sensory additive (colourant).
* **Maximum Content Levels:** Sets maximum levels of indigo carmine in complete feed: 250 mg/kg for cats and dogs, and 1000 mg/kg for ornamental fish.
* **Composition and Characteristics:** Specifies the composition, chemical formula, description (sodium salt of disodium 3,3'-dioxo-2,2'-bi-indolylidene-5,5'-disulfonate and disodium 3,3'-dioxo-2,2'-bi-indolylidene-5,7'-disulfonate), and characteristics of the authorized indigo carmine. It also defines limits for organic compounds other than coloring matters, unsulphonated primary aromatic amines, ether extractable matter, and lead.
* **Purity:** Establishes a minimum purity level of 85% for total colouring matter.
* **User Safety Measures:** Mandates feed business operators to establish operational procedures and organizational measures to address potential inhalation risks. Requires personal skin and breathing protective equipment where those risks cannot be eliminated.
* **Analytical Methods:** Specifies analytical methods for quantifying indigo carmine content in the feed additive and compound feed.
* **Transitional Measures:** Allows for the continued placement on the market and use of existing stocks of indigotine and premixtures produced and labelled before 1 November 2025, under the previous rules, until stocks are exhausted. Similarly, allows for the continued use of compound feed and feed materials containing indigotine produced and labelled before 1 May 2027, until stocks are exhausted.
* **End of Period of Authorisation:** Sets the end of the authorisation period as 1 May 2035.
* **Labelling Requirements:** Specifies that the directions for use of the additive and premixtures, the storage conditions and solid form stability to heat treatment shall be indicated.
**6. Target Audience and Stakeholders:**
The directly affected target audience and stakeholders include:
* Feed manufacturers producing feed for cats, dogs, and ornamental fish.
* Manufacturers and suppliers of indigo carmine feed additive.
* Businesses that use feed additives, premixes and feed materials in the production of feed for cats, dogs and ornamental fish.
* Pet owners and ornamental fish keepers (indirectly affected by feed composition).
* Regulatory bodies responsible for enforcing feed additive regulations.
* The Reference Laboratory set up by Regulation (EC) No 1831/2003
* European Food Safety Authority (EFSA)
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The European Commission is the primary body responsible for the regulation's adoption. Member States are responsible for its enforcement within their jurisdictions. The Standing Committee on Plants, Animals, Food and Feed provided an opinion on the measures.
* **Timelines/Procedures:**
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union (April 11, 2025).
* Transitional periods are provided for existing stocks, with deadlines of 1 November 2025 and 1 May 2027 depending on the product.
* The authorization period ends on 1 May 2035.
* **User Safety Measures:** Companies must ensure user safety when handling indigo carmine.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this regulation include:
* **Harmonized Use:** Standardized and harmonized the use of indigo carmine as a feed additive across the EU.
* **Animal Safety:** Ensured the safety of cats, dogs, and ornamental fish consuming feed containing indigo carmine, within the defined limits.
* **User Safety:** Mitigated risks to human health through mandatory protective measures for those handling the additive.
* **Clarity and Legal Certainty:** Provided clarity and legal certainty for feed manufacturers and suppliers regarding the permitted use of indigo carmine.
**9. Conclusion:**
Commission Implementing Regulation (EU) 2025/714 provides a comprehensive framework for the authorization and use of indigo carmine as a feed additive for cats, dogs, and ornamental fish. The regulation aims to balance the benefits of using indigo carmine as a colorant with the need to protect both animal and human health. The specified maximum levels, user safety measures, and transitional provisions are crucial aspects of this policy that will shape the feed manufacturing industry and regulatory oversight in the coming years. The regulation's significance lies in its contribution to ensuring feed safety and promoting responsible use of feed additives within the European Union.
Key Entities Referenced
COMMISSION IMPLEMENTING REGULATION EU 2025/714: Regulation concerning the authorisation of indigo carmine as a feed additive for cats, dogs and ornamental fish
Treaty on the Functioning of the European Union: Basis for the regulation.
Regulation EC No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Article 9(2): Article within Regulation EC No 1831/2003 related to authorisation.
Article 10(2): Article within Regulation EC No 1831/2003 related to re-evaluation of additives.
Council Directive 70/524/EEC: Directive concerning additives in feedingstuffs.
indigo carmine: Feed additive authorized for ornamental fish, dogs and cats.
Article 7(3): Article within Regulation EC No 1831/2003 related to application requirements.
European Food Safety Authority: Authority that concluded on the safety of indigo carmine.
250 mg/kg: Maximum level of indigo carmine deemed safe for cats and dogs.
1 000mg/kg: Maximum level of indigo carmine deemed safe for ornamental fish.
Article 5: Article within Regulation EC No 1831/2003 related to conditions for authorisation.
Standing Committee on Plants, Animals, Food and Feed: Committee that provided an opinion in accordance with the regulation.
Article 1: Authorizes the use of the substance in the Annex.
Article 2: Provides transitional measures for the use of indigotine
Directive 70/524/EEC: Directive under which indigotine was previously authorized.
1 November 2025: Date before which existing stocks of indigotine can be produced and labeled.
1 May 2025: Date used to determine which rules are applicable to the production of indigotine.
1 May 2027: Date before which stocks can continue to be placed on the market
Ursula VON DER LEYEN: The President of the European Commission.
Regulation EU No 231/2012: Regulation that lays down specifications for food additives.
Regulation EC No 1333/2008: Regulation of the European Parliament and of the Council
Official Journal EN
of the European Union L series
2025/714 11.4.2025
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
(2) The substance indigo carmine was authorised under the name ‘indigotine’ without a time limit in accordance with
Directive 70/524/EEC as a feed additive for ornamental fish belonging to the group ‘colourants, including
pigments’, under the heading ‘other colourants’. It was also authorised without a time limit as a feed additive for
dogs and cats belonging to the group ‘colourants, including pigments’, under the heading ‘colouring agents
authorised for colouring foodstuffs by Community rules’. That substance was subsequently entered in the Register
of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the authorisation of indigo carmine as a feed additive for cats, dogs and ornamental
fish. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the
functional group ‘colourants: substances that add or restore colour in feedingstuffs’. The application was
accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 April 2015(3) and 27 June
2024(4) that indigo carmine (purity of at least 85 % colouring matter) is safe for cats and dogs at levels up to
250 mg/kg complete feed, and for ornamental fish up to 1 000mg/kg complete feed. The Authority concluded that
it would be prudent to regard users as being at risk of inhalation exposure to dust from the additive and that in the
absence of information on the inhalation toxicity of indigo carmine, such exposure is regarded as hazardous. Indigo
carmine is not an irritant to skin and eyes but it should be considered a potential skin and respiratory sensitiser in
humans. Indigo carmine is effective in adding colour to feedingstuffs for dogs, cats and ornamental fish. The
Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference
Laboratory set up by Regulation (EC) No 1831/2003.
(5) In view of the above, the Commission considers that indigo carmine satisfies the conditions provided for in Article 5
of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the
Annex to this Regulation. In addition, the Commission considers that appropriate protective measures should be
taken to prevent adverse effects on the health of the users of the additive.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http://
data.europa.eu/eli/dir/1970/524/oj).
(3) EFSA Journal 2015; 13(5):4108, https://doi.org/10.2903/j.efsa.2015.4108.
(4) EFSA Journal 2024; 22(7):e8909, https://doi.org/10.2903/j.efsa.2024.8909.
ELI: http://data.europa.eu/eli/reg_impl/2025/714/oj 1/4EN
OJ L, 11.4.2025
(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the substance concerned, it is appropriate to provide for a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the authorisation.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
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
2025in accordance with the rules applicable before 1 May 2025may 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 2027in accordance with the rules applicable before 1 May 2025may 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 April 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/714/ojANNEX
Minimum Maximum
Identifica
content content
tion Species or
Composition, chemical formula, description, Maximum End of period of
number of Additive category of Other provisions
analytical method age mg additive/kg complete authorisation
the feed animal
feedingstuff with 12 %
additive
moisture content
Category: sensory additives. Functional group: colourants: (i) substances that add or restore colour in feedingstuffs
2a132 Indigo carmine Additive composition: Cats 250 1. In the directions for use of 1.5.2035
Dogs the additive and premixtures,
Indigo carmine
the storage conditions and
Ornamen 1 000
Solid form stability to heat treatment
tal fish
shall be indicated.
Characterisation of the active substance:
2. For users of the additive and
Indigo carmine, described as the sodium premixtures, feed business
salt, consists essentially in a mixture of operators shall establish
disodium 3,3′-dioxo-2,2′-bi- operational procedures and
indolylidene-5,5′-disulfonate, and organisational measures to
disodium 3,3′-dioxo-2,2′-bi- address potential risks
indolylidene-5,7′-disulfonate resulting from their use.
Where those risks cannot be
Calcium and potassium salts are also
eliminated by such
allowed with the same characterisation
procedures and measures,
as sodium salt.
the additive and premixtures
Produced by chemical synthesis shall be used with personal
skin and breathing protective
Chemical formula: C 16H 8N 2Na 2O 8S 2 equipment.
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 %
ELI:
http://data.europa.eu/eli/reg_impl/2025/714/oj
3/4
OJ
L,
11.4.2025
ENMinimum Maximum
Identifica
content content
tion Species or
Composition, chemical formula, description, Maximum End of period of
number of Additive category of Other provisions
analytical method age mg additive/kg complete authorisation
the feed animal
feedingstuff with 12 %
additive
moisture content
Category: sensory additives. Functional group: colourants: (i) substances that add or restore colour in feedingstuffs
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)
(1) Commission Regulation (EU) No 231/2012 of 9 March 2012laying 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).
4/4
ELI:
http://data.europa.eu/eli/reg_impl/2025/714/oj
EN
OJ
L,
11.4.2025