Commission Implementing Regulation (EU) 2026/85 of 14 January 2026 concerning the authorisation of tartrazine as a feed additive for its use in baits for freshwater food-producing finfish

Official Journal EN of the European Union L series 2026/85 15.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/85 of 14 January 2026 concerning the authorisation of tartrazine as a feed additive for its use in baits for freshwater food- producing finfish (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 2003 on 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 authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of tartrazine as a feed additive for its use in baits for freshwater fish. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of tartrazine as a feed additive for use in baits for freshwater fish, requesting that additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants, (i) substances that add or restore colour in feedingstuffs’. The additive is intended to be incorporated in fishing baits to colour them and attract fish in freshwater and is not intended for use in aquaculture.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 September 2024(2)that the use of tartrazine in the preparation of baits for freshwater fish under the proposed conditions of use is of no concern for the target animals and is safe for the consumer and the environment. It also concluded that the additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. It could not conclude on its irritation potential. In the opinion of 6 May 2025(3), the Authority concluded that tartrazine has the potential to be efficacious in colouring fishing baits under the proposed conditions of use.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the tartrazine in animal feed are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that tartrazine satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, this substance should be authorised with specific regard to its use in fishing baits which fall within the definition of feed laid down in Article 3(4) of Regulation (EC) No 178/2002 of the European Parliament and of the Council(5), where they are designed to be scattered to attract fish to an area. 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) EFSA Journal, 22(10), e9021. https://doi.org/10.2903/j.efsa.2024.9021.

(3) EFSA Journal, 23(6), e9461. https://doi.org/10.2903/j.efsa.2025.9461.

(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

(5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj).

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(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 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.

Article 2 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, 14 January 2026.

For the Commission The President Ursula VON DER LEYEN 2/5 ELI: http://data.europa.eu/eli/reg_impl/2026/85/ojANNEX Minimum Maximum content content Identification Species or End of period Composition, chemical formula, Maximum number of the Name of the additive category of Other provisions of description, analytical method age mg of active substance / kg of feed additive animal authorisation 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 Freshwater - - 30 1. In the directions for use of 4 February food- the additive and 2036 Tartrazine producing premixture, the storage Solid form finfish conditions and stability to ——————————————— heat treatment shall be Characterisation of the active substance indicated.

as the sodium salt

2. The additive shall only be Tartrazine, described as the sodium used in fishing baits. The salt, consists essentially of trisodium additive shall not be used 5-hydroxy-1-(4-sulfonatophenyl)- in aquaculture feed.

4-(4-sulfonatophenylazo)-H-

3. For users of the additive pyrazole-3-carboxylate and and premixtures, feed subsidiary colouring matters business operators shall together with sodium chloride and/ establish operational or sodium sulphate as the principal procedures and uncoloured components.

organisational measures Calcium and potassium salts are also to address potential risks allowed with the same resulting from their use. characterisation as sodium salt. Where those risks cannot be eliminated by such

Chemical formula: C H N Na O S 16 9 4 3 9 2 procedures and measures, CAS number 1934-21-0 the additive and Produced by chemical synthesis premixtures shall be used with personal skin, eye and breathing protective equipment.

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http://data.europa.eu/eli/reg_impl/2026/85/oj 3/5 OJ L,

15.1.2026 ENMinimum Maximum content content Identification Species or End of period Composition, chemical formula, Maximum number of the Name of the additive category of Other provisions of description, analytical method age mg of active substance / kg of feed additive animal authorisation complementary feed with a moisture content of 12 %

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)).

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ELI:

http://data.europa.eu/eli/reg_impl/2026/85/oj EN OJ L,

15.1.2026Minimum Maximum content content Identification Species or End of period Composition, chemical formula, Maximum number of the Name of the additive category of Other provisions of description, analytical method age mg of active substance / kg of feed additive animal authorisation complementary feed with a moisture content of 12 % For the quantification of tartrazine 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, ELI: http://data.europa.eu/eli/reg/2012/231/oj).

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