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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 nutritionnote, 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.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of ponceau 4R 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 ponceau 4R as a feed additive for use in baits for freshwater fish, requesting that additive to be classified in the 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 15 October 2024note that the use of ponceau 4R 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 consumers and the environment. It also concluded that the additive is not skin irritant but it should be considered a skin and respiratory sensitiser. The Authority could not conclude on the eye irritation potential of the additive. In the opinion of 6 May 2025note, the Authority concluded that ponceau 4R 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 a previous assessment regarding the methods used for the control of the ponceau 4R in animal feed are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that ponceau 4R 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 Councilnote, 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.
(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 1Authorisation#
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 2Entry 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.
| Identification number of the feedadditive | Name of the 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 of active substance/kg of complementary feed with a moisture content of 12 % | ||||||||
| Category: Sensory additives. Functional group: Colourants: (i) substances that add or restore colour in feedingstuffs | ||||||||
| 2a124 | Ponceau 4R | Additive compositionPonceau 4RSolid form---------------------------------------------Characterisation of the active substance as the sodium saltPonceau 4R, described as the sodium salt, consists essentially of trisodium 2-hydroxy-1-(4-sulfonato1-naphthylazo) naphthalene-6,8-disulfonate 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 allowed with the same characterisation as sodium saltChemical formula: C20H11N2O10S3Na3CAS No: 2611-82-7Produced by chemical synthesisPurity criteriaTotal colouring matters calculated as the sodium salt ≥ 80% (assay);Subsidiary colouring matter ≤ 1%;Organic compounds other than colouring matters ≤ 0,5%;Unsulfonated primary aromatic amines (calculated as aniline) ≤ 0,01%.---------------------------------------------Analytical methodnoteFor the quantification of total colouring matters content of ponceau 4R in the feed additive:Spectrophotometry at 505 nm and titration with Titanous chloride as described in Commission Regulation (EU) No 231/2012 referring to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4); and the Monograph No. 11 (2011) Ponceau 4R.For the quantification of ponceau 4R in compound feed:High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) | Freshwater food-producing finfish | - | - | 15 | 1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.The additive shall only be used in fishing baits. The additive shall not be used in aquaculture feed.3.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, eye and breathing protective equipment. | 8 February 2036 |
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