Commission Implementing Regulation (EU) 2026/108 of 16 January 2026 concerning the authorisation of ponceau 4R as a feed additive for its use in baits for freshwater food-producing finfish

• CELEX: Implementing Regulation (EU) 2026/108
• Articles: 3

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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed

additive

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 composition

Ponceau 4R

Solid form

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Characterisation of the active substance as the sodium salt

Ponceau 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 salt

Chemical formula: C 20 H 11 N 2 O 10 S 3 Na 3

CAS No: 2611-82-7

Produced by chemical synthesis

Purity criteria

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Total 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%.

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Analytical method

( 1 )

For 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

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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

( 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