Efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish (GIFAP)

TL;DR

This paper evaluates the effectiveness of ponceau 4R as a colorant in fishing baits for freshwater fish, concluding it is effective under specific conditions.

Contribution

The study confirms the efficacy of ponceau 4R in coloring fishing baits for freshwater fish based on new data.

Findings

Ponceau 4R is effective in coloring fishing baits for freshwater fish under proposed conditions.

The additive is not harmful to fish, consumers, or the environment when used as intended.

Ponceau 4R is a skin and respiratory sensitiser, posing inhalation and dermal exposure risks.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of ponceau 4R. Ponceau 4R is intended to be used as a sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs) in baits for freshwater fish up to a maximum content of 15 mg/kg in complementary feed. Ponceau 4R is intended to be incorporated in fishing baits in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. The characterisation of the additive, its safety and its efficacy were evaluated in a previous opinion of the Panel. In that opinion, the Panel concluded 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, for the consumer and the environment. Regarding the user safety, the additive is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. Finally, in the previous opinion, the Panel concluded that in absence of data no conclusion could be reached on the efficacy of ponceau 4R in freshwater fish baits. Based on the new data submitted by the applicant, the Panel concluded that ponceau 4R has the potential to be efficacious in colouring fishing baits under the proposed conditions of use.

Tables

TABLE 1. Description of the additive.

Category of additive	Sensory additives
Functional group of additive	Colourants: (i) substances that add or restore colour in feedingstuffs
Description	Ponceau 4R
Target animal category	Freshwater fish
Applicant	GIFAP
Type of request	New opinion – Request for scientific opinion pursuant to Article 29(1)(a) of Regulation (EC) No 178/2002

Full text

INTRODUCTION

1

Background and Terms of Reference as provided by the requestor

1.1

Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition; in particular, Article 9 defines the terms of the authorisation by the Commission.

The applicant is seeking a Union authorisation of the feed additive described in Table 1.

On 15.10.2024, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in its opinion on the safety and efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish, could not conclude on the efficacy of the additive.

The European Commission gave the possibility to the applicant to submit supplementary information and data to complete the assessment and to allow a revision of the EFSA's opinion.

The new supplementary information and data have been transmitted by the applicant using the E‐Submission Food Chain Platform (application number FEED‐2025‐34985).2

In view of the above and in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission requests EFSA to deliver a new scientific opinion on a feed additive consisting of ponceau 4R for its use in baits for freshwater fish under the conditions of Regulation (EC) No 1831/2003, based on the supplementary information and data submitted by the applicant.

Additional information

1.2

EFSA issued an opinion on the safety and efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish (EFSA FEEDAP Panel, 2024a). The additive is currently not authorised.

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information3 to a previous application on the same product.4 The dossier was received on 08‐04‐2025 and the general information and supporting documentation are available on Open. EFSA at https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00250.

The FEEDAP Panel used the data provided by the applicant to deliver the present output.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the efficacy of ponceau 4R is in line with the principles laid down in Regulation (EC) No 429/20085 and the relevant guidance document: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024b).

ASSESSMENT

3

Ponceau 4R is intended to be used as a sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs) in baits for freshwater fish up to a maximum content of 15 mg/kg in complementary feed. Ponceau 4R is intended to be incorporated in fishing baits to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture.

The additive under assessment (ponceau 4R) is a sulfonated mono azo dye and consists of trisodium 2‐hydroxy‐1‐(4‐sulfonato‐1‐naphthylazo)naphthalene‐6,8‐disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

The characterisation of the additive, its safety and its efficacy were evaluated in the previous opinion of the Panel (EFSA FEEDAP Panel, 2024a). In that opinion, the Panel concluded that the use of ponceau 4R in the preparation of baits for freshwater fish under the proposed conditions of use (maximum use level of 15 mg/kg complementary feed) is of no concern for the target animals, for the consumer and the environment. Regarding the user safety, the additive is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. In absence of data, no conclusion could be reached on the efficacy of ponceau 4R in freshwater fish baits.

The applicant provided additional information to support the efficacy of the additive.

Efficacy

3.1

In its previous opinion (EFSA FEEDAP Panel, 2024a), the FEEDAP Panel concluded that: ‘Ponceau 4R is authorised as a food additive. In principle, where the function requested for feed is the same as that used in food, no further demonstration of efficacy is necessary, provided that the effect seen when used in food could reasonably be expected to be seen when used in feed at the recommended concentration, and that food and feed matrices are of comparable nature. However, considering the uncertainty in the equivalence of the food and feed matrices and the use levels, efficacy demonstration for this use as feed additive is considered necessary.’

The applicant provided an in vitro study in which the capacity of the additive to colour fishing baits was measured using colorimetric analysis.6

Samples of three batches of fishing baits (boilies) manufactured either without the additive (control) or supplemented with 15 mg ponceau 4R/kg feed were analysed with a spectrophotometer 10 times each, measuring the transmittance wavelength range between 300 and 800 nm with a D65 light source (illuminant) and a 10° observer angle. The colorimetric measurement was aimed to measure the following three parameters: L*, which represents luminosity/lightness takes values between 0 (black) and 100 (reference white); a* scale reports intensity of red (+a*) or green (−a*) colour components. The b scale reports the intensity of the yellow (+b*) or blue (−b*) colour components (CIE, 2007).

These parameters were used to calculate ΔEab which quantifies the perceived difference between the colour of the treated feed and the control feed, with the following ranges: ΔEab = 0, identical; ΔEab = 1 to 2: difference noticeable only after close inspection; ΔEab = 2 to 10: difference noticeable at naked eyes, even if it might not be obvious and ΔEab = > 10: clearly different.

The use of the additive in the treated feed resulted in a reduction of the L* from 65.7 to 64.2, an increase in a* from 4.1 to 11.3 and a reduction of b* from 48.8 to 45.0. As a result, the ΔE_ab_ ranged between 6.97 and 10.64 (average 8.03), indicating a difference of colour between the treated feed and the control feed.

Conclusions on efficacy

3.1.1

The FEEDAP Panel concludes that ponceau 4R has the potential to be efficacious in colouring fishing baits under the proposed conditions of use.

CONCLUSIONS

4

Ponceau 4R has the potential to be efficacious in colouring fishing baits (boilies) at the recommended dose of 15 mg/kg.ABBREVIATIONFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal Feed

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2025‐00250

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PANEL MEMBERS

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe and Katerina Theodoridou.