# Assessment of the feed additive consisting of Patent Blue V for all non‐food‐producing animal species for the renewal of its authorisation (Versele‐Laga NV)

**Authors:** Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Gabriele Aquilina, Jaume Galobart, Orsolya Holczknecht, Paola Manini, Maria Vittoria Vettori, Fabiola Pizzo

PMC · DOI: 10.2903/j.efsa.2024.8722 · 2024-04-05

## TL;DR

This paper assesses the safety of Patent Blue V as a feed additive for non-food-producing animals, finding insufficient data to confirm its safety.

## Contribution

The paper highlights the lack of compliance and data on Patent Blue V's safety, preventing a definitive conclusion on its authorisation renewal.

## Key findings

- The FEEDAP Panel could not confirm the additive's compliance with current authorisation conditions.
- Insufficient data exists to determine Patent Blue V's safety for target species and its potential as an irritant or sensitiser.
- The additive's potential genotoxicity remains unruled, suggesting the need to minimize user exposure.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Patent Blue V as a sensory feed additive for non‐food‐producing animals. The additive is already authorised for use with non‐food‐producing animals. The applicant has not provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive remains safe for the target species due to the non‐compliance with the specifications and the lack of adequate data on the potential aneugenicity of the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a dermal and eye irritant nor a dermal and respiratory sensitiser. Since the potential genotoxicity of the additive was not ruled out, the exposure to the additive of the unprotected users should be minimised. The Panel retains that the previously made conclusion on the efficacy remains valid.

## Linked entities

- **Chemicals:** Patent Blue V (PubChem CID 77073)

## Full-text entities

- **Chemicals:** Patent Blue V (MESH:C008769)

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Source: https://tomesphere.com/paper/PMC10995816