Safety Assessment on the Safety and Efficacy of the Authorised Feed Additive Patent Blue V, for Its Use in All Non-Food Producing Animals

Food Standards Agency (FSA) and Food Standards Scotland (FSS) assessed the authorised feed additive Patent Blue V (2a131) for use in non-food-producing animals under Article 12A(1) of assimilated Regulation (EC) No 1831/2003. A renewal application (July 2022) could not be fully supported by the current applicant following a change of ownership, and the renewal assessment ceased with the coming into force of the Food and Feed (Regulated Products) Regulations 2025. FSA and FSS noted that EFSA had published an unfavourable opinion on this product citing unresolved safety concerns. The FSA and FSS continued the assessment with the available information under Article 12A(1) of assimilated Regulation (EC) No 1831/2003. To support the FSA and FSS in evaluating the application, the Advisory Committee on Animal Feedingstuffs (ACAF) was asked to review the dossier and the supplementary information from the applicant at the time. The ACAF concluded that the additive was not equivalent to the additive originally authorised, and that due to insufficient information, the additive was not fully characterised. The ACAF could not discard the aneugenicity potential of the additive, and could therefore not conclude on the safety for the target species of Patent Blue V. It should be considered a potential skin and eye irritant, and a potential respiratory sensitiser. No evaluation of safety for the consumer, safety for the environment or efficacy was required for an additive proposed for use in non-food producing animals. FSA and FSS agree and accept ACAF’s advice on the safety of the additive Patent Blue V. This safety assessment represents the opinion of the FSA and FSS.