Patent Blue V disappears from feed for non-food-producing animals: batches of the colourant had 86–89.9 % colouring matters instead of the required minimum of 90 %, and aneugenicity was not investigated
Commission Implementing Regulation (EU) 2025/2543, published on 12 December 2025, refuses to renew the authorisation of Patent Blue V as a colourant in feed for non-food-producing animals and repeals Regulation (EU) No 643/2013. The additive and premixtures must be withdrawn from the market by 1 April 2026, and feed produced with them by 1 July 2026.
- Condition of the 2013 authorisation: at least 90 % of total colouring matters calculated as the sodium, calcium or potassium salts and not more than 1.0 % leuco base. According to EFSA’s opinion of 13 March 2024, five batches had an average purity of 86.8 % (86–89 %) and five further batches 88.9 % (88.7–89.9 %), with the sum of chlorides, sulfates and moisture at 11.06 %.
- EFSA confirmed the absence of concern for gene mutations and structural chromosomal aberrations on the basis of the in vivo comet assay, but noted that the existing studies did not cover numerical chromosomal aberrations, so it could not rule out aneugenicity. The earlier safety conclusions applied only to a product with a purity of at least 90 % and leuco base up to 1 %.
- The applicant provided no new studies, and the only relevant paper from the literature review (an in vitro study in human peripheral blood lymphocytes with positive results) concerned a colourant of unspecified purity, so EFSA did not take it into account. To the Commission’s letter of 1 July 2024 the applicant replied on 20 September 2024 that it would not submit additional data.
- Until now Patent Blue V was authorised up to 250 mg/kg complete feed for all non-food-producing animals. EFSA could not assess skin and eye irritation or sensitisation and recommended minimising the exposure of unprotected users because genotoxicity had not been ruled out.