Scientific Opinion on the safety and efficacy of Patent Blue V (E 131) as feed additive for non food-producing animals

Sensory additive, colouring agents, Patent Blue V, safety
First published in the EFSA Journal
1 March 2013
31 January 2013
Scientific Opinion


Patent Blue V (E131) is intended to add colour to feedingstuffs. It is applied for use in non food-producing animals only. The assessment is therefore limited to its safety for the target animals and the users and its efficacy. As no tolerance data were available, the safe feed concentration for target animals was derived from a NOAEL (no observable adverse effect level) from a chronic toxicity study in mice. The maximum safe feed concentration of Patent Blue V is 250 mg/kg complete feed for non food-producing animals. Patent Blue V is not genotoxic. This conclusion is limited to Patent Blue V having a minimum purity of 90 % and containing not more than 1 % of leuco base. Patent Blue V is poorly absorbed and has low systemic toxicity. In the absence of data on irritancy, sensitisation and inhalation toxicity, it would be prudent to treat Patent Blue V as an irritant and a skin sensitiser and as toxic by inhalation. Although a demonstration of efficacy is not required for additives that are used for the same function in food, an assessment of efficacy with respect to different doses and the nature of the feedingstuffs and their processing was not possible. The safety assessment is based on a Patent Blue V with a specification different from that currently used for the food additive. It is strongly recommended that the specification should be adjusted to match that of the product used in the critical genotoxicity study (in vivo comet assay). The specification for the feed additive should be: Patent Blue V with a minimum purity of 90 % and containing not more than 1 % of leuco base.

Panel members at the time of adoption

Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Josep Gasa-Gasó, Mikolaj Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal 2013;11(3):3108
Question Number
On request from
European Commission