Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive

Patent Blue V, E 131, CAS Registry Number calcium salt: 3536-49-0, CAS Registry Number sodium salt: 129-17-9, food colouring substance.
First published in the EFSA Journal
1 March 2013
4 July 2012
Last Updated
25 April 2013. This version replaces the previous one/s.
Scientific Opinion

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Patent Blue V (E 131). Patent Blue V (E 131) is a triarylmethane dye permitted for use as a food additive in the EU, that has been previously evaluated by JECFA in 1970 and 1975 and the EU SCF in 1983; JECFA established a Temporary Acceptable Daily Intake (ADI) of 0-1 mg/kg bw/day in 1970, but withdrew it in 1975. Until now JECFA has not allocated an ADI to Patent Blue V (E 131). The SCF established an ADI of 0-15 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel concluded that the present dataset provides a rationale for a re-definition of the ADI. Using the NOAEL of 500 mg/kg bw/day derived from a chronic toxicity study in mice and applying an uncertainty factor of 100 to this NOAEL, the Panel establishes an ADI of 5 mg/kg bw/day. The Panel noted that at the maximum permitted levels of use of Patent Blue V (E 131), exposure estimates for high consumers are above the ADI of 5 mg/kg bw/day in toddlers and children. At the maximum reported use levels of Patent Blue V (E 131), exposure estimates are below the ADI of 5 mg/kg bw/day for all groups of the population.

Panel members at the time of adoption
: Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, John Gilbert, David Gott, Ursula Gundert-Remy, Juergen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright.
Panel on Food Additives and Nutrient Sources Added to Food
ans [at]
EFSA Journal 2013;11(3):2818
Question Number
On request from
European Commission