Following a request from the European Commission to the European Food Safety Authority (EFSA), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of Patent Blue V (E 131) - a triarylmethane dye authorised as a food additive in the EU - when used as a food colouring substance.
In response, the Panel revised the ADI (acceptable daily intake) for Patent Blue V down to 5 mg/kg bw/day.
Data available on the absorption, distribution, metabolism and excretion of Patent Blue V after oral administration in rats and dogs show that Patent Blue V has low absorption, limited systemic availability and is mainly excreted unchanged in the faeces. In vitro data on the metabolism in humans and in rats showed that Patent Blue V is not metabolised.
The main contributors to the total anticipated exposure to Patent Blue V were flavoured drinks, flavoured fermented milk products, fine bakery wares,; and sauces.
The Panel further noted that the specifications for Patent Blue V need to be updated with respect to the percentage of material not accounted for that may represent sodium chloride and/or sodium sulphate as the principal uncoloured components.
