Scientific Opinion on the re-evaluation of Brown FK (E 154) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Brown FK (E 154). Brown FK is a food colouring substance permitted only in kippers at a maximum concentration of 20 mg/kg, which has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the EU Scientific Committee for Food (SCF) in 1983. The SCF established an Acceptable Daily Intake (ADI) of 0.15 mg/kg body weight (bw)/day. JECFA withdrew their temporary ADI of 0.075 mg/kg bw/day for Brown FK at their latest evaluation in 1987, as the toxicological data were considered inadequate. 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 calculated an anticipated refined dietary exposure to Brown FK for European children ranging from 0.03 to 0.07 mg/kg bw/day in average, and from 0.03 to 0.14 mg/kg bw/day at the 95th percentile. For the adult population the anticipated mean dietary exposure ranged from 0.002 to 0.07 mg/kg bw/day, and from 0.007 to 0.14 mg/kg bw/day at the 95th percentile. The Panel noted uncertainties surrounding the NOAELs reported for Brown FK in a chronic toxicity study and a carcinogenicity study in rats. It also noted the treatment related changes occurring at the highest dose level in the latter study and that, as reported by JECFA, histopathological examination of the lower groups had not been carried out. The Panel considered, in line with JECFA, that this examination should have been carried out. The Panel considers therefore that it is unable to conclude on the safety of Brown FK given the deficiencies in the available toxicity database on the colour.