Regulators could not confirm it was safe
When the European Food Safety Authority re-evaluated Brown FK in 2010, it concluded that the available toxicity data were too incomplete to make a safety determination. A key long-term rat study showed treatment-related changes at the highest dose, but the lower dose groups had not been examined histologically, making it impossible to identify a level at which no harmful effects occurred. On that basis EFSA recommended the additive not be included in the approved list.
EFSA concluded it could not determine a safe intake level for Brown FK due to deficiencies in the toxicity database, including incomplete histopathological examination of animals in a long-term carcinogenicity study.
2010Regulatory reviewEFSA Scientific Opinion on the re-evaluation of Brown FK (E 154) as a food additive, EFSA Journal 2010;8(4):1535
JECFA assigned a temporary ADI of 0-0.075 mg/kg body weight in 1985 (29th meeting, WHO TRS 733), then withdrew it in 1986 (30th meeting, WHO TRS 751) when it concluded that no ADI could be allocated due to inadequate toxicological data.
1986Regulatory reviewJECFA evaluations database, Brown FK (inchem.org/documents/jecfa/jeceval/jec_239.htm); meeting numbers confirmed against WHO TRS 733 (1985) and TRS 751 (1986)
Azo dye breakdown and aromatic amine risk
Brown FK is a mixture of azo dyes, meaning its molecules contain nitrogen-nitrogen double bonds that gut bacteria and liver enzymes can cleave. This reduction process releases aromatic amines, a chemical class that includes known human carcinogens. Whether the specific amines released by Brown FK are harmful at food exposure levels was one of the unresolved questions flagged during EFSA's re-evaluation.
Azo dyes can be metabolised in humans through reductive cleavage to aromatic amines; some of these metabolites have mutagenic or carcinogenic properties depending on their structure.
2000Lab + animalMutagenicity and carcinogenicity of aromatic amines metabolically produced from azo dyes, Journal of Environmental Science and Health Part C, Vol 18 No 1
Genotoxicity testing of Brown FK and related azo dyes in bacterial systems found activity linked to amino substituents and azo-reduction products; results were not uniformly negative across test conditions.
1980LabGenotoxicity of the food colours red 2G and brown FK in bacterial systems, Food and Chemical Toxicology, Vol 18
Asthma and hypersensitivity
Like other azo dyes, Brown FK has been identified as a histamine liberator, meaning it can trigger the release of histamine in sensitive individuals. This can worsen asthma symptoms and may cause hives, eczema, or breathing difficulties in people with salicylate sensitivity. The evidence for Brown FK specifically is limited because it was rarely used and data were not gathered at scale.
Brown FK, as an azo dye, is classed as a histamine liberator that may exacerbate asthma symptoms in susceptible individuals.
ObservationalFood-Info.net E154 entry (Wageningen University food information platform)
EFSA noted that no well-documented cases of intolerance reactions after oral exposure to Brown FK had been formally reported in the scientific literature, partly because use of the dye was so restricted.
2010Regulatory reviewEFSA Scientific Opinion on the re-evaluation of Brown FK (E 154), EFSA Journal 2010;8(4):1535
Hyperactivity and benzoate combination
When azo dyes are consumed alongside benzoate preservatives, there is an association with increased hyperactive behaviour in children. The Southampton study demonstrated this for a mixture of six azo dyes plus sodium benzoate. Brown FK was not among the six colours tested in that specific trial, but it belongs to the same chemical class and was often used alongside benzoates in cured fish products.
A randomised controlled trial found that a mixture of six azo food dyes with sodium benzoate significantly increased hyperactivity in children aged 3 and 8-9 years compared to placebo.
2007RCTMcCann et al., The Lancet, Vol 370