EFSA halved the acceptable daily intake after animal studies
In 2010, EFSA completed a full re-evaluation of Brown HT and cut the acceptable daily intake from 3 mg/kg body weight per day (the level set by the EU's Scientific Committee on Food) to 1.5 mg/kg per day. The reduction was driven by long-term animal studies showing adverse effects, including slightly reduced weight gain, at doses lower than those previously used to set the limit. EFSA also noted data gaps and requested further toxicological studies.
EFSA reduced the ADI for Brown HT from 3 mg/kg bw/day to 1.5 mg/kg bw/day after a long-term carcinogenicity and toxicity study in mice showed adverse effects at lower doses than previously evaluated.
2010Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources, Re-evaluation of Brown HT (E 155) as a food additive, EFSA Journal
JECFA independently established an ADI of 0 to 1.5 mg/kg bw/day for Brown HT, consistent with EFSA's 2010 conclusion.
1984RegulatoryJECFA (Joint FAO/WHO Expert Committee on Food Additives), evaluation 1984, as referenced in IACM Color Profile for Brown HT
Azo dyes are broken down by gut bacteria into aromatic amines
Gut bacteria carry enzymes called azoreductases that cleave the azo bonds in dyes like Brown HT, releasing aromatic amine breakdown products. Some of these metabolites have mutagenic or carcinogenic properties, even when the parent dye itself is not classified as carcinogenic. Researchers have noted that current regulatory safety assessments may not fully account for the toxicity of these in-gut metabolites.
Human intestinal microbiota can reduce azo dyes to aromatic amines; some of these metabolites, including o-toluidine (IARC Group 1) and benzidine, have been shown to be carcinogenic, even when the parent azo dye is not classified as such.
2018LabFeng et al., Toxicological significance of azo dye metabolism by human intestinal microbiota, Environmental Health and Preventive Medicine, PMC5870118
Further studies on the in vivo reduction of azo food dyes by human gut bacteria and the potential to produce genotoxic aromatic compounds are needed; current regulatory assessments may be incomplete.
2018LabFeng et al., Toxicological significance of azo dye metabolism by human intestinal microbiota, Environmental Health and Preventive Medicine, PMC5870118
Reactions in people with aspirin intolerance or asthma
Like other azo dyes, Brown HT can provoke pseudo-allergic reactions in people who are sensitive to aspirin or non-steroidal anti-inflammatory drugs. Reactions range from hives and skin rashes to worsening asthma. The dye also acts as a histamine liberator, which can intensify asthma symptoms. Evidence for these reactions is better established for azo dyes as a class than for Brown HT in isolation.
Brown HT may intensify asthma symptoms and trigger adverse reactions in people sensitive to aspirin or salicylates through histamine liberation and pseudo-allergic mechanisms.
ObservationalFood-Info.net UK, E155 Brown HT entry (citing established azo dye pharmacology)
Azo dyes as a class are associated with bronchoconstriction and urticaria in aspirin-sensitive individuals; cross-reactivity among structurally similar azo dyes is documented.
1979ObservationalStevenson and Simon, Incidence of bronchoconstriction due to aspirin, azo dyes, non-azo dyes, and preservatives in a population of perennial asthmatics, Journal of Allergy and Clinical Immunology
Hyperactivity in children: Brown HT was assessed but not found to be among the primary culprits
The 2007 McCann et al. Southampton study prompted EFSA to review azo dyes for links to hyperactivity in children. The Southampton Six colours (E102, E104, E110, E122, E124, E129) were found to have the strongest association. EFSA's 2010 review of Brown HT did not result in its inclusion in the EU's mandatory hyperactivity warning list, and Brown HT was not directly tested in the Southampton study. EFSA noted, however, that as a precautionary measure, limiting children's intake of azo dyes broadly was reasonable.
Following the McCann et al. 2007 Southampton study, EFSA reviewed Brown HT but did not add it to Annex V of Regulation 1333/2008, which requires the mandatory 'may have an adverse effect on activity and attention in children' warning label. That list covers only E102, E104, E110, E122, E124, and E129.
2010RegulatoryEU Regulation 1333/2008 Annex V; EFSA re-evaluation of Brown HT (E 155), EFSA Journal
McCann et al. found that a mixture of six synthetic food colours and sodium benzoate increased hyperactivity in 3-year-old and 8 to 9-year-old children; Brown HT was not one of the colours tested.
2007RCTMcCann et al., Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial, The Lancet
Banned in several countries, permitted in UK and EU
Brown HT is not approved in the United States (where it was never authorised for food, drug or cosmetic use), Australia, and a number of European countries including Germany, France, Belgium, Austria, Denmark, Norway, Sweden, and Switzerland. It remains permitted in the UK and EU under specific conditions of use. This widespread prohibition by some regulators reflects differing risk tolerances and data-sufficiency standards, not a settled scientific consensus that it is unproblematic.
Brown HT has never been authorised for use in food, drugs or cosmetics in the United States.
RegulatoryInternational Association of Color Manufacturers, Brown HT Color Profile
E155 is authorised in England, Scotland and Wales under assimilated Regulation (EU) No 1333/2008 and classified as a Group III food colour with a combined maximum limit alongside other approved colours.
2025RegulatoryUK FSA Regulated Products database, E-155 entry (data.food.gov.uk), last updated April 2025