JECFA withdrew approval: no safe level could be set
The Joint FAO/WHO Expert Committee on Food Additives evaluated Black 7984 in 1977 and declined to allocate an Acceptable Daily Intake, citing insufficient toxicological data to establish safety. Specifications were formally withdrawn in 1984. Without an ADI, the additive had no internationally recognised safe use level.
JECFA allocated no ADI for Black 7984 (Food Black 2). Specifications were withdrawn in 1984 due to inadequate toxicological data.
1977RegulatoryJECFA, WHO Food Additives Series 12, Monograph 434; WHO JECFA database (Chemical 1105)
Animal studies: conflicting tumour findings
Rat feeding studies gave mixed results. In one long-term study, rats receiving the dye in drinking water showed no abnormalities in growth, survival, or tissue pathology for over 500 days. A separate study reported increased male mortality and mammary tumours in female rats. The conflicting findings, combined with thin data overall, were a key reason regulators could not establish a safe level.
Long-term rat study (543+ days, 0.5% in drinking water) found no abnormalities in growth, survival, or histopathology.
1977AnimalJECFA monograph 434, WHO Food Additives Series 12
A separate long-term rat study reported increased male mortality and mammary tumours in females; no subcutaneous tumours were found in another subcutaneous-dose study despite high serum-protein binding.
1977AnimalJECFA monograph 434, WHO Food Additives Series 12
Azo dye class concern: gut bacteria release potentially genotoxic amines
Azo dyes as a class are reduced by intestinal bacteria to aromatic amines. Those amines can then be activated by liver enzymes into reactive compounds that bind to DNA. This mechanism has been demonstrated for multiple azo food dyes in laboratory and animal models, and is the reason that an azo dye's metabolic breakdown products are scrutinised as carefully as the parent molecule. Whether Black 7984's specific aromatic amine breakdown products are genotoxic at food-relevant exposures has not been established, because the dye was withdrawn before detailed modern genotoxicity testing was completed.
Azo dyes are metabolised by intestinal microflora via azoreductase enzymes to aromatic amines, which mammalian microsomal enzymes can further activate to genotoxic compounds capable of binding DNA.
2022Lab + animalPMC review of azo dye degradation by microorganisms, PMC9483650
Black 7984 showed rapid reductive splitting of its azo linkages following intravenous injection in dogs, with metabolites excreted in urine; gastrointestinal absorption of the intact dye was poor.
1977AnimalJECFA monograph 434, WHO Food Additives Series 12
EU removal: deleted from the positive list by the Scientific Committee on Food
Black 7984 was one of several artificial colours removed from the EU positive list when it was revised. The European Commission's Scientific Committee on Food reviewed new toxicological data and deleted the dye from the permitted list, removing its food authorisation at the end of 1976. It has not been permitted in EU food at any point since.
E152 was approved under EU Directive 62/2645/EEC as a food colorant until end of 1976. The Scientific Committee on Food reviewed new toxicological data and deleted it from the positive list of colours; it has not been re-authorised.
1976RegulatoryWikipedia, Black 7984; NATCOL Foods Colors Legislation review