Allura Red AC

Allura Red AC, also known asFD&CRed 40orE129, is aredazo dyecommonly used in food. It was developed in 1971 by theAllied Chemical Corporation, who gave the substance its name.
It is usually supplied as its redsodiumsaltbut can also be used as thecalciumandpotassiumsalts. These salts are soluble inwater. Insolution, its maximumabsorbancelies at about 504 nm.
Allura Red AC is manufactured byazo couplingbetweendiazotized5-amino-4-methoxy-2-toluenesulfonic acid and 6-hydroxy-2-naphthalene sulfonic acid.
Allura Red AC is a popular dye used worldwide.  Annual production in 1980 was greater than 2.3 million kilograms.It was introduced as a replacement foramaranthin the United States.
TheEuropean Unionapproved Allura Red AC as a food colorant in 1994, but EU countries' local laws banning food colorants were preserved.In the United States, Allura Red AC is approved by the FDA for use incosmetics, drugs, and food. When prepared as alake pigmentit is disclosed as Red 40 Lake or Red 40 Aluminum Lake. It is used in some tattoo inks and is used in many products, such ascotton candy,soft drinks,cherry-flavored products, children's medications, anddairyproducts. It is occasionally used to dye medicinal tablets, such as theantihistaminefexofenadine, to help with identification.It is by far the most commonly used red dye in the United States,completely replacingamaranth (Red 2)and also replacingerythrosine (Red 3)in most applications due to the negative health effects of those two dyes.
Allura Red has been heavily studied by food safety groups in North America and Europe, and remains in wide use. However, chronic exposure to the dye has been shown to increase susceptibility to bowel disorders in mice.The dye has been shown to damage the DNA of mice.
The UK'sFood Standards Agencycommissioned a study of six food dyes (tartrazine, Allura red,Ponceau 4R,Quinoline Yellow,sunset yellow,carmoisine(dubbed the "Southampton 6")), andsodium benzoate(a preservative) on children in the general population, who consumed them in beverages.The study found "a possible link between the consumption of these artificial colours and a sodium benzoate preservative and increased hyperactivity" in the children;the advisory committee to the FSA that evaluated the study also determined that because of study limitations, the results could not be extrapolated to the general population, and further testing was recommended.
TheEuropean Food Safety Authority(EFSA), with a stronger emphasis on theprecautionary principle, required labelling and temporarily reduced theacceptable daily intake(ADI) for the food colorings; the UK FSA called for voluntary withdrawal of the colorings by food manufacturers.However, in 2009, the EFSA re-evaluated the data at hand and determined that "the available scientific evidence does not substantiate a link between the color additives and behavioral effects",and in 2014, after further review of the data, the EFSA restored the prior ADI levels.In 2015, the EFSA found that the exposure estimates did not exceed the ADI of 7 mg/kg per day in any population.
The US FDA did not make changes following the publication of the Southampton study. Following a citizen petition filed by theCenter for Science in the Public Interestin 2008, requesting the FDA ban several food additives, the FDA commenced a review of the available evidence but found no evidence to justify changes.
Allura Red AC has previously been banned inDenmark,Belgium,France,Switzerland, andSweden.This changed in 2008, when the EU adopted a common framework for authorizing food additives,under which Allura Red AC is not currently banned.InNorwayandIceland, it was banned between 1978 and 2001, a period in which azo dyes were only legally used in alcoholic beverages and some fish products.