Sunset yellow FCF

Sunset yellow FCF (also known as orange yellow S, or C.I. 15985) is a petroleum-derived orange azo dye with a pH-dependent maximum absorption at about 480 nm at pH 1 and 443 nm at pH 13, with a shoulder at 500 nm.<ref name=EncycFoodSafety/><ref>Template:Cite book</ref>Template:Rp When added to foods sold in the United States, it is known as FD&C Yellow 6; when sold in Europe, it is denoted by E Number E110.<ref name="isbn1-85573-722-1">Template:Cite book</ref>

Uses

Sunset yellow is used in foods, cosmetics, and drugs. Sunset yellow FCF is used as an orange or yellow-orange dye.<ref>Codex Alimentarius (Codex GFSA) Online. Updated up to the 37th Session of the Codex Alimentarius Commission (2014) Sunset yellow FCF (110)</ref><ref>FDA December 2009 Color Additive Status List</ref><ref>EU Food Additive Database Sunset Yellow FCF/Orange Yellow S Template:Webarchive. Database accessed 6 December 2014]</ref><ref>European Medicines Agency 19 June 2007 [Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product]</ref>Template:Rp For example, it is used in candy, desserts, snacks, sauces, and preserved fruits.<ref name=EncycFoodSafety>Template:Cite book</ref>Template:Rp Sunset yellow is often used in conjunction with E123, amaranth, to produce a brown colouring in both chocolates and caramel.<ref name="choc">Template:Cite book</ref>

Safety

The acceptable daily intake (ADI) is 0–4 mg/kg under both EU and WHO/FAO guidelines.<ref name=EncycFoodSafety/>Template:Rp<ref name=EFSA2014>Template:Cite journal</ref> Sunset yellow FCF has no carcinogenicity, genotoxicity, or developmental toxicity in the amounts at which it is used.<ref name=EncycFoodSafety/>Template:Rp<ref name=EFSA2014/>

It has been claimed since the late 1970s, under the advocacy of Benjamin Feingold, that sunset yellow FCF causes food intolerance and ADHD-like behavior in children, but there is little scientific evidence to support these broad claims.<ref>Tomaska LD and Brooke-Taylor, S. Food Additives - General pp 449-454 in Encyclopedia of Food Safety, Vol 2: Hazards and Diseases. Eds, Motarjemi Y et al. Academic Press, 2013. Template:ISBN</ref>Template:Rp It is possible that certain food colorings may act as a trigger in those who are genetically predisposed, but the evidence is weak.<ref name=Peds2012>Template:Cite journal</ref><ref name=FDAdyecomm/>

Regulation as food additive

Europe

"European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs" harmonized rules and approved Sunset Yellow FCF for use in foodstuffs in the whole of the European Union. Before that time, approved amounts was up to each country, but naming and composition was standardized.

Sunset yellow FCF was not approved in Norway before 2001. That was the time when the 94/36/EC directive of 1994 was included in EFTA (now EEC) rules and came into effect, after years of delaying tactics from the Norwegian side and a heated political debate.<ref name="norway">{{#invoke:citation/CS1|citation |CitationClass=web }}.</ref>

In 2008, the Food Standards Agency of the UK called for food manufacturers to voluntarily stop using six food additive colours, tartrazine, allura red, ponceau 4R, quinoline yellow WS, sunset yellow and carmoisine (dubbed the "Southampton 6") by 2009,<ref name=FSAguideline>Sarah Chapman of Chapman Technologies on behalf of Food Standards Agency in Scotland. March 2011 [Guidelines on approaches to the replacement of tartrazine, allura red, ponceau 4R, quinoline yellow, sunset yellow and carmoisine in food and beverages]</ref> and provided a document to assist in replacing the colors with other colors.<ref name="replacements">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

An EU regulation came into effect in 2010 mandating that food manufacturers include a label on foods containing the Southampton 6 stating: "may have an adverse effect on activity and attention in children".<ref name=FSAguideline/>

United States

Sunset yellow FCF is known as FD&C yellow No. 6 in the US and is approved for use in coloring food, drugs, and cosmetics with an acceptable daily intake of 3.75 mg/kg.<ref name=FDAdyecomm>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>Template:Rp

Society and culture

Since the 1970s and the well-publicized advocacy of Benjamin Feingold, there has been public concern that food colorings may cause ADHD-like behavior in children.<ref name=FDAdyecomm/> These concerns have led the FDA and other food safety authorities to regularly review the scientific literature, and led the UK FSA to commission a study by researchers at Southampton University of the effect of a mixture of the "Southampton 6" and sodium benzoate (a preservative) on children in the general population who consumed them in beverages; the study was published in 2007.<ref name=FDAdyecomm/><ref name=FSAguideline/> The study found "a possible link between the consumption of these artificial colours and a sodium benzoate preservative and increased hyperactivity" in the children;<ref name=FDAdyecomm/><ref name=FSAguideline/> 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".<ref name=FDAdyecomm/>

The European regulatory community, with a stronger emphasis on the precautionary principle, required labelling and temporarily reduced the acceptable daily intake (ADI) for the food colorings; the UK FSA called for voluntary withdrawal of the colorings by food manufacturers.<ref name=FDAdyecomm/><ref name=FSAguideline/> 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"<ref name=FDAdyecomm/><ref name=EFSA2009>Template:Cite journal</ref> and in 2014 after further review of the data, the EFSA restored the prior ADI levels.<ref name=EFSA2014/>

The US FDA did not make changes following the publication of the Southampton study, but following a citizen petition filed by the Center for Science in the Public Interest in 2008, requesting the FDA to ban several food additives, the FDA commenced a review of the available evidence, and still made no changes.<ref name=FDAdyecomm/>

See also

• Sulfarsazene, a metal indicator
• Tartrazine, also known as Yellow 5