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Which Synthetic Food Colors Are Still Legal in U S Foods but Banned or Restricted Overseas?

Angelo (admin)
Close-up of a spilled bag of colorful candy, featuring a mixture of vibrant candies in various shapes and hues, on a white surface.
Image source: Depositphotos.com

Vivid color is one of the oldest quality cues of healthy food: ripe fruits look vibrant, baked bread has a golden hue, and consumers instinctively associate certain hues with freshness, flavor and even safety. However, because industrial processing often strips or dulls those natural pigments, food technologists have long turned to added colorants to “put back” the visual appeal— and even create new looks.

The practice began with spices such as saffron (yellow-orange food coloring derived from the flower of the saffron crocus) and annatto (orange-red food coloring derived from the seeds of the achiote tree) but accelerated in the 19th century with synthetic coal‑tar dyes (color additives derived primarily from petroleum, made from aromatic coal‑tar intermediates, sometimes known “synthetic-organic colors”), giving us today’s wide palette of synthetic US FD&C (Food, Drug and Cosmetic Act) approved colors.

Yet the very chemicals that make candies glow neon blue or snack chips blaze orange have also drawn scrutiny from toxicologists and regulators, leading some jurisdictions to ban or restrict dyes that the United States still permits. Understanding why those differences exist—and what safer, plant‑based alternatives are already available—sets the stage for the detailed analysis that follows.

The Regulation Artificial Food Colorings

Food color additives are regulated nation‑by‑nation, so a pigment (coloring) that is used routinely in the United States can be completely prohibited—or tightly curtailed—elsewhere. This article reviews the main synthetic colors that remain authorised by the U.S. Food & Drug Administration (FDA) but are banned outright or subject to major restrictions in other advanced jurisdictions, chiefly the European Union (EU/EEA), the United Kingdom and Canada.

For each color you will find its chemical identity, U.S. uses, overseas regulatory status and the toxicological concerns on which regulators based their decisions. Only primary government or inter‑governmental documents (FDA, EFSA, EU Regulations, IARC, NTP) are cited; where official sources simply list “not authorised”, that absence is corroborated with peer‑reviewed comparative studies. Data current as at time of writing (April 2025).

Note: Colors that the EU merely allows with reduced maximum levels or with a front‑of‑pack warning (e.g. Tartrazine) are treated under “Restricted, not banned”.

US‑Approved Colors That Are Banned Overseas

The following U.S.–certified additives illustrate how regulatory lines diverge: each remains legal in American foods yet has been removed entirely from ingredient lists in one or more overseas markets.

1. Titanium dioxide

2. Fast Green FCF

3. Citrus Red No. 2

4. Orange B

5. Erythrosine

US Colors That Are Allowed in The EU But Carry Special Restrictions

The following six artificial food colorings have the following specific overseas restriction:

The rationale for the restriction is as follows:

1. Tartrazine

U.S. cert. name & CI No.  FD&C Yellow No. 5, CI 19140
Chemical name / CAS No.  Trisodium 5‑hydroxy‑1‑(4‑sulfonatophenyl)‑4‑[(4‑sulfonatophenyl) azo]‑1H‑pyrazole‑3‑carboxylate; CAS 1934‑21‑0
Typical U.S. applications  Carbonated beverages, breakfast cereals, confectionery coatings, savoury snack seasonings.
Overseas status  EU/UK – permitted at defined maximum levels, but any food containing Tartrazine must carry the label “may have an adverse effect on activity and attention in children” (Annex V, Reg. 1333/2008). ADI (Acceptable Daily Intake) maintained at 7.5 mg kg⁻¹ bw day⁻¹. (European Food Safety Authority, EUR-Lex)
Scientific basis for restriction  EFSA confirmed a small hyperactivity signal from the 2007 Southampton study and episodes of intolerance reactions; it kept the ADI but required the precautionary label. (European Food Safety Authority)

2. Sunset Yellow FCF

U.S. cert. name & CI No.  FD&C Yellow No. 6, CI 15985
Chemical name / CAS No.  Disodium 6‑hydroxy‑5‑(4‑sulfonatophenylazo)‑2‑naphthalenesulfonate; CAS 2783‑94‑0
Typical U.S. applications  Orange‑flavoured soft drinks, gelatin desserts, bakery icings, snack‑chip coatings.
Overseas status  EU/UK – same children’s‑behaviour label as above; EFSA in 2014 raised a revised ADI of 4 mg kg⁻¹ bw day⁻¹ after additional data but kept exposure reviews. (European Food Safety Authority, European Food Safety Authority, EUR-Lex)
Scientific basis for restriction  Hyperactivity evidence plus uncertainties in earlier reproductive‑toxicity tests prompted EFSA to operate a lower ADI than the U.S. and keep the warning label. (European Food Safety Authority)

3. Quinoline Yellow

U.S. cert. name & CI No.  Not FDA‑certified; CI 47005
Chemical name / CAS No.  Mixture of sulfonated 2‑(2‑quinolyl)‑1,3‑indandiones; CAS 8004‑92‑0
Typical applications outside U.S.  Coloured beverages, ice‑lollies, smoked fish coating.
Overseas status  EU – permitted with the children’s‑behaviour label; ADI cut to 0.5 mg kg⁻¹ bw day⁻¹, the lowest of the Southampton dyes, because intake modelling showed exceedances for children. (European Food Safety Authority , EUR-Lex)
Scientific basis for restriction  EFSA derived the new ADI from a NOAEL of 50 mg kg⁻¹ in a long‑term rat study and highlighted the same hyperactivity findings. (European Food Safety Authority)

4. Carmoisine (Azorubine)

U.S. cert. name & CI No.  Not FDA‑certified; CI 14720
Chemical name / CAS No.  Disodium 4‑hydroxy‑3‑(4‑sulfonato‑1‑naphthylazo)‑2‑naphthalene‑sulfonate; CAS 3567‑69‑9
Typical applications outside U.S.  Fruit fillings, jams, fondant creams.
Overseas status  EU – permitted with children’s‑behaviour label; ADI 4 mg kg⁻¹ bw day⁻¹. (European Food Safety Authority, EUR-Lex)
Scientific basis for restriction  EFSA exposure modelling showed the ADI could be exceeded by 1‑to‑10‑year‑olds at maximum‑permitted levels; label retained pending further exposure reduction. (European Food Safety Authority)

5. Allura Red AC

U.S. cert. name & CI No.  FD&C Red No. 40, CI 16035
Chemical name / CAS No.  Disodium 6‑hydroxy‑5‑[(2‑methoxy‑5‑methyl‑4‑sulfophenyl)azo]‑2‑naphthalene‑sulfonate; CAS 25956‑17‑6
Typical U.S. applications  Sports drinks, breakfast cereals, confectionery, gelatin desserts.
Overseas status  EU – permitted with children’s‑behaviour label; ADI 7 mg kg⁻¹ bw day⁻¹ (unchanged). (European Food Safety Authority, EUR-Lex)
Scientific basis for restriction  EFSA noted occasional genotoxic signals (in‑vivo comet assay) and children’s hyperactivity data; exposure for some child groups may approach the ADI, justifying the warning label. (European Food Safety Authority)

6. Ponceau 4R

U.S. cert. name & CI No.  Not FDA‑certified; CI 16255
Chemical name / CAS No.  Trisodium 2‑hydroxy‑1‑(4‑sulfonato‑1‑naphthylazo)‑naphthalene‑6,8‑disulfonate; CAS 2611‑82‑7
Typical applications outside U.S.  Dessert toppings, candied fruit, pastry glazes.
Overseas status  EU – permitted with children’s‑behaviour label; EFSA lowered ADI to 0.7 mg kg⁻¹ bw day⁻¹, and current intakes for children may still exceed it at MPLs (the maximum amount of an additive legally allowed in a food product). (European Food Safety Authority, EUR-Lex)
Scientific basis for restriction  EFSA based the ADI on nephro‑toxicity in mice plus the hyperactivity dataset; the sharply lower ADI triggered reformulation pressure. (European Food Safety Authority)

The following three artificial food colorings have the following specific overseas restriction:

The rationale for the restriction is as follows:

7. Brilliant Blue FCF

U.S. cert. name & CI No.  FD&C Blue No. 1, CI 42090
Chemical name / CAS No.  Disodium α‑[(4‑(diethylamino)‑2‑methylphenyl)(4‑ethylphenyl)methylene]‑[6‑hydroxy‑5‑(4‑sulfonatophenylazo)]‑cyclohexadien‑1‑ylidene] (sulfonate); CAS 3844‑45‑9
Typical U.S. applications  Bright‑blue beverages, popsicles, chewing‑gum coatings, bakery icings.
Overseas status  EU – permitted without the hyperactivity label but ADI cut from 10 → 6 mg kg⁻¹ bw day⁻¹; high‑percentile child exposure can exceed the ADI at MPLs. (European Food Safety Authority)
Scientific basis for restriction  Re‑evaluation pointed to data gaps and high intake in children; ADI was tightened to ensure a ten‑fold margin below the rat NOAEL. (European Food Safety Authority)

8. Indigotine (Indigo Carmine)

U.S. cert. name & CI No.  FD&C Blue No. 2, CI 73015
Chemical name / CAS No.  Disodium 3,3′‑dioxo‑2,2′‑biindolylidene‑5,5′‑disulfonate; CAS 860‑22‑0
Typical U.S. applications  Chocolate‑flavoured dairy desserts, capsule shells, coated confections.
Overseas status  EU – permitted (no hyperactivity label); ADI maintained at 5 mg kg⁻¹ bw day⁻¹, but EFSA warns that lower‑purity grades would need new data. (European Food Safety Authority)
Scientific basis for restriction  Testicular effects in one low‑purity study underline the need for high‑purity manufacturing; exposure modelling shows ADI exceedance only at maximal permitted levels for toddlers. (European Food Safety Authority)

9. Green S

U.S. cert. name & CI No.  Not FDA‑certified; CI 44090
Chemical name / CAS No.  Triarylmethane sulphonic‑acid sodium salt; CAS 3087‑16‑9
Typical applications outside U.S.  Canned peas, mint‑flavoured jellies, dessert sauces.
Overseas status  EU – permitted (no hyperactivity label); ADI 5 mg kg⁻¹ bw day⁻¹. Intake at MPLs can exceed the ADI for children, so use levels are being reviewed. (European Food Safety Authority)
Scientific basis for restriction  Data gaps in genotoxicity plus exposure estimates above the ADI for high‑consumer children led EFSA to keep the existing ADI but caution Member States on maximum use. (European Food Safety Authority)

Why These Artificial Colors Were Restricted or Banned Overseas

Regulators outside the United States did not act on whim: each prohibition or limitation stems from a distinct line of scientific evidence that challenged the additive’s margin of safety. Broadly, four toxicological red‑flags emerged—genotoxicity, carcinogenicity, systemic‑organ toxicity and neuro‑behavioural effects in children—driving the decisions summarised below.

  1. Genotoxic nanoparticles – Titanium dioxide is poorly soluble; nano‑sized particles accumulate and can damage DNA strands. EFSA concluded “no safe level” could be set. (European Food Safety Authority)
  2. Rodent carcinogenicity – Fast Green FCF, Citrus Red 2 and Erythrosine produced statistically significant tumour increases in two‑year rodent bioassays (NTP; IARC). Regulators in Europe apply the “zero‑tolerance” rule for colour additives with positive cancer signals. (ResearchGate, IARC)
  3. Endocrine or organ toxicity – Orange B caused liver and bile‑duct pathology in dogs; the dossier was never resubmitted to EFSA, so authorisation lapsed. (eCFR)
  4. Behavioural effects in children – The “Southampton six” colours; Tartrazine (E 102), Sunset Yellow (E 110), Quinoline Yellow (E 104), Carmoisine (E 122), Allura Red (E 129), Ponceau 4R (E 124); did not trigger bans but obliged EU industry either to carry the hyperactivity label or reformulate with natural pigments. (EUR-Lex, European Food Safety Authority)

Case Study — Artificial colors in U.S. Skittles®

U.S. Skittles® rely on six artificial colors, one of which (titanium dioxide) is now outright forbidden in the EU and another three that trigger prominent behaviour‑warning labels there.

European recipes therefore swap in alternative coatings and, increasingly, natural pigments to keep the familiar rainbow without breaching regional safety rules.

Artificial colours in U.S. Skittles® that run into bans or special rules overseas:

What this means in practice:

Natural and Nature‑identical Food Coloring Alternatives

One of the most influential models for replacing synthetic dyes (food colorings) is the European system, which draws a clear legal line between conventional colour additives, and pigments that come directly from edible plants. Understanding this “colouring‑foods” concept shows how manufacturers can use concentrated fruit‑ and vegetable‑based ingredients as ordinary foods rather than as regulated additives—making it a cornerstone of clean‑label reformulation.

The ‘Coloring‑Foods’ Approach in Europe

Since 2013 the EU encourages the use of “colouring foods”—aqueous or oily concentrates of edible plants that meet a technical “enrichment‑factor” test, and are legally treated as ingredients, not additives. Guidance endorsed by the Standing Committee on Plants, Animals, Food and Feed explains classification and labelling. (JRC Publications Repository)

Common Natural Food Color Replacements in Commercial Use

ColorTypical natural colorantRegulatory/technical notes
Bright redBeet‑juice (betanin) or radish & black‑carrot anthocyaninsHeat‑sensitive; encapsulation or post‑bake spraying used in baked goods.
Orange / yellowPaprika oleoresin, β‑carotene, curcuminOil‑soluble; micro‑emulsified versions disperse in soft drinks.
GreenSpirulina extract (phycocyanin) for blue base + turmeric for yellow gives vivid green candiesEU approved as colour additive E 161g in 2013.
BluePhycocyanin or heat‑stable genetically selected purple potato anthocyaninspH‑dependent; buffered confectionery systems keep hue stable.
WhiteCalcium carbonate or rice‑starchEU industry has reformulated chewing gum coatings without TiO₂ since 2022.

Multinationals have already demonstrated feasibility: Nestlé replaced all certified dyes in Smarties™ with colouring‑food concentrates in 2012, retaining the product’s visual appeal. (New Food Magazine)

The Safety Profile of Natural Food Pigments

Natural pigments are generally non‑genotoxic, non‑carcinogenic and possess long dietary histories. European Food Safety Authority (EFSA) assigns many of them the designation “quantum satis” (no numerical limit) after reviewing toxicology, provided good‑manufacturing limits on heavy‑metal impurities are met. The 2024 EFSA re‑evaluations of curcumin (E 100) and annatto (E 160b) reconfirmed their ADIs (Acceptable Daily Intake). (European Food Safety Authority)

Case Study — Froot Loops: Natural Pigments Replace Synthetic Dyes Across Borders

Image source: Depositphotos.com

Kellogg’s decision to market its Froot Loops® breakfast cereals with entirely different color systems on either side of the border, US and Canada, shows—more clearly than any lab study—that petroleum‑derived dyes are not technologically indispensable. 

The recipe sold in the United States still relies on four FD&C petroleum-derived synthetic food colorings, whereas the Canadian version achieves the same rainbow solely with plant‑based concentrates. Because both cereals are extruded, sugar‑coated rings that go through identical high‑temperature and drying steps, the Canadian formula is a real‑world proof‑of‑concept for natural‑colour stability in mass production. (SmartLabel, SmartLabel)

Synthetic vs. natural hue replacements in Froot Loops:

(No artificial colour appears in the Canadian ingredient list; hence each synthetic hue in the U.S. SKU can be—and has been—replaced by one or more of the natural sources shown above.)

Is There Still a Case for Contentious Synthetic Food Colorings?

Thanks to today’s micro‑encapsulation, emulsification and pH‑buffering techniques, food technologists can reproduce virtually every hue once provided by synthetic pertoleum-derived FD&C dyes with plant‑based or nature‑identical pigments that withstand the same heat, light and processing stresses. 

That technological reality is beginning to shape U.S. policy: the FDA’s January 2025 final rule revoking Red No. 3 for foods—and its pending decision on a citizen petition to ban titanium‑dioxide—show a gradual convergence with the EU’s more precautionary stance.

Meanwhile, market forces are already ahead of the regulators; American brands that export to Europe, Canada or the U.K. routinely reformulate with coloring‑food concentrates to comply with stricter foreign rules, demonstrating that large‑scale natural‑color conversion is both technically feasible and commercially viable.

In summary, the key take‑aways for formulators and consumers are:

  1. Only five U.S.‑certified colour additives are truly banned overseas—TiO₂, Fast Green FCF, Citrus Red 2, Orange B and, in most foods, Erythrosine.
  2. Six more dyes carry EU front‑of‑pack hyperactivity warnings, prompting many manufacturers to avoid them voluntarily.
  3. Safe, plant‑based replacements exist for every banned or flagged dye, and are already standard in European confectionery, beverages and bakery.
  4. Regulatory tides favour precaution; investing in natural colour systems now reduces future reformulation costs and meets rising consumer demand for “clean‑label” ingredients.

Seeing the big picture makes the decision even clearer. Friendly‑sounding labels such as “Red 40” or “Yellow 5” can obscure the fact that these colors are highly engineered petroleum derivatives—e.g., Red 40’s full IUPAC name is Disodium 6‑hydroxy‑5‑[(2‑methoxy‑5‑methyl‑4‑sulfophenyl) azo]‑2‑naphthalenesulfonate. 

When the same vivid scarlet can be achieved with beet, radish or black‑carrot concentrates—ingredients that add micronutrients to our diets instead of toxicological questions—continuing to rely on the synthetic version becomes difficult to justify. Choosing (or formulating with) naturally derived pigments is therefore not just a regulatory hedge; it is a straightforward way to align product safety, consumer trust and nutritional value.

References

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