Is Red 40 Safe? What Health Canada, EFSA, and FDA Say

What is Red 40?

Red 40, formally named Allura Red AC and assigned the European food additive number E129, is a synthetic azo dye that produces red, orange-red, and pink colors in food. It has been the most widely used artificial color in North America since the late 1970s, when it replaced FD&C Red No. 2 (which the FDA banned in 1976 over rodent carcinogenicity concerns). Red 40 is derived from petroleum chemistry and has no insect components. The dye that comes from insects is Carmine (E120, cochineal extract), a chemically unrelated compound sometimes confused with Red 40 because of its similar color.

Red 40 is water-soluble, bright, and stable across a wide pH range, which explains its appearance in breakfast cereals, candy, fruit-flavored beverages, snack foods, processed meats, and some pharmaceutical coatings. In the US and Canada, any food containing Red 40 must list it by name in the ingredient declaration. It also exists in a "lake" form (an aluminum salt used in dry seasonings and coatings), subject to the same certification requirements.

Is Red 40 banned in Canada?

No. Red 40 (Allura Red AC) is not banned in Canada. It is a permitted food colour listed on Health Canada's List of Permitted Colouring Agents. Health Canada states there is no demonstrated human health risk at approved use levels. In 2025, the U.S. FDA announced it will work toward phasing out petroleum-based synthetic dyes (including Red 40) by the end of 2026. Health Canada has not followed that action and continues to permit Red 40 as of 2026.

Is Red 40 safe? Regulatory positions

Health Canada

Health Canada permits Allura Red AC under the Food and Drug Regulations, List of Permitted Colouring Agents (List 2: Colouring Agents That May Be Used as Food Additives). The dye is allowed in a range of food categories including beverages, confectionery, desserts, and other processed foods at specified maximum use levels. Health Canada has not established a separate Canadian ADI, instead relying on the international assessments from JECFA (the Joint FAO/WHO Expert Committee on Food Additives) and EFSA as part of its pre-market approval framework.

European Union and EFSA

The European Food Safety Authority's Panel on Food Additives and Nutrient Sources (ANS Panel) re-evaluated Allura Red AC in 2009, publishing its scientific opinion in the EFSA Journal (2009; 7(11):1108). The panel set an acceptable daily intake of 7 mg/kg body weight per day, the same value that had been established previously by JECFA. This means a 30 kg child could theoretically consume 210 mg of Red 40 per day before exceeding the ADI, though exposure modeling has shown some children in the EU approach or exceed this level through typical dietary patterns.

Separately from the EFSA safety assessment, EU Regulation 1333/2008 mandated that any food or drink containing one of six synthetic dyes (including Red 40) must carry the warning label: "may have an adverse effect on activity and attention in children." This requirement was driven by the 2007 Southampton study results and has been in force since 2010. The label does not mean the product is banned; it is a disclosure requirement.

FDA

The US Food and Drug Administration regulates Red 40 as a color additive subject to certification under the FD&C Act. It is listed at 21 CFR Part 74, Section 74.340 (FD&C Red No. 40) and 21 CFR Part 74, Section 74.340a (FD&C Red No. 40 Aluminum Lake). Every batch of Red 40 used in food sold in the US must be certified by the FDA, meaning the manufacturer must submit a sample and receive a lot number before using the dye. The FDA does not publish a formal ADI in its CFR listing; the US follows JECFA's 7 mg/kg bw/day figure as the internationally recognized benchmark.

In 2025, the US Department of Health and Human Services announced plans to work with the FDA toward phasing out petroleum-based synthetic dyes from the food supply, citing the precautionary concerns reflected in state-level actions like California's AB 2316. As of mid-2026, Red 40 remains fully approved for use in the US pending any regulatory rulemaking.

California

California's AB 2316, the California School Food Safety Act, was signed by Governor Newsom on September 28, 2024. It prohibits six synthetic food dyes (Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3) from being used in foods served as school meals and in competitive foods sold on K-12 public school campuses during school hours. The prohibition takes effect December 31, 2027, giving school food service operators and manufacturers time to reformulate. California is the first US state to enact a school-specific synthetic dye ban; several other states had similar bills in various stages as of 2025-2026.

UK Food Standards Agency

Following the 2007 Southampton study, the UK Food Standards Agency (FSA) wrote to food manufacturers in 2008 requesting voluntary removal of the six dyes studied (including Red 40) from food and beverages. This was a non-binding request, not a ban. The FSA concluded that parents who noticed hyperactive behavior in their children might benefit from reducing these dyes, but did not classify the dyes as unsafe for the general population. After the UK left the EU, it retained the EU's warning label requirement for these six dyes in products sold in Great Britain.

What the research says

The pivotal study in this area is McCann et al. 2007, published in The Lancet on November 3, 2007 (DOI: 10.1016/S0140-6736(07)61306-3). The randomized, double-blind, placebo-controlled trial tested two mixtures of artificial food colors plus sodium benzoate in 153 three-year-olds and 144 eight-to-nine-year-olds in the general population. Both mixtures contained Red 40 (Allura Red AC) alongside five other dyes and a preservative. Children who consumed the color mixtures showed significantly greater hyperactivity scores compared to placebo, as rated by trained observers, parents, and teachers. The effect size was modest at the population level but statistically significant. The paper's conclusion (that artificial colors or sodium benzoate in the diet increase hyperactivity) directly prompted the EU to act.

A key methodological limitation: the study used dye mixtures, not individual dyes, so it cannot attribute the hyperactivity increase to Red 40 alone. EFSA's 2009 review noted this explicitly. Whether the effect comes from Red 40, one of the other five dyes, sodium benzoate, or their combination remains unclear based on current evidence.

More recent work has shifted focus to exposure levels. Stevens, Burgess, Stochelski, and Kuczek (2014, Clinical Pediatrics, DOI: 10.1177/0009922813502849) analyzed dye concentrations in commonly consumed beverages and found that FDA-certified artificial food color consumption per capita increased more than five-fold between 1950 and 2012, from 12 mg to 68 mg per day. Their review of challenge studies found that doses at or above 50 mg produced greater behavioral effects in more children than lower doses, relevant because some heavy consumers of dye-containing beverages could reach that threshold.

The same group's 2015 paper (Clinical Pediatrics, DOI: 10.1177/0009922814530803) extended this to foods and sweets, documenting that children consuming typical diets heavy in processed foods could be ingesting far more dye than either JECFA's assessments or earlier FDA exposure models assumed.

Vojdani and Vojdani (2015, Alternative Therapies in Health and Medicine, PMID: 25599186) proposed a mechanism linking synthetic food dyes to immune reactivity, suggesting some individuals may develop cross-reactive immune responses. This work has not been replicated at scale and represents a hypothesis rather than established consensus.

The honest summary: at typical dietary exposure, regulatory bodies in three major jurisdictions have concluded Red 40 is safe. The hyperactivity association from the Southampton study is real, replicated at a population level, and was significant enough to change EU labeling law. The debate is not about whether the effect exists but about how large it is, for which children, and at what dose.

Where you'll find Red 40

Red 40 appears most commonly in foods where visual appeal drives purchase decisions: candy, breakfast cereals, fruit-flavored snacks and drinks, sports drinks, flavored dairy products, and some baked goods. It also shows up in processed meats that use it to maintain an appealing red color, condiments like some ketchups and hot sauces, gelatin desserts, and certain medications.

Common products containing Red 40

These five products are verified against Open Food Facts data (product codes included for reference). Each is NOVA Group 4 (ultra-processed), which is consistent with the ingredient profiles.

Brand	Product	OFF Code	Nutri-Score	NOVA	Notes
General Mills	Lucky Charms	0016000123991	D	4	Red 40 listed with Yellow 5, Yellow 6, Blue 1; the dyes color the marshmallow pieces
Frito-Lay (PepsiCo)	Doritos Nacho Cheese	0028400516464	D	4	Red 40 in the cheese seasoning blend alongside other artificial colors
Frito-Lay (PepsiCo)	Cheetos Flamin' Hot Crunchy	0028400589895	E	4	Listed as "Red 40 Lake" (aluminum salt form, used in dry seasoning coatings)
Just Born	Hot Tamales	0070970474088	E	4	Red 40 plus Yellow 5 and Yellow 6; primarily candy, low serving weight
Smucker's	Strawberry Preserves (low-sugar)	0051500040423	Not rated	4	Red 40 used to boost color that processing diminishes; ironic in a fruit product

The Smucker's entry is worth highlighting: Red 40 in a strawberry preserve exists specifically because heat processing degrades the natural anthocyanins (the pigment in real strawberries). The dye restores a color consumers expect, even though the strawberries are already there. This is common across fruit-based processed products.

How do Red 40 and Red 3 compare?

Red 40 and Red 3 are often discussed together because both were targeted by U.S. regulatory action in 2025, but they are different dyes with different chemistry, colors, and regulatory outcomes.

Property	Red 40 (Allura Red AC)	Red 3 (Erythrosine)
FDA code	FD&C Red No. 40	FD&C Red No. 3
EU code	E129	E127
Chemical class	Azo dye, petroleum-derived	Xanthene dye, iodine-based
Color	Orange-red to bright red	Deep cherry red, vivid pink
Current FDA action	Approved; voluntary phase-out targeting end of 2026	Food-use authorization revoked January 2025
Primary concern cited	Behavioral effects in children; genotoxicity research	Thyroid tumors in male rats (Delaney Clause)
Manufacturer compliance deadline	End of 2026 (voluntary)	January 15, 2027 (food); January 18, 2028 (ingested drugs)
Still in products as of May 2026	Yes, widely	Yes, until compliance deadline

Red 3 was revoked under the Delaney Clause, which requires the FDA to ban any additive shown to cause cancer in animals or humans, regardless of dose. That revocation was finalized in Federal Register notice 2025-00830. Red 40 faces no such Delaney Clause trigger as of 2026; the phase-out is voluntary and driven by precautionary concerns rather than a formal carcinogenicity finding.

Is Red 40 in over-the-counter children's medication?

Yes. Red 40 is a common colorant in liquid OTC medications and chewable tablets marketed to children, used for visual appeal and product identification. Common examples include liquid diphenhydramine (children's allergy syrups), some liquid ibuprofen and acetaminophen formulations in berry or fruit-punch flavors, chewable and gummy multivitamins, and some throat syrups.

This creates a secondary exposure pathway most parents don't track. A child receiving a dose of antihistamine or fever reducer also receives Red 40 from the inactive ingredient, on top of any dietary intake that day. For families trying to reduce total dye exposure, medication labels matter as much as food labels.

Dye-free formulations exist for most common children's OTC medications. Look for "dye-free" on the front of the package, or check the inactive ingredient list for the absence of FD&C Red No. 40, Allura Red, or Allura Red AC. Pharmacists can recommend dye-free alternatives when asked directly.

What to use instead

Natural alternatives have improved since the 2010s, though none exactly replicate Red 40 across all applications. Beet juice concentrate gives a deep red-to-magenta range suited to yogurt and smoothies, but fades above about 80C and can impart an earthy flavor at high concentrations. Anthocyanins from black carrot or elderberry are more heat-stable and hold a red-to-pink range in acidic products like sodas and gummies. For orange-red tones in savory applications, paprika extract (E160c) has been the snack industry's default for decades.

Some manufacturers have already reformulated: Kraft removed synthetic dyes from its mac and cheese in 2016. General Mills removed them from several cereal lines around the same time, though Lucky Charms' marshmallow pieces still contain Red 40 as of 2026. Gatorade announced plans to reformulate away from synthetic dyes, with work ongoing.

FAQ

Is Red 40 banned in Canada?

No. Red 40 (Allura Red AC) is not banned in Canada. It is a permitted food colour listed on Health Canada's List of Permitted Colouring Agents. Health Canada states there is no demonstrated human health risk at approved use levels. In 2025, the U.S. FDA announced plans to phase out petroleum-based synthetic dyes including Red 40 by the end of 2026. Health Canada has not followed that action and continues to permit Red 40 as of 2026.

Is Red 40 banned in any country?

Red 40 is not outright banned in any country that permits it in food, but it has faced significant restrictions. The EU requires a warning label ("may have an adverse effect on activity and attention in children") on any product containing it. The UK's Food Standards Agency asked manufacturers to voluntarily remove six artificial dyes including Red 40 after the 2007 Southampton study. California banned Red 40 from K-12 school meals under AB 2316 (signed September 28, 2024, effective December 31, 2027), making it the first US state to do so.

What does Red 40 do to kids?

The McCann et al. 2007 Lancet trial found measurably increased hyperactivity in children aged 3 and 8-9 after consuming a mixture of artificial food colors including Red 40 plus sodium benzoate. The effect was observed in the general population, not just children already diagnosed with ADHD. Because the study used a mixture of six dyes, it cannot isolate Red 40's individual contribution. EFSA reviewed this study in 2009 and concluded the evidence justified monitoring but could not attribute the effect to any single dye.

What foods contain Red 40?

Red 40 is common in breakfast cereals (Lucky Charms, Froot Loops), salty snacks (Doritos, Flamin' Hot Cheetos), candy (Hot Tamales, gummies, fruit chews), fruit-flavored preserves, sports drinks, sodas, flavored yogurts, and some processed meats. In Canada and the US, it must appear by name in the ingredient list, so searching for "Red 40" or "Allura Red" on a label will find it.

Is Red 40 made from bugs?

No. Red 40 is synthesized from petroleum-derived aromatic chemistry. The red dye derived from insects is Carmine (E120, cochineal extract), which is chemically unrelated to Red 40 and governed by entirely different regulations. The two are sometimes confused because both produce red or pink hues, but they are made differently, regulated differently, and have different allergen profiles. People with carmine sensitivity have no cross-reactivity with Red 40.

What is a natural alternative to Red 40?

Beet juice concentrate works well in ambient-temperature applications like yogurt and smoothies but fades with heat. Anthocyanins from black carrot or elderberry are more stable and work in acidic products like gummies and sodas. Paprika extract handles orange-red tones in savory applications. Lycopene from tomatoes produces an orange-red useful in some beverages. None of these are exact drop-in replacements for Red 40 across all uses, which is why reformulation typically requires both formula and process adjustment.

Why did the EU put a warning label on Red 40?

EU Regulation 1333/2008 mandated the warning label "may have an adverse effect on activity and attention in children" on foods containing any of six synthetic dyes including Red 40, following the 2007 Southampton study published in The Lancet. The label has applied to all EU and UK products containing these dyes since 2010. It is a disclosure requirement, not a prohibition.

Does Red 40 cause cancer?

No health authority (Health Canada, FDA, or EFSA) has concluded that Red 40 is carcinogenic to humans at dietary exposure levels. EFSA's 2009 reassessment found no carcinogenicity concern requiring a reduction in the ADI. Some advocacy groups including the Center for Science in the Public Interest (CSPI) have called for additional carcinogenicity studies based on older animal data, but these have not resulted in regulatory action. The current scientific consensus is that cancer risk at normal dietary exposure is not established.

Sources

1. McCann D, Barrett A, Cooper A, 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. November 3, 2007; 370(9598):1560-1567. DOI: 10.1016/S0140-6736(07)61306-3

2. Stevens LJ, Burgess JR, Stochelski MA, Kuczek T. "Amounts of artificial food colors in commonly consumed beverages and potential behavioral implications for consumption in children." Clinical Pediatrics. 2014 February; 53(2):133-140. DOI: 10.1177/0009922813502849

3. Stevens LJ, Burgess JR, Stochelski MA, Kuczek T. "Amounts of artificial food dyes and added sugars in foods and sweets commonly consumed by children." Clinical Pediatrics. 2015 April; 54(4):309-321. DOI: 10.1177/0009922814530803

4. Vojdani A, Vojdani C. "Immune reactivity to food coloring." Alternative Therapies in Health and Medicine. 2015; 21(Suppl 1):52-62. PMID: 25599186

5. EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources Added to Food). "Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive." EFSA Journal. 2009; 7(11):1108. DOI: 10.2903/j.efsa.2009.1108

6. California Legislature. AB 2316, California School Food Safety Act. Approved by Governor September 28, 2024. Effective December 31, 2027. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB2316

7. European Parliament and Council. Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. Official Journal of the European Union. December 16, 2008.

8. US Food and Drug Administration. 21 CFR Part 74, Section 74.340: FD&C Red No. 40. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-A/section-74.340

9. Health Canada. List 2: Colouring Agents That May Be Used as Food Additives. Food and Drug Regulations. https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/2-colouring-agents.html

10. UK Food Standards Agency. "Food colours and hyperactivity." FSA voluntary withdrawal request to manufacturers, 2008.

11. Open Food Facts database. Product entries for: Lucky Charms (0016000123991), Doritos Nacho Cheese (0028400516464), Cheetos Flamin' Hot (0028400589895), Hot Tamales (0070970474088), Smucker's Strawberry Preserves (0051500040423). https://world.openfoodfacts.org (accessed May 2026)

12. CSPI (Center for Science in the Public Interest). "Food Dyes: A Rainbow of Risks." Washington DC, 2010. https://www.cspi.org/resource/food-dyes-rainbow-risks

Last reviewed: May 2026

Frequently asked questions

Common questions about this ingredient.

Is Red 40 banned in Canada?

No. Red 40 (Allura Red AC) is not banned in Canada. It is a permitted food colour listed on Health Canada's List of Permitted Colouring Agents. Health Canada states there is no demonstrated human health risk at approved use levels. In 2025, the U.S. FDA announced plans to phase out petroleum-based synthetic dyes including Red 40 by the end of 2026. Health Canada has not followed that action and continues to permit Red 40 as of 2026.

Is Red 40 banned in any country?

Red 40 is not outright banned in any country that uses it, but it has faced significant restrictions. The European Union requires a warning label: 'may have an adverse effect on activity and attention in children' on any product containing Red 40. The UK's Food Standards Agency asked manufacturers to voluntarily remove six artificial dyes including Red 40 from food after the 2007 Southampton study. California became the first US state to ban Red 40 specifically from school meals and competitive foods sold on school campuses, effective December 31, 2027, under AB 2316 signed September 28, 2024.

What does Red 40 do to kids?

The most cited evidence comes from the McCann et al. 2007 trial published in The Lancet. The double-blind, randomized study found that children aged 3 and 8-9 who consumed a mixture of artificial food colors (including Allura Red) plus sodium benzoate showed measurably increased hyperactivity compared to placebo. The effect was observed in the general child population, not just children already diagnosed with ADHD. EFSA reviewed this and other studies in 2009 and concluded the findings could not be attributed to the dyes alone given the study's mixture design, but still noted the results were a reason for continued monitoring.

What foods contain Red 40?

Red 40 is found in a wide range of processed foods: breakfast cereals (Lucky Charms, Froot Loops), salty snacks (Doritos Nacho Cheese, Flamin' Hot Cheetos), candy (Hot Tamales, red gummy products), fruit-flavored preserves, sports drinks, sodas, flavored yogurts, and processed meats with red coloring. It also appears in some medications and cosmetics. In Canada and the US, the ingredient must be listed by name on food labels.

Is Red 40 made from bugs?

No. Red 40 (Allura Red AC) is synthesized from petroleum-derived compounds, specifically from coal tar or arachnoid naphthalenesulfonic acid chemistry. It has no insect-derived components. The dye sometimes confused with insect origin is Carmine (E120), which is extracted from cochineal scale insects. Carmine and Red 40 are entirely different compounds with different chemical structures and different regulatory profiles.

What is a natural alternative to Red 40?

Several plant-based alternatives produce red and pink shades. Beet juice concentrate (E162) gives a red-to-pink range but fades with heat. Anthocyanins from black carrot, elderberry, or red cabbage produce purplish reds stable in low-pH products. Lycopene from tomatoes gives an orange-red. Paprika extract (E160c) works for orange-red tones in savory products. These alternatives are generally considered more stable at low pH and are not subject to the EU's hyperactivity warning label requirement.

Why did the EU put a warning label on Red 40?

The EU warning label ('may have an adverse effect on activity and attention in children') was mandated by Regulation (EC) 1333/2008, driven largely by the 2007 Southampton study published in The Lancet. That trial found increased hyperactivity in children after consuming a cocktail of six artificial dyes including Red 40. The UK Food Standards Agency asked manufacturers to voluntarily phase out these dyes before the warning label became law. The label applies in the EU to any food or beverage containing one or more of six specific synthetic dyes: Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3.

Does Red 40 cause cancer?

Current regulatory consensus does not classify Red 40 as carcinogenic to humans. The FDA has set no carcinogenicity concern at approved use levels. EFSA's 2009 reassessment found no evidence requiring a change to the ADI on carcinogenicity grounds. Some animal studies have examined high-dose exposure, and the CSPI has called for further study, but no major health authority (Health Canada, FDA, or EFSA) has concluded that Red 40 causes cancer in humans at dietary exposure levels. This remains an area of ongoing scientific discussion.

Is Red 40 the same as Red Dye 40?

Yes. Red 40, Red Dye 40, FD&C Red No. 40, Allura Red AC, and E129 all refer to the same substance. The names differ by regulatory region and context, but they are chemically identical. The EU requires a warning label stating 'may have an adverse effect on activity and attention in children,' which the U.S. does not. You may also see 'Red 40 Lake,' which is the oil-dispersible aluminum salt form used in dry seasonings, coatings, and some medications.

What products use Red 40 in Canada vs. the U.S.?

Both the US and Canada approve Red 40 for use in food, beverages, and OTC medications under similar conditions. Health Canada's permitted food additives list allows it in the same product categories as the FDA's approval: fruit-flavored candy, cereals, beverages, gelatin desserts, maraschino cherries, and children's medications and vitamins. In Canada the dye is declared by its Canadian common name, 'Allura Red' (Health Canada also permits the form 'Allura Red (Red 40)'). Quebec requires a French ingredient declaration, so the French list shows 'rouge allura.' Neither country requires manufacturers to disclose the quantity, only the presence by name.

How much Red 40 is in a typical candy serving?

The exact amount is not on the label. Neither the FDA nor Health Canada requires quantity disclosure for color additives. The FDA's Acceptable Daily Intake is 7 mg per kilogram of body weight per day. A child weighing 25 kg has a daily ceiling of about 175 mg. A single candy serving typically falls below that, but a child who also drinks a dyed beverage, takes a flavored vitamin, and receives a colored liquid medication the same day is drawing from multiple sources simultaneously, with no individual label showing how much is in each item.

Is Red 40 in over-the-counter children's medication?

Yes. Red 40 is commonly used as a colorant in children's liquid medicines and chewable tablets, particularly fever reducers, antihistamines, and cough syrups. It appears in the inactive ingredient list. This creates a secondary exposure pathway most parents don't track: a child receiving ibuprofen or antihistamine syrup also gets Red 40 on top of any dietary intake that day. Dye-free formulations exist for most common children's OTC medications; look for 'dye-free' on the front of the package or check the inactive ingredient list for the absence of FD&C Red No. 40, Allura Red, or Allura Red AC.

Is the FDA phasing out Red 40?

Yes. In April 2025, the FDA and HHS announced a plan to eliminate petroleum-derived synthetic food dyes from the US food supply. Red 40 was included alongside Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 in a voluntary phase-out targeting end of 2026. This is not a ban: Red 40 remains approved under 21 CFR 74.340. Red 3 (erythrosine) had its food-use approval formally revoked separately in January 2025 under the Delaney Clause. Major manufacturers are pledging reformulation; the regulatory direction is clear even if the timeline is voluntary.