In light of the news of the FDA’s ban on Red Dye 3, we’ve decided to deep dive into its cousin, Red Dye 40.
Red Dye 40, also known as Allura Red AC, is a synthetic petroleum-derived food colouring agent widely used in the food and nutraceuticals industry. It is a substance created through chemical reactions involving sulphonic acids and typically comes in the form of a dark red powder or small granules that can be dissolved in water and other solutions.
Common uses of Red Dye 40
Red Dye 40 is probably more common than most expect. The colourant was first developed in 1971 by the Allied Chemical Corporation as a replacement for amaranth (Red 2) in the United States. The popularity of Red Dye 40 grew rapidly after its introduction and by 1980, annual production of Allura Red AC exceeded 2.3 million kilograms. The European Union approved Red Dye 40 in 1994 and it has since become the most commonly used red dye in the United States, completely replacing amaranth (Red 2) and largely replacing erythrosine (Red 3) in most applications.
The rapid adoption of Red Dye 40 can be attributed to its versatility, stability, and the fact that it was developed as a ‘safer alternative’ to previously used red dyes. Its widespread use in various products, from candy and cereals to medications and cosmetics, has made it a ubiquitous colouring agent in the FnB industry.
Used to add colour to various products, including
- Gelatins and puddings
- Beverages (alcoholic and non-alcoholic)
- Dairy products
- Baked goods
- Candies and sweets
- Condiments
- Processed meats and poultry
- Medications and cosmetics
- Arts and crafts supplies like crayons and markers
Listed on ingredient labels in several ways:
- Allura Red AC
- FD&C Red No. 40
- Red 40
- Red 40 Lake
- FD&C Red No. 40 Aluminum Lake
- CI Food Red 17
- INS No. 129
- E129
Why are consumers concerned about Red Dye 40?
Since its inception in the 70’s, Red Dye 40 has undergone significant scientific testing, uncovering a staggering amount of evidence that show the potential harmful impacts of consuming this synthetic colourant.
A 2021 report from the state of California indicated that children consuming synthetic food dyes, including Red Dye 40, can experience hyperactivity and other neurobehavioral issues. The mechanisms behind these effects may include:
- Depletion of minerals crucial for growth and development, such as zinc and iron
- Chemical changes in the brain
- Hypersensitivity leading to allergic reactions and inflammation
A 2024 study published in PMC found that sensitivity to processed colour additives is not exclusive to children with Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Even children without pre-existing behavioural disorders may also manifest neurobehavioural abnormalities when consuming synthetic dyes. Ongoing research at Ohio State University suggests that food dyes can make some children and teens hyperactive, moody, or irritable.
Red Dye 40 also contains benzene, a known carcinogen. Another 2024 study found that Red Dye 40 specifically has been linked to kidney, stomach, and lung diseases, as well as anemia.
Last year, the Office of Environmental Health Hazard Assessment (OEHHA) conducted a comprehensive peer-reviewed assessment integrating evidence from 27 clinical trials in humans and various animal studies. They concluded that:
- Synthetic food dyes, including Red Dye 40, can cause harmful neurogological effects, particularly in children.
- The FDA’s current “safe levels” or Acceptable Daily Intakes (ADIs) are inadequate to protect children from these harmful effects.
It’s hard to deny the impacts of these extensive studies and especially considering the FDA ban of Red Dye 3, we can predict that Red Dye 40 will soon be added to the list of no-go colourants.
As of February 2025, Red Dye 40 is not universally banned in any country. However, its use is restricted or regulated in several nations:
- Norway, Germany, Denmark, Switzerland, Sweden, France, Austria, and Belgium have previously banned or restricted its use.
- The European Union requires products containing Red 40 to carry a warning label stating that it may affect attention in children.
- In the United States, California has passed legislation to ban Red Dye 40 in schools starting December 31, 2027.
Natural alternatives to Red Dye 40
Colouring foodstuffs are clean label ingredients that naturally impart colour to food, beverages, dietary supplements and nutraceuticals. They are produced from edible fruits, vegetables, flowers, algae, and spices through simple processing methods that do not involve chemical or solvent extraction of pigments. These ingredients are primarily concentrated juices made from high-quality raw materials, which are standardised for colour and carefully processed into various formats.
Several natural colouring foodstuffs can replace Red Dye 40 in food, beverages, and medications:
- Beet juice and beet powder: A vibrant red colour and are widely used in various products.
- Pomegranate juice: A deep red hue and is rich in antioxidants.
- Hibiscus: Dried hibiscus flowers contain anthocyanins, which provide a deep red when steeped in water.
- Carmine: Derived from cochineal insects, but is not suitable for vegetarian or vegan products.
- Paprika: This spice can provide a reddish-orange hue.
- Fruit and vegetable-based dyes: These include extracts from cherries, cranberries, and strawberries.
- Purple corn: Givaudan Sense Colour has developed a corn-derived anthocyanin colour called Amaize Orange-Red, which closely matches Red Dye 40.
- Lycopene: A pigment, found in tomatoes and other red fruits.
- Annatto: While more orange than red, it can be used in combination with other natural colourants.
The industry is under extreme pressure to adapt their product formulations to appeal to the more discerning customer. The key to success is how brands will adapt to this ‘clean’ new world.
Future-proof your product lines with expert regulation and compliance services
The clock is ticking. By January 15, 2027, Red Dye 3 (erythrosine) will be off the table for food products, followed by a ban on ingested drugs a year later. The FDA’s decision, driven by studies linking this dye to increased thyroid cancer risk, marks a significant shift in the regulatory landscape.
Don’t let this change catch you off guard. The transition to alternative colourants requires careful planning, formulation expertise, and a deep understanding of regulatory compliance.