Why is Red 40 banned in some countries but permitted in others?

January 9, 2026 •

3 min read

In 2007, a study conducted at the University of Southampton found that a mixture of artificial food colorings and a common preservative could increase hyperactivity in children. These findings are a key reason why Red 40, also known as Allura Red AC, has been banned or restricted in some countries but not in others. The global discrepancy in regulating this common food dye highlights significant differences in scientific interpretation and regulatory philosophies.

Quick Summary

Differing scientific interpretations and regulatory approaches globally have led to some nations banning or restricting Red 40 due to links to hyperactivity and allergies, while others deem it safe within limits.

Key Points

Regulatory Discrepancies: The reason Red 40 is banned or restricted in some countries stems from differing interpretations of scientific studies and regulatory philosophies between national health bodies.
Hyperactivity Concerns: Evidence, notably from the 2007 Southampton study, linked Red 40 to increased hyperactivity in some children, leading to mandatory warning labels in the EU.
Allergic Reactions: Red 40 can cause allergic-like symptoms in sensitive individuals, including rashes and hives, contributing to caution in various regulatory bodies.
Precautionary Principle vs. Evidence: European regulators often apply a precautionary principle, while the U.S. FDA requires conclusive proof of harm before banning an additive.
Natural Alternatives: In markets with strict regulations, food manufacturers commonly substitute Red 40 with natural colorings derived from sources like beetroot and fruit extracts to achieve a red hue.
Global Market Impacts: The varying regulations mean that multinational food companies must produce and label their products differently for different international markets.

The Controversies Behind Red 40

Red 40, or Allura Red AC, is a synthetic food dye derived from petroleum used to color many processed foods, beverages, and cosmetics red. Its safety is debated, leading to varied regulations globally. Concerns include behavioral issues in children, potential allergic reactions, and possible links to carcinogens, though scientific consensus is not universal.

Hyperactivity and The Southampton Study

The 2007 University of Southampton study is significant, investigating the link between synthetic food dyes, including Allura Red, and children's behavior. The study indicated increased hyperactivity in children consuming a mix of six food dyes. While the FDA reviewed this evidence and did not find conclusive proof for the general population, it prompted action elsewhere. The European Union mandated a warning label on products with these dyes: “May have an adverse effect on activity and attention in children”. This led many European manufacturers to reformulate products to avoid the label.

Potential Allergies and Sensitivities

Red 40 may cause allergy-like symptoms in sensitive individuals, such as hives and rashes. Though usually mild and rare, these potential reactions contribute to regulatory caution in some countries.

Differing Regulatory Philosophies: A Global Divide

Varied regulations for Red 40 stem from different approaches to food safety. The U.S. FDA requires conclusive evidence of harm to ban an additive and considers Red 40 safe within limits. The European Union and others often use the "precautionary principle," taking action against potential harm without definitive proof. This philosophical difference explains why products are formulated differently for different markets.

Comparison of Red 40 Regulations


Aspect	United States (FDA)	European Union (EFSA)	Norway & Austria (Previously)
Regulatory Stance	Approved as safe for use within specified limits.	Approved, but requires warning labels on products.	Previously banned; restrictions since harmonizing with EU.
Precautionary Principle	Generally not applied; relies on proven harm.	Employed, leading to mandatory warning labels.	Historically employed, resulting in outright bans.
Labeling	Must be listed as 'Red 40' or 'Color Added'.	Must list as 'Allura Red' (E129) and include a hyperactivity warning.	Follows EU labeling requirements for Allura Red.
Rationale	Safe based on available scientific data; no conclusive link to harm.	Concerns about potential effects on children's behavior, informed by the Southampton study.	Historically based on broader concerns about synthetic colorings and the precautionary principle.

Countries with Red 40 Restrictions

Many countries have restricted or require stringent labeling for Red 40. This includes:

Norway: Previously banned synthetic colors, now aligns with EU warning label rules.
Austria: Similarly lifted a ban to align with EU standards, with strict labeling.
Finland, France, United Kingdom: Follow EU directives, requiring warning labels.

Natural Alternatives to Red 40

Due to restrictions and controversy, companies use natural red colorings derived from fruits, vegetables, and other sources. These include:

Beetroot juice
Anthocyanins from berries, grapes, or red cabbage
Lycopene from tomatoes
Annatto extract

Conclusion: A Continuous Global Debate

The differing regulations for Red 40 show how scientific interpretation, public opinion, and regulatory approaches vary globally. While the FDA finds it safe, the EU and others are more cautious. This leads manufacturers to reformulate products for different markets, often using natural colorings. The debate over synthetic dyes like Red 40 will likely continue to influence food production and regulation as consumer awareness grows. To learn more about EU food additive regulations, visit the European Food Safety Authority.

Frequently Asked Questions

While Red 40 is not universally banned, countries like Norway and Austria have previously had strict bans or restrictions on synthetic food dyes. Though some of these regulations have aligned with EU standards, many manufacturers still opt for natural alternatives in these markets.

No, the European Union has not issued a complete ban on Red 40. However, it requires products containing the dye to carry a warning label stating, “May have an adverse effect on activity and attention in children”.

The U.S. FDA permits Red 40 because its scientific reviews have determined the dye is safe for consumption when used within regulated limits. The FDA has not found conclusive evidence to justify a ban.

The main concern is the potential link between Red 40 and increased hyperactivity and behavioral problems in sensitive children, a finding supported by studies like the 2007 Southampton study.

The precautionary principle is a regulatory approach that takes action against a potential harm even without definitive proof. European countries used this principle to require warning labels on Red 40-containing products, unlike the US approach which demands stronger evidence.

Yes, many natural alternatives are available, including beet juice, anthocyanins (from berries or grapes), and lycopene (from tomatoes). These are often used by manufacturers catering to markets with stricter regulations.

While some animal studies have raised concerns about carcinogenic potential in other food dyes, and some initial studies mentioned this possibility for Red 40, no conclusive research has established a direct link to cancer in humans.