In 2025, the United States officially banned the use of Red Dye #3 (Erythrosine) in food products, marking a significant step toward stricter ingredient regulations. The decision follows decades of scientific research linking the synthetic dye to potential health risks, including carcinogenicity in animal studies. However, the new food ban does not yet extend to cosmetics or personal care products, raising questions about regulatory inconsistencies and how the U.S. compares to other countries like the European Union and Australia.

Let’s delve into the current status of Red Dye #3 in food and cosmetics, exploring global regulations and the ongoing safety debate.

What is Red Dye #3?

Red Dye #3, or Erythrosine, is a synthetic color additive derived from petroleum. It has been widely used in foods, pharmaceuticals, and cosmetics to provide a bright cherry-red hue. Historically, it has appeared in products like:

• Foods: Candies, baked goods, and frozen desserts.
• Cosmetics: Lipsticks, blushes, nail polishes.
• Medications: Coatings for pills and syrups.

Despite its vibrant appeal, Red Dye #3 has been the subject of controversy for decades due to studies suggesting its potential health risks.

Red Dye #3 in Food: The U.S. Ban

The 2025 Food Ban

The U.S. Food and Drug Administration (FDA) announced the prohibition of Red Dye #3 in food products starting in 2025. This decision aligns with growing concerns over the dye’s links to cancer in animal studies. In fact, Red Dye #3 was already prohibited in some uses (like cosmetics applied near the eyes) after being flagged as a carcinogen in 1990.

Key Reasons for the Ban:

1. Carcinogenicity: Studies have shown that Red Dye #3 can cause thyroid tumors in rats, prompting calls for stricter regulation.
2. Advocacy Pressure: Consumer advocacy groups like the Environmental Working Group (EWG) have lobbied for years to remove synthetic dyes linked to health risks.
3. Global Trends: The move reflects increasing international pressure to align U.S. regulations with stricter global standards.

Despite this progress, the FDA’s decision has not yet addressed Red Dye #3’s use in cosmetics and personal care products.

Red Dye #3 in Cosmetics: The Regulatory Gap

While the U.S. ban on Red Dye #3 in food is a milestone, the dye remains approved for use in cosmetics, such as lipsticks, blushes, and nail polishes. The FDA’s stance is that cosmetic formulations differ significantly from food products, often involving external rather than internal exposure.

Why the Gap?

1. Safety Evaluation: The FDA evaluates color additives in cosmetics separately from food. For now, Red Dye #3 is considered safe in cosmetics under specific conditions.
2. Exposure Levels: Proponents argue that the amount of Red Dye #3 in cosmetics is minimal and does not pose significant health risks compared to ingestion.
3. Regulatory Lag: Changes to cosmetic regulations often trail food updates due to separate testing and approval processes.

Europe: A Strict Approach

The European Union (EU) has long been a global leader in stringent cosmetic regulations. Under the EU Cosmetics Regulation (Regulation (EC) No 1223/2009):

• Red Dye #3 is banned in all cosmetics.
• The EU bases bans on comprehensive safety data, often erring on the side of caution to protect consumers.

This strict stance contrasts sharply with the U.S., where Red Dye #3 remains permissible in many non-food products. The EU’s precautionary principle—restricting ingredients with any significant safety concerns—has positioned it as a global model for cosmetic safety.

Other Countries: Global Regulations on Red Dye #3

Australia

• Food: Red Dye #3 is restricted or banned due to potential health risks.
• Cosmetics: Permitted in limited quantities, but safety concerns mirror those in the U.S.

Canada

• Food and Cosmetics: Red Dye #3 is allowed but closely monitored. Recent advocacy efforts aim to push for stricter regulations in line with the EU.

Japan

• Food and Cosmetics: Red Dye #3 faces restrictions due to health concerns. Japanese regulations emphasize consumer safety and often align with EU standards.

Key Differences: U.S. vs. EU and Beyond

Why Cosmetic Regulations Matter

The distinction between food and cosmetic regulations raises important questions about consumer safety. Skin is the body’s largest organ, and while not all topical applications are absorbed into the bloodstream, studies suggest that certain ingredients—especially those used near sensitive areas like the lips—can penetrate the skin barrier.

With Red Dye #3 linked to health risks in food, the rationale for its continued use in cosmetics is increasingly scrutinized. Advocacy groups argue for harmonizing U.S. regulations with EU standards to eliminate potential exposure risks.

What’s Next for Red Dye #3?

The 2025 U.S. food ban is a significant first step, but it’s unlikely to be the last word on Red Dye #3. Key developments to watch include:

1. Cosmetic Safety Reviews: Advocacy groups are urging the FDA to re-evaluate Red Dye #3’s safety in cosmetics, particularly lip products.
2. Global Harmonization: Pressure is mounting for the U.S. to align with EU standards, banning Red Dye #3 across all product categories.
3. Consumer Awareness: As consumers become more informed, demand for "clean beauty" products free of synthetic dyes like Red Dye #3 is growing.

Conclusion

The U.S. ban on Red Dye #3 in food is a welcome step toward improved ingredient safety, but the regulatory gap for cosmetics highlights ongoing challenges in consumer protection. As other countries, particularly in the EU, adopt stricter bans, the U.S. and others may face increasing pressure to follow suit.

By understanding the global landscape of Red Dye #3 regulations, consumers can make more informed decisions about the products they use. Whether choosing food, cosmetics, or personal care items, prioritizing safety and transparency remains key to a healthier future. Be sure to check the labels.

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Cindy Barberes, the founder of H. Honeycup, encourages self-care and a giving community. She prefers a relaxed culture, which translates to her plant-based body care products. As a family affected by addiction, H. Honeycup donates products to those in recovery, hoping to help heal body and mind naturally.