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Is E127 Safe to Use? Understanding the Facts and Global Regulations

4 min read

In January 2025, the US FDA officially banned the food colorant E127, also known as Red Dye No. 3, citing evidence that it caused thyroid tumors in animal studies. This recent action highlights a long history of debate and shifting global regulations surrounding the safety of this common synthetic dye.

Quick Summary

E127 (Erythrosine/Red Dye No. 3) is a synthetic colorant with varied global regulations due to health concerns. Recent US bans and longstanding EU restrictions exist over links to thyroid issues and hyperactivity, though its use persists in some products and countries.

Key Points

  • FDA Ban: In January 2025, the US FDA banned E127 (Red Dye No. 3) from food, supplements, and oral medications due to links with cancer in animal studies.

  • Global Restrictions: Many countries, including the EU, Australia, and Canada, have significantly restricted or banned E127's use, especially in food.

  • Thyroid Risks: E127 has been linked to thyroid dysfunction and tumors in animal studies due to its iodine content and interference with thyroid hormone regulation.

  • Behavioral Concerns: In regions like the EU, products containing E127 must carry a warning label about potential effects on hyperactivity in children.

  • Check Labels: Consumers can avoid E127 by reading labels for "E127," "Erythrosine," or "FD&C Red No. 3" and choosing products with natural alternatives like beetroot extract.

In This Article

What is E127 (Erythrosine)?

E127, more commonly known as Erythrosine or FD&C Red No. 3 in the United States, is a synthetic, iodine-based red colorant that imparts a distinctive pink-red hue. For decades, it has been widely used to color a variety of products, from candied fruits and gelatin desserts to pharmaceuticals and cosmetics. Chemically, it belongs to the xanthene class of dyes, which are known for their vibrant and stable color properties. Its use has been controversial for years, leading to a complex patchwork of regulations worldwide.

The Global Regulatory Landscape for E127

Regulation of E127 varies significantly depending on the country, reflecting differing interpretations of scientific evidence on its safety. The following list outlines some major regulatory stances:

  • United States: Historically, the FDA approved E127 for food use but banned it from cosmetics and externally applied drugs in 1990 due to animal studies linking it to thyroid tumors. In a landmark decision, the FDA announced a nationwide ban on its use in all foods, dietary supplements, and oral medications in January 2025. This ban will be phased in, with manufacturers having until early 2027 for food products and 2028 for oral medications to comply.
  • European Union (EU): The EU has taken a more restrictive approach for a longer period. Since 1994, the use of E127 has been heavily limited to only a few products, such as glacé cherries, candied cherries, and certain decorative items. Products containing E127 within the EU must also carry a warning label indicating its potential effects on children's activity and attention.
  • United Kingdom (UK): Following a similar path to the EU, the UK also restricts E127 use to limited items like preserved cherries and decorative fruits. UK food labels must also provide the hyperactivity warning.
  • Other Countries: Many other nations have also banned or restricted the use of Erythrosine. For instance, countries like Norway, Japan, Australia, and Canada have significant restrictions or outright bans in place. Conversely, some countries, including India, still allow its use in a wider range of food products.

Key Health Concerns Associated with E127

Scientific studies have raised several health concerns regarding E127, which have driven regulatory action globally:

Thyroid Issues and Cancer Risk

One of the most significant concerns stems from animal studies demonstrating a link between high doses of Erythrosine and thyroid tumors in rats. E127 is known to interfere with the thyroid gland's ability to absorb iodine, a crucial element for producing thyroid hormones. This mechanism, coupled with evidence of increased tumor formation in rodents, was a key factor in the US FDA's recent ban under the Delaney Clause. While the relevance of these high-dose animal studies to typical human exposure levels has been debated, it demonstrates a potential risk.

Hyperactivity in Children

Multiple studies, including research published in The Lancet, have indicated a link between synthetic food dyes and behavioral issues, such as hyperactivity and attention deficits, in some children. This has prompted mandatory warning labels on products containing E127 in the EU and UK and has been a driving factor for consumer advocacy groups in other regions.

Other Potential Side Effects

Though less common, other adverse effects have been reported. Some individuals may experience increased photosensitivity, a dermatological condition where the skin is overly sensitive to sunlight. In high concentrations, E127 has also been linked to potential carcinogenic and mutagenic effects, though typical food consumption levels are unlikely to reach such concentrations.

Comparison of E127 vs. Natural Alternatives

Feature E127 (Erythrosine) Natural Red Alternatives
Source Synthetic, iodine-based dye Plant-based (beetroot, cabbage), insect-based (carmine)
Safety Status Controversial; banned/restricted in many countries Generally considered safer, fewer reported risks
Application Wide use in processed foods, pharmaceuticals, cosmetics Used in food, often in products appealing to health-conscious consumers
Color Stability Highly stable and vibrant Can be less vibrant or stable under certain conditions (heat, light)
Regulatory Status Heavily restricted or banned in many regions (e.g., US, EU) Widely permitted, with varying specific regulations based on source
Potential Health Concerns Linked to thyroid issues, hyperactivity, potential carcinogen Few to none at normal intake levels; some may cause allergic reactions (e.g., carmine)

How to Avoid E127

Given the varied regulations and ongoing safety debates, many consumers opt to avoid Erythrosine altogether. Here are some simple steps to take:

  • Read ingredient labels carefully. Look for the term “E127,” “Erythrosine,” or “FD&C Red No. 3” in the ingredients list on packaged food products.
  • Choose products with natural colorants. Many brands now use plant-derived alternatives for coloring. Look for natural sources like beetroot extract (E162), anthocyanins (E163), or carmine (E120), if suitable.
  • Support brands committed to cleaner labels. Many companies are proactively removing artificial colors from their products in response to consumer demand.

Conclusion: The Final Verdict on E127 Safety

While regulatory bodies like the European Food Safety Authority (EFSA) have historically maintained that E127 is safe at regulated, low levels of exposure, the increasing evidence and subsequent actions by the US FDA point toward a growing trend of caution. For consumers, especially those with children or pre-existing thyroid conditions, the precautionary principle suggests that minimizing or avoiding E127 is the safest approach. The availability of effective natural alternatives further diminishes the need for this controversial synthetic dye in most products, allowing consumers to make more informed and health-conscious choices.

Read more about the FDA's Red Dye No. 3 ban here

Frequently Asked Questions

The US FDA banned E127 based on scientific evidence showing it caused thyroid tumors in laboratory animals. This action was mandated under the Delaney Clause, which prohibits the use of any additive found to cause cancer in humans or animals.

No, the regulation of E127 varies globally. While it is banned for food use in the US and heavily restricted in the EU, UK, Australia, and Canada, it is still used more widely in some other countries, like India.

Health concerns linked to E127 include potential thyroid issues (tumors, dysfunction), increased hyperactivity and attention deficits in children, and, in high doses, possible carcinogenic and mutagenic effects. Photosensitivity has also been reported.

Common natural alternatives to achieve a red color include beetroot extract (E162), berry anthocyanins (E163), and carmine (E120), a dye derived from cochineal insects. Some companies are also shifting to alternative plant-based sources.

You can check a product's ingredient list for "E127," "Erythrosine," or "Red No. 3." In regions with restrictions, its use is limited, but reading labels is the most reliable way to know for sure.

Yes, but its use is very limited. The EU permits E127 only in specific items like cocktail cherries, candied cherries, and certain decorative applications. A warning label is also required on these products.

Yes, the US FDA banned Erythrosine (Red Dye No. 3) for use in cosmetics and externally applied drugs much earlier, in 1990, due to concerns about its carcinogenic potential from animal studies.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.