What is Erythrosine?
Erythrosine, also designated as FD&C Red No. 3 or E127 in the European Union, is a synthetic food colouring derived from petroleum. For decades, it has been used to impart a vibrant cherry-red or pink hue to a wide array of products. Its bright, stable colour made it a popular choice for manufacturers seeking to enhance the visual appeal of their goods. Before the recent changes, it was commonly found in items such as candied cherries, cake decorations, cereals, popsicles, gelatin desserts, and various candies. Erythrosine has also been used to colour certain medications, especially in syrup or tablet form.
The Long History of Safety Concerns
Despite its widespread use, the safety of erythrosine has been a subject of regulatory scrutiny for many years. Initial concerns emerged from animal studies, which linked high doses of the dye to thyroid issues and carcinogenic effects.
- Thyroid Dysfunction: Because erythrosine contains iodine, studies have shown that high consumption can disrupt thyroid hormone regulation. In rats, this led to increased thyroid-stimulating hormone (TSH) levels, and long-term hyperstimulation was associated with benign thyroid tumors in some studies. While differences in thyroid physiology exist between humans and rats, the effect raised significant regulatory questions.
- Cancer Risk: The potential for carcinogenicity was a major driver for re-evaluations. In 1990, the FDA banned erythrosine from cosmetics and topical drugs after it was shown to cause cancer in male rats, citing the Delaney Clause. However, the ban was not extended to food at that time, leading to a long period of regulatory inaction.
- Behavioral Effects: Some research has also indicated potential links between erythrosine and behavioural issues in children, such as hyperactivity and ADHD-like symptoms. This is thought to be a result of the dye interfering with neurotransmitter function and causing oxidative stress in the brain.
The US FDA Bans Erythrosine
After years of advocacy from public health groups like the Center for Science in the Public Interest, the FDA finally moved to ban Red No. 3 in January 2025. The decision was based on decades-old animal studies that met the statutory test for delisting the additive. The ban applies to all foods, dietary supplements, and ingested drugs.
Manufacturers have been given a grace period to reformulate their products to remove the additive and find safe alternatives:
- Foods: Must comply by January 15, 2027.
- Ingested Drugs: Must comply by January 18, 2028.
International Regulations: A Comparison
Regulatory bodies across the globe have adopted different stances on erythrosine, reflecting varying interpretations of the scientific data. This comparison table highlights some of the key differences.
| Aspect | United States (Pre-2025) | United States (Post-2025) | European Union (E127) | Canada | Other Countries (e.g., Australia/NZ) |
|---|---|---|---|---|---|
| Status | Approved for food/drugs, banned in cosmetics | BANNED in all food and ingested drugs | Restricted to specific uses (e.g., cherries) | Permitted at set levels, deemed safe by Health Canada | Permitted with low ADI (Australia/NZ), some bans elsewhere |
| Carcinogen Concerns | Acknowledged potential based on rat studies | Found to meet threshold for ban based on rat studies | Acknowledged but deemed of limited human relevance | Deemed low risk at regulated levels | Deemed of limited human relevance |
| Acceptable Daily Intake (ADI) | Based on previous assessments | N/A (Banned) | Set at 0-0.1 mg/kg bw per day | Based on regulatory assessment | Set at 0-0.1 mg/kg bw per day |
Alternatives to Erythrosine
With manufacturers in the US required to reformulate their products, the focus is shifting towards natural and safer synthetic alternatives. Examples of potential replacements include:
- Beetroot Red (E162): A natural, vibrant red colour derived from beets.
- Anthocyanins (E163): Pigments extracted from plants like grapes and berries, which produce a range of red to purple colours.
- Lycopene (E160d): A red carotenoid pigment from tomatoes.
- Red No. 40 (Allura Red): Another synthetic azo dye. While still approved federally in the US, it has its own controversies and was banned in California public schools in 2025.
Making Informed Choices as a Consumer
For consumers concerned about food additives, especially in countries where erythrosine is still permitted or during the US transition period, it is crucial to read ingredient labels carefully. Look for "Erythrosine," "FD&C Red No. 3," or "E127" on the label. This vigilance allows individuals to consciously avoid products containing the dye if they wish.
Conclusion
The question, "Is erythrosine colour safe to consume?" has a more definitive answer in the US following the recent FDA ban. While opinions and regulations vary globally, the US FDA's decision underscores serious long-standing concerns about its safety, primarily linked to older animal studies suggesting carcinogenic effects and thyroid disruption. For US manufacturers, the path forward is clear: find alternatives before the compliance deadlines in 2027 and 2028. For consumers everywhere, the action serves as a powerful reminder to stay informed about food additives and prioritize products with natural ingredients. As regulators worldwide continue to evaluate food additive safety, consumer awareness remains a key factor in driving industry change and promoting public health.
