A Regulatory Perspective on the Ban of Red Dye No. 3

By Elizabeth Valdes

Imagine reaching for your favorite snack, only to find out that one of its key ingredients has just been banned. That’s exactly what’s happening with Red Dye No. 3—a synthetic food colouring long used in candies, snacks, and processed foods. After years of controversy and mounting health concerns, regulators have finally pulled the plug. But why now? And what does this mean for the future of food safety? Let’s dive into the details behind the ban of Red 3 and what it could mean for your grocery cart.

Synthetic food dyes have been widely used in food, pharmaceuticals, and cosmetics to enhance visual appeal. Among them, Red Dye No. 3 has been particularly controversial due to its suspected adverse health effects. Regulatory agencies worldwide have evaluated its safety, leading to varied restrictions and outright bans. The  U.S. Food and Drug Administration (FDA) claims that the chemical must be banned from all foods as early as 2027.

Regulatory History and Actions
The FDA banned the use of Red 3 in cosmetics and externally applied drugs in 1990 after animal studies linked it to thyroid tumours in rats. However, its continued use in food and oral medications remains contentious. Other regulatory agencies, such as the European Food Safety Authority (EFSA) and the World Health Organization (WHO), have also reviewed its safety, leading to different regulatory stances. The contrast in these decisions highlights gaps in risk assessment methodologies and policy enforcement.

Health Risks

As previously mentioned, research has demonstrated an association between Red 3 exposure and an increased incidence of thyroid tumours in rodent models. A 1989 National Toxicology Program (NTP) study found a significant dose-dependent increase in thyroid follicular cell adenomas in male rats exposed to Red 3. Although direct human carcinogenicity remains unconfirmed, the mechanistic pathways suggest a plausible risk. Some studies indicate that synthetic dyes, and therefore Red 3, may exacerbate hyperactivity and attention-deficit symptoms in children. Additionally, a 2007 study by McCann et al. in The Lancet also found that synthetic food dyes contributed to increased hyperactivity in children, prompting calls for regulatory reassessment. Preliminary studies suggest potential endocrine-disrupting properties. Lastly, a 2013 study published in Toxicology in Vitro reported that Red 3 could interfere with thyroid hormone homeostasis by affecting iodine uptake and thyroid-stimulating hormone (TSH) levels in cultured cells, ultimately leading to further toxicological evaluations.

Alternatives and Industry Adaptation
With increasing consumer demand for natural additives, industries are exploring replacements such as beetroot extract, carmine, and anthocyanins. However, cost implications, stability issues, and allergenic potential pose challenges to complete substitution. The evidence supporting the ban of Red 3 in certain applications underscores the need for more stringent regulatory oversight. The continued presence of Red 3 in consumables raises concerns regarding long-term exposure risks, particularly in vulnerable populations such as children. Public advocacy for cleaner food labels and regulatory harmonization could drive policy shifts towards safer alternatives.

References:

McCann, D., Barrett, A., Cooper, A., Crumpler, D., Dalen, L., Grimshaw, K., … & Stevenson, J. (2007). Food additives and hyperactive behavior in 3-year-old and 8/9-year-old children in the community: a randomized, double-blinded, placebo-controlled trial. The Lancet, 370(9598), 1560-1567.

National Toxicology Program (1989). Toxicology and carcinogenesis studies of Erythrosine (FD & C Red No. 3) in F344/N rats and B6C3F1 mice (feed studies). NTP Technical Report Series, 378.

EFSA Panel on Food Additives and Nutrient Sources added to Food (2011). Scientific opinion on the re-evaluation of Erythrosine (E127) as a food additive. EFSA Journal, 9(1), 1854.

Lohner, S., Toews, I., & Meerpohl, J. J. (2020). Health effects of food dyes: A systematic review. Deutsches Ärzteblatt International, 117(3), 19-26.

Poul, M., Jarry, G., Elhkim, M. O., & Poul, J. M. (2009). Lack of genotoxic effects of food dyes Erythrosine and Tartrazine in the intestine of mice. Food and Chemical Toxicology, 47(2), 443-448.

Axelstad, M., Boberg, J., Hougaard, K. S., Christiansen, S., Jacobsen, P. R., & Mandrup, K. (2013). Effects of prenatal exposure to Erythrosine on thyroid hormone homeostasis in rats. Toxicology in Vitro, 27(1), 84-91.

Edited by: Sofía Oural Martínez