On April 22, 2025, the U.S. Food and Drug Administration (FDA) announced a forthcoming ban on several petroleum-based synthetic dyes from the American food supply, to take effect by the end of 2026.

The announcement was made by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, marking a pivotal shift in U.S. food policy aimed at public health protection1.

The dyes being phased out include FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 and Green No. 3. These synthetic colourants are commonly used across a variety of food categories, including baked goods, snacks and beverages.

Health and Policy Context

The FDA’s decision reflects mounting scientific and public concerns over the safety of artificial food dyes, especially in relation to children's health. Dr. Makary stated,

“Today, the FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada. We have a new epidemic of childhood diabetes, obesity, depression, and ADHD. Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children” 2.

This position aligns with a growing body of evidence suggesting potential behavioural and developmental effects of synthetic dyes, particularly in children. Red No. 3 (erythrosine), which had already been banned from cosmetics in the U.S. due to cancer risks in animal studies, is among those now being removed from foods as well.

Impact on European Producers

Although the regulation directly targets the U.S. market, the implications are relevant for food manufacturers in Europe:

• Market Compliance: Companies exporting to the U.S. will need to reformulate affected products. This may not require major changes for many European producers, given that several of these dyes are already restricted or banned in the EU.

  
  

• Supply Chain Ripple Effects: Changes in demand and availability of food-grade colorants may affect international suppliers, possibly influencing ingredients used in products within the European Economic Area.

  
  

• Unified Standards and Expectations: With the U.S. moving closer to EU norms, the change could accelerate a global trend toward more harmonised standards for food additives, which may simplify compliance for transatlantic producers over time.

  
  

• Public Perception: The FDA’s move may also impact consumer expectations across Europe. Food retailers and brand owners might increasingly favour dye-free or naturally coloured products to pre-empt consumer concerns, even in jurisdictions without new regulations.

  
  

The European Framework

Europe’s regulatory stance on synthetic dyes is already strict. Regulation (EC) No 1333/2008 governs the use of food additives in the EU and EFSA has re-evaluated many synthetic dyes, including Allura Red (E129), adjusting acceptable intake levels accordingly 3, 4. Certain dyes, including Red No. 3, are banned outright, while others require clear labelling such as: “may have an adverse effect on activity and attention in children.”

This puts many European manufacturers in a comparatively strong position. Nevertheless, the FDA’s timeline adds urgency for those still using synthetic dyes in exports or for brands operating in multiple jurisdictions.

Looking Ahead

As U.S. regulators call for reformulation, many in the industry are turning to natural alternatives like beetroot, spirulina, turmeric and butterfly pea flower. While these can pose technical challenges—such as variability in colour stability and cost—they are increasingly viable and align with the rising consumer demand for clean-label foods.

For producers already operating under EU regulations, this could present an opportunity to strengthen market position globally. Early and transparent communication around reformulation efforts can also build trust with both regulators and consumers.

References:

[1] U.S. Food and Drug Administration. (2025). FDA Announces Phase-Out of Petroleum-Based Synthetic Dyes. https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply

[2] Reuters. (2025). U.S. to Phase Out Many Synthetic Food Dyes, FDA Commissioner Says. https://www.reuters.com/business/healthcare-pharmaceuticals/us-phase-out-many-synthetic-food-dyes-fda-commissioner-says-2025-04-22/

[3] European Commission. (2008). Regulation (EC) No 1333/2008 on food additives.

[4] EFSA. (2021). Re-evaluation of Allura Red AC (E129) as a food additive. EFSA Journal. https://www.efsa.europa.eu/en/efsajournal/pub/6234