The Growing Importance of Food Coloring in Product Development
Whether you're involved in product development, quality assurance, or ingredient sourcing, chances are you’ve encountered the topic of food coloring more than once. In the U.S., food color additives play a central role in how consumers perceive and experience products, particularly in categories like snacks, beverages, baked goods, and confectionery. However, the FDA announced in April 2025 it was planning on phasing out petroleum-based synthetic food dyes (FDA, 2025c). With growing scrutiny from regulators, in addition to advocacy groups and consumers, it's important for food ingredient professionals to understand what’s in their color palette.
Understanding Color Additives Under U.S. Regulations
In U.S. regulatory jargon, food colors are called color additives. Section 201(t) of the Federal, Drug, and Cosmetic Act defines color additive as a substance intended to color food, drugs, or cosmetics. They fall into two main regulatory categories: certified (synthetic) color additives and colors exempt from certification (typically referred to as “naturally derived”) (Barrows, 2003).
Certified vs. Exempt: The Two Color Categories
Certified colors—such as Red 40, Yellow 5, and Blue 1—are synthetically produced, primarily from petroleum-derived compounds. Each produced batch of synthetic colors is tested by the FDA to ensure consistency and safety within approved limits.
Colors exempt from certification, by contrast, are sourced from materials like beet juice, annatto, paprika, spirulina, and turmeric. They don’t require the same batch-by-batch testing by the FDA like synthetic colors, but they must still meet general safety standards. Natural derived colors have been categorized into four main chemical groups: flavonoid derivatives (such as anthocyanins); isoprenoid derivatives (such as carotenoids); pyrrole derivatives (such as chlorophyll); and nitrogenous heterocyclic derivatives (such as betalains)(Barciela et al., 2023). In addition to adding color to foods, some can also impart flavor and preservation characteristics if they contain antioxidants or similar types of compounds. While nature derived colors offer a clean label advantage, they come with formulation challenges—such as pH sensitivity, light instability, and limited color intensity.
Regulatory Pathway for New Food Colors
To be compliant with regulations, new ingredients that are intended to impart color in food are not allowed to go through a generally recognized as safe (GRAS) pathway but must instead go through a color additive petition. The petition is submitted to the FDA and must include safety data, manufacturing details, proposed uses, and labeling requirements. The FDA reviews toxicological evidence and exposure estimates before approving or denying the request. If approved, the color is listed in the Code of Federal Regulations, often with specific usage conditions.
Industry Shifts in Response to Regulation and Consumer Demand
Over the past decade (and, more recently, in the past few months), brands like Kraft, General Mills, and Mars have made headlines for reformulating popular products to remove synthetic colors in response to consumer demand and, more recently, FDA’s intention to phase out certain synthetic dyes. This trend puts pressure on the ingredient supply chain, from color manufacturers to R&D teams, to find viable replacements that maintain visual appeal, shelf life, and cost-effectiveness.
Challenges and Innovations in Naturally Derived Color Formulation
Formulators know about the trade-offs between synthetic and naturally derived dyes. Naturally derived blues and greens remain difficult to achieve, and heat or light exposure can degrade many natural pigments. Costs can also be higher and less predictable due to supply chain fluctuations or crop variability. However, ongoing innovation, especially in fermentation-based colors and encapsulation technology, is helping close the gap between synthetic and naturally derived performance. Furthermore, FDA is expediting the approval of food colors from natural sources, as has been shown in May 2025 with the approval of colors that were derived from Galdieria extract, Butterfly pea flower, and calcium phosphate (FDA, 2025b) and in July 2025 with color derived from gardenia flowers (FDA, 2025a).
How SGS Nutrasource Can Support Your Color Additive Journey
If you are a color manufacturer that is ready to bring forth a new color product, reach out to SGS Nutrasource for assistance in compiling and filing your color additive petition. As consumer preferences evolve and regulatory discussions continue, the role of food coloring will remain a dynamic piece of product formulation. For those working in the food ingredient industry, staying informed is crucial.
About the Author
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Dr. Kayla Preece brings extensive experience assessing the scientific and regulatory compliance of ingredients for food and dietary supplements, including botanicals, microorganisms, and more. These assessments have predominantly been for self-determined and FDA GRAS notifications and New Dietary Ingredient Notifications. With a background in integrative medicine, Dr. Preece practiced medicine before transitioning to regulatory affairs and safety assessment. Dr. Preece has been involved in producing and publishing toxicological manuscripts for dietary ingredients and has received a Diplomate of the American Board of Toxicology. Additionally, Dr. Preece is a full member of the Society of Toxicology. |
References
Barciela, P., Perez-Vazquez, A. and Prieto, M. A. (2023) 'Azo dyes in the food industry: Features, classification, toxicity, alternatives, and regulation', Food Chem Toxicol, 178, pp. 113935.
Barrows, J., Arthur Lipman, and Catherine Bailey (2003) Color Additives History. Available at: https://www.fda.gov/industry/color-additives/color-additives-history (Accessed: July 1 2025).
FDA (2025a) FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-gardenia-genipin-blue-color-additive-while-encouraging-faster-phase-out-fdc-red-no-3 (Accessed: July 14, 2025 2025).
FDA (2025b) FDA Approves Three Food Colors from Natural Sources. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-three-food-colors-natural-sources (Accessed: July 1, 2025 2025).
FDA (2025c) 'HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply'. Available at: https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply (Accessed July 1, 2025).
