There’s a common misconception that a food substance is banned in some countries but allowed in others, and that those differences mean the substance must be unsafe. In reality, regulatory frameworks differ across regions. This table offers a helpful snapshot of how synthetic food color additives are regulated in the U.S., European Union, Canada, and Australia/New Zealand, as well as globally by JECFA, highlighting differences in approval and naming—not safety.
Myth: FD&C (synthetic) colors are banned in Europe and Canada.
Fact: There is a common misconception that there are colors banned in Europe or Canada but allowed in the United States. While there are regional differences in which colors are approved, in general, the EU and Canada allow the use of FD&C colors, but they are listed on ingredient labels by their chemical names or E-numbers. In fact, the EU allows for NINE additional synthetic colors in food, including Azorubine/Carmoisine (E122) and Amaranth (E123), which were delisted by the FDA.
Myth: The U.S. FDA has banned synthetic colors as of 2026.
Fact: FD&C colors are not banned in the United States. On April 22, 2025, Robert F. Kennedy Jr., the Secretary of Health and Human Services, and Marty Makary, MD, MPH, the FDA Commissioner, held a press briefing to announce a series of new measures to “phase out” all synthetic food dyes in the U.S. food supply. The written announcement laid out six actions to be taken by FDA, which are detailed in the links above.
The actions included establishing a national standard and timeline for the food industry to transition from FD&C dyes to natural alternatives. While the announcement states that FDA will be “working with industry to eliminate” six FD&C dyes by the end of 2026, importantly, no legal or regulatory action to mandate such a transition was announced.
Myth: The same product is made with natural colors in Europe, Canada, etc.
Fact: It is true that natural colors are used more prevalently in Europe. However, differences in formulation are due to consumer preference, not safety. When consumers indicate a willingness to purchase naturally colored products regardless of the impact on the way they look, taste, or cost, then U.S. food companies have and will respond in their product offerings.
Additionally, regulatory differences affect the speed at which natural options reach the market. The European Union offers pathways for ingredients from edible sources with coloring properties, such as safflower or spirulina, to be brought to market quickly as “coloring foods” rather than go through the premarket approval process. In contrast, due to the strict premarket review process for color additives in the U.S., every color additive must go through the FDA Color Additive Petition (CAP) process, regardless of source. The CAP process typically takes a minimum of five years, from research and development to regulatory approval. This same process is required for any alternatives to existing FDA-approved color additives to be legally approved as a color additive in the U.S. Based on the experience of IACM members, it is not uncommon for a new food color to take 15 years from concept to approval.
Myth: U.S. manufacturers can easily replace FD&C colors in food products.
Fact: There is no “one-to-one” solution for switching from a synthetic to a natural color. Individual colors are often blended to match distinct flavor profiles or create brand identities. While the color industry is actively innovating to produce new colors to meet the current demand for more natural products, color reformulation is not an easy task and requires heavy lifting across the supply chain from sourcing to packaging. Selecting, sourcing, and preparing facilities to use natural (exempt[1]) colors takes longer and includes different logistical considerations than sourcing FD&C (synthetic) colors. Additionally, the supply of natural colors is limited, and they can’t replace FD&C color additives in all applications due to their technical limitations. For more on the considerations for color reformulation, click here.
Myth: Colors are generally recognized as safe (GRAS) and not reviewed for safety by the FDA.
Fact: Colors are unique among intentionally added ingredients in that FDA requires pre-approval before they can be used in food and other FDA-regulated products. No GRAS exemption exists for using color additives, ensuring that no color additive is marketed before an extensive and rigorous FDA safety evaluation. As a result, colors have significant safety data underlying their use, and consumers can be sure that the colors used in consumer products have been subject to strict regulatory oversight.
Myth: FDA has not reviewed FD&C color additives in more than 30 years.
Fact: The Color Additive Amendments of 1960 defined “color additive” and required that the approximately 200 color additives that were in commercial use at that time be provisionally listed until scientific data establishing their safety was provided. As a result, many color additives were never listed, mostly due to a lack of commercial interest. Of the approximately 30 color additives listed for use in food because of the Color Additive Amendments, 20 were exempt colors such as annatto extract, caramel, fruit and vegetable juice, grape skin extract, paprika and carrot oil[2], while the rest were those requiring certification, including the FD&C colors. FDA continuously monitors information relating to the safety of all color additives and maintains a Color Master File containing data on their safety. FDA has also confirmed that all exposure estimates for FD&C color additives are well below the acceptable intake levels established by FDA in a study published in 2017. FDA has also specifically considered FD&C color additives and behavioral effects in children, most recently in 2019. FDA representatives also serve on the WHO/FAO Joint Expert Committee on Food Additives (JECFA), which re-evaluated the synthetic colors used in the U.S. between 2011 and 2019.
Myth: Synthetic color additives have been linked to health harms in children, including cancer, damage to the immune system, neurobehavioral issues, and hyperactivity.
Fact: There is no evidence suggesting that food colors cause cancer in humans or are a significant driver of weight gain or chronic diseases. Hyperactivity and neurobehavioral issues are multifactorial and removing FD&C colors from food will not “fix” hyperactive behavior.
Myth: Synthetic colors are made from petroleum.
Fact: Certified color additives are organic chemicals that can be produced from simple chemical building blocks. Petroleum is a source of those simple chemicals, which also serve as the building blocks for many other commonly ingested chemicals, including nutrients, therapeutics, aspirin, and vitamins. Using different combinations of these simple chemical building blocks, or reacting them together in various ways, results in different chemical structures, which then also result in different properties that render one substance different than another in terms of function and toxicity. This variation accounts for the difference in colors. Certified color manufacturers are required to submit every batch of color to the FDA for testing to ensure it meets purity standards and regulatory specifications before it can be used in food.
Myth: Colors are not necessary.
Fact: Consumer testing has shown that consumers are unlikely to purchase or consume products if the color they are presented with is in any way unexpected. During processing (e.g., heating, transport, storage, etc.), the inherent color in foods is often lost. This can have the effect of making otherwise nutritious foods unappealing to humans. So, color additives are used to replace color that is lost during the processing of foods. Color additives also serve to correct for natural color variation. Again, consumers judge the nutritional value of foods by color. Color additives are therefore added to ensure an even, consistent appearance, and this gives consumers confidence that food is safe.
[1] https://www.fda.gov/food/color-additives-information-consumers/color-additives-foods
[2] https://www.fda.gov/industry/color-additives/summary-color-additives-use-united-states-foods-drugs-cosmetics-and-medical-devices
Read here for more myths around food colors.