Colors enhance our experiences every day, from the meals we enjoy with our families to the beverages we sip and the treats we savor. They help make foods and products look appealing, consistent, and familiar. Color additives have also been used safely for decades, supported by rigorous scientific evaluation and oversight.
This FAQ provides simple, fact-based answers to help explain what colors are, why they’re used, and how their safety is ensured.
Color additives are substances added to foods, drugs or cosmetics to impart, restore, or maintain color. They can be synthetic or derived from natural sources such as plants, minerals, or animals. They serve a visual purpose, enhancing the appearance of the final product while not increasing calories or adding a flavor. In food, color additives can replace the natural color that is sometimes lost during processing, ensure a consistent appearance each time a food is produced.
Colors are added to products like foods or drugs primarily to enhance visual appeal and ensure a consistent, recognizable appearance. Many consumers associate certain colors with freshness, quality, and flavor, and research has shown that consumers are less likely to purchase or eat foods that look unexpected or uneven in color. Colors give consumers confidence that a food or ingested drug is safe to consume.
During processing, such as heating, transportation, and storage, a product’s natural colors can fade or change, making foods look dull or unappealing. Color additives help restore color lost during processing and correct for natural variation between batches. By ensuring a consistent, familiar appearance, color additives give consumers confidence in a product’s quality and wholesomeness.
Color additives are purely visual additions to foods and beverage products. They do not provide nutritional value, add calories, or change a food’s flavor. However, appearance plays an important role in how consumers perceive taste and quality. People often associate certain colors with specific flavors, or as an indication that the foods are fresh, which can influence expectations and overall eating experience. By ensuring foods look familiar and appealing, colors help align what consumers see with what they expect to taste, even though the color itself does not change the product’s nutrition or flavor.
In some cases, yes, companies make food without added colors, and many products already do not use added colors. When they are used, producers use color additives selectively and only in the amount required to serve a clear purpose. During processing, storage, and transportation, consumer products often lose their natural color or develop visual variations that can make them appear less fresh or less appealing, even when they remain safe and nutritious. Natural variation between ingredients or batches—due to different growing regions, or due to seasonal variation—can lead to inconsistent appearance. For many products, color additives help restore color lost during processing or ensure a consistent, familiar look that meets consumer expectations.
Because consumers often rely on appearance when judging a product’s quality, food without expected color may be perceived as less flavorful or lower quality.
For more information, visit What Are Colors?
Color additives are evaluated for safety through rigorous scientific review in the United States and around the world. Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has a color safety evaluation program in place and these evaluations are used by many countries around the world as the basis for regulatory decisions.
In the United States, every color used must undergo extensive safety evaluations by the Food and Drug Administration (FDA) before it can be approved for use in foods or pharmaceuticals. Colors that do not meet FDA safety requirements are not allowed on the market. In addition, certified color manufacturers are required to submit every batch of certified colors to the FDA for testing to make sure that they are safe. Internationally, many other countries and regions, including Europe and Japan, have robust color safety evaluation programs in place. Together, these systems help ensure that color additives remain safe when used as approved and intended.
No, color additives do not cause health problems. Before they are used, color additives undergo extensive safety evaluations and are subject to strict regulations.
Although they do not provide nutritional value, color additives play an important and well established role in food or drugs without posing a health risk to consumers. There is no credible scientific evidence suggesting that color additives contribute to health problems such as cancer, weight gain, chronic diseases, or other adverse health conditions.
No. There is no credible scientific evidence showing that approved color additives cause cancer in humans. Before a color additive can be authorized for use, regulatory agencies and risk assessors including FDA, the European Food Safety Authority (EFSA), and JECFA require extensive safety evaluations, including studies specifically designed to assess cancer risk over both short‑ and long‑term exposure to ensure there is no increased risk.
Only color additives that demonstrate a wide margin of safety are approved for use, and strict limits control how and where they may be used in foods, drugs or cosmetics. After approval, ongoing scientific review and monitoring continue to help ensure that color additives remain safe for consumers when used as intended.
No. The source of a color additive, whether it comes from a plant, mineral, animal, or is produced synthetically, does not determine its safety. Color additives are often grouped into two general categories: “natural” color additives and “synthetic” (or artificial) color additives.
Regardless of their source, all color additives must meet the same safety standards and are evaluated by regulatory authorities before being approved for use in food, drugs or cosmetics. As a result, both naturally and synthetically derived color additives can be used safely when they are used as intended.
No, there is no credible evidence that color additives cause ADHD or behavioral issues in children. While one study, the Southampton (Lancet) study, is frequently cited, scientific experts and regulatory authorities have found the study’s results to be limited and inconsistent evidence of very small effects on children’s activity and attention levels. Importantly, the conclusions of the Southampton study have not been corroborated further. In fact, a 2013 study (Lok et al.) attempted to recreate the study with children in Hong Kong but was unable to identify any significant adverse effects. This discrepancy was noted by the FDA in its October 2019 Science Board meeting on Color Additives and Behavioral Effects in Children.
Notably, European authorities have similarly determined that the study is not of sufficient significance and offers only limited evidence that food additives, including colors, affect children’s behavior. Based on the full body of research, regulatory authorities in both Europe and the United States have not recommended banning or restricting the use of any color additives on this basis. These additives have been safely used in foods and drugs around the world for many years, and consumers, including children, are not considered to be at risk when consumed as approved and intended.
JECFA is an international scientific body that evaluates the safety of food additives, including color additives. Since 1956, JECFA has developed and established principles for the safety assessment of food and color additives. JECFA collects and evaluates scientific data on additives and makes recommendations on safe levels of use for consumers worldwide.
JECFA’s work includes setting specifications for the identity and purity of additives and evaluating toxicological data to determine acceptable intake levels. JECFA has evaluated and concluded that the color additives in use globally are safe. More information on JECFA’s evaluation of color additives is available at this link.
When regulators, including JECFA, EFSA and the FDA, evaluate a color additive for safety, they set an acceptable daily intake (ADI). An ADI represents the maximum amount of a substance that can safely be consumed each day over a lifetime without posing a health risk. It is calculated using scientific data and includes a large margin of safety. An ADI is expressed on a body weight basis, in units of milligrams (mg) per kilogram (kg) body weight. This allows regulators to account for differences in body size when setting safe intake levels in different food and beverage categories.
ADIs have been established for most color additives. Some color additives are allowed for use at levels consistent with Good Manufacturing Practice (GMP). GMP is a rigorous standard ensuring that colors are used only at the levels needed to achieve their intended purpose in a food or drug. However, in practice, the amount used is self‑limiting due to factors such as appearance or technical functionality. Because of this, actual consumer intake remains well below established ADIs.
Many countries, including Japan and the United States, permit the use of certain colors at GMP levels. The European Union has established ADIs for some colors but also permits certain colors to be used at GMP levels, expressed as quantum satis. The regulators in these countries have estimated the daily intakes of all foods through scientific surveys, and these surveys consistently show that the color intakes from all foods are much lower than the safe intake levels established by ADI levels.
Food safety standards evolve as scientific knowledge advances. The removal of certain color additives in the past reflects the process is working as intended. When new data emerge or testing methods improve, regulators reassess previously approved ingredients and act if safety concerns are identified.
In 2025, the FDA amended its color additive regulations to no longer allow for the use of FD&C Red No. 3 while also noting that “[t]he way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.” The FDA also states that “[s]tudies in other animals and humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.” The decision specifically removes approval for FD&C Red No. 3 in food and ingested drugs in response to a petition from a coalition of non-governmental organizations, despite the FDA’s acknowledgment that the color additive does not pose a risk to human health based on available scientific evidence.
Notably, while the U.S. FDA issued an order to revoke the use of FD&C Red No. 3 in foods and ingested drugs due to its domestic legal framework (the Delaney Clause), international risk assessment bodies such as JECFA noted that this action was not prompted by new scientific information and reiterated that JECFA’s most recent safety evaluation of erythrosine from 2018 remains valid.
The color additives approved for use today have been evaluated using modern scientific methods and extensive safety testing, including studies on long term exposure and potential health effects. Their use is strictly regulated, with clear limits on how and where they may be used.
Regulatory agencies continue to review new scientific evidence and reassess approved additives as needed. This ongoing monitoring and reevaluations helps ensure that the color additives used today meet current safety standards and remain safe for consumers when used as intended.
No. Color additives do not inherently contain gluten or other common food allergens. All color additives are produced according to manufacturing processes and conform to the specifications and quality standards explicitly stated in regulations. Neither the raw materials nor the processes involved in the production of synthetically derived color additives contain gluten, or any source of gluten, or gluten-related substances. Naturally derived color additives generally include dyes and pigments derived from natural sources such as vegetables, minerals, or animals, that also do not contain or are derived from sources of gluten.
Color additives are also subject to strict regulatory requirements. If a color additive, or any ingredient used to make it, contained a major food allergen (such as milk, eggs, soy, peanuts, tree nuts, wheat, fish, or shellfish), that allergen would be required to be declared on the food label under food allergen labeling laws.
Consumers with gluten intolerance or food allergies should always check product labels for complete ingredient information, but approved color additives themselves are not considered a source of gluten or other common allergens when used as intended.
For more information, visit Why Colors Are Safe.
Color additives in the U.S. fall into two categories:
Color additives are strictly regulated by the FDA and other global authorities to ensure safety. Color additives in the U.S. must be approved by the FDA to be used, and the same safety standards apply whether the colors are certified or exempt.
In many cases, they can, but color reformulation is rarely simple. There is no direct “one-to-one” substitute for switching from synthetic to natural colors. Colors are often blended to achieve specific shades or create distinct brand identities—combinations that are not always achievable using naturally-derived colors alone.
Color reformulation requires significant effort across the entire supply chain, from sourcing and processing to manufacturing and packaging. Naturally derived colors often take longer to source as the supply can be limited. They can also take longer to prepare, and the process involves different regulatory and logistical considerations than sourcing FD&C (synthetic) colors. In addition, naturally derived colors are often less stable and more sensitive to heat, light, or acidity, which means they cannot readily replace FD&C color additives in all applications.
While the color industry continues to innovate and expand naturally derived color options, replacing synthetic colors with those that are naturally derived is a complex and resource-intensive process. For more on the technical and regulatory considerations for color reformulation, click here.
Color additives are required to be listed on ingredient labels, so consumers are aware of their presence in food, drugs, or cosmetics. While specific labeling requirements vary by region, they all are designed to support transparency and informed choice.
On a product label, the ingredients are listed in order of predominance, with the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts.
In the U.S., certified colors are declared by their name, such as “Yellow 5 (color).” Exempt from certification colors can be listed as “Colored with beta-carotene,” “beta-carotene for Color, or Color (beta-carotene).”
Currently, only cochineal extract and carmine are the two exempt colors that require declaration by name. According to 21 CFR 101.22(a)(2), paprika, turmeric, and saffron or other spices which are also colors, can be declared as “spice and coloring” unless declared by their common or usual name. Use of the term “natural color” is prohibited on an ingredient statement, regardless of the source of the color.
In the European Union, color additives are listed by name or by their assigned E number, making them easy to identify. Ingredients used primarily for coloring from foods (often called “coloring foods”) do not have E numbers and are listed by their source, such as carrot or beetroot.
Because labeling systems differ, the same color may appear under different names depending on the region.
For example, Brilliant Blue is labeled as FD&C Blue No. 1 in the U.S., while in the EU it is labeled Colour: E 133. Similarly, In the U.S., when used as a color additive, lycopene can be labeled as Colored with Lycopene, Lycopene (for Color) or simply as Color Added, whereas in the EU it would be labeled as Colour: E 160d or Colour: Lycopene.
Differences in color additive approvals reflect differences in regulatory frameworks, risk assessment approaches, and policy priorities, not necessarily differences in safety standards. In both the U.S. and the EU, color additives must undergo rigorous scientific review before they are approved for use.
U.S. and EU regulators may evaluate the same scientific data but reach different conclusions based on factors such as how much is typically consumed, broader policy goals, or consumer expectations. As a result, a color additive that is approved for use in the U.S. may be restricted or not authorized in Europe, and vice versa.
In all cases, approved color additives are permitted only at specified levels and are continually reviewed to ensure they remain safe for consumers under their intended conditions of use.
Naturally derived and synthetically produced colors are used in both Europe and the U.S., but regulatory differences affect how readily natural options reach the market. In the European Union, ingredients from edible sources that have coloring properties, such as safflower or spirulina, can be used as “coloring foods” and may reach the market more quickly, without going through the premarket approval process.
In contrast, in the U.S., every color additive, including naturally derived ones, must go through the FDA Color Additive Petition (CAP) process before it can be used in food, drugs or cosmetics. This process applies regardless of the source and typically takes a minimum of three years between submission and final approval.
As a result, naturally derived colors are often introduced more quickly in Europe, while the U.S. approval process emphasizes extensive premarket review for all color additives.
Yes. In the U.S., colors are unique among intentionally added ingredients. The FDA requires pre-approval before they can be used in food and other FDA-regulated products via a CAP.
There is no GRAS (Generally Recognized as Safe) provision for color additives. As a result, approved colors are supported by significant safety data, and consumers can be confident that the colors used in food, drugs and cosmetics are subject to strict regulatory oversight.
Globally, many other jurisdictions including the European Union, Canada, Australia/New Zealand, also evaluate color additives prior to their use in consumer products. Some countries rely on the pre-market safety evaluations on color additives conducted by JECFA as part of their regulatory decision making.
For more information, visit How Colors Are Regulated.
The terms “artificial color” and “synthetic color” are often used interchangeably. Both typically refer to color additives that are not derived from natural sources such as plants, animals, or minerals, but are instead manufactured through chemical processes. However, “synthetic color” refers to the method of production, where “artificial color” is used primarily as a labeling term. For example, in the U.S., according to 21 CFR 101.22(a)(4), the term “artificial color” or “artificial coloring” when used on a label refers to any color additive, regardless of source.
No, FD&C (synthetic colors) have not been banned in the United States as of 2026 and remain legally approved for use.
In April 2025, federal health officials announced a series of proposed, voluntary measures intended to encourage the gradual phase‑out of FD&C color additives from the U.S. food supply. The stated goal was to work collaboratively with industry to transition away from FD&C colors to alternative color sources.
Importantly, these announcements were not based on any specific safety concern or new scientific information, nor did it establish a legal ban or regulatory mandate. While the FDA indicated it would work with industry to eliminate the use of six FD&C colors by the end of 2026 (which has since been updated to 2027), this effort is voluntary. Unless and until formal regulatory action is taken, FD&C colors are considered safe based on the FDA’s most recent reviews and remain legally approved for use under existing regulations.
No. A common misconception is that color additives are banned in Europe or Canada while remaining allowed in the U.S. In reality, the EU and Canada both permit the use of both synthetic and naturally derived color additives, including FD&C colors that are also approved in the U.S.
The main differences across regions are which specific colors are approved and how they are labeled. In the EU, colors are typically identified on labels by their chemical names or E‑numbers (for example, tartrazine is labeled as E102 in the EU and as Yellow 5 in the U.S.).
Additionally, the EU permits NINE synthetic colors that are not approved in the United States, including azorubine/carmoisine (E122) and amaranth (E123), which were delisted (i.e., no longer allowed) by the FDA. These differences reflect regional regulatory approaches rather than overall stricter or looser safety standards.
When color additives are described as petroleum‑based, it means that some of the basic chemical building blocks may originate from petroleum‑derived raw materials. Petroleum is a common source of simple organic chemicals that are also used to produce many substances people commonly consume safely every day, including vitamins, aspirin, and other medicines.
Through controlled chemical processes, these basic building blocks are combined to create compounds with specific properties, including specific colors. The safety of a synthetically derived color additive is determined by its final chemical structure and how it behaves in the body, not by the original source of the raw materials. Like the vitamins and medicines that are also petroleum-based, color additives do not contain any petroleum or petroleum by-products.
To further ensure safety, every batch of a certified (FD&C) color additive must be submitted to the FDA for testing. The FDA verifies that each batch meets strict purity and quality standards before it can legally be used in food, drugs or cosmetics.
No. This claim is incorrect. The modern regulatory framework for color additives was established by the Color Additive Amendments of 1960, which required the FDA to formally review and list all existing color additives based on scientific safety data. At that time, approximately 200 color additives were provisionally listed. Many were never permanently listed, largely due to a lack of commercial interest rather than safety concerns.
Under the Color Additive Amendments of 1960, approximately 30 color additives were recognized as in use and deemed safe by the FDA Commissioner for use in food. Most of these were exempt colors such as annatto extract, caramel, fruit and vegetable juice, grape skin extract, paprika oleoresin and carrot oil, while the rest were subject to additional studies prior to determining their continued safe use. This subset requiring additional studies ultimately became what is now known as FD&C colors.
Since then, the FDA has continued to monitor safety data for all approved color additives. The agency maintains a Color Master File and periodically updates exposure assessments and reviews new scientific evidence as it becomes available. For example, recent studies by the U.S. FDA have shown that the estimated dietary exposures to FD&C colors were found to be well below established safe intake levels. The FDA has also specifically reviewed research related to potential behavioral effects in children, most recently in 2019.
In addition, FDA scientists participate in international scientific evaluations through JECFA, which re‑evaluated synthetic food colors used in the U.S. and elsewhere between 2011 and 2019. Together, these ongoing reviews by government experts and international scientists from around the world help ensure that approved FD&C color additives continue to meet current safety standards.
It is true that naturally derived colors are used more often in some regions, particularly in Europe. However, differences in formulation are due to consumer preference, not safety standards. When consumers indicate a strong preference for products colored with naturally derived color additives, regardless of the impact on the way they look, taste, or cost, then food and drugs companies respond by adjusting their formulations. In markets where consumers prioritize naturally derived colors, companies are more likely to offer products using those alternatives.
In contrast, consumer preferences in the U.S. have traditionally supported a wider range of color, including bolder options that are possible via synthetically produced colors, which can lead to different formulations for the same product across regions.
Yes. While both the U.S. and the EU evaluate color additives for safety, differences in regulatory systems affect how quickly new color options, especially those derived from natural sources, reach the market.
In the EU, certain ingredients from edible sources that possess coloring properties, such as safflower or spirulina extract, may be used as “coloring foods.” These ingredients can be brought to market quickly because they don’t require a premarket approval process.
In contrast, the U.S. requires every color additive, regardless of source, to go through the FDA Color Additive Petition (CAP) process before it can be used in food, drugs or cosmetics. This process involves extensive scientific review and typically takes a minimum of five years from research and development to final regulatory approval. This same process is required for new alternatives intended to replace existing FDA-approved color additives. Based on the experience of IACM members, this process takes an average of about 5 years, but it is not uncommon for a new color additive to take 15 years from concept to approval.
As a result, new naturally derived colors often reach the European market more quickly, while the U.S. approval system emphasizes a comprehensive premarket safety review for all color additives.
While color additives exempt from certification do not require FDA batch certification, all color manufacturers must ensure that their color additives meet the identity and specifications in the listing regulations at 21 CFR Part 73. Most regulations include stringent heavy metal and solvent residue limits. Color additives that exceed these levels are considered adulterated. Resources exist to further aid color manufacturers in meeting these requirements, including Food Chemical Codex’s (FCC) Appendix XXI: Guidelines for the Control of Contaminants in Food Colors from Natural Sources.
Precision fermentation offers a new way to produce naturally derived color additives using microorganisms like yeast, fungi or bacteria. Instead of extracting dyes from plants or synthesizing them chemically, microbes are engineered to make the same additives through controlled fermentation. These color additives are evaluated for safety using the same risk assessment frameworks as other color additives. Color additives produced using precision fermentation can provide a more consistent and sustainable option to other naturally derived colors, including anthocyanins, carotenoids, and betalains.
Many naturally derived color additives sourced from fruits, vegetables, and spices are recognized not only for their vibrant hues but also for their association with bioactive compounds that have been studied for potential nutritional and health-related benefits.
For example, lycopene (responsible for the red color in tomatoes) and beta-carotene (found in carrots and other orange vegetables) are well-known carotenoids that have been extensively researched for their antioxidant properties. Similarly, turmeric, which provides a rich yellow color, contains curcumin, a compound studied for its anti-inflammatory properties. Beetroot delivers a deep red color through betalains, pigments that have also been investigated for their antioxidant activity.
It is important to note that before these ingredients can be added to food to provide color, they must be approved for that purpose by the FDA via a CAP. When used as color additives, these ingredients are present at the lowest levels possible to achieve visual appeal, not necessarily to deliver measurable nutritional or health benefits.