FAQs on Color Safety

Q. What types of colors are used in food?
A. Color additives must be approved by the FDA to be used in the US. Synthetic color additives are known in the US as FD&C or certified colors.  There are also a number of color additives that are approved for safe use in the US that are sourced from nature, and these colors are referred to as exempt from certification colors.

Q. How do we know that colors are safe?
A. Each and every color used in the US has undergone an extensive safety evaluation as required by the FDA. All colors have met the safety requirements of the FDA before being added to any food or pharmaceuticals. If they do not, they are not 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.

Q. Doesn’t the source of a color impact its safety?
A. The source of a color additive, whether it is from plant, mineral, animal, or synthetic sources, has no bearing on its safety. However, color additives are often considered to be members of one of two classes—“natural” color additives and “synthetic” color additives. Natural color additives may be from plant, mineral or animal sources, and synthetic color additives are derived from organic chemicals.

Q. What is JECFA and how is it related to color additives?
A. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has throughout its existence developed and established principles for the safety assessment of food and color additives. Since 1956, JECFA has been engaged in collecting and evaluating scientific data on additives and making recommendations on safe levels of use. This has been accomplished (a) by elaborating specifications for the identity and purity of individual additives that have been toxicologically tested and are in commerce and (b) by evaluating the toxicological data on these additives and estimating acceptable intakes by humans. More information on JECFA’s evaluation of color additives is available at this link.

Q. What is a JECFA ADI?
A.The Acceptable Daily Intake (ADI) is an estimate of the amount of a substance in food or drinking-water, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable risk. The ADI is expressed in units of milligrams (mg) per kilogram (kg) body weight.

Q. US regulations allow many colors at “GMP.” How is that different from ADI?
A. JECFA has established ADIs for most commonly used color additives. The ADIs suggest that most current maximum limits can be safely increased to good manufacturing practice (GMP) levels. GMP implies that the color in question is self-limiting in food for technological, organoleptic or other reasons. Consequently many countries, such as Japan and the United States, permit the use of colors at GMP levels. 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 JECFA ADI levels.

Q. How can you guarantee the safety of US consumers given the results of the Southampton Study?
A. The data from the Southampton Study does not clearly indicate a causal link between the intake of color additives and hyperactive behavior.  Therefore consumers, including children, are not at risk from colors in foods. These colors have been legally and safely used in the US and in much of the world for many years.

Q. Didn’t Europe conclude that these colors cause hyperactivity?
A. No. In fact, European authorities have concluded that the data from the Southampton Study provides only limited evidence that food additives, including colors, cause even very small effects on a child’s activity and attention levels.  In addition, experts in the US and Europe consider the results of the Southampton Study to be inconsistent and have not recommended banning or limiting the use of colors in foods.

Q. What about the labeling of colors in Europe?
A. In the EU, colors are listed by name or E number and therefore are easily recognizable to a consumer.

Q. Why shouldn’t the US follow European labeling?
A. In the US, every color is listed by name, so the US already requires that colors are labeled in such a way as to allow consumers to make informed choices at the grocery store.

Q. How can you justify the use of color additives? They don’t provide any health benefits! Why risk consumer safety?
A. Colors provide benefits in foods.  The most important benefit is to indicate the palatability, or tastiness, of a product.  Research has consistently shown that if foods don’t have the right color, people won’t eat them.

Q. Why do we need to add color to foods?
A. Consumers judge the nutritional value of foods by color. Colors are added to ensure an even, consistent appearance, and this gives consumers confidence that food is safe. One example is that during processing, the naturally occurring color in foods is often lost, which can make otherwise nutritious foods unappealing to humans. So, color additives are used to replace color that is lost during the processing of foods.

Q. Which food products contain synthetic (FD&C) colors, and will any food products be unsafe to use if the colors are not removed?
A. FD&C colors are not limited to any particular categories of food. Years of testing and ongoing reviews throughout the world have confirmed that the mere presence of colors in food does not impact its safety.

Q. If the FDA concludes that a color additive is unsafe for use in food, what will be the response from industry?
A. If the FDA were to declare a color to be unsafe, the food and color industries would immediately stop production and distribution in the US.

Q. Do FD&C colors contain gluten?
A. FD&C colors are produced according to US FDA approved manufacturing process and conforms to the specifications and quality standards explicitly stated in the 21CFR74. Neither the raw materials nor the process involved in the production of FD&C colors contain gluten, or any source of gluten, or gluten-related substances.