At JECFA, as well as in the EU, an additive used to add or restore color in food is considered a food color. The US FDA defines a color additive as “a material which is a dye, pigment, or other substance … and when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto.” ((FD&C Act Section 201(t)). The EU also classifies food that contain coloring properties as a secondary effect as coloring foods.
Types of Color Additives
Technically, color additives are any dye, pigment or substance that can impart color when added or applied to a food, drug, cosmetic or to the human body.
A color additive is often considered to belong to one of two classes: “natural” color additives, or “synthetic” color additives. The distinction is not always meaningful because there are some color additives that are considered natural that are produced through chemical synthesis.
Whether a color additive is synthetic or natural has no bearing on its overall safety. Both types of color additives are subject to rigorous standards of safety prior to their approval for use in food.
Straight Colors
- Refers to dyes (soluable in water) and pigments (typically insoluable in water).
- No mixing or chemical reaction with any other substance.
Lakes
- Formed by chemically reacting straight colors with precipitants and substrata.
- In the US, food lakes must be made from certified batches of straight colors with the exception of carmine made from cochineal extract.
- Lakes are used in situations where bleeding is undesirable, such as frostings.
Mixtures
- Formed by mixing one color additive with one or more other color additives, or one or more straight colors and one or more diluents.
FAQs on Color
- What is JECFA and how is it related to color additives?
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.
- What types of colors are used in food in the US?
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 an increasing 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.
- How do we know that colors are safe?
Internationally, JECFA has a color safety evaluation program in place. JECFA evaluations serve as the basis for safety for many countries throughout the world. Additionally, each color used in the US has undergone an extensive safety evaluation as required by the FDA and 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. Internationally, many countries, including Europe and Japan have color safety evaluation programs in place.
- What is a JECFA ADI?
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.
- Some regulations allow colors at “GMP.” How is that different from ADI?
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.
- Doesn’t the source of a color impact its safety?
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.
- How can you guarantee the safety of consumers who consume synthetic color additives given the results of the Southampton Study?
The data from the Southampton Study does not clearly indicate a causal link between the intake of synthetic 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 much of the world for many years.
- Didn’t Europe conclude that the "Southampton" colors cause hyperactivity?
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.
- What about the labeling of colors in Europe and the US?
In the EU, color additives are listed by name or E number and therefore are easily recognizable to a consumer. In the US, every color is listed by name in the ingredient list. Both methods allow consumers to make informed choices at the grocery store.
- How can you justify the use of color additives? They don’t provide any health benefits! Why risk consumer safety?
While they are not nutritional, color additives play an important role in food, and they do so without posing a health risk to consumers. 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.
- Why do we need to add color to foods?
Color is added for aesthetic purposes for those who enjoy vibrant colors and food in general. Colors are also added to ensure an even, consistent appearance, and this gives consumers confidence that food is fresh.
- Which food products contain synthetic (FD&C) colors and will any food products be unsafe to use if the colors are not removed?
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.
- If a regulatory body concludes that a color additive is unsafe for use in food, what will be the response from industry?
If any regulatory body were to declare a color to be unsafe, the food and color industries would immediately stop production and distribution.
- Do colors contain gluten?
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.