Color Additive – A color additive is a dye, pigment or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetic, or to the human body. The legal definition can be found in Section 201(t) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provides exclusions as well. Color additives for use in food, drugs, and cosmetics require premarket approval. Color additives for use in or on a medical device are subject to premarket approval if the color additive comes in direct contact with the body for a significant period of time. For additional information, consult the Color Additive Program on the CFSAN Internet.
Colorant – A colorant is a dye, pigment, or other substance that is used to impart color to or to alter the color of a food-contact material, but that does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye. The term ‘colorant’ includes substances such as optical brighteners and fluorescent whiteners, which may not themselves be colored, but whose use is intended to affect the color of a food-contact material. (21 CFR 178.3297(a)).
Food Contact Substance (FCS) – Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food. Additional information can be found on the Food Contact Substances Notification Program page.
There is a hierarchy from Food Contact Substance (FCS) through Food Contact Material (FCM) to Food Contact Article (FCA).
- The Food Contact Substance (the subject of an FCN) is a single substance, such as a polymer or an antioxidant in a polymer. As a substance, it is reasonably pure (the Chemist’s definition of substance). Even though a polymer may be composed of several monomers, it still has a well-defined composition.
- Food Contact Material (FCM) is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable.
- The Food Contact Article is the finished film, bottle, dough hook, tray, or whatever that is formed out of the FCM.
Guidance Document – Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue. Guidance documents include but are not limited to, documents that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies. Guidance documents do not legally bind the public or FDA or establish legally enforceable rights or responsibilities. They represent the agency’s current thinking. (21 CFR 10.115). A complete listing of CFSAN’s guidance documents is available on the Internet.
Prior Sanctioned Substance – A substance whose use in or on food is the subject of a letter issued by FDA or USDA offering no objection to a specific use. The prior sanction exists only for a specific use of a substance in food delineating level(s), condition(s) and product(s) set forth by explicit approval by FDA or USDA prior to September 6, 1958. Some prior sanctioned substances are codified in 21 CFR Part 181.
Secondary Direct Food Additive – This term is in the title of 21 CFR 173, which was created during recodification of the food additive regulations in 1977. A secondary direct food additive has a technical effect in food during processing but not in the finished food (e.g., processing aid). Some secondary direct food additives also meet the definition of a food contact substance. For more on food contact substances, consult the Food Contact Substance Notification Program.