Next Upcoming Seminar: Implementing SQF 8.0 Systems – May 17-18, 2017

Specializing in FDA Regulatory Matters

Glossary of Terms

Food Ingredients and Packaging Terms

The Food and Drug Administration (FDA) Data Standards Council is standardizing vocabulary across the FDA. Therefore, the wording in some terms below may change slightly in the future.

Biotechnology – refers to techniques used by scientists to modify deoxyribonucleic acid (DNA) or the genetic material of a microorganism, plant, or animal in order to achieve a desired trait. In the case of foods, genetically engineered plant foods are produced from crops whose genetic makeup has been altered through a process called recombinant DNA, or gene splicing, to give the plant desired traits. Genetically engineered foods are also known as biotech, bioengineered, and genetically modified, although “genetically modified” can also refer to foods from plants altered through methods such as conventional breeding. While in a broad sense biotechnology refers to technological applications of biology, common use in the U.S. has narrowed the definition to foods produced using recombinant DNA. For additional information, see the Biotechnology Program on the CFSAN Internet.

CEDI/ADI Database – For a large number of food contact substances, CFSAN maintains a database of Cumulative Estimated Daily Intakes (CEDIs) and Acceptable Daily Intakes (ADIs). The CEDIs and ADIs are based on currently available information and may be revised when information is submitted or made available. The CEDI/ADI database is updated approximately twice annually. The CEDIs and ADIs are based on currently available information and may be subject to revision on the basis of new information as it is submitted or made available to OFAS.

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)).

EAFUS – The “Everything Added to Food in the United States” (EAFUS) database is an informational database maintained by CFSAN under an ongoing program known as the Priority-based Assessment of Food Additives (PAFA). PAFA contains administrative, chemical and toxicological information on over 2000 substances directly added to food, including substances regulated by the FDA as a direct food additive, secondary direct food additive, color additive, GRAS and prior-sanctioned substance. In addition, the database contains only administrative and chemical information on approximately 1000 such substances. Information about the more than 3000 total substances comprise EAFUS. For a complete listing of EAFUS substances, see the EAFUS list.

Food Additive – A food additive is defined in Section 201(s) of the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 19581 or otherwise excluded from the definition of food additives.

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.

GRAS – “GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. GRAS substances are distinguished from food additives by the type of information that supports the GRAS determination, that it is publicly available and generally accepted by the scientific community, but should be the same quantity and quality of information that would support the safety of a food additive. Additional information on GRAS can be found on the GRAS Notification Program page.

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.

Indirect Food Additive – In general, these are food additives that come into contact with food as part of packaging, holding, or processing, but are not intended to be added directly to, become a component, or have a technical effect in or on the food. Indirect food additives mentioned in Title 21 of the U.S. Code of Federal Regulations (21CFR) used in food-contact articles, include adhesives and components of coatings (Part 175), paper and paperboard components (Part 176), polymers (Part 177), and adjuvants and production aids (Part 178). Currently, additional indirect food additives are authorized through the food contact notification program. In addition, indirect food additives may be authorized through 21 CFR 170.39.

PAFA – The Priority based Assessment of Food Additive (PAFA) database is a database that serves as CFSAN’s institutional memory for the toxicological effects of food ingredients known to be used in the United States. Currently, PAFA contains oral toxicology information on over 2100 of approximately 3300 direct food ingredients used in food in the US. PAFA also contains minimal information on over 3200 indirect additives including the names, CAS number and regulatory information of the indirect additives in the Code of Federal Regulations. The EAFUS list and the Indirect Additive list on the CFSAN Internet consist of selected fields of information generated from PAFA.

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.

SCOGS Report – “SCOGS” is the acronym for the Select Committee On GRAS Substances. Beginning in 1972, under a contract with FDA, the Life Sciences Research Office of the Federation of American Societies for Experimental Biology convened the Select Committee, which independently undertook a comprehensive review of the safety and health aspects of GRAS food substances on the FDA’s then proposed GRAS list. The Select Committee published its evaluations in a series of reports known as the SCOGS Reports. A listing of opinions and conclusions from 115 SCOGS reports published between 1972 and 1980 is available on the CFSAN Internet.

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.

Threshold of Regulation (TOR) Exemption – A substance used in a food contact article may be exempted from the requirement of a food additive listing regulation if the use in question has been shown to meet the requirements in 21 CFR 170.39. For details, see 21 CFR 170.39. For a complete listing of the TOR exemptions, consult the Threshold of Regulation inventory on the CFSAN Internet.