Best if printed in landscape.
Standards of Identity, Food Additives, and Food Ingredients (including GRAS)
This page addresses
- identity standards for food products,
- food additives, and
- food ingredients (including the concept of GRAS).
Standards of Identity for Food Products
- The Food Drug and Cosmetic Act (FDCA) directs the FDA to establish definitions and standards for food, see 21 U.S.C. §341.
- "Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container."
- FDCA standards specify minimum and maximum requirements, optional ingredients, and prohibited ingredients.
- FSIS (USDA) also establishes standards of identity for the food products it regulates; see “Definitions and Standards of Identity or Composition” for meat products at 9 CFR Part 319 (authorized by Meat Inspection Act)
- Also see 9 CFR §381.155 to §381.174 for standards for poultry products.
- Identity standards are established to help consumers
- The standards establish a common name for the food product
- The standards also set content requirements for the food product
- Identity standards do not address quality issues - such as inadvertent adulteration, or whether the item meets the consumer's individual nutritional needs.
- What about identity standards for products from commingled commodities, e.g., frozen dinners? See 21 CFR 102.26, for example.
Do not overlook standards established by other entities, such as the standards specified by the Codex; see Current Official Standards.
Question: When there is no standard of identity, is the processor free to name the food product whatever it wants?
Response: The following example may provide an answer.
"FDA established a standard of identity for white chocolate in response to petitions filed separately by the Hershey Foods Corporation and by the Chocolate Manufacturers Association of the United States of America."
"On October 4, 2002, FDA published a final rule in the Federal Register that established a standard of identity for white chocolate (67 FR 62171)."
Establishing a standard of identity appears to follow a process similar to "petitioning for a regulation" for a food additive, as discussed in the next section of this web page.
Food Additives and Food Ingredients (see 21 CFR parts 170 to 189 and 21 CFR part 582; also see 21 CFR parts 570 and 571)
FDA has information about food additives on its web site. This page includes links to an Overview and several Industry Guidances.
As stated previously, federal law prohibits adulterated food from entering interstate commerce. Food can be adulterated in a variety of ways, for example,
1) the omission or removal of a valuable component (21 USC §342(b)),
2) using ag commodities that are not fit for human food (21 USC §342(a)(3) and (a)(5)), or
“(a) A food shall be deemed to be adulterated … (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or … (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter … ”
3) by adding unsafe/unacceptable substances when processing the food (21 USC §342(a)(2)(C)(i), 21 USC §321(s), and 21 USC §348(a)(2)).
“(a) A food shall be deemed to be adulterated … (2)(C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title;"
"(s) The term “food additive” means any substance the intended use of which results ... , directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food ...) if such substance is not generally recognized, among experts ... as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use ..."
"(a) A food additive shall, with respect to any particular use ... , be deemed to be unsafe ... unless ... (2) there is in effect, and it and its use ... are in conformity with, a regulation ... prescribing the conditions under which such additive may be safely used;"
This section of the course addresses the third situation – adding substances during the processing. Some basic principles:
- Substances added to food fit the broad categories of 1) food additives, 2) food ingredients that are generally recognized as safe (GRAS), and 3) prohibited substances.
- The law recognizes that substances can be added to the food 1) as a component of the food, 2) through contact with packaging material, and 3) through contact with surfaces on processing equipment.
- The law recognizes that both the substance and its use must be safe.
- The law recognizes that GRAS ingredients can be identified based on either a long history of use or scientific evidence that the item is safe.
With these basic rules/observations, we can now address some key concepts.
“A substance that will be added to food [that is, a food additive] is subject to pre-market approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.” Excerpt from GRAS Notification Program.
“Food additives includes all substances … the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food.
“A material used in the production of containers and packages is subject to the definition [of food additive] if it may reasonably be expected to … affect the characteristics … of food packed in the container … If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive.
“A substance that does not become a component of food, but that is used, for example, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.”
Source: 21 CFR 170.3(e)(1).
Mandatory Reading -- Now is a good time to read an edited excerpt from the Federal Register April 1997; it explains many of the events impacting the regulation of food additives beginning in 1958.
With this background, let's now discuss the concept of GRAS
GRAS and Food Ingredients
(a) An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201(s)(4) of the Act is exempt from classification as a food additive. 21 CFR 181.1
(l) Prior sanction means an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food and Drug Administration or the United States Department of Agriculture pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act. 21 CFR 170.3(l) Also see 21 CFR 181.5 which discusses the limit and amendment of prior sanctions.
GRAS and GMP – 21 CFR 182.1
"(a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use. This part includes additional substances that, when used for the purposes indicated, in accordance with good manufacturing practice, are regarded by the Commissioner as generaly recognized as safe for such uses.
(b) For the purposes of this section, good manufacturing practice shall be defined to include the following restrictions:
(1) The quantity of a substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritional, or other technical effect in food; and
(2) The quantity of a substance that becomes a component of food as a result of its use in the manufacturing, processing, or packaging of food, and which is not intended to accomplish any physical or other technical effect in the food itself, shall be reduced to the extent reasonably possible.
(3) The substance is of appropriate food grade and is prepared and handled as a food ingredient. Upon request the Commissioner will offer an opinion, based on specifications and intended use, as to whether or not a particular grade or lot of the substance is of suitable purity for use in food and would generally be regarded as safe for the purpose intended, by experts qualified to evaluate its safety."
- Having GRAS status means the substance can be used in the food product as long as the substance is used for its intended purpose and in accordance with good manufacturing practices (GMP); for example, see 21 CFR 184.1(b).
Note that GRAS status addresses both the substance and how the substance is being used; for example, a substance may be GRAS for one use but not for another use, or a substance may be GRAS for a particular use as long as it is used within the specified limit. For example, see acetic acid at 21 CFR 184.1005.
- See 21 CFR part 182 for a list of GRAS substances. However, the large number of substances intended for use in food renders it impracticable to list all substances that are GRAS.
- GRAS status may be based only on (1) scientific procedures or (2) common use in food prior to January 1, 1958 (21 CFR 170.30).
- GRAS status based on scientific procedures is ordinarily based on published scientific studies
- Safe means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. (21 CFR 170.3(i)).
- GRAS status based on common use in food prior to 1958 is based solely on the food use of the substance prior to 1958 and generally available data and information. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS.
- An ingredient not in common use in food prior to 1958 may achieve GRAS status only through scientific procedures.
- "Beginning in 1969, the Food and Drug Administration has undertaken a systematic review of the status of all ingredients used in food on the determination that they are GRAS or subject to a prior sanction. All determinations of GRAS status or food additive status or prior sanction status pursuant to this review shall be handled pursuant to Secs. 170.35, 170.38, and 180.1 of this chapter.
- Over time, substances on the GRAS list will be re-evaluated. Based on the outcome, the substance will be listed as 1) “affirmed as GRAS'' (see 21 CFR part 184 or 186) 2), “food additive regulation'' (see 21 CFR parts 170 through 180), 3) “interim food additive regulation'' (see 21 CFR part 180), or 4) “prohibited from use in food'' (see 21 CFR part 189) (21 CFR 182.1(d)).
- Affirmation of GRAS status shall be announced in part 184 or Sec. 186.1 of this chapter." Taken from 21 CFR 170.30(e)
- As these re-evaluation occur, the significance of the 1958 date will decline, and substances will be removed from "part 182" of the regulations to one of the other "parts," as described in the preceding point.
(a) The Commissioner, either on his initiative or on the petition of an interested person, may affirm the GRAS status of substances that directly or indirectly become components of food. 21 CFR 170.35(a)
(a) The direct human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed. 21 CFR 184.1(a)
(a) The indirect human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed, providing they comply with the purity specifications… 21 CFR 186.1(a)
Food Additives Subject to "Food Additive Regulation"
Now let's address how to get an additive approved if it does not quality as GRAS; that is, how to have a regulation put into effect that prescribes how the additive may be used.
21 USC 348(b)(1) Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.
- A food business intending to use a new substance in its food product must petition for FDA approval (21 CFR part 171). The business is expected to submit data it has on the safety of using the substance as a food component. FDA will provide an opportunity for public and industry comment on the request. Based on the information and comments, FDA will determine a status for the substance, e.g., GRAS, a food additive, or prohibited. This determination will be incorporated into FDA’s regulations. The requesting business and other businesses can then use the substance according to FDA’s determination.
- A substance that is not GRAS, but can be used as a food additive, generally has limitations imposed on its use. For example, see dehydroacetic acid at 21 CFR 172.130. For a more complete listing of food additives, see 21 CFR parts 172 to 178.
- Note the distinction between direct and indirect food additives. For example, a direct food additive is intended to become a component of the food or affect the characteristic of the food (see 21 CFR 170.3(e)). An indirect additive includes "substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels..." (21 CFR 174.6).
Now let's address what is left if the substance is not GRAS (an ingredient) or an additive --
Some substances are prohibited from being used in food; see 21 CFR part 189.
Color Additives: FDA's Regulatory Process
and Historical Perspectives
"The Color Additive Amendments of 1960 defined "color additive" and required that only color additives ... listed as "suitable and safe" for a given use could be used in foods, drugs, cosmetics, and medical devices... Under these amendments, the approximately 200 color additives that were in commercial use at the time were provisionally listed and could be used on an interim basis until they were either permanently listed or terminated due to safety concerns or lack of commercial interest. Permanently listing a color additive for a proposed use was prohibited unless scientific data established its safety."
See 21 USC §379e --
"A color additive in or on food... [shall] be deemed unsafe unless there is in effect a regulation listing such additive for such use, including ... conditions under which such additive may be safely used, and such additive either (i) is from a batch certified or (ii) has, with respect to such use, been exempted from the requirement of certification ..."
- 21 CFR 70.3(f) A color additive is any material capable of imparting color to food
- 21 CFR 70.3(i) "Safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive."
See 21 CFR parts 70 to 82
- 21 CFR part 73 -- color additives and uses allowed without having to be "batch certified;" that is, they have been exempted from the reguirement of certification.
- 21 CFR part 71 -- process for petitioning that a color additive be exempted from certification.
- 21 CFR part 74 -- color additives and uses that must be "batch certified."
- 21 CFR part 80 -- process for requesting that a batch of color additive be certified.
- Do not overlook international standards, such as Codex.
March 19, 2010