Overview
The GRAS is greener in the Food Additive Regulations.
Note: This article focuses on substances that FDA has independently assessed and determined to be Generally Recognized as Safe (GRAS) when used as components of food – and in turn, by way of appropriate cross-reference – for use in food contact applications. This article does not, however, address GRAS self-determinations, which is a developing topic. For more information on that front, see our article, Is a New Era for GRAS Determinations Here?
In the second edition of our StepLadder Series (FDA's Food Additive Regulations), we discussed the definition of a "food additive" under Section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act):1
- Any substance the intended use of which results or may reasonably be expected to result — directly or indirectly — in its becoming a component of or otherwise affecting the characteristic of any food.
Since the definition continues on to state that food additives may include substances intended for "producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food…" it's clear that food packaging may be considered a "food additive" in certain situations.
Under Section 409 of the FD&C Act, substances qualifying as "food additives" must undergo premarket review, unless they are the subject of a specific exception or exemption. For over 60 years, FDA has interpreted the FD&C Act consistently—substances that are Generally Recognized as Safe (GRAS) under their intended conditions of use are exempt from the premarket review process applicable to food additives.
FDA's regulation describing the eligibility for GRAS substances is found at 21 C.F.R. § 170.30 ("Eligibility for classification as Generally Recognized as Safe"). Under this regulation, general recognition of safety requires a "common knowledge" throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is a reasonable certainty that a substance is not harmful under the conditions of its intended use. More specifically, Section 201(s) of the Act defines a GRAS substance as one that is "generally recognized, among experts qualified by scientific training and experience to evaluate its safety, 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."
For substances not widely used in food prior to 1958, general recognition based on "scientific procedures" requires the same quantity and quality of scientific evidence as is required to obtain a food additive regulation for the substance.
Importantly, safety in the abstract is not a sufficient basis to establish general recognition of safety (emphasis added). FDA states that "it is the use of a substance, rather than the substance itself, that is eligible for the GRAS exemption… it is well settled that a mere showing that the use of a substance is 'safe' is not sufficient to exempt the substance from the act's definition of a 'food additive.'"2 More (and often, much more) is required, and intended use always matters!
Following passage of the 1958 amendments to the FD&C Act, FDA began compiling a list of substances that were "widely used in food," for specific purposes (and in accordance with good manufacturing practice), prior to 1958, effectively creating the initial list of GRAS substances. This list of substances first appeared in 21 C.F.R. § 121.01(d) and was later incorporated into 21 C.F.R. Parts 182 and 582 (both entitled, "substances generally recognized as safe") for human food and animal feed, respectively.3 Importantly, FDA acknowledged that it would be "impracticable to list all substances that are GRAS for their intended use," such that the GRAS list was neither expected, nor intended to be exclusive. (Indeed, one of the most commonly understood GRAS substances – sodium chloride – or table salt, appears nowhere in the GRAS list for general and direct addition to food!)
Ten years later, and as part of a reassessment of GRAS substances ordered by President Richard Nixon in response to questions regarding the safety of cyclamate salts when used in nonnutritive sweeteners, FDA began the process of re-evaluating, and thereby affirming, those substances presumed to be GRAS.4 Substances that were the successful subject of such a reassessment were later transferred from Part 182 ("Substances Generally Recognized as Safe") to Part 184 ("Direct Food Substances Affirmed as Generally Recognized as Safe") of the food additive regulations. Due to a combination of intervening historical events and funding and resource limitations, however, FDA did not complete the process of evaluating all of the substances that appear in Part 182. Therefore, substances listed today in the Code of Federal Regulations are now colloquially referred to as "GRAS listed" in Part 182 or "GRAS affirmed" in Part 184 of the Food Additive Regulations for specified uses for direct addition to food, respectively.
With FDA having established a basis for a GRAS determination (and, by extension, an exemption from the need for premarket approval) for certain substances when used as specified in food, we rely on two additional cross-referencing provisions of the Food Additive Regulations to demonstrate that these substances also may be used as intended in food contact applications:
- 21 C.F.R. § 174.5(d)(1) ("General provisions applicable to indirect food additives") provides that substances generally recognized as safe in or on food may be safely used as components of food contact articles. Section 174.5 specifically applies to GRAS substances that are listed at Part 182; and
- Similarly, 21 C.F.R. § 184.1(a) provides that ingredients affirmed as GRAS in Part 184 are also GRAS for use in food contact applications.
On these bases, substances listed and affirmed as GRAS for use in food may properly be considered GRAS when used in food contact applications and are properly exempt from the need for premarket approval. Of course, suitable purity and Good Manufacturing Practice (GMP) requirements continue to apply when these GRAS substances are used as intended in food contact applications.
1 See Section 201(s) of the Federal Food, Drug and Cosmetic Act.
2 See Proposed Rule, "Substances Generally Recognized as Safe," 62 Fed. Reg. 18938 (April 17, 1997), citing United States v. An Article of Food… 752 F.2d 11, 15 n. 4 (1st Cir. 1985).
3 See 24 Fed. Reg. 9368 (November 20, 1959).
4 See, e.g., FDA's Approach to the GRAS Provision: A History of Processes, available at: https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes.
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About the Steptoe StepLadder Series
Steptoe LLP is pleased to publish the Stepladder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.
This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn’t a 'food additive,' in which case you’re not food packaging.
