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Background: The GRAS Framework

The Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) was established by Congress in 1958. In the Code of Federal Regulations, the rules that the FDA applies to food additives are spelled out in sections 21 CFR 170.3 and 170.30. A food additive is considered to be any substance that is intentionally added to food or may reasonably be expected to become a component of food, such as leachable components from packaging. These additives are required to be reviewed and approved by the FDA before the additives can be used in food products as part of a premarket approval process.

However, there are exceptions to this review requirement. If the substance is Generally Recognized by qualified experts As having been adequately shown to be Safe (GRAS) under the conditions of its intended use, the substance does not require FDA approval and is not considered a food additive. GRAS assessment can be performed through scientific analysis, or from safe historical consumption of the substance if it has been used in food prior to 1958.

The Self-Affirmation Pathway and Its Controversy

Since 2016, the FDA has operated a voluntary GRAS notification program.  Under this system, any qualified individual can notify the FDA that a substance is not subject to the premarket approval process as it is considered GRAS. The FDA may not question the basis for the GRAS conclusion, or it may conclude that there is insufficient information to make a GRAS conclusion.

Although the FDA had a GRAS affirmation process in place around 1972, it was discontinued by 1997 due to lack of resources and was replaced with the notification process. The FDA maintains a GRAS database of notifications. The GRAS list, which is not comprehensive, is located in 21 CFR 182, 184, and 186.[1] Notably, the GRAS notification process is voluntary, and does not require either notification or affirmation from the FDA.

This self-affirmation pathway has been criticized as a “loophole,” enabling manufacturers to introduce new food ingredients without sufficient safety data or transparency. While the process allows for efficiency and rapid market entry, it also means that the FDA and consumers may be unaware of new substances in the food supply.

Proposed Changes in 2025

In March 2025, the Health and Human Services secretary directed the FDA to consider removing the self-affirmation process of the GRAS program.[2] Companies would need to publicly notify the FDA of their intended use of substances in food products, along with safety data, before they could go to market with the substances. This substantial change in legislation would require many companies to re-evaluate their safety data and may require retroactive approval from the FDA.

Current vs. Proposed GRAS Process

Aspect	Current GRAS Program	Proposed Changes (2025)
FDA Notification	Voluntary	Mandatory
Public Disclosure	Not required	Required
FDA Premarket Review	Not required	Required
Industry Burden	Lower	Higher
Transparency	Limited	Enhanced
Time to Market	Shorter	Longer

Implementing these changes will not be immediate. The FDA must conduct formal rulemaking, and because the GRAS exemption is written into federal law, Congressional action may be required. These steps could take years and may face industry resistance and legal challenges.

Establishing Safety Profiles for Food Additives

• Deliberately Added Ingredients: Toxicological evaluation of the ingredients based on the chemistry and amount can assist in establishing the safety profile.
  
  
• Inadvertent Additives (e.g., from Packaging): Inadvertent food additives may be introduced from materials contacting food products, including food processing equipment, containers, or food preparation surfaces. In these cases, substances may diffuse into the food from the contact materials, which are often plastic and may contain antioxidants, colorants, plasticizers, and other stabilizers. For these substances, migration testing needs to be performed using food simulants to assess the amount of substance that is anticipated to be incorporated into the food product. This testing is comparable to leachables/extraction testing performed for medical devices.

Contact Cambridge Polymer Group for questions about migration testing in plastic products used in food contact.