The U.S. Food and Drug Administration (FDA) is planning a significant change to how certain food-related substances, including those used in food packaging, are regulated. As part of its Spring 2025 Unified Regulatory Agenda, the FDA has announced a proposed rule that would change how companies declare substances to be “Generally Recognized as Safe” (GRAS).
This proposed rule, expected to be published in October 2025, would require companies to formally notify the FDA whenever they determine a substance is GRAS. The proposed GRAS rule would amend FDA’s regulations in 21 CFR parts 170 and 570, which govern food additives and substances used in both human and animal food.
What Is GRAS?
GRAS stands for Generally Recognized as Safe, a legal term used by the FDA. A substance can be classified as GRAS if it’s considered safe for its intended use by qualified experts and there’s widespread agreement about its safety, often based on scientific data or long history of use.
This applies not just to food ingredients, but also to substances that may migrate from packaging into food, like:
- Plasticizers used to make plastics flexible
- Polymer additives that improve strength or heat resistance
- Antioxidants or stabilizers used in plastic films
- Adhesives or coatings on food-contact surfaces
- Monomers and oligomers that remain in trace amounts in packaging materials
Right now, companies can make their own internal GRAS determination for these substances—without telling the FDA. This is called the self-affirmed GRAS pathway. The FDA’s new rule would require companies to notify the FDA and share supporting safety data before using such substances in the food supply chain.
Key Changes in the Proposed Rule
If finalized, the new rule would:
- Make GRAS notifications mandatory: Companies would be required to submit a GRAS notice to the FDA for any substance (including those used in packaging) they claim is GRAS.
- Clarify exemptions: Substances already listed in the FDA’s GRAS inventory or those that have received a “no questions” letter from the agency would be exempt.
- Increase transparency: The FDA would maintain a public list of all GRAS notices, so that stakeholders can see what substances are being reviewed and under which conditions of use.
- Outline how substances may be rejected: The rule would clearly define the process the FDA uses to determine if a substance is not GRAS, adding transparency and consistency to enforcement actions.
Why This Matters for the Plastics and Packaging Industry
For manufacturers of food-contact materials, this rule could have wide-reaching impacts. Companies that previously relied on self-determined GRAS status for certain chemical additives or polymers may now need to:
- Submit scientific evidence to the FDA,
- Wait for regulatory review, and
- Adjust operations to align with any FDA concerns.
What’s Next?
The FDA is targeting October 2025 for publication of the proposed rule, but that date may shift. After publication, there will be a public comment period, during which stakeholders—including companies in the plastics and packaging industries—can provide feedback. After which the final rule can be expected between 2026 and 2027
This update signals the FDA’s commitment to stronger oversight of all substances that could end up in food, whether added directly or through packaging materials.
To prepare, companies should review self-affirmed GRAS ingredients, align with upcoming notification requirements, and monitor FDA comments for regulatory updates.