The United States Food and Drug Administration's Proposed Mandatory Generally Recognized as Safe Notification Rule: What It Means for Food Ingredient and Food Contact Material Manufacturers

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Sustainable food packaging including kraft paper containers, a takeaway cup, and cardboard boxes.
27 Aug 2026

The United States (U.S.) Food and Drug Administration (FDA) recently proposed a rule change which would transform its voluntary notification structure for Generally Recognized as Safe (GRAS) substances into a mandatory pathway.

This potential rule update has generated significant discussion across the food industry. While many conversations have focused on the impact on food ingredients, the proposal would also affect companies that manufacture food contact materials, such as packaging components, coatings, adhesives, processing aids, pigments, and other substances that may directly or indirectly become part of the food supply.

At the time of writing, this remains a proposed rule. The final requirements, timelines, and implementation details could change as the FDA reviews stakeholder feedback. However, companies that understand the proposal today will be better positioned to evaluate potential impacts and develop regulatory strategies if the rule is finalized.

This post is the first in a three-part series where we; 1) give an overview of what the proposed rule is and what it means for companies in this space, 2) describe what companies can do right now to better prepare for this potential rule change, and 3) describe the options and opportunities to reach or maintain FDA compliance if the rule goes into effect. The purpose of this series is to educate companies on what the FDA is proposing, what they can do to prepare for it, and strategic options to move forward.

A Quick Refresher: What Is Generally Recognized as Safe?

FDA defines GRAS as a substance whose intended use in food is considered safe by qualified experts based on either a long history of common use in food before 1958 or on publicly available scientific evidence establishing safety. Companies may independently conclude that a substance is GRAS and, under the current system, may voluntarily submit a GRAS notice to FDA describing the substance, its intended use, manufacturing process, exposure assessment, and supporting safety data. FDA reviews the submission and typically responds with either a "No Questions" letter, indicating it has no questions regarding the company's GRAS conclusion, or identifies issues that prevent it from reaching that response.

Importantly, the FDA does not currently require companies to submit their self‑determined GRAS conclusion for review. Companies may choose to submit a GRAS notice, but participation in the notification program is considered voluntary.

Since its introduction through the Federal Food, Drug, and Cosmetic Act in 1958, many ingredient manufacturers, food companies, and food contact material suppliers have utilized the self-determined GRAS pathway to support commercialization of new technologies and substances.

What Is the FDA Proposing?

The core change is relatively simple: the FDA is proposing to make its voluntary GRAS notification system largely mandatory. Companies currently using or introducing substances into interstate commerce under the GRAS provision would be required to notify the FDA of the basis for their GRAS conclusion unless a specific exemption applies. It is still unclear what the review process would look like for a GRAS notification, but the FDA is proposing a 1-year “streamlined” GRAS reporting pathway for materials that have already been introduced into interstate commerce and rely on self-determined GRAS status.

The FDA states that the proposed change is intended to increase transparency, improve visibility into substances entering the food supply, and provide the agency with additional information to support food safety oversight.

Who Could Be Impacted?

A wide range of industries should be paying attention.

Food Ingredient Manufacturers

Companies producing novel, functional, or fermentation-derived ingredients; processing aids; and/or specialty food additives may be affected if their products currently rely on self‑determined GRAS conclusions.

Food Contact Material Manufacturers

The proposal applies to substances added indirectly to food, including substances associated with food packaging and food contact applications.

Potentially impacted industries may include:

  • Packaging manufacturers;
  • Polymer suppliers;
  • Coating manufacturers;
  • Adhesive suppliers;
  • Recycling technology companies;
  • Paper and fiber packaging developers; and
  • Food contact material innovators.

Many organizations in the food contact sector have historically used Food Contact Notifications (FCNs) or other regulatory pathways. However, some food contact substances currently rely on self-determined GRAS conclusions, which could place them within the scope of the FDA proposal.

Food Manufacturers and Brand Owners

Companies that purchase ingredients or packaging materials supported by self‑determined GRAS conclusions may also need to better understand the regulatory status of substances within their supply chain.

Why Food Contact Materials Deserve Special Attention

Most of the conversation surrounding the proposed rule has focused on food ingredients, but the proposal is broader than many organizations realize. Its potential impact on food contact substances has been largely overlooked.

The FDA explicitly notes that food substances include ingredients added to food indirectly, such as materials that migrate into food from food packaging, food processing materials, and other materials that come into contact with food. The proposal also discusses the growing complexity of food contact technologies, alternative packaging systems, and emerging materials entering the marketplace.

This is particularly relevant as companies continue to invest in sustainable packaging, recycled, bio-based materials, novel polymer systems, and circular economy initiatives. These technologies often require sophisticated regulatory strategies involving toxicology, migration assessments, exposure analyses, and analytical characterization.

For many organizations, the key question is not whether a product is safe. Instead, the question is whether the current regulatory pathway remains the most appropriate route if the FDA finalizes the proposed rule.

What Is Not Changing

Equally important is understanding what the proposed rule does not do.

The proposal does not eliminate the GRAS pathway; companies would still be able to reach their own GRAS conclusions based on scientific evidence and expert review. The FDA is also not proposing a system where every GRAS substance must be formally approved before entering the market. Materials that meet some of the specified exemptions would not be required to submit a GRAS notification to the FDA.

In addition, several alternative routes to market would remain available under the proposed framework, including certain FCN pathways and Threshold of Regulation Exemptions, where applicable.

Understanding these distinctions is critical because the most effective future regulatory strategy may differ from one product or technology to another.

What Companies Should Be Thinking About Today

Although the proposal is still under review, now is a good time for companies to begin evaluating:

  • Which of its products currently rely on self-determined GRAS conclusions;
  • What supporting data packages exists;
  • Whether its manufacturing processes have changed since the original assessment;
  • If current toxicology and exposure assessments remain up to date;
  • Whether its food contact materials are supported through GRAS, FCNs, or other mechanisms; and
  • Which products could require additional regulatory attention if the proposal is finalized.

The organizations that begin gathering this information now will be in a stronger position to respond efficiently to any future regulatory changes.

Coming Up – What Companies Can Do Now to Prepare

In our next post, Self-Determined GRAS Today: How Ingredient and Food Contact Companies Should Prepare for Potential Changes, we take a deep dive into what companies can and should be doing now to prepare for this potential rule change. It is critical that companies begin to prepare for this rule change, even before the rule may be finalized and approved.

How Intertek Can Help

At Intertek, our role is not to advocate for regulatory outcomes. Our role is to help clients understand and make informed, science-based decisions about evolving requirements like the FDA’s proposed rule change.

Whether your products are food ingredients, food contact substances, packaging materials, or emerging technologies, navigating regulatory changes requires more than a single area of expertise. Intertek's multidisciplinary teams work together to help clients evaluate regulatory options and build scientifically robust compliance strategies. Our capabilities include:

  • FDA regulatory consulting;
  • GRAS assessment and notification support;
  • FCN support;
  • Toxicological risk assessments;
  • Migration and exposure modeling;
  • Analytical chemistry and extractables and leachables testing;
  • Food contact compliance evaluations; and
  • Global regulatory strategy development.

As the FDA's proposed rule continues through the regulatory process, our goal remains the same: to help companies understand potential impacts, identify practical pathways, and make confident decisions.  

Professional headshot of Dennis Ashford
Dennis Ashford

Manager, Senior Consultant, Staff Scientist, Intertek Assuris

Dennis graduated with a B.S. in Chemistry from Northern Kentucky University and received his Ph.D. in Chemistry from the University of North Carolina at Chapel Hill researching artificial photosynthesis. He then worked at Eastman Chemical Company for four years developing new materials for medical devices and then spent eight years as an Associate Professor of Chemistry at Tusculum University in Eastern Tennessee. While at Tusculum, Dennis served as the Principle Investigator researching new anti-cancer prodrugs that limit the harsh side effects of traditional chemotherapeutics. He has been with the Intertek Assuris team for a year, utilizing his chemistry expertise to help clients design, implement, and execute complex analytical projects to support FCN submissions. He works directly with our clients and analytical chemist to ensure the analytical strategies are robust and meet agency requirements.

Outside of his professional career, Dennis is an avid whitewater kayaker and mountain biker, often spending his time off outside.  He is excited to bring his expertise and excitement to the team.

Professional headshot of Rebekah Morrow
Rebekah Morrow

Director, Regulatory Notifications and Compliance, Intertek Assuris

Rebekah is currently Director, Food Contact Notifications & Compliance for Intertek Assuris’ Regulatory Market Access (RMA) team.  Rebekah is based out of Intertek Assuris’ US RMA group in Boca Raton, Florida but works from her home office in Kingsport, Tennessee.   Rebekah is a subject matter expert on global food contact regulations and food contact notification submissions.  She advises clients on the regulations that apply to food packaging in the United States and other countries around the globe.

Rebekah graduated with a B.S. degree in Chemistry from King University.  Prior to joining Intertek in May of 2021, she spent 22 years working in the chemical industry.  The first seven years were spent in polymer research and development followed by 15 years in Regulatory Affairs supporting product safety and compliance in the areas of food additives, food packaging, pharmaceuticals, medical devices, and cosmetics.

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