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Issue of the Month

Summary of FDA’s 2026 Proposed Rule on GRAS Substances

By Tim Lombardo, EAS Consulting Group Senior Director for Food Services

FDA has proposed significant changes to the Generally Recognized as Safe (GRAS) notification program that would introduce mandatory notification requirements for human food, animal feed, and many food-contact substances. While the proposal would not eliminate self-determined GRAS conclusions or change the scientific standard supporting them, it would establish new disclosure requirements and transition provisions that could affect many manufacturers.

In this month's Issue of the Month, Tim Lombardo summarizes the proposed rule, highlights what would change, explains what remains the same, and outlines practical considerations for companies that rely on GRAS determinations.

Whether you develop food ingredients, evaluate supplier documentation, or manage regulatory compliance, understanding these proposed changes now can help you prepare for future requirements.

Under the Microscope

What is GRAS (Generally Recognized as Safe)?

Reviewed and Approved by Tim Lombardo, EAS Consulting Group Senior Director, Food Consulting Services

As a member of the Certified Group family, EAS clients have access to world-class food safety expertise and analytical testing resources. In this edition's Under the Microscope, we highlight a Certified Laboratories article reviewed by Tim Lombardo that explains the fundamentals of the FDA's Generally Recognized as Safe (GRAS) framework and how it differs from the Food Additive Petition process.

With FDA proposing significant changes to the GRAS notification process, understanding the existing regulatory framework is more important than ever. The article explains how GRAS determinations are established, when a Food Additive Petition may be required, and why evaluating novel ingredients or new uses of existing ingredients requires careful scientific and regulatory review.

Whether you're developing a new food ingredient, reformulating an existing product, or evaluating regulatory pathways for market entry, this companion article provides valuable context to this month's Issue of the Month and serves as an excellent primer on one of FDA's most important food ingredient frameworks.

Recommended companion reading: This article provides foundational background for this month's Issue of the Month: Summary of FDA's 2026 Proposed Rule on GRAS Substances.

FDA and USDA Regulatory Updates

Key regulatory developments shaping compliance and market access:

▪ FDA’s Proposed GRAS Rule Clears White House Review

▪ FDA Releases Agenda and Opens Public Docket for Listeria monocytogenes Prevention Meeting

▪ FDA and NOAA Update Certification Procedures for Seafood Exported to the European Union

▪ FDA Proposes Mandatory GRAS Notifications for Human and Animal Food Substances

▪ FDA Finalizes Food Safety Guidance for Ready-to-Eat Fresh-Cut Produce Operations

▪ FDA Issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products

▪ USDA Launches Child Nutrition Programs Food Industry Toolkit

Stay current with EAS events, training, and industry engagement:

Consultant Corner

EAS offers over 200 independent consultants strategically located around the globe whose expertise provide core value for clients.

Meet This Month's Author

Tim Lombardo

Senior Director for Food Consulting Services

Tim Lombardo is Senior Director for Food Consulting Services at EAS Consulting Group and a recognized food safety and microbiology expert with more than 25 years of experience in food manufacturing and regulatory compliance. His expertise spans dairy, infant formula, produce, meat and poultry, spices, ingredients, and other food categories. Tim is a Lead Instructor for the Food Safety Preventive Controls Alliance (FSPCA) and the HACCP Controls Alliance, is certified in Thermal Processing and Sterilization through the Better Process Control School, and is a published author and international speaker.

Consultant Spotlight

Adam Orr, PhD, PAS
EAS Consulting Group, Independent Consultant

Adam Orr recently joined Tim Lombardo in presenting EAS Consulting Group's on-demand webinar, Animal Food GRAS: Unpacking the Essentials, where they explored FDA's regulatory pathways for animal food ingredients, including GRAS notifications, Food Additive Petitions, and other pre-market options.

A Certified Professional Animal Scientist and Animal Nutritionist, Adam spent more than 15 years at FDA's Center for Veterinary Medicine (CVM) as a Subject Matter Expert in the Division of Animal Food Ingredients. His experience includes pre-market review of animal food ingredients and additives, regulatory submissions, ingredient labeling, and GRAS notifications.

Today, Adam helps EAS clients navigate complex regulatory pathways for animal food ingredients, while collaborating with EAS's multidisciplinary team of consultants supporting both human and animal food GRAS projects.

Watch the on-demand webinar: Animal Food GRAS:
Unpacking the Essentials  Watch Now

EAS Consulting Group's GRAS consulting practice is supported by a multidisciplinary team with expertise in human food, animal food, ingredient safety, regulatory strategy, labeling, and scientific review.