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Summary of FDA’s 2026 Proposed Rule on GRAS Substances

By Tim Lombardo, Senior Director for Food Consulting Services

Top Takeaway

The FDA’s 2026 Proposed Rule would make GRAS notifications mandatory for human food, animal feed, and food contact substances—transforming what has long been a voluntary system into a required disclosure framework. Companies could still market GRAS substances without waiting for FDA approval, but they must notify FDA and provide sufficient information for potential independent review.

Key Changes at a Glance

  • Mandatory FDA notification for new GRAS determinations
  • Food-contact substances included
  • One-year transition pathway for existing GRAS substances
  • New administrative timelines
  • Scientific standard for GRAS remains unchanged

The proposed rule changes the notification process, not the scientific standard required to support a GRAS determination.

What the Proposed Rule Does

Mandatory GRAS Notification

FDA proposes revising 21 C.F.R. § 170.205(a) to require any company relying on self-determination of GRAS status to notify the Agency before or while marketing the substance.

This is not a premarket approval requirement. Companies may continue marketing the substance during FDA review.  However, failure to notify may increase the likelihood of post‑market assessment and potential FDA findings that a use is not GRAS.

FDA’s Filing Standard

FDA distinguishes between:

  • Submitting a notification, and
  • Satisfying the requirement (i.e., FDA accepts the filing).
  • FDA intends to make filing decisions within 45 days, but companies often wait 5–6 months for filing letters.

Food‑Contact Substances (FCS)

Food‑contact substances would also be subject to mandatory GRAS notification unless they already have:

FDA also proposes expanding ToR exemptions to include direct food additives, not just packaging materials.

One‑Year Transitional “Abbreviated Notification”

For GRAS substances already on the market, FDA proposes a one‑year window to submit an abbreviated filing.

This filing would include:

  • Substance identity
  • Intended uses and use levels
  • Evidence of interstate commerce prior to the Final Rule’s effective date

No safety data required.  FDA may later require full GRAS notifications or food‑additive petitions if safety concerns arise.

Additional Administrative Provisions

Key procedural elements include:

  • Electronic submission
  • 180‑day review period, with up to two 90‑day extensions
  • Rule effective 60 days after publication, with 18‑month compliance period
  • Expectation of GRAS notices for FEMA‑GRAS flavorings
  • Alignment of human food and animal feed GRAS processes

What the Rule Does Not Change

  • The statutory GRAS exemption remains intact.
  • The scientific standard for GRAS determinations remains unchanged: GRAS must be supported by the same quantity and quality of evidence required for a food additive regulation

Practical Considerations for Industry

Companies should:

  • Review all substances currently relying on GRAS self‑determinations
  • Identify which may qualify for the one‑year abbreviated pathway
  • Consider alternative regulatory pathways (e.g., FCNs, ToR exemptions)
  • Prepare for public disclosure of GRAS uses via FDA’s listings

Organizations evaluating the potential impact of the proposed rule should review their current regulatory strategy, supporting scientific evidence, and documentation before implementation.

    Need Help Evaluating FDA's Proposed GRAS Rule?

    Whether you’re reviewing an existing GRAS determination, planning a new ingredient submission, or evaluating how FDA’s proposed rule could affect your regulatory strategy, EAS Consulting Group’s multidisciplinary team can help.

    Speak with Our GRAS Experts

    How EAS Can Help

    EAS Consulting Group assists companies with GRAS notifications, Food Additive Petitions, Food Contact Notifications, ingredient safety evaluations, and broader FDA regulatory strategy. Our multidisciplinary team can help evaluate existing determinations, prepare new submissions, and navigate proposed regulatory changes.

    Issue of the Month 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.

    Posted in Foods, Issue of the Month.