FDA Proposes Mandatory GRAS Notifications: The End of Self-Affirmed Ingredients

Special edition · US regulation

The FDA has proposed ending the era of silent, self-affirmed GRAS. Every substance added to human or animal food on the strength of a company’s own safety conclusion would have to be notified to the agency — including the ones already in your products. Comments close 9 December 2026.

iComplai · Food Safety Research Team/ Special edition · Last reviewed August 2026
Linocut-style illustration of a person and their dog at a kitchen table, each reading their own official notification about their own meal, while a cat on the windowsill stretches a paw toward the dog’s food bowl
The proposal covers both parts of dinner: 21 CFR part 170 for human food, part 570 for animal food. The cat, as ever, considers itself exempt.

“Generally Recognized as Safe” (GRAS) is the 1958 exemption that lets a substance be added to food without FDA pre-market approval, provided qualified experts generally recognise it as safe under its intended conditions of use. Until now, telling the FDA about that conclusion has been optional. On 11 August 2026, the agency proposed making it mandatory.1

The proposed rule — Substances Generally Recognized as Safe, 91 FR 51834 — would amend 21 CFR parts 170 (human food) and 570 (animal food) to require a GRAS notice for any substance marketed on the basis of a GRAS conclusion: new or already in the food supply, ingredients and packaging-derived substances alike.1 The scale is why this matters — FDA estimates around 2,000 self-affirmed GRAS conclusions on the market, 94% in human food, held by roughly 1,028 firms.1

For almost seventy years, ingredient safety could be decided in private. The FDA now wants to be told.

≈2,000
Self-affirmed GRAS conclusions FDA estimates are on the market1
1,028
Firms holding at least one independent GRAS conclusion1
18 mo
From final rule to mandatory compliance1
The proposal

What would change for food manufacturers?

Five moves, all pointing the same direction: the agency wants to see the conclusions industry has been keeping to itself.

  1. 1Notification becomes mandatory. Anyone introducing a substance into interstate commerce under the GRAS provision must notify FDA of the basis for their conclusion — whether the substance is new or has been in the food supply for years.1
  2. 2Human and animal food alike. Part 570 mirrors part 170, so feed and pet-food ingredients face the same requirement. Indirect substances, including migration from food-contact materials, are in scope.1
  3. 3Non-compliance gets a consequence. If the notification requirement is not met, FDA would treat that as a factor when prioritising substances for post-market safety review.1
  4. 4Confidentiality gets harder to hide behind. Data withheld from disclosure must be identified at submission — and the notifier must explain how a substance can be “generally recognised” as safe when qualified experts cannot see the withheld evidence.1
  5. 5Submissions go electronic. GRAS notices would be filed through the Human Foods Program’s Centralized Online Submission Module (COSM), with complete English translations required for any foreign-language material.1
Exceptions

Who would not need to submit a GRAS notice?

Proposed § 170.205(b) lists seven situations in which no notice is required.1 Most of them have one thing in common: FDA has already seen the substance through some other door.

  1. 1“No questions” letter. An FDA no-questions letter already covers the substance under the same conditions of use.
  2. 2Listed or affirmed as GRAS. The substance appears in 21 CFR parts 182, 184 or 186 (582/584 for animal food).
  3. 3Common use in food before 1958. The substance qualifies as GRAS under the criteria of § 170.30.
  4. 4Already considered by FDA. An established evaluation process has covered the use, with public documentation identifying no need for a notice.
  5. 5Threshold-of-regulation (TOR) exemption. The use holds a TOR exemption under § 170.39.
  6. 6Effective food-contact notification (FCN). An FCN covers the substance, sourced from the same manufacturer or supplier.
  7. 7Streamlined submission on file. The existing use is on FDA’s public list (see below) and FDA has not demanded more.

One boundary to keep clear: pesticide residues, pesticide chemicals, colour additives, pre-1958 sanctioned substances, new animal drugs and dietary-supplement ingredients are excluded from the food-additive definition altogether — they cannot be the subject of a GRAS notice at all.1

Quick check · does my ingredient need a GRAS notice?
Is the use a pesticide, colour additive, new animal drug, pre-1958 sanction, or a dietary-supplement ingredient?
Yes → Outside GRAS entirely — these categories follow their own pathways.1
NO ↓
Is the use already covered — a no-questions letter, a GRAS listing in parts 182/184/186, a TOR exemption, or an effective FCN?
Yes → No notice needed (§ 170.205(b)).1
NO ↓
Is it GRAS through common use in food before 1958?
Yes → No notice needed.
NO ↓
Was the substance on the market before the final rule takes effect?
Yes → Streamlined submission — but only within the one-year window. After that, full notice.1
NO ↓
Full GRAS notice to FDA via COSM before marketing— or a food-additive petition, if general recognition cannot be shown.
Legacy ingredients

What is the streamlined pathway for ingredients already on the market?

Instead of forcing a full dossier for every legacy ingredient at once, proposed Subpart F offers a one-time, time-limited shortcut.1

For a substance already in interstate commerce before the final rule’s effective date, a company may file a streamlined submission instead of a full GRAS notice. Five things go in:1

  • Who — submitter name and address
  • What — the name of the substance
  • How used — which foods, at what levels, for what purpose
  • Since when — evidence it was on the market before the effective date
  • History — the prior GRN number, if FDA once sent a “cease to evaluate” letter

FDA posts qualifying submissions to a public list — posting does not mean review. The agency can ask questions and can still demand a full notice or a food-additive petition; the route is closed where FDA has already flagged an insufficient basis or found the use not GRAS.1

The streamlined window closes one year after the rule takes effect. After that, it is the full dossier.

Linocut-style illustration of a checkpoint with two lanes: existing ingredients pass a fast desk with a single stamped card, while a new ingredient waits in a slow lane with a tall stack of dossiers
Two lanes after the rule: ingredients already on the market file five data points into a one-time listing lane — a listing, not a safety review — while new ingredients carry the full dossier.
Timeline

When would mandatory GRAS notification take effect?

Left to right: solid dates first, then the clocks that start ticking only if the rule is finalised.

1958
Congress enacts the Food Additives Amendment — pre-market approval for additives, and the GRAS exemption from it.1
1997 → 2016
FDA replaces affirmation petitions with the voluntary notification programme (proposed 1997; finalised 2016).1
10 MAR 2025
The HHS Secretary directs FDA to end self-affirmation without notification.1
11 AUG 2026
Proposed rule published: 91 FR 51834, Docket FDA-2025-N-3262.1
9 DEC 2026
Public comments close, 23:59 US Eastern.14
FINAL RULE + 60 DAYS · ≈ EARLY 2028
The rule takes effect 60 days after publication of the final rule.1
+ 1 YEAR · ≈ EARLY 2029
The streamlined submission window for existing substances closes.1
+ 18 MONTHS · ≈ MID 2029
Compliance date for the notification requirement (§§ 170.205 / 570.205).1

Drag sideways for the full timeline · green = fixed dates · orange = clocks that only start if the rule is finalised. The orange year figures are our estimates, assuming FDA finalises the rule about a year after comments close (late 2027); if finalisation slips, every orange date slips with it.

Precedent

Has anything like this happened before?

Once — and the parallel is instructive.

In 1969, FDA deleted cyclamate sweeteners from the GRAS list over rat bladder-tumour findings — and President Nixon ordered a re-examination of every substance on the list.1 That was the last full-scale crisis of confidence in GRAS, answered then, as now, with systematic re-examination rather than abolition. The difference is who does the work: in the 1970s FDA reviewed its own list; in 2026, industry must bring its private conclusions to FDA. The nearer arc runs 2010 → 2016 → 2026: a Government Accountability Office report found FDA generally has no information about unnotified GRAS conclusions15, the 2016 rule formalised voluntary notices, and this proposal makes them mandatory.

The proposal even names the incident behind it: the 2022 tara flour recall — roughly 400 adverse event reports, from gastrointestinal illness to hospitalisations. When FDA asked for the records behind the ingredient’s presumed GRAS status, the firm produced none.1 Mandatory notification moves that conversation to before an ingredient ships, not after the recall.

Analysis

Which ingredients will struggle most?

The rule does not change what GRAS means — it changes who can comfortably claim it. Substances covered by no-questions letters or well-published safety literature will barely notice. Four categories will. This is our read, not the agency’s.

Linocut-style illustration of a waiting room: a flavour bottle backed by a crowd of identical bottles, a chained briefcase, a spiky botanical pod and a fermentation flask, each holding a queue ticket outside a review office
The waiting room: the flavour crowd, the confidential dossier, the novel botanical and the fermentation flask — the four categories with the hardest road to “general recognition”.
  1. 1Association-panel flavourings. By FDA’s own estimate, 1,740 of the roughly 2,000 legacy self-affirmed conclusions trace to expert panels convened by trade associations — most prominently the flavour industry’s.1 FDA expects these to arrive largely as bulk streamlined submissions, but every entry becomes individually visible on the public list, and any of them can be pulled up for a full notice. A parallel safety system that ran alongside FDA for decades is being folded into public view.
  2. 2Conclusions built on confidential studies. General recognition requires evidence qualified experts can actually see. The proposal forces notifiers to identify withheld data and explain how a GRAS conclusion survives without it1 — a needle that gets harder to thread the more the pivotal evidence is secret. Expect some of these conclusions to migrate to food-additive petitions, and others to finally publish their studies.
  3. 3Novel botanicals and “clean label” ingredients. The tara-flour class: plant-derived ingredients with short market histories and thin published toxicology. These were always the weakest GRAS claims; they are now the most exposed, because the claim has to be written down and shown.
  4. 4Fermentation-made and cell-derived ingredients. Where the science is newest, “general recognition among qualified experts” is genuinely contested and publication lags innovation. For some of these, the food-additive petition — slower, but built for confidential data — may prove the more honest fit.
Evidence

What would a GRAS conclusion need to rest on?

The substantive standard does not move: general recognition of safety requires the same quantity and quality of scientific evidence as a food-additive approval, resting on data that are generally available and accepted — or on common use in food before 1958.1 What changes is that the standard would finally be enforced through visibility.

In practice, a conclusion that comfortably survives a mandatory notice rests on four pillars — the informal era of an expert panel’s signature in a drawer is precisely what the rule is built to end:

Published studies
Peer-reviewed pivotal safety data that experts can actually see
Right-sized toxicology
Genotoxicity → subchronic → higher tiers as intake rises
Quantified exposure
Estimated intake across all intended uses, stacked
Named experts
A written consensus narrative from identifiable qualified experts

Where this is likely to land. Expect the comment period to pull in both directions: FDA explicitly invites burden-reducing alternatives, such as widening the streamlined route to all substances1, while health advocates will push the other way — towards requiring the underlying safety data with every notice. And whichever way the final text moves, the public inventory will be read by more than FDA: NGOs, retailers, plaintiffs’ lawyers and state legislatures will mine it. After this rule, a weak GRAS file is not only a regulatory risk. It is a public artefact.

Action list

What should QA and regulatory teams do now?

Nothing is mandatory yet — which is exactly why the next months are the cheap time to prepare.

  1. 1Inventory your exposure. List every ingredient, processing aid and contact material in your products whose legal status rests on a self-affirmed GRAS conclusion — your own or a supplier’s.
  2. 2Ask suppliers the hard question. Which of their ingredients rely on independent GRAS conclusions, and do they hold the dossier a notice requires — identity, manufacturing method, dietary exposure, safety narrative?
  3. 3Choose a pathway per substance. Full GRAS notice, streamlined submission inside the one-year window, food-contact notification where applicable — or reformulation where the dossier will not stand up.
  4. 4Use the comment period. Docket FDA-2025-N-3262 is open until 9 December 2026. Definitions, timelines and burden all get shaped now, not after finalisation.4
Where iComplai fits in

Two ways we help you get ahead of this

iComplai monitors RASFF, FDA, FSA and 50+ official sources continuously — billions of data points daily — and turns them into ingredient- and supplier-level risk signals.

Option one

Regulatory horizon scanning

We track this rulemaking — and every other authority signal that touches your ingredients — so the final rule, its compliance clocks and any FDA statements of concern reach you the day they land, not when a customer asks.

  • Alerts as the GRAS rule moves: comment deadlines, final publication, effective and compliance dates
  • Per-ingredient safety signals from recalls, import alerts, border rejections and media
  • Early sight of which additive categories draw regulator attention next

Where to start: iComplai regulatory monitoring

Option two

Ingredient & supplier exposure mapping

Send us your ingredient and supplier list. We map which items carry additive-safety signals across official databases and global media — so you know which self-affirmed ingredients to document first, and which suppliers to question hardest.

  • Which of your ingredients and suppliers already show safety or compliance signals
  • Risk assessment on a new ingredient or supplier within 30 seconds
  • A prioritised order for the dossier work the rule would trigger

Where to start: Supplier verification · Risk assessment

FAQ

Frequently asked questions

What does GRAS mean?

GRAS stands for “Generally Recognized as Safe” — a category created by the 1958 Food Additives Amendment to the US Federal Food, Drug, and Cosmetic Act. A substance is GRAS when qualified experts generally recognise it as safe under its intended conditions of use, which exempts that use from FDA’s pre-market food-additive approval.

Is submitting a GRAS notice currently mandatory?

No. Under the programme FDA finalised in 2016, notifying the agency of a GRAS conclusion is voluntary. Companies may lawfully market a substance on a self-affirmed GRAS conclusion without telling FDA. The rule proposed on 11 August 2026 would make notification mandatory, with limited exceptions.

Does the proposed rule cover ingredients already on the market?

Yes. Substances already in the food supply based on self-affirmed GRAS conclusions would need either a full GRAS notice or a streamlined submission under proposed Subpart F — a one-time option that closes one year after the final rule’s effective date.

Does it apply to animal food?

Yes. The proposal amends 21 CFR part 570 in parallel with part 170, so substances in animal food and feed — including pet food — face the same notification requirement.

When would companies have to comply?

Not yet — this is a proposal. Comments close on 9 December 2026. If finalised, the rule would take effect 60 days after publication of the final rule, with a compliance date 18 months after the effective date for the notification requirement. If FDA finalises about a year after comments close, that would put mandatory compliance around mid-2029 — an estimate, not a published date.

How many of your ingredients rest on a GRAS conclusion the FDA has never seen?

Send us your ingredient and supplier list, and we will show you where the signals already are — before the rule makes the question urgent.

Talk to iComplai
References

Where these claims come from

  1. FDA — Substances Generally Recognized as Safe; Proposed Rule. 91 FR 51834–51881, 11 August 2026. Docket FDA-2025-N-3262, RIN 0910-AJ02. Mandatory notification (§§ 170.205/570.205), exceptions list, Subpart F streamlined submissions, COSM electronic filing, effective/compliance dates, and FDA’s estimates of independent GRAS conclusions and affected firms.
    federalregister.gov
  2. Official PDF of the proposed rule. Government Publishing Office print edition.
    govinfo.gov
  3. HHS press release, 10 August 2026. Announcement of the GRAS proposal and the ultra-processed-foods definition submitted for final review; statements by the HHS Secretary and the Acting FDA Commissioner.
    hhs.gov
  4. Public comment docket FDA-2025-N-3262. Where to submit comments until 9 December 2026.
    regulations.gov
  5. US Government Accountability Office — Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). GAO-10-246, February 2010. Found FDA generally lacks information about GRAS conclusions never submitted to the voluntary programme.
    gao.gov
  6. iComplai — Regulatory monitoring. Continuous monitoring of RASFF, FDA, FSA and 50+ official sources.
    icomplai.com/regulatory

Disclaimer. This article summarises a proposed rule as published in the Federal Register and reflects iComplai’s reading as of 12 August 2026; sections marked as analysis are our own interpretation. It is general information, not legal or regulatory advice — verify details against the cited primary sources and consult your regulatory counsel before acting. Prepared with AI assistance and reviewed by the iComplai team.

Ömer Korkmaz