If you make or source food packaging, you’ve probably run into the acronym GRAS — Generally Recognized As Safe — and wondered whether the resin, adhesive, coating, or additive in your material actually qualifies. It’s a fair question: GRAS status isn’t a single certificate you can request, and it isn’t automatic just because a supplier says a material is ‘food safe.’
This guide walks through what GRAS actually means for packaging (as opposed to food ingredients), the specific FDA databases and CFR sections where a substance can be confirmed, and the questions to ask a supplier when the paperwork doesn’t clearly answer whether your material is covered.
Quick Answer
To confirm a packaging substance is GRAS, check whether it’s listed in 21 CFR Part 182 (GRAS listed) or affirmed in Parts 184/186 (GRAS affirmed for direct or indirect food use), search FDA’s GRAS Notice Inventory for a company-submitted GRAS notice on that substance, and ask your supplier for the specific regulatory basis — CFR citation, GRAS notice number, or Food Contact Substance Notification (FCN) — rather than accepting ‘GRAS’ as a standalone claim.
GRAS Is One of Several Compliance Paths — Not the Only One
FDA doesn’t require every substance used in food or food packaging to go through formal pre-market approval. A substance can be lawfully used in a food-contact material if it falls into one of several categories: it’s covered by an existing indirect food additive regulation (21 CFR Parts 174-179, which address adhesives, coatings, paper and paperboard components, polymers, and production aids); it’s GRAS; it was ‘prior sanctioned’ by FDA or USDA before 1958 (21 CFR Part 181); it qualifies for a Threshold of Regulation exemption because migration into food is negligible; or it’s the subject of an effective Food Contact Substance Notification (FCN) specific to one manufacturer’s use.
GRAS itself splits into two categories that matter for packaging. Part 182 contains substances ‘listed’ as GRAS between 1958 and 1962 based on common use at the time, without a full modern safety review. Parts 184 and 186 contain substances FDA formally reviewed and ‘affirmed’ as GRAS — Part 184 for direct food ingredients, Part 186 for indirect (i.e., packaging-related) use. A substance affirmed as GRAS for direct food use under Part 184 is also GRAS for indirect use per section 184.1(a), so it’s worth checking both parts, not just 186.
Step-by-Step: Confirming a Substance Is GRAS-Listed
Start with the CFR text itself. Search the current, official text of 21 CFR Parts 182, 184, and 186 on eCFR.gov for the substance’s chemical name or CAS number. If it appears with conditions matching your intended use (type of food, contact surface, temperature, etc.), you have your citation.
If it’s not in the CFR, check FDA’s GRAS Notice Inventory. Since 1998, companies have been able to voluntarily notify FDA of their own GRAS determination for a substance. FDA responds to a notice in one of three ways: a ‘no questions’ letter saying it doesn’t question the notifier’s GRAS basis, an ‘insufficient basis’ letter saying the notice doesn’t support a GRAS conclusion, or a ‘cease to evaluate’ letter closing the review at the notifier’s own request — often because the company plans to resubmit after addressing gaps FDA flagged informally. Only a ‘no questions’ response reflects FDA’s agreement with the GRAS claim, so check the actual letter type, not just whether a GRN number exists. These notices and FDA’s response letters are indexed by GRN number and searchable by substance name at fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory. Search using both the chemical name and any trade or common name, since notices are filed under whatever name the submitting company used.
If neither the CFR nor the GRAS Notice Inventory turns up a match, check the Inventory of Effective Food Contact Substance (FCS) Notifications for an FCN instead. FCNs are narrower than GRAS status — an effective FCN typically covers only the specific manufacturer, use, and conditions named in that notification, so it doesn’t automatically clear the same substance made or used by someone else.
Finally, remember that a substance can be ‘GRAS’ in the abstract but still not be cleared for your specific use. GRAS status (and every other pathway above) is tied to a use, a food type or contact surface, and often a concentration or migration limit. A packaging additive GRAS for dry, non-fatty foods at room temperature isn’t automatically fine for hot, fatty, or acidic contents — check the conditions listed alongside the citation.
Tips and Common Mistakes
Don’t accept ‘GRAS’ as a bare claim on a supplier spec sheet — ask for the CFR section, GRAS notice number, or FCN number backing it up, and verify it yourself in the source database. Supplier documentation is sometimes outdated, generalized from a different use case, or simply wrong.
If a supplier cites a GRN number, don’t stop there — pull up the actual FDA response letter for that GRN and confirm it’s a ‘no questions’ letter. A cease-to-evaluate or insufficient-basis letter on file for that substance means FDA never agreed the use was GRAS, even though a notice exists in the inventory.
Don’t assume a substance approved for direct food use (like a food additive or ingredient) automatically covers its use in packaging — direct-food GRAS and indirect/packaging GRAS are evaluated for different exposure levels and migration pathways, even though Part 184 substances often carry over into indirect use.
A company can determine a substance is GRAS on its own, without ever notifying FDA — this is sometimes called ‘self-affirmed’ or ‘independent’ GRAS. It’s legally permitted, but it means there’s no FDA record to check, so if a supplier cites ‘GRAS’ with no CFR citation and no GRN number, ask them directly for the safety data and expert conclusions behind that determination.
Multi-layer or multi-component packaging (a coated paperboard box, a laminated film, a printed label with inks and adhesives) has more than one substance to clear. Each layer and additive needs its own compliance basis — one GRAS citation for the base resin doesn’t cover the coating, adhesive, or ink on top of it.
Explore more: More packaging compliance guides.
GRAS substances for packaging FAQs
What does GRAS mean for food packaging specifically?
GRAS (Generally Recognized As Safe) means a substance is considered safe for its intended use in food or food-contact materials, either through general recognition by qualified experts or through FDA’s formal review and affirmation. For packaging, the relevant category is usually ‘indirect’ GRAS use under 21 CFR Part 186, since packaging substances are expected to migrate into food only in trace amounts.
Is a GRAS notice the same as FDA approval?
No. A GRAS notice is a voluntary submission where a company tells FDA it has independently determined a substance is GRAS. FDA reviews the notice and responds with one of three letter types — ‘no questions,’ ‘insufficient basis,’ or ‘cease to evaluate’ (closed at the notifier’s request) — and even a ‘no questions’ letter isn’t a formal approval or a guarantee against future re-evaluation. This is different from a Food Contact Substance Notification, which does grant a form of FDA clearance for a specific use.
Where can I search for a food-contact substance’s GRAS status for free?
Use the free public tools directly: eCFR.gov to search the current text of 21 CFR Parts 182, 184, and 186, FDA’s GRAS Notice Inventory to search company-submitted notices and their response letters, and FDA’s Inventory of Effective Food Contact Substance Notifications for FCNs. All three are searchable by substance name and don’t require an account.
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Photo: John Loo / CC BY 2.0, via Wikimedia Commons.