Your Supplier’s FCN Number Is Real. That Doesn’t Mean It Is Still Effective.
FDA can now withdraw a food contact notification for reasons that have nothing to do with safety. In January 2025 it did that to 35 of them at once, and most compliance files never noticed.
Trimmed plates stacked for packing at a molded fiber production site. Body：Bench checks at a molded fiber production site.A supplier’s FCN number is a claim that three things are true at once: the number exists, it is still effective, and it is effective for the entity that supplied you and for the use you are buying. Most files record only the first. Since 2024 the second has become easier to get wrong, and on 6 January 2025 it went wrong for 35 notifications in a single Federal Register notice.
An FCN is a notification, not an approval
FDA does not issue a certificate for a food contact notification. A manufacturer or supplier files a notification for a substance and an intended use; if FDA does not object during its review, that notification becomes effective for that party and that use, not for a chemistry in general and not for a finished product.
The sentence FDA uses on its own inventory page is the part buyers skip: “a food contact notification (FCN) is only effective for the manufacturer or supplier identified in the notification.” The page then says that anyone buying the substance from that identified party may rely on the notification for the use it covers, within its stated limitations. That second half is generous. The first half is the trap: run the same chemistry through a different plant, a repackager or a trading company that is not the notifier, and the paper does not travel with the goods.
FDA keeps that list, titled Inventory of Effective Food Contact Substance (FCS) Notifications, here: https://www.fda.gov/food/packaging-food-contact-substances-fcs/inventory-effective-food-contact-substance-fcs-notifications
Four ways a notification can stop being effective
For most of the programme’s history an FCN stopped being effective for one reason: the use was no longer shown to be safe. A final rule published on 22 March 2024, effective 21 May 2024, added other reasons under 21 CFR 170.105(a). They are not equivalent to each other even though they end in the same administrative result. The rule text shows all four: https://www.govinfo.gov/content/pkg/FR-2024-03-22/html/2024-05802.htm
Ground: the use is no longer safe, 170.105(a)(1). What it means for your file: the only one of the four that is a finding about the product.
Ground: the manufacturer or supplier has ceased, or intends to cease, producing, supplying or using the substance for that use, 170.105(a)(2). What it means for your file: nothing about safety. The commercial actor walked away.
Ground: the use is already authorised by a food additive regulation, 170.105(a)(3). What it means for your file: the route to market moved. The substance may still be lawful through that regulation, but the notification is no longer the document that proves it.
Ground: the use is the subject of an issued threshold of regulation exemption, 170.105(a)(4). What it means for your file: same shape. The notification retires because a different exemption covers the use.
Three of the four can end a notification without anyone suggesting the substance became unsafe. That matters when a number vanishes from a list and the buyer assumes the worst.
What happened on 6 January 2025
The notice is 90 FR 653, docket FDA-2021-N-0403. Its dates block holds two different dates, and both matter:
“Applicable date: This determination for the FCNs listed in table 1 and table 2 is effective January 6, 2025.”
“Compliance date: June 30, 2025, is the compliance date for the FCSs listed in table 2 that were produced, supplied, or used by the manufacturer or supplier prior to the effective date of this determination.”
Thirty-five notifications stopped being effective on the publication date. Thirty-one are in the first table, where FDA says existing stock should already have cleared the market on the end-of-sales dates the manufacturers gave. Four are in the second table, the one that matters commercially: for stock produced, supplied or used before 6 January 2025, the agency set a compliance date of 30 June 2025 to exhaust it.
The basis was not safety. FDA says the manufacturers had already told it in writing that they had stopped producing, supplying or using the substances, that the agency wrote to them after the 2024 rule took effect, received no disagreement, and so determined under 170.105(a)(2)(ii)(B) that the notifications were no longer effective “based on abandonment”. The notice is three pages and worth keeping next to the numbers it retires: https://www.govinfo.gov/content/pkg/FR-2025-01-06/html/2024-31692.htm
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It also restates the mechanic that makes this a live document problem rather than a historical one: under 170.105(b), the date the notice publishes in the Federal Register is the date the notification is no longer effective. No letter goes to your supplier’s customers. There is a notice, and there is a list.
Every one of the 35 covers a fluorinated substance
In both tables, all 35 entries are fluorinated: fluoropolymers, telomers, perfluoroalkyl acrylates and their reaction products. That matters because fluorinated chemistry is what PFAS declarations are written about, and a “PFAS-free” declaration and an FCN are two documents answering two different questions. Neither substitutes for the other.
It is also not a warning about those substances. The notifications were removed because the notifiers stopped supplying the uses, not because FDA changed its view of safety. Treating abandonment as a safety signal is the mirror image of the mistake this article is about: reading a document for something it never said.
Why the file does not notice
Before 2024 there was one list to check. Now there are two: FDA created a list of FCS notifications that are no longer effective, and updated the inventory of effective notifications so the retired numbers no longer appear there. Both are public and both are searchable by number.
So a number missing from the effective inventory can mean three different things.
It was never effective, and the number on the spec sheet was mistyped, invented or copied from another product.
It was effective and then lapsed, which is the case for the 35 in January 2025.
It is effective, but for a different notifier or a different use than the one in front of you.
Only the first is a paper problem you can fix by asking for a correction. The other two are supply problems.
Eight checks before the number goes into the file
- Search the number in FDA’s inventory of effective notifications, not in the supplier’s covering letter.
2. Search it in the list of notifications that are no longer effective as well, since a retired number will not appear in the first list at all.
3. Match the notifier’s legal entity, not the brand name on the drum or the logo on the certificate.
4. Read the intended use text and check that it describes your application rather than a neighbouring one.
5. Read the conditions of use and limitations attached to the notification, including any restriction on food type, temperature or contact.
6. Compare the effective date with the date your material was produced, and with the date of the shipment you are clearing.
7. Keep a dated record of the screen: a PDF or a screenshot of the entry you matched, not a copy of the supplier’s summary.
8. If the number is missing from the effective list, ask which notification now covers the material being supplied, and ask for that number rather than a reassurance.
A lapsed notification is not a dead end
Under 170.105(c), the determination does not stop anyone submitting a new notification for the same substance and the same use afterwards. The useful question is rarely “is this chemistry banned” but “which notification covers the material I am being supplied now, and is it effective”.
That reframing pays off in procurement. “We have an FCN” tells you almost nothing. A supplier that can name the notification, the notifier entity, the use it covers and the date it became effective has given you something you can check in two minutes.
What the check does not answer
Not safety. Abandonment is not a safety finding, and an effective notification is not a safety certificate either.
Not state chemical restrictions or EU packaging rules. Those are separate systems with their own definitions, their own lists and their own dates, and a federal notification neither satisfies nor overrides them.
Not the finished article or the factory that made it. A notification covers a substance and a use.
In our own file work, a notification number, a certificate of compliance and a declaration of composition arrive in one folder and get read as one thing. They are three documents with three different authors and three different lifetimes, and the notification is the only one that can lapse without anyone sending you a new version.
Zhongxin Packaging buys barrier and grease-proofing additives from chemical suppliers that hold their own food contact notifications for the substance and intended use, and the certificate and document library we keep for customers is here: https://www.zhongxinpacking.com/honor-certificate/
The number in the file is a starting point. The useful thing is the date you last checked it.
