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The U.S. Food and Drug Administration (FDA) recently added 15 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substance and the manufacturer are listed below.
| FCN No. | Food Contact Substance | Manufacturer/ Supplier | Effective Date |
|---|---|---|---|
| 2455 | Poly(N-vinylformamide), 20-100 percent hydrolyzed hydrochloride salts. The FCS is specifically known as one of the following: a. formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8); or b. formamide, ethenyl-, homopolymer, hydrolyzed, hydrochlorides (CAS Reg. No. 183815-54-5) |
SNF S.A. SNF Inc. |
January 11, 2026 |
| 2451 | Acrylic copolymers of styrene (CAS Reg. No. 100-42-5), glycidyl methacrylate (CAS Reg. No. 106-91-2), and, optionally, ethyl acrylate (CAS Reg. No. 140-88-5), butyl acrylate (CAS Reg. No. 141-32-2), methyl methacrylate (CAS Reg. No. 80-62-6), methacrylic acid (CAS Reg. No. 79-41-4), acrylic acid (CAS Reg. No. 79-10-7), hydroxyethyl methacrylate (CAS Reg. No. 868-77-9), butyl methacrylate (CAS Reg. No. 97-88-1), and/or lauryl methacrylate (CAS Reg. No. 142-90-5). REPLACES FCNs 2175 and 2226 |
PPG Industries, Inc. | January 8, 2026 |
| 2448 | Long-chain branched polylactic acid | TotalEnergies Corbion B.V. | January 4, 2026 |
| 2465 | Polyisoprene grafted polypropylene and/or poly(propylene-co-ethylene) | GINPO PACK Co., Ltd. | January 1, 2026 |
| 2464 | An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), and optionally, sulfuric acid (SA) (CAS Reg. No. 7664-93-9) | Hydrite Chemical Co. | December 27, 2025 |
| 2463 | Trisodium N-hydroxyethylenediaminetriacetate (CAS Reg. No. 139-89-9) | Henkel Corporation | October 29, 2025 |
| 2441 | 2-propenoic acid, 2-(dimethylamino)ethyl ester, polymer with 2-propenamide and 2-propenoic acid (CAS Reg. No. 32840-16-7) modified with less than 0.5 wt-% N,N′-methylenebis(2-propenamide) (CAS Reg.No. 110-26-9) | Nalco Water, An Ecolab Company | October 18, 2025 |
| 2457 | 2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1) polymer with N-ethenylformamide, hydrolyzed, hydrochlorides (CAS Reg. No. 2803877-67-8) | SNF SA SNF Inc. |
October 10, 2025 |
| 2456 | Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C12-14-alkyl ethers, sodium salts (CAS Reg. No. 68891-38-3) | KLK Kolb Specialties B.V. KLK Tensachem S.A. |
October 9, 2025 |
| 2450 | Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C12-16-alkyl ethers, sodium salts (CAS Reg. No. 161074-78-8) | Pilot Chemical Co. | October 4, 2025 |
| 2453 | 2-Propenoic acid, polymer with sodium phosphinate (1:1), neutralized as sodium salt (CAS Reg. No. 129898-01-7), magnesium sodium salt (CAS Reg. No. 935545-65-6), calcium sodium salt, or calcium magnesium sodium salt REPLACES FCN 1956 |
Coatex and Affiliates | October 2, 2025 |
| 2452 | Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7) | Versalis S.p.A. | September 27, 2025 |
| 2449 | Boric Acid (CAS Reg. No. 10043-35-3) | Mitsubishi Chemical Corporation | September 20, 2025 |
| 2436 | An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), and optionally, sulfuric acid (SA) (CAS Reg. No. 7664-93-9) | Hydrite Chemical Co. | September 11, 2025 |
| 2430 | Polyurethane resin formulated from bitolylene diisocyanate (CAS Reg. No. 91-97-4); 1,4-butanediol (CAS Reg. No. 110-63-4); poly(carbonic acid-co-hexamethylene glycol) (CAS Reg. No. 25037-68-7); and trimethylolpropane (CAS Reg. No. 77-99-6) | Freudenberg Sealing Technologies GmbH | September 5, 2025 |
The Food and Drug Administration Modernization Act of 1997 amended the Federal Food, Drug, and Cosmetic Act to provide for the submission of food-contact notifications (FCNs). Under the FCN system, a manufacturer or supplier of a food-contact material may submit an FCN to FDA regarding the identity and use of a new food-contact substance (FCS), along with information supporting the conclusion that the substance is safe for the intended use.
If FDA does not object in writing within 120 days to the substance's use based on safety grounds, the submitter and its customers may market the substance. Once the notification becomes effective, FDA will add it to its Inventory of Effective FCS Notifications. For more background on submission of FCNs, please see the packaginglaw.com article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?
