In late 2021 and early 2022, the US Food and Drug Administration (FDA) added 15 entries to its Inventory of Effective Food Contact Substance Notifications (FCNs). These include substances used in the production of paper food packaging, in polymer blends, as a fluid absorber, and in synthetic corks.
Manufacturers draft FCNs to inform the FDA when they use a new food contact substance. If the FDA does not respond within 120 days with any safety concerns, then the manufacturer is allowed to use or market the substance and the notification is added to the list. According to the FDA, FCNs are “effective only for the listed manufacturer” so each manufacturer must submit an FCN even if others have been approved for the same substance.
The newly added substances are included with the following FCN numbers and descriptions:
- 2171: An aqueous mixture of peroxyacetic acid (PAA, CAS 79-21-0), hydrogen peroxide (CAS 7722-84-1), acetic acid (CAS 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP, CAS 2809-21-4), dipicolinic acid (DPA) (CAS 499-83-2), and optionally sulfuric acid (CAS 7664-93-9)
- 2180: Methacrylic acid, polymer with cyclohexyl methacrylate, 2-ethylhexyl acrylate, itaconic acid, acrylamide tert-butylsulfonic acid, acrylamide, and acrylic acid, sodium salt.
- 2162: Styrene block polymer with 1,3-butadiene, hydrogenated (CAS 66070-58-4)
- 2176: Phenol, 4,4’-sulfonylbis-, polymer with 1,1’-sulfonylbis(4-chlorobenzene) (CAS 25667-42-9 and 25608-63-3).
- 2175: Poly(acrylic acid-co-ethyl acrylate-co-glycidyl methacrylate-co-styrene) (CAS 27968-38-3). Replaces FCN 1212
- 2174: Cross-linked 2-propenoic acid, homopolymer, sodium salt (CAS 9003-04-7).
- 2153: 5-Chloro-2-methyl-4-isothiazolin-3-one (CIT, CAS 26172-55-4).
- 2159: [1,1-Biphenyl]-4,4-diol, polymer with 1,1-sulfonylbis[4-chlorobenzene] (CAS 25608-64-4 and 25839-81-0).
- 2154: 2-propenoic acid, polymer with sodium phosphinate (1:1), neutralized with sodium, calcium, and/or magnesium
- 2156: Copolymer of acrylonitrile, methacrylonitrile, methyl methacrylate, methacrylic acid, and trimethylolpropane trimethacrylate (CAS 1173902-42-5).
- 2169: 1,6-hexanediol (CAS 629-11-8).
- 2168: An aqueous mixture of peroxyacetic acid (PAA, CAS 79-21-0), hydrogen peroxide (CAS 7722-84-1), acetic acid (CAS 64-19-7), dipicolinic acid (DPA, CAS 499-83-2), and optionally sulfuric acid (CAS 7664-93-9).
- 2178: 1,4-Benzenedicarboxylic acid, polymer with 1,2-ethanediol and octahydro-4,7-methano-1H-indene5,_dimethanol (CAS 106127-84-8), optionally cross-linked with ≤0.15 wt.-% glycerin.
- 2165: An aqueous solution of hydrogen peroxide (CAS 7722-84-1).
- 2164: Niobium-doped titanium dioxide, coated with calcium titanate
The FDA on January 26, 2022, proposed an update to the FCN system. The proposed rule would change how the agency determines when an FCN is no longer effective. While there would be more ways to decide an FCN is no longer effective, the new rule would ensure manufacturers “have the opportunity to provide input before we could determine that an FCN is no longer effective.” The public comment period for the proposal ends on April 11, 2022.
Read More
FDA. “Inventory of Effective Food Contact Substance (FCS) Notifications.” US Department of Health and Human Services
FDA (January 26, 2022). ” Food additives: Food Contact Substance Notification that Is no longer effective.” Federal Register
Packaging Law (January 26, 2022). “FDA proposes revising regulations for determining when an FCN is no longer effective.”
