From February to April of 2022, the US Food and Drug Administration (FDA) added 11 entries to its Inventory of Effective Food Contact Substance Notifications (FCNs). These include a colorant in plastic food packaging, substances in polymer blends and in coatings, as well as a stabilizer in polyolefin polymers.
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:
- 2209: Butanedioic acid, hydroxy-, polymer with butanedioic acid, 1,4-butanediol and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (CAS 864132-20-7), optionally reacted with 1,6-diisocyanatohexane (CAS 822-06-0)
- 2207: 1-Decene, homopolymer, hydrogenated (CAS 68037-01-4)
- 2206: Chromium iron oxide (C.I. Pigment Brown 29; CAS 109414-04-2 and CAS 12737-27-8)
- 2201: Glycidyl methacrylate (CAS 106-91-2)
- 2200: Ethylene propylene copolymer (CAS 9010-79-1)
- 2199: Ethylene propylene copolymer (CAS 9010-79-1) [a different use case with separate notification]
- 2197: N,N’-dioleoylethylenediamine (CAS 110-31-6)
- 2191: 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 4-hydroxybutyl acrylate, acetates (salts) (CAS 2374117-56-1)
- 2187: 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine (CAS 32687-78-8)
- 2184: Siloxane and Silicones, di-Me, Me hydrogen polymers with di-Me, Me vinyl siloxanes, 1,1’-(1-methylethylidene)bis[4-(2-propen-1-yloxy)benzene]-2,4,6,8-tetramethylcyclotetrasiloxane reaction products, vinyl group-terminated di-Me siloxanes and hydrogen-terminated di-Me siloxanes
- 2183: Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS 13170-05-3)
Read more
FDA. “Inventory of Effective Food Contact Substance (FCS) Notifications.” US Department of Health and Human Services
