From August of 2022 through February 2023, the US Food and Drug Administration (FDA) added 26 entries to its Inventory of Effective Food Contact Substance Notifications (FCNs). 

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” meaning that 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. 

  • 2253: Ethanaminium, N,N,N- trimethyl-2-[(1-oxo-2-propen-1-yl)oxy]-, chloride (1:1), polymer with 2-propenamide (CAS 69418-26-4) modified with up to 2.0 % by weight of propenoic acid (CAS 79-10-7). 
  • 2247: 2-Propenoic acid, 2-methyl-, 1,1’-(1,2-ethanediyl) ester, polymer with phenylmethyl 2-methyl-2-propenoate (CAS 126969-53-7). 
  • 2262: Hypochlorous acid (CAS 7790-92-3). 
  • 2251: Ethylene/octene copolymers containing up to 30 weight percent polymer units derived from 1-octene (CAS 26221-73-8). 
  • 2248: Naphthalenesulfonic acid, C8-C10, C9-rich alkylderivatives, calcium salts, primarily calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate) (CAS 1474044-79-5). 
  • 2261: Aluminum oxide (CAS 1344-28-1). 
  • 2259: Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 1,3-diisocyanato-2-methylbenzene and 2,4-diisocyanato-1-methylbenzene (CAS 68227-13-4). 
  • 2245: A hydrogen peroxide solution (CAS 7722-84-1). 
  • 2254: 1,4-Benzenedicarboxylic acid, polymer with 1,2-ethanediol and β,β,β′,β′,-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS 102070-64-4). 
  • 2252: Titanium nitride (CAS 25583-20-4). Replaces FCN 818 
  • 2249: Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent 2,3-epoxypropyltrimethylammonium chloride (CAS 56780-58-6). 
  • 2241: Rice bran wax, oxidized (CAS 1883583-80-9) and its calcium salt (CAS 1850357-57-1) or sodium salt (CAS 2759532-87-9). 
  • 2236: An aqueous mixture of peroxyacetic acid (CAS 79-21-0), hydrogen peroxide (CAS 7722-84-1), acetic acid (CAS 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS 2809-21-4), and optionally, octanoic acid (CAS 124-07-2) and peroxyoctanoic acid (CAS 33734-57-5). 
  • 2246: Quino[2,3-b]acridine-7,14-dione, 5,12-dihydro-2,9-dimethyl-, also known as 2,9-dimethylquinacridone and C.I. Pigment Red 122 (CAS 980-26-7). 
  • 2244: Oleic acid, mono ester with oxybis(propanediol) (CAS 49553-76-6). 
  • 2243: Pentaerythritol (CAS 115-77-5). Replaces FCN 2069 
  • 2242: An aqueous mixture of peroxycitric acid (PCA) (CAS 127542-89-6), hydrogen peroxide (HP) (CAS 7722-84-1), citric acid (CAS 77-92-9), lactic acid (CAS 50-21-5), acetic acid (CAS 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS 2809-21-4), and optionally sulfuric acid (CAS 7664-93-9). 
  • 2238: A copolyester made from dimethyl terephthalate (DMT), ethylene glycol (EG), and 2,2,4,4-tetramethyl-1,3-cyclobutanediol (TMCD) (CAS 185625-67-6). Replaces FCN 1878 
  • 2235: Glass-based pearlescent pigments. 
  • 2233: 2(3H)-Benzofuranone, 5,7-bis(1,1-dimethylethyl)-3-[3,5-dimethyl-4-[[2,4,8,10-tetrakis(1,1-dimethylethyl)-12-methyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin-6-yl]oxy]phenyl]- (CAS 1893088-15-4). 
  • 2231: Dipentaerythritol, hexaesters with 3,5,5-trimethylhexanoic, decanoic, heptanoic, and octanoic acids (CAS 2640167-40-2). 
  • 2230: Pentaerythritol (CAS 115-77-5). Replaces FCN 2116 
  • 2228: Cross-linked 2-propenoic acid, homopolymer, sodium salt (CAS 9003-04-7). 
  • 2217: Poly-1-butene homopolymer (CAS 9003-28-5). 
  • 2226: Poly(ethyl acrylate-co-glycidyl methacrylate-co-methacrylic acid-co-methyl methacrylate-co-styrene) (CAS 29437-40-9). Replaces FCN 1213 
  • 2216: Ethylene/1-butene copolymer (CAS 25087-34-7). 

 

Read more  

FDA. “Inventory of Effective Food Contact Substance (FCS) Notifications.” US Department of Health and Human Services 

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