In two articles published on March 1 and March 4, 2021, law firm Keller and Heckman LLP informed that the US Food and Drug Administration (FDA) has added 18 entries to its Inventory of Effective Food Contact Substance (FCS) Notifications. Food contact substances within the inventory are those that “have been demonstrated to be safe for their intended use.”

Among the new entries is the substance zinc pyrithione (CAS 13463-41-7). This chemical is also present, among others, in the food contact coating and polymer dispersion list of the German Federal Institute for Risk Assessment, according to the Food Contact Chemicals database (FCCdb; FPF reported).

The other new substances are included with the following entry numbers:

  • 2027: Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6)
  • 2032: 1,4-benzenedicarboxylic acid, (or dimethyl ester) polymer with 1,4-butanediol, adipic or sebacic acid, hexamethylene diisocyanate and further reacted with no more than 1 percent by weight of the polyhydric alcohol described in the notification
  • 2035: Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS 2082-79-3)
  • 2044: Siloxanes 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 and vinyl group-terminated di-Me siloxanes (CAS 2305613-79-8)
  • 2046: An aqueous mixture of peroxyacetic acid (PAA) (CAS 79-21-0), hydrogen peroxide (HP) (CAS 7722-84-1), acetic acid (AA) (CAS 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS 2809-21-4), and/or dipicolinic acid (DPA) (CAS 499-83-2), and optionally sulfuric acid (SA) (CAS 7664-93-9); replaces FCNs 1968, 1745, 1495, 1236, 1096, 921 and 140
  • 2051: Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS 624-03-3)
  • 2055: Ethylene glycol dipalmitate (CAS 624-03-3)
  • 2081: 2-Methyl-4-isothiazolin-3-one (CAS 2682-20-4)
  • 2082: Aluminum oxide (CAS 1344-28-1)
  • 2088: 1H-Azepine-1-carboxamide, N,N’,N”-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)]]tris[hexahydro-2-oxo- 1H-azepine-1-carboxamide] (CAS 68975-83-7)
  • 2090: Zinc pyrithione (CAS 13463-41-7)
  • 2096: An aqueous mixture of peroxyacetic acid (PAA) (CAS 79-21-0), hydrogen peroxide (HP) (CAS 7722-84-1), acetic acid (AA) (CAS 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS 2809-21-4), and/or dipicolinic acid (DPA) (CAS 499-83-2), and optionally sulfuric acid (SA) (CAS 7664-93-9)
  • 2097: Polymer of butyl acrylate and 4-hydroxybutyl acrylate, with a methylene diphenyl diisocyanate based crosslinker; replaces FCN 1716
  • 2099: An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9); replaces FCN 2060
  • 2100: An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), sulfuric acid (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4); replaces FCN 2000
  • 2104: 2-Propenoic acid, 2-methyl-, polymer with 2-methyloxirane polymer with oxirane monoether with 1,2-propanediol mono(2-methyl-2-propenoate) and 2-propenoic acid, sodium salt (CAS 2272985-43-8)
  • 2106: An aqueous solution of hydrogen peroxide (CAS 7722-84-1) stabilized with 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS 2809-21-4)
  • 2029: Replaced by FCN 2106

For more information regarding the FCCdb or how to obtain more information on toxicity and authorization of food contact chemicals in other countries, please also refer to the video tutorial (FPF reported).

Read More

KH (March 4, 2021). “FDA Adds Eleven New Substances to its Inventory of Effective FCS Notifications.

KH (March 1, 2021). “FDA Adds Seven New Substances to its Inventory of Effective FCS Notifications.

Share