In an article published on November 19, 2020, law firm Keller and Heckman LLP (KH) informed that the US Food and Drug Administration (FDA) has added thirteen additional 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.” The new substances are included in the following entry numbers:

  • 2079: Ethanol, 2-amino- (CAS 141-43-5); replaces FCN 1756
  • 2076: Tris(2,4-di-tert-butylphenyl)phosphite (CAS 31570-04-4); replaces FCN 524
  • 2075: Glass-based pearlescent pigments
  • 2071: Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a radio-frequency plasma as described in the notification
  • 2070: 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-hydroxyethylidene-1,1- diphosphonic acid (HEDP) (CAS 2809-21-4), and optionally sulfuric acid (CAS 7664-93-9)
  • 2069: Pentaerythritol (CAS 115-77-5)
  • 2068: Alcohols, C10-14-branched, C11-rich, reaction products with ethylene oxide, [(2-propenyloxy)methyl]oxirane and sulfamic acid (CAS 905843-50-7). The FCS is comprised primarily of poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-(hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich, C10-14-branched alkyl ethers, ammonium salts (CAS 403983-53-9); replaces FCN 1945
  • 2067: Tricyclodecanedimethanol (CAS 26896-48-0 and 26160-83-8)
  • 2066: Copolymers of terephthalic acid (CAS 100-21-0), ethylene glycol (CAS 107-21-1), diethylene glycol (CAS 111-46-6), and 1,4-cyclohexanedimethanol (CAS 105-08-8), optionally branched with trimellitic anhydride (CAS 552-30-7)
  • 2065: alcohols, C10-14-branched, C11-rich, reaction products with polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane (CAS 403983-11-9 and 1000866-04-5); replaces FCN 1944
  • 2064: Fatty acids, C18-unsaturated, dimers, hydrogenated, polymers with caprolactam and hexamethylenediamine (CAS 475994-94-6)
  • 2063: Styrene block polymer with 1,3-butadiene, hydrogenated (CAS 66070-58-4)
  • 2062: 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), sulfuric acid (SA) (CAS 7664-93-9), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS 2809-21-4)

Read More

KH (November 19, 2020). “FDA Adds Thirteen New Substances to its Inventory of Effective FCS Notifications

National Law Review (November 19, 2020). “FDA Adds Thirteen New Substances to its Inventory of Effective FCS Notifications.”

FDA (November 2020). “Inventory of Effective Food Contact Substance (FCS) Notifications.”

Share