• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

  • Print
  • Share
  • E-mail
-

FCN No. 785

Indorama Ventures USA Inc. and its stewarded affiliates around the world
Mitsubishi Gas Chemical Company, Inc.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Nylon MXD-6 (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) (CAS Reg. No.25718-70-1) meeting the analytical specifications in 21 CFR 177.1500(b), item 10.2.
Notifier: Indorama Ventures USA Inc. and its stewarded affiliates around the world
Mitsubishi Gas Chemical Company, Inc.
Manufacturer: Indorama Ventures USA Inc. and its stewarded affiliates around the world
Mitsubishi Gas Chemical Company, Inc.
Intended Use: The FCS will be used as a modifier for polyethylene terephthalate copolyesters described in Food Contact Notification No. 72 and Food Contact Notification No. 498.
Limitations/Specifications*: The FCS is intended for use in: (1) polyethylene terephthalate copolyesters described in FCN No.72, at levels up to 5 weight percent of the finished food-contact article, in the making of repeat-use food-contact articles intended to contact aqueous, acidic, and low-alcohol food at temperatures ≤49°C, and (2) polyethylene terephthalate copolyesters described in FCN No. 498, at levels up to 5 weight percent of the finished food-contact article, in the making of single and repeat-use food-contact articles intended to contact Food Types I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII, under Conditions of Use C through G, as described in Tables 1 and 2, respectively.
Effective Date: Mar 7, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
-
-