Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 1147
Indorama Ventures USA LLC and its Steward Affiliates Around the World
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 (CAS Reg. No. 25718-70-1) (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b) item 10.1 and used in conjunction with either cobalt stearate (CAS Reg. No. 13586-84-0) or cobalt acetate (CAS Reg. No. 71-48-7). |
|---|---|
| Notifier: | INVISTA Resins & Fibers GmbH |
| Manufacturer/Supplier: | Indorama Ventures USA LLC and its Steward Affiliates Around the World |
| Intended Use: | The FCS will be used as a modifier for polyethylene terephthalate (PET), including copolyesters. |
| Limitations/Specifications: | The FCS may be used at a level not to exceed 5 weight percent of the finished food-contact article in conjunction with either cobalt stearate or cobalt acetate used at a level not to exceed 0.015 weight percent (measured as cobalt) of the finished food-contact article. The finished food-contact article may be used in contact with food types I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII, except for carbonated soft drinks, under Conditions of Use C through G, as described in Tables 1 and 2. |
| Effective Date: | Apr 11, 2012 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
-
