Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2298
Perstorp AB
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: | 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 Reg. No. 102070-64-4). REPLACES FCN 2254 |
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| Notifier: | Perstorp AB |
| Manufacturer/Supplier: | Perstorp AB |
| Intended Use: | As the basic polymer in the manufacture of films, coatings, and molded articles for single-use and repeated-use food-contact applications, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used (a) in contact with all food types under Conditions of Use C through G as set forth in Tables 1 and 2, where the spiro glycol content constitutes < 30 mol% total glycol units in the polyester; and (b) in contact with all food types under Conditions of Use B through H as set forth in Tables 1 and 2, where the spiro glycol content constitutes between 30 mol% to 50 mol% total glycol units in the polyester. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Sep 1, 2023 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 268 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 229 kB) |
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