Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 1663
Chitec Technology Co., Ltd.
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: | Amines, bis(hydrogenated palm-oil alkyl)hydroxy (CAS Reg. No. 1374859-51-4). |
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| Notifier: | Chitec Technology Co., Ltd. |
| Manufacturer/Supplier: | Chitec Technology Co., Ltd. |
| Intended Use: | For use as an antioxidant to stabilize polypropylene (PP) polymers complying with 21 CFR 177.1520(c) as well as high density polyethylene polymers (HDPE) and copolymers complying with 21 CFR 177.1520(c); intended for single and repeat food contact use, except for use in contact with infant formula and breast milk (see Limitations/Specifications). |
| Limitations/Specifications: |
1. At levels not to exceed 0.1 percent by weight of PP polymers complying with 21 CFR 177.1520(c), item 1.1, 1.2, 1.3, 3.1a (with a density of 0.85-0.91 gram per cubic centimeter), 3.2b, and 3.4. The finished polymers may be used in contact with: (a) food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H and, (b) types III, IV-A, V, VI-C, VII-A, and IX under Conditions of Use B through H. 2. At levels not to exceed 0.1 percent by weight of PP polymers complying with 21 CFR 177.1520(c), item 3.5. The finished polymers may be used in contact with food types I, II, IV-B, VI, VII-B and VIII described under Condition of Use D through H. 3. At levels not to exceed 0.1 percent by weight of HDPE polymers and copolymers complying with 21 CFR 177.1520(c), item 2.1, 2.3, 3.1a, 3.1b, 3.6 (with a density not less than 0.94 gram per cubic centimeter) and 5. The finished polymers may be used in contact with: (a) food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H, and (b) food types III, IV-A, V, VI-C, VII-A, and IX under Conditions of Use B through H. |
| Effective Date: | Jul 29, 2016 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) and (j) |
| FDA Decision: | Categorical Exclusion Memo |
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