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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2338

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). REPLACES FCN 1663
Notifier: Chitec Technology Co., Ltd.
Manufacturer/Supplier: Chitec Technology Co., Ltd.
Intended Use: As an antioxidant and/or stabilizer in olefin polymers, intended for single and repeat food contact use, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 0.1 percent of the finished olefin polymer. Polypropylene homopolymers and copolymers (with a density of 0.85-0.91 gram per cubic centimeter) and high density polyethylene homopolymers and copolymers (with a density not less than 0.94 gram per cubic centimeter) containing the FCS may be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H as described in Tables 1 and 2, and food types III, IV-A, V, VI-C, VII-A, and IX under Conditions of Use B through H as described in Tables 1 and 2. Other olefin homopolymers and copolymers (with a density less than 0.94 gram per cubic centimeter) containing the FCS may be used in contact with all food types under Conditions of Use B through H as described in Table 2. 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: Jun 1, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 178 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 202 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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