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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. 2051

Shanghai Xinxin Chemical 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: Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS. Reg. No. 13170-05-3).
Notifier: Shanghai Xinxin Chemical Co., Ltd.
Manufacturer/Supplier: Shanghai Xinxin Chemical Co., Ltd.
Intended Use: As an additive to increase rigidity and impact modulus in polypropylene homopolymer and high propylene olefin copolymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a level not to exceed 0.1 percent by weight of the finished polymer. The finished polymers may be used in the form of molded articles in contact with all types of food under Conditions of Use A 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: Jul 29, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 545 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Supplement (in PDF, 127 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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