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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. 2183

Shandong Rainwell New Materials Technology Company, 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: Shandong Rainwell New Materials Technology Company, Ltd.
Manufacturer/Supplier: Shandong Rainwell New Materials Technology Company, 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: Mar 10, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 814 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 177 kB)

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