Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2344
ADEKA Corporation
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: | [1,1'-Biphenyl]-4,4'-diol, reaction products with 4-cyclohexylphenol and 2,4,6-trichloro-1,3,5- triazine (CAS Reg. No. 2561414-35-3). |
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| Notifier: | ADEKA Corporation |
| Manufacturer/Supplier: | ADEKA Corporation |
| Intended Use: | As a clarifying agent in polypropylene homopolymers and copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | For use at levels not to exceed 0.15 weight percent in finished polypropylene homopolymers and copolymers that may contact all food types under Conditions of Use A through H and J (microwave-only, excluding susceptor applications), as described in Tables 1 and 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 15, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 315 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 233 kB) |
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