Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2326
SI Group
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: | Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5). |
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| Notifier: | SI Group |
| Manufacturer/Supplier: | SI Group |
| Intended Use: | As an antioxidant in polyethylene terephthalate (PET) polymers. Use of the FCS in PET polymers in contact with infant formula and human milk is the subject of effective FCN 1753 (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at levels not to exceed 2000 parts per million (ppm) in PET polymers authorized for use in contact with all food types under Conditions of Use A through H. The FCS may also be used in PET polymers as authorized in effective FCN 1753 for use (1) in repeat use articles intended for the feeding of infant formula and human milk, and (2) as packaging for powdered infant formula. The FCS may be used in conjunction with triisopropanolamine (CAS Reg. No. 122-20-3, TIPA) at a maximum use level of 0.75 percent by weight of the FCS. |
| Effective Date: | Mar 1, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 176 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 218 kB) |
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