Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2308
Chemigate Oy
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: | Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 56780-58-6). |
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| Notifier: | Chemigate Oy |
| Manufacturer/Supplier: | Chemigate Oy |
| Intended Use: | The FCS is intended for use as a retention aid, drainage aid, and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The modified industrial starch will be used in compliance with 21 CFR 178.3520(a)(1), (b), and (c). The FCS may be added to the paper manufacturing process at a maximum level of 2% by weight of the dry pulp when used in the manufacture of paper and paperboard intended to contact all food types under Condition of Use E through H. In addition, the FCS may be added to the manufacturing process at a maximum level of 1% by weight of the dry pulp when used in the manufacture of paper and paperboard that is intended for use in contact with all food types under Conditions of Use A through H, 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: | Nov 3, 2023 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
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