Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 1349
Sekisui Specialty Chemicals America, LLC
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: | Polyvinyl alcohol (CAS Reg. No. 25213-24-5). |
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| Notifier: | Sekisui Specialty Chemicals America, LLC |
| Manufacturer/Supplier: | Sekisui Specialty Chemicals America, LLC |
| Intended Use: | The FCS will be used as a component of paper and paperboard in applications covered by 21 CFR 176.170 (Components of paper and paperboard in contact with aqueous and fatty food), except for use in contact with infant formula and breast milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used in coatings on paper and paperboard. The FCS has a minimum viscosity of 3 centipoises in a 4% aqueous solution at 20°C. The food-contact surface of the paper and paperboard in the finished form in which it is to contact food must meet the extractive limitations set forth under 21 CFR 176.170 (c). The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Apr 8, 2014 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) and (j) |
| FDA Decision: | Categorical Exclusion Memo |
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