Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2401
BYK-Chemie GmbH
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: | Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate (Type 1, containing fluorine) (CAS Reg. No. 85085-18-3), lithium magnesium sodium silicate (Type 2, without fluorine) (CAS Reg. No. 53320-86-8). |
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| Notifier: | BYK-Chemie GmbH |
| Manufacturer/Supplier: | BYK-Chemie GmbH |
| Intended Use: | As a barrier additive in the production of food contact: (1) adhesives, and (2) polymeric dispersions used as coatings for plastic, metal, and paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The finished adhesives and polymeric dispersions used as coatings for plastic, metal, and paper and paperboard containing the FCS may contact all food types, except alcoholic foods, under Conditions of Use (COU) E through G, as described in Tables 1 and 2. The maximum use level for the FCS in adhesives and coatings will not exceed 50%. The maximum application rate for adhesives or coatings containing the FCS is 10 grams/m2 (or 6.46 mg/in2). 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 12, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 210 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 163 kB) |
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