Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 1691
Henan Billions Chemicals Co. Ltd.
Billions Europe Ltd.
Billions America 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: | Trimethylolpropane (CAS Reg. No. 77-99-6). |
|---|---|
| Notifier: |
Henan Billions Chemicals Co. Ltd. Billions Europe Ltd. Billions America Corporation |
| Manufacturer/Supplier: |
Henan Billions Chemicals Co. Ltd. Billions Europe Ltd. Billions America Corporation |
| Intended Use: |
As a dispersant for pigments: 1) at levels up to 0.6 percent by weight of the pigment when the pigment is used as a colorant, complying with 21 C.F.R. 178.3297 (Colorants for Polymers), in all types of polymers; and 2) at levels up to 1.0 percent by weight of the pigment when the pigment is used in inks that may come into contact with food. The FCS is not intended for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The finished polymers and inks may contact all food types under Conditions of Use A through H. 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: | Dec 23, 2016 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 673 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
-
