Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 366
BASF 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: | 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine (CAS Reg. No. 32687-78-8). |
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| Notifier: | Ciba Specialty Chemicals Corporation |
| Manufacturer/Supplier: | BASF Corporation |
| Intended Use: | As an antioxidant in high density polyethylene (HDPE), polyethylene copolymers as described in 21 CFR 177.1520(c) item 3.2a, and in polyolefin repeat-use articles. |
| Limitations/Specifications: | For use 1) in HDPE at levels up to 0.12 percent by weight of the finished article in contact with all food types under Conditions of Use B through H as described in Table 2, 2) in polyethylene copolymers as described in 21 CFR 177.1520(c), item 3.2a at levels up to 0.18 percent by weight of the finished article in contact with aqueous and acidic foods under Conditions of Use B through H, and 3) in polyolefin repeat-use articles at levels of up to 0.12 percent by weight of the finished article in contact with all foods under Conditions of Use A through H. |
| Effective Date: | Dec 11, 2003 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) and (j) |
| FDA Decision: | Categorical Exclusion Memo |
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