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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 235

Colors and Effects USA 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: Tin antimony oxide (CAS Reg. No. 12673-86-8). The food contact substance is also known as tin antimony gray cassiterite.
Notifier: BASF Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a pigment for all polyolefins for food contact applications.
Limitations/Specifications: This pigment is limited to use levels not to exceed 0.5 percent by weight of the polymer, and is subject to limitations and specifications in 21 CFR 178.3297 Colorants for polymers. The finished food-contact articles may contact food under Conditions of Use A through H, as described in Table 2.
Effective Date: Sep 12, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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