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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. 1395

Clariant International AG

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: 1,3-Benzenedicarboxamide, N,N-bis(2,2,6,6-tetramethyl-4-piperidinyl) (CAS Reg. No. 42774-15-2).
Notifier: Clariant International AG
Manufacturer/Supplier: Clariant International AG
Intended Use: As a processing stabilizer in polyethylene terephthalate (PET) homo- and co-polymers, complying with all applicable authorizations, except for use in contact with infant formula or breast milk. (see Limitations/Specifications).
Limitations/Specifications: At a level not to exceed 0.5 wt-% in PET homo- and co-polymers used to make articles in contact with all food types under the Conditions of Use C through H, as described in Tables 1 and 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 21, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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