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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. 1660

Clariant Corporation USA Inc.

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 Plastics & Coatings USA Inc.
Manufacturer/Supplier: Clariant Corporation USA Inc.
Intended Use: The FCS is intended for use as a processing stabilizer in polyamide (PA) and ethylene/vinyl alcohol (EVOH) copolymers complying with applicable authorizations, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended for use at:
  1. levels up to 0.3% in polyamide food-contact films not exceeding 100 μm thickness when used in contact with fatty foods;
  2. levels up to 0.2% in polyamide food-contact films not exceeding 50 µm thickness when used in contact with aqueous, acidic and alcohol containing foods; and,
  3. levels up to 0.2% in ethylene/vinyl alcohol copolymers used as the nonfood-contact layer in multilayer films.
The FCS/EVOH layer will not exceed 12 μm. The food-contact layer shall be any polymer that is authorized for such use by regulation or effective FCN. The finished food-contact articles containing the FCS may be used 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: Oct 19, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 5.1 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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