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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. 2117

Susonity LLC

Consult the regulation(s) cited below to see if your substance is authorized for your intended use.
Food Contact Substance: Fluorphlogopite-based pearlescent pigments.
Notifier: Merck KGaA, Darmstadt, Germany and its affiliated companies
Manufacturer/Supplier: Susonity LLC
Intended Use: As a colorant in all food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels up to 5% by weight in polymers in contact with all food types under Conditions of Use A through H, and J, as described in Tables 1 and 2, respectively. 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: Apr 7, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 63 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 170 kB)

* Definitions

  • CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number® for the substance or a numerical code (other ID) assigned by HFP to those substances that do not have a CAS Registry Number (977nnn-nn-n series).
  • Substance: The name of the additive as recognized by HFP.
  • 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation.

Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.
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