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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. 2212

Merck KGaA, Darmstadt, Germany and its affiliated companies

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 gray cassiterite (CAS Reg. No. 68187-54-2 and CAS Reg. No. 12673-86-8).
Notifier: Merck KGaA, Darmstadt, Germany and its affiliated companies
Manufacturer/Supplier: Merck KGaA, Darmstadt, Germany and its affiliated companies
Intended Use: For use as a laser-marking agent for all food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use levels up to:
  1. 0.5% by weight in polymers in contact with all food types under Conditions of Use E through G, as described in Tables 1 and 2, respectively;
  2. 0.1% by weight in polymers in contact with all food types under Conditions of Use C through D, 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 26, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 783 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 191 kB)

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