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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*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.

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