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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. 2346

Polysecure GmbH

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: Diyttrium dioxide sulfide (CAS Reg. No.: 12340-04-4) doped with lanthanide ions.
Notifier: Polysecure GmbH
Manufacturer/Supplier: Polysecure GmbH
Intended Use: For use as an additive in all food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use as a fluorescent tracer at a maximum level of 200 ppm, in contact with all food types, under Conditions of Use B through H, as described in Tables 1 and 2. The FCS is intended to be used in both single and repeated use applications. The FCS is not intended for use in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 13, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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