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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. 1380

Troy Corporation

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: The reaction products of paraformaldehyde (CAS Reg. No. 30525-89-4) and ethylene glycol (CAS Reg No. 107-21-1).
Notifier: Troy Corporation
Manufacturer/Supplier: Troy Corporation
Intended Use: As a stabilizer for aqueous biocides used to preserve filler or other additive mixtures or coating solutions for use in uncoated or clay-coated paper and paperboard intended to contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level not to exceed 150 ppm of the filler or additive mixture, or 75 ppm of the coating solution. The finished paper may be used in contact with all food types under all use conditions. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 15, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.2 MB)
FDA Decision: Finding of No Significant Impact (FONSI)