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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. 1457

Hubergroup Canada Ltd.

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: Trimethylolpropane tricaprylate/tricaprate (CAS Reg. No. 11138-60-6)
Notifier: Hubergroup Canada Ltd.
Manufacturer/Supplier: Hubergroup Canada Ltd.
Intended Use: As a solvent in offset ink applied to paper and paperboard that may contact dry food, except for use in contact with infant formula (see Limitations/Specifications).
Limitations/Specifications: The FCS may be applied at levels up to 1.2 g/m2 on the non-food contact side of paper and paperboard with an overprint varnish of no less than 4-5 g/m2 (wet basis). Finished paper and paperboard is intended for contact with dry food under Conditions of Use E through G, as described in Table 2. The FCS is not for use in contact with infant formula. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 28, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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