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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. 2097

Avery Dennison 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: Polymer of butyl acrylate and 4-hydroxybutyl acrylate, with a methylene diphenyl diisocyanate based crosslinker. REPLACES FCN 1716
Notifier: Avery Dennison Corporation
Manufacturer/Supplier: Avery Dennison Corporation
Intended Use: As an adhesive for use in contact with all food types, except for use in contact with infant formula and human milk (see Limitations and Specifications).
Limitations/Specifications: For use at a coat weight up to 23 g/m2 in contact with all food types under Condition of Use A through H as described in Tables 1 and 2. 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: Dec 29, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 94 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 165 kB)