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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. 1891

Silgan Holdings, Inc.

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: 2-2'-[1,3-Phenylenebis(methylene)]bis[2,3-dihydro-1H-isoindol-1-one] (CAS Reg. No. 935739-41-6), also known as m-Xylylenediamine-bis(phthalamide) (MXBI), used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2).
Notifier: Silgan Holdings, Inc.
Manufacturer/Supplier: Silgan Holdings, Inc.
Intended Use: As an oxygen scavenger in polypropylene (PP)-based multi-laminate food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is used as a component of one or more non-food-contact layer(s) in PP-based multi-laminate food-contact articles whereby the cobalt neodecanoate component of the FCS is used at a level not to exceed 0.035 weight-percent of the layer to which the FCS is added. Cobalt neodecanoate will be present in the PP-based multi-laminate food-contact articles at a maximum level of 42 micrograms per square inch. The mass ratio of cobalt neodecanoate to MXBI will not exceed 0.0875. The multi-laminate articles containing the FCS may contact all food types under the Conditions of Use A through H and microwave-only applications under Conditions of Use J, as described in Table 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: Jul 12, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo