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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. 1378

GEO Specialty Chemicals UK 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: 1,4-Butanediol dimethacrylate (CAS Reg. No. 2082-81-7).
Notifier: GEO Specialty Chemicals Inc.
Manufacturer/Supplier: GEO Specialty Chemicals UK Ltd.
Intended Use: As a component of low density polyethylene (LDPE) coatings for use in contact with food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be incorporated at a level not to exceed 0.10 mol percent relative to the ethylene concentration. The LDPE may be used as a coating on food contact articles with a coating thickness not to exceed 100 μm, in contact with all food types and under Conditions of use C through G, as described in Tables 1 and 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 1, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo