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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. 642

Ashland, 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: Copolymer of monoacryloxyethyl succinate (MAES) (CAS Reg. No. 50940-49-3) and monoacryloxyethyl hexahydrophthalate (MAHP) (CAS Reg. No. 57043-35-3), and lauryl acrylate (LA) (CAS Reg. No. 2156-97-0). The ratio of the MAES: MAHP is in the range of 75:25 percent to 50:50 percent by weight. LA may be used at 0-10 percent by weight of the total monomer units.
Notifier: Northwest Coatings
Manufacturer/Supplier: Ashland, Inc.
Intended Use: As an electron beam (EB) curable laminating adhesive, for use in multilayer films when separated from food by a barrier layer.
Limitations/Specifications: The barrier layer must have barrier properties equal to or greater than 0.0015 inch thick low density polyethylene (LDPE). The adhesive will be applied at a maximum thickness of 1.5 pounds per 3000 square feet of packaging area and will be cured by exposure to EB radiation at a dosage ranging from 3.2 to 3.7 Mrads. The EB-cured adhesive may be used in contact with all Food Types under temperature conditions equivalent to FDA's Conditions of Use C through G as described in Tables 1 and 2.
Effective Date: Sep 29, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo