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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. 37

Perstorp Polyols, 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: Dimethylolbutanoic acid, (CAS Name: butanoic acid, 2,2-bis(hydroxymethyl)-,) (CAS Reg. No. 10097-02-6)
Notifier: Perstorp Polyols, Inc.
Manufacturer/Supplier: Perstorp Polyols, Inc.
Intended Use: As a monomer in the production of polyurethane resins used in adhesives complying with 21 CFR 175.105.
Limitations/Specifications*: The finished polyurethane resins are prepared by the reaction of dimethylolbutanoic acid with disocyanates and with one or more of the polyols and polyesters listed in 21 CFR 175.105 and optionally with any of the amines listed in 21 CFR 175.105 for use in polyurethane resins. The finished polyurethane resins may safely be used as components of adhesives used in food contact materials held at temperatures not to exceed 120°F, except when separated from the food by a functional barrier in compliance with 21 CFR 177.1390(e)(2)(ii). Manufacturers of the polyurethane resins may market the finished polyurethane resins in accord with section 409(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act, provided the intended use is in conformity with this notification.
Effective Date: Jun 3, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)