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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. 732

RohMax U.S.A., LP RohMax Canada Inc. RohMax France S.A.S. RohMax Additives GmbH RohMax Asia Pacific Pte 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: Poly(alkyl methacrylates) made from one or more C12 - C17 alkyl methacrylates (where the alkyl groups may be branched or linear and may be even- or odd-numbered in chain length), polymerized alone or in combination with one or more of the C18 - C22 alkyl methacrylate monomers permitted as reactants for poly(alkyl methacrylate) under 21 CFR 172.886(c)(2).
Notifier: RohMax U.S.A., LP RohMax Canada Inc. RohMax France S.A.S. RohMax Additives GmbH RohMax Asia Pacific Pte Ltd.
Manufacturer: RohMax U.S.A., LP RohMax Canada Inc. RohMax France S.A.S. RohMax Additives GmbH RohMax Asia Pacific Pte Ltd.
Intended Use: As a processing aid in the manufacture of petroleum wax that may be used as a direct food ingredient in compliance with CFR 172.886 and as a food-contact substance in compliance with 21 CFR 178.3710.
Limitations/Specifications*: The concentration of the FCS remaining in the finished wax will not exceed 1,050 ppm.
Effective Date: Oct 1, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (347 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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