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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. 11

Rohm and Haas Company

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: 4,5-dichloro-2-n-octyl-3(2H)-isothiazolone
Notifier: Rohm and Haas Company
Manufacturer: Rohm and Haas Company
Intended Use: As a preservative and slimicide in the manufacture of paper and paperboard intended to contact aqueous and fatty food.
Limitations/Specifications*: 1. As a slimicide, in compliance with 21 CFR 176.300, at a maximum level of 0.034 pound per ton of dry weight fiber.2. As a mold-proofing agent applied to the surface of uncoated paper and paperboard and in coatings for paper and paperboard, in compliance with 21 CFR 176.170(b), at a level not to exceed 100 parts per million (ppm) based on dry fiber weight.3. As a preservative in wet lap and sheet pulp, in compliance with 21 CFR 176.170(a) prior to repulping to produce paper and paperboard, at a level not to exceed 100 parts per million (ppm) based on dry fiber weight.4. As a preservative in pigment dispersions, in compliance with 21 CFR 176.170(b), at a level not to exceed 50 parts per million (ppm).
Effective Date: Apr 1, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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