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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. 69

W.R. Grace, 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) Styrene -butadiene -methacrylic acid terpolymer (CAS Reg. No. 9010-93-9), (2) 1,2-benzisothiazolin-3-one (CAS Reg. No. 2634-33-5), and (3) sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, disodium salt (CAS Reg. No. 39354-45-5).
Notifier: W.R. Grace, Ltd.
Manufacturer: W.R. Grace, Ltd.
Intended Use: As components of can end cements.
Limitations/Specifications*: 1. Styrene-butadiene-methacrylic acid terpolymer: shall contain no more than 1.5 weight-percent of monomer units derived from methacrylic acid and no more than 50 weight-percent of monomer units derived from butadiene; for use at levels not to exceed 75 percent by weight of the cement solids in can-end cements complying with 21 CFR 175.300(b)(3)(xxxi).2. 1,2-benzisothiazolin-3-one: for use at levels not to exceed 113 ppm in the finished can-end cements complying with 21 CFR 175.300(b)(3)(xxxi).3. Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, sodium salt: for use at levels not to exceed 1 percent in the finished can-end cements complying with 21 CFR 175.300(b)(3)(xxxi).
Effective Date: Jul 13, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (138 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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