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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. 1535

Paramount Minerals and Chemicals Limited

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: Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-[(4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-, tetrasodium salt (CAS Reg. No. 16470-24-9).
Notifier: Paramount Minerals and Chemicals Limited
Manufacturer: Paramount Minerals and Chemicals Limited
Intended Use: As an optical brightener in paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS is intended for use as an optical brightener in paper and paperboard, complying with 21 CFR 176.170 and 21 CFR176.180, in contact with all food types at levels not to exceed those needed to achieve the desired technical effect, except for the following: 1) when the substance is used in uncoated paper and paperboard intended for contact with Food Types I, II, IV-B, VI, and VII-B, as described in Table 1, the optical brightener is limited to use at levels not to exceed 0.5 pound per ton of paper; and 2) when the substance is used in clay coatings for paper and paperboard intended for use in contact with Food Types I, II, IV-B, VI, and VII-B, as described in Table 1, the optical brightener is limited to use at levels not to exceed 0.25 pound per ton of coated paper.
Effective Date: Jun 4, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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