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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. 837

Sun Rise Chemical Ind. Co., Ltd. (Taiwan); Sun Rise Chemical Ind. Co. (China)

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: Sun Rise Chemical Ind. Co., Ltd. (Taiwan)
Manufacturer: Sun Rise Chemical Ind. Co., Ltd. (Taiwan); Sun Rise Chemical Ind. Co. (China)
Intended Use: The FCS is intended for use as an optical brightener in paper and paperboard complying with 21 CFR 176.170.
Limitations/Specifications*: The FCS will be used 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 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 brightener is limited to use at levels not to exceed 0.5 pound per ton of paper, and (2) when 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 brightener is limited to use at levels not to exceed 0.25 pound per ton of coated paper.
Effective Date: Nov 12, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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