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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. 828

GCH Technology Company 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: 1,3:2,4-di-O-(p-chlorobenzylidene)-D-sorbitol (CAS Reg. No. 82203-23-4).
Notifier: GCH Technology Company Ltd.
Manufacturer: GCH Technology Company Ltd.
Intended Use: As a nucleating/clarifying agent.
Limitations/Specifications*: For use at levels not to exceed 0.3 percent by weight in polypropylene homopolymer and high propylene olefin copolymers molded articles (non-film). The final articles may contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Sep 27, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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