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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. 812

Danisco A/S

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: Octadecanoic acid, 1-(12-acetyloxy)-, 2,3-bis(acetyloxy)propyl ester; 1-(12-acetoxystearoyl)-2,3-diacetylglycerol (CAS Reg. No. 736150-63-3).
Notifier: Danisco A/S
Manufacturer: Danisco A/S
Intended Use: As a colorant carrier/dispersant for use in polymeric food packaging articles, e.g. beverage bottles, molded storage containers, etc.
Limitations/Specifications*: For use in polyester, polyamide, polystyrene, polylactic acid, and acrylic polymers at levels up to 0.5 percent by weight of finished articles. For use only in contact with aqueous, acidic, and alcoholic foods containing up to 15 percent alcohol under Conditions of Use B through H as described in Table 2.
Effective Date: Jun 19, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo