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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. 750

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: For use as: 1. a plasticizer at levels up to 34 percent by weight in polyvinylchloride bottle cap sealing rings for use in contact with all foods under Conditions of Use B through H, as described in Table 2; 2. a plasticizer at levels up to 3 percent by weight in polymers used to manufacture articles intended for repeated-use in contact with all foods under Conditions of Use E through H, as described in Table 2; and, 3. a colorant carrier or dispersant at levels up to 0.5 percent by weight in polymers used to manufacture articles intended for repeated-use in contact with all foods.
Limitations/Specifications*: SEE INTENDED USE
Effective Date: Oct 18, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (522 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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