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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. 1126

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/Supplier: Danisco A/S
Intended Use: As a plasticizer in repeat-use food-contact polyvinylchloride tubing.
Limitations/Specifications: For use in polyvinylchloride plastic at levels up to 50 percent by weight of the finished article, in contact with all non-fatty foods, except foods containing greater than 15 percent alcohol (Food Types I, II, IVB, VIA, VIB, VIC {up to 15 percent alcohol}, and VIIB) at temperatures not to exceed 74°C as described in Tables 1 and 2.
Effective Date: Jan 26, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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