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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. 2120

Sasol Limited

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: Paraffin waxes and hydrocarbon waxes, oxidized (CAS Reg. No. 68153-22-0).
Notifier: Sasol Limited
Manufacturer/Supplier: Sasol Limited
Intended Use: The FCS will be used as a component of:
  1. Resinous and polymeric coatings complying with 21 CFR 175.300;
  2. Resinous and polymeric coatings on polyolefin films complying with 21 CFR 175.320;
  3. Coatings for paper and paperboard complying with 21 CFR 176.170 and 21 CFR 176.180;
  4. Defoaming agents used in the manufacture of paper and paperboard complying with 21 CFR 176.210; and;
  5. Cellophane complying with 21 CFR 177.1200.
The FCS is not intended for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: When used as a component of resinous and polymeric coatings complying with 21 CFR 175.300, resinous and polymeric coatings on polyolefin films complying with 21 CFR 175.320, coatings for paper and paperboard complying with 21 CFR 176.170 and 21 CFR 176.180, defoaming agents used in the manufacture of paper and paperboard complying with 21 CFR 176.210, and cellophane complying with 21 CFR 177.1200, the FCS is intended to contact all types of food under Conditions of Use A through H. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 7, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 112 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 160 kB)

*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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