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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. 2108

W. R. Grace & Co.-Conn.

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: Silicic acid, aluminum magnesium sodium salt, CAS Reg. No. 12040-43-6. REPLACES FCN 2027
Notifier: W. R. Grace & Co.-Conn.
Manufacturer/Supplier: W. R. Grace & Co.-Conn.
Intended Use: The FCS is intended for use as an acid scavenger in polypropylene (PP), at levels up to 1800 parts per million (ppm) by weight, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: In contact with all food types under Conditions of Use A through H and J, as described in Tables 1 and 2. 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: Feb 6, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 730 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 130 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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