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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. 1435

Nabaltec AG

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: Calcium aluminum hydroxyl carbonate (CAS Reg. No. 65997-16-2).
Notifier: Nabaltec AG
Manufacturer/Supplier: Nabaltec AG
Intended Use: As an acid scavenger in food-contact polyolefin and polyvinyl chloride materials.
Limitations/Specifications: The FCS is intended for use at levels up to 0.05% in polyolefin materials and at levels up to 2% in polyvinyl chloride materials intended to contact all food types under Conditions of Use A through H as described in Table 2. Permitted uses in contact with infant formula and breast milk: the FCS may be used in articles intended for feeding infants.
Effective Date: Jul 24, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
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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