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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. 2519

Advancion Corporation

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: 3-Amino-3-methyl-2-butanol (AMB; CAS Reg. No. 13325-14-9)
Notifier: Advancion Corporation
Manufacturer/Supplier: Advancion Corporation
Intended Use: As a dispersant for mineral pigment suspensions used as a component of fillers or coatings for paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used as a component of:
  1. coatings at a level not to exceed 0.25% by weight of the mineral pigment
  2. fillers at a level not to exceed 0.05% by weight of the mineral pigment.
The finished paper and paperboard may contact all food types under Conditions of Use A through H, and J (microwave-only, excluding susceptor applications).
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 11, 2026
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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