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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. 2443

REPI (UK) 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: Anthranilamide (CAS name: Benzamide, 2-amino-) (CAS Reg. No. 88-68-6).
Notifier: REPI (UK) Limited
Manufacturer/Supplier: REPI (UK) Limited
Intended Use: As a scavenger for acetaldehyde in polyethylene terephthalate (PET) packaging intended for use in contact with beverages, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended for use:
  1. at levels not to exceed 500 mg/kg (ppm) in PET packaging in contact with water;
  2. at levels not to exceed 250 mg/kg (ppm) in PET packaging in contact with aqueous, acidic, and low-alcoholic (up to 15% alcohol) beverages.
The articles containing the FCS may be used under Conditions of Use E through G, as described in Table 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: Aug 15, 2025
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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