Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Cumulative Estimated Daily Intake (CEDI)
  • Print
  • Share
  • E-mail
-

FCN No. 2443

REPI (UK) Limited

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

*Definitions

  • CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number© for the substance or a numerical code (other ID) assigned by CFSAN to those substances that do not have a CAS Registry Number (977nnn-nn-n or 809777nnn-nn-n series).
  • Substance: A name of the additive or impurity as recognized by CFSAN.
  • Calculation/Update Date: The date on which the CEDI was calculated or re-evaluated.
  • CDC: Cumulative Dietary Concentration (CDC, parts-per-billion, ppb)
  • CEDI: Cumulative Estimated Daily Intake (micrograms/kilogram body weight/person/day, µg/kg bw/d)
  • 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation. Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.
-
-