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U.S. Department of Health and Human Services

Cumulative Estimated Daily Intake (CEDI)
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FCN No. 2436

Hydrite Chemical Co.

Food Contact Substance: An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), and optionally, sulfuric acid (SA) (CAS Reg. No. 7664-93-9).
Notifier: Hydrite Chemical Co.
Manufacturer/Supplier: Hydrite Chemical Co.
Intended Use: As an antimicrobial agent used in process water during the production of lactose, including lactose used as an ingredient in infant formula.
Limitations/Specifications: The components of the FCS will not exceed 33 ppm PAA, 155 ppm HP, 42 ppm AA and 1 ppm SA in process water used in the production of lactose, including lactose used as an ingredient in infant formula.
Effective Date: Sep 11, 2025
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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.
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