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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1284

Recombinant bovine lactoferrin isolate produced by Komagataella phaffii Ppas_337 expressing the gene encoding bovine lactoferrin

Intended Use: As an ingredient in foods at the maximum levels shown in Table 1 of the response letter.
Basis: Scientific procedures
Notifier: All G Co Holdings Pty Limited
Notifier Address: 723-725 Elizabeth Street
Waterloo NSW 2017
AUSTRALIA
GRAS Notice (releasable information): GRN 1284 (in PDF) (3.8 MB)
  Part 2: GRN 1284 amendments (in PDF) (1.5 MB)
Date of closure: Mar 25, 2026
FDA's Letter: FDA has no questions (in PDF) (201 kB)

*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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