- On September 3, 2025, and in response to a food additive petition filed by Cargill, FDA published an expansion to the secondary direct additive clearance for hydrogen peroxide in 21 CFR 173.356. The previous version of Section 173.356 permitted the use of hydrogen peroxide as an antimicrobial agent in the production of modified whey at a level not to exceed 0.001% by weight of the whey. The revised version more broadly permits the use of hydrogen peroxide at levels consistent with GMP as an antimicrobial agent, oxidizing and reducing agent, bleaching agent, and to remove sulfur dioxide.
- The revised regulation maintains the requirement to remove residual hydrogen peroxide. FDA does not expect the expanded uses authorized by the regulation to increase dietary exposure to hydrogen peroxide because of this removal requirement and the inherent instability of hydrogen peroxide.
- FDA is also updating the regulation to cross-reference the specifications in the hydrogen peroxide monograph in the 14th edition of the Food Chemicals Codex (FCC) instead of the previously listed 7th edition. However, this is just a technicality, and the FCC monograph for hydrogen peroxide has not changed between editions.
- Hydrogen peroxide is also affirmed as GRAS in 21 CFR 184.1366 for a variety of other uses. The GRAS affirmation was issued pursuant to 21 CFR 184.1(b)(2), which purports to require a food additive regulation for any extension of use.
