1. (a) Sanitizers — Criteria.* Chemical sanitizers and other chemical antimicrobials applied to food-contact surfaces shall meet the requirements specified in 40 C.F.R. § 180.940, Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (food-contact surface sanitizing solutions). ^P

2. (b) Chemicals for washing, treatment, storage, and processing fruits and vegetables — Criteria.*

   1. (1) Chemicals, including those generated on-site, used to wash or peel raw, whole fruits and vegetables shall:

      1. (A) Be an approved food additive listed for this intended use in 21 C.F.R. pt. 173; ^P or
      2. (B) Be generally recognized as safe (GRAS) for this intended use; ^P or
      3. (C) Be the subject of an effective food contact notification for this intended use, only effective for the manufacturer or supplier identified in the notification; ^P and
      4. (D) Meet the requirements in 40 C.F.R. pt. 156, Labeling requirements for pesticides and devices. ^P
   2. (2) Ozone as an antimicrobial agent used in the treatment, storage, and processing of fruits and vegetables in a retail food establishment shall meet the requirements specified in 21 C.F.R. § 173.368, Ozone. ^P
3. (c) Boiler water additives — Criteria.* Chemicals used as boiler water additives shall meet the requirements specified in 21 C.F.R. § 173.310, Boiler water additives. ^P

4. (d) Drying agents — Criteria.* Drying agents used in conjunction with sanitization shall:

   1. (1) Contain only components that are listed as one of the following:

      1. (A) Generally recognized as safe for use in food as specified in 21 C.F.R. pt. 182, Substances generally recognized as safe, or 21 C.F.R. pt. 184, Direct food substances affirmed as generally recognized as safe; ^P
      2. (B) Generally recognized as safe for the intended use as specified in 21 C.F.R. pt. 186, Indirect food substances affirmed as generally recognized as safe; ^P
      3. (C) Generally recognized as safe for the intended use as determined by experts qualified in scientific training and experience to evaluate the safety of substances added, directly or indirectly, to food as described in 21 C.F.R. § 170.30, Eligibility for classification as generally recognized as safe (GRAS); ^P
      4. (D) Subject of an effective food contact notification as described in Section 409(h) of the Federal Food, Drug, and Cosmetic Act; ^P
      5. (E) Approved for use as a drying agent under a prior sanction specified in 21 C.F.R. pt. 181, Prior-sanctioned food ingredients; ^P
      6. (F) Specifically regulated as an indirect food additive for use as a drying agent as specified in 21 C.F.R. pts. 175 – 178; ^P or
      7. (G) Approved for use as a drying agent under the threshold of regulation process established by 21 C.F.R. § 170.39, Threshold of regulation for substances used in food-contact articles; ^P and
   2. (2) When sanitization is with chemicals, the approval required under subdivisions (d)(1)(C) or (d)(1)(E) of this section or the regulation as an indirect food additive required under subdivision (d)(1)(D) of this section shall be specifically for use with chemical sanitizing solutions. ^P

Codification Notes: Section 409 of the Federal Food, Drug, and Cosmetic Act is codified at 21 U.S.C. § 348.