TECHNICAL BULLETIN Requirements for Surface Sanitizers to be FDA Food Code Compliant
1. Federal and State Registration: The product must be registered with the EPA and have an EPA registration number. The product must also be registered in the state that it is being used in. a. FDA does not review and approve food contact surface sanitizers. b. Jurisdiction for antimicrobial substances used to sanitize or disinfect food-contact surfaces was transferred to the EPA under the Food Quality Protection Act (FQPA) passed by Congress in 1996 (http://npic.orst.edu/reg/laws.html). c. EPA must review the product formulation, acute toxicity, and efficacy data as well as approve/ prescribe product labeling i. In order for EPA to permit labeling for Food Contact Surface Sanitizing with no rinse required EPA must check that the active ingredient and any inert ingredients are acceptable for this use per 7-204.11 Sanitizers, Criteria of the 2013 Food Code (referencing 40 CFR 180.940, 950, or 960). The 2005 - 2013 FDA Food Code recognizes this.
ii. EPA must review the efficacy data and assure that the product kills 99.999% of bacteria within 30 seconds (Staphylococcus aureus and E. Coli). Note: Even though a product has proven to kill 99.999% of bacteria in 30 seconds or less and FDA Food Code requires a contact time of at least 30 seconds for other chemical sanitizing solutions, EPA requires that a product's directions for use indicate 60 seconds for sanitizing food contact surfaces.
2. Test Device: A test kit or other device that accurately measures the active concentration level of sanitizing solutions must be available as per 4-302.14 Sanitizers, Criteria of the 2013 Food Code.
3. Follow Directions for Use: If a sanitizer other than chlorine, iodine, or a quaternary ammonium compound is used, it shall be applied in accordance with the EPA-registered label use instructions. a. As identified above within Federal Registration, EPA will approve as well as prescribe product labeling. b. An area that is prescriptive is the 'directions for use' for EPA registered food contact surface sanitizers. EPA requires food contact surface sanitizers to indicate a 60-second dwell time even if the product has data that proves 99.999% reduction of bacteria in 30 seconds or less.
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