Sanitizing Rinses (for previously cleaned food-contact surfaces)
DIS/TSS-4 Jan 30, 1979
EFFICACY DATA REQUIREMENTS
Sanitizing rinses (for previously cleaned food-contact surfaces)
Sanitizers applied to food contact surfaces are defined as incidental food additives under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 201 et seq.), and require establishment of a food additive tolerance. Recommendation of a potable water rinse after treatment does not preclude this requirement.
- Halide chemical products. Efficacy of sanitizing rinses formulated with iodophors, mixed halides, and chlorine bearing chemicals must be substantiated with data derived from the AOAC Available Chlorine Germicidal Equivalent Concentration Method.
- Test requirements. Data from one test on each of 3 samples, representing 3 different batches, one of which is at least 60 days old, against S. typhi are required.
- Performance standard. Test results must show product concentrations equivalent in activity to 50, 100, and 200 ppm of available chlorine. (The reference standard is sodium hypochlorite.)
- Other chemical products. Efficacy of sanitizing rinses formulated with quaternary ammonium compounds, chlorinated trisodium phosphate, and anionic detergent-acid formulations must be substantiated with data derived from the AOAC Germicidal and Detergent Sanitizers Method.
- Test requirements. Data from the test on one sample from each of 3 different batches, one of which is at least 60 days old, against both E. coli and S. aureus are required. When claims for the effectiveness of the product in hard water are made, all required data must be developed at the hard water tolerance claimed.
- Performance standard. Acceptable results must demonstrate a 99.999% reduction in the number of microorganisms within 30 seconds. The results must be reported according to the actual count and percentage reduction over the control. The minimum concentration of the product which provides the results required above is the minimum effective concentration.