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.
(1) 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.
(i) 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.
(ii) 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.)
(2) 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.
(i) 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.
(ii) 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.
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