Jump to main content.

Confirmatory Efficacy Data Requirements

DIS/TSS-5 Sept. 22, 1982
CONFIRMATORY EFFICACY DATA REQUIREMENTS

  1. When Applicable. In certain situations an applicant is permitted to rely on previously submitted efficacy data to support an application or amendment for registration of a product and to submit only minimal confirmatory efficacy data on his own product to demonstrate his ability to produce an effective formulation. These situations are as follows:


    1. Duplicated Product Formulations. In this situation, the applicant manufactures a formulation which duplicates a product that is already registered with complete supporting efficacy data. The chemical composition, manufacturing procedure, label claims, and directions for use are identical in substance to those of the original registration, and specific references to the supporting data developed for the original product are furnished by the applicant.


    2. Minor Formulation Change in a Registered Product. In this situation, the change in the formulation is relatively minor, e.g., a change of an inert ingredient. The label claims and directions for use are unchanged from those accepted for the registered formulation, and specific references to the supporting data developed for the original formulation are cited by the registrant.


  2. Confirmatory Data Required. The following data must be developed on the applicant's own finished product. When the test methodology utilized in deriving the original supporting efficacy data were modified to include additional elements not specified in the recommended method, such as organic soil, hard water, longer or shorter contact time, etc., the confirmatory data must be produced under similarly modified conditions. The specified confirmatory data are required to be developed only at the dilution and condition which represents the highest level of efficacy and most stringent condition claimed on the label, e.g., as a hospital disinfectant in organic soil for a product which may be used at different dilutions for hospital or general disinfection or in the presence or absence of organic soil, or additionally as a sanitizing rinse for food contact surfaces.


    1. Disinfectants for Use in Hospital or Medical Environments.


      1. Test Requirements. Ten carriers on each of 2 samples representing 2 different batches are required against each of Salmonella choleraesuis ATCC 10708, Staphylococcus aureus ATCC 6538, and Pseudomonas aeruginosa ATCC 15442, employing the AOAC Use-Dilution Method for liquid products, or the AOAC Germicidal Spray Products Test for spray products.


      2. Performance Standard. Killing on all carriers is required.


    2. General Broad-Spectrum Disinfectants.


      1. Test Requirements. Ten carriers on each of 2 samples representing 2 different batches are required against each of S. choleraesuis and S. aureus, employing the AOAC Use-Dilution Method for liquid products, or the AOAC Germicidal Spray Products Test for spray products.


      2. Performance Standard. Killing on all carriers is required.


    3. Disinfectants with Limited Efficacy.


      1. Test Requirements. Ten carriers on each of 2 samples representing 2 different batches are required against either S. choleraesuis or S. aureus, depending upon the microorganism against which the activity of the product is limited, employing the AOAC Use-Dilution Method for liquid products, or the AOAC Germicidal Spray Products Test for spray products.


      2. Performance Standard. Killing on all carriers is required.


    4. Sanitizing Rinses for Food-Contact Surfaces.


    1. Test Requirements. One test on one sample, with or without hard water (depending on the label claim), is required using either: the AOAC Germicidal and Detergent Sanitizers Method against Escherichia coli ATCC 11229 for quaternary ammonium compounds, chlorinated trisodium phosphate, and anionic detergent-acid formulations; or the AOAC Available Chlorine Germicidal Equivalent Concentration Test against Salmonella typhi ATCC 6539 for iodophors, mixed halides, and chlorine-bearing chemicals.


    2. Performance Standard.


      1. AOAC Germicidal Detergent Sanitizers Method. Acceptable results must show a 99.999% reduction in the number of microorganisms within 30 seconds. The results must be reported as the actual counts and the percentage reduction over the control.


      2. AOAC Available Chlorine Germicidal Equivalent Concentration Test. Test results must show product concentrations equivalent in activity to 50, 100, and 200 ppm of available chlorine. (The reference standard is sodium hypochlorite.)

      3. Note: For pressurized spray disinfectants, certification is required that all parts and materials used in the aerosol container are identical to those specified for the original product.

  3. When Not Applicable. Products proposed for registration which are merely relabeled, repackaged, or simple dilutions of a product already registered and manufactured by another registrant require only documentation of this identity and specific references to the supporting data developed for the original product. Confirmatory test data are not required for these situations. For use patterns other than disinfectants and sanitizers as specified above, required bridging data will be determined (or waived) on a case-by-case basis.

Publications | Glossary | A-Z Index | Jobs

Local Navigation

Jump to main content.