Australia TGA Updates Guidance on Regulation of Listed Disinfectants

The Therapeutic Goods Administration (TGA) Australia has published the updated guidance document on the regulation of listed disinfectants in December 2021. 

The main update is based on the changes to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019, where information pertaining to claims of residual activity has been incorporated in the document. 

To make a claim of residual activity, the required test data must be provided and can only be made for bacteria, yeast, or viruses. The TGA Instructions for Disinfectant Testing contains the prerequisites for the test and provides information on the approved test methodologies, acceptance criteria and maximum claim duration, which is 30 days.  

The definition of residual activity is the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface. This is only applicable when the disinfectant is used in accordance with the information provided on the label of the disinfectant. 

The new prerequisites, as mentioned in the TGA Instructions for Disinfectant Testing, will be applicable from 1 July 2022 for products that are included in the Register as of 1 January 2022 and for existing applications received prior to 1 January 2022. 

More details can be found in “Guidance on the regulation of listed disinfectants in Australia, December 2021”: https://www.tga.gov.au/publication/guidance-regulation-listed-disinfectants-australia  

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