Proposal for clarifying regulatory requirements for residual claims for disinfectants

Closed 26 Mar 2021

Opened 1 Mar 2021

Overview

This consultation is to obtain feedback in relation to proposals to provide clarity on residual claims for disinfectants.

The Therapeutic Goods Administration (TGA) has received a number of enquiries relating to residual activity claims for disinfectants, including whether statements can be made for disinfectants such as ‘residual activity for up to 30 days’, and what testing methods should be used to provide evidence for these claims.

At present, there is no definition of “residual activity” included in the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) 2019 (the Order) or the TGA published guidance document: TGA Instructions for Disinfectant Testing. There are also no defined test methods or specified acceptance criteria for such testing. To date, claims have been considered (and continue to be considered) by the TGA assessors on a case by case basis. The approach we have taken is that the sponsor/manufacturer should formulate a test method to justify the claims they wish to make. Any sponsor/manufacturer of a disinfectant product can make an application to list a product in the Australian Register of Therapeutic Goods (ARTG) including claims of “residual activity” if they have test methods and data to justify the claims.

Guidance to date on residual claims has been in part informed by the Publicly Available Specification (PAS) published by the British Standards Institute, which defines good practice standards for disinfectants (PAS 2424:2014).

Why we are consulting

We are seeking feedback on the following:

  1. A definition of residual activity of a disinfectant product
  2. Testing standards for residual activity claims
  3. Acceptance criteria for residual activity claims
  4. Whether there should be a limit on the period over which residual activity is claimed
  5. Whether residual activity claims should be restricted to general bacteria only and other specific organisms
  6. Whether residual activity claims should be disallowed.

Feedback from the Consultation Paper may inform changes to the regulatory framework, including the TGO 104 or other accompanying documentation relating to disinfectants.

For further background and information, please refer to the consultation paper
Proposal for clarifying regulatory requirements for residual claims for disinfectants, downloadable via a link at the bottom of this page.

We invite you to complete our online survey (click on the link below).

If you prefer, you can make a submission directly to the Department via post or email at the following addresses:

Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

devicereforms@tga.gov.au

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).

Outcomes from the consultation will be provided to the Government for consideration.

Audiences

  • Medical Devices & IVDs

Interests

  • Health technology