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Submissions received: Proposal for clarifying the regulation of residual-activity claims for disinfectants

24 September 2021

We thank those who responded to our consultation paper. We sought feedback on several proposals related to residual-activity claims for hard-surface disinfectants, including:

  • a definition of residual activity
  • testing standards to be used to provide evidence for these claims
  • acceptance criteria for claimed activity.

We also asked for feedback on whether or not:

  • there should be a limit on the period over which residual activity is claimed
  • residual-activity claims should be restricted to general bacteria only or other specific organisms
  • residual-activity claims should be allowed in the interim
  • new testing requirements should apply to new listings only.

Submissions received

We received a total of 25 submissions, which included 5 through targeted consultations, and 20 responses to our public consultation (1–26 March 2021). Respondents included:

  • one industry body and one consumer association
  • 14 from the health, hygiene and medical device sectors
  • one from a regulatory affairs consulting company
  • 4 from government agencies.

All submissions from respondents that gave permission for publication on the TGA website are now available in PDF format.

Summary of submissions

In relation to the definition, we received 4 kinds of responses:

  • Five agreed with the proposed definition.
  • Ten suggested amendments to the definition.
  • One did not support the definition.
  • Five had no specific comment.

Twelve respondents supported the use of the Publicly Available Specification (PAS) standard, with 6 of these also supporting use of the US Environmental Protection Agency (EPA) protocol, and 3 suggesting other methods as also suitable. Seven of those who supported the use of the PAS requested additional guidance be provided. One respondent considered the method to be inappropriate as it is too harsh; another proposed the use of ISO 21702 Measurement of antiviral activity on plastics and other non-porous surfaces as more appropriate; and 6 had other, non-specific comments. One said the standards currently accepted by the TGA for initial testing should apply.

Thirteen respondents considered the proposed acceptance criteria appropriate (2 of those specifically stated that the criteria were also appropriate for viruses, and some had caveats); 6 considered that the criteria should be the same as for initial testing; and 2 had no comment.

In response to the proposal that no limitations be set on the period over which residual activity is claimed, as long as the claims are substantiated by test data:

  • 9 respondents supported the proposal
  • 6 were against (stating variously that the period should be: set at 24 hours or less; no longer than 30 days; and no longer than 7 days)
  • 5 considered that other factors, such as the intended use of the product, should be taken into account. One considered that the TGA should stipulate set periods.

On the proposal that residual-activity claims can be made against general bacteria and/or specific organisms, if substantiated by test data:

  • 15 respondents agreed
  • 2 considered that only specified organisms should be allowed
  • one suggested the claims should be limited to bacteria and yeast
  • one submitted that claims for other organisms should be allowed only if the method permitted
  • one said allowing different organisms would require different test methods with different criteria
  • one was against the proposal on the basis that users would need to understand the relevance to the particular clinical setting.

On the interim approval of residual-activity claims:

  • 8 respondents supported the proposal, although one suggested new requirements should be applied retrospectively to existing listings if the manufacturer had applied an inferior method
  • 10 disagreed with the proposal. Most of those thought the requirements should be retrospective, although 2 submitted that the decision should not be made until the requirements had been determined, and 2 said claims should be disallowed until the requirements are set
  • 3 submissions had no comment.

Conclusion

The proposed definition appeared to have general support, although there were several suggested amendments.

The majority of respondents supported the use of the PAS standard, and several also supported the US EPA protocol. There were several requests for additional guidance, on topics such as:

  • claims for organisms other than those specified in the Standard
  • variations in claimed residual-activity period
  • which claims are in or out of scope, or make the product Listable rather than exempt or excluded.

The majority of respondents also supported the proposed acceptance criteria for residual activity, although there was also a reasonably strong view that the products should meet the same criteria as required for initial disinfection, with some stating that a lower acceptance criterion meant that a surface was 'sort of clean'.

We received mixed responses to the proposal that no limitations be set on the period over which residual activity is claimed, as long as the claims are substantiated by test data. Those who were against the proposal preferred that allowable timeframes be stipulated, but the timeframes suggested varied from 24 hours or less, to 30 days.

Most respondents agreed with the proposal that residual-activity claims could be made against general bacteria and/or specific organisms, if substantiated by test data. However, there was some concern over extending claims to include viruses due to variability of virus behaviour.

The majority of respondents who answered the question on the interim approval of residual claims disagreed with the proposal. Most of those thought the requirements should be retrospective, although 2 said the decision should not be made until the requirements had been determined, and 2 thought claims should be disallowed until standards were set.

What happens next?

After we have carefully considered the feedback received, the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 and the TGA Instructions for Disinfectant Testing will be revised to include a definition, acceptable test methods and acceptance criteria for residual activity. Updates to these documents are expected to be published soon.

Published submissions

All submissions that gave permission to be published on the TGA website are available below in PDF format.

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