Important changes to labelling of hand sanitiser

Since the start of the COVID-19 pandemic many companies have been making hand sanitiser. But issues have arisen about their effectiveness, alcohol content and the risk of ingestion.  New rules commenced on 25 November 2020 to address these issues.  The rules apply to hand sanitiser that is regulated under cosmetics regulations.  From 25 May 2021 their container must be labelled with:

  • the amount of alcohol contained in the hand sanitiser as a percentage (%), by volume per volume (v/v) on the container; and
  • compulsory wording (or pictograms) setting out the risks of the product.

Products manufactured up until 24 May 2021 can comply with either the new rules or can be labelled in accordance with the existing cosmetics regulations.

The new rules apply to hand sanitiser that, in summary:

  • is an antibacterial skin care product containing one or more antimicrobial active substances;
  • is represented as, or is likely to be taken to be:
    • for use on hands when soap and water are not available;
    • applied to the hands without rinsing off; and
    • intended to destroy bacteria on the skin; and
  • contains alcohol as the primary active ingredient;
  • but the rules do not apply to:
    • hand sanitiser regulated by the Therapeutic Goods Act 1989 (TGA) (products that claim to kill specific organisms (e.g. E. coli or viruses) or are to be used in clinics or hospitals; or
    • hand sanitiser that is excluded from the TGA (80% ethanol hand sanitiser and 75% isopropyl alcohol hand sanitiser that comply with specific requirements as to their formulation, manufacture and labelling).

I am experienced in advising on product labelling.  Please contact me for more details of the new hand sanitiser rules.

This article provides general information only, and is not intended as legal advice specific to your circumstances. Please seek the advice of a legal professional if you have any particular questions.

© Margaret Ryan Melbourne, Victoria, 2020

Important changes to labelling of hand sanitiser