Stellina Popplewell

Antimicrobial coatings that are incorporated in manufacture or applied to surfaces (physical barrier) to protect itself are generally considered sanitation/environmental control/environmental detoxification equipment and fall under item 12 of Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018. Therefore not regulated by TGA.

It would be considered an industrial chemical and regulated by AICIS (Australian Industrial Chemicals Introduction Scheme). Requires checking that the ingredients are on the AICS inventory and label compliance for hazardous chemicals.

The words hospital grade disinfectant, hard surface disinfectant or disinfection etc, should not be used to describe this product, limited only to antimicrobial coating.

The TGA consider antimicrobial coatings that are in the same form as disinfectants, i.e. liquids, sprays, wipes, sponges and aerosols and applied to a surface like these types of disinfectants, are disinfectants and therefore regulated by TGA. Following are the regulatory pathways for these types of products:

  • If the antimicrobial coating is marketed as general cleaner with claims limited to antibacterial or bacteriostatic, then this is not regulated by TGA. It would be considered an industrial chemical and regulated by AICIS (as above).
  • Antimicrobial coatings with bactericidal claims are regulated by TGA but exempt from TGA listing. This means no formal approval is need by TGA (no application) but the sponsor/manufacturer must ensure that the product complies with TGA requirements and the information must be kept on file, if requested by TGA.
  • Antimicrobial coatings in a disinfectant form with specific claims, i.e. virucidal, sporicidal, tuberculocidal, fungicidal require listing (AUSTL) with TGA. This requires an application to TGA and has a set of data requirements.

As manufacturers develop “smarter” disinfectants and sanitisers the regulators are being forced to play catch-up. Getting these new products to market can be frustrating but the rewards are there for those who persist.