Disinfectants – TGA – Hospital Grade & Household Grade

Disinfectants are a specialised group of products which are ‘recommended by its manufacturer for application to an inanimate object to kill micro-organisms’. These products come in different forms including products for household use such as disinfectant sprays, and disinfectant wipes. There are also industrial and hospital grade disinfectants available in bulk quantities

Disinfectants can be marketed for a variety of uses including offices, laboratories, clean-rooms, as well as premises such as medical suites, doctors offices, dentist labs, hospitals,  barbers and hair dressers and other premises wanting to practice infection control.If products make only generalised claims against bacteria, then they are exempt from TGA listing requirements. However, the label must still pass TGO 104 requirements, and you must have satisfactory evidence on file to support disinfectant claims. Usually this will be the TGA Disinfectant Test or European equivalent.

If products make specific claims such as claims against viruses in general, named bacteria and viruses then the product will need to be listed with the TGA.

We can assist you with all aspects of disinfectant compliance. We have submitted over 20 disinfectant applications to the TGA and dozens of label and claims changes for our clients products over the last 5 years. We are well versed with the TGA expectations when it comes to label requirements and efficacy studies – this means we can review your paperwork and predict the outcome for you and let you know before you submit anything to the TGA whether you have all the required documentation.

We can complete the appropriate TGA submissions for ingredients not already on the TGA list of approved ingredients. We can also advise you on how to present products for cleaning use only if you do not wish to make disinfection claims.

COVID-19 Claims:
We have assisted a number of clients to amend their existing disinfectant listings to make successful COVID-19 claims. The TGA will accept Human Coronavirus 229E or Murine Hepatitis Virus as surrogate viruses in lieu of COVID-19.

Documentation requirements
In order to assist you, we will need to see:

    • Product artwork
    • Quantitative Formula – i.e. list of ingredients and percentages
    • Tests already completed

Label Changes
In most cases you will need to make label changes to comply with Australia specific TGA requirements. Some of the required information includes:

    • Common name – e.g. ‘Hospital Grade Disinfectant’ to be stated near the product name
    • Australian Sponsor – name and address
    • List of active ingredients and percentages
    • Statement of dilution – or ‘use undiluted’
    • Statement: “Do not mix with detergents or other chemicals”
    • Statement: ‘”Not to be used on Medical Devices”
    • Statement: “Not to be used on skin”

Further reading

TGA Disinfectant Landing Page:
https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products

TGO 104: Disinfectants – TGA – Hospital Grade & Household Grade
https://www.legislation.gov.au/Details/F2019L00482

TGA Instructions for Disinfectant Guidance:
https://www.tga.gov.au/publication/tga-instructions-disinfectant-testing

TGA Disinfectant Claim Guide:
https://www.tga.gov.au/publication/disinfectant-claim-guide-specific-claims-and-non-specific-claims

Please feel free to contact us for more information.