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With more than 70 years of experience in safety and quality, Mérieux NutriSciences AQ offers guidance and expertise on the regulatory requirements, design, and content of labels for disinfectant and sanitiser products. We support household-grade and hospital-grade disinfectant manufacturers.
Getting your disinfectant label right is critical for every manufacturer as it plays an important role in the product’s effectiveness and safe use. Our consultants review your disinfectant labels thoroughly to identify any potential issues or non-compliance with regulations. This includes checking for accurate and complete ingredient lists, proper usage instructions, required warnings, and other specific requirements mandated by regulatory authorities.
Understanding Disinfectant Labelling Requirements in Australia
Disinfectants in Australia are regulated by the Therapeutic Goods Administration (TGA) as either exempt disinfectants or listed disinfectants depending on the product claims.
Exempt disinfectants are disinfectants that make non-specific claims. Some examples include but are not limited to ‘Kills E.coli,’ ‘Kills bacteria,’ Kills germs,’ and ‘Kills bacterial growth.’Exempt disinfectants are not required to be listed on the Australian Register of Therapeutic Goods (ARTG) prior to their supply however they still must meet all relevant regulatory requirements.
Listed disinfectants are disinfectants that make specific claims. Some examples include but are not limited to ‘kills spores,’ ‘kills viruses’ and ‘fungicidal’. Listed disinfectants are required to be listed on the Australian Register of Therapeutic Goods (ARTG) prior to their supply and must meet all relevant regulatory requirements.
The kinds of information that are included on a disinfectant label include but are not limited to how to use the disinfectant, dwell/contact time, first aid, precautionary statements, safety, storage, disposal, quantity/proportion of active ingredients, the organisms they kill, expiry date, claims and common name of disinfectant. These are just some of the considerations when reviewing a disinfectant label.
Selling goods that don’t comply with labelling laws can incur penalties, legal action, negative reputation, recalls, waste, market delays, injury and sometimes death.
Master Disinfectant Labelling Compliance with us
Merieux NutriSciences provides both labelling consulting and laboratory testing services for your disinfectants. Our tests allow manufacturers of disinfectants, hand sanitisers, and other antimicrobials, to receive a certificate of analysis required by TGA to sell their products locally. Learn about our antimicrobial tests here.
Disinfectant labels must meet the requirements of the Therapeutic Goods Administration (TGA) legislation and may also need to comply with the below certification bodies. Merieux NutriSciences AQ checks your label against the following institutions and standards:
- The Poisons Standard (the SUSMP)
- Australian Industrial Chemicals Introduction Scheme (AICIS)
- The Australian Dangerous Goods Code
- Safety Data Sheet
- The National Measurement Institute
- The Aerosol Standard AS 2278.1
What are disinfectants?
It is important to ensure your products meet the definition of a disinfectant product before seeking regulatory services. A disinfectant is a substance:
- that is recommended by its manufacturer for application to an inanimate object to kill microorganisms; Examples of inanimate objects include floors, walls, door handles, bench tops, carpets and furniture.
- that is not represented by the manufacturer to be suitable for internal use and is not intended for use on medical devices.
Do you need to validate the efficacy of your disinfectants and antimicrobial products? Whether you need a TGA disinfectant test to expand your business in Australia or if you need a bespoke analysis due to a product formulation change, Mérieux NutriSciences AQ can support you with all your analytical testing needs.
Contact us to discover how we can help you.
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