Published 13th April 2022

Australian Pesticides and Veterinary Medicines Authority proposes amendments to how the efficacy of certain pool and spa chemicals is assessed

The Australian Government Australian Pesticides and Veterinary Medicines Authority (APVMA) is inviting submissions on the proposed amendments to how the how the efficacy of certain pool and spa chemicals is assessed.

Current arrangements

Under the current legislation pool and spa sanitisers are considered to be agricultural chemical products. Before new products can be registered and allowed into the marketplace, the APVMA must be satisfied of certain statutory criteria that relate to their safety, efficacy, trade and labelling. This guideline sets out how applicants may demonstrate that a proposed new pool or spa sanitiser would satisfy the APVMA’s efficacy criteria.

For many years, disinfection of swimming pools and spa pools has relied mainly on chemical sanitisers based principally on chlorine and bromine. While the efficacy of these traditional sanitisers is well established with regard to different kinds of pathogenic microorganisms, new types of chemical sanitisers lack such an established record.

All new pool and spa sanitiser products need to demonstrate that they are efficacious, regardless of whether they are novel chemicals or traditional sanitisers with a long history of safe use. While manufacturers may choose to satisfy efficacy criteria by demonstrating that the product meets the current performance characteristics, the APVMA is highlighting that they are prepared to consider alternative information and arguments aimed at satisfying the efficacy criteria.

Currently, guidance on how to demonstrate the efficacy of pool and spa sanitisers is available on the APVMA website.

In addition to satisfying the efficacy criteria, a new sanitiser must meet the APVMA’s safety criteria relating to human health and to the environment. For example, there should be no adverse impact on bathers or toxic effect from the sanitiser or its by-products that exceeds health standards because of either short-term or extended immersion in water treated with the sanitiser.

The APVMA has made a legislative instrument in relation to efficacy. This includes criteria based on demonstrated effectiveness. Under these criteria, a product is taken to be effective if it would, to a reasonable degree, achieve one of the effects listed in paragraphs 4(2)(a) to (e) of the current Agricultural and Veterinary Chemicals Code (Agvet Code) and this is evidenced or demonstrated by:

1. results from efficacy trials or experiments; or
2. valid scientific argument; or
3. demonstrated history of sale and effective use in equivalent uses; or
4. full results from overseas efficacy trials or experiments and the associated assessment reports by an overseas regulator that are relevant to the proposed product and use; or
5. a combination of  two or more of the above.

The current Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014 (Efficacy Criteria Determination 2014) does not include specific performance-based criteria against which the efficacy of products, including pool and spa sanitisers, are compared.

Proposed arrangements

The APVMA therefore proposes to amend the Efficacy Criteria Determination 2014. The amendments will include a change to clause 3, for agricultural chemical products, to refer to specific performance standards established for certain types of products. A schedule, containing the performance standards referred to in this clause, would also be added to the determination.

The APVMA’s current guidance on how to demonstrate efficacy of pool and spa sanitisers draws on international best practice, as set out in the Organisation for Economic Co-operation and Development (OECD) guidance document for demonstrating efficacy of pool and spa disinfectants¹. In maintaining the commitment to follow international best practice, the APVMA cites it will continue to rely on the OECD guidance.

How to make a submission

Submissions from interested stakeholders on the proposed approach to the assessment of pool and spa chemicals are welcomed by APVMA.

More information

For more information, head to the Australian Pesticides and Veterinary Medicines Authority webpage here: https://apvma.gov.au/node/98301