Certain domestic swimming pool and spa chemicals

Key issues

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has received reports of adverse experiences associated with a lack of efficacy that highlighted the need for a review of the registration of hydrogen peroxide and/or polyhexanide hydrochloride domestic swimming pool and spa pool sanitiser products. No commercial products containing these active constituents are registered as swimming pool and spa pool sanitiser products.

Polyhexanide hydrochloride products were subject to a formal reconsideration (under Part 2, Division 4 of the Code), and that review concluded in 2018. The scope of that review was limited to human health, and considered only whether products would be carcinogenic when used in accordance with label instructions. The APVMA determined that these products were safe in both occupational and public settings.

Focus of the review

The scope of this review was limited to the antibacterial performance of these products relative to the APVMA efficacy guidelines for pool and spa sanitisers.

In accordance with the legislation, the APVMA notified relevant holders and state and territory chemical coordinators of its proposed regulatory decisions (PRD) to cancel product registrations and label approvals pursuant to section 41 (2) of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 on 6 March 2020 and invited submissions related to this proposed decision until 27 April 2020.

The APVMA also invited submissions from the public on the ability of products containing hydrogen peroxide and polyhexanide hydrochloride to satisfy the APVMA target performance characteristics for swimming and spa pool sanitisers from 24 March to 28 April 2020. The consultation information was published in the Gazette and on the APVMA public consultations webpage.

Outcome of the review

Between 6 March 2020 and 28 April 2020 the APVMA received submissions from eight different interested parties, including one late submission that was also considered.

During and after the consultation period holders and peak bodies were provided the opportunity to speak with staff from both chemical review and registration areas about the proposed decisions. Advice was also provided about how to make an application to the APVMA to vary a product registration and label approval to remove claims of pool or spa sanitisation using the online application portal.

In accordance with the legislation, the APVMA considered all the information submitted to the consultation and further reviewed relevant information submitted through the consultation process in finalising its decisions. The APVMA’s statement of reasons and the material which was relied on for the decisions were published in the Gazette on 28 July 2020.

The final regulatory decisions to cancel products and associated labels for spa and swimming pool products containing hydrogen peroxide and polyhexanide hydrochloride were published in the Gazette on 28 July 2020. The Gazette notice includes information about possession, supply, custody, and use for cancelled products, which are permitted in accordance with the instructions in the notice until 31 January 2021.

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