Polihexanide chemical review

Polihexanide is an antibacterial chemical and an algaecide. It is used in swimming pools and spas to control algae, as a disinfectant in veterinary products, and as a sanitiser for milk handling equipment.

This nomination was based on advice from the Office of Chemical Safety (OCS), which identified polihexanide as a potential carcinogen.

After a comprehensive toxicological assessment in 2011, the APVMA determined that polihexanide is not carcinogenic when used in accordance with label instructions. Although the assessments identified polihexanide as a potential carcinogen in rodents, this was only at high exposure levels which are unlikely to be encountered in occupational or public settings from use of polihexanide products. For more information, see the Polihexanide carcinogenicity hazard assessment report (June 2011).

The APVMA also assessed the risk to human health from exposure to polihexanide. Specifically, it assessed risk from occupational exposure and risk from post-application exposure (e.g. from bathing or swimming in pools treated with polihexanide). The APVMA determined that products containing polihexanide can be used safely provided that appropriate signal headings and first aid instructions and safety directions are included onto labels. For more information, see the Human Health Risk Assessment of Polihexanide (January 2018).

Based on the toxicology and human health risk assessments, the APVMA proposed to vary relevant particulars of label approvals to satisfy human health and, worker health and safety requirements. Specifically the APVMA proposed to include appropriate signal headings, first aid instructions and safety directions on the product labels for safe handling of the product and first aid in the event of an accident caused by the handling of the product. See the Polihexanide: Proposed Regulatory Decisions report for detailed information.

On 25 January 2018, the Polihexanide Proposed Regulatory Decisions report was published for a 3-month stakeholder consultation.

The APVMA invited comment on the polihexanide proposed regulatory decisions. The closing date for submissions was 27 April 2018.

Only one submission was received. The APVMA assessed the submission, and taking into account the points raised in the submission, made amendments to the safety directions of three products.

The review of product registrations and label approvals for polihexanide was completed in May 2018. The APVMA published the Polihexanide Regulatory Decisions report on 25 May 2018.

The regulatory outcomes of the review are:

1. product labels have been updated to strengthen the first aid instructions and safety directions; and
2. the product registrations have been affirmed.
3. all previous product label approvals that are not consistent with the review outcomes have been cancelled.