Proposed Re-evaluation Decision PRVD2022-21, Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-use Products

Pest Management Regulatory Agency
14 December 2022
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2022-21E-PDF (PDF version)

Table of contents

• Proposed re-evaluation decision
• Next steps
• Other information
• Additional scientific information

Proposed re-evaluation decision

Under the Pest Control Products Act, all registered pesticides must be re-evaluated regularly by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet health and environmental safety standards and continue to have value. The re-evaluation considers data and information from various sources such as information from pesticide manufacturers, incident reports, and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods, risk management approaches and policies to all re-evaluations.

This document (Proposed Re-evaluation Decision PRVD2022-21, Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of hypochlorite cluster (that is, available chlorine, present as calcium hypochlorite; available chlorine, present as sodium hypochlorite; and sodium hypochlorite), including any proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based.

Products containing sodium hypochlorite or calcium hypochlorite are registered as antimicrobials in industrial settings, commercial ornamental water systems, municipal water treatment of sewage and industrial effluent, certain indoor hard surfaces, laundry additive, and swimming pools and spas. They are registered as commercial- and domestic-class products. In addition, sodium hypochlorite and calcium hypochlorite are listed in Schedule 2 of the Pest Control Products Regulations. These scheduled products are also included in the re-evaluation. Calcium hypochlorite products are formulated as solids and sodium hypochlorite products are formulated as liquids. Currently registered technical grade active ingredients, manufacturing concentrates, and end-use products containing sodium hypochlorite or calcium hypochlorite are listed in Appendix I of PRVD2022-21. Registered uses of sodium hypochlorite and calcium hypochlorite considered during the current re-evaluation are summarized in Appendix II of PRVD2022-21.

In addition, some registered sodium hypochlorite products contain uses not regulated under the Pest Control Products Act. These include uses on beef carcass, poultry carcass, agriculture and dairy, food process plants, poultry reprocessing, poultry water immersion, fish process plant water, disinfectant uses in health care facilities and schools, and the claim “removes stains, disinfects and deodorizes.” These uses and claims were not assessed in the current re-evaluation. Health Canada is proposing a new set of regulations under the Food and Drugs Act that will include surface sanitizers (currently regulated under the Pest Control Products Act) and surface disinfectants (currently regulated under the Food and Drug Regulations), collectively referred to as biocides. For more information about what is being proposed, please refer to Canada Gazette, Part I, Volume 156, Number 19: Biocides Regulations.

Sodium hypochlorite and calcium hypochlorite are non-selective and broad-spectrum antimicrobial agents. They are effective in controlling and preventing the growth of bacteria, algae, fungi, and viruses when used in aqueous solution. When the proposed label updates are followed (Appendix III of PRVD2022-21), potential risks to human health (dietary, occupational, residential and bystander) and the environment (aquatic and terrestrial organisms) are considered to be acceptable.

Under the authority of the Pest Control Products Act and based on an evaluation of currently available scientific information, products containing sodium hypochlorite and calcium hypochlorite (Appendix I of PRVD2022-21) are being proposed for continued registration in Canada, with proposed label amendments, including:

• updated signal words, precautionary statements, first aid statements, and personal protective equipment (PPE) requirements for users handling domestic-class swimming pool products;
• addition of PPE (protective eyewear) to all commercial-class calcium hypochlorite product labels;
• addition of the statement “Do not apply in windy conditions” to the granular domestic-class calcium hypochlorite product labels;
• updated environmental precautionary statements; and
• updated storage and disposal statements.

Refer to Appendix III of PRVD2022-21 for all proposed label amendments.

All products containing sodium hypochlorite and calcium hypochlorite regulated under the Pest Control Products Act in Canada are subject to this proposed re-evaluation decision. This document (PRVD2022-21) is subject to a public consultation, ^{Footnote 1} during which written comments and additional information may be submitted to PMRA Publications. The final re-evaluation decision will be published taking into consideration the comments and information received during the consultation period.

Next steps

The public, including the registrants and stakeholders, are encouraged to submit written comments and additional information during the 90-day public consultation period upon publication of this proposed re-evaluation decision.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document,^{Footnote 2} which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada’s responses.

Other information

When Health Canada makes its re-evaluation decision, it will publish a Re-evaluation Decision on calcium hypochlorite and sodium hypochlorite (based on the Science Evaluation of PRVD2022-21). In addition, the test data referenced in PRVD2022-21 will be available for public inspection, upon application, in the PMRA’s Reading Room.

Additional scientific information

Additional scientific data are not required at this time.