Re-evaluation Decision RVD2023-14, Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-use Products

• Pest Management Regulatory Agency
• 29 August 2023
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2023-14E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation decision for sodium hypochlorite, calcium hypochlorite and associated end-use products
• Re-evaluation decision for sodium hypochlorite and calcium hypochlorite
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered products containing calcium hypochlorite and sodium hypochlorite in Canada

Re-evaluation decision for sodium hypochlorite, calcium hypochlorite and associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

This document (RVD2013-14, Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-use Products) presents the final re-evaluation decision^{Footnote 1} for the re-evaluation of the hypochlorite cluster (that is, available chlorine, present as calcium hypochlorite; available chlorine, present as sodium hypochlorite; and sodium hypochlorite), including the response to comments received and the required label updates. All products containing sodium hypochlorite and calcium hypochlorite regulated under the Pest Control Products Act in Canada are subject to this re-evaluation decision.

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. Related products 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 and are exempt from registration. 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.

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.

Currently registered technical grade active ingredients, manufacturing concentrates, and end-use products containing sodium hypochlorite or calcium hypochlorite can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2022-21, Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-use Products^{Footnote 2} containing the evaluation of sodium hypochlorite and calcium hypochlorite and proposed decision, underwent a 90-day consultation period ending on 14 March 2023. PRVD2022-21 proposed continued registration of sodium hypochlorite and calcium hypochlorite products in Canada, with the proposed updates to label directions and precautions to reflect the current labelling standards and improve clarity.

Health Canada received one comment during the public consultation. The comment did not result in revisions or changes to the proposed re-evaluation decision as described in PRVD2022-21. A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2022-21.

Re-evaluation decision for sodium hypochlorite and calcium hypochlorite

Health Canada has completed the re-evaluation of sodium hypochlorite and calcium hypochlorite. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing sodium hypochlorite and calcium hypochlorite is acceptable. An evaluation of available scientific information found that the use of sodium hypochlorite and calcium hypochlorite products meet current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration which includes label amendments.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required updated label statements as a result of the re-evaluation of sodium hypochlorite and calcium hypochlorite, are summarized below. These label amendments will be applied to Schedule 2 of the Pest Control Products Regulations as part of future regulatory amendments, as the label amendments for domestic-class products equally apply to products listed in Schedule 2. Refer to Appendix IV of RVD2023-14 for details.

Human health

Label amendments:

• update signal words, precautionary statements, first aid statements, and personal protective equipment (PPE) requirements for user 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 the windy conditions" to the granular domestic-class calcium hypochlorite product labels.

Environment

Label amendments:

• Update environmental precautionary statements; and
• Updated storage and disposal statements.

Next steps

To comply with this decision, the required label updates must be implemented on all product labels no later than 24 months after the publication date of this decision document. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on sodium hypochlorite and calcium hypochlorite and their associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-21) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Appendix I Registered products containing calcium hypochlorite and sodium hypochlorite in Canada