Exceptional importation and sale of biocides in relation to COVID-19:  For industry

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How to propose an addition to the list of designated biocides

The following actions must be taken to propose an addition to the list of designated biocides.

Step 1: Submit proposal

To add a biocide to the List of Biocides for Exceptional Importation and Sale, email us at hc.biocidesIBR-IPR.sc@canada.ca for a biocide IBR list proposal form. You will receive, as needed, detailed instructions on eligibility criteria and other applicable supporting documents. Email the completed biocide IBR list proposal form to hc.biocidesIBR-IPR.sc@canada.ca.

Health Canada will assess the proposal and may contact you to clarify information or to ask for product-specific information.

Importers are required to make the labelling information, including a detailed description of the designated biocide’s conditions of use, available in both official languages.

Note: We may also add a product to the list without receiving a proposal form.

How to import and sell designated biocides

Step 1: Approval to import and sell designated biocides

Importers will be permitted to import and sell designated biocides once

Although the importer is permitted to sell designated biocides once included on the list of designated biocides, they must still notify Health Canada when designated biocides are imported.

Step 2: Pre-importation notification requirements

Importers must notify Health Canada at least 5 calendar days before the day they import a designated biocide. They must do so by sending an email to hc.biocidesIBR-IPR.sc@canada.ca.. The email must contain the following information:

Step 3: Information to support safe use requirements

Under section 13 of the interim order, importers are required to ensure information is available in a manner that supports safe use of the biocide, which includes providing the information in both official languages.

Regulatory requirements for selling designated biocides

During the application of the interim order, importers may bring designated biocides into the country without meeting all the requirements of the Food and Drug Regulations. However, Health Canada wishes to highlight the following:

As indicated in the interim order, the following provisions of the Regulations do not apply to a designated biocide that is imported:

Release process

For more information on the fabrication, control and distribution of disinfectants, importers can refer to the voluntary Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049).

Release documentation should clearly indicate that the biocide was released under the Interim Order No.2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19.

Contact us

To add a biocide to the List of Designated Biocides, request a proposal form and email proposals to hc.biocidesIBR-IPR.sc@canada.ca.

To import designated biocides, email notifications to hc.biocidesIBR-IPR.sc@canada.ca.

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