Guidance on evaluation fees for biocides: Overview

On this page

• Background
• Introduction
• Objective
• Policy statement
• Scope and application

Health Canada is introducing a new Guidance document on fees for the review of biocide applications as per the Biocides Regulations (hereafter referred to as the Regulations). The guidance takes effect on May 31, 2025.

Background

Biocides were previously regulated under separate regulatory frameworks in Canada with surface sanitizers and disinfectants having different associated requirements, fees and timelines, despite having similar ingredients and uses. Surface disinfectants and surface sanitizers were regulated under the Food and Drugs Act (FDA) and Pest Control Products Act (PCPA), respectively. This fragmented regulatory approach presented challenges during the COVID-19 pandemic when there was a subsequent increase in demand for biocides.

As of May 31, 2025, Health Canada implemented a new framework (the Biocides Regulations) that would transition disinfectants that were previously regulated under the Food and Drug Regulations (FDR), surface sanitizers for use in food premises previously subject to the FDA and certain surface sanitizers that were previously regulated under the PCPA, to the Regulations.

The Regulations created a new, modern authorization and regulatory framework with safety, efficacy and quality requirements tailored to biocides, including the use of a foreign decisions pathway. We have drafted this guidance for the new biocide fees that support activities under the Biocides Regulations.

This guidance document should be used for:

• New biocides applications submitted on or after May 31, 2025;
• Post-authorization change applications submitted under the Regulations.

Introduction

Before a biocide is authorized for sale in Canada, the Minister must have sufficient evidence to support the conclusion that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties related to the benefits and risks. This is a requirement of the Food and Drugs Act and the Regulations.

We charge industry fees for these pre-market regulatory activities to recover some of the associated costs of reviewing this evidence.

Objective

This document provides guidance on how fees for the review of biocide applications will be administered. Fees are in accordance with the Regulations and are stipulated in the Fees in Respect of Drugs and Medical Devices Order.

Policy statements

Throughout this document, an "application" refers to an application for a new market authorization or a major change, or a written description for a minor change.

Applicants submitting a biocide application will be charged a fee. Fees are in proportion to the type and complexity of the regulatory activity.

Unpaid fees are subject to collection procedures in accordance with the federal government's directive on public money and receivables. Health Canada has the authority to withhold services, approvals or rights and privileges for unpaid fees.

New fees for biocides came into effect on May 31, 2025. For further details, see the page on applicable fees.

In addition, Health Canada may:

• waive or reduce fees in specific circumstances (see the section on mitigation measures) for:
  • small businesses
  • publicly funded health care institutions
  • federal, provincial or territorial governments
• charge a reduced fee or credit a portion of the fee to the applicant's account in the event that a performance standard is missed (see the page on missed performance standards)

Scope and application

This guidance applies to applicants submitting an application for a market authorization or for a notice of acceptance or a written description for a minor change in support of a biocide, either pre- or post-authorization. Any other type of submission or application, including those for other products, is excluded.