Biocides: New Application and Sales Fees

Summary#

This Order (SOR/2024-121) adds fees for products called biocides and puts those fees into the Fees in Respect of Drugs and Medical Devices Order. Health Canada will start charging application fees and an annual “right to sell” fee for biocides when the new Biocides Regulations come into force. The Order was registered on June 4, 2024 and published in the Canada Gazette, Part II on June 19, 2024.

What it does#

• Defines which submissions about biocides will be charged a fee (new Division 2.1 in the Fees Order).
  • This includes market authorization applications, certain major- and minor-change notices, and applications that rely on comparisons to foreign-authorized products.
• Sets a new annual right-to-sell fee for each market authorization that has had sales in the prior year: $1,535.
• Creates specific fee categories and fixes the dollar amounts (Schedule 2.1):
  • Biocide full review — novel biocide: $41,685
  • Biocide full review — tier I: $8,595
  • Biocide full review — tier II: $11,469
  • Biocide full review — tier III: $13,523
  • Biocide comparison — labelling only: $2,748
  • Biocide comparison — administrative application: $975
  • Biocide — use of foreign decisions: $3,100
  • Biocide monograph (needs supporting info): $1,861
  • Biocide major change — monograph: $1,363
  • Biocide major change — quality and risks: $4,955
  • Biocide minor change: $1,363
• Explains when fees are payable and partial payments:
  • If a preliminary check finds an application incomplete, 10% of the fee is payable on that notice; the full fee is payable if the application is accepted for full review.
• Keeps small-business relief similar to other health-product fees:
  • 100% remission for a qualifying small business’s first pre-market application (if they haven’t previously filed a biocide application or certain drug submissions).
  • 50% remission on subsequent pre-market applications for qualifying small businesses.
  • 25% remission on the annual right-to-sell fee for qualifying small businesses.
• Adds performance standards for biocide fee categories. If a performance standard is missed, a remission of 25% of the fee may be given.
• Describes transition rules: existing disinfectants and surface sanitizers can use a transition application without paying the examination fee, but they must obtain a biocide market authorization within four years. Surface sanitizers for use in food premises have a six-year transition period to come into compliance.
• Explains fee-setting and annual adjustments: fees are based on cost-recovery ratios (75% for application examination fees; 67% for the right-to-sell fee), are adjusted for inflation each year on April 1, and include an added 4.4% inflation adjustment to account for the delayed start year.

Who's affected#

• Manufacturers, importers and distributors of disinfectants and surface sanitizers that will be regulated as biocides.
• Small businesses that make or sell biocides (they may qualify for the remissions described above).
• Companies that want to rely on foreign authorizations (for example, U.S. registrations) to speed Canadian approvals.
• operators of food premises and businesses that make surface sanitizers for food use (they have a longer transition window).
• It is not always clear from the Order exactly which existing products will move immediately; affected businesses should check the Biocides Regulations and Health Canada guidance for details.

Why it matters#

• One fee framework replaces several different rules. That makes costs and steps more predictable for companies that make or sell disinfectants and surface sanitizers.
• Some businesses will pay new or different fees. For example, the annual right-to-sell fee ($1,535 per marketed authorization) could be a recurring cost. Small businesses get relief measures to reduce that burden.
• A new “use of foreign decisions” review category aims to bring some products to market faster by using foreign approvals.
• The Order funds pre-market reviews and post-market checks (inspections, incident monitoring, enforcement). That affects how quickly products are reviewed and how products on shelves are monitored for safety and claims.
• There are multi-year transition periods, so many companies have time to adapt. The rules take effect on the anniversaries tied to when the Biocides Regulations are registered (the Order itself does not set a single calendar date; it refers to the first anniversary and some parts to the fifth anniversary of the Regulations’ registration).