Proposed Biocide Regulation in Canada

14 Apr 2023

Biocides Look for a Regulation to Call Home in Canada

What are biocides?

Health Canada defines biocides as products that sanitize or disinfect hard or soft non-living and non-liquid surfaces to prevent disease in humans and animals.

How does Canada regulate biocides?

In Canada, biocide products are currently regulated under two different acts: disinfectants are regulated under the Food and Drugs Act (FDA), while surface sanitizers are regulated under the Pest Control Products Act (PCPA). During the COVID-19 pandemic, however, Health Canada streamlined the biocides application process by allowing products intended to be marketed as both disinfectants and sanitizers to be registered solely under the FDA. Previously, these products were registered under the PCPA.

Why do we need a revamp of the regulations if biocides are already addressed?

The regulations as they stand can be incredibly confusing for companies looking to enter the Canadian market. A clear regulatory path is vital for stakeholders, from those in the industry to Canadian consumers. The COVID-19 pandemic demonstrated the current confusion, regulatory burden, varying fees for similar products, and lengthy timelines associated with the registration of these types of products in Canada and how these factors deter many companies from registering novel products or entering the Canadian market altogether.

In response, Health Canada has developed the proposed Biocide Regulations, published in the CanadaGazette Part I, 07 May 2022. The proposed Biocide Regulations capture disinfectants that are currently regulated under the FDA, in addition to surface sanitizers that meet the FDA definition of a drug. This includes disinfectants and sanitizers that are intended for use on hard or soft non-living and non-liquid surfaces. The important distinction between biocides and pharmaceuticals is that biocides are intended to be applied to non-living surfaces only and are not authorized for the diagnosis or treatment of disease.

Proposed Biocide Regulations – Exclusions

The following products would be excluded from the proposed Biocide Regulations, as they are clearly captured under other Canadian regulations:

• Sanitizers that do not meet the definition of a drug under the FDA (i.e., algaecides, slimicides, material preservatives, and products for odour control);
• Sanitizers and disinfectants that meet the definition of a drug but are intended for use in air or water;
• High-level disinfectant (99.9999% with a short contact time) and sterilant solutions (i.e., contact lens disinfectants and disinfectants intended for use on medical devices);
• Disinfectants and surface sanitizers exclusively used directly on the surface of a food, such as fruits, vegetables, and meat products;
• Drugs with antimicrobial activity for use on humans or animals, such as human use antiseptic drugs (e.g., hand sanitizers); and
• Cleaners.

When the proposed Biocide Regulations are implemented, what do I do?

The proposed Biocide Regulations would include a registration pathway based on the existing requirements in the Food and Drug Regulations (FDR) for disinfectants. Canada Gazette, Part II will provide guidance on the information required to support registration.

How do I expedite my application?

To facilitate timely authorization of your product, the regulators have implemented different pathways to market.

1. Comparison to already authorized biocides in Canada

To use this regulatory pathway you will need to demonstrate the following:

• The biocide has the same active ingredients in the same quantities as another authorized biocide;
• The formulants in the biocide are among those permitted to be included in another authorized biocide;
• The uses or purposes, intended users, settings, and directions for use fall within the parameters of those approved for another authorized biocide;
• The risk information and directions for storage and disposal are the same as those approved for another biocide; and
• The biocide has the same decontamination procedure as another authorized biocide, if the other biocide label bears such a procedure.

The applicant must also demonstrate that the biocide would be manufactured in accordance with the same master formula as the precedent biocide.

2. Use of Foreign Decisions (UFD)

This regulatory pathway allows you to leverage the decision of a trusted foreign regulatory authority when applying for market authorization for an identical product in Canada. At the present time, the list of trusted foreign regulatory authorities consists only of the United States Environmental Protection Agency (U.S. EPA).

For both of these regulatory pathways, the post-market requirements would be the same as those required for a product that underwent a full authorization review. These pathways would allow for a shorter timeline and a lower regulatory fee to place these products on the market.

Things to keep in mind

The proposed Biocide Regulations would allow for one application to contain multiple products with minor variations to be submitted for a market approval. This aligns with the application process for biocides in the United States, European Union, and United Kingdom.

The proposed Biocide Regulations includes regulations for food-contact sanitizers and disinfectants for use on surfaces in commercial or household settings. This is an important distinction, as those familiar with Pest Control Products Regulations (PCPR) would assume that food-contact sanitizers are exempt, since they are currently covered under the FDA.

Coming into force

The proposed Biocide Regulations will come into effect one year after its official publication. Thus, any applications received one year after the publication of the Biocide Regulations must meet all the regulatory requirements in the regulation.

Health Canada plans to publish the Biocide Regulations in the Canada Gazette, Part II, in spring 2023.

Do not panic – you have time!

The proposed Biocide Regulations will allow existing registration and authorization holders to clear their current stock and update labels within their regular business cycle. Existing disinfectants and sanitizers will need an abbreviated application and will receive authorization under the Biocide Regulations. The timeline to move over to the Biocide Regulations will be laid out once the regulations are officially published. In the case of existing biocides registered under the PCPA, since renewals occur every five years, the transition period for PCPA products will be four years or whenever the product is set to expire.

A lot to digest? Intertek can help!

The proposed Biocide Regulations are not yet in effect but will provide a clearer path to market for industry. Do you have questions about this topic, current regulations of pesticides or drugs in Canada, the Pest Control Products Act (PCPA), the Food and Drugs Act (FDA) or a related topic? Do you need assistance preparing a registration application for sanitizers or disinfectants in Canada? Contact our experts at Intertek. We're here to help!

References:

Forward Regulatory Plan 2022-2024: Biocide Regulations - Canada.ca

Canada Gazette, Part 1, Volume 156, Number 19:

Pest control Products Act (S.C. 2002, c. 28)

Food and Drugs Act (R.S.C., 1985, c. F-27)