Navigating the complexity of Canadian regulations for antimicrobial products
Launching an antimicrobial product in Canada can be a complex undertaking. While Health Canada oversees all regulatory matters at a strategic level, the practicalities are handled by various agencies, each of which has different requirements. When developing a new product or looking to import a product for the first time, it’s important to understand how it is categorized by Health Canada, and which regulations will apply. In this paper, we look at situations where antimicrobial products are classified as ‘pesticides’, ‘drugs’ or ‘incidental additives’ in Canada, offering guidance on registration and authorization requirements.
Defining antimicrobial products in Canada
Under Canadian legislation, antimicrobial products fall into two principal categories: ‘pesticides’ or ‘drugs’. Depending on this classification, they are regulated under Health Canada’s Pest Control Products Act (PCPA) or Food and Drugs Act (FDA) respectively. The situation becomes more complex for antimicrobial products intended for use in food processing establishments. These products can also fall within the ‘incidental additives’ category which is regulated by Health Canada’s Food Directorate. Understanding where your product sits in relation to these regulations is essential, as it impacts a wide range of factors. Compliance activities such as premarket assessment, registration, licensing and supporting documentation, as well as product packaging and labeling requirements, all vary depending on a product’s classification. However, determining the most appropriate category – then ensuring a product meets its requirements – is not always straightforward. This is particularly challenging for new market entrants or companies looking to import antimicrobial goods into Canada for the first time.
Health Canada, which has oversight of all three agencies, considers three key factors in the classification of an antimicrobial product:
- Ingredients’ history of use
- Product representation (use, function, marketing, label claims).
Providing adequate and acceptable information related to these factors plays a key role in obtaining the necessary approvals to market antimicrobial products. In this paper we look at the specific product classifications and requirements of each of the three agencies in turn. Our aim is to offer some insight into the way antimicrobial products are regulated in Canada.