Disinfectants and sanitizers compliance – Canada
Disinfectants can be regulated by either Health Canada’s Pest Management Regulatory Agency (PMRA) or the Natural and Non-prescription Health Products Directorate (NNHPD), formerly Natural Health Products Directorate (NHPD). PMRA is given authority to regulate disinfectants through the Pest Control Act (PCA) and the Pest Control Products Regulations. NNHPD is given authority to regulate disinfectants through the Food and Drugs Act and the ensuring Food and Drugs Regulations.
Antimicrobial products such as sterilants and disinfectants intended for use on environmental surfaces, inanimate objects and to reprocess medical devices are regulated as drugs under Health Canada’s Food and Drugs Act because they decrease the chance of transmitting disease. NNHPD thoroughly reviews these products including their ingredients, uses, and claims before they can be marketed.
Similarly to the United States, Canada also uses monographs to describe the requirements that topical antiseptics and wound cleaners must meet before being offered for sale and use. These products are required to have a Drug Identification Number (DIN) or Natural Product Number (NPN) before entering the marketplace.
TSG can help
- Regulatory product jurisdictional mapping
- Prepare and submit registrations
- Strategy development for addressing data requirements
- Develop and review labels
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG’s team specializes in assisting companies to prepare and submit registrations for sterilants and disinfectants, as well as supporting clients with label compliance.
Frequently asked questions
Disinfectants and sanitizers help combat the spread of germs in the home, restaurants, hospitals and other industrial and public health settings. Disinfectants destroy microorganisms on surfaces while sanitizers significantly reduce the level of microorganisms to acceptable levels established by federal or provincial authorities.
Non-food contact surface sanitizers, soft surface sanitizers, greenhouse disinfectants and swimming pool and spa disinfectants are regulated under the Pest Control Products Act and Pest Control Regulations.
The following disinfectants / sanitizers are regulated by the Food and Drugs Act and the Food and Drug Regulations: hard surface disinfectants for use in food processing facilities, hard surface disinfectants for use in federally registered food establishments, food contact surface sanitizers and sanitizers for use in federally registered food establishments. Antimicrobial products such as sterilants and disinfectants intended for use on environmental surfaces, inanimate objects and to reprocess medical devices are also regulated under the Act.
Alcohol hand sanitizers, such as alcohol hand rubs, gels or rinse sanitizers are disinfectants containing at least 60% alcohol. They are regulated under the Food and Drugs Act and Regulations. TSG’s experts can advise on data requirements, as well as help prepare and submit product registrations.
A Drug Identification Number, otherwise known as DIN, is an eight-digit computer-generated number that uniquely identifies a product’s manufacturer, name, active ingredient(s), strength(s) of active ingredient(s), pharmaceutical form and route of administration. Health Canada issues a DIN to all authorized prescription and over-the-counter drugs in Canada, permitting the manufacturer to market the drug in Canada. The DIN number is included on the product’s label. TSG’s regulatory experts can assist in preparing the information and filing the DIN application to Health Canada.