CANADA Law and Practice Contributed by: Sylvie Rodrigue, Grant Worden, Nicole Mantini and Anne Merminod, Torys LLP
(d) requirements for medical foods and infant formulas. • Pharmaceuticals: (a) standards for drug fabrication, packaging, (c) product safety requirements and requirements for pharmaceutical approval and marketing in Canada; and (d) requirements for post-market surveillance, pharmacovigilance, and adverse drug reaction reporting. • Medical devices: (a) product safety and licensing requirements for medical devices; (b) mandatory incident reporting and recall proce - dures; and (c) complaint handling standards. • Natural health products: (a) product licensing requirements; (b) manufacturing requirements; (c) labelling standards; and (d) safety requirements. • Cosmetics: (a) labelling requirements and advertising; labelling, testing, and storage; (b) requirements for clinical trials; The Safe Food for Canadians Act mandates preventive controls, hazard analyses, import licences and trace - ability within the food supply chain. This is supported by inspections and recalls managed jointly by Health Canada and the Canadian Food Inspection Agency. Transportation The Motor Vehicle Safety Act (MVSA), the Railway Safety Act (RSA), the Transportation of Dangerous Goods Act (TDGA), and the Canadian Aviation Regu - lations (CAR) under the Aeronautics Act establish requirements for those operating in the transporta - tion sector. • The MVSA prescribes standards for the design, construction, and importation of vehicles, mandat - ing compliance prior to their sale within Canada. • The RSA imposes obligations on railway operators to maintain equipment and infrastructure. (b) notification of first sale; (c) safety requirements; and (d) restrictions on ingredients.
• The TDGA regulates the classification, packaging, and transportation of hazardous materials. • The Aeronautics Act, through the CAR, regulates aircraft, including aircraft maintenance and opera - tion to ensure airworthiness and safety. Toxic substances The Canadian Environmental Protection Act (CEPA) sets out a framework for identifying, assessing, and managing risks associated with substances identified as toxic (including chemicals, polymers, and living organisms). Under CEPA, substances are evaluated to determine if they are toxic or capable of becom - ing toxic to the environment or human health. Toxic substances listed in Schedule 1 of CEPA are subject to regulations that may restrict their manufacture, use, release or disposal. CEPA also provides for risk assessments, pollution prevention planning, and the development of regulations or codes of practice to manage or eliminate risks from specific chemicals. The Hazardous Products Act restricts or bans specific hazardous substances in products, especially those targeting children or vulnerable populations, while the Cosmetic Regulations prohibit or limit ingredients in personal care items that are considered to be toxic. The Food and Drugs Act and associated regulations further control the use of potentially toxic substances in food, drugs, and medical devices. Children’s safety The Toys Regulations under the CCPSA set out a framework to protect children from choking, strangula - tion, toxic substances, and other physical and chemi - cal hazards. Sharp points and edges, small parts, flammability, and the presence of hazardous chemi - cals such as lead or phthalates in children’s products are regulated. The Electronic Toys Regulations set out safety standards that apply to toy products that are operated with 120 volts or less electricity. The Cribs, Cradles and Bassinets Regulations mandate require - ments governing structural integrity, spacing of slats, and secure locking mechanisms. Pest control and agricultural products Pest control products (including herbicides and pes - ticides) are regulated under the Pest Control Prod - ucts Act (PCPA) and its regulations. Canada regulates
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