CA Kanada
  • 11 - Medizintechnik
  • 71 - Chemische Verfahrenstechnik

Sterilization and disinfection (ICS: 11.080), Chemicals for industrial and domestic disinfection purposes (ICS: 71.100.35)

Biocides Regulations; (100 page(s), in English and French)

Products that sanitize or disinfect hard or soft non-living surfaces to prevent disease in humans or animals (collectively referred to as biocides) are currently subject to different requirements, despite having similar risks, benefits, uses and ingredients. Health Canada is proposing a new set of regulations under the Food and Drugs Act (FDA) specific to biocides, that would see:

·         the transfer of disinfectants that are currently regulated under the Food and Drug Regulations (FDR) and surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug, to the proposed Biocides Regulations;

·         the creation of a modern authorization and regulatory framework with safety, efficacy and quality regulatory requirements better suited to biocides;

·         the maintenance of a life-cycle approach to the regulation of biocides while supporting requirements and authorities for the continuous post-market monitoring of a biocide's risks and benefits; and

·        the creation of a pathway for authorization based on decisions from foreign regulatory authorities.