TBT BSN | Notification

Notification Detail :: G/TBT/N/CAN/672/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Biocides Regulations and Order Amending the Fees in Respect of Drugs and Medical Devices Order (Biocides)

Objective

Other (TBT)

Product Covered

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

Document Notification

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HSCODE

ICSCODE

11.080 - Sterilization and disinfection; 11.080 - Sterilization and disinfection; 71.100.35 - Chemicals for industrial and domestic disinfection purposes; 71.100.35 - Chemicals for industrial and domestic disinfection purposes

Keywords

Specific Regions

Description

Health Canada has introduced new regulations under the Food and Drugs Act (FDA) specific to biocides that will see:the transfer of surface sanitizers that meet the definition of a drug and are regulated under the Pest Control Products Act, disinfectants that are currently regulated under the Food and Drug Regulations, and all surface sanitizers for use in food premises that fall under the purview of the FDA, to the Biocides Regulationsthe creation of a new, modern authorization and regulatory framework with safety, efficacy and quality requirements specific to biocides;requirements and authorities that support the continuous post-market oversight of a biocide’s benefits and risks; andthe creation of a pathway for authorization based on decisions from foreign regulators, starting with the United States Environmental Protection Agency.In support of regulatory activities under the Biocides Regulations, Health Canada will be charging fees for the examination of applications for market authorization and for changes to authorized biocides, as well as for post-market monitoring of biocides on the Canadian market, once the new regulations come into force. These fees will be set in the Fees in Respect of Drugs and Medical Devices Order (Fees Order).

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/CAN/672/Add.1

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