Biocides Regulations (SOR/2024-110)

Marginal note:Records — quality control

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  52 (1) The holder of the market authorization for a biocide and the importer of a biocide must maintain records that demonstrate that each lot or batch of the biocide that they sell has been manufactured, packaged, labelled and stored in accordance with the master formula for the biocide.

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  Marginal note:Records — manufacturer, packager or labeller

  (2) Any person that manufactures, packages or labels a biocide that is the subject of a market authorization must, for each lot or batch of the biocide that they sell, maintain records demonstrating that they have manufactured, packaged or labelled, as the case may be, the lot or batch in accordance with the master formula for the biocide and have stored it in accordance with the master formula.

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  Marginal note:Retention period

  (3) The holder, importer or person must — even if they cease to hold the market authorization or no longer import or sell the biocide, as the case may be — retain each record for at least one year after the last day of the month in which the shelf life of the biocide ends or, if that day cannot be determined, for at least six years after the day on which they sold the biocide.

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  Marginal note:Requirement to provide information

  (4) Anyone that is required to retain a record under subsection (3) must provide the information in the record to the Minister, on request, within five days after the request is made or, if the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health, within any shorter period specified by the Minister.

Marginal note:Prohibition — sterile biocides

53 It is prohibited to manufacture or package a biocide that is intended to be sterile unless the manufacturing or packaging is carried out

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  (a) in a separate and enclosed area;

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  (b) under the supervision of an individual who is trained in microbiology; and

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  (c) using a method that is scientifically proven to ensure the sterility of the biocide.

Marginal note:Investigation of complaints

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  54 (1) If any of the following persons receives a complaint in respect of the quality of a biocide that is the subject of a market authorization, the person must investigate it and, if necessary, take corrective action:

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    (a) the holder of the market authorization;

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    (b) an importer of the biocide; or

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    (c) a person that manufactures, packages or labels the biocide and sells it.

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  Marginal note:Records

  (2) The person must maintain a record of each complaint and investigation and any corrective action taken.

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  Marginal note:Retention period

  (3) The person must — even if they cease to hold the market authorization or no longer import or sell the biocide, as the case may be — retain each record for at least one year after the latest of

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    (a) the last day of the month in which the shelf life of the biocide to which the complaint relates ends, if that day can be determined,

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    (b) if no corrective action is taken, the day on which the investigation is completed, and

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    (c) if corrective action is taken, the day on which the action is completed.

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  Marginal note:Requirement to provide information

  (4) Anyone that is required to retain a record under subsection (3) must provide the information in the record to the Minister, on request, within five days after the request is made or, if the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health, within any shorter period specified by the Minister.

Marginal note:Temporary exemptions — Pest Control Products Act

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  66 (1) A biocide that is a pest control product is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if the biocide is registered under the Pest Control Products Act and the registration is made either

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    (a) before the first anniversary of the day on which these Regulations are registered; or

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    (b) in the case of registration on the basis of an application referred to in subsection (3), on or after that anniversary.

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  Marginal note:End of exemption

  (2) The exemption referred to in subsection (1) ceases to apply on the earliest of

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    (a) the day on which the registration ceases;

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    (b) the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

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    (c) the day on which an application for a market authorization for the biocide is withdrawn; and

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    (d) the fifth anniversary of the day on which these Regulations are registered.

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  Marginal note:Temporary exemption — pending decision

  (3) A biocide that is a pest control product is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

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    (a) the biocide is the subject of an application for registration under the Pest Control Products Act; and

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    (b) no final decision has been made in respect of the application.

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  Marginal note:End of exemption

  (4) The exemption referred to in subsection (3) ceases to apply on the earliest of

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    (a) the day on which the Minister makes a final decision in respect of the application for registration under the Pest Control Products Act;

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    (b) the day on which the application for registration under the Pest Control Products Act is withdrawn;

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    (c) the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

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    (d) the day on which an application for a market authorization for the biocide is withdrawn; and

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    (e) the fifth anniversary of the day on which these Regulations are registered.

Marginal note:Exception — pest control products

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  67 (1) The information referred to in paragraphs 10(1)(h), (i) and (l) — other than information relating to the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — may be omitted from an application for a market authorization for a biocide that is exempt from the application of these Regulations under subsection 66(1) if

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    (a) the application is submitted under section 10; and

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    (b) the information referred to in paragraphs 10(1)(c) to (g) that is set out in the application corresponds to the relevant conditions of registration under the Pest Control Products Act.

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  Marginal note:Definition of conditions of registration

  (2) In subsection (1), conditions of registration has the same meaning as in subsection 2(1) of the Pest Control Products Act.

Marginal note:Temporary exemptions — Food and Drug Regulations

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  68 (1) A biocide is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if the biocide is a drug

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    (a) to which a drug identification number has been assigned under the Food and Drug Regulations

    • (i) before the first anniversary of the day on which these Regulations are registered, or

    • (ii) in the case of a drug identification number that is assigned on the basis of an application referred to in subsection (3), on or after that anniversary; and

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    (b) whose drug identification number has not been cancelled.

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  Marginal note:End of exemption

  (2) The exemption referred to in subsection (1) ceases to apply on the earliest of

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    (a) the day on which the drug identification number is cancelled under the Food and Drug Regulations;

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    (b) the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

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    (c) the day on which an application for a market authorization for the biocide is withdrawn; and

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    (d) the fifth anniversary of the day on which these Regulations are registered.

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  Marginal note:Temporary exemption — pending decision

  (3) A biocide is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

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    (a) the biocide is a drug that is the subject of an application for a drug identification number that is made under section C.01.014.1 of the Food and Drug Regulations or of a new drug submission that is filed under section C.08.002 of those Regulations; and

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    (b) no final decision has been made in respect of the application or submission.

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  Marginal note:End of exemption

  (4) The exemption referred to in subsection (3) ceases to apply on the earliest of

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    (a) the day on which the Minister makes a final decision in respect of the application or submission under the Food and Drug Regulations;

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    (b) the day on which the application or submission is withdrawn;

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    (c) the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

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    (d) the day on which an application for a market authorization for the biocide is withdrawn; and

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    (e) the fifth anniversary of the day on which these Regulations are registered.

Marginal note:Exception — drug identification number

69 The information referred to in paragraphs 10(1)(h), (i), (l) and (n) — other than information relating to the net quantity of the biocide in the package, the type of package and the properties and qualities of the packaging material — may be omitted from an application for a market authorization for a biocide that is exempt from the application of these Regulations under subsection 68(1) if

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  (a) the application is submitted under section 10; and

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  (b) the information referred to in paragraphs 10(1)(c) to (g) that is set out in the application corresponds to the relevant matters that are authorized in respect of the biocide under the Food and Drug Regulations.

Marginal note:Temporary exemption — certain sanitizers

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  70 (1) A surface sanitizer for use in food premises is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

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    (a) a drug identification number has not been assigned to the surface sanitizer for use in food premises under the Food and Drug Regulations; and

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    (b) the surface sanitizer for use in food premises is not a pest control product that is registered under the Pest Control Products Act.

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  Marginal note:End of exemption

  (2) The exemption ceases to apply on the earliest of

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    (a) the day on which the Minister makes a final decision in respect of an application for a market authorization for the surface sanitizer for use in food premises;

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    (b) the day on which an application for a market authorization for the surface sanitizer for use in food premises is withdrawn; and

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    (c) the seventh anniversary of the day on which these Regulations are registered.

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  Marginal note:Definition of surface sanitizer for use in food premises

  (3) In this section, surface sanitizer for use in food premises means a biocide that is manufactured, sold or represented for use exclusively in premises in which food is manufactured, prepared or kept for sale.