Biocides Regulations (SOR/2024-110)

Marginal note:Issuance

11 The Minister must issue a market authorization for a biocide to an applicant if

• (a) the application meets the applicable requirements set out in section 10 or 26, as the case may be;

• (b) the applicant has provided the Minister with any additional information and material that is requested under subsection 10(4) or 26(5);

• (c) the Minister has sufficient evidence to support the conclusion that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks; and

• (d) the Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the Act and these Regulations.

Marginal note:Content of market authorization

• 12 (1) A market authorization for a biocide must set out

  • (a) the identification number assigned by the Minister to the biocide;

  • (b) the name and civic address of the holder of the authorization and the names and civic addresses of any importers of the biocide;

  • (c) the biocide’s brand names;

  • (d) the physical form of the biocide and the methods of application;

  • (e) a list of the biocide’s active ingredients and formulants, including their CAS registry numbers, if they have one;

  • (f) the quantity of each active ingredient and formulant that a given quantity of the biocide contains;

  • (g) the conditions of use of the biocide;

  • (h) the terms and conditions of the authorization, if any;

  • (i) the date on which the authorization is issued;

  • (j) the dates, if any, on which the authorization is amended;

  • (k) in the case where the authorization was issued on the basis of an application that met the applicable conditions set out in subsection 10(2),

    • (i) a statement that the application was based on a comparison, and

    • (ii) the other biocide’s identification number;

  • (l) in the case where the authorization was issued on the basis of an application submitted under section 26,

    • (i) a statement that the sale of the biocide has been authorized on the basis of a foreign decision,

    • (ii) the name of the relevant foreign regulatory authority, and

    • (iii) a description of the foreign biocide;

  • (m) in the case where the authorization was issued on the basis of an application submitted under section 10 and the biocide had been registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product,

    • (i) a statement that the application for registration was based on a comparison, and

    • (ii) the registration number assigned to the other biocide under that Act;

  • (n) in the case where the authorization was issued on the basis of an application submitted under section 10 and a drug identification number had been assigned to the biocide under the Food and Drug Regulations on the basis of a comparison to another biocide,

    • (i) a statement that the application for a drug identification number was based on a comparison, and

    • (ii) the drug identification number assigned to the other biocide under those Regulations; and

  • (o) in the case where an application for a notice of acceptance in respect of a major change that affected the biocide met the applicable conditions set out in subsection 15(3),

    • (i) a statement that the application was based on a comparison, and

    • (ii) the applicable information referred to in subparagraph 15(3)(c)(i), (ii) or (iii) in respect of the other biocide.

• Marginal note:Public notice

  (2) The Minister must, after issuing a market authorization, publish on the Government of Canada website the applicable information referred to in subsection (1), except for the following information:

  • (a) the quantity of the formulants that a given quantity of the biocide contains;

  • (b) the CAS registry numbers of the biocide’s active ingredients and formulants, if they have one;

  • (c) in the case where the authorization was issued on the basis of an application that met the applicable conditions set out in subsection 10(2), the information referred to in subparagraph (1)(k)(ii);

  • (d) in the case where the authorization was issued on the basis of an application submitted under section 26, the information referred to in subparagraph (1)(l)(iii);

  • (e) if the biocide had been registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product, the information referred to in subparagraph (1)(m)(ii); and

  • (f) if a drug identification number had been assigned to the biocide under the Food and Drug Regulations on the basis of a comparison to another biocide, the information referred to in subparagraph (1)(n)(ii).

• Marginal note:Information not confidential business information

  (3) Subject to subsection (4), any information referred to in subsection (1) that is confidential business information ceases to be confidential business information when the Minister issues the market authorization.

• Marginal note:Exception

  (4) Subsection (3) does not apply to information referred to in paragraphs (2)(a) to (f).

Terms and Conditions

Marginal note:Terms and conditions

• 13 (1) The Minister may, at any time, impose terms and conditions on a market authorization, or amend them, after considering

  • (a) whether there are significant uncertainties relating to the benefits or risks associated with the biocide to which the authorization relates;

  • (b) whether the requirements under the Act are sufficient to

    • (i) optimize the benefits and minimize the risks associated with the biocide,

    • (ii) manage the uncertainties relating to the benefits and risks, and

    • (iii) collect information to be able to continuously assess the benefits and risks, identify any changes to them and manage the uncertainties; and

  • (c) whether the terms and conditions that the Minister intends to impose may contribute to meeting the objectives set out in subparagraphs (b)(i) to (iii).

• Marginal note:Obligation to amend

  (2) If, after issuing a market authorization, the Minister imposes terms and conditions on the authorization or amends the terms and conditions imposed on the authorization, the Minister must

  • (a) amend the authorization to reflect the terms and conditions that have been imposed or the amendment of the terms and conditions, as the case may be; and

  • (b) amend the information published under subsection 12(2) accordingly.

Changes

Marginal note:Deemed creation of new biocide

14 If the holder of the market authorization for a biocide makes any of the following changes in respect of the biocide, the holder is deemed to have created a new biocide that is not authorized to be imported, sold or advertised under the authorization:

• (a) the substitution, addition or removal of an active ingredient;

• (b) a change to the quantity of an active ingredient that a given quantity of the biocide contains; or

• (c) a change to the physical form of the biocide.

Marginal note:Major change

• 15 (1) It is prohibited for the holder of the market authorization for a biocide to sell any version of the biocide that is affected by a major change unless the Minister has provided the holder with a notice of acceptance in respect of the major change under subsection 16(1).

• Marginal note:Content of application

  (2) An application for a notice of acceptance must be submitted to the Minister and contain

  • (a) the biocide’s identification number;

  • (b) a description of the major change; and

  • (c) subject to subsections (3) and (6), the information referred to in subsection 10(1) to which the major change relates.

• Marginal note:Conditions — application based on comparison

  (3) The information referred to in paragraph 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 the application if

  • (a) the application is submitted on the basis of a comparison between the version of the biocide that is affected by the major change and one of the following biocides (referred to in paragraphs (b) to (i) as “the other biocide”):

    • (i) in the case where the biocide’s market authorization was issued on the basis of an application that met the applicable conditions set out in subsection 10(2), a version of the other biocide referred to in paragraph 10(2)(a) that is also affected by the major change,

    • (ii) in the case where the biocide had been registered under the Pest Control Products Act on the basis of a comparison to the other biocide referred to in subparagraph 10(1)(o)(ii), a version of that other biocide that is also affected by the major change, or

    • (iii) in the case where a drug identification number had been assigned to the biocide under the Food and Drug Regulations on the basis of a comparison to the other biocide referred to in subparagraph 10(1)(p)(ii), a version of that other biocide that is also affected by the major change;

  • (b) one of the following conditions is met in respect of the other biocide:

    • (i) in the case referred to in subparagraph (a)(i), it is the subject of a market authorization,

    • (ii) in the case referred to in subparagraph (a)(ii), it is registered under the Pest Control Products Act, or

    • (iii) in the case referred to in subparagraph (a)(iii), a drug identification number has been assigned to it under the Food and Drug Regulations and has not been cancelled;

  • (c) the application contains the following information in respect of the other biocide:

    • (i) in the case referred to in subparagraph (a)(i), its identification number,

    • (ii) in the case referred to in subparagraph (a)(ii), the registration number assigned to it under the Pest Control Products Act, or

    • (iii) in the case referred to in subparagraph (a)(iii), the drug identification number assigned to it under the Food and Drug Regulations;

  • (d) the application contains information that demonstrates that

    • (i) for a given quantity of biocide, the version of the biocide that is affected by the major change contains the same active ingredients in the same quantities as the other biocide,

    • (ii) the formulants that the version of the biocide that is affected by the major change contains are among the formulants that the other biocide may contain under the applicable authorization referred to in subparagraph (b)(i), (ii) or (iii),

    • (iii) for a given quantity of biocide, the quantity of each formulant that the version of the biocide that is affected by the major change contains is the same as the quantity of that formulant that the other biocide may contain under the applicable authorization referred to in subparagraph (b)(i), (ii) or (iii),

    • (iv) subject to subparagraph (v), the conditions of use of the version of the biocide that is affected by the major change fall within the conditions of use of the other biocide, and

    • (v) the version of the biocide that is affected by the major change has the same risk information and directions for storage as the other biocide;

  • (e) the application contains, if the applicant is not the holder of the applicable authorization referred to in subparagraph (b)(i), (ii) or (iii) for the other biocide, an attestation, by an individual who has authority to bind the holder, that

    • (i) confirms that either

      • (A) the major change resulted in an amendment to the master formula for the other biocide and the holder provided the applicant with the updated master formula for the other biocide, or

      • (B) the major change did not result in an amendment to the master formula for the other biocide, and

    • (ii) mentions, in respect of the other biocide, its brand names and the applicable information referred to in subparagraph (c)(i), (ii) or (iii);

  • (f) the application contains an attestation, by an individual who has authority to bind the applicant, that confirms that

    • (i) if the major change resulted in an amendment to the master formula for the other biocide, the version of the biocide that is affected by the major change will be manufactured in accordance with the updated master formula for the other biocide, and

    • (ii) the specifications for the version of the biocide that is affected by the major change — other than in respect of the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — are the same as those for the other biocide;

  • (g) in the case referred to in subparagraph (a)(i),

    • (i) the Minister has provided to the holder of the market authorization for the other biocide a notice of acceptance in respect of the major change, and

    • (ii) the other biocide’s market authorization is not suspended;

  • (h) in the cases referred to in subparagraph (a)(ii) and subsection (4), the other biocide was not registered under the Pest Control Products Act on the basis of a comparison to a third biocide that is a pest control product; and

  • (i) in the cases referred to in subparagraph (a)(iii) and subsection (5), the drug identification number assigned to the other biocide under the Food and Drug Regulations was not assigned on the basis of a comparison to a third biocide.

• Marginal note:Deemed comparison — Pest Control Products Act

  (4) For the purposes of subparagraph (3)(a)(i), if a biocide that was exempted from the application of these Regulations under subsection 66(1) was registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product and that other biocide is the subject of a market authorization, the following rules apply:

  • (a) the biocide’s market authorization is deemed to have been issued on the basis of an application that met the applicable conditions set out in subsection 10(2); and

  • (b) that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).

• Marginal note:Deemed comparison — Food and Drug Regulations

  (5) For the purposes of subparagraph (3)(a)(i), if a biocide that was exempted from the application of these Regulations under subsection 68(1) had been assigned a drug identification number under the Food and Drug Regulations on the basis of a comparison to another biocide and that other biocide is the subject of a market authorization, the following rules apply:

  • (a) the biocide’s market authorization is deemed to have been issued on the basis of an application that met the applicable conditions set out in subsection 10(2); and

  • (b) that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).

• Marginal note:Conditions — foreign regulatory authority

  (6) 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 the application if

  • (a) the biocide’s market authorization was issued on the basis of an application submitted under section 26;

  • (b) the application is submitted on the basis of a comparison between

    • (i) the version of the biocide that is affected by the major change; and

    • (ii) a version of the foreign biocide described in the market authorization that is also affected by the major change (referred to in paragraphs (c) to (f) as “the other foreign biocide”);

  • (c) the foreign regulatory authority named in the market authorization has authorized the major change in respect of the other foreign biocide, other than on the basis of a type of application that is set out in the List of Foreign Regulatory Authorities in connection with that regulatory authority;

  • (d) the name of the foreign regulatory authority appears in that List when the application is submitted;

  • (e) the application contains

    • (i) evidence of the authorization provided by the foreign regulatory authority in respect of the major change, and

    • (ii) an attestation, by an individual who has authority to bind the holder of the market authorization, that confirms that the holder possesses or has immediate access to the information that was submitted to the foreign regulatory authority to obtain the authorization referred to in subparagraph (i); and

  • (f) the application contains an attestation, by an individual who has authority to bind the holder of the market authorization, that

    • (i) confirms that either

      • (A) the major change resulted in an amendment to the master formula for the other foreign biocide and the version of the biocide that is affected by the major change will be manufactured in accordance with the updated master formula for the other foreign biocide, or

      • (B) the major change did not result in an amendment to the master formula for the other foreign biocide, and

    • (ii) confirms that the specifications for the version of the biocide that is affected by the major change — other than in respect of the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — are the same as those for the other foreign biocide.

• Marginal note:Additional information and material

  (7) The Minister may request the holder of the market authorization to provide any additional information or any material, including samples, that is necessary to enable the Minister to determine whether the notice of acceptance must be provided in respect of the major change.

• Marginal note:Non-application of subsection (3)

  (8) Subsection (3) does not apply to a biocide that was exempted from the application of these Regulations under subsection 66(1) or 68(1) if the biocide’s market authorization was issued on the basis of an application submitted under section 26.

• Marginal note:Definitions of applicant and holder

  (9) The following definitions apply in subsection (3).

  applicant

  applicant means the holder of a market authorization for a biocide that submits an application for a notice of acceptance in respect of a major change under subsection (2). (demandeur)

  holder

  holder

  • (a) in respect of a registration under the Pest Control Products Act, has the meaning assigned by the definition registrant in subsection 2(1) of that Act; and 

  • (b) in respect of a drug identification number assigned under the Food and Drug Regulations, means the person to whom the document setting out the drug identification number was issued under subsection C.01.014.2(1) of those Regulations. (titulaire)

• Marginal note:Definition of authorization

  (10) In paragraphs (3)(d) and (e), authorization means any of the following:

  • (a) a market authorization;

  • (b) a registration under the Pest Control Products Act; or

  • (c) a drug identification number that has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations and has not been cancelled.