Biocides Regulations (SOR/2024-110)

Marginal note:Sale as preventative only

8 A biocide is exempt from the application of subsection 3(2) of the Act with respect to its sale by a person if

• The following provision is not in force.

  (a) the biocide is not represented by label as a treatment or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act; and

• The following provision is not in force.

  (b) the person does not advertise the biocide to the general public as a treatment or cure for any of those diseases, disorders or abnormal physical states.

Marginal note:Import, sale or advertising

• The following provision is not in force.

  9 (1) Subject to subsection (2), it is prohibited to import, sell or advertise a biocide unless the biocide is the subject of a market authorization issued under section 11.

• The following provision is not in force.

  Marginal note:Exception — testing

  (2) Subsection (1) does not prohibit the import or sale of a biocide for the purpose of testing to support an application for a market authorization for that biocide submitted under section 10 or 26.

Marginal note:Application requirements

• The following provision is not in force.

  10 (1) An application for a market authorization for a biocide must be submitted to the Minister and contain

  • The following provision is not in force.

    (a) the applicant’s name and contact information;

  • The following provision is not in force.

    (b) the brand names under which the biocide is proposed to be sold or advertised;

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    (c) the physical form of the biocide and the methods of application;

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

  • The following provision is not in force.

    (e) a list of the formulants that the biocide contains, including formulants that only a particular version of the biocide contains, and their CAS registry numbers, if they have one;

  • The following provision is not in force.

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

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    (g) the conditions of use of the biocide;

  • The following provision is not in force.

    (h) information regarding the benefits and risks associated with the biocide and any uncertainties relating to those benefits and risks, including reports of any tests and studies conducted by or on behalf of the applicant to identify and assess those benefits, risks and uncertainties;

  • The following provision is not in force.

    (i) a summary of the information referred to in paragraph (h);

  • The following provision is not in force.

    (j) the names and contact information of

    • (i) the persons that will manufacture the biocide, excluding individuals who are employees or agents of such persons,

    • (ii) any persons that will import the biocide, and

    • (iii) if known, the persons that will package or label the biocide, excluding individuals who are employees or agents of such persons;

  • The following provision is not in force.

    (k) the civic addresses of the locations where the biocide will be manufactured and, if known, packaged and labelled;

  • The following provision is not in force.

    (l) the specifications for the biocide;

  • The following provision is not in force.

    (m) the shelf life of the biocide;

  • The following provision is not in force.

    (n) the text of every label to be used in connection with the biocide, including any supplementary information on the use of the biocide that is to be provided to users on request;

  • The following provision is not in force.

    (o) if the biocide is a pest control product that is registered under the Pest Control Products Act,

    • (i) the registration number assigned to it under that Act, and

    • (ii) in the case where the biocide’s registration was based on a comparison with another biocide that is a pest control product, a statement to that effect and the registration number assigned to the other biocide under that Act; and

  • The following provision is not in force.

    (p) if a drug identification number has been assigned to the biocide under the Food and Drug Regulations and has not been cancelled,

    • (i) the drug identification number assigned to it under those Regulations, and

    • (ii) in the case where the biocide’s drug identification number was assigned on the basis of a comparison with another biocide, a statement to that effect and the drug identification number assigned to the other biocide under those Regulations.

• The following provision is not in force.

  Marginal note:Application based on comparison

  (2) The information referred to in paragraphs (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 a statement of the properties and qualities of the packaging material — may be omitted from the application if

  • The following provision is not in force.

    (a) the application is based on a comparison between the biocide and another biocide that is the subject of a market authorization;

  • The following provision is not in force.

    (b) the application contains the other biocide’s identification number;

  • The following provision is not in force.

    (c) the application contains information that demonstrates that

    • (i) for a given quantity of biocide, the biocide contains the same active ingredients in the same quantities as the other biocide,

    • (ii) the formulants that the biocide contains are among the formulants that the other biocide may contain under its market authorization,

    • (iii) for a given quantity of biocide, the quantity of each formulant that the biocide contains is the same as the quantity of that formulant that the other biocide may contain under its market authorization,

    • (iv) subject to subparagraph (v), the conditions of use of the biocide fall within the conditions of use of the other biocide, and

    • (v) the biocide has the same risk information and directions for storage as the other biocide;

  • The following provision is not in force.

    (d) the application contains, if the applicant is not the holder of the market authorization for the other biocide, an attestation, by an individual who has authority to bind the holder, that

    • (i) confirms that the holder has provided the applicant with the master formula for the other biocide, and

    • (ii) mentions the other biocide’s brand names and identification number;

  • The following provision is not in force.

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

    • (i) the biocide will be manufactured in accordance with the master formula for the other biocide, and

    • (ii) the specifications for the biocide — 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;

  • The following provision is not in force.

    (f) the following conditions are met in respect of the other biocide’s market authorization:

    • (i) subject to subsection (3), the other biocide’s authorization was not issued on the basis of a comparison to a third biocide, and

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

  • The following provision is not in force.

    (g) in the case where the other biocide was exempted from the application of these Regulations under subsection 66(1), 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

  • The following provision is not in force.

    (h) in the case where the other biocide was exempted from the application of these Regulations under subsection 68(1), 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.

• The following provision is not in force.

  Marginal note:Exception — foreign biocide

  (3) Subparagraph (2)(f)(i) does not apply if

  • The following provision is not in force.

    (a) the application for the other biocide’s market authorization was submitted under section 26; and

  • The following provision is not in force.

    (b) the holder of the market authorization for the other biocide is also the holder of the authorization to sell the foreign biocide.

• The following provision is not in force.

  Marginal note:Additional information and material

  (4) The Minister may request the applicant to provide any additional information or any material, including samples, that is necessary to enable the Minister to determine whether the market authorization must be issued.

Marginal note:Issuance

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

• The following provision is not in force.

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

• The following provision is not in force.

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

• The following provision is not in force.

  (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

• The following provision is not in force.

  (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

• The following provision is not in force.

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

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

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

  • The following provision is not in force.

    (c) the biocide’s brand names;

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

    (g) the conditions of use of the biocide;

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

    (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;

  • The following provision is not in force.

    (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;

  • The following provision is not in force.

    (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;

  • The following provision is not in force.

    (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

  • The following provision is not in force.

    (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.

• The following provision is not in force.

  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:

  • The following provision is not in force.

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

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

  • The following provision is not in force.

    (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);

  • The following provision is not in force.

    (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);

  • The following provision is not in force.

    (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

  • The following provision is not in force.

    (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).

• The following provision is not in force.

  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.

• The following provision is not in force.

  Marginal note:Exception

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