Biocides Regulations (SOR/2024-110)

Marginal note:Application

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  26 (1) Subject to subsection (2), a person may submit to the Minister an application for a market authorization for a biocide that is based on a comparison to a foreign biocide that is authorized for sale

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    (a) by a foreign regulatory authority named in the List of Foreign Regulatory Authorities; and

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    (b) under a statute or other legislative instrument that is set out in that List in connection with the regulatory authority.

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  Marginal note:Exceptions

  (2) An application cannot be submitted under subsection (1) if the foreign regulatory authority has authorized the sale of the foreign biocide on the basis of a type of application that is set out in the List of Foreign Regulatory Authorities in connection with the regulatory authority.

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  Marginal note:Content of application

  (3) The application must contain

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    (a) the information referred to in paragraphs 10(1)(a) to (g), (j), (k), (m) and (n) — and, if applicable, subparagraph(o)(i) or (p)(i) — in respect of the biocide for which the market authorization is sought;

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    (b) information relating to the net quantity of the biocide in the package and the type of its package as well as a statement of the properties and qualities of the packaging material;

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    (c) subject to subsection (4), an attestation, by an individual who has authority to bind the applicant, that

    • (i) confirms that the applicant possesses or has immediate access to the information referred to in paragraphs 10(1)(h) and (l) that was submitted to the foreign regulatory authority to obtain the authorization to sell the foreign biocide, and

    • (ii) confirms that

      • (A) if the summary referred to in paragraph 10(1)(i) was submitted to the foreign regulatory authority to obtain that authorization, the applicant possesses or has immediate access to that summary, or

      • (B) if the summary referred to in paragraph 10(1)(i) was not submitted to the foreign regulatory authority to obtain that authorization, the summary was not so submitted;

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    (d) 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 foreign biocide may contain under the authorization to sell the foreign biocide,

    • (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 foreign biocide may contain under the authorization to sell the foreign biocide, and

    • (iv) the biocide has the same conditions of use as the foreign biocide;

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    (e) 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 foreign 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 foreign biocide;

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    (f) a list of the tests and studies that have been submitted to the foreign regulatory authority in connection with the authorization to sell the foreign biocide;

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    (g) information that demonstrates that the sale of the foreign biocide is authorized by the foreign regulatory authority;

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    (h) the terms and conditions that the foreign regulatory authority has imposed on the authorization to sell the foreign biocide, if any; and

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    (i) the text approved by the foreign regulatory authority for every label to be used in connection with the foreign biocide.

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  Marginal note:Exception — packaging

  (4) The attestation referred to in paragraph (3)(c) does not need to confirm that the applicant possesses or has immediate access to any information relating to packaging that was submitted to the foreign regulatory authority.

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  Marginal note:Additional information and material

  (5) 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:Follow-up obligations

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  27 (1) The holder of a market authorization for a biocide that is issued on the basis of an application submitted under section 26 must

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    (a) subject to subsection (3), possess or have immediate access to the information referred to in paragraphs 10(1)(h) and (l) that was submitted to the foreign regulatory authority named in the market authorization in order to obtain

    • (i) the authorization to sell the foreign biocide, and

    • (ii) any authorization in respect of a major change for a version of the foreign biocide that is affected by the major change, if

      • (A) a version of the biocide is also affected by the major change,

      • (B) the holder made an application under subsection 15(6) on the basis of a comparison between the version of the biocide that is affected by the major change and the version of the foreign biocide that is affected by the major change, and

      • (C) the Minister has provided the holder with a notice of acceptance in respect of the major change under subsection 16(1);

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    (b) possess or have immediate access to the summary referred to in paragraph 10(1)(i), if the summary was submitted to the foreign regulatory authority to obtain the authorization to sell the foreign biocide;

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    (c) possess or have immediate access to the summary referred to in paragraph 10(1)(i) that relates to a major change that affects a version of the foreign biocide, if

    • (i) the summary was submitted to the foreign regulatory authority to obtain any authorization in respect of the major change for the version of the foreign biocide that is affected by the major change, and

    • (ii) the conditions set out in clauses (a)(ii)(A) to (C) are met in respect of the major change;

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    (d) provide the Minister, on request, with any information referred to in any of paragraphs (a) to (c) within 48 hours after the request is made or any longer period specified by the Minister;

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    (e) inform the Minister in writing and without delay if they become aware that

    • (i) the foreign biocide has been recalled, or

    • (ii) the foreign regulatory authority has revoked or suspended the authorization to sell the foreign biocide; and

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    (f) provide the Minister, without delay after becoming aware that the foreign regulatory authority has required a change in respect of the foreign biocide, with a written description of the change and the reasons for it, if they are known.

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  Marginal note:Clarification

  (2) For greater certainty, subsection (1) applies even if a version of the biocide is affected by a major change or minor change that has not affected any version of the foreign biocide.

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  Marginal note:Exception

  (3) The holder is not required to possess or have immediate access to information relating to packaging that was submitted to the foreign regulatory authority.

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  Marginal note:Additional information to be provided

  (4) When providing information to the Minister under paragraph (1)(d) or (e), the holder must also provide the biocide’s identification number and a description of the foreign biocide.

Marginal note:Definitions

28 The following definitions apply in this section and in sections 29 to 37.

designated container

designated container means a disposable metal container that is designed to release pressurized contents by the use of a manually operated valve that forms an integral part of the container. (contenant désigné)

household biocide

household biocide means a biocide that is intended to be distributed only to the general public for personal use. (biocide domestique)

immediate container

immediate container means the package that is in direct contact with a biocide. (contenant immédiat)

inner label

inner label means a label that is on or attached to the immediate container of a biocide. (étiquette intérieure)

outer label

outer label means a label that is on or attached to the outside of a package, other than the immediate container, of a biocide. (étiquette extérieure)

Pressurized Containers Labelling Document

Pressurized Containers Labelling Document means the document entitled Labelling Requirements for Pressurized Containers Containing Biocides, dated December 18, 2021 and published by the Government of Canada on its website. (Document sur l’étiquetage des contenants sous pression)

principal display panel

principal display panel means the part of the label that

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  (a) is on or attached to all or part of the surface of the package that is displayed or visible under normal conditions of sale or use; or

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  (b) if the package does not have a surface described in paragraph (a), is on or attached to any part of the package except the bottom. (espace principal)

Marginal note:Requirement for label

29 A biocide must have an inner label and, if the immediate container of the biocide is packaged in another package, an outer label.

Marginal note:Bilingual labelling

30 The information that is required to be shown on a label of a biocide must be clearly and prominently displayed in both English and French.

Marginal note:Principal display panel

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  31 (1) The following information must be shown on the principal display panel of the inner label of a biocide and, if there is an outer label, on the principal display panel of the outer label:

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    (a) the brand name of the biocide;

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    (b) at least one of the intended uses or purposes of the biocide;

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    (c) the settings in which the biocide is intended to be used;

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    (d) the biocide’s identification number, preceded by the designation “DIN” in capital letters;

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    (e) the net quantity of the biocide in the package;

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    (f) the statements “Keep out of reach of children.” and “Tenir hors de la portée des enfants.”; and

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    (g) if the biocide is sterile, the words “sterile” and “stérile”.

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  Marginal note:Limit

  (2) If the biocide has more than one brand name, only one of those names may be shown on the label that is displayed or visible under normal conditions of sale.

Marginal note:Additional information

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  32 (1) The following information must be shown on the inner label of a biocide — and, if there is an outer label, on the outer label — but is not required to be shown on the principal display panel:

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    (a) the conditions of use of the biocide, other than the conditions of use that are required to be shown on the principal display panel under paragraphs 31(1)(b) and (c);

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    (b) the quantity of each active ingredient that a given quantity of the biocide contains;

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    (c) the lot number of the biocide;

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    (d) the expiry date of the biocide, unless the biocide is a household biocide with a shelf life of more than one year and the package contains a quantity of the biocide that may reasonably be expected to be used within one year after it is sold;

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    (e) the name and contact information of the holder of the market authorization for the biocide; and

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    (f) the physical form of the biocide, unless it is obvious.

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  Marginal note:Contact information — accessibility

  (2) For the purposes of paragraph (1)(e), the contact information must provide a means for persons in Canada to contact the holder of the market authorization without cost.

Marginal note:Small packages

33 In the case where the immediate container of a biocide is not large enough to accommodate an inner label that complies with sections 31 and 32, those sections do not apply in respect of the inner label if

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  (a) the immediate container is packaged in another package and the outer label complies with the labelling requirements of these Regulations; and

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  (b) the inner label shows

  • (i) the brand name of the biocide,

  • (ii) the quantity of each active ingredient that a given quantity of the biocide contains,

  • (iii) the net quantity of the biocide in the immediate container,

  • (iv) the settings in which the biocide is intended to be used, and

  • (v) the information referred to in paragraphs 32(1)(c) to (f).