Biocides Regulations (SOR/2024-110)

Marginal note:Application

• 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

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

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

• 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.

• Marginal note:Content of application

  (3) The application must contain

  • (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;

  • (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;

  • (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;

  • (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;

  • (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;

  • (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;

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

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

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

• 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.

• 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.