Biocides Regulations (SOR/2024-110)

AMENDMENTS NOT IN FORCE

• — SOR/2024-110, s. 72

  • 72 Subsection 10(1) of these Regulations is amended by adding “and” at the end of paragraph (m) and by repealing paragraphs (o) and (p).

• — SOR/2024-110, s. 73

  • 73 Subparagraph 12(1)(o)(ii) of these Regulations is replaced by the following:

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

• — SOR/2024-110, s. 74

  • • 74 (1) Paragraphs 15(3)(a) to (i) of these Regulations are replaced by the following:

      • (a) the market authorization for the biocide was issued on the basis of an application that met the applicable conditions set out in subsection 10(2);

      • (b) the application is submitted on the basis of a comparison between the version of the biocide that is affected by the major change and a version of the other biocide referred to in paragraph 10(2)(a) that is also affected by the major change (referred to in paragraphs (c) to (k) as “the other biocide”);

      • (c) the other biocide is the subject of a market authorization;

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

      • (e) 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 its market authorization,

        • (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 its market authorization,

        • (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;

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

      • (g) 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;

      • (h) 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;

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

      • (j) in the case referred to in 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

      • (k) in the case referred to in 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.

    • (2) Subsections 15(4) and (5) of these Regulations are replaced by the following:

      • Deemed comparison — Pest Control Products Act

        (4) 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) for the purposes of paragraph (3)(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) for the purposes of paragraph (3)(b), that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).

      • Deemed comparison — Food and Drug Regulations

        (5) 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) for the purposes of paragraph (3)(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) for the purposes of paragraph (3)(b), that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).

    • (3) Subsection 15(9) of these Regulations is replaced by the following:

      • Definition of applicant

        (9) In subsection (3), 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).

    • (4) Subsection 15(10) of these Regulations is repealed.

• — SOR/2024-110, s. 75

  • 75 Paragraph 26(3)(a) of the Regulations is replaced by the following:

    • (a) the information referred to in paragraphs 10(1)(a) to (g), (j), (k), (m) and (n) in respect of the biocide for which the market authorization is sought;