Biocides Regulations — 15
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). 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. 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 st