Biocides Regulations — 10
Application requirements 10 (1) An application for a market authorization for a biocide must be submitted to the Minister and contain (a) the applicant’s name and contact information; (b) the brand names under which the biocide is proposed to be sold or advertised; (c) the physical form of the biocide and the methods of application; (d) a list of the biocide’s active ingredients and their CAS registry numbers, if they have one; (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; (f) the quantity of each active ingredient and formulant that a given quantity of the biocide contains; (g) the conditions of use of the biocide; (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; (i) a summary of the information referred to in paragraph (h); (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; (k) the civic addresses of the locations where the biocide will be manufactured and, if known, packaged and labelled; (l) the specifications for the biocide; (m) the shelf life of the biocide; (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; (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 (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. 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 (a) the application is based on a comparison between the biocide and another biocide that is the subject of a market authorization; (b) the application contains the other biocide’s identification number; (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; (d) the application