Biocides Regulations — 1
Definitions 1 (1) The following definitions apply in these Regulations. Act means the Food and Drugs Act . ( Loi ) active ingredient means a component of a biocide that is directly responsible for any of the biocide’s intended effects. ( ingrédient actif ) biocide means a drug that is manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface, but it does not include (a) such a drug that is manufactured, sold or represented for use exclusively on the surface of food; (b) such a drug that is manufactured, sold or represented for use on the surface of a contact lens that is a medical device , as defined in section 1 of the Medical Devices Regulations ; or (c) such a drug that (i) is manufactured, sold or represented for use on the surface of (A) an invasive device , as defined in section 1 of the Medical Devices Regulations , or (B) a medical device , as defined in section 1 of the Medical Devices Regulations , that is not an invasive device , as defined in that section, but is intended to channel or store gases, liquids, tissues or body fluids, for the purpose of being introduced into the body by infusion or other means of administration, and (ii) is capable of destroying or irreversibly inactivating either (A) all types of pathogenic micro-organisms, but not necessarily large numbers of pathogenic bacterial spores, or (B) all types of micro-organisms. ( biocide ) CAS registry number means the identification number that is assigned to a chemical substance by the Chemical Abstracts Service division of the American Chemical Society. ( numéro d’enregistrement CAS ) conditions of use , in respect of a biocide, means (a) its intended uses or purposes; (b) the settings in which it is intended to be used; (c) its risk information; (d) its directions for use; and (e) its directions for storage. ( conditions d’utilisation ) contact information includes civic address, except in paragraphs 32 (1)(e), 49 (2)(d) and 50 (1)(a). ( coordonnées ) expiry date , in respect of a biocide, means the year and month in which its shelf life ends. ( date limite d’utilisation ) foreign regulatory authority means a government agency or other entity outside Canada that controls the manufacture, sale or use of biocides within its jurisdiction and that may take enforcement action to ensure that biocides marketed within its jurisdiction comply with the applicable legal requirements. ( autorité réglementaire étrangère ) formulant means any component of a biocide other than an active ingredient or contaminant. ( formulant ) import means import for the purpose of sale. ( importer ) List of Foreign Regulatory Authorities means the document entitled List of Foreign Regulatory Authorities for Biocides that is published by the Government of Canada on its website, as amended from time to time. ( Liste des autorités réglementaires étrangères ) lot number means any combination of letters, figures or both by which a biocide can be traced in manufacture and identified in distribution. ( numéro de lot ) major change means a change, other than a change referred to in section 14 , that relates to the information or material provided to the Minister in connection with a biocide and that may reasonably be expected to have a major impact on the quality of the biocide, the benefits or risks associated with the biocide or the uncertainties related to the benefits and risks, including (a) a change to a method of application, unless the changed method is similar to an approved method of application for the biocide; (b) the addition of a method of application, unless the new method is similar to an approved method of application for the biocide; (c) the addition of a formulant, unless the formulant is replacing a similar formulant in a similar quantity in a given quantity of the biocide; (d) the removal of a formulant, unless the formulant is being replaced by a similar