Biocides Regulations — 1
nt, 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 formulant in a similar quantity in a given quantity of the biocide; (e) a change to the quantity of a formulant that a given quantity of the biocide contains; and (f) a change to the conditions of use of the biocide, other than (i) the removal of an intended use or purpose, (ii) the removal of a setting in which the biocide is intended to be used, (iii) the addition of risk information, (iv) a change to or the addition or removal of a direction for use, if the change, addition or removal does not require an update to the information on the biocide’s safety or effectiveness that was provided to the Minister, or (v) the removal of a direction for use that is due to the removal of a method of application or a change to the biocide’s intended use or purpose. ( changement majeur ) master formula , in respect of a biocide, means a document that sets out (a) the ingredients that are used in the manufacture of the biocide and the quantities of those ingredients that are required to manufacture a given quantity of the biocide; (b) the specifications for the biocide; (c) a detailed description of the procedures required to manufacture, package, label and store the biocide, including safety precautions and in-process controls; (d) a detailed description of the methods used to test and examine the packaging material; and (e) a statement of tolerances for the properties and qualities of the packaging material. ( formule type ) minor change means a change 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 minor 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 the name or contact information of the holder of the market authorization for the biocide; (b) a change to the biocide’s brand names; (c) the removal of a method of application; (d) the replacement of a formulant with a similar formulant in a similar quantity in a given quantity of the biocide; (e) a change referred to in any of subparagraphs (f)(i) to (v) of the definition major change ; (f) the addition, replacement or removal of an importer of the biocide or a person that manufactures the biocide or a change to the name or contact information of such an importer or person; and (g) a change in the location where the biocide is manufactured. ( changement mineur ) pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act . ( produit antiparasitaire ) shelf life means the period, beginning on the day on which a biocide is packaged for sale to consumers, during which the biocide will, when stored appropriately, retain without any appreciable deterioration its stability and any other qualities claimed for it by the holder of the market authorization for it. ( durée de conservation ) specifications , in respect of a biocide, means (a) a statement of its properties and qualities, and of the properties and qualities of its active ingredients and formulants, including the identity, potency and purity of the biocide and those ingredients and formulants; (b) 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; (c) a detailed description of the methods used to test and examine the biocide and its active ingredients and formulants; and (d) a statement of tolerances for the properties and qualities of the biocide and for the properties and qualities of its active ingredients and formulants. ( spécifications ) Definition of serious adverse drug reaction (2) For the purposes of section 21.8 of the Act as it relates to biocides, serious adverse drug reaction means