Biocides Regulations — 15
 — 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 biocide’s market authorization was issued on the basis of an application submitted under section 26 ; (b) the application is submitted on the basis of a comparison between (i) the version of the biocide that is affected by the major change; and (ii) a version of the foreign biocide described in the market authorization that is also affected by the major change (referred to in paragraphs (c) to (f) as “the other foreign biocide”); (c) the foreign regulatory authority named in the market authorization has authorized the major change in respect of the other foreign biocide, other than on the basis of a type of application that is set out in the List of Foreign Regulatory Authorities in connection with that regulatory authority; (d) the name of the foreign regulatory authority appears in that List when the application is submitted; (e) the application contains (i) evidence of the authorization provided by the foreign regulatory authority in respect of the major change, and (ii) an attestation, by an individual who has authority to bind the holder of the market authorization, that confirms that the holder possesses or has immediate access to the information that was submitted to the foreign regulatory authority to obtain the authorization referred to in subparagraph (i); and (f) the application contains an attestation, by an individual who has authority to bind the holder of the market authorization, that (i) confirms that either (A) the major change resulted in an amendment to the master formula for the other foreign biocide and 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 foreign biocide, or (B) the major change did not result in an amendment to the master formula for the other foreign biocide, and (ii) confirms that 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 foreign biocide. Additional information and material (7) The Minister may request the holder of the market authorization to provide any additional information or any material, including samples, that is necessary to enable the Minister to determine whether the notice of acceptance must be provided in respect of the major change. Non-application of subsection (3) (8) Subsection (3) does not apply to a biocide that was exempted from the application of these Regulations under subsection 66 (1) or 68 (1) if the biocide’s market authorization was issued on the basis of an application submitted under section 26 . Definitions of applicant and holder (9) The following definitions apply 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). ( demandeur ) holder (a) in respect of a registration under the Pest Control Products Act , has the meaning assigned by the definition registrant in subsection 2(1) of that Act; and (b) in respect of a drug identification number assigned under the Food and Drug Regulations , means the person to whom the document setting out the drug identification number was issued under subsection C.01.014.2(1) of those Regulations. ( titulaire ) Definition of authorization (10) In paragraphs (3)(d) and (e), authorization means any of the following: (a) a market authorization; (b) a registration under the Pest Control Products Act ; or (c) a drug identification number that has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations and has not been cancelled.