Tobacco Reporting Regulations

Tobacco Reporting Regulations Whereas, pursuant to section 42.1 of the Tobacco Acta, the Minister of Health laid a copy of the proposed Tobacco Reporting Regulations, substantially in the annexed form, before the House of Commons on May 12, 2000 and the House of Commons concurred on June 8, 2000 in a report from the Standing Committee on Health approving the proposed Regulations; Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to sections 7 and 33 of the Tobacco Acta, hereby makes the annexed Tobacco Reporting Regulations. S.C. 1997, c. 13 Definitions The definitions in this section apply in these Regulations. accredited representative means a person who is entitled to the tax exemptions specified in Article 34 of the Convention set out in Schedule I to the Foreign Missions and International Organizations Act or Article 49 of the Convention set out in Schedule II to that Act. (représentant accrédité) Act means the Tobacco and Vaping Products Act. (Loi) brand means all of the brand elements that as a whole are used by a manufacturer to identify to a consumer a tobacco product made by the manufacturer. (marque) 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) cigar means a roll or tubular construction intended for smoking, other than a little cigar, that contains a filler composed of natural or reconstituted tobacco, and that has a wrapper, or a wrapper and a binder, composed of natural or reconstituted tobacco. (cigare) cigarette includes any roll or tubular construction that contains tobacco and is intended for smoking, other than a bidi, cigar, kretek or little cigar. (cigarette) civic address means for an address in Canada, the unit number, civic number, street name, municipality name, province name and postal code; and for an address outside Canada, the unit number, civic number, street name, municipality name, state or province name, postal or ZIP code and country name. (adresse municipale) constituent means a constituent listed in column 1 of Schedule 1. (constituant) consumer tobacco product means any of the following types of tobacco product that is for use by a consumer: bidis; cigarettes; cigarette tobacco; cigars; kreteks; little cigars; pipe tobacco; smokeless tobacco. (produit du tabac pour consommation) designated tobacco product means either of the following types of consumer tobacco product: kreteks. (produit du tabac désigné) duty free shop has the same meaning as in subsection 2(1) of the Customs Act. (boutique hors taxes) emission means, in the case of an emission contained in mainstream smoke, an emission listed in column 1 of Schedule 2 and, in the case of an emission contained in sidestream smoke, an emission listed in column 1 of Schedule 3. (émission) equivalent unit[Repealed, SOR/2019-64, s. 1] identical products[Repealed, SOR/2019-64, s. 1] ingredient[Repealed, SOR/2019-64, s. 1] kit[Repealed, SOR/2019-64, s. 1] mainstream smoke means the smoke that is drawn through the port of a smoking machine when a tobacco product is placed in the machine and combusted. (fumée principale) manufacturer does not include an individual or entity that only packages, only labels or only distributes tobacco products on behalf of a manufacturer. (fabricant) new brand means a brand of consumer tobacco product that a manufacturer sells in a year and that was not referred to in a report submitted under section 13 for any portion of the preceding year; and a brand of cigarette papers, tubes or filters that a manufacturer sells in a year and that was not referred to in a report submitted under section 11 for the preceding year. It does not include any product that was mentioned under a different brand name in a report referred to in paragraph (a) or (b). (nouvelle marque) sidestream smoke means the smoke, other than mainstream smoke, that leaves a tobacco product when the product is placed in a smoking machine and combusted. (fumée latérale) smokeless tobacco means chewing tobacco, nasal snuff and oral snuff. (tabac sans fumée) type of package includes each of the following types of packages as well as each of their sizes: slide and shell package; slide and shell package with lateral moving slide; flip-top package; soft package; pouch; bag; can; tub; tube; flip-top box; bundle; plastic or metal container; shoulder box. (type d’emballage) type of tobacco includes the types of tobacco leaves commonly known as Virginia flue-cured; Maryland; Burley; and Oriental. (type de tabac) unit[Repealed, SOR/2019-64, s. 1] year means a calendar year. (année) [Repealed, SOR/2019-64, s. 2] Application Every provision of these Regulations that applies to a brand of tobacco product also applies to every size of product of that brand. Information These Regulations prescribe the information that manufacturers of tobacco products are required to submit to the Minister, as well as the manner in which it is to be submitted. Content of reports In addition to the information required for each type of report set out in these Regulations, every report must set out the following information: the name of the manufacturer on whose behalf the report is submitted, as well as the telephone number, email address and civic address of its principal place of business in Canada; the name, telephone number and email address of the individual who prepared the report and, if that individual works for an entity other than a manufacturer on whose behalf the report is submitted, the name of the entity, as well as the telephone number, email address and civic address of its principal place of business; the date of the report; the period covered by the report; and the section of these Regulations under which the report is made. Attestation The individual who prepared the report must attach to the report an attestation that states that the information in the report is true and complete to the best of their knowledge and belief and is provided in good faith. Brand name The manufacturer must use a unique brand name to identify each consumer tobacco product in a report submitted under section 13 and must use it in a uniform manner in all other reports submitted in respect of the same consumer tobacco product. Change to brand name However, a manufacturer may change the brand name used to identify a consumer tobacco product in a report by submitting a report under section 13 that identifies the brand name that was previously used, as well as the changed brand name. Exception — export The reports referred to in sections 10 to 12, 14, 15 and 17 to 24 are not required for consumer tobacco products that are manufactured solely for export. Data collection Any data used in the preparation of a report must be obtained from tests performed on tobacco products that are sampled and tested during the period covered by the report. Laboratory accreditation Any test performed on a tobacco product for the purposes of these Regulations must be performed by a laboratory that is accredited by the Standards Council of Canada or any other accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, under the most recent version of the International Organization for Standardization standard ISO/IEC 17025, entitled General Requirements for the Competence of Testing and Calibration Laboratories; and has been issued a document by the body that accredited it, specifying the test methods set out in these Regulations for which the laboratory is accredited. Documents to submit A manufacturer that uses data obtained from a test performed by a laboratory for the purpose of preparing any report under section 12, 14 or 14.2 must attach a copy of the following documents to the report: the laboratory report that includes the data used in the preparation of the report required by these Regulations and that specifies the type of tobacco product that was tested, as well as its brand name; and the document referred to in paragraph 5(b) that proves the laboratory’s accreditation at the time when the test was performed. Electronic format The reports and other information are to be submitted in a legible electronic format. Reports under sections 12, 14 and 14.2 The information referred to in subsections 12(7), 14(2) and 14(7) and the toxicity data collected in accordance with subsection 14.2(3) must be set out in an orderly and logical manner and clearly labelled through the use of headings or tables and must be submitted in an electronic format that permits the Minister to have access to the information or data; and process the information or data electronically without having to recopy or re-enter them. [Repealed, SOR/2019-64, s. 3] Content of report The profile report on a manufacturer of tobacco products must set out a list of every type of tobacco product that the manufacturer sells; for each type of tobacco product that the manufacturer sells, other than a consumer tobacco product, a list of brand names used to identify the brands of tobacco products that the manufacturer sells; and the name and civic address of each warehouse in Canada that the manufacturer uses to store tobacco products for distribution and sale. Digital images The report must include, for each brand of consumer tobacco product that the manufacturer sells, a digital image of the following items: each type of package, showing all of the sides that are visible when the package is closed; any promotion that is on an interior side of the package or that accompanies the package; any overwrap on which a promotion is displayed, that is used over a package or carton or that is used as a carton; and any brand element displayed on a unit of the consumer tobacco product. Digital image characteristics The digital image of an item must be taken on a white background and be clear and display colours that are as close as possible to the colours of the item; display any text that appears on the item, in legible characters; include the brand name associated with the item; and include a graphical scale in millimetres. Time limit — new manufacturer The report must be submitted on or before the day on which a manufacturer begins to sell tobacco products. Time limit — existing brands However, in the case of a brand of consumer tobacco product that is sold on the day on which this subsection comes into force, or that was sold at any time during the preceding year or the portion of the year before that day, the report must be submitted on or before the 180th day after the day on which this subsection comes into force. Time limit — changes to information If any of the information referred to in paragraphs (1)(a) to (c) is changed by the manufacturer, the manufacturer must advise the Minister of the change by submitting, on or before January 31 of the following year, a description of the information that was previously submitted, as well as of the change made to the information. Time limit — changes to items If the appearance of any package, promotion, overwrap or brand element referred to in subsection (2) is changed by the manufacturer, the manufacturer must, within 30 days after the day on which the consumer tobacco product is sold using that changed item, advise the Minister of the change by submitting the digital image previously submitted, as well as a description of the change made to the item; and a digital image of the changed item. Time limit — new brand A manufacturer must, on or before the day on which the manufacturer first sells a new brand of consumer tobacco product in a year, submit the digital images referred to in subsection (2). Manufacturing processes The report on manufacturing must set out, by brand, the following information in respect of the manufacturing processes for each consumer tobacco product that a manufacturer sells, as well as for any cigarette papers, filters or mouthpieces or tips used in the manufacture of those consumer tobacco products: a detailed description and schematic of the sequential steps that are involved in the manufacture of the consumer tobacco product, cigarette paper, filter or mouthpiece or tip, including any steps where additives, such as processing aids, are used; and a detailed description of the conditions and parameters relating to each of those steps. Processing aids The report must set out the common, chemical and brand name of each processing aid and, if applicable, its CAS registry number. Product specifications The report must include, for each brand of cigarettes, kreteks and little cigars that the manufacturer sells, the type of cigarette paper used in the product, and its specifications; the type of any filter used in the product, and its specifications and pressure drop, as well as, for those brands analyzed in accordance with subsection 14(13), its efficiency with respect to nicotine, determined in accordance with Official Method T-106, entitled Determination of Filter Efficiency in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017; and an engineering drawing of the product. In the case of a brand of consumer tobacco product that is sold on the day on which this subsection comes into force, or that was sold at any time during the preceding year or the portion of the year before that day, the report must be submitted on or before the 180th day after the day on which this subsection comes into force. A manufacturer must, on or before the day on which the manufacturer first sells a new brand of consumer tobacco product in a year, submit a report in respect of the new brand. Exception — sales volume of cigars However, in the case of a brand of cigars, the manufacturer is not required to submit the report until the manufacturer’s total sales of that brand in a year is at least 1 000 000 units. In that case, the report must be submitted on or before January 31 of the following year. Exception — identical manufacturing processes A manufacturer is not required to submit a report in respect of a particular brand of consumer tobacco product if the manufacturer uses identical manufacturing processes to manufacture a consumer tobacco product that is sold under more than one brand; submits a report under this section in respect of one of those brands; and identifies in the report all other brands that are manufactured using those identical manufacturing processes, including the particular brand. Time limit — changes If there are changes to the manufacturing processes, processing aids or product specifications, the manufacturer must, on or before the last day of the month following the month in which the change is made, submit a new report that sets out the information referred to in subsections (1) to (3) and that indicates the changes made to the information previously submitted. Time limit — efficiency with respect to nicotine In the case of brands of cigarettes analyzed in accordance with subsection 14(13), if there are any changes to the type of filter used in the cigarette, the filter’s specifications or the filter’s pressure drop, the manufacturer must submit a new report that indicates the efficiency with respect to nicotine, as well as the changes made to the information previously submitted, no later than 90 days after the day on which the change is made. The report on ingredients must set out, by type and brand of tobacco product, the following information for each ingredient, other than a processing aid, that is used in the manufacture of a consumer tobacco product, cigarette paper, filter or tube that a manufacturer sells during a year: its common, chemical and brand names; in the case of tobacco — other than reconstituted tobacco that is used as an ingredient in the manufacture of a consumer tobacco product — the type of tobacco, its country of origin and its biological origin, in standard Latin nomenclature; if applicable, its CAS registry number; its amount in milligrams per unit of the product, in the case of an ingredient used in the manufacture of a bidi, cigarette, cigar, kretek, little cigar, cigarette paper, filter or tube, or per gram of the product, in the case of an ingredient used in the manufacture of cigarette tobacco, pipe tobacco or smokeless tobacco; and the name and civic address of its supplier. More than one substance in an ingredient For greater certainty, if more than one substance was used in the manufacture of any ingredient mentioned in the report, the report must set out, by ingredient, the information referred to in subsection (1) for each substance used in the manufacture of that ingredient. Weight of unit If any bidi, cigar, cigarette, kretek, little cigar, cigarette paper, filter or tube is mentioned in the report, the report must also set out, by brand, the weight of one unit of the product in milligrams. Initial report Despite subsection (1), the initial report must include information in respect of each consumer tobacco product, cigarette paper, filter or tube that a manufacturer sells during the portion of the year remaining after the day on which this subsection comes into force and for which a report has not already been submitted. Inventory In addition to the information referred to in subsections (1) to (3), the report must also set out the name and civic address of each establishment where the ingredients are used in the manufacture of the consumer tobacco product, cigarette paper, filter or tube during the period covered by the report; the total quantity and cost of each ingredient, including any processing aid, that is purchased during the period covered by the report for use in the manufacture of cigarettes; and the total quantity and cost of each ingredient, including any processing aid, that is used during the period covered by the report in the manufacture of cigarettes. Time limit The report must be submitted on or before January 31 of the year after the period covered by the report. A manufacturer must, on or before the day on which the manufacturer first sells a new brand of consumer tobacco product, cigarette paper, filter or tube in a year, submit a report setting out the information referred to in subsections (1) to (3) in respect of the new brand. Report The report on tobacco constituents must set out, by brand, the information referred to in subsection (7) in respect of each type of consumer tobacco product that a manufacturer sells during a year. Method of collecting data The applicable official method listed in column 2 of Schedule 1 must be used to collect data on a constituent. Sampling The sampling of a consumer tobacco product for the purpose of determining the amount of a constituent is to be performed in accordance with the following procedures: in the case of cigarettes, the procedures described in items A and B of Table 1 of the International Organization for Standardization standard ISO 8243, entitled Cigarettes — Sampling, as amended from time to time; in the case of bidis, cigars, kreteks or little cigars, the procedures referred to in paragraph (a), modified in the following manner: in the case of bidis, kreteks, and little cigars, a reference to a “cigarette” is to be read as a reference to the type of consumer tobacco product being sampled, and a reference to a “carton” is to be read as a reference to 200 units of the type of consumer tobacco product being sampled, and in the case of cigars, a reference to a “cigarette” is to be read as a reference to cigar, a reference to a “sale unit” is to be read as a reference to one cigar, and a reference to a “carton” is to be read as a reference to 200 grams of the cigars being sampled; in the case of cigarette tobacco, the procedures described in the International Organization for Standardization standard ISO 15592-1, entitled Fine-cut tobacco and smoking articles made from it — Methods of sampling, conditioning and analysis — Part 1: Sampling, as amended from time to time; and in the case of pipe tobacco or smokeless tobacco, the procedures described in paragraph (c), modified so that a reference to “fine-cut tobacco” is to be read as a reference to the type of consumer tobacco product being sampled. Preparation The sample is to be prepared in accordance with Official Method T-402, entitled Preparation of Sample for Testing of Cigarettes, Tobacco Sticks, Cigarette Tobacco, Cigars, Little Cigars, Kreteks, Bidis, Leaf, Pipe and Smokeless Tobacco, prepared by the Department of Health, dated December 31, 2017. Replicates The mean, standard deviation and 95% confidence limits of the amount of each constituent must be based on three replicates of a sample. Adjustment for moisture The amount of each constituent must be corrected for moisture in accordance with the AOAC International Official Method 966.02, entitled Loss on Drying (Moisture) in Tobacco, published in Official Methods of Analysis of AOAC International, as amended from time to time. The report must set out the following information: in the case of bidis, cigarettes, cigars, kreteks and little cigars, the weight of tobacco in milligrams per unit; the name of each constituent in the consumer tobacco product; the mean, standard deviation and 95% confidence limits of the amount of each constituent in milligrams, micrograms or nanograms per gram of the consumer tobacco product, and in the case of bidis, cigarettes, cigars, kreteks and little cigars, per unit; the pH of the consumer tobacco product, determined in accordance with Official Method T-310, entitled Determination of the pH of Whole Tobacco, prepared by the Department of Health, dated December 31, 2017; and the percentage of moisture in the consumer tobacco product, determined in accordance with the method referred to in subsection (6). Exception — short report A manufacturer may, instead of submitting a report with respect to all constituents in a consumer tobacco product, submit a report in accordance with this section solely on the amounts of nicotine, nitrosamines, nickel, lead, cadmium, chromium, arsenic, selenium and mercury in the product, if in the case of cigarettes and cigarette tobacco, the manufacturer’s total sales for that type of consumer tobacco product in the year preceding the period covered by the report is less than 1% of the total sales of that type of consumer tobacco product in that year in Canada; and in the case of bidis and kreteks, the manufacturer’s total sales for that type of consumer tobacco product in the year preceding the period covered by the report is less than 5% of the total sales of that type of consumer tobacco product in that year in Canada. Exception — sales volume A manufacturer is not required to submit a report in respect of the following consumer tobacco products if the total sales of the manufacturer for the year preceding the period that would otherwise be covered by the report is less than in the case of cigars and little cigars, 1 000 000 units per brand; and in the case of pipe tobacco, 8000 kg per brand. Exception — eugenol If clove, clove extract or eugenol has not been added to a consumer tobacco product, the manufacturer of the product need not test it for eugenol. Exception — identical products submits a report under this section in respect of another brand of consumer tobacco product; and identifies in the report all other brands of identical products, including the particular brand. Definition of identical products In this section, identical products means consumer tobacco products that are sold by a manufacturer under more than one brand, that are manufactured using identical manufacturing processes and that contain in the case of bidis, cigarettes and kreteks, identical ingredients per gram of tobacco blend; in the case of pipe tobacco, cigarette tobacco and smokeless tobacco, identical ingredients; and in the case of cigars and little cigars, identical ingredients in the filler and wrapper, and in the binder, if any. The report must be submitted on or before January 31 of the year after the year covered by the report. The report on sales of consumer tobacco products and leaf tobacco must set out the information referred to in subsections (2) and (3) in respect of each type of consumer tobacco product and leaf tobacco that a manufacturer sells during the period covered by the report, for each of the following categories: in Canada; in each province; in each duty free trade customer and operator; as ships’ stores in accordance with the Ships’ Stores Regulations; to accredited representatives; and for export, by country of destination. Total sales The report must set out the Canadian dollar value, including the excise duty, of the total sales and, as applicable, the total number of units sold or the total weight in kilograms of the consumer tobacco product and leaf tobacco sold. Sales by brand and package type The report must set out the following information, by brand and type of package: in the case of bidis, cigarettes, cigars, kreteks and little cigars, the number of units sold, the number of packages sold and the number of units in each package, and the Canadian dollar value of sales, including the excise duty; and in the case of cigarette tobacco, pipe tobacco, leaf tobacco and smokeless tobacco, the weight, in kilograms, of the product sold, the number of packages sold and the weight, in grams, of the product in each package, and the Canadian dollar value of sales, including the excise duty. The report must be submitted for cigarettes and cigarette tobacco, on or before the 15th day of each month, for the previous month; and for every other consumer tobacco product, for the period beginning on January 1 and ending on March 31 of a year, on or before April 30 of that year, for the period beginning on April 1 and ending on June 30 of a year, on or before July 31 of that year, for the period beginning on July 1 and ending on September 30 of a year, on or before October 31 of that year, and for the period beginning on October 1 and ending on December 31 of a year, on or before January 31 of the following year. The report on emissions from designated tobacco products must set out, by brand, the information referred to in subsection (2) in respect of each type of designated tobacco product that a manufacturer sells during a year. The report must, in respect of the emissions contained in the mainstream and sidestream smoke produced from a designated tobacco product that is placed in a smoking machine and combusted, identify the emissions set out in column 1 of Schedules 2 and 3 and the mean, standard deviation and 95% confidence limits of the number of puffs; of each emission, expressed in milligrams, micrograms or nanograms per unit; and of the weight of tobacco contained in the designated tobacco product, expressed in milligrams per unit. The sampling of designated tobacco products for the purpose of determining the amount of an emission is to be performed in accordance with the following procedures: in the case of cigarettes, the procedures described in paragraph 12(3)(a); and in the case of kreteks, the procedures described in paragraph 12(3)(b). The sample to be used for the purpose of determining the amount of an emission is to be conditioned and smoked in an environment as described in the International Organization for Standardization standard ISO 3402, entitled Tobacco and tobacco products — Atmosphere for conditioning and testing, as amended from time to time. The mean, standard deviation and 95% confidence limits of the amount of each emission must be based in the case of tar, nicotine and carbon monoxide, on 20 replicates of a sample; and in every other case, on 7 replicates of a sample. The following official methods must be used to collect data on the emissions contained in smoke produced from a designated tobacco product: in the case of mainstream smoke, the applicable official method set out in column 2 of Schedule 2; and in the case of sidestream smoke, the applicable official method set out in column 2 of Schedule 3. Conditions for the collection of data For the purpose of subsection (2), the following conditions are to be used to determine the amount of an emission: in the case of sidestream smoke, the conditions set out in the International Organization for Standardization standard ISO 3308, entitled Routine analytical cigarette-smoking machine — Definitions and standard conditions, as amended from time to time; and in the case of mainstream smoke, the conditions referred to in paragraph (a), in addition to those same conditions as modified in the following manner: puff volume must be increased from 35 mL to 55 mL, puff frequency must be increased from one puff every 60 s (± 0.5 s) to one puff every 30 s (± 0.5 s), and all ventilation holes must be blocked by placing over them a strip of Mylar adhesive tape, Scotch Brand product no. 600 Transparent Tape, and the tape must be cut so that it covers the circumference and is tightly secured from the end of the filter to the tipping overwrap seam, or by another method of equivalent efficiency. pH levels The report must also set out the pH level of the mainstream smoke, determined in accordance with Official Method T-113, entitled Determination of Mainstream Tobacco Smoke pH, prepared by the Department of Health, dated December 31, 2017. Short report A manufacturer may, instead of submitting the report referred to in subsection (1), submit a short report every two years in respect of its designated tobacco products sold during that two-year period if in the case of cigarettes, the manufacturer’s total sales of that type of designated tobacco product, per year, is less than 1% of the total sales of that type of designated tobacco product in Canada in the year preceding the two-year period, as well as in the first year of that two-year period; and in the case of kreteks, the manufacturer’s total sales of that type of designated tobacco product, per year, is less than 5% of the total sales of that type of designated tobacco product in Canada in the year preceding the two-year period, as well as in the first year of that two-year period. Short report — content The short report must set out the information referred to in subsection (2) in relation to the tar, nicotine, carbon monoxide, benzene, hydrogen cyanide and formaldehyde emissions contained in the smoke produced from the designated tobacco product, as well as the information referred to in subsection (7). [Repealed, SOR/2019-64, s. 10] Exemption — functional relationship of certain emissions A manufacturer may apply to the Minister for an exemption from the requirement to submit the report referred to in subsection (1) in respect of the emissions that are contained in the smoke produced from a particular brand of cigarettes that is sold in a year, on or before December 1 of the year before the year for which the exemption is sought, if the manufacturer provides to the Minister, with respect to emissions contained in the sidestream smoke, the information contained in subsection (2) and, with respect to the emissions contained in the mainstream smoke, the same information as well as the contents and results of a statistical analysis done under the conditions set out in paragraph (6)(b) that demonstrates, within a 95% confidence limit and in relation to the type of emission exemption sought, the existence of a functional linear relationship between tar and each of the other emissions, other than nicotine, produced from the combustion of the cigarettes by using the formula yis the amount of the other emission, is the amount of the other emission, mis the slope, is the slope, xis the mean amount of tar as determined by 7 replicates, and is the mean amount of tar as determined by 7 replicates, and bis the intercept, is the intercept, by applying a regression analysis to the results obtained under subparagraph (i), and by applying an F-test to the results obtained under that subparagraph; and between nicotine and each of the other emissions, other than tar, produced from the combustion of the cigarettes, by making the calculation and applying the steps described in paragraph (a), except that the reference to “tar” in subparagraph (a)(i) is to be read as a reference to “nicotine”. Sample size To qualify for an exemption under subsection (11), the manufacturer must submit to the Minister a cohort that is composed of two reference cigarette types, as well as of at least 28 different brands that represent the range of tar and nicotine emissions specific to cigarettes sold in Canada, as determined in the case of mainstream smoke, in accordance with Official Method T-115, entitled Determination of Tar, Water, Nicotine and Carbon Monoxide in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017, and in the case of sidestream smoke, in accordance with Official Method T-212, entitled Determination of Tar and Nicotine in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017; a list of the brands of cigarette for which the application for exemption is made; and a list of the properties of the cigarettes, such as the type of tobacco, type of filter and characteristics of the cigarette paper used, that demonstrate the functional linear relationship between the brands of cigarette that form the cohort, and each of the brands of cigarette for which the application for exemption is made. Joint cohort For the purposes of subsection (13), two or more manufacturers may submit a joint cohort of their cigarette brands. Minister’s decision The Minister must, without delay, decide to accept or reject an application made under subsection (11), based on the methodology used, and the demonstration of a satisfactory functional linear relationship based on the mean and standard deviations of the amount of the emissions, other than tar and nicotine, contained in the mainstream smoke, the estimates and 95% confidence limits for the slope m and the intercept b referred to in subparagraph (11)(a)(i), regression statistics, including the degree of freedom for error, degree of freedom for regression, mean square regression, mean square error and the F statistic, and the fact that the data must fall under a 95% prediction interval; and a cohort submitted in accordance with subsection (13) or (14), based on the methodology used and the representativeness of the cohort. Satisfactory functional relationship For the purposes of paragraph (15)(a), a satisfactory functional linear relationship exists if a linear model demonstrates a significant portion of the variation of the other emissions about the mean of those other emissions, with a statistical significance of less than 0.01. If an application made under subsection (11) is accepted, a manufacturer must submit a report setting out the information referred to in subsection (2) in relation to the tar, nicotine and carbon monoxide emissions contained in the smoke produced from the particular brand of cigarettes, as well as the information referred to in subsection (7). A manufacturer is not required to submit a report in respect of a particular brand of designated tobacco product if the manufacturer submits a report under this section in respect of another brand of designated tobacco product; and In this section, identical products means designated tobacco products that are sold by a manufacturer under more than one brand, that are manufactured using identical manufacturing processes and that contain identical ingredients, except those used in the manufacture of colouring agents in the cigarette papers; have identical dimensions; and perform in an identical manner under the same conditions. The following definitions apply in this section and section 14.2. cigarette means any roll or tubular construction that contains tobacco, has a wrapper or cover made of paper and is consumed through the inhalation of the products of combustion, but does not include a bidi, cigar, kretek or little cigar. (cigarette) identical cigarettes means cigarettes that are sold by a manufacturer under more than one brand, that are manufactured using identical manufacturing processes and that perform in an identical manner under the same conditions. (cigarette identiques) Annual testing The report on the toxicity of cigarette emissions must set out the results of toxicity testing performed in accordance with subsection (6) on every brand of cigarettes that the manufacturer sells during a year. Presentation of results The report must set out the date of manufacture of the cigarettes tested, the start and end dates of the tests and the name of the applicable official method prepared by the Department of Health that is used to perform the tests. The following official methods must be used to collect toxicity data: Official Method T-501, entitled Bacterial Reverse Mutation Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017; Official Method T-502, entitled Neutral Red Uptake Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017; and Official Method T-503, entitled In Vitro Micronucleus Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017. Number of replicates of sample The results of the tests performed in accordance with paragraph (3)(a) or (b) must be based on three replicates of a sample. The sampling of cigarettes for the purpose of toxicity testing is to be performed in accordance with the procedures referred to in paragraph 12(3)(a). Conditioning The sample to be used for the purpose of toxicity testing is to be conditioned in an environment described in the standard referred to in subsection 14(3.1). Exception — identical cigarettes A manufacturer is not required to submit a report in respect of a particular brand of cigarettes if the manufacturer submits a report under this section in respect of another brand of cigarettes; and identifies in the report all other brands of identical cigarettes, including the particular brand. The manufacturer must submit the report on or before January 31 of the year after the year covered by the report. The report on research and development activities must set out the information referred to in subsection (2) for any research and development activity that was undertaken, continued or completed by or on behalf of the manufacturer in respect of a consumer tobacco product during a year, whether the tobacco product is for sale or not, including in respect of its toxicity; its health effects; its ingredients; its taste and flavour; its modification; its marketing, if applicable; and the manner in which it is used by consumers, if applicable. The report must include a full copy of every research report or, if the research and development activity is not complete, any progress reports, synopses or outlines made in respect of that activity; the date on which the activity began; and the date of completion of the activity or the expected duration of the activity. Report — declaration However, if no research and development activities were undertaken, continued or completed during a year, the manufacturer must include a statement to that effect in the report. Reports Each report described in sections 17 to 24 pertains to promotional activities undertaken during a semi-annual period referred to in subsection (3). Reports — declaration If none of the activities described in sections 17 to 24 is undertaken during a semi-annual period, the manufacturer must include a statement to that effect in the reports required under those sections. Each report must be submitted at the following times: for the semi-annual period beginning on January 1 and ending on June 30 of a year, on or before July 31 of that year; and for the semi-annual period beginning on July 1 and ending on December 31 of a year, on or before January 31 of the following year. Definition of product For the purposes of sections 17, 18 and 22, product means a consumer tobacco product, as well as any accessory or product that displays a consumer tobacco product-related brand element or a manufacturer’s name. The report must set out the following information in respect of the advertising of products in a publication: every province in which the publication was distributed; the dates the advertisement was published; for each province, the amount of the expenses incurred, by brand or, if applicable, by brand family, for market research, development and design in relation to the advertisement; and the amount of consideration given by the manufacturer for the publication of the advertisement and, if a consideration other than money is given, a description of the consideration and its money value. Digital image The report must include a digital image of the advertisement, which image must be clear and display colours that are as close as possible to the colours of the advertisement; display any text that appears on the advertisement, in legible characters; include the brand name associated with the advertisement or, if the advertisement relates to a brand family, the brand elements used to identify the brand family; and include the dimensions of the advertisement. The report must set out the following information in respect of the advertising of a product by means of information advertising or brand-preference advertising on a sign that is posted in a place where young persons are not permitted by law: the amount of the expenses incurred for market research, development and design in relation to the sign; the amount of the expenses incurred for the manufacturing of the sign; for each province, by brand or, if applicable, by brand family, the amount of consideration given by the manufacturer for the posting of the sign and, if a consideration other than money is given, a description of the consideration and its money value; for each province, the number of places, as well as their names and civic addresses, in which the sign was posted; and the period during which the sign was posted in each place. The report must include a digital image of the sign, which image must be clear and display colours that are as close as possible to the colours of the sign; display any text that appears on the sign, in legible characters; include the brand name associated with the sign or, if the sign relates to a brand family, the brand elements used to identify the brand family; and include the dimensions of the sign. The report must set out the following information in respect of a consumer tobacco product-related brand element or name of a manufacturer that appears in a promotion that is displayed on a permanent facility: the name, the civic address and a description of the facility; the expected duration of the display of the promotion on the facility; the amount of the expenses incurred for market research, development and design in relation to the promotion; the amount of the expenses incurred for the manufacturing of the promotion; and for each province, by brand or, if applicable, by brand family, the amount of consideration given by the manufacturer for the display of the promotion on the facility and, if a consideration other than money is given, a description of the consideration and its money value. The report must include a digital image of the promotion that is displayed on the permanent facility, which image must be clear and display colours that are as close as possible to the colours of the promotion; display any text that appears in the promotion, in legible characters; and include the dimensions of the promotion. The report must set out, by brand and type of package, the following information in respect of expenses relating to the packaging of cigarettes, little cigars, smokeless tobacco and cigarette tobacco: the amount of the expenses incurred for market research, development and design in relation to the packaging; and the amount of the expenses incurred for the manufacturing of each package, by unit, including any promotional material that accompanies the package and any packaging material that is used in or over the package. [Repealed, SOR/2019-64, s. 16] The report must set out the following information in respect of a sign, display unit or other means of promotion that is provided by a manufacturer for use at retail to indicate the sale of a product or its price: the amount of the expenses incurred for market research, development and design of the sign, display unit or other means of promotion, manufacturing of the sign, display unit or other means of promotion, and distribution of the sign, display unit or other means of promotion; for each province, by brand or, if applicable, by brand family, the amount of the consideration given by the manufacturer for the following purposes and, if consideration other than money is given, a description of consideration and its money value: the posting of the sign or placement of the display unit, the display or sale of the product, or any other promotion of the product; and for each province, the number of establishments to which consideration has been given by the manufacturer to post a sign, place a display unit or display or sell a product. The report must include a digital image of the sign, display unit or other means of promotion on which a brand element or a manufacturer’s name appears, which image must be clear and display colours that are as close as possible to the colours of the sign, display unit or other promotion; display any text that appears on the sign, display unit or other promotion, in legible characters; and include the dimensions of the sign, display unit or other means of promotion. The report must set out the following information in respect of accessories that are sold by the manufacturer and that display a consumer tobacco product-related brand element or a manufacturer’s name: the number of accessories sold, by province; and market research, development and design in relation to the accessory, the manufacturing of the accessory, and the distribution of the accessory. The report must include a digital image, taken on a white background, of each side of the accessory on which a brand element or a manufacturer’s name appears, which image must be clear and display colours that are as close as possible to the colours of the accessory and of the brand element or name; display any text that appears on the side of the accessory, in legible characters; and include the dimensions of the accessory. The report must set out the following information in respect of non-tobacco products, other than accessories, that are sold by a manufacturer and that display a consumer tobacco product-related brand element or a manufacturer’s name: the number of non-tobacco products sold, by province; and market research, development and design in relation to the product, the manufacturing of the product, and the distribution of the product. The report must include a digital image, taken on a white background, of each side of the non-tobacco product on which a brand element or a manufacturer’s name appears, which image must be clear and display colours that are as close as possible to the colours of the non-tobacco product and of the brand element or name; display any text that appears on the side of the non-tobacco product, in legible characters; and include the dimensions of the non-tobacco product. [Repealed, SOR/2019-64, s.

18] Nicotine Nornicotine Anabasine Myosmine Anatabine Glycerol Propylene glycol Triethylene glycol Nickel Lead Cadmium Chromium Arsenic Selenium Mercury N-nitrosonornicotine 4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanone N-nitrosoanatabine N-nitrosoanabasine Official Method T-309A, Determination of Tobacco Specific Nitrosamines in Whole Tobacco by GC-TEA, prepared by the Department of Health, dated December 31, 2017, or Official Method T-309B, Determination of Tobacco Specific Nitrosamines in Whole Tobacco by LC-MS/MS, prepared by the Department of Health, dated December 31, 2017 [2-methoxy-4-(2-propenyl)phenol] 1-aminonaphthalene 2-aminonaphthalene 3-aminobiphenyl 4-aminobiphenyl Formaldehyde Acetaldehyde Acetone Acrolein Propionaldehyde Crotonaldehyde Butyraldehyde NO NOx Official Method T-111A, Determination of Tobacco Specific Nitrosamines in Mainstream Tobacco Smoke by GC-TEA, prepared by the Department of Health, dated December 31, 2017, or Official Method T-111B, Determination of Tobacco Specific Nitrosamines in Mainstream Tobacco Smoke by LC-MS/MS, prepared by the Department of Health, dated December 31, 2017 Pyridine Quinoline Styrene Hydroquinone Resorcinol Cathecol Phenol m+p-Cresol o-Cresol Tar Carbon Monoxide 1,3-butadiene Isoprene Acrylonitrile Benzene Toluene Official Method T-203A, Determination of Benzo[a]pyrene in Sidestream Tobacco Smoke by HPLC, prepared by the Department of Health, dated December 31, 2017, or Official Method T-203B, Determination of Benzo[a]pyrene in Sidestream Tobacco Smoke by GC/MS, prepared by the Department of Health, dated December 31, 2017 Official Method T-209A, Determination of Tobacco Specific Nitrosamines in Sidestream Tobacco Smoke by GC-TEA, prepared by the Department of Health, dated December 31, 2017, or Official Method T-209B, Determination of Tobacco Specific Nitrosamines in Sidestream Tobacco Smoke by LC-MS/MS, prepared by the Department of Health, dated December 31, 2017 The following definitions apply in this section and sections 42 to 44. former Regulations means the Tobacco Reporting Regulations, as they read immediately before the day on which these Regulations come into force. (règlement antérieur) reporting period means a quarter, month or semi-annual or annual period that is referred to in subsection 11(4), 13(4), 15(1), 15(3) or 16(1) of the former Regulations and in respect of which a report is required to be submitted to the Minister under those Regulations. (période de déclaration) Sections 12, 14 and 14.2 Despite sections 6, 10 and 11 of these Regulations, a manufacturer may report to the Minister, in accordance with the former Regulations, any data obtained in accordance with section 12, 14 or 14.2 of the former Regulations from the analysis of tobacco products performed during the period beginning on January 1, 2019 and ending on December 31, 2019. Sections 11, 13 and 15 Despite these Regulations, every manufacturer must report to the Minister, in accordance with the former Regulations, the information required under sections 11, 13 and 15 of the former Regulations in respect of the reporting period during which these Regulations come into force. For greater certainty, any analyses performed under subparagraph 11(3)(b)(ix) of the former Regulations for the purpose of reporting in respect of a filter may be performed after the day on which these Regulations come into force. Sections 16 to 24 — if these Regulations come into force during the first half of 2019 Despite these Regulations, every manufacturer must report to the Minister, in accordance with the former Regulations, the information required under sections 16 to 24 of the former Regulations in respect of any reporting period that occurs during the portion of 2019 beginning on January 1 and ending on June 30 if these Regulations come into force during that portion of the year. Sections 16 to 24 — if these Regulations come into force during the second half of 2019 Despite these Regulations, every manufacturer must report to the Minister, in accordance with the former Regulations, the information required under sections 16 to 24 of the former Regulations in respect of any reporting period that occurs during the portion of 2019 beginning on July 1 and ending December 31 if these Regulations come into force during that portion of the year. Paragraph 10(3)(b) Despite section 4 of these Regulations, during the period beginning on the day on which these Regulations come into force and ending on December 31, 2019, a manufacturer may determine filter efficiency with respect to nicotine as required under paragraph 10(3)(b) of the Tobacco Reporting Regulations by using Official Method T-106, entitled Determination of Filter Efficiency in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 1999.