Tobacco Reporting Regulations (SOR/2000-273)

Marginal note:Electronic format

• 7 (1) The reports and other information are to be submitted in a legible electronic format.

• Marginal note:Reports under sections 12, 14 and 14.2

  (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

  • (a) have access to the information or data; and

  • (b) process the information or data electronically without having to recopy or re-enter them.

8 [Repealed, SOR/2019-64, s. 3]

Reports

Manufacturer Profile Report

Marginal note:Content of report

• 9 (1) The profile report on a manufacturer of tobacco products must set out

  • (a) a list of every type of tobacco product that the manufacturer sells;

  • (b) 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

  • (c) the name and civic address of each warehouse in Canada that the manufacturer uses to store tobacco products for distribution and sale.

• Marginal note:Digital images

  (2) The report must include, for each brand of consumer tobacco product that the manufacturer sells, a digital image of the following items:

  • (a) each type of package, showing all of the sides that are visible when the package is closed;

  • (b) any promotion that is on an interior side of the package or that accompanies the package;

  • (c) any overwrap on which a promotion is displayed, that is used over a package or carton or that is used as a carton; and

  • (d) any brand element displayed on a unit of the consumer tobacco product.

• Marginal note:Digital image characteristics

  (3) The digital image of an item must be taken on a white background and

  • (a) be clear and display colours that are as close as possible to the colours of the item;

  • (b) display any text that appears on the item, in legible characters;

  • (c) include the brand name associated with the item; and

  • (d) include a graphical scale in millimetres.

• Marginal note:Time limit — new manufacturer

  (4) The report must be submitted on or before the day on which a manufacturer begins to sell tobacco products.

• Marginal note:Time limit — existing brands

  (5) 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.

• Marginal note:Time limit — changes to information

  (6) 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.

• Marginal note:Time limit — changes to items

  (7) 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

  • (a) the digital image previously submitted, as well as a description of the change made to the item; and

  • (b) a digital image of the changed item.

• Marginal note:Time limit — new brand

  (8) 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).

Report on Manufacturing

Marginal note:Manufacturing processes

• 10 (1) 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) 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

  • (b) a detailed description of the conditions and parameters relating to each of those steps.

• Marginal note:Processing aids

  (2) The report must set out the common, chemical and brand name of each processing aid and, if applicable, its CAS registry number.

• Marginal note:Product specifications

  (3) The report must include, for each brand of cigarettes, kreteks and little cigars that the manufacturer sells,

  • (a) the type of cigarette paper used in the product, and its specifications;

  • (b) 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

  • (c) an engineering drawing of the product.

• Marginal note:Time limit — existing brands

  (4) 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.

• Marginal note:Time limit — new brand

  (5) 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.

• Marginal note:Exception — sales volume of cigars

  (6) 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.

• Marginal note:Exception — identical manufacturing processes

  (7) A manufacturer is not required to submit a report in respect of a particular brand of consumer tobacco product if the manufacturer

  • (a) uses identical manufacturing processes to manufacture a consumer tobacco product that is sold under more than one brand;

  • (b) submits a report under this section in respect of one of those brands; and

  • (c) identifies in the report all other brands that are manufactured using those identical manufacturing processes, including the particular brand.

• Marginal note:Time limit — changes

  (8) 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.

• Marginal note:Time limit — efficiency with respect to nicotine

  (9) 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.

Report on Ingredients

Marginal note:Content of report

• 11 (1) 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:

  • (a) its common, chemical and brand names;

  • (b) 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;

  • (c) if applicable, its CAS registry number;

  • (d) its amount in milligrams

    • (i) 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

    • (ii) per gram of the product, in the case of an ingredient used in the manufacture of cigarette tobacco, pipe tobacco or smokeless tobacco; and

  • (e) the name and civic address of its supplier.

• Marginal note:More than one substance in an ingredient

  (2) 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.

• Marginal note:Weight of unit

  (3) 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.

• Marginal note:Initial report

  (4) 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.

• Marginal note:Inventory

  (5) In addition to the information referred to in subsections (1) to (3), the report must also set out

  • (a) 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;

  • (b) 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

  • (c) 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.

• Marginal note:Time limit

  (6) The report must be submitted on or before January 31 of the year after the period covered by the report.

• Marginal note:Time limit — new brand

  (7) 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 on Tobacco Constituents

Marginal note:Report

• 12 (1) 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.

• Marginal note:Method of collecting data

  (2) The applicable official method listed in column 2 of Schedule 1 must be used to collect data on a constituent.

• Marginal note:Sampling

  (3) 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:

  • (a) 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;

  • (b) in the case of bidis, cigars, kreteks or little cigars, the procedures referred to in paragraph (a), modified in the following manner:

    • (i) in the case of bidis, kreteks, and little cigars,

      • (A) a reference to a “cigarette” is to be read as a reference to the type of consumer tobacco product being sampled, and

      • (B) 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

    • (ii) in the case of cigars,

      • (A) a reference to a “cigarette” is to be read as a reference to cigar,

      • (B) a reference to a “sale unit” is to be read as a reference to one cigar, and

      • (C) a reference to a “carton” is to be read as a reference to 200 grams of the cigars being sampled;

  • (c) 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

  • (d) 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.

• Marginal note:Preparation

  (4) 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.

• Marginal note:Replicates

  (5) The mean, standard deviation and 95% confidence limits of the amount of each constituent must be based on three replicates of a sample.

• Marginal note:Adjustment for moisture

  (6) 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.

• Marginal note:Content of report

  (7) The report must set out the following information:

  • (a) in the case of bidis, cigarettes, cigars, kreteks and little cigars, the weight of tobacco in milligrams per unit;

  • (b) the name of each constituent in the consumer tobacco product;

  • (c) the mean, standard deviation and 95% confidence limits of the amount of each constituent in milligrams, micrograms or nanograms

    • (i) per gram of the consumer tobacco product, and

    • (ii) in the case of bidis, cigarettes, cigars, kreteks and little cigars, per unit;

  • (d) 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

  • (e) the percentage of moisture in the consumer tobacco product, determined in accordance with the method referred to in subsection (6).

• Marginal note:Exception — short report

  (8) 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

  • (a) 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

  • (b) 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.

• Marginal note:Exception — sales volume

  (9) 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

  • (a) in the case of cigars and little cigars, 1 000 000 units per brand; and

  • (b) in the case of pipe tobacco, 8000 kg per brand.

• Marginal note:Exception — eugenol

  (10) 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.

• Marginal note:Exception — identical products

  (11) A manufacturer is not required to submit a report in respect of a particular brand of consumer tobacco product if the manufacturer

  • (a) submits a report under this section in respect of another brand of consumer tobacco product; and

  • (b) identifies in the report all other brands of identical products, including the particular brand.

• Marginal note:Definition of identical products

  (12) 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

  • (a) in the case of bidis, cigarettes and kreteks, identical ingredients per gram of tobacco blend;

  • (b) in the case of pipe tobacco, cigarette tobacco and smokeless tobacco, identical ingredients; and

  • (c) in the case of cigars and little cigars, identical ingredients in the filler and wrapper, and in the binder, if any.

• Marginal note:Time limit

  (13) The report must be submitted on or before January 31 of the year after the year covered by the report.