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Tobacco Reporting Regulations (SOR/2000-273)

Regulations are current to 2022-06-20 and last amended on 2019-03-04. Previous Versions

Reports (continued)

Report on Emissions from Designated Tobacco Products

[
  • SOR/2019-64, s. 9
]

Marginal note:Report

  •  (1) 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.

  • Marginal note:Content of report

    (2) 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

    • (a) of the number of puffs;

    • (b) of each emission, expressed in milligrams, micrograms or nanograms per unit; and

    • (c) of the weight of tobacco contained in the designated tobacco product, expressed in milligrams per unit.

  • Marginal note:Sampling

    (3) 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:

    • (a) in the case of cigarettes, the procedures described in paragraph 12(3)(a); and

    • (b) in the case of kreteks, the procedures described in paragraph 12(3)(b).

  • Marginal note:Preparation

    (3.1) 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.

  • Marginal note:Replicates

    (4) The mean, standard deviation and 95% confidence limits of the amount of each emission must be based

    • (a) in the case of tar, nicotine and carbon monoxide, on 20 replicates of a sample; and

    • (b) in every other case, on 7 replicates of a sample.

  • Marginal note:Method of collecting data

    (5) The following official methods must be used to collect data on the emissions contained in smoke produced from a designated tobacco product:

    • (a) in the case of mainstream smoke, the applicable official method set out in column 2 of Schedule 2; and

    • (b) in the case of sidestream smoke, the applicable official method set out in column 2 of Schedule 3.

  • Marginal note:Conditions for the collection of data

    (6) For the purpose of subsection (2), the following conditions are to be used to determine the amount of an emission:

    • (a) 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

    • (b) 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:

      • (i) puff volume must be increased from 35 mL to 55 mL,

      • (ii) puff frequency must be increased from one puff every 60 s (± 0.5 s) to one puff every 30 s (± 0.5 s), and

      • (iii) 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.

  • Marginal note:pH levels

    (7) 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.

  • Marginal note:Short report

    (8) 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

    • (a) 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

    • (b) 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.

  • Marginal note:Short report — content

    (9) 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).

  • (10) [Repealed, SOR/2019-64, s. 10]

  • Marginal note:Exemption — functional relationship of certain emissions

    (11) 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

    • (a) between tar and each of the other emissions, other than nicotine, produced from the combustion of the cigarettes

      • (i) by using the formula

        y = mx + b

        where

        • y is the amount of the other emission,

        • m is the slope,

        • x is the mean amount of tar as determined by 7 replicates, and

        • b is the intercept,

      • (ii) by applying a regression analysis to the results obtained under subparagraph (i), and

      • (iii) by applying an F-test to the results obtained under that subparagraph; and

    • (b) 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”.

  • (12) [Repealed, SOR/2019-64, s. 10]

  • Marginal note:Sample size

    (13) To qualify for an exemption under subsection (11), the manufacturer must submit to the Minister

    • (a) 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

      • (i) 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

      • (ii) 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;

    • (b) a list of the brands of cigarette for which the application for exemption is made; and

    • (c) 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

      • (i) the brands of cigarette that form the cohort, and

      • (ii) each of the brands of cigarette for which the application for exemption is made.

  • Marginal note:Joint cohort

    (14) For the purposes of subsection (13), two or more manufacturers may submit a joint cohort of their cigarette brands.

  • Marginal note:Minister’s decision

    (15) The Minister must, without delay, decide to accept or reject

    • (a) an application made under subsection (11), based on the

      • (i) methodology used, and

      • (ii) the demonstration of a satisfactory functional linear relationship based on

        • (A) the mean and standard deviations of the amount of the emissions, other than tar and nicotine, contained in the mainstream smoke,

        • (B) the estimates and 95% confidence limits for the slope m and the intercept b referred to in subparagraph (11)(a)(i),

        • (C) 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

        • (D) the fact that the data must fall under a 95% prediction interval; and

    • (b) a cohort submitted in accordance with subsection (13) or (14), based on the methodology used and the representativeness of the cohort.

  • Marginal note:Satisfactory functional relationship

    (16) 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.

  • Marginal note:Content of report

    (17) 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).

  • Marginal note:Time limit

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

  • Marginal note:Exception — identical products

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

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

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

  • Marginal note:Definition of identical products

    (20) 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

    • (a) contain identical ingredients, except those used in the manufacture of colouring agents in the cigarette papers;

    • (b) have identical dimensions; and

    • (c) perform in an identical manner under the same conditions.

Report on Toxicity of Cigarette Emissions

Marginal note:Definitions

 The following definitions apply in this section and section 14.2.

cigarette

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

identical cigarettes means cigarettes that are sold by a manufacturer under more than one brand, that are manufactured using identical manufacturing processes and that

  • (a) contain identical ingredients, except those used in the manufacture of colouring agents in the cigarette papers;

  • (b) have identical dimensions; and

  • (c) perform in an identical manner under the same conditions. (cigarette identiques)

Marginal note:Annual testing

  •  (1) 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.

  • Marginal note:Presentation of results

    (2) 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.

  • Marginal note:Method of collecting data

    (3) The following official methods must be used to collect toxicity data:

    • (a) Official Method T-501, entitled Bacterial Reverse Mutation Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017;

    • (b) Official Method T-502, entitled Neutral Red Uptake Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017; and

    • (c) Official Method T-503, entitled In Vitro Micronucleus Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017.

  • Marginal note:Number of replicates of sample

    (4) The results of the tests performed in accordance with paragraph (3)(a) or (b) must be based on three replicates of a sample.

  • Marginal note:Sampling

    (5) 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).

  • Marginal note:Conditioning

    (6) 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).

  • Marginal note:Exception — identical cigarettes

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

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

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

  • Marginal note:Time limit

    (8) The manufacturer must submit the report on or before January 31 of the year after the year covered by the report.

Report on Research and Development Activities

Marginal note:Report

  •  (1) 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

    • (a) its toxicity;

    • (b) its health effects;

    • (c) its ingredients;

    • (d) its taste and flavour;

    • (e) its modification;

    • (f) its marketing, if applicable; and

    • (g) the manner in which it is used by consumers, if applicable.

  • Marginal note:Content of report

    (2) The report must include

    • (a) 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;

    • (b) the date on which the activity began; and

    • (c) the date of completion of the activity or the expected duration of the activity.

  • Marginal note:Report — declaration

    (3) 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.

  • Marginal note:Time limit

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

 
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