Source: http://gazetteducanada.gc.ca/rp-pr/p2/2019/2019-03-20/html/sor-dors64-eng.html
Timestamp: 2020-08-13 14:24:50
Document Index: 249295724

Matched Legal Cases: ['art 2', 'art 6', 'art 2', 'arts 2', 'art 2', 'art 2', 'art 2', 'art 1', 'art 2', 'art 2']

Canada Gazette, Part 2, Volume 153, Number 6: Regulations Amending the Tobacco Reporting Regulations
Regulations Amending the Tobacco Reporting Regulations: SOR/2019-64
SOR/2019-64 March 4, 2019
P.C. 2019-135 February 28, 2019
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to sections 7 footnote a and 33 footnote b of the Tobacco and Vaping Products Act footnote c, makes the annexed Regulations Amending the Tobacco Reporting Regulations.
1 (1) The definitions equivalent unit, identical products, ingredient, kit and unit in section 1 of the Tobacco Reporting Regulations footnote 1 are repealed.
(m) shoulder box. (type d’emballage)
type of tobacco includes the types of tobacco leaves commonly known as
civic address means
(b) 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)
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)
2 Sections 1.1 to 7 of the Regulations are replaced by the following:
3 Section 8 of the Regulations is repealed.
4 The heading before section 9 and sections 9 to 11 of the Regulations are replaced by the following:
(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
Time limit — efficiency with respect to nicotine
5 The heading before section 12 of the Regulations is replaced by the following:
6 (1) Subsections 12(1) to (6) of the Regulations are replaced by the following:
(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.
(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
Definition of identical products
7 The heading before section 13 of the Regulations is replaced by the following:
8 (1) The portion of subsection 13(1) of the Regulations before paragraph (a) is replaced by the following:
9 The headings before section 14 of the Regulations are replaced by the following:
(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.
(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;
11 The headings before section 14.1 and sections 14.1 to 15 of the Regulations are replaced by the following:
(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.
12 The headings before section 16 and section 16 of the Regulations are replaced by the following:
Reports — declaration
13 The heading before section 17 of the Regulations is replaced by the following:
14 (1) The portion of subsection 17(1) of the Regulations before paragraph (a) is replaced by the following:
15 The heading before section 18 and sections 18 to 20 of the Regulations are replaced by the following:
16 Section 21 of the Regulations and the heading before it are repealed.
17 The heading before section 22 and sections 22 to 24 of the Regulations are replaced by the following:
18 Part 6 of the Regulations is repealed.
19 Schedule 1 to the Regulations is amended by replacing the reference after the heading “SCHEDULE 1” with the following:
20 The portion of items 1 to 6 of Schedule 1 to the Regulations in column 2 is replaced by the following:
Official Method T-301, Determination of Nicotine-Related Alkaloids in Whole Tobacco by GC-TSD, prepared by the Department of Health, dated December 31, 2017
Official Method T-302, Determination of Ammonia in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
Official Method T-304, Determination of Humectants in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
Official Method T-306, Determination of Toxic Trace Metals (Ni, Pb, Cd, Cr, As, Se, Hg) in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
Official Method T-307, Determination of Benzo[a]pyrene in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
Official Method T-308, Determination of Nitrate in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
21 Item 7 of Schedule 1 to the Regulations is replaced by the following:
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
22 The portion of items 8 to 10 of Schedule 1 to the Regulations in column 2 is replaced by the following:
Official Method T-311, Determination of Triacetin in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
Official Method T-312, Determination of Sodium Propionate in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
Official Method T-313, Determination of Sorbic Acid in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
23 Item 11 of Schedule 1 to the Regulations is replaced by the following:
Official Method T-314, Determination of Eugenol in Whole Tobacco, prepared by the Department of Health, dated December 31, 2017
24 Schedule 2 to the Regulations is amended by replacing the reference after the heading “SCHEDULE 2” with the following:
25 The portion of item 1 of Schedule 2 to the Regulations in column 2 is replaced by the following:
Official Method T-101, Determination of Ammonia in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
26 Item 2 of Schedule 2 to the Regulations is replaced by the following:
Official Method T-102, Determination of Aromatic Amines in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
27 The portion of items 3 and 4 of Schedule 2 to the Regulations in column 2 is replaced by the following:
Official Method T-103, Determination of Benzo[a]pyrene in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-104, Determination of Selected Carbonyls in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
28 Item 5 of Schedule 2 to the Regulations is replaced by the following:
Official Method T-105, Determination of Eugenol in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
29 The portion of items 6 to 9 of Schedule 2 to the Regulations in column 2 is replaced by the following:
Official Method T-107, Determination of Hydrogen Cyanide in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-108, Determination of Mercury in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-109, Determination of Toxic Trace Metals (Ni, Pb, Cd, Cr, As, Se) in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-110, Determination of Oxides of Nitrogen in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
30 Item 10 of Schedule 2 to the Regulations is replaced by the following:
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
31 The portion of items 11 to 13 of Schedule 2 to the Regulations in column 2 is replaced by the following:
Official Method T-112, Determination of Pyridine, Quinoline and Styrene in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-114, Determination of Phenols in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-115, Determination of Tar, Water, Nicotine and Carbon Monoxide in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
32 (1) The portion of item 14 of Schedule 2 to the English version of the Regulations in column 1 is replaced by the following:
Official Method T-116, Determination of Selected Volatiles in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
33 Schedule 3 to the Regulations is amended by replacing the reference after the heading “SCHEDULE 3” with the following:
34 The portion of item 1 of Schedule 3 to the Regulations in column 2 is replaced by the following:
Official Method T-201, Determination of Ammonia in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
35 Item 2 of Schedule 3 to the Regulations is replaced by the following:
Official Method T-202, Determination of Aromatic Amines in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
36 The portion of items 3 to 8 of Schedule 3 to the Regulations in column 2 is replaced by the following:
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-204, Determination of Selected Carbonyls in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-205, Determination of Hydrogen Cyanide in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-206, Determination of Mercury in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-207, Determination of Toxic Trace Metals (Ni, Pb, Cd, Cr, As, Se) in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-208, Determination of Oxides of Nitrogen in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
37 Item 9 of Schedule 3 to the Regulations is replaced by the following:
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
38 The portion of items 10 to 12 of Schedule 3 to the Regulations in column 2 is replaced by the following:
Official Method T-210, Determination of Pyridine and Quinoline in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-211, Determination of Phenols in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
Official Method T-212, Determination of Tar and Nicotine in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
39 (1) The portion of item 13 of Schedule 3 to the English version of the Regulations in column 1 is replaced by the following:
Official Method T-213, Determination of Selected Volatiles in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
40 Item 14 of Schedule 3 to the Regulations in column 2 is replaced by the following:
Official Method T-214, Determination of Carbon Monoxide in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2017
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)
45 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.
46 Subsection 8(1) of the Tobacco Products Information Regulations footnote 2 is replaced by the following:
8 (1) Section 5 and subsections 12(3) to (6) of the Tobacco Reporting Regulations apply to the testing of a tobacco product for the purpose of obtaining information that is to be displayed in accordance with section 10 of these Regulations.
47 The portion of items 1 to 3 of Schedule 2 to the Regulations in column 2 is replaced by the following:
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
48 Despite section 47 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 the mean amount of toxic constituents as required under paragraph 10(a) of the Tobacco Products Information Regulations by using the version of the applicable official method set out in column 2 of Schedule 2 to the Tobacco Products Information Regulations as they read immediately before the day on which these Regulations come into force.
49 These Regulations come into force on the day on which they are registered.
In 2000, the Standing Joint Committee for the Scrutiny of Regulations (SJCSR or the Committee) reviewed the Tobacco Reporting Regulations (TRR or the Regulations) and made several recommendations regarding definitions and requirements that needed clarification, inconsistencies identified between the English and French versions and, most importantly, the requirements of sections 5 to 8 of the Regulations, which, in its opinion, were inconsistent with the regulatory powers granted in the Tobacco Act (the Act). footnote 3
In line with the life-cycle approach of regulation making, as recommended in the Cabinet Directive on Regulation, Health Canada (the Department) conducted a thorough review of the TRR in order to ensure that the Regulations continue to be appropriate and effective. As a result, several redundancies and discrepancies were noted. Additional changes to the Regulations were also identified to align the requirements with the 2009 amendments to the Act.
The Regulations Amending the Tobacco Reporting Regulations (RATRR) are put forth in order for the Regulations to continue to support the Department’s tobacco control efforts.
The Regulations set out the requirements for the reporting of information on the sales, manufacturing processes, ingredients, constituents, emissions, research and development activities as well as promotional activities undertaken by tobacco manufacturers (including importers). The Regulations support the Government of Canada’s approach to tobacco control and the goals of Canada’s Tobacco Strategy (CTS) by providing the Department with timely and relevant information about the tobacco market. CTS was introduced in May 2018 and replaced the Federal Tobacco Control Strategy.
CTS focusses on
helping Canadians quit tobacco;
protecting young people and non-users of tobacco products; and
strengthening the foundation in science and partnerships.
CTS’s ultimate goal is to reach less than 5% tobacco use by 2035, thereby reducing tobacco-related death and disease among Canadians.
The Act was modified in October 2009 and again, more recently, as part of Bill S-5, footnote 4 which received royal assent on May 23, 2018. In the last amendment to the Act, the statute title changed to the Tobacco and Vaping Products Act. The Act sets out the powers under which the TRR and other tobacco regulations are made.
The TRR is being amended to
1.	address the recommendations of the SJCSR; and
2.	update and clarify the requirements in order to make them more relevant to the current environment and to eliminate redundant requirements; update the official testing methods for the sampling and testing of tobacco products to reflect technological advances; require electronic submissions of reports; improve the clarity of the requirements; and align the requirements with the 2009 amendments to the Act.
The Department expects that the amendments will enhance the quality and completeness of the information submitted by the tobacco industry. This will facilitate the review of that information and increase the efficiency of the Department in using the information for the purpose of achieving the objectives of CTS. The changes are therefore expected to contribute to informed decisions on tobacco control policies and activities in the future.
Following the coming into force of the TRR in June 2000, the SJCSR made several recommendations to the Department after its review of the Regulations. The Committee noted that, in its opinion, some sections of the TRR were inconsistent with the power granted by the Act prior to the 2009 amendments and that requirements relating to the reporting of tobacco product ingredients were not clear. The Department addresses these recommendations as follows:
(a)	Section 5 — Alternative Method
This section is repealed. Section 5 of the TRR permitted manufacturers to use alternate methods to those prescribed by the Regulations to test tobacco products if the alternate methods resulted in the generation of information that was at least as accurate and precise as the prescribed method. Upon review of the TRR, the SJCSR indicated that the test methods used for the purposes of the TRR must all be prescribed, as per paragraph 7(b) of the Act. Consequently, the Committee recommended that this section be repealed.
To address this issue, additional Health Canada official methods for the testing of certain emissions and constituents are added to schedules 1, 2 and 3 of the Regulations. These new methods, which are available to manufacturers, provide additional options to those already prescribed for the testing of emissions and constituents (please refer to part 2(k) for further details).
Section 6 dealing with urgent requests is repealed. Section 6 of the TRR allowed the Minister of Health (the Minister), in cases where information required by Parts 2 to 5 of the TRR was needed urgently, to request the information before its prescribed due date. The SJCSR noted that the effect of this provision was that the time limit provided was not prescribed by the Regulations, as required by section 6 of the Act prior to 2009. Consequently, the SJCSR recommended that section 6 of the TRR be repealed.
Section 7 dealing with requests for additional information is repealed. Section 7 allowed the Minister to request additional information on reports that have already been submitted pursuant to the TRR. The SJCSR noted that the discretionary power of the Minister to determine what information is to be submitted was inconsistent with the power of the Act prior to the 2009 amendments.
Section 8, which deals with the time to submit information under sections 6 and 7 is also repealed.
To address the concerns of the Department with regard to its ability to request additional information, power was added to the Act in 2009, namely subsection 6(2) and paragraph 7(c.2), which allow the Minister to request supplementary information related to information submitted pursuant to the TRR. The proposed Regulations that were prepublished on May 27, 2017, included a new section 8 that would have required manufacturers to provide any supplementary information that is requested by the Minister within 30 days of receipt of the request. However, in May 2018, Bill S-5 changed the Minister’s enabling authority concerning the supplementary information (subsection 6(2)) so that manufacturers are now required to submit the supplementary information in the form and manner and within the time specified by the Minister. Therefore, section 8 that was proposed in the draft Regulations prepublished on May 27, 2017, is withdrawn.
The requirement with respect to a component of an ingredient, in paragraph 11(3)(c), is removed. The SJCSR commented that the requirements with respect to a “component of an ingredient” in section 11 were unclear due to lack of a definition that would explain the difference between an ingredient and a component.
A definition of “ingredient” was introduced in the 2009 amendments to the Act that incorporated the concept of components identified by the Committee. Hence, the Department no longer needs to refer to components in the Regulations and will continue to receive information on ingredients, including on components of consumer tobacco products (please refer to part 2(e) for further details).
Subsection 15(3), which dealt with research activities on new consumer tobacco products, is repealed. Subsection 15(3) required manufacturers to report annually their research activities for consumer tobacco products that were under development. The SJCSR was of the opinion that paragraph 7(c) of the Act prior to the 2009 amendments did not grant the power to request information on tobacco products in the development stage. The Committee therefore recommended that the requirements under subsection 15(3) be repealed.
Subsection 6(1) of the Act was amended in 2009 such that it provides the power to require manufacturers to provide information on research and development, whether the tobacco products are for sale or not. Amendments in section 15 of the TRR reflect the power in the Act that was added as a result of the 2009 amendments (please refer to part 2(i) for further details).
2.	Update and clarify the requirements
The amendments to the TRR allow the Department to update the reporting requirements and to respond to a number of issues encountered since their enactment in 2000. Firstly, the tobacco product market in Canada has evolved significantly over the years and these changes need to be reflected in the TRR. Secondly, the Department has identified several gaps in the information provided by tobacco manufacturers, possibly as a result of a lack of clarity in some of the provisions of the TRR. As well, it was observed that the reporting frequencies of certain reports could be streamlined to eliminate redundancies. Furthermore, the 2009 amendments to the Act brought about several changes, such as new definitions for “little cigar” and “ingredients” that are reflected in the TRR for consistency purposes.
As a result of the updates to the requirements of the TRR, the following changes are made to the definitions.
“CAS registry number” — This definition is added for the purpose of ingredient reporting. A 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.
“Civic address” — This definition is added to clarify the elements of the address that are required to be provided when an address is inside or outside Canada.
“New brand” — This definition is added to specify that a new brand of consumer tobacco product, for the purpose of reporting, is a brand that did not appear in any sales report made under section 13 of the TRR in the preceding year. In the case of filters, tubes and cigarette papers sold, a new brand is a brand that did not appear in an ingredient report made under section 11 of the TRR in the preceding year.
“Year” — This definition is added to specify that, for the purpose of reporting, a year commences on January 1.
“Cigar,” “cigarette” and “consumer tobacco product” — These definitions are updated to reflect the addition of the definition of “little cigar” that was introduced in the 2009 amendments to the Act.
“Consumer tobacco product” — This definition is modified to exclude leaf tobacco, tobacco sticks and kits as these tobacco products have a very low dollar value of sales or they are no longer sold on the Canadian market.
“Designated tobacco product” — This definition is updated to exclude leaf tobacco, cigarette tobacco and tobacco sticks. Emissions testing and reporting are no longer required for these products (please refer to part 2(o) for further explanation).
“Manufacturer” — This definition is modified to exclude an individual or entity that only packages, labels or distributes tobacco products on behalf of a manufacturer.
“Smokeless tobacco” — This definition is modified to mean chewing tobacco, nasal snuff and oral snuff.
“Type of package” — This definition is updated to reflect newer types of packages that have been introduced into the Canadian market since 2000.
Repealed definitions
“Ingredient” — This definition is repealed in the TRR as it is no longer needed as a result of the 2009 amendments to the Act, which added the definition of “ingredient” in the legislation.
“Unit,” “equivalent unit,” “identical products” and “kit” —These definitions are repealed as they are no longer needed due to changes in requirements.
(b)	Sections 2 to 7 — General Requirements
Sections 1.1 to 8 of the TRR are reorganized into new sections 2 to 7 as described below.
Section 2 is modified to describe the application of the TRR, while sections 3 to 7 lay out the general requirements relating to the manner in which the reports required under sections 9 to 24 of the TRR are to be prepared and submitted to the Department.
To respond to inconsistencies in the information submitted by manufacturers in different reports, manufacturers are required, in section 3, to ensure they use unique brand names in a uniform manner in all the reports submitted to the Department. Any changes to brand names have to be reported pursuant to section 13, specifying the previous brand name and the changed brand name.
To facilitate data processing, section 7 requires that all reports under the TRR be submitted electronically. This is in line with the industry’s current reporting practices. The electronic format that was previously prescribed only for the data collected under subsection 14.2(6), now subsection 14.2(3), is now extended to apply to reports required under subsections 12(7), 14(2) and 14(7).
To clarify the laboratory testing reporting requirements, section 4 specifies that tobacco products must be sampled and tested during the period covered by the report.
Following the recommendation of the Standards Council of Canada (SCC), a reference to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC-MRA) is added in section 5. Laboratories that are accredited by bodies that are signatories to the ILAC-MRA, such as the SCC for Canadian laboratories, are considered to have comparable levels of proficiency. In order to ensure that laboratories used by manufacturers for the purpose of testing tobacco products are accredited for the testing methods prescribed in the TRR, any document issued by the accreditation bodies have to specify the methods set out in the TRR for which the laboratory is accredited.
To verify the accuracy of the submitted information, section 6 of the TRR is amended to require that a copy of the laboratory report that was used to prepare a report pursuant to sections 12, 14 and 14.2 of the TRR be submitted to the Department. Manufacturers also have to provide a copy of the document that demonstrates that the laboratory used was accredited to perform the prescribed tests at the time the tests were carried out.
The following changes are made to section 9. The title is replaced by “Manufacturer Profile Report” to better reflect the type of information referred to in this section.
The requirement to provide samples or reasonable facsimiles is removed, in line with the modernization of the reporting requirements. Manufacturers of “consumer tobacco products,” as defined in the TRR, have to provide digital images of their packages and overwraps, of the brand elements found on the tobacco product itself, and of any promotional items (such as information leaflets) found inside the package or that accompanies the package.
Furthermore, the manufacturers are required to provide the types of tobacco products that they sell. In addition, manufacturers of tobacco products, other than products that are defined as “consumer tobacco products” in the TRR, have to provide a list of all the brand names by type of tobacco product that they sell. This information, combined with the information required pursuant to section 13, will allow the Department to identify all tobacco products and their brand names that are sold by manufacturers.
To assist the Department in conducting its inspections, in accordance with subsection 35(1) of the Act, manufacturers of tobacco products have to provide the names and addresses of the warehouses in Canada where their tobacco products are stored for distribution and sale.
The Department is therefore clarifying the requirements by specifying that manufacturers must provide, for each brand of consumer tobacco product that they sell as well as for any filter, mouth tip and cigarette paper used in the manufacture of the consumer tobacco product, a detailed description and schematic of the sequential steps involved in the manufacture of the product as well as the conditions and parameters relating to each of those steps. Manufacturers also have to indicate any steps where additives such as processing aids are used. In addition, a manufacturer of cigarettes, kreteks and little cigars is required to provide engineering drawings of their product.
For cigars, reporting on manufacturing processes is required for cigar brands whose sales exceeded one million units in the preceding year. Cigars with low sales volumes are often traditional hand-rolled cigars, and their manufacturing process is fairly basic. Therefore, the manufacturers of most of these products benefit from an exception from reporting on their manufacturing processes.
In response to comments from tobacco manufacturers, and as a result of the Department’s own observations, the reporting frequency for this section is changed from quarterly to once a year, and a new provision is added requiring that the ingredients report for new brands be provided on or before the day that they are sold for the first time. The amendments remove the redundancies associated with the review of the extra three reports per year while allowing a more timely access to reports on new brands that are introduced during the year.
Furthermore, the information on the inventory of tobacco product ingredients is now only required for cigarette manufacturers (including importers). Most of the other consumer tobacco products (less than 5% of the total tobacco products market by sales volume) are imported; hence, the majority of the importers of these products cannot provide the required report on inventory (the amount and cost of raw materials purchased, used or stored), as these products are manufactured by foreign suppliers.
The required information about the ingredients of consumer tobacco products has been clarified in the amendments to indicate that the manufacturer must clearly identify each substance used in the manufacture of a tobacco product and its components including any substance used in the manufacture of each substance.
The requirements relating to components, i.e. subparagraphs 11(3)(c)(i) to (vi), are repealed as they become redundant as a result of the addition of the definition of “ingredient” in the Act in 2009, which includes any substance used in the manufacture of a tobacco product or their components as well as any substance used in the manufacture of that substance.
The required information on filters, namely their specifications (including the pressure drop and filter efficiency of a cigarette), which were required under section 11, is moved to a new subsection under section 10 addressing product specifications. These characteristics are more closely linked to manufacturing processes, wherein tobacco products are manufactured according to product specifications.
Manufacturers now have to report the percentage of moisture in the consumer tobacco product, determined in accordance with AOAC International Official Method 966.02, entitled Loss on Drying (Moisture) in Tobacco, which they use to correct for moisture in the amounts of constituents they report. Before the present amendments to the TRR, the moisture content of consumer tobacco products was determined by the laboratory that was conducting the testing on behalf of the manufacturer, but was not provided. The moisture content had to be inferred from the constituents’ data by conducting further calculations.
The definition of “identical products” is modified to clarify which consumer tobacco products qualify for exceptions to the requirements in section 12.
(g)	Section 13 — Report on Sales of Consumer Tobacco Products and Leaf Tobacco
The required information on the sales of cigarette tobacco is harmonized with that of the other consumer tobacco products by requiring the dollar value of sales. This modification corrects a gap in the required information on the sales of consumer tobacco products.
The tar, nicotine and carbon monoxide emissions and pH levels for cigarettes and kreteks will now be reported once a year (measured under both smoking conditions) instead of being reported in two parts (one smoking condition reported on at a six-month interval). The two reports are consolidated into one, resulting in more timely access to a more comprehensive data set.
Before the present amendments to the TRR, manufacturers were required to submit the results of a statistical analysis that demonstrated the existence of a functional linear relationship for both mainstream smoke (released through the mouth end of a designated tobacco product) and sidestream smoke (released from the lit end of a designated tobacco product) in order to qualify for the exemption pursuant to subsection 14(11) of the TRR. The statistical analysis of the sidestream smoke emissions is no longer required. Over the past decade, only the results of the statistical analysis of mainstream smoke have been considered by the Department in order to determine whether the exemption could be granted.
The exception that allows small manufacturers of cigarettes and kreteks, whose sales are under 1% and 5% of the total market for these types of products respectively, to report every two years, is clarified. For the exception, the manufacturer’s sales of cigarettes or kreteks have to be below the prescribed sales limit for both years covering the two-year period. If the sales limit is exceeded in any one of the two years in the reporting period, the exception no longer applies.
The exception from emission testing for identical cigarettes and kreteks is clarified to require that they have identical ingredients (excluding ingredients that are colouring agents used in cigarette papers), have identical dimensions and perform in an identical manner under the same conditions as another designated tobacco product already being tested.
The requirements are amended to additionally require that a manufacturer submit a report on research and development activities in respect of a consumer tobacco product, whether the tobacco product is for sale or not. This regulatory power to require information on tobacco products that are not for sale was included in the 2009 amendments (paragraph 7(c.1)) to the Act. Also, a full copy of all reports relating to research and development activities, regardless of the format used by the manufacturer (e.g. slides, email, meeting notes), is required. This requirement is also applicable to the full copy of progress reports, synopses or outlines made in respect of research and development activities that are not complete.
If no research and development activities have been conducted during the reporting period, the manufacturer is required to notify the Department by providing a statement to that effect. The reports on research and development activities are expected to provide valuable insight into tobacco products that are available on the Canadian market and new products that are in development.
The requirements in section 16 to submit information on a semi-annual basis on promotional activities, as described in sections 17 to 24, by province and by brand family and, where applicable, by brand, are removed to be included in each of sections 17 to 24. The requirement in section 16 to provide semi-annual reports with the required national totals for all promotional activities is removed. Reporting frequencies of sections 17 to 24 are decreased from quarterly to semi-annually. Section 18, dealing with reports on tobacco sponsorship promotions, is repealed, as sponsorship promotion has been prohibited pursuant to the Act since October 1, 2003. Section 21 is repealed, as no promotional activities relating to services have ever been reported or observed. For better tracking of the submission of reports on promotional activities, manufacturers have to notify the Department if no promotional activity is undertaken for that reporting period.
The requirements under sections 17 to 24 are updated to reflect the current practices used by tobacco manufacturers to promote their products. Manufacturers have to report the amount of a consideration and, if a consideration other than money is given, describe the consideration and its money value when it is given in exchange for any promotional activity as set out in sections 17 to 19 and 22. Digital images instead of reasonable facsimiles or photographs of any promotional material referred to in sections 17, 18, 19 and 22 are now required to be submitted. The new section 18 (Report on Advertising on Signs) specifies additional requirements with respect to advertisements on signs permitted by section 22 of the Act that were captured under the former paragraph 22(d) of the TRR.
The requirements under section 20 (Report on Packaging Expenses) is updated to include the costs of the packaging material along with the other materials, such as the carton, foil or cellophane, that are used to make the final product package. This information is required for cigarettes, cigarette tobacco, little cigars and smokeless tobacco. The requirement for packaging costs for pipe tobacco, cigars, bidis and kreteks is removed, as these products are mostly packaged outside of Canada and they are imported products.
The requirements under section 22 (Report on Signs, Displays and Other Promotions at Retail) is modified to require that all promotions at retail relating to the use of signs, display units and any other types of promotions are to be reported on. Before the present amendments to the TRR, manufacturers only reported promotions that appeared on signs at retail.
The TRR prescribe a number of Health Canada official methods for the testing of tobacco products, namely the T-100, T-200, T-300, T-400 and T-500 series. These methods are outlined in technical documents that are incorporated by reference in the Regulations. Over the last few years, the Department has worked to update these methods in consultation with interested stakeholders, namely manufacturers of tobacco products and tobacco testing laboratories. The Health Canada official methods are replaced by the December 31, 2017, versions.
Four new methods, namely T-111B, T-203B, T-209B and T-309B, are added to schedules 1, 2 and 3 of the TRR. These methods were updated to use the most recent testing technology for tobacco-specific nitrosamines (TSNAs) and benzo[a]pyrene in smoke emissions and in whole tobacco. The new requirements specify that the data obtained (e.g. testing results) for the preparation of the reports submitted to Department must be generated by a laboratory that is accredited to perform the test method that generated the testing results.
Schedule 2 (Official Methods for the Collection of Data on Toxic Constituents in Chewing Tobacco and Snuff) of the Tobacco Products Information Regulations is amended to include the December 31, 2017, version of methods T-301, T-306 and T-309A (previously T-309). An additional method, T-309B, that is an alternate method to T-309A, is included in the Schedule for consistency with the amended TRR.
The references to international standards, such as ISO standards, that are prescribed in the TRR are revised to reflect the latest versions. Henceforth, those references are ambulatory; therefore, the latest version of the standard applies.
Sections 12, 14 and 14.2 of the TRR require manufacturers to sample and test some of their tobacco products and report the results of those tests to the Department. These sections also specify that identical products need not be tested. The criteria for determining whether a product is an identical product to another one are now included in each of these sections.
The requirements for the sampling of tobacco products are clarified in sections 12, 14 and 14.2 to specify how each of the types of tobacco products is to be sampled for testing. In section 12, cigarettes, bidis, little cigars, cigars and kreteks are sampled in accordance with the ISO 8243 standard, entitled Cigarettes — Sampling, with the appropriate modification to the application of the method. Cigarette tobacco and pipe tobacco are sampled as per the ISO 15592-1 standard, entitled Fine-cut tobacco and smoking articles made from it — Methods of sampling, conditioning and analysis — Part 1: Sampling. The same sampling requirements now apply in section 14 in the case of designated tobacco products and section 14.2 in the case of cigarettes. The modification is expected to clarify the sampling requirements for each type of tobacco product.
Before the present amendments to the TRR, the designated tobacco products, namely cigarette tobacco, leaf tobacco and tobacco sticks, had to be assembled into equivalent units of cigarettes for the purpose of emissions testing pursuant to the requirements of section 14 (Report on Emissions from Designated Tobacco Products). The prescribed methods for the preparation of equivalent units of cigarettes for emissions testing were (i) the Canadian General Standards Board standard CAN/CGSB-176.1-92, entitled Preparation of Cigarettes from Cigarette Tobacco for Testing; and (ii) Health Canada Official Method T-401, entitled Preparation of Cigarettes from Leaf Tobacco for Testing. In 2010, manufacturers pointed out that there were significant issues with the prescribed methods. In their opinion, the prescribed methods could not be used to make equivalent units of cigarettes from expanded tobacco (currently the dominant type of tobacco in cigarette tobacco), as they were developed for regular cigarette tobacco, which was the main type of tobacco used prior to 2001. Furthermore, the filter material prescribed in the method to make equivalent units of cigarettes is no longer commercially available. Given that the sales of cigarette tobacco, leaf tobacco and tobacco sticks have decreased since the early 2000s and in the absence of an available suitable alternative method, the Department has decided to withdraw the requirement for emissions testing for cigarette tobacco, leaf tobacco and tobacco sticks.
Certain amendments increase administrative costs to businesses while others decrease these costs. The overall impact of the amendments is a net increase in the administrative costs.
Forty businesses (13 medium/large and 27 small) are affected by the RATRR. The bulk of the savings result from the reduction of the reporting frequencies in sections 11 and 16 to 24 of the TRR. The costs mostly originate from new or updated requirements in sections 9, 10 and 17 to 24. The estimates also include the costs that the manufacturers of tobacco products will have to assume in order to learn about the amended requirements and costs relating to the retrieval of information for reporting purposes.
Based on calculations carried out using the Standard Cost Model methodology, these regulatory changes have been estimated to result in an annualized average increase in total administrative costs to all businesses subject to the Regulations of an annualized average of approximately $3,696 or $92 per business. footnote 5 This estimate is expressed in constant 2012 Canadian dollars, using a 7% rate discount over 10 years.
Section 9 — Manufacturer profile report
Section 13 — Report on sales of consumer tobacco products and leaf tobacco
Cost savings as a result of a reporting frequency decrease from quarterly to semi-annually. The requirements in section 16 are removed.
Savings related to reporting of leaf tobacco
$5,935 footnote 6
The small business lens applies, as there are impacts on small businesses associated with the amendments to the TRR. Of the 40 businesses impacted by these changes, 27 are considered small businesses. The total cost of the amendments to the Regulations is estimated to be less than $1 million and the small business costs have been determined not to be disproportionately large.
As per the Cabinet Directive on Regulation, affected and interested parties have been consulted during the development of the RATRR in order to provide them with opportunities to provide input.
The proposals to require additional documentation such as laboratory reports and full copies of the reports on research and development activities were received unfavourably by tobacco manufacturers.
The removal of section 5 on alternative methods did not garner support from tobacco industry stakeholders. The tobacco industry argued that there is value in the Department retaining flexibility to authorize minor variations in testing methods or to agree to the use of alternative or new methodologies that have been appropriately validated. The Department considered this input; however, it has not maintained this provision allowing manufacturers to use a method that is not provided for in the Regulations, following the SJCSR opinion that it was inconsistent with the regulatory power granted in the Act. The Department is examining options to facilitate the update of the methods in a more timely manner in the future (for additional details, see Health Canada Official Methods below).
During the consultation, the tobacco industry also recommended the removal of sections 6 to 8 whereby the Minister may require additional information from manufacturers. These sections are repealed with the RATRR; however, power to require supplementary information is found in subsection 6(2) of the Act as a result of the 2009 amendments to the Act.
In February 2007, draft versions of the updated methods were sent out to stakeholders for comment. The Department took each response into consideration to ensure that the official methods were updated to improve clarity and include recent improvements in laboratory practices and technology. In a follow-up consultation in 2009 relating to the compliance costs of the updated methods, the stakeholders noted that there would not be any significant additional compliance costs. Finally, an additional consultation in 2012 on the addition of three new methods to test for tobacco-specific nitrosamines yielded no comments from the stakeholders.
The proposed Regulations were prepublished in the Canada Gazette, Part I, on May 27, 2017. Over 60 comments were received from 8 manufacturers and 3 NGOs and they are discussed below, by theme. The NGOs supported the changes to the TRR and provided comments to further improve the requirements.
Clarity of proposed requirements
The Department received comments that some of the proposed requirements were unclear. To address comments received, changes to the text of the amendments were made to clarify the requirements and additional explanations are provided in this document. For example, changes were made to subsection 9(1) [Content of report] to clarify its scope, namely that the manufacturers are only required to provide the type of tobacco products that they sell. Thus, manufacturers are not required to provide a list of every type of tobacco product sold by their suppliers.
A discrepancy between the description of the proposed amendment to subsection 10(1) [manufacturing processes] in the Regulatory Impact Analysis Statement that was prepublished on May 27, 2017, and the wording in the proposed draft Regulations was brought to the attention of the Department. Part 2(d) of the Regulatory Impact Analysis Statement (Report on Manufacturing) was modified to reflect that reporting of the manufacturing processes is required for all consumer tobacco products as well as any cigarette papers, filters or mouth tips used in the manufacture of consumer tobacco products. The detailed manufacturing processes of consumer tobacco products and all cigarette papers, filters or mouth tips will help the Department understand how the ingredients listed in section 11 (Report on Ingredients) are assembled.
Upon further review by the Department of the contents of the report on manufacturing as a result of comments received, the conditions to submit the engineering drawings were modified to require them for all cigarettes, kreteks and little cigars that the manufacturer sells, and not only in the cases where they were available (which is what the version prepublished on May 27, 2017, of the RATRR required). This information will help the Department further understand the structure of these products and impact other information collected by the Department (e.g. emissions).
The change to the requirement for engineering drawings will result in a minor change to the compliance costs to the tobacco industry if the manufacturers have to produce them in order to comply with these requirements. It is assumed that large and medium size manufacturers will have engineering drawings of cigarettes, kreteks and little cigars. The compliance costs stated within the Rationale section of the Regulatory Impact Analysis Statement below take this change into consideration.
In response to a concern about the number of reports required when there are changes to the manufacturing processes, the processing aids or the product specifications, the time limits for the changes were modified by the Department to streamline the reporting schedule. The manufacturers have to provide any change by the last day of the month following the month during which the change was made.
Further reducing the administrative burden
The tobacco industry stakeholders requested the elimination of some reporting requirements. For example, the cigar manufacturers have commented that the burden of complying with the TRR is particularly onerous. Exceptions to several reporting requirements were requested for cigars and pipe tobacco. However, there were already exceptions to reporting on manufacturing for cigars in the RATRR (please refer to part 2(d) above for further details) and on constituents for cigars and pipe tobacco with low sales volumes in the TRR. The suggestions were not implemented, as it would have meant that the Department would no longer receive valuable information on those products.
The tobacco industry requested changes to several provisions of the RATRR to decrease the administrative burden. For example, manufacturers mentioned that they wanted the requirements to be modified to exclude products that were still sold but no longer manufactured (e.g. modification to subsection 9(5)). As the report on sales as set out in section 13 requires information on the products that were sold by the manufacturer, these changes were not adopted.
In contrast, the NGOs commented that some requirements of the TRR should not be removed. For example, the proposal to remove leaf tobacco from the definition of consumer tobacco products was not supported despite the fact that its sales volume was very low. Following the comments received, section 13, which pertains to the report on sales, was amended to also require the reporting of the sales information on leaf tobacco. The initial administrative costs analysis had not taken into consideration the savings that would result from the removal of this requirement since there were no reported sales of leaf tobacco at the time of the analysis. However, two manufacturers have recently reported sales of leaf tobacco. The “‘One-for-One’ Rule” section was updated to take the changes in reporting on leaf tobacco products into consideration.
The NGOs requested the addition of new requirements for manufacturers to submit information on other types of tobacco products and on promotional activities. Several changes proposed by the NGOs (for example to change the definition of “consumer tobacco product” to include other types of tobacco products such as waterpipe tobacco and heated tobacco products) were not incorporated in these amendments as they were out of scope of the proposed Regulations (see Objectives). However, the Department intends to consider these proposals for future amendments to the TRR. In the interim, changes to the RATRR were made to require that manufacturers provide a list of the brand names used to identify the brands of the tobacco products they sell, other than consumer tobacco products, by type of tobacco product, in section 9. Furthermore, sections 17 and 19 were amended to add requirements for information in the case that consideration (in money or not) is given by the manufacturer in exchange for the publication of an advertisement or for the display of a promotion on a permanent facility.
At the same time as the draft Regulations were published in the Canada Gazette, Part I, the Health Canada official methods were made available to stakeholders. The stakeholders provided technical comments about the Health Canada official methods. The methods were modified to incorporate the minor changes (e.g. correction of terms or abbreviations, change in model name or equipment manufacturer name because those indicated in the method are no longer available). It is recognized that technological advances offer the opportunity to continuously improve the testing methods. As such, the Department is committed to further improve the methods in the future and is considering options to facilitate the update of the methods in a more timely manner, including through the use of new powers provided in the Act following royal assent of Bill S-5.
The Department received comments that the laboratories will need more time to implement the new methods and obtain the accreditation by the Standards Council of Canada or any other accreditation body that is a signatory to the ILAC-MRA. Therefore, the transitional provisions were modified to allow additional time for the laboratories to implement the new methods and to obtain the accreditation. For example, the manufacturers may determine the efficiency with respect to nicotine as required under paragraph 10(3)(b) using the Health Canada official method dated December 31, 1999, until December 31, 2019. One stakeholder expressed concern that the same information would have to be reported more than once when the Regulations come into force (e.g. in the case of the Reports on Promotional Activities where the reporting frequency has changed). Therefore, the transitional provisions were modified in order to minimize the repetition of information provided to the Department.
The TRR, introduced in 2000, set out the requirements for the reporting of information on the sales, manufacturing processes, ingredients, constituents, emissions of tobacco products, as well as on research and promotional activities undertaken by tobacco manufacturers. The Regulations support the overall goals of the CTS by providing the Department with timely and relevant information about the tobacco market. This information has been used to inform various policy decisions and the implementation of effective tobacco control strategies to protect the health of Canadians.
Following its review of the Regulations, the SJCSR made several recommendations regarding definitions and requirements that needed clarification, inconsistencies identified between the English and French versions and, most importantly, the requirements of sections 5 to 8 of the Regulations, which in their opinion, were inconsistent with the regulatory power granted in the Act prior to the 2009 amendments.
In line with the life-cycle approach of regulation making, as recommended in the Cabinet Directive on Regulation, the Department also conducted a thorough review of the TRR in order to assess their effectiveness, efficiency and accountability. As a result, the RATRR address certain redundancies and discrepancies in the requirements and align the requirements with the 2009 amendments to the Act.
The amendments to the TRR address the recommendations of the SJCSR and update the requirements as a result of the Department’s review of the Regulations. The amendments (i) eliminate redundancies, including reducing the reporting frequency of certain reports; (ii) update the requirements such that they reflect current practices; (iii) allow for reports on new products to be provided in a more timely manner; and (iv) update the testing methods to reflect technological advances.
Stakeholders were consulted in 2008 to seek comments on the proposed amendments to the TRR. In general, NGOs agreed with the proposal with regard to section 22 (Display at Retail) of the TRR that would require information on any consideration given to retailers by manufacturers to promote tobacco products. They also supported the proposed changes to section 20 (Packaging) of the TRR that would require manufacturers to also provide the cost of market research, development of packaging and package design. Tobacco manufacturers were in support of a reduction in certain reporting frequencies while they were not favourable to the proposed requirement of submitting full reports instead of a summary report under section 15 of the TRR (Research Activities). Furthermore, the proposed repeal of section 5, following the opinion of the SJCSR that this provision is inconsistent with the power of the Act, did not receive support from tobacco manufacturers, as it would no longer allow the use of alternative methods for the testing of tobacco products for the purposes of reporting. Affected stakeholders were also consulted on the proposed updates to the Health Canada’s official methods on numerous occasions, namely in 2007, 2009 and 2012. Many of their suggestions were included in the updated methods.
The amendments to the TRR have been estimated to result in an additional annualized administrative cost of $5,935 to all businesses. The removal of the requirement for the emission testing for leaf tobacco, tobacco sticks and cigarette tobacco products has been estimated to result in annualized compliance cost savings to all businesses selling cigarette tobacco of approximately $856,000. Overall, the amendments would result in annualized cost savings of about $850,000 for all businesses.
The Department expects that the amendments would enhance the quality and completeness of the information submitted by the tobacco industry. This will facilitate the review of that information and increase the efficiency of the Department to use the information for the purpose of achieving the objectives of CTS. The changes are therefore expected to contribute to improved decisions on tobacco control policies and activities in the future.
The amendments will not affect the existing enforcement mechanisms of the Act. Compliance monitoring and enforcement activities will continue to be undertaken by the Department under the powers provided for under the Act.
The Department will inform the manufacturers of the changes to the reporting requirements. Information sessions will also be set up by the Department to provide opportunities for manufacturers to seek clarification on the changes to the TRR.
The Act, as enacted in 1997 (S.C. 1997, c. 13).
At the time the proposed regulations were prepublished, it was estimated that these regulatory changes would result in an annualized average increase in total administrative costs of $4,021. However, this amount has changed as a result of the coming into force being in 2019 instead of 2018, as previously proposed, and the changes to reporting of leaf tobacco products.
When expressed in constant 2012 Canadian dollars using a discount rate of 7% given the introduction of the amendment in 2019, the annualized average of $5,935 is equal to $3,696 (as reported in the “‘One-for-One’ Rule” section).