FEDERAL REG

Regulations Amending the Tobacco Reporting Regulations

PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE

Proposed
May 27, 2017


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues 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 Engli... (Click for more)


Published on May 27, 2017

Bill Summary

Regulations Amending the Tobacco Reporting Regulations

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues 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 authority granted in the Tobacco Act (TA). In line with the life-cycle approach of regulation making, as recommended in the Cabinet Directive on Regulatory Management, Health Canada (the Department) conducted a thorough review of the TRR in order to assess the effectiveness, efficiency and accountability of the Regulations. As a result, several redundancies and discrepancies were noted, which are addressed by these proposed Regulations. Additional changes to the Regulations were also identified to align the requirements with the 2009 amendments to the TA. These modifications are put forth in order for the TRR to continue to support the Department’s tobacco control efforts. Background The TRR 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 overall goals of the Government of Canada’s Federal Tobacco Control Strategy (FTCS) by providing the Department with timely and relevant information about the tobacco market. The FTCS, introduced in 2001 and renewed in 2012, focusses on preventing children and youth from starting to smoke; helping people to quit smoking; and helping people protect themselves from second-hand smoke. The FTCS’s ultimate goal is to reduce tobacco-related death and disease among Canadians. Information collected by the Department under the TRR has been used to inform various policy decisions and the implementation of effective tobacco control strategies to protect the health of Canadians. For example, ingredients data submitted pursuant to the TRR were used by the Department to inform tobacco product regulation, especially with regard to ingredients that appeal to youth. Furthermore, information on the costs relating to the manufacturing of certain types of tobacco products has been used to accurately estimate the impact of proposed regulations on manufacturers. The Department also relies on tobacco product sales and promotions data for trend analysis purposes, in order to be able to identify emerging tobacco control issues. Objectives The Department is proposing to amend the TRR to address the recommendations of the SJCSR; and 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 TA. The Department expects that the proposed amendments would enhance the quality and completeness of the information submitted by the tobacco industry. This would 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 the FTCS. The proposed changes are therefore expected to contribute to improved decisions on tobacco control policies and activities in the future. Description 1. Address the recommendations of the SJCSR 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 authority granted by the TA prior to the 2009 amendments and that requirements relating to the reporting of tobacco product ingredients were not clear. The Department proposes to address these recommendations as follows: (a) Section 5 — Alternative Methods This section would be repealed. Section 5 of the TRR currently permits manufacturers to use alternate methods to those prescribed by the Regulations to test tobacco products if the alternate methods result in the generation of information that is 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 TA. 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 proposed to be added to Schedules 1, 2 and 3 of the Regulations (please refer to part 2(k) for further details). These new methods, that would provide additional options to those currently prescribed for the testing of emissions and constituents, would be made available to manufacturers. (b) Sections 6 to 8 — Special Requests Section 6 dealing with urgent requests would be repealed. In cases where information required by Parts 2 to 5 of the TRR is needed urgently, section 6 of the TRR allows the Minister to request the information before its prescribed due date. The SJCSR noted that the effect of this provision was that the time limit provided is not prescribed by the Regulations, as required by section 6 of the TA. Consequently, the SJCSR recommended that section 6 of the TRR be repealed. Section 7 dealing with requests for additional information would be repealed. This section relates to the Minister’s ability 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 is inconsistent with the authority of the TA prior to the 2009 amendments. Section 8, which deals with the time to submit information under sections 6 and 7, would also be repealed. To address the concerns of the Department with regard to its ability to request additional information, authority was added to the TA in 2009, namely subsection 6(2) and paragraph 7(c.2), that allow the Minister to request supplementary information related to information submitted pursuant to the TRR (please refer to part 2(b) for further details). (c) Section 11 — Ingredients The requirement with respect to a component of an ingredient, in paragraph 11(3)(c), would be 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 TA that would address the issue identified by the Committee. Hence, the Department would continue to receive information on ingredients, including on components of consumer tobacco products (please refer to part 2(e) for further details). (d) Section 15 — Research Activities Subsection 15(3), which deals with research activities on new consumer tobacco products, would be repealed. Subsection 15(3) requires manufacturers to report annually their research activities for consumer tobacco products that are under development. The SJCSR was of the opinion that paragraph 7(c) of the TA prior to the 2009 amendments did not grant the authority 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 TA was amended in 2009 such that it now provides the authority to require manufacturers to provide information on the research and development whether the tobacco products are for sale or not. Amendments proposed in section 15 of the TRR would reflect the authority in the TA (please refer to part 2(i) for further details). 2. Update and clarify the requirements Amendments to the TRR are being proposed to update the 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 the 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 TA brought about several changes such as new definitions for “little cigar” and “ingredients” that should be reflected in the TRR for consistency purposes. The proposed amendments are summarized below. (a) Section 1 — Definitions As a result of the proposed updates to the requirements of the TRR, the following changes to the definitions are proposed. Definitions to be added “CAS registry number” — This definition would be added for the purpose of ingredient reporting. A CAS registry number would mean the identification number that is assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society. “New brand” — This definition would be 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 would be a brand that did not appear in an ingredient report made under section 11 of the TRR in the preceding year. “Year” — This definition would be added to specify that, for the purpose of reporting, a year commences on January 1 of the calendar year. Definitions to be modified “Cigar,” “cigarette” and “consumer tobacco product” — These definitions would be updated as a result of the definition of “little cigar” introduced in the 2009 amendments to the TA. “Consumer tobacco product” — This definition would also be modified to exclude leaf tobacco and kits as these tobacco products are no longer sold on the market. “Designated tobacco product” — This definition would be updated to exclude leaf tobacco, cigarette tobacco, and tobacco sticks. Emissions testing and reporting would no longer be required for these products (please refer to part 2(o) for further explanation). “Manufacturer” — This definition would be modified to exclude an individual or entity that only packages, labels or distributes tobacco products on behalf of a manufacturer. “Smokeless tobacco” — This definition would be modified to mean chewing tobacco, nasal snuff and oral snuff. “Type of package” — This definition would be updated to reflect newer types of packages that have been introduced in the Canadian market since 2000. Definitions to be repealed “Ingredient” — This definition would be repealed as it is no longer needed as a result of the 2009 amendments to the TA, which added the definition of “ingredient.” “Unit,” “equivalent unit,” “identical products” and “kit” —These definitions would be repealed as they would no longer be needed due to changes in requirements. (b) Sections 2 to 8 — General Requirements Current sections 1.1 to 8 of the TRR would be reorganized into new proposed sections 2 to 8 as described below. Section 2 would be modified to describe the application of the Regulations, while sections 3 to 8 would 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 would be required, in section 3, to ensure they use brand names in a uniform manner in all the reports submitted to the Department. Any changes to brand names would have to be reported pursuant to section 13, specifying the previous brand name and the changed brand name. To facilitate data processing, section 7 would require that all reports under the TRR be submitted electronically. This is in line with the industry’s current reporting practices. The current electronic format that was prescribed for subsection 14.2(6) would be 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 would specify 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) would be 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 would have to specify the methods set out in these Regulations for which the laboratory is accredited. To verify the accuracy of the submitted information, section 6 of the TRR would 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 would 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. Authority to require supplementary information is now found in subsection 6(2) of the TA as a result of the 2009 amendments to the TA. As per the proposed new section 8 in the TRR, manufacturers would have to provide any supplementary information that is requested by the Minister within 30 days of receipt of the request. (c) Section 9 — Manufacturer Profile Report The following changes would be made to section 9. The title would be 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 would be removed, in line with the modernization of the reporting process. Manufacturers of “consumer tobacco products,” as defined in the TRR, would 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. In addition, manufacturers of tobacco products, other than products that are defined as “consumer tobacco products” in the TRR, would have to provide a list of all types of tobacco products and the brands that they sell. This would allow the Department to identify all tobacco products and their brand names. To assist the Department in conducting its inspections, in accordance with subsection 35(1) of the TA, manufacturers of tobacco products would have to provide the names and addresses of the warehouses in Canada where their tobacco products are stored for distribution and sale. (d) Section 10 — Report on Manufacturing Several tobacco manufacturers have pointed out that section 10 lacks clarity with respect to the information to be provided in a report on the manufacturing of tobacco products. The Department is therefore proposing to clarify the requirements by specifying that manufacturers must provide, for each brand of consumer tobacco product, filter, mouth tip and cigarette paper that they sell, 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 would also have to indicate any steps where additives such as processing aids are used. The manufacturer would be required to provide engineering drawings of the consumer tobacco product, if available. For cigars, reporting on manufacturing processes would only be 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 would benefit from an exemption from reporting on their manufacturing processes. (e) Section 11 — Report on Ingredients In response to comments from tobacco manufacturers, and as a result of the Department’s own observations, the reporting frequency for this section would be changed from quarterly to once a year, and a new provision would be 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 proposed 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 would now only be required for cigarette manufacturers. 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 proposed amendments to indicate that the manufacturer must clearly identify each substance used in the manufacture of the ingredients. The requirements relating to components, i.e. subparagraphs 11(3)(c)(i) to (vi), would be repealed as they become redundant as a result of the addition of the definition of “ingredient” in the TA in 2009. The required information on filters, namely their specifications (including the pressure drop and filter efficiency of a cigarette), which is currently required under section 11, would be 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. (f) Section 12 — Report on Tobacco Constituents Manufacturers would 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. Currently, the moisture content of consumer tobacco products has to be inferred from the constituents’ data by conducting further calculations. This information is already determined by the laboratory that is conducting the testing on behalf of the manufacturer. The definition of “identical products” would be modified to clarify which tobacco product brands qualify for exemptions to the requirements in section 12. (g) Section 13 — Report on Sales of Consumer Tobacco Products The required information on the sales of cigarette tobacco would be harmonized with that of the other consumer tobacco products by requiring the dollar value of sales. (h) Section 14 — Report on Emissions from Designated Tobacco Products The tar, nicotine and carbon monoxide emissions and pH levels for cigarettes and kreteks would 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 would be consolidated into one, resulting in more timely access to a more comprehensive data set. In order to qualify for the exemption pursuant to subsection 14(11) of the TRR, manufacturers are required to submit the results of a statistical analysis that demonstrates 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). The statistical analysis of the sidestream smoke emissions would no longer be 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 would be clarified. For the exception, the manufacturer’s sales of cigarettes or kreteks would 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 would no longer apply. The exception from emission testing for identical cigarettes and kreteks would be 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 brand already being tested. (i) Section 15 — Report on Research and Development Activities The requirements would be clarified to require that a manufacturer submit a report on research and development activities in respect of consumer tobacco products that are currently in development and not for sale. This regulatory authority was included in the 2009 amendments (paragraph 7(c.1)) to the TA. Also, a full copy of all research reports relating to research and development activities, regardless of the format used by the manufacturer (e.g. slides, email, meeting notes), would be required. This requirement would also be 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 would be 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. (j) Sections 16 to 24 — Reports on Promotional Activities 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, would be 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 would be removed. Reporting frequencies of sections 17 to 24 would be decreased from quarterly to semi-annually. Section 18, dealing with reports on tobacco sponsorship promotions, would be repealed, as sponsorship promotion has been prohibited pursuant to the TA since October 1, 2003. Section 21 would be 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 would have to notify the Department if no promotional activity is undertaken for that reporting period. The requirements under sections 17 to 24 would be updated to reflect the current practices used by tobacco manufacturers to promote their products. Manufacturers would 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 18 and 22. Digital images instead of reasonable facsimiles or photographs of any promotional material referred to in sections 17, 18, 19 and 22 would be required to be submitted. The new proposed section 18 (Report on Advertising on Signs) would specify additional requirements with respect to advertisements on signs permitted by section 22 of the TA that are currently captured under paragraph 22(d) of the TRR. The requirements under section 20 (Report on Packaging Expenses) would be 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 would be required for cigarettes, cigarette tobacco, little cigars and smokeless tobacco. The requirement for packaging costs for pipe tobacco, cigars, bidis and kreteks would be removed, as these products are mostly packaged outside of Canada and they are imported products. Therefore, information on these packaging costs is of limited value to the Department. The requirements under section 22 (Report on Signs, Displays and Other Promotions at Retail) would be 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. Currently, manufacturers only report promotions that appear on signs at retail. (k) Health Canada official methods 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. 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 would be replaced by the December 31, 2016, versions. Four new methods, namely T-111B, T-203B, T-209B, and T-309B, would be 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. (l) Consequential amendments to the Tobacco Products Information Regulations Schedule 2 (Official Methods for the Collection of Data on Toxic Constituents in Chewing Tobacco and Snuff) of the Tobacco Products Information Regulations would be amended to include the December 31, 2016, 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, would be included in the Schedule for consistency with the amended TRR. (m) International standards and test methods The references to international standards, such as ISO standards, that are prescribed in the TRR would be revised to reflect the latest versions. Henceforth, those references would be ambulatory; therefore, the latest version of the standard would apply. (n) Requirements relating to the sampling and testing of tobacco products Sections 12, 14 and 14.2 of the TRR currently 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 have been included in each of these sections. The requirements for the sampling of tobacco products would be 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 would be 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 would be 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 would apply in section 14 in the case of designated tobacco products and section 14.2 in the case of cigarettes. The proposed modification is expected to clarify the sampling requirements for each type of tobacco product. (o) Emissions testing of cigarette tobacco, leaf tobacco and tobacco sticks The designated tobacco products, namely cigarette tobacco, leaf tobacco and tobacco sticks, must 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 are (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 that 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. Therefore, in the absence of a suitable alternative method, the Department has decided to withdraw the requirement for emissions testing for cigarette tobacco, leaf tobacco and tobacco sticks. “One-for-One” Rule Certain proposed amendments would increase administrative costs to businesses while others would decrease these costs. The overall impact of the proposed amendments would be a net increase in the administrative costs. Forty businesses (13 medium/large and 27 small) would be affected by the regulatory proposal. 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 would 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 a present value of approximately $4,021 or $101 per business. This estimate is expressed in constant 2012 Canadian dollars, using a 7% rate discount over 10 years. The table below shows the breakdown of the costs by the general changes to the Regulations. This table presents the breakdown of the costs by the general changes to the Regulations. Change in requirement Total Present Value (All Businesses) Annualized Average (All Businesses) Costs Costs Costs Learning about the changes to the Regulations This activity takes into account the one-time cost to businesses to attend information sessions on the amended Regulations. $53,010 $7,550 Section 9 — Report on manufacturer profile Costs relating to the reporting of digital images of all existing brands of consumer tobacco products. $59,880 $8,530 Section 9 — Report on manufacturer profile Costs relating to reporting of digital images of new consumer tobacco products. $40,470 $5,760 Costs relating to the retrieval of existing consumer tobacco products for which a digital image is required. $29,920 $4,260 Section 10 — Report on manufacturing Costs relating to the reporting of updated manufacturing processes (on the basis of clarified requirements) for all brands except for cigar brands whose sales volume is under a million units annually. $104,760 $14,920 Section 11 — Report on ingredients Costs relating to the new requirement for businesses to provide an ingredient report for each new brand of consumer tobacco product on or before the day the manufacturer first sells a new brand in a year. $29,590 $4,210 Section 13 — Report on sales of consumer tobacco products Costs relating to the new requirement to provide the dollar amount of the sales information for cigarette tobacco only. $41,570 $5,920 Section 15 — Report on research and development activities Costs relating to the new requirement to provide full copies of reports on research and development activities. $20,700 $2,950 Sections 17 to 24 — Reports on promotional activities Costs relating to the new requirements. $171,880 $24,470 Total costs $551,770 $78,560 Savings Savings Savings Section 11 — Report on ingredients Cost savings relating to the change in the frequency of the reporting from quarterly to annually. $304,095 $43,295 Section 14 — Report on emissions from designated tobacco products Cost savings resulting from the removal of the requirement of providing a report for cigarette tobacco, leaf tobacco and tobacco sticks. $3,475 $495 Sections 16 to 24 — Reports on promotional activities Cost savings as a result of a reporting frequency decrease from quarterly to semi-annually. The requirements in section 16 would be removed. $201,825 $28,735 Total savings $509,395 $72,525 Net cost $42,380 $6,034 (see footnote 1) Small business lens The total cost of the proposed Regulations is estimated to be less than $1M and the small business costs have been determined not to be disproportionately large. Therefore, the small business lens does not apply. Consultation As per the Cabinet Directive on Regulatory Management, affected and interested parties have been consulted during the development of this regulatory proposal in order to provide them with opportunities to provide input. Consultation on the proposed amendments On February 29, 2008, a consultation letter entitled “Proposal to Amend the Tobacco Reporting Regulations” was mailed to 75 stakeholders, consisting of 45 tobacco product manufacturers, 28 non-governmental organizations (NGOs) and 2 tobacco testing laboratories. Manufacturers of tobacco products were in favour of reducing the reporting frequency in section 11 on ingredients from quarterly to annually, of reducing the reporting frequency in section 14 on emissions from three reports to two reports annually, and of reducing the reporting frequency in sections 17 to 24 on promotional activities from quarterly to semi-annually. Furthermore, they also supported the proposed changes relating to clarifying the requirements of section 11 on ingredients. The proposals to require additional documentation such as laboratory reports and full copies of research and development activities were received unfavourably by tobacco manufacturers. 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. The removal of section 5 on alternative methods as recommended by the SJCSR did not garner support from tobacco industry stakeholders. The tobacco industry argued that there is value in Health Canada 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 could not maintain these requirements in light of the SJCSR opinion that they were inconsistent with the regulatory authority granted in the TA. 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 would be repealed with this regulatory proposal; however, authority to require supplementary information is now found in subsection 6(2) of the TA as a result of the 2009 amendment to the TA. As per the new proposed section 8 in the TRR, manufacturers would have to provide any supplementary information that is requested by the Minister within 30 days of receipt of the request. Consultations on Health Canada official methods 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. Rationale 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 FTCS, 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 authority granted in the TA. In line with the life-cycle approach of regulation making, as recommended in the Cabinet Directive on Regulatory Management, the Department also conducted a thorough review of the TRR in order to assess their effectiveness, efficiency and accountability. As a result, changes to address certain redundancies and discrepancies in the requirements and to align the requirements with the 2009 amendments to the TA are proposed. The proposed amendments to the TRR would address the recommendations of the SJCSR and update the requirements as a result of the Department’s review of the Regulations. Proposed amendments would (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 timelier 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 deemed ultra vires by the SJCSR 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 proposed amendments to the TRR have been estimated to result in an additional annualized administrative cost of $6,034 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 proposed amendments would result in annualized cost saving of about $850,000 for all businesses. The Department expects that the proposed amendments would enhance the quality and completeness of the information submitted by the tobacco industry. This would 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 the FTCS. The proposed changes are therefore expected to contribute to improved decisions on tobacco control policies and activities in the future. Implementation, enforcement and service standards The proposed amendments would not affect the existing enforcement mechanisms under the provisions of the TA. Compliance monitoring and enforcement activities would continue to be undertaken by the Department under the authorities provided for under the TA. The Department would inform the manufacturers of the changes to the reporting requirements. Information sessions would also be set up by the Department to provide opportunities for manufacturers to seek clarification on the changes to the TRR. Contact Mr. Mathew Cook Manager Scientific Regulations Division Tobacco Products Regulatory Office Tobacco Control Directorate Health Canada Address Locator 0301A 150 Tunney’s Pasture Driveway Ottawa, Ontario K1A 0K9 Fax: 613-948-8495 Email: [email protected] PROPOSED REGULATORY TEXT Notice is given that the Governor in Council, pursuant to sections 7 (see footnote a) and 33 (see footnote b) of the Tobacco Act (see footnote c), proposes to make the annexed Regulations Amending the Tobacco Reporting Regulations. Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mathew Cook, Manager, Scientific Regulations Division, Tobacco Products Regulatory Office, Tobacco Control Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9 (fax: 613-948-8495; email: [email protected]). Ottawa, May 18, 2017 Jurica Čapkun Assistant Clerk of the Privy Council Regulations Amending the Tobacco Reporting Regulations Amendments 1 (1) The definitions equivalent unit, identical products, ingredient, kit and unit in section 1 of the Tobacco Reporting Regulations (see footnote 2) are repealed. (2) The definitions cigar, cigarette, consumer tobacco product, designated tobacco product, manufacturer, smokeless tobacco and type of package in section 1 of the Regulations are replaced by the following: cigar means a roll or tubular construction intended for smoking, other than a little cigar, that contains a filler composed of natural or reconstituted tobacco, and that has a wrapper, or a wrapper and a binder, composed of natural or reconstituted tobacco. (cigare) cigarette includes any roll or tubular construction that contains tobacco and is intended for smoking, other than a bidi, cigar, kretek or little cigar. (cigarette) consumer tobacco product means any of the following types of tobacco product that is for use by a consumer: (a) bidis; (b) cigarettes; (c) cigarette tobacco; (d) cigars; (e) kreteks; (f) little cigars; (g) pipe tobacco; and (h) smokeless tobacco. (produit du tabac pour consommation) designated tobacco product means either of the following types of consumer tobacco product: (a) cigarettes; or (b) kreteks. (produit du tabac désigné) manufacturer does not include an individual or entity that only packages, only labels or only distributes tobacco products on behalf of a manufacturer. (fabricant) smokeless tobacco means chewing tobacco, nasal snuff and oral snuff. (tabac sans fumée) type of package includes each of the following types of packages as well as each of their sizes: (a) a slide and shell package; (b) a slide and shell package with a lateral moving slide; (c) a flip-top package; (d) a soft package; (e) a pouch; (f) a bag; (g) a can; (h) a tub; (i) a tube; (j) a flip-top box; (k) a bundle; (l) a plastic or metal container; and (m) a shoulder box. (type d’emballage) (3) The portion of the definition type of tobacco in section 1 of the Regulations before paragraph (a) is replaced by the following: type of tobacco includes the following types of tobacco leaves commonly known as (type de tabac) (4) Section 1 of the Regulations is amended by adding the following in alphabetical order: CAS registry number means the identification number that is assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society. (numéro d’enregistrement CAS) new brand means (a) a brand of consumer tobacco product that a manufacturer sells in a year and that was not referred to in a report submitted under section 13 for any portion of the preceding year; and (b) a brand of cigarette papers, tubes or filters that a manufacturer sells in a year and that was not referred to in a report submitted under section 11 for the preceding year. It does not include any product that was mentioned, although under a different brand name, in a report referred to in paragraph (a) or (b). (nouvelle marque) year means a calendar year commencing on January 1. (année) 2 Sections 1.1 to 11 of the Regulations are replaced by the following: Application 2 Every provision of these Regulations that applies to a brand of tobacco product also applies to every size of that brand. General Requirements Information 3 (1) These Regulations prescribe the information that manufacturers of tobacco products are required to submit to the Minister, as well as the manner in which it is to be submitted. Content of reports (2) In addition to the information required for each type of report described in these Regulations, every report must set out the following information: (a) the name of the manufacturer on whose behalf the report is submitted, as well as the telephone number, email address and the street address of their principal place of business in Canada; (b) the name, telephone number and email address of the individual who prepared the report and, if that individual works for an entity other than a manufacturer on whose behalf the report is submitted, the name of the entity, as well as the telephone number, email address and the street address of its principal place of business; (c) the date of the report; (d) the period covered by the report; and (e) the section of these Regulations under which the report is made. Attestation (3) The individual who prepared the report must attach to the report an attestation that states that the information in the report is true and complete to the best of their knowledge and belief and is provided in good faith. Brand name (4) The manufacturer must use a brand name to identify each consumer tobacco product in a report submitted under section 13 and must use it in a uniform manner in all other reports submitted in respect of the same consumer tobacco product. Change to brand name (5) However, a manufacturer may change the brand name used to identify a consumer tobacco product in a report by submitting a report under section 13 that identifies the brand name that was previously used, as well as the changed brand name. Exception — export (6) The reports referred to in sections 10 to 12, 14, 15 and 17 to 24 are not required for consumer tobacco products that are manufactured solely for export. Data collection 4 Any data used in the preparation of a report must be obtained from tests performed on tobacco products that are sampled and tested during the period covered by the report. Laboratory accreditation 5 Any test performed on a tobacco product for the purposes of these Regulations must be performed by a laboratory that (a) is accredited by the Standards Council of Canada or any other accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, under the most recent version of the International Organization for Standardization standard ISO/IEC 17025, entitled General Requirements for the Competence of Testing and Calibration Laboratories; and (b) has been issued a document by one of those bodies, specifying the test methods set out in these Regulations for which the laboratory is accredited. Documents to submit 6 A manufacturer that uses data obtained from a test performed by a laboratory for the purpose of preparing any report under section 12, 14 or 14.2, must attach a copy of the following documents to the report: (a) the laboratory report that includes the data used in the preparation of the report required by these Regulations and that specifies the type of tobacco product that was tested, as well as its brand name; and (b) the document referred to in paragraph 5(b) that is evidence of the laboratory’s accreditation when the test was performed. Electronic format 7 (1) The reports and other information are to be submitted in a legible electronic format. 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. Time limit — supplementary information 8 For the purposes of subsection 6(2) of the Act, any supplementary information requested by the Minister is to be submitted no later than 30 days after the day on which the request is received. Reports Manufacturer Profile Report 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 they sell; (b) a list of every brand name used to identify the brands of tobacco products, other than consumer tobacco products, that they sell; and (c) the name and street address of each warehouse in Canada where tobacco products are stored for distribution and sale. Digital images (2) The report must include, for each brand of consumer tobacco product that the manufacturer sells, a digital image of (a) each type of package, showing all of the sides which 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. Digital image characteristics (3) A digital image of an item must be taken with a white background and (a) 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 centimetres. Time limit — new manufacturer (4) The report must be submitted on or before the day on which a manufacturer begins to sell tobacco products. Time limit — existing brands (5) However, the report must be submitted no later than 90 days after the day on which this subsection comes into force, in the case of any brand of consumer tobacco product that is for sale on the day on which this subsection comes into force, or that was for sale at any time during the preceding year or the portion of the year before that day. Time limit — changes to information (6) If any of the information described in paragraphs (1)(a) to (c) is changed by the manufacturer, the manufacturer must advise the Minister of the change by submitting, on or before January 31 of the following year, a description of the information that was previously submitted, as well as of the change made to the information. Time limit — changes to items (7) If the appearance of any package, promotion, overwrap or brand element mentioned 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. 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 image described in subsection (2) in respect of the new brand. Report on Manufacturing 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 mouth 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 mouth 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. Processing aids (2) The report must set out the common, chemical and commercial name of each processing aid and, if applicable, its CAS registry number. 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, 2016; and (c) if available, an engineering drawing of the product. Time limit — existing brands (4) The report must be submitted no later than 90 days after the day on which this subsection comes into force, in the case of any brand of consumer tobacco product that is for sale on the day on which this subsection comes into force or that was for sale at any time during the preceding year or the portion of the year before that day. 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 on the new brand. 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. 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. Time limit — changes (8) If the manufacturer changes the manufacturing processes, processing aids or product specifications, the manufacturer must, no later than 30 days after the day on which the change is made, submit a new report that sets out the information described in subsections (1) to (3) and that indicates the changes made to the information previously submitted. Report on Ingredients Content of report 11 (1) The report on ingredients must set out, by type of tobacco product and brand, 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 commercial 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, country of origin and 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 street address of its supplier. 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 described in subsection (1) for each substance used in the manufacture of that ingredient. 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. 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. Inventory (5) In addition to the information described in subsections (1) to (3), the report must also set out (a) the name and street 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. Time limit (6) The report must be submitted on or before January 31 of the year after the period covered by the report. 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 described in subsections (1) to (3) in respect of the new brand. 3 The heading before section 12 of the Regulations is replaced by the following: Report on Tobacco Constituents 4 (1) Subsections 12(1) to (6) of the Regulations are replaced by the following: Report 12 (1) The report on tobacco constituents must set out, by brand, the information described in subsection (7) in respect of each type of consumer tobacco product that a manufacturer sells during a year. 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. 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. 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, 2016. 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. 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. (2) The portion of subsection 12(7) of the Regulations before paragraph (b) is replaced by the following: 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; (3) The portion of paragraph 12(7)(c) of the Regulations before subparagraph (i) is replaced by the following: (c) the mean, standard deviation and 95% confidence limits of the amount of each constituent in milligrams, micrograms or nanograms (4) Subparagraph 12(7)(c)(ii) of the Regulations is replaced by the following: (ii) in the case of bidis, cigarettes, cigars, kreteks and little cigars, per unit; (5) Paragraph 12(7)(d) of the Regulations is replaced by the following: (d) the pH of the consumer tobacco product, determined in accordance with Official Method T-310, entitled Determination of Whole Tobacco pH, prepared by the Department of Health, dated December 31, 2016; and (e) the percentage of moisture in the consumer tobacco product, determined in accordance with the method referred to in subsection (6). (6) Subsection 12(8) of the Regulations is replaced by the following: 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 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 total sales of the manufacturer 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 total sales of the manufacturer 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. (7) The portion of subsection 12(9) of the Regulations before paragraph (b) is replaced by the following: 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 (8) Subsections 12(10) and (11) of the Regulations are replaced by the following: 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. 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. 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. Time limit (13) The report must be submitted on or before January 31 of the year after the year covered by the report. 5 The heading before section 13 of the Regulations is replaced by the following: Report on Sales of Consumer Tobacco Products 6 (1) The portion of subsection 13(1) of the Regulations before paragraph (a) is replaced by the following: Report 13 (1) The report on sales of consumer tobacco products must set out the information described in subsections (2) and (3) in respect of each type of consumer tobacco product that a manufacturer sells during the period covered by the report, for each of the following categories: (2) Subsections 13(2) and (3) of the Regulations are replaced by the following: Total sales (2) The report must set out the Canadian dollar value of the total sales and, as applicable, the total number of units sold or the total weight in kilograms of the consumer tobacco product sold. Sales by brand and package type (3) The report must set out the following information, by brand and by each type of package: (a) in the case of bidis, cigarettes, cigars, kreteks and little cigars, (i) the number of units sold, (ii) the number of packages sold and the number of units in each package, and (iii) the Canadian dollar value of sales; and (b) in the case of cigarette tobacco, pipe tobacco and smokeless tobacco, (i) the weight, in kilograms, of the consumer tobacco product sold, (ii) the number of packages sold and the weight, in grams, of the consumer tobacco product in each package, and (iii) the Canadian dollar value of sales. (3) The portion of subsection 13(4) of the Regulations before paragraph (b) is replaced by the following: Time limit (4) The report must be submitted (a) for cigarettes and cigarette tobacco, on or before the 15th day of each month, for the previous month; and 7 The headings before section 14 of the Regulations are replaced by the following: Report on Emissions from Designated Tobacco Products 8 (1) Subsection 14(1) of the Regulations is replaced by the following: Report 14 (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. (2) The portion of subsection 14(2) of the Regulations before paragraph (a) is replaced by the following: 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 (3) Paragraphs 14(2)(b) and (c) of the Regulations are replaced by the following: (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. (4) Subsection 14(3) of the Regulations is replaced by the following: 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). 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. (5) The portion of subsection 14(4) of the Regulations before paragraph (a) is replaced by the following: Replicates (4) The mean, standard deviation and 95% confidence limits of the amount of each emission must be based (6) Paragraphs 14(4)(a) and (b) of the French version of the Regulations are replaced by the following: a) dans le cas des émissions de goudron, de nicotine ou de monoxyde de carbone, 20 réplicats d’un échantillon; b) dans le cas de toute autre émission, 7 réplicats d’un échantillon. (7) The portion of subsection 14(5) of the Regulations before paragraph (a) is replaced by the following: 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: (8) The portion of subsection 14(6) of the English version of the Regulations before paragraph (a) is replaced by the following: 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: (9) Paragraph 14(6)(a) of the Regulations is replaced by the following: (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 (10) The portion of paragraph 14(6)(b) of the Regulations before subparagraph (i) is replaced by the following: (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: (11) Subparagraph 14(6)(b)(ii) of the Regulations is replaced by the following: (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 (12) Subsections 14(7) to (10) of the Regulations are replaced by the following: 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, 2016. 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 their designated tobacco products sold during that two-year period, if (a) in the case of cigarettes, the manufacturer’s total sales of that product, per year, is less than 1% of the total sales of that product in Canada in the year preceding the two-year period, as well as in the first year of that period; and (b) in the case of kreteks, the manufacturer’s total sales of that product, per year, is less than 5% of the total sales of that product in Canada in the year preceding the two-year period, as well as in the first year of that period. 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). (13) The portion of subsection 14(11) of the Regulations before subparagraph (a)(ii) is replaced by the following: Exemption — functional relationship of certain emissions (11) A manufacturer may, on or before December 1 of the year before the year for which the exemption is sought, 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, if the manufacturer provides to the Minister the content 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 following 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, (14) Paragraph 14(11)(b) of the Regulations is replaced by the following: (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 analysis and test described in subparagraph (a)(i), except that the reference to “tar” is to be read as a reference to “nicotine”. (15) Subsection 14(12) of the Regulations is repealed. (16) Paragraphs 14(13)(a) to (c) of the Regulations are replaced by the following: (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, 2016, 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, 2016; (b) a list of the brands of the cigarettes 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 the cigarettes that form the cohort, and (ii) each of the brands of the cigarettes for which the application for exemption is made. (17) Subsection 14(14) of the Regulations is replaced by the following: Joint cohort (14) For the purposes of subsection (13), two or more manufacturers may submit a joint cohort of their cigarette brands. (18) The portion of subsection 14(15) of the English version of the Regulations before paragraph (a) is replaced by the following: Minister’s decision (15) The Minister must, without delay, decide to accept or reject (19) Clauses 14(15)(a)(ii)(A) and (B) of the Regulations are replaced by the following: (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), (20) Paragraph 14(15)(b) of the Regulations is replaced by the following: (b) a cohort submitted in accordance with subsection (13) or (14), based on the methodology used and the representativeness of the cohort. (21) Section 14 of the Regulations is amended by adding the following after subsection (16): 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). Time limit (18) The report must be submitted on or before January 31 of the year after the period covered by the report. 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. 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. 9 The headings before section 14.1 and sections 14.1 to 15 of the Regulations are replaced by the following: Report on Toxicity of Cigarette Emissions Definitions 14.1 The following definitions apply in this section and section 14.2. cigarette means any roll or tubular construction that contains tobacco, has a wrapper or cover made of paper and is consumed through the inhalation of the products of combustion, but does not include a bidi, cigar, kretek or little cigar. (cigarette) identical cigarettes means cigarettes that are sold by a manufacturer under more than one brand, that are manufactured using identical manufacturing processes and that (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) Annual Testing 14.2 (1) The report on the toxicity of cigarette emissions must include the results of toxicity testing performed in accordance with subsection (6) on every brand of cigarettes that the manufacturer sells during a year. Presentation of results (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. 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, 2016; (b) Official Method T-502, entitled Neutral Red Uptake Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016; and (c) Official Method T-503, entitled In Vitro Micronucleus Assay for Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016. 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. 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). 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). 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. 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 Report 15 (1) The report on research and development activities must include the information described in subsection (2) for any 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 research regarding (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. 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. 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. Time limit (4) The report must be submitted on or before January 31 of the year after the year covered by the report. 10 The headings before section 16 and section 16 of the Regulations are replaced by the following: Reports on Promotional Activities Semi-annual Reports Report 16 (1) Each report on a promotional activity must include, for the semi-annual period covered by the report, the information described, respectively, in sections 17 to 24. Report — declaration (2) If none of the activities described in one of those sections is undertaken during a semi-annual period, the manufacturer must include a statement to that effect in the report. Time limit (3) The report must be submitted at the following times: (a) for the period beginning on January 1 and ending on June 30 of a year, on or before July 31 of that year; and (b) for the period beginning on July 1 and ending on December 31 of a year, on or before January 31 of the following year. Definition of “product” (4) For the purposes of sections 17, 18 and 22, product means a consumer tobacco product, as well as any accessory or product that displays a consumer tobacco product-related brand element or a manufacturer’s name. 11 The heading before section 17 of the Regulations is replaced by the following: Report on Advertising in Publications 12 (1) The portion of subsection 17(1) of the Regulations before paragraph (a) is replaced by the following: Content of report 17 (1) The report must set out the following information in respect of the advertising of products in a publication: (2) Subsection 17(1) of the Regulations is amended by striking out “and” after paragraph (b) and by replacing paragraph (c) with the following: (c) for each province, the amount of the expenses incurred, by brand or, if applicable, by brand family, for market research, development, and design in relation to the advertisement; and (d) the amount of the expenses incurred for the publication of the advertisement. (3) Subsection 17(2) of the Regulations is replaced by the following: Digital image (2) The report must include a digital image of the advertisement and the image must display (a) colours that are as close as possible to the colours of the advertisement; (b) any text that appears on the advertisement, in legible characters; (c) the brand name associated with the advertisement or, if the advertisement relates to a brand family, the brand elements used to identify the brand family; and (d) the dimensions of the advertisement. 13 The heading before section 18 and sections 18 to 20 of the Regulations are replaced by the following: Report on Advertising on Signs Content of report 18 (1) The report must set out the following information in respect of the advertising of a product by means of information advertising or brand-preference advertising on a sign that is posted in a place where young persons are not permitted by law: (a) the amount of the expenses incurred for market research, development and design in relation to the sign; (b) the amount of the expenses incurred for the manufacturing of the sign; (c) for each province, by brand or, if applicable, by brand family, the amount of consideration given by the manufacturer for the posting of the sign and, if a consideration other than money is given, a description of the consideration and its money value; (d) for each province, the number of establishments, as well as their names and street addresses, in which the sign was posted; and (e) the period during which the sign was posted in the establishment. Digital image (2) The report must include a digital image of the sign and the image must (a) display colours that are as close as possible to the colours of the sign; (b) display any text that appears on the sign, in legible characters; (c) include the brand name associated with the sign or, if the sign relates to a brand family, the brand elements used to identify the brand family; and (d) include the dimensions of the sign. Report on Promotions on Permanent Facilities Content of report 19 (1) The report must set out the following information in respect of a consumer tobacco product-related brand element or name of a manufacturer that appears in a promotion that is displayed on a permanent facility: (a) the name, the street address and a description of the facility; (b) the expected duration of the display of the promotion on the facility; (c) the amount of the expenses incurred for market research, development and design in relation to the promotion; (d) the amount of the expenses incurred for manufacturing the promotion; and (e) for each province, by brand or, if applicable, by brand family, the amount of expenses incurred for the display of the promotion on the facility. Digital image (2) The report must include a digital image of the promotion that is displayed on the permanent facility and the digital image must (a) display colours that are as close as possible to the colours of the promotion; (b) display any text that appears in the promotion, in legible characters; and (c) include the dimensions of the promotion. Report on Packaging Expenses Content of report 20 The report must set out, by brand and type of package, the following information in respect of expenses relating to the packaging of cigarettes, little cigars, smokeless tobacco and cigarette tobacco: (a) the amount of the expenses incurred for market research, development and design in relation to the packaging; and (b) the amount of the expenses incurred for the manufacturing of each package, including any promotional material that accompanies the package and any packaging material that is used in or over the package. 14 Section 21 of the Regulations and the heading before it are repealed. 15 The heading before section 22 and sections 22 to 24 of the Regulations are replaced by the following: Report on Signs, Displays and Other Promotions at Retail Content of report 22 (1) The report must set out the following information in respect of a sign, display unit or other means of promotion provided by a manufacturer for use at retail, to indicate the sale of a product or its price: (a) the amount of the expenses incurred for (i) market research, development and design in relation to the sign, display unit or other means of promotion, (ii) the distribution of the sign, display unit or other means of promotion, and (iii) the manufacturing of the sign, display unit or other means of promotion; and (b) for each province, by brand or, if applicable, by brand family, the amount of the consideration given by the manufacturer for the following purposes and, if a consideration other than money is given, a description of the consideration and its money value: (i) the posting of the sign or placement of the display unit, (ii) the display or sale of the product, or (iii) any other promotion of the product; and (c) for each province, the number of establishments to which consideration has been given by the manufacturer to post a sign, place a display unit or to display or sell a product. Digital image (2) The report must include a digital image of the sign, display unit or other means of promotion on which a brand element or a manufacturer’s name appears and the image must (a) display colours that are as close as possible to the colours of the sign, display unit or other promotion; (b) display any text that appears on the sign, display unit or other promotion, in legible characters; and (c) include the dimensions of the sign, display unit or other means of promotion. Report on Accessories Content of report 23 (1) The report must set out the following information in respect of accessories that are sold by the manufacturer and that display a consumer tobacco product-related brand element or a manufacturer’s name: (a) the number of accessories sold, by province; and (b) the amount of the expenses incurred for the following: (i) market research, development and design in relation to the accessory, (ii) the manufacturing of the accessory, and (iii) the distribution of the accessory. Digital image (2) The report must include a digital image, taken on a white background, of each side of the accessory on which a brand element or a manufacturer’s name appears and the image must (a) display colours that are as close as possible to the colours of the accessory and of the brand element or name; (b) display any text that appears on the side of the accessory, in legible characters; and (c) include the dimensions of the accessory. Report on Other Products Content of report 24 (1) The report must set out the following information in respect of non-tobacco products, other than accessories, that are sold by a manufacturer and that display a consumer tobacco product-related brand element or a manufacturer’s name: (a) the number of non-tobacco products sold, by province; and (b) the amount of the expenses incurred for the following: (i) market research, development and design in relation to the product, (ii) the manufacturing of the product, and (iii) the distribution of the product. Digital image (2) The report must include a digital image, taken on a white background, of each side of the non-tobacco product on which a brand element or a manufacturer’s name appears and the image must (a) display colours that are as close as possible to the colours of the non-tobacco product and of the brand element or name; (b) display any text that appears on the side of the non-tobacco product, in legible characters; and (c) include the dimensions of the non-tobacco product. 16 Part 6 of the Regulations is repealed. 17 Schedule 1 to the Regulations is amended by replacing the reference after the heading “SCHEDULE 1” with the following: (Section 1 and subsection 12(2)) 18 The portion of items 1 to 6 of Schedule 1 to the Regulations in column 2 is replaced by the following: This table presents the portion of items 1 to 6 of Schedule 1 to the regulations in column 2 that is replaced by the following. Item Column 2 Official Method 1 Official Method T-301, Determination of Nicotine-Related Alkaloids in Whole Tobacco by GC-TSD, prepared by the Department of Health, dated December 31, 2016 2 Official Method T-302, Determination of Ammonia in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 3 Official Method T-304, Determination of Humectants in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 4 Official Method T-306, Determination of Toxic Trace Metals (Ni, Pb, Cd, Cr, As, Se and Hg) in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 5 Official Method T-307, Determination of Benzo[a]pyrene in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 6 Official Method T-308, Determination of Nitrate in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 19 Item 7 of Schedule 1 to the Regulations is replaced by the following: This table presents Item 7 of schedule 1 to the regulations which are replaced by the following. Item Column 1 Constituent Column 2 Official Method 7 (a) N-nitrosonornicotine (b) 4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanone (c) N-nitrosoanatabine (d) N-nitrosoanabasine Official Method T-309A, Determination of Tobacco Specific Nitrosamines in Whole Tobacco by GC-TEA, prepared by the Department of Health, dated December 31, 2016, or Official Method T-309B, Determination of Tobacco Specific Nitroamines in Whole Tobacco by LC-MS/MS, prepared by the Department of Health, dated December 31, 2016 20 The portion of items 8 to 10 of Schedule 1 to the Regulations in column 2 is replaced by the following: This table presents the portion of items 8 to 10 of schedule 1 to the regulations in column 2 that are replaced by the following. Item Column 2 Official Method 8 Official Method T-311, Determination of Triacetin in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 9 Official Method T-312, Determination of Sodium Propionate in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 10 Official Method T-313, Determination of Sorbic Acid in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 21 Item 11 of Schedule 1 to the Regulations is replaced by the following: This table presents item 11 of schedule 1 to the regulations which is replaced by the following. Item Column 1 Constituent Column 2 Official Method 11 Eugenol[2-methoxy-4-(2-propenyl)phenol] Official Method T-314, Determination of Eugenol in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 22 Schedule 2 to the Regulations is amended by replacing the reference after the heading “SCHEDULE 2” with the following: (Section 1, subsection 14(2) and paragraph 14(5)(a)) 23 The portion of item 1 of Schedule 2 to the Regulations in column 2 is replaced by the following: This table presents the portion of item 1 of Schedule 2 to the Regulations in column 2 which it replaces. Item Column 2 Official Method 1 Official Method T-101, Determination of Ammonia in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 24 Item 2 of Schedule 2 to the Regulations is replaced by the following: This table presents item 2 of Schedule 2 of the regulations which is to be replaced by the following. Item Column 1 Emission Column 2 Official Method 2 (a) 1-aminonaphthalene (b) 2-aminonaphthalene (c) 3-aminobiphenyl (d) 4-aminobiphenyl Official Method T-102, Determination of Aromatic Amines in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 25 The portion of items 3 and 4 of Schedule 2 to the Regulations in column 2 is replaced by the following: This table presents the portion of items 3 and 4 of Schedule2 to the Regulations in column2 which is replaced by the following. Item Column 2 Official Method 3 Official Method T-103, Determination of Benzo[a]pyrene in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 4 Official Method T-104, Determination of Selected Carbonyls in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 26 Item 5 of Schedule 2 to the Regulations is replaced by the following: This table presents Item 5 of Schedule 2 to the Regulations which is to be replaced by the following. Item Column 1 Emission Column 2 Official Method 5 Eugenol[2-methoxy-4(2-propenyl)phenol] Official Method T-105, Determination of Eugenol in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 27 The portion of items 6 to 9 of Schedule 2 to the Regulations in column 2 is replaced by the following: This table presents the portion of items 6 to 9 of Schedule 2 to the regulations in column2 which is replaced by the following. Item Column 2 Official Method 6 Official Method T-107, Determination of Hydrogen Cyanide in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 7 Official Method T-108, Determination of Mercury in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 8 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, 2016 9 Official Method T-110, Determination of Oxides of Nitrogen in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 28 Item 10 of Schedule 2 to the Regulations is replaced by the following: This table presents item 10 of Schedule 2 to the regulations which is replaced by the following. Item Column 1 Emission Column 2 Official Method 10 (a) N-nitrosonornicotine (b) 4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanone (c) N-nitrosoanatabine (d) N-nitrosoanabasine 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, 2016, 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, 2016 29 The portion of items 11 to 13 of Schedule 2 to the Regulations in column 2 is replaced by the following: This table presents the portion of items 11 to 13 of Schedule2 to the regulations in column 2 which is replaced by the following. Item Column 2 Official Method 11 Official Method T-112, Determination of Pyridine, Quinoline and Styrene in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 12 Official Method T-114, Determination of Phenols in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 13 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, 2016 30 (1) The portion of item 14 of Schedule 2 to the English version of the Regulations in column 1 is replaced by the following: This table presents what replaces the portion of item 14 of Schedule 2 to the English version of the Regulations in column1. Item Column 1 Emission 14 (a) 1,3-butadiene (b) Isoprene (c) Acrylonitrile (d) Benzene (e) Toluene (2) The portion of item 14 of Schedule 2 to the Regulations in column 2 is replaced by the following: This table presents the portion of item 14 of schedule 2 to the English version of the regulations in column 1 which is replaced by the following. Item Column 2 Official Method 14 Official Method T-116, Determination of Selected Volatiles in Mainstream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 31 Schedule 3 to the Regulations is amended by replacing the reference after the heading “SCHEDULE 3” with the following: (Section 1, subsection 14(2) and paragraph 14(5)(b)) 32 The portion of item 1 of Schedule 3 to the Regulations in column 2 is replaced by the following: This table presents what replaces the portion of item 1 of Schedule 3 to the Regulations in column 2. Item Column 2 Official Method 1 Official Method T-201, Determination of Ammonia in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 33 Item 2 of Schedule 3 to the Regulations is replaced by the following: This table presents what replaces Item 2 of Schedule 3 to the Regulations. Item Column 1 Emission Column 2 Official Method 2 (a) 1-aminonaphthalene (b) 2-aminonaphthalene (c) 3-aminobiphenyl (d) 4-aminobiphenyl Official Method T-202, Determination of Aromatic Amines in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 34 The portion of items 3 to 8 of Schedule 3 to the Regulations in column 2 is replaced by the following: This table presents what replaces the portion of items 3 to 8 of Schedule 3 to the Regulations in column 2. Item Column 2 Official Method 3 Official Method T-203A, Determination of Benzo[a]pyrene in Sidestream Tobacco Smoke by HPLC, prepared by the Department of Health, dated December 31, 2016, 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, 2016 4 Official Method T-204, Determination of Selected Carbonyls in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 5 Official Method T-205, Determination of Hydrogen Cyanide in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 6 Official Method T-206, Determination of Mercury in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 7 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, 2016 8 Official Method T-208, Determination of Oxides of Nitrogen in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 35 Item 9 of Schedule 3 to the Regulations is replaced by the following: This table presents what replaces item 9 of Schedule 3 to the Regulations. Item Column 1 Emission Column 2 Official Method 9 (a) N-nitrosonornicotine (b) 4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanone (c) N-nitrosoanatabine (d) N-nitrosoanabasine 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, 2016, 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, 2016 36 The portion of items 10 to 12 of Schedule 3 to the Regulations in column 2 is replaced by the following: This table presents what replaces the portion of items 10 to 12 of Schedule 3 to the Regulations in column 2. Item Column 2 Official Method 10 Official Method T-210, Determination of Pyridine and Quinoline in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 11 Official Method T-211, Determination of Phenols in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 12 Official Method T-212, Determination of Tar and Nicotine in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 37 (1) The portion of item 13 of Schedule 3 to the English version of the Regulations in column 1 is replaced by the following: This table presents what replaces the portion of item 13 of Schedule 3 to the English version of the Regulations in column 1. Item Column 1 Emission 13 (a) 1,3-butadiene (b) Isoprene (c) Acrylonitrile (d) Benzene (e) Toluene (f) Styrene (2) The portion of item 13 of Schedule 3 to the Regulations in column 2 is replaced by the following: This table presents what replaces The portion of item 13 of Schedule 3 to the Regulations in column 2. Item Column 2 Official Method 13 Official Method T-213, Determination of Selected Volatiles in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 38 Item 14 of Schedule 3 to the Regulations in column 2 is replaced by the following: This table presents what replaces Item 14 of Schedule 3 to the Regulations in column 2. Item Column 2 Official Method 14 Official Method T-214, Determination of Carbon Monoxide in Sidestream Tobacco Smoke, prepared by the Department of Health, dated December 31, 2016 Transitional Provisions Definitions 39 The following definitions apply in this section and sections 40 and 41. former Regulations means the Tobacco Reporting Regulations, as they read before the day on which these Regulations come into force. (règlement antérieur) reporting period means a quarter, a month or a semi-annual or annual period that is referred to in subsection 11(4), 13(4), 15(1), 15(3) or 16(1) of the former Regulations and in respect of which a report is required to be submitted to the Minister under those Regulations. (période de déclaration) Sections 12, 14 and 14.2 40 (1) Every manufacturer must report to the Minister, in accordance with the former Regulations, any data obtained under section 12, 14 or 14.2 of the former Regulations from the analyses of tobacco products performed during the portion of the year before the day on which these Regulations come into force. Reports (2) Despite these Regulations, every manufacturer must continue to comply with sections 12, 14 and 14.2 of the former Regulations during the portion of the year remaining after the day on which these Regulations come into force, and each report that is required to be submitted under those sections in respect of that portion of the year must be submitted in accordance with the former Regulations. However, a manufacturer need not submit a report in respect of the same data more than once. Sections 11, 13, 15 and 16 to 24 41 Despite these Regulations, every manufacturer must report to the Minister, in accordance with the former Regulations, the information required under sections 11, 13, 15 and 16 to 24 of the former Regulations in respect of the reporting period during which these Regulations come into force. For greater certainty, any analyses performed under subparagraph 11(3)(b)(ix) of the former Regulations for the purpose of reporting in respect of a filter may be performed after the day on which these Regulations come into force. Consequential Amendments To The Tobacco Products Information Regulations 42 Subsection 8(1) of the Tobacco Products Information Regulations (see footnote 3) is replaced by the following: Test methods (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. 43 The portion of items 1 to 3 of Schedule 2 to the Regulations in column 2 are replaced by the following: This table presents what replaces The portion of items 1 to 3 of Schedule 2 to the Regulations in column 2. Item Column 2 Official Method 1 Official Method T-309A, Determination of Tobacco Specific Nitrosamines in Whole Tobacco by GC-TEA, prepared by the Department of Health, dated December 31, 2016 or Official Method T-309B, Determination of Tobacco Specific Nitroamines in Whole Tobacco by LC-MS/MS, prepared by the Department of Health, dated December 31, 2016 2 Official Method T-306, Determination of Toxic Trace Metals (Ni, Pb, Cd, Cr, As, Se and Hg) in Whole Tobacco, prepared by the Department of Health, dated December 31, 2016 3 Official Method T-301, Determination of Nicotine-Related Alkaloids in Whole Tobacco by GC-TSD, prepared by the Department of Health, dated December 31, 2016 Coming into Force 44 These Regulations come into force on the day on which they are registered. [21-1-o] Footnote a S.C. 2009, c. 27, s. 8 Footnote b S.C. 1998, c. 38, s. 3 Footnote c S.C. 1997, c. 13 Footnote 1 When expressed in constant 2012 Canadian dollars using a discount rate of 7% given the introduction of the proposed amendment in 2018, the annualized average of $6,034 is equal to $4,021 (as reported in the “’One-for-One’ Rule” section). Footnote 2 SOR/2000-273 Footnote 3 SOR/2000-272

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