ARCHIVED — Vol. 145, No. 21 — October 12, 2011

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Registration

SOR/2011-179 September 22, 2011

TOBACCO ACT

Regulations Amending the Tobacco Products Information Regulations

P.C. 2011-927 September 22, 2011

Whereas, pursuant to section 42.1 of the Tobacco Act (see footnote a), the Minister of Health laid a copy of the proposed Regulations Amending the Tobacco Products Information Regulations, substantially in the annexed form, before the House of Commons on June 9, 2011 and the House of Commons concurred on June 22, 2011 in a report from the Standing Committee on Health approving the proposed Regulations;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to sections 17 and 33 (see footnote b) of the Tobacco Act (see footnote c), hereby makes the annexed Regulations Amending the Tobacco Products Information Regulations.

REGULATIONS AMENDING THE
TOBACCO PRODUCTS INFORMATION
REGULATIONS

AMENDMENTS

1. (1) The definitions “cigarette”, “equivalent unit”, “mainstream smoke”, “toxic emission” and “unit” in section 1 of the Tobacco Products Information Regulations (see footnote 1) are repealed.

(2) The definitions “carton”, “cigar”, “health information”, “manufacturer”, “slide” and “source document” in section 1 of the Regulations are replaced by the following:

“carton”
« cartouche »

“carton” means a package that contains two or more packages of a tobacco product, other than a tube, a filter or cigarette paper.

“cigar”
« cigare »

“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.

“health information”
« information de santé »

“health information” means the information set out in Part 4 of the source document, but does not include the attribution of that information to its source as provided for in subsection 4(1).

“manufacturer”
« fabricant »

“manufacturer” does not include an individual or entity that only packages or only distributes tobacco products on behalf of a manufacturer.

“slide”
« tiroir »

“slide” means the sliding portion of a slide and shell package.

“source document” « document source »

“source document” means the document entitled Health Warnings and Information for Tobacco Products, published by the Department of Health, dated May 12, 2000, as amended on March 30, 2007.

(3) Paragraph (a) of the definition “kit” in section 1 of the Regulations is repealed.

(4) Paragraph (a) of the definition “health warning” in section 1 of the Regulations is replaced by the following:

  • (a) in respect of cigarette tobacco, kreteks, leaf tobacco and tobacco sticks, the warnings that are set out in Part 1 of the source document;

(5) The definition “health warning” in section 1 of the Regulations is amended by striking out “and” at the end of paragraph (b), by adding “and” at the end of paragraph (c) and by adding the following after paragraph (c):

  • (d) in respect of bidis, chewing tobacco and snuff, the warnings that are set out in subsections 5(4) to (6).

This definition does not include the attribution of those warnings to their source as provided for in subsection 4(1).

(6) The portion of paragraph (a) of the definition “type of package” in section 1 of the Regulations before subparagraph (i) is replaced by the following:

  • (a) in respect of bidis, kreteks and tobacco sticks,

(7) Paragraph (a) of the definition “type of package” in section 1 of the Regulations is amended by adding the following after subparagraph (i):

(i.1) a slide and shell package with a lateral slide,

(8) Section 1 of the Regulations is amended by adding the following in alphabetical order:

“identical products”
« produits identiques »

“identical products” means tobacco products that

  • (a) contain identical ingredients;
  • (b) are manufactured in an identical manner;
    (c) have identical dimensions; and
  • (d) perform in an identical manner under the same testing conditions.

2. Section 2 of the Regulations is replaced by the following:

Retail sale

2. These Regulations apply to every package of tobacco products, other than cigarettes as defined in section 1 of the Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) and little cigars, that is intended for retail sale.

3. Subsection 3(1) of the French version of the Regulations is replaced by the following:

Lisibilité des renseignements écrits

3. (1) Les renseignements écrits à fournir en application du présent règlement sont, à la fois :

  • a) présentés dans les deux langues officielles, de la même façon;
  • b) lisibles et bien en évidence.

4. Section 4 of the Regulations is replaced by the following:

Attribution

4. (1) If a manufacturer attributes health warnings or health information that in accordance with these Regulations must be displayed, the manufacturer shall do so by displaying only the phrase “Health Canada” under the English health warning or health information and the phrase “Santé Canada” under the French health warning or health information. The attribution, which is contained in the electronic files referred to in paragraph 3(2)(a), shall be displayed in the same colour as the text of the health warning or health information and in Universal type in a pitch that is not greater than the smallest pitch used in the attributed health warning or health information.

Removal of attribution

(2) Every manufacturer that does not attribute a health warning or health information may remove the attribution contained in the electronic files referred to in paragraph 3(2)(a).

5. (1) Subsection 5(1) of the Regulations is replaced by the following:

Obligation to display

5. (1) Subject to subsections (4) to (6), every manufacturer of bidis, chewing tobacco, cigarette tobacco, kreteks, leaf tobacco, pipe tobacco (other than pipe tobacco described in section 6), snuff or tobacco sticks shall display the applicable health warnings for the tobacco product on every package of the tobacco product that it manufactures, in accordance with this section.

(2) Paragraph 5(2)(d) of the Regulations is replaced by the following:

  • (d) be selected, except in the case of bidis, chewing tobacco and snuff, from the formats that are set out in the source document for each health warning and based on the shape of the space as determined in accordance with paragraph (b).

(3) The portion of subsection 5(7) of the Regulations before paragraph (b) is replaced by the following:

Equal display

(7) Every manufacturer shall, in respect of each type of package of each brand of tobacco product that the manufacturer packages in a year, display each health warning

  • (a) in the case of cigarette tobacco, kreteks, leaf tobacco and tobacco sticks, on between 3.25% and 9.25% of those tobacco products; and

6. Section 6 of the Regulations is replaced by the following:

Pipe tobacco and cigars

6. (1) Every manufacturer of pipe tobacco contained in a pouch or cigars contained in a box shall display, on only one side of the pouch or box, one of the bilingual health warnings set out in Part 3 of the source document such that the warning is not severed when the pouch or box is opened, as follows:

  • (a) if the side on which the warning is displayed is less than or equal to 149 cm2, using a warning of at least 20 cm2 with the width of the warning measuring not less than 4 cm; and

  • (b) if the side on which the warning is displayed is greater than 149 cm2, using a warning placed on any side of the package other than the bottom, of at least 40 cm2 with the width of the warning measuring not less than 4 cm.

Cigars in bundles

(2) Every manufacturer of cigars contained in a bundle shall display anywhere on the bundle, other than the top and bottom surfaces, one of the bilingual health warnings set out in Part 3 of the source document such that the warning is at least 40 cm2 with the width of the warning measuring not less than 4 cm.

7. (1) The portion of subsection 7(1) of the Regulations before paragraph (a) is replaced by the following:

Display

7. (1) Every manufacturer of cigarette tobacco (other than cigarette tobacco contained in a pouch), kreteks, leaf tobacco or tobacco sticks shall display health information in the following manner:

(2) The portion of paragraph 7(1)(a) of the French version of the Regulations before subparagraph (ii) is replaced by the following:

  1. a) dans le cas de tout emballage, à l’exception d’un paquet à coulisse ou d’un pot :

    1. (i) soit en un endroit quelconque de l’emballage, à l’exception de la principale surface exposée et du dessous, de façon que les versions française et anglaise soient côte à côte, qu’elles soient centrées et qu’ensemble elles occupent de 60 % à 70 % de la surface du côté utilisé,

(3) The portion of paragraph 7(1)(b) of the French version of the Regulations before subparagraph (i) is replaced by the following:

  1. b) dans le cas d’un paquet à coulisse :

(4) Subsection 7(3) of the Regulations is replaced by the following:

Equal display

(3) Every manufacturer shall, in respect of each type of package of each brand of tobacco product specified in subsection (1) that the manufacturer packages in a year, display each message on between 3.25% and 9.25% of those tobacco products.

8. Sections 8 and 9 of the Regulations are replaced by the following:

Test methods

8. (1) Section 4 and subsections 12(4), (5) and (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.

Exception

(2) A manufacturer is not required to perform the tests in respect of a particular brand of tobacco product if the manufacturer

  • (a) sells identical products under more than one brand, including the particular brand;

  • (b) performs the tests in respect of another of those brands of identical products (in this subsection referred to as the “reference brand”);

  • (c) displays, in accordance with section 10, on the packages of the reference brand the information obtained from the tests described in paragraph (b); and

  • (d) displays, in accordance with section 10, the same information on the packages of all of the other brands of identical products, including the particular brand.

Toxic emissions

9. Every manufacturer of cigarette tobacco, kreteks, leaf tobacco and tobacco sticks shall display on every package, other than a carton, kit or wrapper, of those tobacco products the texts “Some of the toxic emissions: Tar, Nicotine, Carbon monoxide, Formaldehyde, Hydrogen cyanide, Benzene” and “Quelques-unes des émissions toxiques : goudron, nicotine, monoxyde de carbone, formaldéhyde, acide cyanhydrique, benzène” such that those texts are one under the other.

9. (1) The marginal note to section 11 of the English version of the Regulations is replaced by “Placement, presentation and expression.”

(2) Paragraph 11(b) of the Regulations is replaced by the following:

  • (b) in Helvetica bold type in black characters of 10 points on a white background, or, if it is impossible to display the information without occupying more than 70% of the surface on which it is to be displayed under paragraph (a), in a pitch that results in the information occupying not less than 60% of that area; and

10. The heading before section 12 of the French version of the Regulations is replaced by the following:

PAQUETS À COULISSE

11. (1) Subsection 12(1) of the Regulations is replaced by the following:

Texts to be displayed

12. (1) Every manufacturer of bidis, kreteks or tobacco sticks contained in slide and shell packages shall, in accordance with this section, display on the upper slide-flap the health information that is set out for that purpose in Part 4 of the source document.

(2) Subsection 12(3) of the Regulations is replaced by the following:

Equal display

(3) Every manufacturer shall, in respect of each brand of tobacco product specified in subsection (1) that the manufacturer packages in a year, display each message on between 3.25% and 9.25% of those tobacco products.

(3) Subsection 12(4) of the Regulations is replaced by the following:

Definition of “upper slide-flap”

(4) In this section, “upper slide-flap” means, in respect of a slide and shell package, the extremity of the slide that can be folded and is concealed by the shell when the package is closed and that is visible when the package is used in the customary manner to gain access to the product.

12. (1) The portion of subsection 13(1) of the French version of the Regulations before paragraph (a) is replaced by the following:

Renseignements

13. (1) Le fabricant d’un produit du tabac contenu dans une cartouche ou une trousse doit, en plus des renseignements à inscrire sur chaque emballage, faire figurer sur la cartouche ou la trousse les renseignements suivants :

(2) Clause 13(1)(c)(ii)(B) of the Regulations is replaced by the following:

(B) in any other case except bidis, the texts “Some of the toxic emissions: Tar, Nicotine, Carbon monoxide, Formaldehyde, Hydrogen cyanide, Benzene” and “Quelques-unes des émissions toxiques : goudron, nicotine, monoxyde de carbone, formaldéhyde, acide cyanhydrique, benzène”.

13. Schedule 1 to the Regulations is repealed.

TRANSITIONAL

14. (1) In this section, “former Regulations” means the Tobacco Products Information Regulations as they read immediately before the day on which these Regulations come into force.

(2) In this section, “former source document” means the document defined as “source document” in section 1 of the former Regulations.

(3) Despite these Regulations, if a package of a tobacco product, other than cigarettes or little cigars, or any accompanying leaflet displays information in accordance with the former Regulations, the former Regulations continue to apply to the package or the leaflet until the day that is 18 months after the day on which these Regulations come into force. However, if a package of a tobacco product displays one of the health information messages reproduced from the electronic images obtained from the electronic files used by the Minister to generate the former source document, the manufacturer may continue to display that message until the day that is three years after the day on which these Regulations come into force.

COMING INTO FORCE

15. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary


Issue: Firstly, the current labelling requirements for health warnings, health information messages and toxic emissions information on packages of tobacco products are prescribed in the Tobacco Products Information Regulations (TPIR). In light of the introduction of the new Tobacco Products Labelling Regulations (Cigarettes and Little Cigars), the labelling requirements for cigarettes and little cigars in the TPIR will become obsolete and have to be removed. Secondly, the Standing Joint Committee for the Scrutiny of Regulations identified several technical errors in the TPIR, including grammar, terminology, and accordance of the English and French versions. Thirdly, the numerical values for toxic emissions that currently appear on tobacco product packaging have been found to be confusing and not clearly understood by smokers.

Description: The Regulations Amending the Tobacco Products Information Regulations (the Regulations) serve three main purposes: to remove the application of the TPIR to cigarettes and little cigars, to respond to the problems identified by the Standing Joint Committee for the Scrutiny of Regulations and to remove the obligation to list numerical values for toxic emissions.

Cost-benefit statement: The main benefit of this regulatory initiative will be to the health of Canadians through the removal of the numerical values for toxic emissions, which, in turn, will enable smokers to receive better information about the chemicals in tobacco smoke and obtain a better understanding of the health risks associated with the use of tobacco products. The benefit to the health of Canadians outweighs the relatively minor economic costs to the tobacco industry.

Business and consumer impacts: If the additional packaging costs were to be passed on to consumers, the retail price of a package of a tobacco product would be expected to increase by less than 1%.

Domestic and international coordination and cooperation: Domestic and international manufacturers of tobacco products were notified of the amendments and a 75-day comment period was provided. They will be notified again once these Regulations are made and then published in the Canada Gazette, Part Ⅱ. The Regulations are not expected to affect any international trade agreement or have any significant trade implications.


Issue

The Tobacco Products Information Regulations (TPIR) came into force in 2000. The TPIR have been amended as a result of three main factors: the introduction of the Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) [TPLR-CLC], technical errors identified by the Standing Joint Committee for the Scrutiny of Regulations, and problems associated with the interpretation of numerical values for toxic emissions on packages of most smoked tobacco products.

TPLR-CLC

The new TPLR-CLC specify labelling requirements for health warnings, health information messages and toxic emissions statements for packages of cigarettes and little cigars. Prior to the TPLR-CLC, labelling requirements for those two types of tobacco products have been found in the TPIR. The applicability of the TPIR to these tobacco products are now obsolete and therefore have been removed concurrently with the coming into force of the TPLR-CLC.

Standing Joint Committee for the Scrutiny of Regulations

The Standing Joint Committee for the Scrutiny of Regulations identified problems in the TPIR with respect to redundant language, clarity and consistency in both the English and French language versions, consistency between the English and French renderings and errors in grammar and terminology.

Numerical values for toxic emissions

The TPIR have required that numerical values for the quantity of six toxic emissions (tar, nicotine, carbon monoxide, formaldehyde, hydrogen cyanide and benzene) be displayed on the sides of packages of most smoked tobacco products.

It was intended that this information would serve an educational purpose, supporting one of the main purposes of the Tobacco Act, to enhance public awareness of the health hazards of using tobacco products. However, research conducted for the Department of Health indicated that the numerical values are not clearly understood by some smokers and that most have little idea what the range of numbers displayed for each chemical means.

Objectives

The first objective of the Regulations is to remove the applicability of the TPIR to cigarettes and little cigars, in order to support the introduction of the TPLR-CLC.

The second objective is to correct the technical errors identified by the Standing Joint Committee for the Scrutiny of Regulations as well as minor deficiencies reported by departmental officials and the tobacco industry. Included are minor changes to 5 of the 16 health information messages found in the “source document.”

The third objective is to respond to the evidence that many smokers do not understand the numerical values for toxic emissions and may find it confusing, by removing the obligation to list these values on packages of four types of smoked tobacco products (cigarette tobacco, kreteks, leaf tobacco and tobacco sticks). However, the requirement to display the names of the six toxic emissions continues.

Description

The TPIR came into force in 2000. The TPIR established the requirements for information that must be displayed on tobacco products that are for retail sale in Canada and support the federal Tobacco Act in providing a legislative response to a national health problem of substantial and pressing concern.

The TPIR set out specific requirements for graphics, size, location and content of information to be displayed — all aimed at ensuring that tobacco products display health warning messages, health information messages and information about their toxic emissions or constituents in a way that is easily legible, in a similar manner in both official languages and, where specified, in colour.

The Regulations amend the TPIR in three ways:

(1) Removal of the applicability of the TPIR to cigarettes and little cigars when the TPLR-CLC come into force

The TPLR-CLC are new regulations that replace the TPIR with respect to labelling requirements for cigarettes and little cigars. As a result, several sections of the TPIR have been amended to remove the application of those Regulations to those products. However, the TPIR will continue to apply to other tobacco products, including bidis, cigars, cigarette tobacco, kreteks, leaf tobacco, pipe tobacco, smokeless tobacco and tobacco sticks.

For consistency between the TPLR-CLC and the TPIR, the definition of “cigarette” in the TPIR has been removed and replaced by reference to the definition found in the TPLR-CLC. In addition, the definition of “cigar” has been modified to ensure that the definition excludes little cigars. (Note: The equivalent French definition of “cigare” has been modified slightly since the prepublication in response to comments received.)

(2) Response to the review by the Standing Joint Committee for the Scrutiny of Regulations

The Standing Joint Committee for the Scrutiny of Regulations identified problems in the TPIR with respect to redundant language, clarity and consistency in both the English and French language versions, as well as consistency between the English and French versions and to errors in terminology. In addition, several minor deficiencies reported by departmental officials and the tobacco industry have been addressed at the same time.

Section 1

The Regulations amend section 1 of the TPIR by clarifying the following definitions:

— “carton” — modify the definition to delete the phrase “intended to be sold to consumers” — the words are redundant as the concept is covered in the revised version of section 2 (note: the revision of the definition of “carton” is an addition since prepublication in response to comments received);

— “health information” — modify the definition to clarify that words appearing in Part 4 of the source document that attribute the information to its source are not part of the definition;

— “health warning” — modify the definition to include reference to provisions that set out health warnings but are not currently referenced in the definition, specifically health warnings for bidis (a thin cigarette of tobacco rolled in a dry leaf, usually made in South Asia), chewing tobacco and snuff, and to clarify that words appearing in Parts 1, 2 and 3 of the source document that attribute the information to its source are not part of the definition;

— “manufacturer” — modify the definition to exclude the words “includes an importer of tobacco products” — the words are redundant in that the concept of importing of tobacco products is already in the definition of “manufacture” found in the Tobacco Act;

— “slide” — modify the definition to reflect accurately its use in other sections of the Regulations — this clarifies that slide is part of a “slide and shell” package;

— “source document” — modify the definition in order to provide reference to an amended version of the document Health Warnings and Information for Tobacco Products — the source document has been amended to correct several minor errors and omissions, including minor changes to 5 of the 16 health information messages; and

— “type of package” — modify the definition to add “slide and shell package with a lateral slide” — will maintain consistency among the various regulations under the Tobacco Act.

Section 1 is also amended to add the following definition:

— “identical products” — this definition will support the new wording in subsection 8(2) to describe which tobacco products are exempted from the requirements for toxic constituent testing.

Section 4

The Regulations amend subsection 4(1) by clarifying that manufacturers who wish to attribute health warnings or health information can find the information required by this section for such an attribution in the source document.

Section 5

The Regulations amend section 5 by deleting the word “cigares” (subsection 5(1), French version only), by clarifying that the formats for display of health warnings, except in the case of bidis, chewing tobacco and snuff, be selected from the formats set out in the source document — not, as is currently stated, from formats provided by the Minister (paragraph 5(2)(d)) — and by clarifying that the requirement for equal display of health warnings applies to each type of package of each brand (subsection 5(7)). (Note: the revised wording of subsection 5(7) has been modified slightly since prepublication in response to comments received.)

Section 6

The Regulations amend section 6 to change the word “label” to “warning” for clarity, paragraphs 6(1)(a) and (b) to change the word “surface” to “side” to provide consistency with the terminology used in the first paragraph of subsection 6(1), and subsection 6(2) to reorder the sentence to improve comprehension.

Section 7

The Regulations amend subparagraph 7(1)(a)(i) by deleting the word “extérieur” (French version only) and by clarifying provisions for equal display of health information on leaflets (subsection 7(3)) in English by aligning the wording more accurately with the French version.

Section 8

The Regulations amend section 8 by deleting the reference to section 5 (alternative methods) of the Tobacco Reporting Regulations (TRR) as applying to testing for toxic constituents required by the TPIR (subsection 8(1)) and by deleting the references to subsections 14(3) [emissions — sampling] and 14(4) [emissions — replicates] of the TRR (subsection 8(1)) as well as the reference to section 9 of the TPIR, as the methodology for determining quantities of toxic emissions is no longer required with the removal of the requirement for this information to be displayed on packages (see the last paragraph of “Obligation to display numerical values in the toxic emissions information” following). The Regulations also clarify the wording to describe which tobacco products are exempted from the requirements for toxic constituent testing (subsection 8(2)).

Section 11

The Regulations amend section 11 by clarifying the requirements for the height of characters to be used in the printing of toxic emissions and toxic constituents information on packages (paragraph 11(b)), as the phrase “in a pitch of 10 points” was not correct terminology. The marginal note in the English version has been amended to provide a better description of the section. (Note: the revised wording of paragraph 11(b) has been modified slightly since prepublication in response to comments received.)

Section 12

The Regulations amend section 12 by removing the phrase “Subject to subsection (3)” (subsection 12(1)) as this phrase is unnecessary and by clarifying that the requirement for equal display of health information applies to each brand (subsection 12(3)).

In addition to the above, the French rendition of the term for a “slide and shell package,” “paquet à coulisse,” has been made consistent throughout the Regulations. Also, in the French version, the term “information” has been replaced by the term “renseignements” where health warnings and health information are referred to jointly.

(3) Obligation to display numerical values in the toxic emissions information

The toxic emissions information displayed on packages of certain types of smoked tobacco products was originally intended to provide smokers with information on 6 compounds found in the smoke they inhale to help them gain a better understanding of the health risks associated with the use of tobacco products (there are more than 4 000 compounds found in tobacco smoke).

Currently, numerical values must be displayed on the side of packages of five types of smoked tobacco products, for six toxic substances found in the smoke of these products. The five types of tobacco products are cigarettes, cigarette tobacco, kreteks, leaf tobacco and tobacco sticks, whereas the six toxic substances are tar, nicotine, carbon monoxide, formaldehyde, hydrogen cyanide and benzene.

The toxic emissions values are expressed as a range, with the lower number determined according to smoking conditions set in a method from the International Organization for Standardization (ISO) and the higher number by the same method but with modified smoking conditions (e.g. larger puff volumes). As no two people smoke the same way, it was reasoned that providing a lower and upper value of the yields for various toxic emissions would provide a better indication of the potential amounts of toxic substances a person might inhale.

The Department of Health has had research conducted which indicates that the numerical values for toxic emissions that currently appear on tobacco product packaging are not clearly understood by some smokers. In a 2003 study, most participants stated that they “have no idea” or “don’t really know” what the numbers mean. Participants were also confused about whether the numbers referred to dose per cigarette or per package of cigarettes and the presence of a range of numbers made many of them question the accuracy of the numbers. A second 2003 study found that most people had little idea what the range of numbers for each chemical meant. People also questioned the accuracy of the large range of measurements. As a result, many people concluded that the numbers did not really mean anything. Only 17% of participants understood that the toxic emissions values are related to the fact that some smokers may take in larger amounts of smoke while other smokers may take in less.

In addition, the Guidelines for Implementation of Article 11 of the WHO Framework Convention on Tobacco Control advise Parties to the treaty not to require quantitative or qualitative statements on tobacco product packaging and labelling about toxic emissions that might imply that one brand is less harmful than another, such as tar, nicotine and carbon monoxide figures. The WHO Scientific Advisory Committee on Tobacco Products Regulation had previously recommended that tar, nicotine, and carbon monoxide numerical ratings not be displayed.

Based on the above, the Regulations remove the requirement to have the toxic emissions values displayed on the sides of packages of four types of smoked tobacco products, namely cigarette tobacco, kreteks, leaf tobacco and tobacco sticks. As a result, the list of six toxic substances emitted during smoking will still remain but without the numerical values. The requirement for information on the amount of toxic constituents to be displayed on packages of smokeless tobacco products is not affected by these amendments.

Internationally, Canada joins Australia, Brazil and Venezuela, which have already removed the obligation to display toxic emissions values on tobacco product packaging. It should be noted that many countries, including the United States, do not require toxic emissions values to be displayed on tobacco product packaging.

The Regulations therefore amend section 9, as well as clause 13(1)(c)(ii)(B), by eliminating the requirement for information on the amount of each toxic emission. Concurrently, the Regulations also repeal Schedule 1, which describes the official methods for the collection of data on toxic emissions, and the definitions in section 1 for “equivalent unit,” “mainstream smoke,” “toxic emission” and “unit,” which are no longer required.

Coming into force and transition period

The Regulations came into force upon registration. The coming into force date has been coordinated with the coming into force date for the TPLR-CLC.

The Regulations provide for a transition period of 18 months during which time the current TPIR will continue to apply to packages of tobacco products, other than cigarettes and little cigars, and any accompanying leaflets that are in accordance with that version. For cigarettes and little cigars, transitional provisions in the TPLR-CLC provide transition periods that will allow manufacturers and retailers to continue to sell packages of those products that display information, in accordance with the current TPIR for six months and nine months respectively after the TPLR-CLC come into force. These provisions will allow tobacco product packages and leaflets that have been printed before the Regulations came into force to be sold through the system.

The Regulations also provide a second transitional period to allow packages that display health information messages that have been reproduced from the electronic images obtained from the electronic files used to generate the former “source document” to continue to display those health information messages for three years after the Regulations come into force. This provision will allow manufacturers of the tobacco products still covered by the TPIR to coordinate routine packaging changes with the changes required to the health information messages.

Regulatory and non-regulatory options considered

Given the nature and purpose of the amendments to remove the applicability of the TPIR to cigarettes and little cigars when the TPLR-CLC come into force and to correct technical errors identified by the Standing Joint Committee for the Scrutiny of Regulations, no alternatives were considered.

Regarding the numerical toxic emissions information, various requirements have been implemented since 1989. A consultation, held in 2004, proposed new approaches and sought public input on the type of information to be displayed. Further to this consultation, the Department of Health is introducing in the TPLR-CLC text-based statements with easy to understand information about harmful toxic emissions for cigarettes and little cigars. For the tobacco products that will continue to be regulated by the TPIR, the Department believes that the recommendation of the WHO should be followed and that the removal of the obligation to display the numerical toxic emissions values is the most appropriate public health measure to implement. The following alternatives were considered.

(1) Status quo

The toxic emissions information displayed on packages of certain types of smoked tobacco products was originally intended to provide facts to smokers to help them gain a better understanding of the health risks associated with the use of tobacco products. However, in light of the recommendations from the WHO and of research conducted for the Department of Health indicating that many people do not understand the toxic emissions values, it is a reasonable conclusion that those values should be removed while the list of six toxic emissions should remain.

(2) Public education campaign

A public education campaign to explain how to interpret the toxic emissions values was examined as an alternative. However, this option was not retained given the challenge of explaining the complexity of the smoking process to the general public and considering that the toxic emissions values would still not be reliable as a source of information about individual exposure.

(3) Voluntary removal of toxic emissions values

The voluntary removal of the toxic emissions values by industry is not an option because the inclusion of both the six toxic substances and their corresponding numerical toxic emissions values is a current regulatory requirement.

Benefits and costs

Costs

The amendments to remove the applicability of the TPIR to cigarettes and little cigars when the TPLR-CLC come into force and in response to the Standing Joint Committee for the Scrutiny of Regulations are cost neutral.

While there will be no new costs to the federal government as a result of the Regulations, the tobacco industry will incur costs because of changes required to the packaging of tobacco products, and it could be anticipated that these costs will be passed on to consumers.

Industry costs related to the removal of the obligation to display toxic emissions values

The costs to the tobacco industry associated with the removal of the values from the toxic emissions information have been interpolated from the response of one major cigarette manufacturer to a survey carried out on behalf of the Department of Health in 2006. Taking into account recent changes in tobacco manufacturing in Canada, it was estimated that the one-time costs of removing the toxic emissions values from most smoked tobacco product packaging would have been approximately $1,500,000. The estimate would be much less if limited to those tobacco products that will remain regulated under the TPIR, namely cigarette tobacco, kreteks, leaf tobacco and tobacco sticks. These products comprise a very small portion of the market for tobacco products in Canada.

In addition, inventory-related costs will be mitigated significantly through the provision of an 18-month transition period that will allow tobacco product packages that have been printed before the amendments came into force to be sold through the system.

Industry costs related to modifications of the health information messages

The amendment of the source document includes minor changes to five of the sixteen health information messages, three affecting both the slide and shell and the leaflet versions, one affecting only the slide and shell version and one affecting only the leaflet version.

From estimates done in 2006, the one-time costs of applying the new requirements to cigarette packages, printed using a rotogravure process to engrave printing cylinders, would have been expected to be less than $500,000. The amendments of the TPIR remove cigarettes and little cigars from the application of the TPIR. Manufacturers of the remaining tobacco products that will require health information messages, namely cigarette tobacco, kreteks, leaf tobacco and tobacco sticks, use techniques such as lithography or laser printing for printing health information messages. The costs for these manufacturers to change the health information messages, on both packages and leaflets, will be much less than the costs of engraving cylinders.

Furthermore, costs will be further mitigated through the provision of a three-year transition period that will allow packages that display health information messages that have been reproduced from the electronic images obtained from the electronic files used to generate the former “source document” to continue to display those health information messages. This provision will allow manufacturers of the tobacco products still covered by the TPIR to coordinate routine packaging changes with the changes required to the health information messages.

The maximum total one-time costs for the revisions to the health information messages are expected to be much less than $500,000.

If the additional packaging costs were to be passed on to consumers, the retail price of a package of a tobacco product would be expected to increase by less than 1%.

Benefits

The main health benefits of these Regulations are expected to result from the removal of the obligation to display the toxic emissions values on the tobacco products still regulated by the TPIR (cigarette tobacco, kreteks, leaf tobacco and tobacco sticks). This will better align Canadian regulations with current international expert opinion on the provision of information on toxic emissions and remove information from tobacco packaging that may be confusing and not understood by smokers.

Although the health benefits of the Regulations are very difficult to quantify and while the health benefits are not expected to be large, nevertheless they may result in reduced health care costs, reduced demand on the healthcare system and increased productivity.

Cost-Benefit Statement

Year 1

Year 10

Total (PV)
at 8%

Average
Annual

Quantified impacts $

Costs

Tobacco industry

Less than $2M

$0

$2M

$200K

C. Qualitative impacts

  • Remove information from tobacco packaging that may be confusing and is not understood by smokers;
  • Limit potential that smokers will misinterpret information that may affect their decision to quit smoking and improve their health; and
  • Better align Canadian regulations with current international expert opinion.

Rationale

The removal of the obligation to display toxic emissions values removes information from tobacco packaging that is not understood by smokers. This will mean that smokers will have better information about the chemicals in tobacco smoke and a better understanding of the health risks associated with the use of tobacco products.

The maximum total one-time costs to the tobacco industry for the removal of the numeric values for the toxic emissions and the revisions to the health information messages are expected to be much less than $2,000,000, costs which can be easily recouped through a very small increase in the price of their products.

The benefit of these Regulations to the health of Canadians outweighs the relatively minor economic costs to the tobacco industry.

Consultation

Report of the Standing Committee on Health and concurrence by the House of Commons

The Regulations were laid before the House of Commons on June 9, 2011, with the Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) and the Promotion of Tobacco Products and Accessories Regulations (Prohibited Terms). The Standing Committee on Health held hearings on the three regulations on June 20, 2011. In their report presented to the House of Commons on June 22, 2011, the Committee recommended adoption of the three regulations without amendment.

The House of Commons concurred with the Committee report on June 22, 2011.

Prepublication — February 19, 2011

There were five submissions representing six organizations with respect to the proposed Regulations, one from the tobacco industry, three from health-related non-governmental organizations (NGOs) and one from a provincial government department. The Standing Joint Committee for the Scrutiny of Regulations also reviewed the proposed Regulations and provided brief comments.

Industry

The tobacco industry questioned the accuracy of the new toxic emissions information because it fails to clarify that the toxic substances are emitted by the smoke of the products and not by the product itself.

In addition, the industry suggested that the Department of Health consider the extent to which removing emissions values from packages will prevent smokers from being able to choose their preferred product in the marketplace. The industry also remarked that low tar and nicotine delivery products were introduced into the Canadian cigarette market at the behest of the Canadian government and that the concept of displaying emissions values on packages was the Government’s idea in the first place.

The industry noted that the Regulations Amending the Stamping and Marking of Tobacco Products Regulations (2011) state that the tobacco excise stamp shall not be affixed so as to obstruct “any information that is required by or under an Act of Parliament to appear on the package” and suggested that provisions should be made in the TPIR, similar to those in the TPLR-CLC, allowing a measured encroachment of the federal tax stamp, to enable the affixing of the stamp.

Health non-governmental organizations

The health NGOs generally supported the regulatory proposals but commented that the transition times should be shorter, particularly for the removal of the numeric values in the toxic emissions information.

Government

The provincial government department supported shortening the timelines for industry compliance, suggesting 12 months instead of 18 for the removal of the numeric values in the toxic emissions information, and 2 years instead of 3 to make the corrections required for the health information messages.

Government response

With respect to the comment from industry as to the accuracy of the toxic emissions information, the Department of Health does not agree. The word “emission” means something that is sent out or discharged, hence combusted or smoked. With respect to the comment that removing emissions values from packages will prevent smokers from being able to choose their preferred product in the marketplace, the Department of Health notes that the availability of tobacco products currently on the Canadian market would not be affected by the amended TPIR.

With respect to the suggestion that provisions should be made in the TPIR to allow a measured encroachment of the federal tax stamp, the Department of Health expects the industry to apply the federal tax stamp in a manner that meets the requirements of the Canada Revenue Agency while minimizing the encroachment of the stamp onto the information required by the TPIR. Minimal overlap may be inevitable in some situations but should not affect the legibility and prominence of the information required by the TPIR. It should be noted that the Department continues to work with the Canada Revenue Agency to ensure that packaging changes are coordinated.

With respect to the comments from the NGOs and the provincial government on the transition periods, the rationale is provided previously in this RIAS. Specifically with respect to the requirement to remove the numerical value for the toxic emissions information, the small number of affected products should work their way through the supply chain in the allotted time. With respect to the revised health information messages, the changes are very minor, such as correction of spelling errors.

It should be noted that the Standing Joint Committee for the Scrutiny of Regulations reviewed the proposed Regulations after prepublication and indicated that their concerns had been addressed. However, two additional minor discrepancies between the English and French versions were identified and have been corrected. Several other minor changes were made to the Regulations as noted in the Description section.

First prepublication in the Canada Gazette, Part Ⅰ (May 2008)

Many of the amendments included in these Regulations were first prepublished in the Canada Gazette, Part Ⅰ, on May 31, 2008. That notice outlined the Department of Health’s response to the Standing Joint Committee for the Scrutiny of Regulations and included a proposed amendment to remove the obligation to list numerical values for toxic emissions on tobacco packaging. However, the new TPLR-CLC, which replace the TPIR with respect to cigarettes and little cigars, have necessitated a significant change to the scope of the TPIR which in turn necessitated a new prepublication of the Regulations. Interested persons were invited to provide comments within 75 days of the date of publication of the notice. The Department of Health received nine responses to the proposed Regulations from a variety of stakeholders, including non-governmental organizations (NGOs), the tobacco industry and individual Canadians.

The comments generally fit into six categories: the response to the Standing Joint Committee for the Scrutiny of Regulations, the proposal to remove the obligation to display numerical values in the toxic emissions information, the transition time, the alternatives considered, the benefits and costs and recommendations for future packaging requirements.

August 2004 consultation document

A public consultation paper titled Building on Success: A Proposal for New Health-related Information on Tobacco Product Labels was released in August 2004 and widely disseminated through a mailing to the tobacco industry, non-governmental organizations, public interest groups, professional organizations and others, as well as through posting on the Health Canada Web site. This paper included a proposal to replace the current toxic emissions information with a series of statements that would present clear and concise information about the toxicity of each of eight substances found in tobacco smoke, including its health effect and its range of toxic emissions values.

Respondents from non-governmental and governmental organizations supported the proposal, with four recommending that the range of toxic emissions values be removed. Respondents from the tobacco industry generally neither supported nor opposed the proposal, although they emphasized that the information should be objective and fairly presented.

Implementation, enforcement and service standards

Compliance with these requirements will be monitored through inspections at the retail and manufacturing/importing levels that will be undertaken to ensure that all changes, including those affecting the toxic emissions values, have been made in accordance with these amendments, taking into account the transitional period.

Contact

Manager
Regulations Division
Office of Regulations and Compliance
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Address Locator: 3507C1
123 Slater Street
Ottawa, Ontario
K1A 0K9
Fax: 613-941-1551
Email: pregs@hc-sc.gc.ca

Footnote a
S.C. 1997, c. 13

Footnote b
S.C. 1998, c. 38, s. 3

Footnote c
S.C. 1997, c. 13

Footnote 1
SOR/2000-272