WHO FRAMEWORK

CONVENTION ON
TOBACCO CONTROL

Partial
guidelines
for implementation
articles 9 and 10
Regulation of the contents of
tobacco products and regulation
of tobacco product disclosures
 Articles 9 and 10
Partial guidelines
for implementation of
Articles 9 and 10
Adopted by the Conference of the Parties at its fourth session (decision FCTC/COP4(10))with amendments
adopted at the fifth session (decision FCTC/COP5(6)) and at theseventhsession(decisionFCTC/COP7(14)).

Online version available at http://www.who.int/fctc/treaty_instruments/guidelines_articles_9_10_2017_

english.pdf

© World Health Organization 2017

FCTC/16.3
 Partial guidelines for implementation: Articles 9 and 10

PARTIAL GUIDELINES FOR IMPLEMENTATION OF ARTICLES 9

AND 10 OF THE WHO FRAMEWORK CONVENTION ON
TOBACCO CONTROL1

REGULATION OF THE CONTENTS OF TOBACCO PRODUCTS

AND OF TOBACCO PRODUCT DISCLOSURES

1. PURPOSE, OBJECTIVES AND USE OF TERMS

1.1 Purpose

The purpose of the guidelines is to assist Parties in meeting their obligations

under Articles 9 and 10 of the WHO Framework Convention on Tobacco Control
(WHO FCTC). The guidelines, drawing on the best available scientific evidence
and the experience of Parties, propose measures that may assist Parties in
strengthening their tobacco-control policies through regulation of the contents
and emissions of tobacco products and through regulation of tobacco product
disclosures. Parties are also encouraged to implement measures beyond those
recommended by these guidelines.2

Whereas Article 9 deals with the testing and measuring of the contents and emissions
of tobacco products, and their regulation, Article 10 deals with the disclosure of
information on such contents and emissions to governmental authorities and the
public. Owing to the close relationship between these two articles, guidance for
their implementation has been consolidated into one set of guidelines.

1.2 Objectives

1.2.1 Regulation of the contents and emissions of tobacco products

One objective of the guidelines is to support Parties in developing effective

tobacco product regulation. Tobacco product regulation has the potential to
contribute to reducing tobacco-attributable disease and premature death by
reducing the attractiveness of tobacco products, reducing their addictiveness
(or dependence liability) or reducing their overall toxicity.

1.2.1.1 Attractiveness
Tobacco products are commonly made to be attractive in order to encourage
their use. From the perspective of public health, there is no justification for

1 As adopted by the COP at its fourth session in 2010, with amendments adopted at its fifth session in
2012.
2 Parties are directed to the WHO FCTC web site (http://www.who.int/fctc/) where further sources of
information on topics covered by these guidelines are maintained.

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permitting the use of ingredients, such as flavouring agents, which help make
tobacco products attractive. Other measures to reduce the attractiveness of
tobacco products have been included in the guidelines on the implementation
of Articles 11 and 13 of the WHO FCTC.3

The WHO FCTC, in its preamble, recognizes that tobacco products are harmful
and create and maintain dependence. Any reduction of their attractiveness
resulting from removing or reducing certain ingredients in no way suggests
that those tobacco products are less dangerous for human health.

1.2.1.2 Addictiveness (dependence liability)

(This section has been left blank intentionally to indicate that guidance will be
proposed at a later stage.4)

1.2.1.3 Toxicity
(This section has been left blank intentionally to indicate that guidance will be
proposed at a later stage.)

1.2.2 Disclosure to governmental authorities

Pursuant to Article 10, the primary objective of requiring disclosure to

governmental authorities is to obtain from manufacturers and importers
relevant information on the contents and emissions of tobacco products, as
well as on their toxicity and addictiveness. This information is required for the
development and implementation of relevant policies, activities and regulations,
such as further analysis of tobacco product contents and emissions, monitoring
of market trends, and assessment of tobacco industry claims.

1.2.3 Disclosure to the public

Pursuant to Article 10, the primary objective of public disclosure of information

about the toxic constituents and emissions of tobacco products is to inform the
public of the health consequences, addictive nature and mortal threat posed by
tobacco consumption and exposure to tobacco smoke. This information may
also assist the public in contributing to the development and implementation of
relevant policies, activities and regulations.

1.3 Use of terms

“Attractiveness” refers to factors such as taste, smell and other sensory

attributes, ease of use, flexibility of the dosing system, cost, reputation or image,

3 See WHO Framework Convention on Tobacco Control: guidelines for implementation. Article 5.3;
Article 8; Article 11; Article 13. Geneva, World Health Organization, 2009.
4 The guidelines are partial and will be completed in phases as new country experience, and scientific,
medical and other evidence become available. Further progress will also depend on the validation
of the analytical chemical methods for testing and measuring cigarette contents and emissions and
other work pursuant to the decision by the Conference of Parties at its third session (decision FCTC/
COP3(9)).

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assumed risks and benefits, and other characteristics of a product designed to

stimulate use.5

“Contents” means “constituents” with respect to processed tobacco, and

“ingredients” with respect to tobacco products. In addition:

• “Constituents”:

(This section has been left blank intentionally to indicate that guidance will be
proposed at a later stage.)

• “Ingredients” include tobacco, components (e.g. paper, filter), including

materials used to manufacture those components, additives, processing
aids, residual substances found in tobacco (following storage and
processing), and substances that migrate from the packaging material
into the product (contaminants are not part of the ingredients).

“Design feature” means a characteristic of the design of a tobacco product that

has an immediate causal link with the testing and measuring of its contents
and emissions. For example, ventilation holes around cigarette filters decrease
machine-measured yields of nicotine by diluting mainstream smoke.

“Emissions” are substances that are released when the tobacco product is
used as intended. For example, in the case of cigarettes and other combusted
products, emissions are the substances found in the smoke. In the case of
smokeless tobacco products for oral use, emissions are the substances released
during the process of chewing or sucking, and in the case of nasal use, refer to
substances released by particles during the process of snuffing.

“Expanded tobacco” is tobacco that has been expanded in volume by quick

volatilization of a medium such as dry ice.

“Reconstituted tobacco” is a paper-like sheet material comprised mainly of

tobacco.

“Tobacco industry” means, as defined in Article 1 of the WHO FCTC, “tobacco

manufacturers, wholesale distributors and importers of tobacco products”.

“Tobacco products”, as defined in Article 1 of the WHO FCTC, are “products

entirely or partly made of the leaf tobacco as raw material which are
manufactured to be used for smoking, sucking, chewing, or snuffing”.

5 WHO. The scientific basis of tobacco product regulation: Report of a WHO Study Group. WHO
Technical Report Series 945. Geneva, World Health Organization, 2007.

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2. PRACTICAL CONSIDERATIONS

2.1 Approval and implementation of measures pursuant to Article 9

As stated in Article 9 of the WHO FCTC, each Party shall, where approved
by competent national authorities, adopt and implement effective legislative,
executive and administrative or other measures, for the testing and measuring
of the contents and emissions of tobacco products and for the regulation of
these contents and emissions.

Parties should consider giving the authority responsible for tobacco control
matters the responsibility for, or at a minimum the power to provide input into,
the approval, adoption and implementation of the above-mentioned measures.

2.2 Approval and implementation of measures pursuant to Article 10

As stated in Article 10 of the WHO FCTC, each Party shall, in accordance

with its national law, adopt and implement effective legislative, executive,
administrative or other measures for the disclosure by manufacturers and
importers of tobacco products to governmental authorities of information
about the contents and emissions of tobacco products, as well as for the public
disclosure of information about the toxic constituents of tobacco products and
their emissions.

Parties should consider giving the authority responsible for tobacco control
matters the responsibility for, or at a minimum the power to provide input into,
the adoption and implementation of the above-mentioned measures.

2.3 Financing

Implementing effective tobacco product regulations and operating a programme

for their administration require the allocation of significant resources by Parties.
In order to alleviate governmental budgetary pressure, Parties could consider
placing these costs on the tobacco industry and retailers. There are various
means of financing tobacco product regulation measures.

The list below sets out some options that Parties could consider using:

• designated tobacco taxes;

• tobacco manufacturing and/or importing licensing fees;
• tobacco product registration fees;
• licensing of tobacco distributors and/or retailers;
• non-compliance fees levied on the tobacco industry and retailers; and
• annual tobacco surveillance fees (tobacco industry and retailers).

See Appendix 1 for descriptive examples of means of financing tobacco product

regulation measures.

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2.4 Laboratories used for purpose of disclosure

Laboratories used by manufacturers and importers of tobacco products for

the purposes of disclosure to governmental authorities should be accredited in
accordance with International Organization for Standardization (ISO) Standard
17025 (General requirements for the competence of testing and calibration
laboratories), by a recognized accreditation body. The accreditation methods
used should include, at a minimum, the methods set out in these guidelines.

2.5 Laboratories used for compliance purposes

Laboratories used by Parties for compliance purposes should be either

governmental laboratories or independent laboratories that are not owned
or controlled, directly or indirectly, by the tobacco industry. In addition, such
laboratories should be accredited as set out in the previous paragraph. Parties
may consider making use of governmental or independent laboratories located
in other countries.

2.6 Confidentiality in relation to disclosure to governmental authorities

Parties should not accept claims from the tobacco industry concerning the
confidentiality of information that would prevent governmental authorities from
receiving information about the contents and emissions of tobacco products.
Governmental authorities should apply appropriate rules in accordance with
their national laws when collecting information claimed to be confidential by
tobacco manufacturers and importers in order to prevent unauthorized use
and/or dissemination of this information.6

2.7 Confidentiality in relation to disclosure to the public

Parties should disclose information about the toxic constituents and emissions
of tobacco products to the public in a meaningful way. Parties may determine
in accordance with their national laws the information about the toxic
constituents and emissions of tobacco products that should not be disclosed
to the public.

2.8 Civil society

Civil society has an important role to play in raising public awareness and
building support for the regulation of the contents and emissions of tobacco
products, and for the disclosure of information on these contents and emissions.
Civil society should be involved as an active partner.

6 Guidance regarding public disclosure of this information is left to future guidelines.

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3. MEASURES

3.1 Content

3.1.1 Ingredients (Disclosure)

This section outlines measures that Parties could introduce to require the
disclosure by manufacturers and importers of tobacco products of information
about ingredients.

3.1.1.1 Background
By requiring manufacturers and importers to disclose information about
ingredients to governmental authorities, valuable insight will be gained on
the composition of tobacco products, which in turn will assist authorities in
developing effective, product-appropriate measures.

3.1.1.2 Recommendations
(i) Parties should require that manufacturers and importers of tobacco
products disclose to governmental authorities information on the ingredients
used in the manufacture of their tobacco products at specified intervals, by
product type and for each brand within a brand family. Contrary to disclosing
ingredients as part of a combined list, disclosing on a brand-by-brand basis and
in a standardized format will provide opportunities to governmental authorities
to analyse trends in product composition and keep track of subtle changes in
the market.

(ii) Parties should ensure that manufacturers and importers disclose to

governmental authorities the ingredients used in the manufacture of each
of their tobacco products and the quantities thereof per unit of each tobacco
product, including those ingredients present in the product’s components (e.g.
filter, papers, glue), for each brand within a brand family. Parties should not
accept disclosure only of maximum quantities by category of ingredient, or only
of the total quantity. To do so would seriously limit the kind of analysis that
could be performed.

(iii) Parties should require that manufacturers and importers disclose further
information on the characteristics of the tobacco leaves they used, for example:

(i) type(s) of tobacco leaves (e.g. Virginia, Burley, Oriental), and

percentage of each type used in the tobacco product;

(ii) percentage of reconstituted tobacco used;

(iii) percentage of expanded tobacco used;

(iv) Parties should require that manufacturers and importers notify governmental
authorities of any changes to tobacco product ingredients when the change
is made;

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(v) Parties should require that manufacturers and importers provide

governmental authorities with a statement setting out the purpose7 of the
inclusion of an ingredient in the tobacco product and other relevant information;

(vi) Parties should require that manufacturers disclose the name, address
and other contact information of each ingredient’s supplier to facilitate direct
disclosure to the Party by the supplier, where appropriate, and for compliance
monitoring purposes.

3.1.2 Ingredients (Regulation)

This section outlines measures that Parties could introduce to regulate

ingredients.

Parties should introduce the measures outlined in this section, in accordance

with their national laws, taking into account their national circumstances and
priorities.

3.1.2.1 Background
Regulating ingredients aimed at reducing tobacco product attractiveness can
contribute to reducing the prevalence of tobacco use and dependence among
new and continuing users. The preamble to the WHO FCTC states that Parties
recognize “that cigarettes and some other products containing tobacco are
highly engineered so as to create and maintain dependence”.

Attractiveness and its impact on dependence should be taken into account

when considering regulatory measures. The guidelines on implementation of
Article 13 of the WHO FCTC, on tobacco product advertising, promotion and
sponsorship, recommend that restrictions apply to as many as possible of
the features that make tobacco products more attractive to consumers. Such
features include coloured cigarette papers and attractive smells. Similarly, this
section presents measures that will help limit inducements to use tobacco.

3.1.2.2 Tobacco products

(i) Ingredients used to increase palatability

The harsh and irritating character of tobacco smoke provides a significant

barrier to experimentation and initial use. Tobacco industry documents have
shown that significant effort has been put into mitigating these unfavourable
characteristics. Harshness can be reduced in a variety of ways including: adding
various ingredients, eliminating substances with known irritant properties,
balancing irritation alongside other significant sensory effects, or altering
the chemical properties of tobacco product emissions by adding or removing
specific substances.

Some tobacco products contain added sugars and sweeteners. High sugar

7 Examples include substances that are used as adhesives, binders, combustion modifiers, addictiveness
enhancers, flavours, humectants, plasticizers, casings, smoke enhancers and colourings.

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content improves the palatability of tobacco products to tobacco users. Examples

of sugars and sweeteners used in these products include glucose, molasses,
honey and sorbitol.

Masking tobacco smoke harshness with flavours contributes to promoting

and sustaining tobacco use. Examples of flavouring substances include
benzaldehyde, maltol, menthol and vanillin.

Spices and herbs can also be used to improve the palatability of tobacco
products. Examples include cinnamon, ginger and mint.

Recommendation:
Parties should regulate, by prohibiting or restricting, ingredients that may be
used to increase palatability in tobacco products.

Ingredients indispensable for the manufacturing of tobacco products and not

linked to attractiveness should be subject to regulation according to national
law.

(ii) Ingredients that have colouring properties

Colouring agents are added to various components of tobacco products to make

the resulting product more appealing. Attractively-coloured cigarettes (e.g.
pink, black, denim blue) have been marketed in some countries. Examples of
colouring agents include inks (e.g. imitation cork pattern on tipping paper) and
pigments (e.g. titanium dioxide in filter material).

Recommendation:
Parties should prohibit or restrict ingredients that have colouring properties
in tobacco products. However, Parties should consider allowing the use of
colouring agents for tax-related markings or for health warnings and messages.

(iii) Ingredients used to create the impression that products have health
benefits

Various ingredients have been used in tobacco products to help create the
impression that such products have health benefits, or to create the impression
that they present reduced health hazards. Examples include vitamins, such as
vitamin C and vitamin E, fruit and vegetables (and products resulting from their
processing such as fruit juices), amino acids, such as cysteine and tryptophan,
and essential fatty acids such as omega-3 and omega-6.

Recommendation:
Parties should prohibit ingredients in tobacco products that may create the
impression that they have a health benefit.

(iv) Ingredients associated with energy and vitality

Energy drinks, popular with young people in some parts of the world, are

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perceived to increase mental alertness and physical performance. Examples

of stimulant compounds contained in such drinks include caffeine, guarana,
taurine and glucuronolactone. Tobacco industry documents and patent
applications show that some of these (caffeine and taurine) have also been
considered for use in tobacco products.

Recommendation:
Parties should prohibit ingredients associated with energy and vitality, such as
stimulant compounds, in tobacco products.

3.1.3 Contents (Disclosure to governmental authorities)

This section outlines requirements which Parties could introduce for the
disclosure by manufacturers and importers of tobacco products of information
on the contents of these products to governmental authorities.

3.1.3.1. Background
Given the numerous toxic and addictive substances contained in tobacco
products, governmental authorities with access to information on tobacco
contents are in a better position to understand the nature of their tobacco
product market. Such information can then be used by governmental
authorities to inform the development of policies and regulations respecting the
attractiveness, addictiveness or toxicity of tobacco products. For example, given
that nicotine is the main substance in tobacco involved in the addictive process,
Parties may wish to obtain information on the amount of nicotine present in the
various tobacco products available in their domestic market.

To help collect such information, governmental authorities can mandate the

use of analytical laboratory methods for the testing and measuring of contents
of tobacco products developed under the auspices of WHO8. The WHO Study
Group on Tobacco Product Regulation identified a non-exhaustive list of priority
toxic contents and emissions of tobacco products for regulation under Articles
9 and 10 of the WHO FCTC9. These methods can be easily performed by a
wide spectrum of laboratories. Methods have also been developed by various
governmental authorities and international organizations.

3.1.3.2 Recommendations
(i) Parties should consider requiring manufacturers and importers of
tobacco products to disclose to governmental authorities at specified intervals,
information about the contents of their tobacco products by product type, and
for each brand within a brand family.

(ii) When requiring the testing and measuring of contents, Parties should
consider where it is appropriate specifying that standards agreed by the Parties
to the Convention or recommendations by the WHO Tobacco Laboratory Network
could be used by the laboratories performing the test on behalf of the manufacturers

8 See the list of available WHO methods at http://who.int/tobacco/publications/prod_regulation/en/

9 For the full list, see WHO Technical Report Series, n. 989, WHO Study Group on Tobacco Product
Regulation: report on the scientific basis of tobacco product regulation, available at: http://apps.who.
int/iris/bitstream/10665/161512/1/9789241209892.pdf?ua=1&ua=1

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and importers of tobacco products. On nicotine, Parties should consider specifying

that the Tobacco Laboratory Network Official Method SOP 04, entitled Standard
operating procedure for determination of nicotine in cigarette tobacco filler, World
Health Organization10, be used by the laboratories performing the test on behalf of
the manufacturers and importers of tobacco products.

(iii) Parties should consider requiring that every manufacturer and importer
provides to governmental authorities a copy of the laboratory report that shows
the product tested and the results of the testing and measuring conducted on
that product. Parties should also consider asking for proof of accreditation
or membership in the WHO Tobacco Laboratory Network or be approved by
competent authorities of the Parties in question of the laboratory that performed
the testing and measuring.

3.1.4 Constituents (Regulation)

(This section has been left blank intentionally to indicate that guidance will be
proposed at a later stage.)

3.2 Emission

(This section has been left blank intentionally to indicate that guidance will be
proposed at a later stage.)

3.3 Product characteristics

3.3.1 Disclosure

This section outlines measures that Parties could introduce to require the
disclosure by manufacturers and importers of tobacco products of information
about product characteristics, such as design features.

3.3.1.1 Background
Collecting data on product characteristics, such as design features, will help
Parties improve their understanding of the impact these characteristics have on
smoke emission levels, properly interpret measurements obtained and, more
importantly, keep abreast of any changes to cigarette design features.

Furthermore, when combined with sales figures, such data will help Parties
analyse market trends.

3.3.1.2 Recommendations
(i) Parties should require that manufacturers and importers of tobacco
products disclose information on design features to governmental
authorities at specified intervals, and as appropriate, including the
results of tests conducted by the tobacco industry.

(ii) In order to establish and maintain the consistency of the data

10 See http://apps.who.int/fctc/implementation/database/article/article-10/resources

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reported to them by the tobacco industry, Parties should specify the

recommended methods, where applicable, for the reporting of design
features as set out in Appendix 2.

(iii) Parties should ensure that every manufacturer and importer

provides to governmental authorities a copy of the laboratory report
where a laboratory test was performed for the measurement of a
particular design feature, as well as the proof of accreditation of the
laboratory that performed the analysis.

(iv) Should there be any change to the design features of a particular

brand of tobacco product, Parties should require that manufacturers
notify governmental authorities of the change and provide the updated
information when the change is made.

3.3.2 Regulation

3.3.2.1 Cigarettes – Regulation in relation to fire-risk (reduced ignition propensity)

(i) Background

Lit cigarettes that are laid down and left unattended smoulder and can ignite
upholstery, other furniture, bedding and other textiles, or other material. This
has been observed most often in cases of smoking in bed or smoking while under
the influence of alcohol, illicit drugs or medication. Every year a considerable
number of people around the world are injured or die (e.g. from burns or smoke
gas poisonings) as a result of fires caused by cigarettes.

In order to prevent a significant number of such injuries and deaths, cigarettes

can be designed in a way that the cigarette self extinguishes when not puffed or
left unattended and thereby has a reduced risk of starting fires. These cigarettes
are known as reduced ignition propensity cigarettes (RIP cigarettes).

Reductions in the number of cigarette fires and related victims have been
observed in some jurisdictions that have mandated the replacement of
conventional cigarettes with RIP cigarettes. Although RIP cigarettes do not self-
extinguish in every case, they are expected to reduce the risk of a fire being
ignited, and thus the risk of injuries and deaths. It is important to note that
mandating an RIP standard is aimed at reducing the number of fires caused by
lit cigarettes; it will not eliminate them.

There have been claims that RIP cigarettes may have a different toxicity than
conventional cigarettes. Research suggests that RIP cigarettes are just as toxic
as conventional cigarettes and equally dangerous to human health.

(ii) Regulating the ignition propensity of cigarettes

In regulating the ignition propensity of cigarettes, governmental authorities

usually take a performance-based approach by adopting provisions that

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prescribe the test method to be used, and then provisions that set the pass/fail
criteria (performance standard) applicable to the results obtained after conduct
of the test (see Appendix 4).

In a number of cases, governmental authorities have also laid down

requirements related to a specific technique for achieving RIP, namely banded
paper technology, and requirements related to certification (see Appendix 5).

(iii) Recommendations

(i) Parties should require that cigarettes comply with an RIP standard,
taking into account their national circumstances and priorities.

(ii) When implementing recommendation (i) of this paragraph,

Parties should consider setting a performance standard that
corresponds at a minimum to the current international practice,
regarding the percentage of cigarettes that may not burn their full
length when tested according to the method described in Appendix 4.

(iii) Parties should not allow any claims to be made suggesting that RIP
cigarettes would be unable to ignite fires.

3.3.2.2 Tobacco Products – Regulation in relation to attractiveness

(i). Background

The tobacco industry is continuously aiming at making tobacco products

more attractive by modifying existing product design features or introducing
new ones. An example is the industry’s manufacture of cigarettes with
an ever-smaller circumference (slim, superslim, ultraslim). Another example
is the placement of capsules in cigarette filters that release flavour when
crushed.

Product design features are used by the tobacco industry to develop strategies
making products more attractive to different segments of society, an approach
known as market segmentation. These segments can be based for example on
age, gender, ethnic or cultural background, socioeconomic status and health
concerns. The tobacco industry then targets these segments by developing
product design features that meet their expectations and interests with regard
to health, glamour, novelty, self-image, weight loss, convenience/ease of use,
sensory experience and others.

Regulating product design characteristics to decrease tobacco product

attractiveness can contribute to reducing the prevalence of tobacco use.

(ii). Recommendations

Consistent with 3.1.2.2., Parties should regulate all tobacco product design
features that increase the attractiveness of tobacco products, in order to
decrease the attractiveness of tobacco products.

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3.4 Disclosure to governmental authorities – other information

3.4.1 Background

In order to put effective product regulation in place, including regulation of

ingredients, it is essential that governmental authorities have accurate market
information. Governmental authorities need to know the importance of a
particular tobacco product compared to others to help determine regulatory
needs and priorities. Furthermore, consistent with Article 20.2 of the WHO
FCTC, information on tobacco companies and on their sales will help assess the
magnitude and patterns of tobacco consumption.

3.4.2 Recommendations

Parties should require that manufacturers and importers of tobacco products

disclose general company information, including the name, street address and
contact information of the principal place of business and of each manufacturing
and importing facility. This information may prove useful for compliance
monitoring purposes.

Parties should consider requiring that tobacco manufacturers and importers

disclose, at specified intervals, for each brand within a brand family, sales
volume information in units (e.g. number of cigarettes or cigars, or weight of
roll-your-own tobacco). These disclosures should be on a national basis, and
where appropriate on a sub-national basis as well.

3.5 Disclosure to the public

3.5.1 Background

Many people are not fully aware of, misunderstand or underestimate the risks
for morbidity and premature mortality attributable to tobacco use and exposure
to tobacco smoke. Complementing other measures relating to the reduction of
demand for tobacco, Article 10 of the WHO FCTC requires that each Party shall
adopt and implement effective measures for public disclosure of information
about the toxic constituents of tobacco products and the emissions that they may
produce. As stated in Article 4.1 of the WHO FCTC, Parties shall be guided by
the principle that every person should be informed of the health consequences,
addictive nature and mortal threat posed by tobacco consumption and exposure
to tobacco smoke.

3.5.2 Scope and means of public disclosure

3.5.2.1 Public access to information disclosed to governmental authorities

Detailed information about the toxic constituents and emissions of tobacco
products is difficult to comprehend, and public disclosure of such information
might not directly promote or protect public health. However, such information
may assist other members of civil society, particularly academic institutions and
nongovernmental organizations, in contributing to tobacco control policy.

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In addition, other information disclosed to governmental authorities in

accordance with these guidelines, such as information on ingredients, product
characteristics and the market, may also contribute to raising public awareness
and advancing tobacco control policy.

Recommendation:
Parties should consider, in accordance with their national laws, making
information about the toxic constituents and emissions of tobacco products and
other information disclosed to governmental authorities in accordance with
these guidelines publicly accessible (e.g. via the Internet, or by request to a
governmental authority) in a meaningful way.

3.5.2.2 Public disclosure of constituents and emissions in the context of Articles 11

and 12 of the WHO FCTC
Information on how public disclosure is linked to Articles 11 and 12 of the WHO
FCTC can be found in section 7, “links to other articles of the WHO FCTC”.

4. COMPLIANCE AND ENFORCEMENT

4.1 Comprehensive approach

Effective legislative, executive, administrative or other measures should impose

legal responsibilities for compliance on manufacturers and importers of tobacco
products and should provide penalties for violations. Legislative, executive,
administrative or other measures should identify the authority or authorities
responsible for enforcement, and should include a system both for monitoring
compliance and for prosecuting violators.

4.2 Infrastructure and budget

Parties should consider ensuring that the infrastructure necessary for

compliance monitoring and enforcement activities exists. Parties should also
consider providing a budget for such activities.

4.3 Strategies

To enhance compliance, Parties should inform stakeholders of the requirements

of the law before it comes into force.

Parties should consider using inspectors or enforcement agents to conduct

regular visits to manufacturing and importing facilities, as well as at points of
sale, to ensure compliance. It may not be necessary to create a new inspection
system if mechanisms are already in place that could be extended to inspect
business premises as required.

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4.4 Deadlines

4.4.1 Prohibited or restricted ingredients

Parties should specify a deadline following which tobacco industry and retailers
must only supply tobacco products that comply with requirements.

4.4.2 Reduced ignition propensity

Parties should specify a deadline following which the tobacco industry and
retailers must only supply cigarettes that comply with the required RIP standard.

4.5 Inspections – prohibited or restricted ingredients

Parties should consider conducting visits to manufacturing facilities to verify

whether any prohibited or restricted ingredient is being used. Inspection
should include direct access to the raw supplies storage area and to the finished
products storage area, as well as direct observation of the manufacturing
process. Inspections should not constitute an approval or certification of the
tobacco products, nor recognition of their manufacturing procedures.

4.6 Sampling and testing

4.6.1 Prohibited or restricted ingredients

Parties should consider having samples of tobacco products collected from

importers’ facilities, from retail outlets and, where needed, from manufacturers’
facilities. These samples should then be tested for the presence of prohibited
or restricted ingredients in laboratories used for compliance purposes (see
Appendix 3).

4.6.2 Reduced ignition propensity

Parties should consider having samples of cigarettes collected from manufacturers,

importers or retailers. These samples should then be tested to ascertain whether
they comply with the required RIP performance standard. Both sampling and
testing should be carried out according to the method described in Appendix 4.

4.7 Audits following disclosure to governmental authorities

Parties should consider conducting audits at manufacturers’ facilities to

ensure that information received concerning tobacco products is complete and
accurate. Audits should not constitute an approval or certification of the tobacco
products, nor recognition of their manufacturing procedures.

4.8 Response to non-compliance

Parties should ensure that their enforcement authorities are prepared to respond
quickly and decisively to instances of non-compliance. Strong, timely responses

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to early cases will make it clear that compliance is expected and will facilitate
future enforcement. Parties should consider making the results of enforcement
action public in order to send a strong message that non-compliance will be
investigated and that appropriate action will be taken.

4.9 Sanctions

In order to deter non-compliance with the law, Parties should specify appropriate
sanctions, such as criminal sanctions, monetary amounts, corrective actions,
and the suspension, limitation or cancellation of business and import licences.

4.10 Seizure, forfeiture and destruction

Parties should ensure that they have authority to have non-compliant tobacco
products seized, forfeited and destroyed, under supervision in accordance with
national law.

4.11 Penalties

Parties should specify a range of fines or other penalties commensurate with

the severity of the violation and whether it is a repeat violation.

5. INTERNATIONAL COOPERATION

International cooperation is essential if progress in tobacco product regulation

and disclosure is to be made. Several articles of the WHO FCTC provide for the
exchange of knowledge and experience to promote implementation. As stated
in Article 22 of the WHO FCTC, such cooperation shall promote the transfer of
technical, scientific and legal expertise and technology, as mutually agreed. It
would result in the effective implementation of these guidelines and facilitate
development of the best possible measures for regulating the contents of
tobacco products.

6. MONITORING AND EVALUATION

(This section has been left blank intentionally to indicate that guidance will be
proposed at a later stage.)

7. LINKS TO OTHER ARTICLES OF THE WHO FCTC

7.1 Packaging suggesting the presence of a prohibited ingredient

In the spirit of Articles 11 and 13 of the WHO FCTC, unless Parties have already
adopted measures to ban any type of promotion on tobacco product packages
(as outlined in the guidelines on Articles 11 and 13), Parties should consider
imposing a ban on the sale of tobacco products whose packaging suggests
the presence of an ingredient that has been prohibited or, where appropriate,

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restricted as per the above recommendations.

7.2 Information on relevant constituents and emissions on tobacco
packaging

Tobacco product packaging and labelling are an effective means of public

communication about constituents and emissions of tobacco products, as
recognized in Article 11 of the WHO FCTC. Parties should refer to Article 11
and the guidelines for its implementation.

7.3 Information on relevant constituents and emissions in education,

communication, training and other public awareness programmes

Parties should consider including messages about constituents and emissions

of tobacco products in education, communication, training and other public
awareness programmes. Such messages may reinforce efforts to inform the public
of the health consequences, addictive nature and mortal threat posed by tobacco
use and exposure to tobacco smoke in programmes established in accordance
with Article 12 of the WHO FCTC and the guidelines for its implementation.

APPENDIX 1

Descriptive examples of means of financing tobacco product regulation

measures

(a) Designated tobacco taxes

Designated tobacco taxes require a proportion of tobacco tax revenue to

be allocated to a specified purpose or purposes, such as a tobacco-control
programme or a health promotion fund. The proportion of tobacco tax revenue
might be expressed as a percentage of revenue (e.g. 1%) or as a fixed monetary
amount per unit (e.g. 25 cents per package of 20 cigarettes). Designated tobacco
taxes are sometimes referred to as “earmarked tobacco taxes” or “hypothecated
tobacco taxes”.

(b) Tobacco manufacturing and/or importing licensing fees

A licensing fee on tobacco manufacturers and/or importers could be

implemented in a number of ways. The fee could be a specified monetary
amount per company, regardless of company size. (A separate fee might be
required for each manufacturing and/or importing facility.) The fee could be
a fixed monetary amount per unit sold (e.g. a certain amount per cigarette or
package of cigarettes, or per gram for certain types of tobacco products). The
fee could be based on a total amount for all companies, and determined on the
basis of a company’s market share (e.g. if the total amount to be paid by all
companies was US$ 100 million and a company’s market share was 20%, and
the company’s license fee would be US$ 20 million). The required fee might
have to be paid at specified intervals, such as prior to the beginning of an
annual period. Where a fee is based on a monetary amount per unit sold, the

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payment interval might be more frequent, e.g. monthly.

(c) Tobacco product registration fees

Tobacco product registration fees involve requiring the manufacturer and/

or importer, or potentially a wholesale distributor, to register each tobacco
product sold by the company and to pay an accompanying fee. The amount
of the fee might be set at a level such that government costs (or average costs)
associated with the product, such as testing, measuring and enforcement, are
fully or partially recovered. The required fee might have to be paid at specified
intervals, e.g. prior to the beginning of an annual period.

(d) Licensing of tobacco distributors and/or retailers

A licensing fee could be placed on distributors or retailers, or both. The fee

could be a specified monetary amount per outlet, regardless of company size.
(A separate fee might be required for each manufacturing and/or importing
facility.) The fee could vary based on the size of the distributor and/or retailer,
e.g. based on sales volume. The fee might be set at varying amounts depending
on sales volume (either units or total monetary amount), e.g. a fee if sales are not
higher than amount A, a higher fee if sales are between amount A and amount
B, and a further increased fee if sales are higher than amount B. The required
fee might have to be paid at specified intervals, e.g. prior to the beginning of an
annual period.

(e) Non-compliance fees levied on the tobacco industry and retailers

Revenue could be collected from administrative monetary penalties.

Administrative monetary penalties are a form of civil penalty in which an
administrative body seeks monetary relief against an individual or corporate
body as restitution for unlawful activity. Revenue could also be collected from
fines imposed by a court.

(f) Annual tobacco surveillance fees (tobacco industry and retailers)

Annual tobacco surveillance fees involve assessing the amount to be paid by

the tobacco industry and/or retailers for monitoring and enforcement. For
tobacco manufacturers/importers/distributors, this could be a fixed amount per
company, a fixed amount for each brand variation sold, a fixed amount per unit
sold, or an amount based on market share. For tobacco retailers (or others), a
separate licence and fee might be required for each retail outlet.

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 Partial guidelines for implementation: Articles 9 and 10

APPENDIX 2

Design features of cigarettes11

(a) Dimensions, diameter and weight

(b) Length of filter, shape of the cross-section of the filter

(c) Length of tipping paper

(d) Dimensions and shape of the cross-section of the tobacco rod

(e) Distance of ventilation holes from butt mark in millimetres

(f) Draw resistance of cigarette as determined in accordance with ISO

6565 (Tobacco and tobacco products – Draw resistance of cigarettes and
pressure drop of filter rods – Standard conditions and measurement)

(g) Degree of filter ventilation as determined in accordance with ISO 9512

(Cigarettes –Determination of ventilation – Definitions and measurement
principles)

(h) Degree of paper ventilation as determined in accordance with ISO 9512

(Cigarettes – Determination of ventilation – Definitions and measurement
principles)

(i) Type of cigarette paper used and its air permeability or porosity
determined in accordance with ISO 2965 (Materials used as cigarette
papers, filter plug wrap and filter joining paper, including materials
having an oriented permeable zone – Determination of air permeability)

(j) Product firmness (nominally a measure of packing density)

(k) Pressure drop of the filter as determined in accordance with ISO 6565
(Tobacco and tobacco products – Draw resistance of cigarettes and
pressure drop of filter rods – Standard conditions and measurement)

(l) Moisture content as determined in accordance with Association of

Official Analytical Chemists Official Method 966.02 (Loss on drying
(moisture) in tobacco)12

(m) Type of filter (for example, cellulose acetate) and other characteristics,
where applicable (for example, charcoal content)

(n) Description and explanation of function of all innovative components

11 See ISO 9512 (Cigarettes – Determination of ventilation – Definitions and measurement principles) for
an explanation of the terms used here.
12 See Horwitz W, Latimer G, eds. Official methods of analysis, 18th ed., Revision 3. Gaithersburg, MD,
AOAC International, 2010.

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added to the cigarette, such as capsules.

APPENDIX 3

Analytical methods for ingredients

(a) For the purposes of compliance monitoring and enforcement, there

may be cases in which analytical methods would be required to confirm
the presence of prohibited or restricted ingredients. Such methods
typically consist of several distinct steps: sampling, sample preparation,
separation, identification, quantification and data analysis.

(b) Analytical procedures should be carried out by properly trained

personnel in a suitably equipped laboratory. Such procedures frequently
involve the use of hazardous materials. To ensure the correct and safe
execution of these procedures, it is essential that laboratory personnel
follow standard safety procedures for the handling of hazardous
materials.

(c) For ingredients that are also food additives, suitable analytical
methods may be found in the Combined compendium of food additive
specifications (volume 4).13 This document provides a reference for the
analytical methods mentioned in the specifications for the identity of
additives used in foods or in food production.

(d) For ingredients such as flavouring agents which have a low-boiling

point (that is, which vaporize easily at low temperatures), a technique
called “headspace-gas chromatography” may be used. A description
of this method may be found in the Combined compendium of food
additive specifications (volume 4).

(e) Another laboratory technique for sampling ingredients with a low

boiling point, which can be combined for separation, identification and
quantification with gas chromatography/mass spectrometry, is called
“solid-phase microextraction”. 14 It is very similar to headspace analysis,
but differs in that the headspace is concentrated.

13 Joint FAO/WHO Expert Committee on Food Additives. Combined compendium of food additive
specifications. Volume 4: analytical methods, test procedures and laboratory solutions used by and
referenced in the food additive specifications. Rome, Food and Agriculture Organization of the United
Nations, 2006 (FAO JECFA Monograph No. 1) (http://www.fao.org/docrep/009/a0691e/A0691E00.
htm, accessed 1 April 2010).
14 Pawliszyn J et al. Solid-phase microextraction (SPME). The chemical educator, 1997, 2(4):1–7 (http://
www.springerlink.com/content/h72xx3624q122085/fulltext.pdf, accessed 1 April 2010).

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APPENDIX 4

Performance standard for reduced ignition propensity (RIP) cigarettes and

related standard test methods

The performance standard for RIP cigarettes has been expressed as the
percentage of cigarettes that, when ignited and laid down on a pre-determined
substrate, do not burn through their whole length.

As of 2012, international practice is to require a not-burn-through rate of no

less than 75%.

As of 2012, available standard test methods for sampling and verifying the
conformity of cigarettes with the required not-burn-through rate include: ISO
12863:2010 “Standard test method for assessing the ignition propensity of
cigarettes”; EN ISO 12863:2010 “Standard test method for assessing the ignition
propensity of cigarettes”; AS 4830-2007 “Determination of the extinction
propensity of cigarettes”; NZS/AS 4830:2007 “Determination of the extinction
propensity of cigarettes”; and ASTM E2187-09 “Standard Test Method for
Measuring the Ignition Strength of Cigarettes”.

APPENDIX 5

Reduced ignition propensity cigarettes – additional information

(a) Design of the cigarette paper

Where Parties have required banded paper technology, one of the practices
with respect to both filter and non-filter cigarettes is for one band surrounding
the tobacco column to be located not less than 15 mm from the lighting end of
the cigarette, and for a second such band to be located not less than 10 mm
from the filter end or, in the case of non-filter cigarettes, not less than 10 mm
from the labelled end of the tobacco column.

(b) Certification approach

Where a self-certification approach has been adopted, the practice is to require

the tobacco industry to file with the appropriate governmental authority a
statement of conformity and/or declaration of truth, with the required RIP
standard. An alternative approach would be to mandate third-party certification.

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These guidelines were originally published as WHO Framework Convention on Tobacco Control: guidelines for implementation
Articles 5.3; Article 8; Articles 9 and 10; Article 11; Article 12; Article 13; Article 14 – 2013 edition.

Convention Secretariat
WHO Framework Convention on Tobacco Control
World Health Organization
Avenue Appia 20, 1211 Geneva 27, Switzerland
Tel: +41 22 791 50 43 Fax: +41 22 791 58 30
Email: [email protected]
Web: www.who.int/fctc FCTC/16.7