Consultation-Paper-October-20152

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Public Consultation on
Transposition of the Revised
European Tobacco Products
Directive (2014/40/EU)
October 2015
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1.
Purpose of this consultation
1.1
The purpose of the consultation is to obtain views on discretionary elements within
certain Articles of the revised European Tobacco Products Directive (2014/40/EU).1
1.2
The mandatory requirements of the Directive must be transposed by Member States
into their national legislation. Within a number of those mandatory requirements
Member States may determine certain discretionary elements. This consultation
focuses on those discretionary elements.
1.3
In April 2014, the European Parliament adopted a revised Tobacco Products Directive
(2014/40/EU). The Directive, which is on the approximation of the laws, regulations
and administrative provisions of the Member States concerning the manufacture,
presentation and sale of tobacco and related products, replaces Directive
2001/37/EC.2
1.4
Directive 2001/37/EC set out rules at EU level on the regulation of tobacco products
concerning their composition and labelling. The main provisions established reporting
requirements for ingredients and emissions of cigarettes and set labelling
requirements, including text warnings and optional picture warnings. Directive
2001/37/EC is implemented in Ireland by the European Communities (Manufacture,
Presentation and Sale of Tobacco Products) Regulations 2003 (S.I. No. 524/2003).3
1.5
Directive 2014/40/EU revises many of the provisions of the previous Directive to take
account of the significant international market and scientific changes and
developments since its implementation in 2001. It also sets out rules for areas not
previously covered, for example electronic cigarettes (e-cigarettes) and refill
containers.
1.6
Summary of the Articles in the Directive:




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
Articles 1 and 2 set out the subject matter and the definitions within the
Directive.
Articles 3 to 7 outline the regulations for ingredients and emissions for tobacco
products.
Articles 8 to 14 provide for labelling, packaging, presentation and appearance of
tobacco products.
Articles 15 and 16 deal with the tracking and tracing of tobacco products.
Articles 17 to 19 set out the rules for tobacco for oral use, cross-border sales and
novel tobacco products.
Article 20 relates to electronic cigarettes and refill containers.
1
Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC.
OJ.L 127, 29.4.2014, p.1.
2 Directive 2001/37/EC on the approximation of the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco products. OJ. L194, 18.7.2001 p.26
3European Communities (Manufacture, Presentation and Sale of Tobacco Products) Regulations 2003 (S.I. No. 524/2003) is
available at www.irishstatutebook.ie
Page 2 of 15


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
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


Articles 21 and 22 outline the regulations for herbal products for smoking.
Articles 23 and 24 relate to cooperation, enforcement and free movement.
Articles 25 and 26 provide for committee procedures and the designation of
competent authorities.
Article 27 lays down the conditions for the adoption of delegated acts by the EU
Commission.
Article 28 provides that the EU Commission must submit a report on the
application of the Directive to the European Parliament, the Council and the
European Economic and Social Committee and the Committee of the Regions by
May 2021.
Articles 29 and 30 cover the transposition of and transitional provisions for the
Directive.
Article 31 repeals Directive 2001/37/EC with effect from 20 May 2016.
Articles 32 and 33 are standard provisions relating to the entry into force and the
addressees to the Directive.
1.7
Member States must transpose this Directive into national legislation by 20 May
2016. The transposition will be done by way of secondary legislation, i.e. Regulations.
1.8
The main provisions of the Directive 2014/40/EU are as follows:
a) continue, and enhance in some areas, the reporting of ingredients and emissions
of tobacco products and introduce a standardised reporting format;
b) increase the size of combined health warnings consisting of a text and photograph
warning and cessation information, increased in size to cover 65% of front and
back of pack (previously 30% on front and 40% on back of pack for unilingual
countries);
c) introduce a minimum pack size of 20 cigarettes and minimum weight of 30g for
roll-your-own tobacco;
d) ban certain descriptions on packaging, such as ‘natural’, ‘healing’ or ‘rejuvenating’;
e) ban cigarettes and roll-your-own tobacco containing characterising flavours;
f) introduce a traceability system and security features to track and trace tobacco
products;
g) provide Member States with the option of prohibiting cross-border distance sales
of tobacco products and electronic cigarettes;
h) regulate electronic cigarettes and refill containers;
i) regulate herbal cigarettes; and
j) introduce, at a minimum, a notification system for novel tobacco products Member States may opt to introduce an authorisation system.
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How to get involved in the consultation
1.9
Details of discretionary elements within the provisions of the Directive and a preview
of the questions are set out in this paper. Please use the online questionnaire,
available at http://health.gov.ie/news-centre/ to submit your views. Only views
submitted using the online questionnaire will be included in the consultation process.
1.10 Please note that the questionnaire must be completed in one session. If you would
prefer to prepare your response in advance of making the online submission, it is
possible to copy and paste material from a Word document.
1.11 There are a number of questions at the beginning of the online questionnaire relating
to you or the party you represent which must be answered in order to progress to the
questions on the Directive.
1.12 As a Party of the World Health Organisation’s Framework Convention on Tobacco
Control (FCTC), Ireland has an obligation to protect the development of public health
policy from the vested interests of the tobacco industry. To meet this obligation, the
Department asks all respondents to disclose whether they have any direct or indirect
links to, or receive funding from, the tobacco industry. We will still carefully consider
all consultation responses from the tobacco industry and from those with links to the
tobacco industry.
1.13 All submissions received by the Department are subject to the Freedom of
Information (FOI) Act, 2014 and may be released in response to an FOI request. The
Department publishes responses to FOI requests online.
1.14 The consultation will remain open until 5pm on Wednesday, 18th November 2015.
Any queries should be submitted by email to tpdconsultation@health.gov.ie
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2.
Ingredients and Emissions (Articles 3 to 8)
Overview of Articles 3 to 7: Ingredients and emissions
2.1
Articles 3 to 7 outline the regulations for ingredients and emissions for tobacco
products. Some provisions update or amend regulations established in Directive
2001/37/EC, while others set out new regulations for ingredients and emissions.
2.2
The testing of emission levels of tar, nicotine, carbon monoxide and other substances
(TNCO) in cigarettes against the maximum limits (10mg for tar, 1 mg of nicotine and
10 mg of carbon monoxide) was first laid down in the Directive 2001/37/EC. This
requirement continues in the new Directive.
2.3
Under the new Directive manufacturers are no longer allowed to display TNCO levels
on packs. However this data must be published and made available to the public,
subject to the protection of trade secrets.
2.4
Manufacturers and importers of tobacco products must submit information on
ingredients and emissions, as well as available market research studies and data on
sales volumes. The Directive provides that this information must be published.
2.5
Enhanced reporting obligations will apply to certain additives contained in cigarettes
and roll-your-own tobacco that are included in a priority list (to be established by the
EU Commission by way of an implementing act). Manufacturers of products
containing priority additives will also be obliged to carry out studies examining issues
including toxicity and addictiveness.
2.6
The Directive prohibits the placing on the market of cigarettes and roll-your-own
tobacco with characterising flavours and tobacco products with certain additives,
including vitamins and caffeine.
2.7
Discretionary elements relating to Articles 3 to 7 are set out in the following sections.
Discretionary elements relating to Articles 3 and 4: Measurement of tar, nicotine, carbon
monoxide and other substances in cigarettes
2.8
Under Article 4, manufacturers of tobacco products must measure emission levels of
tar, nicotine, carbon monoxide and other substances in cigarettes against the
maximum limits set out in Article 3. These measurements must be verified by
laboratories which are approved and monitored by the competent authority of the
Member State. Members States may charge manufacturers and importers
proportionate fees for the verification of the measurements required under this
Article.
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Question
Q)
Should manufacturers and importers of tobacco products be charged proportionate
fees for the verification of measurements of tar, nicotine, carbon monoxide and other
substances in cigarettes? Please provide an explanation for your answer (maximum
600 characters (approx. 100 words)).
Discretionary elements relating to Article 5: Reporting of ingredients and emissions
2.9
The Directive requires Member States to require manufacturers and importers of
tobacco products to report information on ingredients and emissions for each
product using a standardised electronic format. The EU Commission must adopt a
standardised reporting format for tobacco products by way of an implementing act.
2.10 Member States may also request manufacturers or importers to carry out studies as
may be prescribed by the competent authority in order to assess the effects of
ingredients on health, taking into account, inter alia, their addictiveness and toxicity.
2.11 Member States may charge manufacturers and importers proportionate fees for
receiving, storing, handling, analysing and publishing the information on ingredients
and emissions of tobacco products under Article 5.
Questions
Q)
Should manufacturers and importers be requested to carry out studies to assess the
effects of ingredients on health as and when required? Please provide an explanation
for your answer (maximum 600 characters (approx. 100 words)).
Q)
Should manufacturers and importers of tobacco products be charged proportionate
fees for receiving, storing, handling, analysing and publishing the information on
ingredients and emissions of tobacco products? Please provide an explanation for
your answer (maximum 600 characters (approx. 100 words)).
Discretionary elements relating to Article 6: Priority list of additives and enhanced
reporting obligations
2.12 Under Article 6, the EU Commission must adopt implementing acts laying down a
priority list of additives to which enhanced reporting obligations shall apply.
Manufacturers and importers of cigarettes and roll-your-own tobacco containing an
additive included on the priority list will be subject to additional obligations for such
products, including the requirement to carry out comprehensive scientific studies on
these priority additives and to submit reports to the EU Commission. Small and
medium enterprises are exempt from the obligations of this Article if a report on an
additive is prepared by another manufacturer.
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2.13 The Directive allows that Member States and the EU Commission may require the
reports to be peer reviewed by an independent scientific body, in particular as
regards their comprehensiveness, methodology and conclusions. Furthermore, the
Directive provides that Members States may charge manufacturers and importers
proportionate fees for those peer reviews.
Questions
Q)
Should scientific reports received from manufacturers and importers of cigarettes and
roll-your-own tobacco be peer reviewed by an independent scientific body? Please
provide an explanation for your answer (maximum 600 characters (approx. 100
words)).
Q)
Should manufacturers and importers of cigarettes and roll-your-own tobacco be
charged proportionate fees for having the scientific reports peer reviewed? Please
provide an explanation for your answer (maximum 600 characters (approx. 100
words)).
Discretionary elements relating to Article 7: Regulation of ingredients
2.14 Under Article 7, Member States must prohibit the placing on the market of tobacco
products with a characterising flavour. A ‘characterising flavour’ is defined as ‘a
clearly noticeable smell or taste other than one of tobacco, resulting from an additive
or a combination of additives’. Products with more than a 3% share of the EU market
are provided with a transitional period of four years.
2.15 Other tobacco products, such as cigars, cigarillos, pipe tobacco, water pipe tobacco
and smokeless tobacco products, are exempted from the ban on characterising
flavours. However the EU Commission is empowered to remove this exemption if
there is a substantial change of circumstances for any of those products.
2.16 The EU Commission will establish an independent advisory panel to assist Member
States and the EU Commission to determine whether a product has a characterising
flavour.
2.17 Member States must also prohibit tobacco products containing certain additives,
including vitamins and caffeine, and additives in quantities that increase the toxic or
addictive effect, or the carcinogenic, mutagenic or reprotoxic (CMR) properties of a
tobacco product to a significant or measureable degree.
2.18 Article 7 allows Member States to charge manufacturers and importers proportionate
fees for assessing whether a tobacco product has a characterising flavour, whether
prohibited additives are used and whether a tobacco product contains additives in
quantities that increase to a significant and measurable degree the toxic or addictive
effect or the CMR properties of the tobacco product concerned.
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Question
Q)
3.
Should manufacturers and importers be charged proportionate fees for assessing
whether a tobacco product has a characterising flavour, whether prohibited additives
are used and whether a tobacco product contains additives in quantities that increase
to a significant and measurable degree the toxic or addictive effect or the CMR
properties of the tobacco product concerned? Please provide an explanation for your
answer (maximum 600 characters (approx. 100 words)).
Labelling and Health Warnings (Articles 8 to 12)
Overview of Articles relating to labelling and health warnings (Articles 8 to 12)
3.1
The Directive strengthens existing labelling requirements for tobacco products. This
includes increasing the size and prominence of health warnings and mandating
combined text and picture health warnings for tobacco products. It sets out the
technical specification on the size, shape and appearance of the general warning and
information message on packets of tobacco products. The general warning and
information message must cover 50% of the surface on which they are printed.
3.2
Discretionary elements relating to Articles 8 to 12 are set out in the following
sections.
Discretionary elements relating to Articles 8 and 9: General warnings on tobacco products
for smoking
3.3
The Directive requires that every unit packet and any outside packaging of tobacco
products for smoking carries a general warning. It also requires that the warning be
in the official languages of the Member State where the product is placed on the
market. Member States can decide which of the general warnings below is to be
used. The Irish translation, which must be included is set out beside each English
version.
(a) ‘Smoking kills – quit now’ ‘Toradh caithimh tobac — bás. Scoir de anois.’
or
(b) ‘Smoking kills’ ‘Toradh caithimh tobac — bás’
Question
Q)
Which general warning as set out above should be used on unit packets and outside
packaging of tobacco products?
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Discretionary elements relating to Article 11: Labelling of tobacco products for smoking
other than cigarettes, roll-your-own tobacco and water pipe tobacco
3.4
The Directive provides that Member States may exempt tobacco products for
smoking other than cigarettes, roll-your-own tobacco and water pipe tobacco from
the obligations to carry the information message laid down in Article 9(2) and the
combined warnings laid down in Article 10.
3.5
This means that tobacco products other than cigarettes, roll-your-own and water pipe
tobacco, for example individually wrapped cigars or cigarillos, would be subject to less
stringent rules in relation to labelling. An exemption would provide that those
products would not carry the ‘Tobacco smoke contains over 70 substances known to
cause cancer’ ‘Cuimsíonn deatach tobac breis agus 70 substaint arb eol dúinn gur
cúiseanna ailse iad.’ message. Nor would they have a combined health warning
(picture and text).
3.6
They would, however, carry a general warning ‘Smoking Kills’ ‘Toradh caithimh tobac
— bás’ or ‘Smoking Kills – Quit Now’‘Toradh caithimh tobac — bás. Scoir de anois.’;
one of the text warnings from the combined warning list but no picture; and smoking
cessation information, on the two most visible surfaces of the unit packaging.
Question
Q)
Should tobacco products other than cigarettes, roll-your-own tobacco and water pipe
tobacco be exempt from carrying the information message and the combined health
warnings as set out above? If yes, to what products should an exemption apply and
why? If no, please provide an explanation for your answer (maximum 1500 characters
(approx. 250 words)).
4.
Cross-border Distance Sales of Tobacco Products (Article 18)
Discretionary elements relating to Article 18: Cross-border distance sales of tobacco
products
4.1
The Directive provides Member States with the option to prohibit the cross-border
distance sales of tobacco products i.e. prohibit businesses in Ireland from selling
tobacco products to consumers in other Member States, for example, via the
internet, telephone or mail order and prohibit businesses in other Member States
from selling to consumers in Ireland.
4.2
Should the Department choose not to exercise this option, it is obliged to introduce a
registration system for all retailers intending to engage in cross-border distance sales
both into and out of Ireland.
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4.3
If a registration system is introduced, Irish retailers selling tobacco products to
consumers in other Member States (provided that Member State has not imposed a
ban) through distance selling arrangements will be required to register with the Irish
competent authority and the competent authority in the Member State(s) where the
consumers are based. All non-Irish business intending to sell in Ireland through
distance selling arrangements must similarly register with the Irish competent
authority. The Directive also provides the option of requiring retailers to nominate a
person to be responsible for verifying that products comply with Irish legislation.
4.4
To register, retailers would be required to provide contact details of their business,
the starting date of activities, and details of the website(s) to be used for selling their
products. Furthermore, they would be obliged to operate and provide details on an
age verification system, ‘which verifies at the time of sale, that the purchasing
consumer complies with the minimum age requirements provided for under the
national law of the Member State of destination.’
4.5
The placing of products on the market via cross-border distance sales arrangements
would only be allowed following receipt of confirmation of registration with the
relevant competent authorities. A list of all retailers registered with the Irish
competent authority would be made publicly available.
Questions
Q)
Should cross-border distance sales of tobacco products be prohibited? Please provide
an explanation for your answer (maximum 1500 characters (approx. 250 words)).
Q)
If cross-border distance sales of tobacco products are not prohibited, thereby
requiring the introduction of a registration system, should retailers be required to
nominate a person to be responsible for verifying that products comply with Irish
legislation? Please provide an explanation for your answer (maximum 600 characters
(approx. 100 words)).
5.
Novel Tobacco Products (Article 19)
Discretionary elements relating to Article 19: Novel tobacco products
5.1
Article 19 requires Member States to introduce at a minimum, a notification system
whereby manufacturers and importers of novel tobacco products must submit an
electronic notification to the competent authority six months before placing any new
product on the market.
5.2
Under a notification system, manufacturers and importers would be required to
provide the following:
(a) a detailed description of the product and instructions for its use;
(b) information on all ingredients, reasons for their inclusion and emissions levels;
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(c) relevant toxicological data;
(d) available scientific studies on toxicity, addictiveness and attractiveness of the
novel tobacco product, in particular on its ingredients and emissions;
(e) available studies, executive summaries thereof and market research on the
preferences of various consumer groups, including young people and current
smokers; and
(f) other available and relevant information, including a risk/benefit analysis of the
product, its expected effects on cessation of tobacco consumption, its expected
effects on initiation of tobacco consumption and predicted consumer perceptions.
5.3
Member States may charge manufacturers and importers proportionate fees for
receiving, storing, handling, analysing and publishing the information provided under
a notification system.
5.4
The Directive also allows Member States to require manufacturers and importers to
carry out additional tests or submit additional information if needed.
5.5
Furthermore, the Directive provides that novel tobacco products placed on the
market shall respect the requirements of this Directive. Therefore, if on receipt of
notification the competent authority deems that the product does not comply with
the requirements under the Directive, the competent authority can prohibit the
product from being placed on the market.
5.6
Notwithstanding the obligation to introduce a notification system, Member States
have the option of going further by introducing an authorisation system whereby
prior authorisation must be obtained by manufacturers and importers before placing
novel tobacco products on the market. Under an authorisation system, the same
information set out in 5.2(a) to (f) above would be required, however unlike a
notification system, official sanction would be required from the competent authority
to permit the manufacturer or importer place a product on the market.
Questions
Q)
Under a notification system should manufacturers and importers of novel tobacco
products be charged proportionate fees for receiving, storing, handling, analysing and
publishing the information provided? Please provide an explanation for your answer
(maximum 600 characters (approx. 100 words)).
Q)
Should an authorisation system be introduced for the sale of novel tobacco products?
Please provide an explanation for your answer (maximum 1500 characters (approx.
250 words)).
Q)
If the Department chooses to implement an authorisation system, should
manufacturers and importers be charged proportionate fees for that authorisation?
Please provide an explanation for your answer (maximum 600 characters (approx.
100 words)).
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6.
Electronic Cigarettes and Refill Containers (Article 20)
Overview of Article relating to Electronic cigarettes and refill containers (Article 20)
6.1
The Directive sets new rules across Member States for nicotine containing electronic
cigarettes (e-cigarettes) and refill containers. The new rules are designed to ensure
the safety and quality of these products and to ensure equal treatment across the EU
for nicotine containing e-cigarettes.
6.2
It provides that Member States must ensure that e-cigarettes and refill containers are
only placed on the market if they comply with the Directive and all other relevant
Union legislation.
6.3
The Directive introduces notification/reporting obligations for manufacturers and
importers of e-cigarettes which will allow authorities to monitor and learn more
about these products.
6.4
It sets mandatory safety and quality requirements for nicotine content, ingredients
and devices. There will be maximum nicotine concentration levels for e-cigarettes and
maximum volumes for cartridges, tanks and containers of nicotine liquids. Only
ingredients of high purity may be used in the nicotine-containing liquid. Products
must be child and tamper-proof and protected against leakage to limit the risk of
exposure to possible adverse effects.
6.5
E-cigarettes will be required to deliver nicotine doses at consistent levels under
normal conditions of use. This means that a similar level of nicotine should be
delivered each time an e-cigarette is puffed for the same amount of time and with the
same strength.
6.6
The Directive introduces packaging and labelling requirements of e-cigarettes and
refill containers. Health warnings on e-cigarettes will be mandatory, as will
instructions for their use, information on addictiveness and toxicity, a list of all
substances contained in the product and information on the product’s nicotine
content. No promotional elements will be allowed on packs.
6.7
E-cigarette manufacturers and importers will be required to notify the designated
competent authority before placing new products on the market. They will also be
required to report annually to the competent authority on sales volumes of their
products, types of users and users’ preferences and trends.
6.8
The Directive extends existing rules for cross-border advertising and promotion of
tobacco products to e-cigarettes. Commercial communications ‘with the aim of direct
or indirect effect of promoting electronic cigarettes’ in the press, on television, on
radio and the internet will be prohibited. So too will sponsorship of events and
activities taking place in more than one Member State or those which have crossborder effects for example, where they are broadcast on television or radio. It also
imposes stricter rules on monitoring of market developments.
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6.9
Member States have the option to prohibit cross-border distance sales of e-cigarettes
and refill containers.
6.10 Under the Directive, the EU Commission has the power to prohibit any e-cigarette or
refill container if concern is raised regarding an unforeseen risk to public health.
6.11 Questions relating to the options with this Article are set out in the following sections.
Notification requirements for e-cigarettes and refill containers (Article 20(2))
6.12 Manufacturers and importers of e-cigarettes and refill containers must submit an
electronic notification to the competent authority of the Member State six months in
advance of placing any product on the market. For products on the market prior to
20 May 2016, notifications must be submitted within six months of that date.
Furthermore a new notification must be submitted for each substantial modification
to any product.
6.13 The notification must contain a range of information, including information on the
manufacturer and importer, the ingredients used, emission levels, toxicological data,
nicotine doses and uptake when consumed, product and production process and a
declaration that the manufacturer and importer bear full responsibility for the quality
and safety of the product under normal use.
6.14 Member States may charge manufacturers and importers proportionate fees for
receiving, storing, handling, analysing and publishing the information on ingredients
for e-cigarettes and refill containers submitted under Article 20.
Question
Q)
Should manufacturers and importers of e-cigarettes be charged proportionate fees
for receiving, storing, handling, analysing and publishing the information on
ingredients for e-cigarettes and refill containers? Please provide an explanation for
your answer (maximum 600 characters (approx. 100 words)).
Health warnings and information requirements for e-cigarettes and refill containers
(Article 20(4))
6.15 Under the Directive, e-cigarette and refill container packs must include a leaflet with
information on instructions for use and storage of the product, contra-indications;
warnings for specific risk groups; possible adverse effects; addictiveness and toxicity;
and contact details of the manufacturer or importer.
6.16 Unit packets and any outside packaging of e-cigarettes and refill containers must
include a list of all ingredients, nicotine content, batch number and a
recommendation to keep the product out of reach of children.
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6.17 Each unit packets and any outside packaging must also carry health warnings. The
Directive provides two options on the wording to be used for e-cigarettes. The Irish
translation, which must be included is set out beside each English version.
(a) ‘This product contains nicotine which is a highly addictive substance. It is not
recommended for use by non-smokers.’ ‘Cuimsíonn an táirge seo nicitín, ar
substaint an-andúile é. Ní mholtar do dhaoine nach gcaitheann tobac é a úsáid.’
or
(b) ‘This product contains nicotine which is a highly addictive substance.’ ‘Cuimsíonn
an táirge seo nicitín, ar substaint an-andúile é.’
Question
Q)
Which general warning as set out above should be used on unit packets and outside
packaging of e-cigarettes and refill containers?
Cross-border distance sales of e-cigarettes and refill containers (Article 20(6))
6.18 The Directive provides Member States with the option to prohibit the cross-border
distance sales of e-cigarettes and refill containers to consumers, i.e. to ban businesses
in Ireland from selling these products to consumers in other Member States, for
example, via the internet, telephone or mail order and to ban businesses in other
Member States from selling to consumers in Ireland.
6.19 Should the Department choose not to exercise this option, it is obliged to introduce a
registration system for all retailers intending to engage in cross-border distance sales
both into and out of Ireland.
6.20 If a registration system is introduced, Irish retailers selling e-cigarettes and refill
containers to consumers in other Member States (provided that Member State has
not imposed a ban) through distance selling arrangements will be required to register
with the Irish competent authority and the competent authority in the Member
State(s) where the consumers are based. All non-Irish businesses intending to sell in
Ireland through distance selling arrangements must register with the Irish competent
authority. Retailers would be required to provide contact details of their business,
the starting date of activities, and details in relation to the website(s) used for selling
such products.
6.21 Furthermore, retailers would be obliged to operate and provide details on an age
verification system, ‘which verifies at the time of sale, that the purchasing consumer
complies with the minimum age requirements provided for under the national law of
the Member State of destination.’ It is worth noting that whilst there is currently no
legislation governing the age at which e-cigarettes and refill can be purchased, the
Government intends introducing legislation prohibiting the sale of these products and
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other non-medicinal nicotine delivery systems to, and by, persons under 18 years of
age.
6.22 The placing of products on the market via cross-border distance sales arrangements
would only be allowed following receipt of confirmation of registration with the
relevant competent authorities. A list of all retailers registered with the Irish
competent authority would be publicly available.
6.23 Member States also have the option of requiring retailers to nominate a person to be
responsible for verifying that products comply with Irish legislation.
Questions
Q)
Should cross-border distance sales of e-cigarettes and refill containers be prohibited?
Please provide an explanation for your answer (maximum 1500 characters (approx.
250 words)).
Q)
If cross-border distance sales of e-cigarettes and refill containers are not prohibited
thereby requiring the introduction of a registration system, should retailers be
required to nominate a person to be responsible for verifying that products comply
with Irish legislation? Please provide an explanation for your answer (maximum 600
characters (approx. 100 words)).
7.
7.1
Queries
If you have any queries relating to this consultation please email
tpdconsultation@health.gov.ie with your query. Please do not send your
consultation submission to this email address as it will not be processed.
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