EUU, Alm.del - 2019-20 - Supplerende svar på spørgsmål 181: Spm. om oversendelse af regeringens svar på spørgeskema om evaluering af tobaksdirektivet, til sundheds- og ældreministeren, kopi til udenrigsministeren

Europaudvalget 2019-20
EUU Alm.del
Offentligt

Member State Questionnaire on the Assessment of

the Tobacco Products Directive

1.1

Introduction

ICF is currently undertaking a study on Directive 2014/40/EU of the European Parliament

and of the Council of 3 April 2014 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 (revised

Tobacco Products Directive)

on behalf of the Directorate-General for Health and Food

Safety of the European Commission (DG SANTE).

The purpose of the study is to examine the practical application of Directive 2014/40/EU

(hereinafter TPD) and its specific provisions, which strengthened existing rules on how

tobacco products are manufactured, produced and presented in the EU, and introduced new

rules for certain tobacco-related products. The study will assess the level of implementation

of the TPD by exploring both achievements and hindering factors.

In particular, the study aims to:

■

Assess its implementation and levels of compliance: exploring the achievements

and successes of the revised Directive, as well as obstacles and shortcomings

encountered by various stakeholders (Member States, Civil Society

Organisations, health experts, and economic operators);

Generate evidence (through primary and secondary data collection) - in

particular on the inputs, outputs, outcomes and impacts of the TPD, with the aim

to assess its overall relevance, effectiveness, efficiency, coherence and EU-

added value.

The study will be used by the Commission for the preparation of its report on the application

of the TPD, required by Article 28 of the Directive.

1.2

Purpose of consultation

The purpose of the consultation is to collect information and gather views from relevant

authorities of EU Member States bound by the Directive on its implementation. We

encourage you to elaborate on your replies and provide references to publicly accessible

studies, surveys, court cases or any other documentation that you consider relevant.

If you have any questions with regard to the study, please do not hesitate to contact the

project manager of the study: Christina Dziewanska-Stringer,

[email protected]

1.3

Your details

Table 1.1 Respondent's details

Denmark

Name(s)

Contact persons:

Ministry of Health: Maria Larsen

Danish Safety Technology Authority: Carl

Christian Lange

Danish Health Authority: Hanne Vibjerg

Ministry of Taxation: Elisabeth Carstensen

Maria Larsen:

[email protected]

Carl Christian Lange:

[email protected]

Email(s)

EUU, Alm.del - 2019-20 - Supplerende svar på spørgsmål 181: Spm. om oversendelse af regeringens svar på spørgeskema om evaluering af tobaksdirektivet, til sundheds- og ældreministeren, kopi til udenrigsministeren

Hanne Vibjerg:

[email protected]

Elisabeth Carstensen

[email protected]

Contact number

1.4

1.4.1

Questions on general implementation

Effectiveness

This series of questions asks about your views on how successful the TPD has been in achieving or supporting progress towards its objectives,

including facilitating the smooth functioning of the internal market and ensuring a high level of human health protection, since it entered into force on

19 May 2014.

Question

Has your Member State faced any issues in

transposing the TPD?

Member State response

Yes / No / To some extent.

Please elaborate, for example, any issues with specific articles.

Mostly regarding the tracking and tracing system, due to the complexity of the system.

Danish Safety Technology Authority:

From the point of a market surveillance authority we have faced no major issues beside what could be expected. It must be underlined that we are not

responsible for transposing the Directive into national legislation. As it is with all new legislation it has taken time to familiarize retail, distributors and

importers with new legislation. This has been clearer when dealing with electronic cigarettes, as the market was rather new and largely divided between

many independent smaller economic operators.

The final implementation of the Directive, namely track and trace, has proved very difficult for some parts of the retail sector and some distributors and

manufacturers.

Did you find the guidance received from the

Commission on transposing the TPD (for

example, through discussions at Expert

Groups, Sub-Groups or guidance documents)

clear and useful?

Yes / No / To some extent.

Please elaborate.

Especially meetings in the Expert Group on Tobacco Policy and Sub-Groups have been useful. Danish authorities have participated in the available

subgroups.

Danish Safety Technology Authority:

Being an enforcement authority, we would like to have seen more focus on this aspect of the TPD, like the meeting that was organized in Copenhagen in

2019.

Overall, have economic operators been

compliant with the TPD in your Member

State?

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

The level of compliance has differed much among various parts of the sector, so the question cannot be answered in a uniform way. In general it can be

said that larger operators such as retail outlets forming part of a larger cooperation has been more compliant than individual operators. In general

Question

Member State response

compliance has been better when dealing with tobacco than with electronic cigarettes. We believe this is mainly due to the fact that electronic cigarettes

today, and even more so 4 years ago, was an young and emerging market, which previously has not been heavily regulated.

Has the TPD achieved its objectives, i.e.

improved the functioning of the internal

market while reducing smoking prevalence?

Yes / No / To some extent.

Please elaborate.

We believe that the TPD has improved the functioning of the internal market. We are not familiar with studies examining the Directive´s impact on smoking

prevalence in Denmark, but we believe that the TPD has improved tobacco control and contributed to a strengthened focus on regulating tobacco products

and electronic cigarettes.

In your view, has the TPD improved public

health in your Member State (e.g. increased

awareness of the harmfulness of products;

decreased smoking rates)?

Yes / No / To some extent.

Please elaborate, including any relevant provisions.

Smoking rates in Denmark have not decreased since the TPD II came into force. It is hard to determine how smoking rates would have evolved it the TPD

had not been in place. However, we find it likely that the same level of regulation would not have been put in place at that time if it had not been for the TPD.

Yes / No.

If yes, please provide the most recent results (web link or attachment)

We collect data through a national survey that outlines the status of the Danish smoking habits (5,017 Danish citizens in the age of 15 years and above).

Data from 2019 are not published yet, but the results from 2018 can be found here:

https://www.sst.dk/-/media/Udgivelser/2019/Danskernes-rygevaner---

aarsrapport-2018.ashx?la=da&hash=FDCC21DAE57E7D411AC3AD4E0F781BD7D425A488

For data on prevalence of use in the age group 11-15 years, please refer to Health Behaviour in School-aged Children

–

Skolebørnsundersøgelsen.

https://www.hbsc.dk/.

Latest available data are from 2018.

For data on prevalence of use in the age group 16-24 years, please refer to The Danish National Health Survey:

https://www.sst.dk/-

/media/Udgivelser/2018/Den-Nationale-Sundhedsprofil-2017.ashx?la=da&hash=421C482AEDC718D3B4846FC5E2B0EED2725AF517

Latest available data are from 2017.

Does your Member State collect national data

on the level of prevalence of use in the under

25 years of age consumer group?

Has the TPD changed tobacco and related

product use in young people in your Member

State?

Yes: it has increased use;

Yes: it has decreased use;

No: it has not changed use.

Please elaborate.

We have not seen a decline in smoking rates or tobacco consumption among young people since the Directive entered into force. We do not have

knowledge of any evaluation of the effect of the TPD on tobacco use among young people. The ban on snus may have had a positive impact on snus use

among young people.

Question

Member State response

1.4.2

Relevance

For the next set of questions, we would like to ask you about the extent to which the TPD and its objectives are still relevant and meeting needs,

considering scientific, technical and epidemiological developments. We are interested in if the TPD is flexible and has the capacity to evolve to

withstand developments in the sector.

Question

In your view, has the TPD remained relevant

to address new market developments in your

Member State, including types of emerging

products? (For example, heated tobacco

products or nicotine containing products).

Member State response

Yes / No / To some extent.

Please elaborate.

We recognize that ensuring that the TPD address all new market developments is challenging and that efforts have been made to ensure the continued

relevance of the directive. However, some market developments have not been fully addressed by the directive, for instance heated tobacco products and

non-tobacco containing nicotine products. The wording concerning novel products may result in different national regulations within the EU. Also, e-liquids

containing THC etc. and shake and vape e-liquids are challenging.

It has proven challenging to establish whether notified novel tobacco products were to be categorized as smokeless tobacco products or tobacco products

for smoking.

In your view, is the TPD ‘future proof’, as new

Yes / No / To some extent.

societal, technical and scientific developments

Please elaborate.

occur in the sector?

Please refer to the answer above.

We would like the Directive to be more adaptable in order to ensure that the directive remains relevant when the market evolves. Also, we find it important

that the Directive does not create unintended restrictions for countries that wish to impose further restrictions to reduce tobacco use.

From a health perspective, we would like to see a continued focus on ingredients.

Question

Member State response

Danish Safety Technology Authority:

It might be useful to include heated tobacco and nicotine products in future updates of the directive. One could imagine in future updates of the directive,

not to included specific standards, as these might as the years pass by prove problematic or out dated. If standards were agreed in other legislative acts,

these could be easier updated.

1.4.3

Efficiency

Questions in this sub-section concern your views on the administrative burdens imposed by the TPD and their magnitude in relation to the benefits

generated.

Question

Has the practical implementation of the TPD

created significant additional administrative

burdens in your Member State?

Member State response

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

For 2019 the total cost of market surveillance of tobacco and electronic cigarettes was approximately 7.5 million DKK (1 million EURO) for Tobacco, which

we intend to increase to 8.9 million DKK (1.2 million EURO) in order to increase our surveillance of the track and trace system. For electronic cigarettes the

total cost for 2019 was approximately 10.8 million DKK (1.4 million EURO).

Please refer to the cost data template also provided.

Would you consider that the benefits the TPD

brings to consumers outweigh the overall

costs that are being incurred to implement the

Directive? To what extent were you able to

recover some of the costs incurred via fees?

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

All costs are sought recovered through fees. For tobacco the fees are based on market shares and for electronic cigarettes fees are based on products

reported to the DSTA. The fee structure for electronic cigarettes are currently being revised, as it has proven difficult to recover all costs through fees on

individual products.

Yes / No / To some extent.

Please elaborate.

Has your Member State provided any specific

support to small and medium enterprises

affected by the TPD?

1.4.4

Coherence

For the next set of questions, we are interested in your thoughts on the extent to which the TPD is still coherent and consistent internally, i.e. with its

own provisions, as well as with other relevant EU and international legislation that is linked to the TPD.

Question

Member State response

Has your Member State faced any issues with

Yes / No / To some extent.

TPD provisions being inconsistent or

Please elaborate.

Question

incoherent with each other? For example,

have the requirements of one article

contradicted the requirements of another?

Member State response

Has your Member States faced any issues

with TPD provisions being inconsistent or

incoherent with other EU legislation, for

example:



The Tobacco Taxation Directive



The audio-visual media services

Directive



Tobacco Advertising Directive



Smoke Free Environments

recommendation



Single Use Plastics Directive



Market Surveillance Regulation



The CLP Regulation for

(Classification, Labelling and

Packaging)



General Product Safety Directive



REACH (Regulation (EC) No

1907/2006)

The definition of tobacco products is different from the definition in the Tobacco Advertising Directive.

We find it important that the directive ensures a high degree of protection of human health and that it is made more clear that the Member States retain the

power to impose further requirements in order to protect public health. We believe that restrictions introduced by Member States should be assessed in

light of the need to take precautionary actions due to the particular harmfulness of tobacco and other nicotine products.

Has your Member State faced any issues with

Yes / No / To some extent.

TPD provisions being inconsistent or

Please elaborate.

incoherent with FCTC guidelines, including

the

Protocol to Eliminate Illicit Trade in

We have not ratified the FCTC Protocol.

Tobacco Products?

1.4.5

EU added value

The final few questions are about your views on the extent to which the TPD adds value at the EU level, in a way that may not be attainable at a

national or global level.

Question

Has the TPD added value to the regulation of

tobacco and tobacco-related products across

the EU?

Member State response

Yes / No / To some extent.

Please elaborate

For instance with regards to ingredients, e-cigarettes, labelling and packaging.

Danish Safety Technology Authority:

From a market surveillance perspective, we believe it is beneficial to have a common legislation across the EU.

Do you feel that the effects of the TPD on

smoking consumption or the illicit trade could

have been achieved at the level of your

Member State, without EU-level involvement?

Yes / No / To some extent.

Please elaborate

We do not have data on the impact of the TPD on tobacco consumption but find it likely that this level of regulation would not have been achieved at the

national level in the same period. One of the reasons being that the TPD regulates numerous technical issues that we as a Member State do not have the

means to examine to the same degree.

Danish Safety Technology Authority:

We believe it is beneficial that the track and trace system has been implemented across the EU, with one common system, instead of numerous local

versions.

1.5

1.5.1

Questions by article of interest

Article 2: Definitions

Member State response

Background

Question

and key

considerations

The directive sets

out 41 definitions to

be applied.

Clear definitions are

indispensable to

ensure that this

Directive is

uniformly

implemented by

Member States.

Have the definitions in the TPD been

clear and unambiguous enough to

allow for clear interpretation and

implementation?

Yes / No / Some unclarities and ambiguities.

Please elaborate: If you consider one or more definitions to be unclear and/or ambiguous, please describe them here and propose improvements.

The definition of smokeless tobacco has proven challenging with regards to the classification of novel tobacco products.

The Danish Health Authority notes that there is no joint specific or accepted level for addictiveness, toxicity or CMR (art. 7, 9).

Danish Safety Technology Authority:

(6) + (8) The definition of chewing tobacco and oral tobacco is unclear. Both products are presented in sachet portions or porous sachets. We have

experienced that the consumer is confused whether the product is chewing tobacco or oral tobacco. Furthermore we have experienced that the rules are

circumvented by means of the unclear definition and the similarities between the products

(16) The definition of an electronic cigarette have not been clear to the manufacturers, importers and retailers. The expression

“the device without cartridge

or tank” has been a subject to discussion several

times. The submitters, think that the rules are unclear and can be interpreted. In Denmark we have made

a scheme with an overview of the specific components to verify whether the product need to be notified or not.

(30) The definition of ’unit packet’ regarding refill containers containing nicotine. It has been unclear whether the unit package was related to the bottle or

the package surrounding the bottle.

For example, definitions including (but

not limited to):

- Novel Tobacco Products

- Electronic cigarettes

- Refill containers

- Roll your own tobacco

However, certain

- Additive

concepts - defined

- Nicotine

within this Directive-

- Chewing, nasal and oral tobacco

may remain

Retail Outlet

unclear, and cause

- Flavouring

interpretation

- Substantial change of circumstances

issues, and/or

- Flavour/flavouring

divergent

- Characterising flavour

interpretations,

- Cross border distance sales

during

implementation.

Also, in the light of

various scientific,

technological and

market

developments,

some of the current

Have you experienced any particular

issues with the classification of

products, based on how they are

defined in the Directive (e.g.

“smokeless tobacco products” versus

“tobacco products for smoking”)?

Yes / No / To some extent.

Please elaborate.

Please refer to the answer to the question above.

Background

Question

and key

considerations

definitions may no

longer be relevant

or appropriate.

*Please refer to

Article 2 of the TPD

for the full list.

Have the definitions laid out in the

TPD remained relevant in view of

scientific, technological and market

developments?

Member State response

The Danish Health Authority finds that the differences between snus and chewing tobacco are in practice very small, and the Health Authority experiences

that people do not see or know the difference between the products, because the products are very similar. They would like TPD to define the differences

more clearly and technically to make it easier to regulate and control the products.

Yes / No / To some extent.

Please elaborate: If you consider one or more definition to be irrelevant in view of scientific, technological and market developments, please describe them

here.

Please refer to the answers above.

From a health perspective it might be relevant to look into the definition

of cigars/cigarillos, taking into account the existence of for instance “little cigars”.

Are there any other products or

categories for which a definition

should be included in the Directive?

Yes / No.

Please elaborate.

It could be considered to define heated tobacco products and nicotine products not containing tobacco.

From a health perspective, if it is unclear how a new product should be classified, it would be preferable if the product had to be treated as the more

harmful product category by default.

Danish Safety Technology Authority finds that it could be relevant to include definitions of tobacco containing products as blunts, wraps etc. They have had

difficulties in categorising these products.

Are the concepts as defined in this

Directive consistent with other EU

legislative instruments (e.g. Tobacco

Taxation Directive, Tobacco

Advertising Directive, Audio-visual

Media Services Directive) or other

legislation at National level?

Yes / No / To some extent.

Please elaborate: have inconsistencies led to any implementation issues in practice?

The TPDII and the Tobacco Advertising Directive are not consistent. The definition of tobacco products in the TPD is different from the definition in the

Tobacco Advertising Directive.

Has your Member State encountered

any other difficulties in the practical

application of the provisions of this

Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Background

Question

and key

considerations

Member State response

See answers above.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 2.

1.5.2

Article 3: Maximum emission levels for tar, nicotine, carbon monoxide and other substances

Member State response

Background

Question

and key

considerations

The TPD sets

maximum emission

levels from

cigarettes placed on

the market or

manufactured in the

Member States for

tar, nicotine, and

carbon monoxide.

Are the provisions on maximum

TNCO emissions (Article 3(1)) still

relevant in view of scientific and

technological developments?

Yes / No / To some extent.

Please elaborate: Is there scope or necessity for changing the TNCO limits or introducing other limits?

We consider it relevant to maintain provisions on maximum TNCO-levels, but also to assess the current maximum emission levels.

Has your Member State set limits for

additional maximum emission levels

for cigarettes (Article 3(3))?

Yes / No.

If no: are you considering it? Why or why not?

If yes: Please elaborate, including when the Commission was notified.

We are not currently considering setting limits for maximum emissions levels for cigarettes. To ensure uniform regulation of the emission levels and due to

the technical aspects we believe there are advantages in handling this at the EU-level.

Yes / No.

If no: are you considering it? Why or why not?

If yes: Please elaborate, including when the Commission was notified.

We are not currently considering setting limits for maximum emission levels for other tobacco products. Again, we find that this matter is better addressed

at the EU-level.

If Member States

set additional

maximum emission

levels for cigarettes,

Has your Member State set limits for

maximum emission levels for other

they must inform

tobacco products (Article 3(3))?

the commission.

In view of new

technical and

scientific

developments,

these may be no

longer or less

relevant.

Has your Member State encountered

any other difficulties in the practical

application of the provisions of this

Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 3.

1.5.3

Article 4: Measurement methods

Member State response

Background

Question

and key

considerations

The TPD sets the

measurement

methods using ISO

standards for tar,

nicotine, and

carbon monoxide

for cigarettes

placed on the

market or

manufactured in the

Member States.

The measurements

must be verified by

independent

approved

laboratories.

In view of new

technical and

scientific

developments,

these measurement

methods may be no

longer relevant, in

which case

delegated acts are

foreseen by this

directive.

Are provisions on measurement

methods (Article 4(1)) still relevant

in view of scientific and

technological developments?

Yes / No / To some extent.

Please elaborate.

We believe that there is a need to investigate and assess the measurement methods, also taking into account the issue of filter ventilation. We find it

important that the emission levels being measured to the greatest extent possible reflect actual levels of emissions that smokers are exposed to. As part of

this work it might be relevant to consider the maximum emission levels as well.

Danish Safety Technology Authority:

The DSTA notes that the ISO standard reads lower levels of TNCO than other methods, and furthermore that the ISO method is developed by the tobacco

industry. On this basis it is the view of the DSTA that the Commission should initiate a thorough investigation into measurements methods of TNCO. This

being said, we do not at this time possess the necessary professional insight to say if the Canadian Intense method is more correct than the currently used

ISO standards.

Would there be necessity or scope

Yes / No / To some extent.

for changing the measurement

Please elaborate.

methods for emissions from the ISO

method to e.g. the Canadian Intense

Please refer to the answers above.

(CI) method?

Has your Member State faced any

issues with regard to the

appointment and monitoring of

laboratories (Article 4(2))? For

example, in ensuring these are fully

independent from the tobacco

industry?

Yes / No / To some extent.

Please elaborate.

How many laboratories have you approved to date? If none, what laboratories do you use for verification?

Danish Safety Technology Authority:

We have not approved any laboratories, and we have not had any applications.

We use LNE located in France for testing.

Has your Member State used any

measurement methods for

emissions for cigarettes other than

Yes / No.

If no: are you considering it? Why or why not?

If yes: Please elaborate, including when the Commission was notified.

Background

Question

and key

considerations

the three specified in Article 4(1)

(Article 4(4))?

Member State response

Has your Member State used any

measurement methods for

emissions for other tobacco

products (Article 4(4))?

Yes / No.

If no: are you considering it? Why or why not?

If yes: Please elaborate, including when the Commission was notified.

Has your Member State charged

manufacturers and importers of

tobacco products proportionate fees

for the verification of these

measurement methods (Article

4(6))?

Yes / No.

If no: are you considering it? Why or why not?

Danish Safety Technology Authority:

The annual fee collected from importers and manufacturers based on market shares, covers all market surveillance, including peer reviews.

Has your Member State

encountered any other difficulties in

the practical application of the

provisions of this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Danish Safety Technology Authority:

The number of notified products in EUCEG does not reflect the number of products on the Danish market. Manufacturers and importers seem to notify

their products all over the EU. This issue makes it difficult to selects products for a control.

The submitters have no obligation to keep their submissions updated in the EUCEG system. As a member state we have no punitive measures to ensure

that our part of EUCEG only reflects the products that is actually marketed in our country.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 4.

1.5.4

Article 5: Reporting of ingredients and emissions

Background and

Question

key considerations

The Directive requires

manufacturers and

importers of tobacco

products to submit to

competent authorities

certain information

concerning the

ingredients and emissions

of tobacco products.

There is an overall lack of

evidence of how this

provision is being

implemented by different

Member States.

Has your Member State faced

any issues in requiring

manufacturers and importers to

submit the required information

in Article 5(1), the statement of

reasoning in Article 5(2), or the

toxicological data in Article

5(3)?

Member State response

Yes / No / To some extent.

Please elaborate, including if there have been any issues with manufacturers or importers informing about modifications of the composition of a product.

Danish Safety Technology Authority:

We have experienced that submitters do not submit any technical documentation setting out a general description of the additives used and their

properties for cigarettes and roll-your-own tobacco. The submitters who does not comply with this are often confused of what the content of these

documents should be.

Has your Member State faced

any issues in making submitted

information publicly available on

a website (Article 5(4))? E.g.

have there been issues with

economic operators requesting

information not be published

due to trade secrets?

Yes / No / To some extent.

Please elaborate.

Please provide a link to the publicly available list.

Danish Safety Technology Authority:

Our currently available public list can be find here: https://www.sik.dk/registre/tobaksregister

Economic operators have marked almost all information in EU-CEG as confidential. The DSTA is currently awaiting the publication from Joint Action on

Tobacco Control, deliverable 5.1

“Report on the principles to distinguish what data is public on confidential”,

including a list of public and confidential

information submitted into EU-CEG and also a final clarification if the Commission will provide a publication tool of this information, or if this will have to be

done on a national level.

Yes / No.

Please elaborate.

Danish Safety Technology Authority:

To some extent consumers uses the public information in order to verify whether the products are legal in Denmark.

Yes / No / To some extent.

Please elaborate, for example any difficulties with scientific capacity to understand and assess data.

Do you know if consumers

make use of the public

information? In what ways / for

what purpose?

Has your Member State faced

any issues with processing and

assessment of submitted

product information?

How has your Member State

reacted to incorrect or

insufficient submissions,

including insufficient data?

Please elaborate, including the actions and follow-up undertaken

Danish Safety Technology Authority_

If the manufacturers or importers have notified insufficient submissions, including insufficient data, we:

Request further information (insufficient submissions)

Has your Member State faced

any issues in requiring and

assessing manufacturers and

importers to submit the studies

required by Article 5(6)?

Inform the submitter about the incorrect / non-compliant data (hearing of parties)

Prohibit marketing of the product if the product notification is not updated with correct / compliant data

Ultimately the case can be handed over to the prosecuting authority in order to fine the submitter

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

Sales volume: the manufacturers and importers are mostly capable of submitting the correct information. When we face issues they are often caused

by the following:

There is no overall consistency in the reported sales volume. Some manufacturers / importers report the sales volume out of the factory and some

the sales volume from the national retailers. There is also a difference in which kind of data we receive depending om whether it is a manufacturer or

an importer that submit the data

Some of the annual sales volumes are reported as a zero sale. This is when either the manufacturers / importers have submitted their products in

Denmark, but they are not marketing the products in Denmark or if the marketing of the product is not started yet. Some submit a zero sale when the

product is on the market in retail, but the manufactor has not produced any new products.

Market surveys, internal and external studies: To this day no useful studies have been submitted.

Has your Member State faced

Yes / No / To some extent.

any issues in ensuring that the

Please elaborate.

Commission and other Member

States have access to this

Danish Safety Technology Authority:

information (Article 5(7))?

The information on sales volumes are stored in our case handling system.

Has your Member State used

information made available by

other Member States for the

purposes of applying this

Directive (Article 5(7))?

Yes / No.

If no: are you considering it? Why or why not?

Danish Safety Technology Authority:

Yes, we have used the classification of tobacco products from other countries, when we assess a case, for instance the Swedish classification of oral

tobacco has been used when we have found similar products on the Danish market, categorized by the importer as chewing tobacco.

Do you consider that the EU-

Yes / No / To some extent.

CEG system works effectively?

Please elaborate.

Would any further

developments be required to

Danish Safety Technology Authority:

improve its functioning?

We would firstly refer to the Joint Action on Tobacco control, in which this point as been discussed and worked with in great detail. Specifically we refer to

deliverable 5.6 Report for M1-18 on the potential improvements/alterations identified through Task 3.1, already available here: https://jaotc.eu/wp-

content/uploads/2019/09/WP5-D5.6-Report-for-M1-18-on-the-potential-improvementsalterations-identified-through.pdf. To this report DSTA has contributed

both as WP5 leader and with actual input to the report. Furthermore we would refer to deliverable 5.7 within the JATC which is a follow up report on the 5.6

report.

The EU-CEG system is working functionally to us, however there is room for improvements. Some examples are mentioned below:

As we have experienced a lot of frustrated submitters, that cannot see the submitted data after loading it into the system, it would be a place for

improvement, if they had a view access to their own submissions after submitting them. We have had a lot of request from the submitters to control

whether or not a specific submission has been completed correctly or submitted to Denmark at all. They would not have made the request if they

were able to see their own submitted data.

In order to ensure more correct data in the submissions, it would be approvable if limit values was predefined for certain fields e.g. emissions.

In order to digitalize our processing of the submission data, it would be valuable if the digital access to the EU-CEG database could be smoother.

The Member States should be able to flag submitted products that need to be removed from the national part of EU-CEG.

What would be the effects on

your work of a possible

European Union database

containing information on

tobacco products, including

ingredients?

Please elaborate, including possible benefits and difficulties with an EU-wide system.

Danish Safety Technology Authority:

We would not have to make an extension for our present lists of registered products.

Since the Directive came into

force, how many times has your

Member State taken actions

(such as product modification,

product withdrawal, fines, or

other punitive measures)

against manufacturers or

importers due to non-

compliance related to reporting

of ingredients and emissions?

Please elaborate.

Danish Safety Technology Authority:

Based on our updated information in our case handling system from days date, we have taken action 2 times against manufacturers or importers due to

non-compliance related to reporting of ingredients and emissions. Please notice that our system is dynamic and reflects the actual updates submitted in

the EU-CEG.

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 5.

1.5.5

Article 6: Priority list of additives and enhanced reporting obligations

Background and

key

considerations

The Directive requires

enhanced reporting

obligations for certain

additives contained in

cigarettes and roll-your-

own tobacco that are

included in a priority list.

In addition, Member

States shall require

manufacturers and

importers to carry out

comprehensive studies

and to establish a report

on the results of these

studies.

Evidence is needed to

understand whether this

provision is being

implemented and how

MS are implementing it.

Question

Member State response

Has your Member State faced

any issues in requiring

manufacturers and importers to

carry out the comprehensive

studies required in Article 6(2)?

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

It is difficult to distinguish the technical reports from Article 5 (3) and the studies required for Article 6(2).

The Danish Health Authority did

not receive any reports on diacetyl, but as we don’t have any products containing this additive, it’s OK.

Has your Member State

assessed reports submitted by

manufacturers or importers to

create the reports required in

Article 6(4)?

Yes / No / To some extent.

Please elaborate, including on possible peer-review by a scientific body

If no: are you considering it? Why or why not?

Danish Safety Technology Authority:

We have yet to assess any reports.

Since the publication of the

priority list of additives, has your

Member State taken regulatory

action on any of the ingredients

identified? Is your Member

State

intending

on taking

regulatory actions of this type?

Yes / No / Considered.

Please elaborate

The Danish Health Authority are waiting for the conclusions and recommendations of the peer review panel.

Danish Safety Technology Authority:

We have taken action on the ingredients Menthol and Diacetyl for the CAS numbers mentioned on the priority list.

For Diacetyl we located which TP-ID’s

contained the ingredient and was missing a submitted study. The result of this was that no product contained Diacetyl

on the Dffanish market

For Menthol we have located which TP-ID’s

contains this ingredient. This ingredient will no longer be permitted in products intended for sale in Denmark as

of 20-05-2020. We will take actions towards these TP-ID’s

if they still contains the ingredient(s) after this date.

New products containing the CAS numbers

mentioned on the priority list will not be allowed to market their products in Denmark after this date.

Has your Member State

charged manufactures and

Yes / No.

If no: are you considering it? Why or why not?

importers proportionate fees for

peer reviews of their reports

Danish Safety Technology Authority:

The annual fee collected from importers and manufacturers based on market shares, covers all market surveillance, including peer reviews.

(Article 6(4))?

Since the Directive came into

force, how many times has your

Member State taken actions

(such as product modification,

product withdrawal, fines, or

other punitive measures)

against manufacturers or

importers due to non-

compliance related to additives

and reporting?

Please elaborate.

Danish Safety Technology Authority:

Since the Directive came into force, we have not taken any actions against manufacturers or importers due to non-compliance related to additives and

reporting.

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 6.

At the moment the expert panel is finalising the peer reviews of the enhanced reporting information submitted by the industry. The Danish Health Authority are waiting for the final report, the conclusions and

recommendations from the peer review panel before taking any action. The Danish Health Authority looks forward to see the report from the peer review panel. The Danish Health Authority is cautious when it comes to

reports from the industry, and they always suggest that regulatory actions are based on independent reports analysing the effects of the additives and not reports from the industry. That said The Danish Health Authority

believes the peer review panel base their conclusions and recommendations on independent literature. In the future The Danish Health Authority suggests that report about effects of the additives are composed by

independents experts and not the industry.

1.5.6

Article 7: Regulation of ingredients

Background and

Question

key considerations

The Directive requires that

tobacco product with

characterising flavours be

prohibited. It also requires

independent advisory

panels to assist the

Commission with

determining the

characterising flavours

requirements.

Tobacco products with

certain additives are also

prohibited.

Has your Member State faced

any issues in prohibiting the

placing on the market tobacco

products containing the

additives listed in Article 7(6)

(vitamins, caffeine, taurine,

etc)?

Has your Member State faced

any issues in prohibiting the

placing on the market tobacco

products with a characterising

flavour (Article 7(1))?

Member State response

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

We have not had any cigarettes or RYO tobacco products with a characterizing flavor notified in Denmark, except for menthol which is legal until 20

May 2020.

Yes / No / To some extent.

Please elaborate on the practical implementation.

Have you further detailed additives covered by this article?

Danish Safety Technology Authority:

According to the submitted data in EU-CEG we have not had any tobacco products containing the additives listed in Article 7(6) (vitamins, caffeine, taurine,

etc.) notified in Denmark.

Yes / No/Under consideration

These provisions only apply

Has your Member State

prohibited any products

Please list the products, if yes.

to certain products, and it is

following scientific evidence of

If yes, did you notify the Commission of all products?

important to understand

their containing additives in

how these bans operate

quantities that increase the toxic

or addictive effect, or the CMR

differently in Member

properties at the stage of

States.

consumption to a significant or

measurable degree (Article

7(9))?

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 7.

For example, does the current system of listing

prohibited

additives work well, or would you prefer a list with

permitted

products or additives?

1.5.7

Articles 8-14: Labelling and Packaging

Article 8: General provisions

Article 9: General warnings and information messages on tobacco products for smoking

Article 10: Combined health warnings for tobacco products for smoking

Article 11: Labelling of tobacco products for smoking other than cigarettes, roll-your-own tobacco and waterpipe tobacco

Article 12: Labelling of smokeless tobacco products

Article 13: Product presentation

Article 14: Appearance and content of unit packets

Background and

Question

key considerations

Has your Member State faced

This Directive includes

any issues in implementing the

requirements for

provisions concerning general

mandatory health warning

warnings and information

labels and packaging of

messages on tobacco products

tobacco and related

for smoking (Articles 8 & 9)?

products. These

requirements refer to the

use of combined health

warnings consisting of a

Has your Member State faced

picture and a text,

any issues in implementing the

Member State response

Yes / No / To some extent.

Please elaborate.

Yes / No / To some extent.

Please elaborate.

Background and

Question

key considerations

information on cessation

services and promotional

elements in and on unit

packets.

We want to understand to

what extent are general

provisions on labelling

and packaging being

implemented and if

Member States are facing

any issues implementing

any of the provisions

outlined in this section.

provisions concerning combined

health warnings for tobacco

products for smoking (Article

10), including the minimum

dimension of warnings (Art.

10(1))?

Member State response

Has your Member State

ensured that the provisions for

combined health warning were

properly implemented on

packages with bevelled edges

(see recital 28)? Which action

was taken if not?

Yes / No / To some extent.

Please describe how you have addressed the issue.

Danish Safety Technology Authority:

We have based our market surveillance on

“Bevelled and Rounded Edges –

Non-paper for discussion by the Tobacco Products Committee and the Expert

Group on Tobacco Policy”,

from 15

of October 2015.

We continues to monitor tobacco products and their compliance with the TPD provisions regarding health warnings.

Has your Member States

received any claims/complaints

concerning the content or

persons depicted on health

warnings?

Yes / No.

Please elaborate on the type of those claims and how you addressed them.

Has your Member State faced

any issues in implementing the

provisions of Article 9(3)

concerning the minimum

dimensions of health warnings

on the lateral surfaces of cuboid

packets such as

slim/flat/shoulder-hinged lid-

packs (taking into account the

guidance provided by the

Commission).

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

On basis of the Commission official guidance issued on September 2017, regarding the minimum dimensions of cuboid packages of cigarettes and roll

your own, the DSTA launched a targeted effort in order to see that the market was compliant. In general the market quickly adopted to the legislation when

stakeholders was confronted with the requirements. One manufacturer disagreed but eventually agreed to change their packages in order to

accommodate the minimum dimensions. We have since this targeted effort not had reports of slim packages etc.

Background and

Question

key considerations

Has your Member State

exempted any tobacco products

for smoking other than

cigarettes, roll-your-own

tobacco and waterpipe tobacco

from the obligations to carry the

information message ‘Tobacco

smoke contains over 70

substances known to cause

cancer’

(Article 11(1))?

Member State response

Yes / No.

If no: are you considering it? Why or why not?

If yes, please elaborate on the exempt products and any benefits or disadvantages.

All other tobacco products for smoking are exempted from the obligation. They must carry a general warning and a text warning. The general warning

must include a reference to the cessation services - Stoplinien: 80 31 31 31 www.stoplinien.dk.

Has your Member State

exempted any tobacco products

for smoking other than

cigarettes, roll-your-own

tobacco and waterpipe tobacco

from the obligations to carry

combined health warnings

(Article 11(1))?

Yes / No.

If no: are you considering it? Why or why not?

If yes, please elaborate on the exempted products and any benefits or disadvantages.

All other tobacco products for smoking. Please refer to the answer above.

If your Member State has

exempted products in this way,

has it faced any issues in

implementing the alternative

labels described in Article 11?

Yes / No / To some extent.

Please elaborate.

Has your Member State faced

Yes / No / To some extent.

any issues in implementing the

Please elaborate.

provisions concerning labelling

of smokeless tobacco products

Danish Safety Technology Authority:

(Article 12)?

We have mainly focused on the labelling of cigarettes and roll your own so far. In the upcoming year a targeted effort has been planned for smokeless

tobacco.

Background and

Question

key considerations

Has your Member State faced

any issues in interpreting and

implementing the provisions

concerning product presentation

(Article 13), e.g. on promotional

elements?

Member State response

Yes / No / To some extent.

Please elaborate and provide examples of promotional elements you have dealt with.

There have been challenges, but after a targeted effort by the Danish Safety Technology Authority, compliance has increased.

Danish Safety Technology Authority:

On the basis of national legislation and the TPD the DSTA has issued a guidance document, regarding the presentation of tobacco products. It is available

here: https://www.sik.dk/sites/default/files/2019-06/praesentation_af_tobaksvarer_-_vejledning_27062019.pdf, unfortunately only in Danish.

In general we have had quite a few disputes over this matter, both in the regard as to which words / and graphic elements could refer to taste, but also to

strength, social status etc. There is on ongoing court case regarding the use of the word “Royal” on a tobacco product.

Has your Member State faced

any issues regarding the

minimum number of sticks per

pack or any of the other

provisions listed in Article 14

(e.g. for RYO, material/opening

of pack, etc.)

Yes / No / To some extent.

Please elaborate, including on possible further rules on pack sizes.

Since the Directive came into

Please indicate the number of actions taken per Article and elaborate on the issue(s) encountered

force, how many times has your

Danish Safety Technology Authority:

Member State taken actions

(such as product modification, We have not taken action against manufacturers or importers due to non-compliance related to labelling and packaging

product withdrawal, fines, or

other punitive measures)

against manufacturers or

importers due to non-

compliance related to labelling

and packaging?

Background and

Question

key considerations

Should there be stricter/clearer

labelling provisions overall? Or

on any specific products

specifically?

Member State response

Yes / No.

Please elaborate.

Labelling of non-tobacco containing nicotine products.

Plain packaging

Danish Safety Technology Authority:

From the perspective of a market surveillance unit, the DSTA believe that the rules should be as clear and well defined as possible.

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

Articles 8-14?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Danish Safety Technology Authority:

According to the submissions in the EU-CEG, we have had some difficulties in distinguishing between the product types of pipe tobacco and RYOT. We

have experienced that some submitters have changed their product type from pipe tobacco to RYOT or the other way around.

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Articles 8-14.

The current provisions regarding smokeless tobacco products have in practice meant that manufacturers of for instance chewing tobacco have often placed health warnings on the side and bottom of the products,

meaning that the health warming is not visible when the tobacco products are displayed in the shops.

1.5.8

Articles 15-16: Traceability and security features

Member State response

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

From an authority point of view we faced no major issues in implementing track and trace in regards of appointment of ID-issuer etc. It is still early stages of

the track and trace system, as it has not yet been running one full year, so further experiences is needed, in order to test if everything works as planned.

The EO’s have struggled with the implementation of the track and trace system.

Background and

Question

key considerations

Has your Member State faced

any issues in implementing the

traceability system required by

Article 15 in relation to its

provisions further specified in

The system on traceability

Commission Implementing

and security features

Regulation (EU) 2018/574, for

requires a unique identifier

example in relation to

appointment of an ID issuer and

be placed on unit packs,

full access to the records

cartons, master cases and

created by anti-tampering

shipping cases that are

devices?

either manufactured in the

This Directive introduced

an interoperable system

on traceability and security

features at Union level.

EU or imported into the EU

market. All economic

Has your Member State faced

any issues in implementing the

operators from

traceability system required by

Article 15 in relation to its

manufacturing to the first

retail outlet need to track all

provisions not reflected in

Commission Implementing

packs by recording the

Regulation (EU) 2018/574, in

entry, intermediate

particular paragraphs 6

movements, and final exit

(maintenance of records of all

relevant transactions) and 7

of the packs in their

possession. We would like

(provision of equipment)?

to gather your preliminary

experiences with this

system.

Yes / No / To some extent.

Please elaborate.

DSTA:

A target effort focused on track and trace was planned to take place from mid-February and forward. The effort has been halted by COVID-19, and thus at

this point we are still missing adequate data in order to fully say if all relevant transactions are being recorded correctly. As far as equipment goes, it follows

from our national legislation that the DSTA has the authority is fully try the decisions of tobacco manufacturers when it comes to compensation. So far we

have received no formal complaints to this matter.

To what extent is the traceability

Please elaborate.

system (Article 15) helping to

Danish Safety Technology Authority:

fight the illicit trade of tobacco

products?

We merely ensure that the track and trace system is working and that economic operators are reporting correctly, whether it will have an impact on illicit

trade, time will tell.

Has your Member State faced

any issues in implementing the

security features system

required by Article 16, for

Yes / No / To some extent.

Please elaborate.

Background and

Question

key considerations

example in relation to the

tamper proof marker?

Member State response

The Ministry of Taxation has not had any issues implementing the tamper proof marks, as tax stamps were already used on some tobacco products (e.g.

cigarettes and fine cut tobacco), and these stamps met the set criteria for tamper proof marks.

To what extent is the security

features system (Article 16)

helping to fight the illicit trade of

tobacco products?

Please elaborate.

The Ministry of Taxation notes that the security feature system is helping to fight the illicit trade of tobacco products to the same extent as our tax stamps

did before, as we already used tax stamps on some tobacco products (e.g. cigarettes and fine cut tobacco), and these stamps met the set criteria for

tamper proof marks.

Please elaborate.

Danish Safety Technology Authority:

As previously mentioned, that system has been running for less than 1 year, at this time, the DSTA believe it is too early to say anything for certain

regarding the independence from the tobacco industry. For now no issues with independence has been found by the DSTA or brought to the attention of

the DSTA.

To what extent do you expect

the procedures governing the

appointment and monitoring of

ID issuers, providers of

repository services and

providers of anti-tampering

devices to provide for a

sufficient level of independence

from the tobacco industry?

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

these Articles?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Articles 15 & 16.

1.5.9

Article 17: Tobacco for oral use

Member State response

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

We have encountered difficulties.

Retailers in Sweden illegally market oral tobacco products to Danish consumers from their website. According to our legislation we only have the possibility

to sanction the retailer. Not the consumer. Oral tobacco products are marketed from social medias, online and physical retailers.

The Danish Health Authority notes that the TPD states that:

“For other

smokeless tobacco products that are not produced for the mass market, strict

provisions on labelling and certain provisions relating to their ingredients are considered sufficient to contain their expansion in the market beyond their

traditional use”. In Denmark, we experience that chewing tobacco is now popular among young people, which indicate that the strict provisions on labelling

etc. are not sufficient to contain their expansion in the market beyond their traditional use.

Are you aware of any efforts to

circumvent the ban on tobacco

for oral use in your Member

State?

Background and

Question

key considerations

The Directive prohibits

placing tobacco for oral

use on the market,

without prejudice to Article

151 of the Act of

Accession of Austria,

Finland and Sweden.

Has your Member State

encountered any difficulties in

implementing the ban on

tobacco for oral use?

Yes / No.

Please elaborate.

Danish Safety Technology Authority:

The definition of chewing tobacco and oral tobacco is unclear. Both products are presented in sachet portions or porous sachets. We have experienced

that the rules are circumvented by means of the unclear definition and the similarities between the products.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 17.

The Danish Health Authority notes that it can be an issue for tobacco control on snus that it is possible for Danish consumers to buy snus in Sweden and have it shipped to Denmark.

1.5.10 Article 18: Cross-border distance sales of tobacco products

Background and

Question

key considerations

The Directive allows

Member States to prohibit

cross-border distance

sales of tobacco products

to consumers. In Member

States where this is not

prohibited, retail outlets

intending to sell products

across borders must

competent authorities of

the Member State where

the retail outlet is

established and the

Member State where the

consumers are located

Retailers who sell

products across borders

are required to have an

age verification system at

sale.

Member State response

Has your Member State

Yes / No.

prohibited cross-border distance

If no: are you considering it? Why or why not?

sales to consumers (Article

18(1))?

We are not currently considering banning cross-border distance sales.

For countries where cross-

border distance sales are

permitted, which retail outlets

have been registered in your

Member States (Article 18(1))?

How many retail outlets located in your Member State have registered with your competent authority?

5 retail outlets located in our Member State.

How many retail outlets located in another Member State with consumers in your Member State have registered with your competent authority?

How many retail outlets located outside the EU with consumers in your Member State have registered with your competent authority?

9 retail outlets located in another Member State or outside the EU.

Where do you publish the lists

Please describe where the list is published.

of the retail outlets registered in

Please provide the list of registered retail outlets.

your Member State (Article

Danish Safety Technology Authority:

18(2))?

The lists are published on our website www.sik.dk

List of cross-border distance sales of tobacco products out of Denmark

List of cross-border distance sales of tobacco products into Denmark

Has the pattern of cross-border

Yes; there have been increased cross-border distance sales / Yes; there have been reduced cross-border distance sales / No; there has been no change.

distance sales in your Member

Please elaborate.

State changed in any significant

Background and

Question

key considerations

way since the TPD was

introduced?

Member State response

We do not have data regarding this. It is the Ministry of Taxation´s assessment that there has not been any change in cross-border distance sales

following the implementation of the TPD.

Are you aware of any

unregistered retail outlets

operating (selling tobacco

products) in your Member

State?

Yes / No.

How do you monitor whether unauthorised retail outlets are active in your Member State?

If yes, do you know the origins of these retail outlets (e.g. other Member States; outside the Union)?

Danish Safety Technology Authority:

If we receive information regarding illegal sale of tobacco products we check if the website is registered for cross-border distance sales into Denmark. So

far we have primarily focused on the marketing of oral tobacco into Denmark.

What type of age verification

systems are being used in your

Member State? Do these age

verification systems (Article

18(4)) work?

Yes / No / To some extent.9

Please elaborate.

How do you monitor whether they work? What issues have you encountered?

Danish Safety Technology Authority:

The age verification system set up is, is a system that will ask the user if the user has reached the minimum age (18) for buying tobacco. Please refer to the

answer below regarding the effectiveness of the age verification systems.

Is further action needed

regarding regulating cross-

border sales?

Yes / No / To some extent.

Please elaborate.

Ensuring that retailers who sell products across borders use effective age verification systems, thus avoiding that tobacco products are sold to

minors.

Cross-border sales of snus to Danish consumers.

Danish Safety Technology Authority:

The DSTA believe that a common developed, adopted and effective age verification system could increase the effectiveness of cross border market

surveillance. Furthermore a further increase in the focus on market surveillance and sharing of best practices across EU member states could also help

increase the effectiveness of the market surveillance of cross border sales.

Background and

Question

key considerations

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Member State response

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Since the Directive came into

force, how many times has your

Member State taken actions

(such as product modification,

product withdrawal, fines, or

other punitive measures)

against retailers due to non-

compliance related to cross-

border distance sales?

Please elaborate

Danish Safety Technology Authority:

We have taken action

time against retailers due to non-compliance related to cross-border distance sales. We have taken actions several times against

retailers selling illegal products to Denmark. If the retailers sell illegal products, for instance snus, that cannot be legally placed on the Danish market, we

do not pursue the matter of a age verification system.

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 18.

1.5.11 Article 19: Notification of novel tobacco products

Background and

Question

key considerations

Manufacturers and

importers are required to

notify Member States

about novel tobacco

products, including certain

pieces of information in

their notification. Member

States may also require

updates or additional

information, and may also

create systems for

authorising novel

products, as well as

charging manufacturers

and importers fees.

These provisions are

intended to monitor novel

products and protect

consumers’ health,

however there may have

been issues with

implementation of these

requirements, and they

may no longer be relevant

following recent market or

scientific developments.

Have there been any issues in

your Member State with

manufacturers and importers

submitting notifications about

novel tobacco products (Article

19(1))?

Member State response

Yes / No / To some extent.

Please elaborate. If there are any examples of incorrect notification, please give them here.

What types of novel products

have been notified to your

competent authority (Article

19(1))? How have these been

classified (smokeless / for

smoking)?

Please list examples of the main families/systems of notified products and their classification, for example IQOS and Heets sticks.

Danish Safety Technology Authority:

Heat sticks for IQOS and for NEO.

The products have not yet been classified as smokeless tobacco or tobacco for smoking.

Have there been any issues in

your Member State with

manufacturers and importers

submitting the information

required under Article 19(1)

when notifying a novel tobacco

product?

Yes / No / To some extent.

Please elaborate.

Has your Member State

confirmed or authorised

products sooner than 6 months

before they were placed on the

market?

Yes / No.

Please elaborate with details of the type of product.

Has your Member State

required manufacturers or

Yes / No.

If yes: how many times and for which novel products?

Background and

Question

key considerations

importers of novel tobacco

products to carry out additional

tests or submit

additional/updated information

(Article 19(2))?

Member State response

If no: are you considering it? Why or why not?

Please specify any issues with regards to such submissions.

Has your Member State

introduced an authorisation

system for novel products

(Article 19(3))?

Yes / No.

If no: are you considering it? Why or why not?

If yes: how does it work? Within what delay do you provide authorisations?

We are not currently considering introducing an authorisation system (article 19(3)).

Danish Safety Technology Authority:

Novel tobacco products are only allowed to be marketed in Denmark if they have been notified to the Danish Safety Technology Authority. Each

manufacturer and importer who wants to market a novel tobacco product must give notification no later than six months before marketing begins.

Notification of a new category of tobacco product costs DKK 36,900 (approx. 5.000 EURO) for each product.

Has your Member State

Yes / No.

prevented any submitted

Please elaborate, describing any barred products.

product entering the market

(through refusal or withdrawal of

application)?

Has your Member State

introduced any other specific

requirements related to novel

tobacco products (in addition to

the transposition of this TPD

article)?

Have TPD provisions

concerning novel tobacco

products accounted for new

market developments? Do you

Yes / No.

Please elaborate why, their purpose, etc.

Yes / No / To some extent.

Please elaborate.

New market developments: Tobacco free nicotine containing products. Heated tobacco products.

Background and

Question

key considerations

consider that the TPD

appropriately addresses all

types and all aspects of

products (e.g. heat

stick/devices)?

Which of the provisions of this

Directive apply to novel tobacco

products placed on the market

in your Member State? (Article

19(4))?

Member State response

Smokeless tobacco product provisions / tobacco products for smoking provisions / combination of both.

Please elaborate.

The novel tobacco products that have been notified in Denmark have not been categorized as smokeless tobacco products or tobacco products for

smoking. Which rules apply depends on this categorization.

Since the Directive came into

Please elaborate.

force, how many times has your

Member State taken actions

Neither the Danish Safety Technology Authority nor the Danish Health Authority have taken action against manufacturers or importers due to non-

(such as product modification, compliance related to notification of novel tobacco products.

product withdrawal, fines, or

other punitive measures)

against manufacturers or

importers due to non-

compliance related to

notification of novel tobacco

products?

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 19.

Please elaborate, including specifying the provisions of difficulty/ challenges in the practical application of this Article

Danish Health Authority notes that the TPDII does not clarify when a novel tobacco products stops being a novel tobacco product.

1.5.12 Article 20: Electronic cigarettes

Background and

Question

key considerations

Manufacturers and

importers of electronic

cigarettes and refill

containers must notify

Member States before

placing them on the

market, and the

notification must contain

certain information.

Member States are

required to ensure that

certain requirements are

met around these

products, including that

nicotine-containing liquid

does not contain nicotine

Have there been any issues

with manufacturers and

importers submitting

notifications about electronic

cigarettes and refill containers

(Article 20(2))?

Member State response

Yes / No / To some extent.

Please elaborate. If there are any examples of incorrect notification, please give them here.

Danish Safety Technology Authority:

We have experienced issues as:

Submitters are not consistent in choosing product type and / or submission type

Documentation are not sufficiently uploaded, e.g. emission reports

Not unique identification of products regarding product names and / or description of the product

Yes / No / under consideration

Please elaborate.

Danish Safety Technology Authority:

To some extent.

If the manufacturers or importers have notified insufficient submissions, including insufficient data, we request further information.

Has your Member State

requested completion of

notification information following

incorrect submission (Article

20(2))?

Background and

Question

key considerations

in excess of 20 mg/ml and

that electronic cigarettes

and refill containers are

child- and tamper-proof.

Unit packets of electronic

cigarettes and refill

containers also must

contain leaflets with

certain information.

Member State response

Has your Member State faced

Yes / No.

any issues in objectively

Please elaborate, providing examples of issues with such requirements and measurement methods accepted.

assessing technical information

Danish Safety Technology Authority:

submitted on the various

product characteristics required To some extent.

We have experienced lack of e.g. emission reports.

in Article 20(2)? For example,

information on nicotine doses

and uptake (Art 20(2)d)?

Has your Member State

confirmed or authorised

products sooner than 6 months

before they were placed on the

market?

Has your Member State

prevented any submitted

products from entering the

market (through refusal or

withdrawal of application)?

Yes / No.

Please elaborate with details of the type of product/procedure.

Yes / No.

Please elaborate, describing any barred products.

Danish Safety Technology Authority:

Barred products:

Electronic cigarettes which can be activated by drawing.

Sqounk MODS

Yes / No / To some extent.

Please elaborate. Is its application consistent with Article 7(6)?

Has your Member State faced

any issues with quality/safety

requirements in Article 20(3)?

Has your Member State faced

any issues in implementing the

provisions concerning leaflets in

unit packets of electronic

cigarettes (Article 20(4a))?

Yes / No / To some extent.

Please elaborate.

The Danish Health Authority notes that Initially, the manufactures claimed difficulties in providing a full list of ingredients on a leaflet and argued that putting

the word “aroma” instead of the full list of ingredients leading to the aroma was in compliance with the TPDII.

Background and

Question

key considerations

Has your Member State faced

any issues in implementing the

provisions concerning unit

packets and outside packaging

of electronic cigarettes,

including ingredients and health

warnings (Article 20(4b and c))?

Has your Member State faced

any issues in interpreting and

implementing provisions of

Article 20(5), which prohibits

commercial communications

and advertising about e-

cigarettes?

Member State response

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

The definition

of ’unit packet’ regarding refill containers containing nicotine. It has been unclear whether the unit package was related

to the bottle or the

package surrounding the bottle.

Yes / No / To some extent.

Please elaborate, describing challenges e.g. promotion on social media, cross border sporting events or magazines, online publications.

The Consumer Ombudsman

–

the authority responsible for enforcing Article 20(5)

–

notes that as an enforcement authority, it can be challenging to assess

when an activity is covered by the far-reaching advertising ban and when the activity is purely legal product information. The Consumer Ombudsman has

interpreted the prohibition on advertising so that it is covered by the advertising definition itself if a company that sells e-cigarettes uses a name that includes

e-cigarettes or associates with e-cigarettes, since the use of the name in our opinion will be aimed at promoting the sale of e-cigarettes or have the direct or

indirect effect. The same applies to such companies’ use of profiles on social media, such as Facebook, YouTube and Instagram

and the distribution of

newsletters.

The Consumer Ombudsman has also found that there is not enough understanding in the industry that it is not allowed to promote e-cigarettes when it is

legal to sell the products.

Has your Member State faced

any issues in implementing

provisions concerning cross-

border distance sales (Article

18) specifically related to e-

cigarettes (Article 20(6))?

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

Retail outlets located in another Member State or outside the EU that are registered at the Danish Safety Technology Authority for cross-border distance

sales often market non-compliant products to the Danish consumers.

Has your Member State faced

Yes / No / To some extent.

any issues in requiring

Please elaborate.

manufacturers and importers to

submit the market data required The quality of the submitted information is a challenge.

in Article 20(7)?

Danish Safety Technology Authority:

To some extent some submitters have been confused of what the requirements has been for Article 7 (ii), (iii) and (iv)

Background and

Question

key considerations

Member State response

How has your Member State

monitored market developments

concerning electronic cigarettes

and refill containers, including

any evidence that their use is a

gateway to nicotine addiction

and ultimately traditional

tobacco consumption among

young people and non-smokers

(Article 20(7)?

Yes / No / To some extent.

Please elaborate.

The prevalence on e-cigarette

use is part of the yearly survey “The survey on smoking prevalence in Denmark” (Danskernes Rygevaneundersøgelse).

A larger proportion of non-smokers among children and adolescents have tried electronic cigarettes than among adult non-smokers (source: Danish

Health Authority. E-cigarettes and Health, 2019).

Has your Member State faced

any issues in making submitted

information publicly available on

a website (Article 20(8))? E.g.

have there been issues with

economic operators requesting

information not be published

due to trade secrets?

Yes / No / To some extent.

Please elaborate.

Please provide a link to the publicly available list.

Danish Safety Technology Authority:

Our currently available public list can be find here: https://www.sik.dk/registre/register_over_e_cigaretter

Economic operators has marked almost all information in EU-CEG as confidential. The DSTA is currently awaiting the publication from Joint Action on

Tobacco Control, deliverable 5.1

“Report on the principles to distinguish what data is public on confidential”,

including a list of public and confidential

information submitted into EU-CEG and also a final clarification if the Commission will provide a publication tool of this information, or if this will have to be

done on a national level.

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

The manufacturers and importers are confused on how to builtd up a functional system. A joint EU system could possibly be preferable.

Has your Member State faced

any issues in requiring

manufacturers, importers and

distributers of electronic

cigarettes and refill containers

to establish and maintain a

system for collecting information

about all of the suspected

adverse effects on human

Background and

Question

key considerations

health of these products (Article

20(9))?

Has your Member State used

Safety Gate (formerly known as

RAPEX) or the Information and

Communication System on

Market Surveillance (ICSMS) to

report on adverse effects?

Have there been any instances

in your Member State of

economic operators

withdrawing or recalling unsafe

or non-compliant products, or

taking corrective action to bring

the product into conformity with

the Directive Article 20(9))?

Has your Member State

competent authority taken any

provisional measures against

manufacturers/importers of e-

cigarettes or refill containers

that comply with the

requirements of Article 20 but

could present a serious risk to

human health (Article 20(11))?

Do the TPD provisions

sufficiently cover all aspects of

emerging e-cigarette products?

Member State response

Safety Gate / ICSMS / both / none.

Please elaborate.

Yes / No.

Please elaborate, describing the products.

Yes / No.

Please elaborate, including when and how the Commission was notified.

Yes / No / To some extent.

Please elaborate.

What relevant changes have occurred in the e-cigarette market since the Directive was implemented?

It could be relevant to address e-liquids containing THC and CBD-oils.

Background and

Question

key considerations

Member State response

The Danish Health Authority notes that the TPDII does not include all products, as it only covers products containing nicotine, and therefore not products

that the consumer can mix with nicotine and use as intended by the manufacturer after purchase.

Since the Directive came into

Please elaborate.

force, how many times has your

Member State taken actions

(such as product modification,

Danish Safety Technology Authority:

We have taken action

220

times against manufacturers or importers due to non-compliance related to e-cigarettes and refill containers.

product withdrawal, fines, or

other punitive measures)

against manufacturers or

importers due to non-

compliance related to e-

cigarettes and refill containers?

Has your Member State applied

Yes / No / To some extent.

similar provisions for non-

Please elaborate, including specifying the provisions of difficulty.

nicotine containing e-

cigarettes?

The provisions regarding smoke free environments apply to both nicotine containing e-cigarettes and non-nicotine containing e-cigarettes. The ban on

sales to minors also applies to non-nicotine containing electronic cigarettes.

In December 2019, the Danish Government and a majority of the political parties in Parliament agreed on a national action plan targeting the use of

tobacco products and similar products among children and young people. The Bill implementing the national action plan will we introduced in 2020.

As a part of this Bill, manufacturers and importers of non-nicotine containing electronic cigarettes will be required to register and submit a notification to the

competent authority, the Danish Safety Technology Authority. As a result of the action plan, display ban and plain packaging will be introduced for both

nicotine containing electronic cigarettes and non-nicotine containing e-cigarettes.

Finally, the planned restrictions on the use of flavorings will apply to both nicotine containing electronic cigarettes and non-nicotine containing e-cigarettes

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Danish Safety Technology Authority:

We have experienced difficulties regarding the definition of child resistance of an electronic cigarette. Manufactures and importers primarily / solely focus

on the risk of contact with the nicotine-containing e-liquid.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 20.

Please elaborate, including specifying the provisions of difficulty/ challenges in the practical application of this Article

Danish Health Authority notes that it is primarily a challenge that the TPDII only applies to nicotine containing products. There is no clear definition on Art. 20, no. 3, e): except for nicotine, only ingredients are used in

the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form and how this is to interpreted or checked.

1.5.13 Article 21 & 22: Herbal products for smoking / Reporting of ingredients of herbal products for smoking

Background and

Question

key considerations

The directive provides

provisions on herbal

products for smoking,

including about health

warnings and reporting of

ingredients and

emissions.

There may be issues

faced in implementing

these requirements,

however.

Member State response

Has your Member State faced

Yes / No / To some extent.

any issues in placing health

Please elaborate.

warnings on packets for herbal

products for smoking; e.g. are

Danish Safety Technology Authority:

Based on our updated information in our case handling system, we have not registered any herbal products on the Danish list of registered products at the

there any herbal products for

smoking which do not carry the moment.

warning (Article 21)?

Has your Member State faced

any issues in requiring

manufacturers and importers to

report the ingredients of herbal

products for smoking (Article

22(1))?

Yes / No / To some extent.

Please elaborate.

Has your Member State faced

Yes / No / To some extent.

any issues in making submitted

information publicly available on

a website (Article 22(2))? E.g.

Please elaborate.

have there been issues with

economic operators requesting

Danish Safety Technology Authority:

Background and

Question

key considerations

information not be published

due to trade secrets?

Member State response

To some extent we have made the information regarding the herbal products for smoking public

–

when herbal products were on the market. We have not

made information regarding ingredients public.

Please provide a link to the publicly available list.

Currently we have no herbal products for smoking on the Danish market, but herbal products for smoking can be found at the same list as tobacco product

are listed on: list of registered tobacco products

What types of products are on

the market in your Member

State which are considered

herbal products for smoking?

Does your Member State apply

TPD provisions for herbal

products for smoking for certain

cannabis or marijuana products

placed legally on the market?

Please list the products.

Danish Safety Technology Authority:

Based on our updated information in our case handling system, we have not registered any herbal products on the Danish list of registered products at the

moment.

Yes / No.

If yes: What additional rules and provisions apply for them beyond the TPD requirements?

No herbal products for smoking are registered and thus placed legally placed on the market.

Since the Directive came into

Please elaborate.

force, how many times has your

Member State taken actions

Danish Safety Technology Authority:

(such as product modification,

We have taken action In 1 case against manufacturers or importers due to non-compliance related to herbal products for smoking

product withdrawal, fines, or

other punitive measures)

against manufacturers or

importers due to non-

compliance related to herbal

products for smoking?

Has your Member State

encountered any other

difficulties in the practical

application of the provisions of

this Article?

Yes / No / To some extent.

Please elaborate, including specifying the provisions of difficulty.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Articles 21 & 22.

Please elaborate, including specifying the provisions of difficulty/ challenges in the practical application of these Articles

1.5.14 Article 23: Cooperation and enforcement

Questions related to this Article should be addressed in parallel together with the costs-data template shared.

Background and

Question

key considerations

The Directive describes

how it should be

implemented and

enforced. There may be

issues with compliance or

enforcement.

Has your Member State faced

any difficulties in ensuring that

manufacturers and importers

provide the Commission and

Member States with complete,

correct and timely information

requested pursuant to the

Directive (Article 23(1))?

Has your Member State faced

any difficulties in enforcing the

responsibility of the

manufacturer, importer or joint

responsibility of manufacturer

and importer pursuant to Art.

23(1)?

Has your Member State faced

any issues in ensuring that

tobacco and related products

Member State response

Yes / No / To some extent.

Please elaborate, including any actions your Member State has taken to enforce this obligation.

Danish Safety Technology Authority:

In general no, at times manufacturers and importers have been reminded of their obligation to disclose all relevant information to the DSTA, in order for us to

carry out our market surveillance. Sometimes the manufacturers or importers have been unaware of the information they had to provide, but after clarification

from the DSTA, the information has been provided. Beside this we have not had to resolve to hand the case over to the prosecuting authority in order to take

further action.

Yes / No / To some extent.

Please elaborate.

Danish Safety Technology Authority:

If the manufacturers / importers do not submit all relevant information to the DSTA they will:

not be registered at the DSTA to market their products in Denmark.

receive a marketing ban for the relevant product

Yes / No / To some extent.

Please elaborate, including any follow up actions you have taken in this regard.

Background and

Question

key considerations

which do not comply with the

Directive and its implementing

and delegated acts are not

placed on the market?

Member State response

Danish Safety Technology Authority:

It has proved difficult to enforce the requirements of the TPD on websites, especially those not located in the Union. The import of oral tobacco has also

proven difficult to stop.

What is your overall experience

Please elaborate.

with the enforcement of the

Danish Safety Technology Authority:

Directive? Do you have

adequate staffing for

The DSTA believe we deliver an overall effective market surveillance with the funds allocated to handling the task.

enforcement activities such as

inspections?

Has your Member State faced

any court cases related to

enforcing the Directive?

Yes / No.

Please elaborate, provide references when available.

Danish Safety Technology Authority:

We have a current court case regarding the use of the term “royal” on a tobacco product.

What measures has your

Please elaborate.

Member State taken to ensure

that penalties for infringements

Danish Safety Technology Authority:

on the national provisions

Depending on the infringement the DSTA can issue and marketing ban, an order to withdraw products from the market, including from consumers or we can

transposing the Directive are

hand the case over to prosecuting authority in order to fine the economic operator for the infringement.

enforced?

What has been the experience

of your Member State in

cooperating with other Member

States? Have there been any

helpful mechanisms to applying

the Directive in a harmonised

way?

Please elaborate, for example correct application, matters of interpretation, or enforcement of the Directive.

Danish Safety Technology Authority:

The enforcement of the directive and the overall sharing of best practises hand been greatly helped by the Expert Group on Tobacco Policy and the

subsequent subgroups and the network developed through this. An subgroup purely focused on enforcement and better cooperation between enforcement

authorities we believe could further assist the enforcement of the TPD.

Background and

Question

key considerations

Member State response

Do you consider that the

Yes/No/

Directive is applied in a conform

Please elaborate, providing examples.

way across Member States?

Danish Safety Technology Authority:

Our understanding is that the Directive in an overall manner has been applied in a conform manner across member states. The implementation of track and

trace is still too recent to assess whether this is also true for this part of the TPD.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 23.

Please elaborate, including specifying the provisions of difficulty/ challenges in the practical application of this Article

1.5.15 Article 24: Free movement

Background and

Question

key considerations

Member States can but

are not required to

implement

plain/standardised

packaging of tobacco

products.

Has your Member State

implemented plain or

standardised packaging for any

products (Article 24(2))?

Member State response

Yes / No.

If no: are you considering it? Why or why not?

If yes: Please describe when and for which products you have done this.

In December 2019, the Danish Government and a majority of the political parties in Parliament agreed on a national action plan targeting tobacco use among

children and young people. As a part of this action plan, plain packaging will be introduced to tobacco products - apart from pipe tobacco and cigars

–

electronic cigarettes and herbal products for smoking.

The directive also allows

Member States to prohibit

If yes:

Please describe any

certain categories of

challenges you faced when

tobacco or related

products, if they justify the

introducing and implementing

plain packaging.

Please elaborate on e.g. industry reaction, public support etc.

Possible issues with e.g. removing older packs from shelves immediately?

Background and

Question

key considerations

grounds for human health

protection.

If yes:

Were you able to

observe/measure any impact of

plain packaging introduction?

Member State response

Please elaborate on

your observations concerning prevalence/awareness/youth uptake etc. levels or possible economic impacts? Provide references when

available.

Are any categories of tobacco

Yes / No.

or related products prohibited in

If no: are you considering it? Why or why not?

your Member State (Article

If yes: Please describe which products are prohibited, and from when (also if these bans pre-dated the Directive).

24(3))?

Not in our current legislation. Reference is made to notification number 2020-228-DK.

Please use this space for further explanation of any of the responses above, AND / OR any other observations you would like to share related to Article 24.

Please elaborate, including specifying the provisions of difficulty/ challenges in the practical application of this Article