Europaudvalget 2019-20
EUU Alm.del
Offentligt
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RESPONDENT INFO
Name of respondent (s):
Organisation
Member state:
Date of completion:
Danish Safety Technology Authority (DSTA), Ministry of Taxation
Denmark
Yes or No:
Q1a. Do you charge any fees for any products or procedures covered
by the TPD2?
Yes
DSTA: please see our answers to Q1b in questionnaire
Tobacco products except for novel products
(mainl Articles 5-6)
Q1b. If yes, please indicate
(mark with an X)
the procedures you
charge fees by the type of product:
Receiving product
reports/notifications
2019
(or cumulative)
2018
If you are unable to provide a breakdown by year, please provide
the cumulative figures. If you are unable to provide a breakdown by
product type, please provide the figures for the "Other" product type
2017
2016
Storing and handling
submitted information
1005000
1005000
1877000
335000
FEES
Novel tobacco products
(Article 19)
Analysis/verification of
submitted information
2019
(or cumulative)
2018
2017
2016
Receiving product
reports/notifications
Storing and handling
submitted information
Analysi
s/verifi
cation
of
Q1c. Please indicate the amount of fees (in Euros) collected by year.
e-cigarettes
(Article 20)
Receiving product
reports/notifications
DSTA: the amount of fee is for e-cigarettes, novel tobacco products
and herbal products
2019
(or cumulative)
2018
2017
2016
DSTA: please see our answers to Q2a in questionnaire
Q2a. Do you charge any fees to verify
measurements
(and methods)
for ingredients and/or emissions related to the implementation of
TPD2?
(Article 4)
Q2b. If yes to Q2a, how much (in Euros) have you collected for these
fees by year?
Yes or No:
Storing and handling
submitted information
684000
844000
1491000
819000
Analysis/verification of
submitted information
Costs related to other procedures, other products and/or that cannot be
broken down
(e.g. additives, ingredients, herbal)
- please describe:
Receiving product
Storing and handling
Analysi
reports/notifications
submitted information
s/verifi
cation
2019
(or cumulative)
2018
2017
2016
2019
2018
2017
2016
DSTA: please see our answers to Q3 in questionnaire
Q3. Do you charge any fees for peer reviews conducted on
additives?
(Article 6(4))
Yes or No:
If yes, please describe:
EU COMMON ENTRY GATE (CEG)
DSTA: we have only registered have many people were dedicated to our work concerning market
surveilliance for tobacco products and e-cigaret products overall.
Tobacco products: 4.9 people / 2019
E-cigarettes: 6.3 people / 2019
Q4a. On average, about how many people (full-time equivalents) are
Receiving product
dedicated to reviewing submissions to the EU-CEG?
reports/notifications
Costs related to other procedures, other products and/or that cannot be broken
down (e.g. additives, ingredients, herbal) - or cumulative
Tobacco products except
for novel products
(Articles 5-6)
Novel tobacco products
(Article 19)
e-cigarettes
(Article 20)
Please use 2019 as your reference ear. If you are unable to provide a
breakdown by product type, please provide the cumulative
estimates in the last column.
Storing and handling
submitted information
Analysis/verification of
submitted information
Q5b. What factors contribute to its variation per one submission?
(e.g. type of product)
 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
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COMPLIANCE COSTS
Q6b. What costs were involved in implementing the provisions of
Article 19 on novel products?
Please indicate the level of costs in 2019 by the categories listed below. If you cannot break
down certain costs, please provide the estimated figures in "Other" and specify what is
IT infrastructure
Please provide an indication of the cost to develop the necessary IT infrastructure to facilitate the authorisation
of novel tobacco products. If there was a labour cost, please provide a rough indication of the number of
employees (full-time equivalent), the time period of the work and the level of the employee
Data assesment
Please provide an indication of the cost to collect and store data on novel tobacco products. If there was a
labour cost, please provide a rough indication of the number of employees (full-time equivalent), the time
period of the work and the level of the employee
Please provide an indication of the cost to collect and store data on novel tobacco products. If there was a
labour cost, please provide a rough indication of the number of employees (full-time equivalent), the time
period of the work and the level of the employee
Please provide an indication of the administration costs involved in creating a system to authorise novel
tobacco products. If there was a labour cost, please provide a rough indication of the number of employees (full-
time equivalent), the time period of the work and the level of the employee
Laboratory testing/assessment
Administration costs
Other
(including costs that cannot be broken down into the
categories listed above)
Please specify what type of costs are included in this category alongside the estimated costs / full-time
The cost to implement the necessary IT-infrastructure and so forth is
equivalent). If applicable, please note how many trainings were carried out and how many people attended a
part of the fee collected on the basis of market shares, please refer to
training (on average)
relevant questions in the questionnaire, including Q 1.4.3. regarding
efficiency. As the implementation of including novel tobacco products
was estimated to be of minor costs, the cost has not been broken down
into further detail. We do charge a fee equivalent to the fee of
electronic cigarettes, for the notification of novel products. The fee is as
of 2019 pr. Product notification 36.900 DKK (approx. 5.000 EURO).
Q7a. What activities do you carry out on a regular basis (not
enforcement - see next section) to support the implementation of
the TPD2 in relation to
tobacco products?
For each activity, please
note approximately the current annual resources allocated
Monitoring of ingredients, additives, and emissions of tobacco
products
(Articles 3-7)
DSTA: we have only registered have many people were
dedicated to our work concerning market surveilliance for
tobacco products overall.
Tobacco products: 4.9 people / 2019
Please provide an indication of the costs involved in the monitoring of ingredients, additives, and emissions of tobacco products. If there was a labour cost, please provide a rough
indication of the number of employees (full-time equivalent), the time period of the work and the level of the employee
Monitoring of labelling and packaging standards for tobacco
products
(Articles 8-13)
Please provide an indication of the costs involved in the monitoring and labelling of packaging standards. If there was a labour cost, please provide a rough indication of the number
of employees (full-time equivalent), the time period of the work and the level of the employee
Facilitating the function of track and tracing systems for tobaco
products
(Articles 15-16)
The implementation of the security features in article 16 have been done through the existing tobacco tax
stamps. New security stamps have been made for the tax-free tobacco products, and the production costs
to the supplier of these are approximately 150.000 DKK on a yearly basis.
Please provide an indication of the costs involved in facilitating the function of tracking and tracing systems. If there was a labour cost, please provide a rough indication of the
number of employees (full-time equivalent), the time period of the work and the level of the employee
Monitoring of cross-border sales for tobacco products
(Article 18)
Other costs for tobacco products, please describe:
Please provide an indication of the costs involved to monitor cross-border sales. If there was a labour cost, please provide a rough indication of the number of employees (full-time
equivalent), the time period of the work and the level of the employee
Please provide an indication of the other costs involved in supporting the implementation of the TPD2. If there was a labour cost, please provide a rough indication of the number of
employees (full-time equivalent), the time period of the work and the level of the employee
Q7b. What activities do you carry out on a regular basis (not
enforcement - see next section) to support the implementation of
the TPD2 in relation to
e-cigarettes and other products?
For each
activity, please note approximately the current annual resources
allocated
DSTA: we have only registered have many people were
dedicated to our work concerning market surveilliance for e-
cigaret products overall.
E-cigarettes: 6.3 people / 2019
Monitoring of ingredients, emissions and quality
Please provide an indication of the costs involved in the monitoring of ingredients, emissions and quality of e-cigarettes. If there was a labour cost, please provide a rough indication
of the number of employees (full-time equivalent), the time period of the work and the level of the employee
Monitoring of labelling and packaging standards
Please provide an indication of the costs involved in the monitoring and labelling of packaging standards. If there was a labour cost, please provide a rough indication of the number
of employees (full-time equivalent), the time period of the work and the level of the employee
Monitoring of cross-border sales for e-cigarettes
(Article 18) - please
include in Q7a above if this cannot be split
Please provide an indication of the costs involved in implementing Article 18 of the TPD. If there was a labour cost, please provide a rough indication of the number of employees (full-
time equivalent), the time period of the work and the level of the employee
 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
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Other costs for e-cigarettes and other products, please describe:
Please provide an indication of the costs involved in implementing Article 20 of the TPD. If there was a labour cost, please provide a rough indication of the number of employees (full-
time equivalent), the time period of the work and the level of the employee
ENFORCEMENT COSTS
Q8a. Have you carried out
tests and/or inspections
related to the
enforcement of the TPD2? Yes/No
Product tests?
Yes
Inspections?
Yes
Q8b. If yes, how many were conducted in each of the following
years?
2019
(or cumulative)
274
2018
198
2017
346
2016
1653
1473
1649
Annual cost for
maintenance of equipment Cost of running a test
(Variable cost)
(Fixed cost)
DSTA: The estimated cost is an average of test
cost of tobacco products and e-cigarettes. The
most expensive costs is test of RYOT
Q9a. On average, on much did a product test cost?
800 EURO
Please explain your
response:
Please explain your
response:
Q9b. On average, how much did an inspection cost?
160 EURO
Yes or No:
Q10a. Have you laid down rules on penalties applicable to
infringements of the national provisions adopted pursuant to the
TPD2?
(Article 23)
Yes
Q10b. For how many products did you take administrative action
since the application of TPD2?
Tobacco products
Novel
products
E-cigarettes
Other (e.g herbal)
tobacco
91
0
220
1
Please specify the number of
products:
DSTA: Our case management system is not
updated with informations regarding the
actions of the manufacturer and importor as an
outcome of our action. As a part of our market
surveillance we check if the manufacturers and
importers market non-compliant products.
Q10c. What was the outcome of the administrative action for these Manufacturer
products?
withdrew product
Please specify the number of
products:
Please explain your
response:
Please explain your
response:
Manufacturer
modified product
Q10d. What kind of penalties were applied?
Q10e. How much did you collect in penalties per year?
2019
(or cumulative)
If you cannot provide a breakdown by year please provide the
cumulative figures
2018
DSTA answer: the penalties are not collected by the DSTA but by the
prosecuting authority, and we do not keep track of the total amount
of fines.
2017
2016
We do not have statistics on this
DSTA: 670-2010 EURO per non-compliant / illegal product
DSTA: the products are either withdrawn by
manufacturers or modified. We do not keep
statistics on this.