REPORT FROM THE COMMISSION on the establishment of a substantial change of circumstances for heated tobacco products in line with Directive 2014/40/EU
Date: 2022-06-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer information, health risk, market research, marketing standard, smoking, tobacco, tobacco industry, traceability

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 15.6.2022  COM(2022) 279 final  REPORT FROM THE COMMISSION on the establishment of a substantial change of circumstances for heated tobacco products in line with Directive 2014/40/EU  
 
 
1. Introduction 

Article 2(28) of Directive 2014/40/EU1 (hereinafter referred to as ‘the Directive’) defines the 
‘substantial change of circumstances’ as an increase of the sales volumes by product category 
by at least 10 % in at least five Member States, based on sales data transmitted in accordance 
with Article 5(6) of the Directive or an increase of the level of prevalence of use in the under 
25  years of  age  consumer  group, by at  least  five percentage points in  at  least  five Member 
States for the respective product category, based on the Special Eurobarometer 385 report of 
May  2012  or  equivalent  prevalence  studies.  According  to  the  same  provision,  a  substantial 
change of circumstances is  deemed not to  have occurred if the sales volume of the product 
category  at  retail  level  does  not  exceed  2.5  %  of  total  sales  of  tobacco  products  at  Union 
level.  Articles  7(12)  and  11(6)  of  the  Directive  require  the  Commission  to  establish  a 
substantial change of circumstances for a specific product category in a report. 

This  Report  provides  information  on  market  developments,  which  are  relevant  to  the 
assessment  of  a  substantial  change  of  circumstances  for  heated  tobacco  products.  Heated 
tobacco  products  are  novel  tobacco  products  that  are  heated  to  produce  an  emission 
containing  nicotine  and  other  chemicals,  which  are  then  inhaled  by  user(s),  and  that, 
depending  on  their  characteristics,  are  smokeless  tobacco  products  within  the  meaning  of 
Article 2(5) of the Directive, or tobacco products for smoking within the meaning of Article 
2(9)  of  the  Directive.  The  analysis  presented  in  this  Report  is  based  on  data  transmitted  in 
accordance with Article 5(6) of the Directive via the EU Common Entry Gate (‘EU-CEG’), 
data  collected  from  the  EU  tobacco  traceability  system  established  under  Article  15  of  the 
Directive  and  “Euromonitor  International  Passport  Tobacco  2021”  data.  The  latter  is  a 
commercial  dataset  that  the  Commission  acquired  from  Euromonitor  International.  This 
Euromonitor  dataset  does  not  include  data  for  LU,  MT  and  CY  (accounting  for  less  than 
0.5% of the EU population). Nevertheless, it was used as a representative proxy for the EU27 
sales. 

2. Analysis of the substantial change of circumstances for heated tobacco products 

2.1 First condition for the substantial change of circumstances:  

To  fulfil  the  first  condition  for  a  substantial  change  of  circumstances,  one  of  the  following 
two circumstances needs to be established. 

2.1.1 Increase of the level of prevalence of use in the under 25 years consumer group by at least 
five percentage points in at least five Member States 

The Special Eurobarometer 506 report2 did not identify an increase of the level of prevalence 
of use in  the under 25  years of age consumer group by  at  least  five percentage points in  at 
least five Member States for heated tobacco products.  

1 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 (OJ L 127, 29.4.2014, 
p. 1). 
2 Attitudes of Europeans towards tobacco and electronic cigarettes - February 2021 - - Eurobarometer survey 
(europa.eu) 

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2.1.2 Increase of the concerned products’ sales volumes by at least 10% in at least five 
Member States  

Table 1 that is based on EU-CEG data, presents the increase of the sales volumes of heated 
tobacco products  at  retail  level  for the period 2018  -  2020 in  the Member States  where the 
relevant increase was established to be higher than 10%.  

Table 1: Sales volumes of heated tobacco products, in million sticks (2018 – 2020) 

Member 
State 

2018 
sales 
volumes 

2019 
sales 
volumes 

2020 
sales 
volumes 

2019-2018 
percentage 
increase 

2020-2019  
percentage 
increase 

2020-2018 
percentage 
increase 

CY 
CZ 
FR 
GR 
HR 
IT 
NL 
PL 
PT 
RO 
EU27 
Source: EU-CEG data 

44.590 
0.859 
36.796 
0.007 
0.003 
0.042 
28.262 
0.010 
338.022 
486.239 
934.854  12 332.655  19 716.820  1219% 

52% 
147.260  117% 
1 744.4  Over 999%  39% 
138% 
186.009  113% 
1 443.958  Over 999%  25% 
289.592  Over 999%  32% 
5 819.033  Over 999%  63% 
66% 
2 466.150  Over 999%  104% 
48% 
25% 
60% 

96.660 
1 284.094 
78.215 
1 159.804 
219.072 
3 571.016 
43.120 
1 206.171 
637.649 
671.053 

944.977  89% 
837.587  38% 

71.618  53% 

230% 
Over 999% 
406% 
Over 999% 
Over 999% 
Over 999% 
153% 
Over 999% 
180% 
72% 
2009% 

The data presented above thus confirm that the sales volumes of heated tobacco products at 
retail level increased by a percentage higher than 10 % in more than five Member States over 
the defined period of 2018 to 2020.  

On this basis, the first condition for a substantial change of circumstances regarding heated 
tobacco products was met. 

2.2 Second condition for  the substantial change of circumstances: sales’  volume of the 
concerned  products  at  retail  level  exceed  2.5%  of  total  sales  of  tobacco  products  at 
Union level 

The market share of heated tobacco products at retail level was  calculated by dividing their 
annual  sales  volume  by  the  overall  sales  volume  of  all  tobacco  products  at  Union  level. 
Alternative data sources were explored to ensure the robustness of such calculation. 

2.2.1 Sales volume of heated tobacco products at retail level 

Table 2 shows the EU27 sales volume of heated tobacco products in 2020 from two different, 
mutually independent data sources.   

Table 2: Sales volumes of heated tobacco products in EU27 in million sticks (2020) 

Data source 

EU-CEG 

Euromonitor 

Sales volume 2020 

19 717 

20 766 

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As shown in the table, the sales volume reported by Euromonitor is slightly higher than the 
EU-CEG  sales  volume.  In  line  with  the  conservative  approach  chosen  for  this  Report,  the 
lowest sales volume (i.e. the EU-CEG volume) was used as the numerator for the calculation 
of the heated tobacco products’ market  share. The numerator expresses their annual  market 
volume in 2020 which is to be compared with the total volume of tobacco products sold in 
EU27 in 2020 at retail level.  

2.2.2 Total sales of tobacco products at Union level 

Table  3  is  based  on  the  Euromonitor  data.  It  shows  the  total  sales  of  tobacco  products, 
including  the  total  sales  of  cigarettes,  cigars,  cigarillos,  roll-your-own  tobacco,  pipe  and 
chewing tobacco and heated tobacco products in 2020.  

Table 3: Total sales volumes of tobacco products (in 2020)  

Cigarettes 
(in million 
sticks) 

Cigars 
(in million 
units) 

Cigarillos 
(in million 
units) 

Roll-your-
own 
tobacco  
(in million 
sticks)* 

Pipe and 
chewing 
tobacco** 
(adjustment) 

Heated 
tobacco  
(in 
million 
sticks) 

408 279 

1 006 

8 459 

108 059 

3 908 

20 766 

Total sales 
of tobacco 
products 
(in million 
sticks 
equivalent) 
550 478 

*  Euromonitor  report:  Roll-your-own  tobacco  products  weigh  75  641  tons.  The  analysis  calculates  the 
equivalent in roll-your-own tobacco sticks by considering that 0.7 grams equals to one stick. 
** Due to the fact that pipe and chewing tobacco sales volume cannot be quantified in sticks in a standardised 
manner,  the  analysis  adjusts  the  total  sales  volume  of  tobacco  products  by  adding  the  corresponding  share  of 
market  value  of  EU27,  which  0.71%  in  2020  (thus    equivalent  to  550  478  *  0.71%  =  3  908  million  sticks 
equivalent). 
Source: Euromonitor International Passport Tobacco 2021 

As  of  May  2019,  the  EU  tobacco  traceability  system  allows  Member  States  to  follow  the 
market  flow  of  cigarettes  and  roll-your-own  tobacco.  Table  4  shows  the  sale  volumes  of 
cigarettes  and  roll-your-own  tobacco  for  2020,  calculated  from  data  based  on  the  tobacco 
traceability  system,  taking  into  consideration  two  alternative  approaches,  each  capturing 
slightly  different  time  periods,  reflecting  the  time  required  for  products  to  move  down  the 
distribution chain. As the data are recorded at the level of manufacturer, one-month delay is 
assumed until the product reaches the retail level (“time-adjusted production figures”). 

As  the  traceability  database  does  not  include  the  pack  size,  the  analysis  cross-checked  the 
traceability  data  with  the  EU-CEG  database  using  the  unique  product  identifier  (TP-ID)  to 
ascertain  the  number  of  cigarettes  per  unit  package  declared  for  each  tobacco  products’ 
identifier in the EU-CEG report.  

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Table 4: Production of cigarettes and roll-your-own tobacco in 20203 

Cigarettes 
Time-adjusted 
production figures 
(in million of sticks) 

Non-time-adjusted 
production figures 
(in million of sticks) 

436 123 

434 164 

Roll-your-own tobacco 
Time-adjusted 
production figures 
 (in million sticks 
equivalent) 
121 239 

Non-time-adjusted 
production figures 
 (in million sticks 
equivalent) 
122 341 

Time-adjusted production figures refer to period: Dec 2019 - Nov 2020.  
Non-time-adjusted production figures refer to period:  Jan 2020 - Dec 2020. 
Source: EU tobacco traceability system 

For the purpose of  the adopted  conservative  calculation, the Report considers the  higher of 
the  two  values  for  the  respective  categories  (i.e.  the  time-adjusted  production  figures  for 
cigarettes and the non-time-adjusted production figures for roll-your-own tobacco). 

As the Directive defers the traceability of other tobacco product categories until 2024, table 5 
combines  the  tobacco  traceability  system’s  data  obtained  for  cigarettes  and  roll-your-own 
tobacco with the relevant Euromonitor data for other tobacco products’ categories:  

Table 5: Total sales of tobacco products (in 2020) 

Tobacco traceability system 
data 

Cigarettes 
(million 
units) 

Roll-your-own 
tobacco (1 
Unique identifier 
= 50 grams) 
(million sticks 
equivalent) 

Euromonitor data 

Adjustment  Tobacco 

Cigars 
(million 
units) 

Cigarillos 
(million 
units) 

HTP 
(million 
sticks) 

Pipe and 
Chewing 
Tobacco* 
(adjustment) 

traceability 
system +                     
Euromonitor data 
All tobacco  
products  
(in million sticks 
equivalent) 

122 341 

8 459 
436 123 
*Due to the fact that pipe and chewing tobacco sales volume cannot be quantified in sticks, the analysis adjusts 
the total sales volume of tobacco products by adding the corresponding share of market value of EU27, which is 
0.71% in 2020 (thus 592 904 * 0.71% = 4 210 million sticks equivalent). 
Source: EU tobacco traceability system, Euromonitor International Passport Tobacco 2021 

592 904 

20 766 

1 006 

4 210 

3  To  estimate  the  sales  volume  of  roll-your-own  tobacco  products,  a  packet  of  roll-your-own  tobacco,  as 
registered in the tobacco traceability system, was considered to contain 50 grams of tobacco, i.e. the equivalent 
of around 71 sticks (assuming 0.7 gram of tobacco per stick).  

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To calculate the exact proportion of the EU total sales of tobacco products that corresponds to 
the sales volume of heated tobacco products at retail level, the analysis used the highest sales 
volume  (i.e.  the  combination  of  the  tobacco  traceability  system  and  Euromonitor  data  on 
sales volume) as the denominator. 

2.2.3 Sales volumes of heated tobacco products at retail level in relation to total sales of 
tobacco products at Union level  

As  explained  above,  to  calculate  the  exact  proportion  of  the  EU  total  sales  of  tobacco 
products that corresponds to the sales volume of heated tobacco products at retail level, the 
lowest  numerator  -  EU-CEG  sales  volume  (i.e.  19  717  million  sticks)  was  used  in 
combination with the highest denominator based on the tobacco traceability and Euromonitor 
volume (i.e. 592 904 million sticks equivalent).  

This  conservative  approach  indicated  that  the  sales  volume  of  heated  tobacco  products  at 
retail level corresponded to 3.33 % of the total sales volume of all tobacco products at Union 
level for the year 2020. 

As this value exceeds the threshold of 2.5%, the second condition for a substantial change of 
circumstances regarding heated tobacco products is also met. 

2.2.4  Sales  value  of  heated  tobacco  products  at  retail  level  in  relation  to  total  sales  of 
tobacco products at Union level  

The  analysis  of  the  sales  value  provides  an  alternative  measurement  of  the  heated  tobacco 
products’  market  share  in  2020  and  allows  for  consideration  of  the  remaining  minor 
categories of tobacco products which cannot be measured in sticks: pipe and chewing tobacco 
(used for adjustments on the principal sales volume analysis). 

The table below shows the total sales value on each product category for all Member States in 
EU27 in billion of euros: 

Table 6: Sales value on each product category (in 2020) 

Product Categories 

Retail value 
EUR billion 

Cigarettes 
Cigarillos 
Cigars 
Fine Cut Tobacco (RYO) 
Pipe Tobacco 
Chewing Tobacco 
Heated Tobacco 
All tobacco products 
Source: Euromonitor International Passport Tobacco 2021 

109.88 
2.33 
2.05 
15.06 
0.93 
0.02 
4.74 
135.01 

Market share 
(%) of total sales at Union level 
81.38% 
1.73% 
1.52% 
11.15% 
0.69% 
0.02% 
3.51% 
100.00% 

These  data  thus  indicate  that  the  sales  value  of  heated  tobacco  products  at  retail  level 
correspond to 3.51 % of the total sales volume of all tobacco products at Union level for the 
year 2020. This further confirms the principal analysis based on the sales volume. 

5 

 
 
 
3. Conclusion 

Considering that the sales volumes of heated tobacco products:  

  have increased by at least 10% in at least five Member States, and  
  the sales volumes of heated tobacco products at retail level exceed 2.5% of total sales of 

tobacco products at Union level,  

the  present  Report  establishes  the  substantial  change  of  circumstances  for  heated  tobacco 
products. 

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