REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products
Date: 2023-08-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, approximation of laws, consumer information, delegated legislation, health risk, labelling, market approval, powers of the institutions (EU), tobacco, tobacco industry

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   EUROPEAN COMMISSION  Brussels, 17.8.2023  COM(2023) 491 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products  
 
 
1. INTRODUCTION 

The objective of 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/EC1 (‘the Tobacco Products Directiveʼ) 
is to approximate the laws, regulations and administrative provisions of the Member States 
concerning: 

(a) the ingredients  and emissions of tobacco products  and related reporting obligations, 
including  the  maximum  emission  levels  for  tar,  nicotine  and  carbon  monoxide  for 
cigarettes; 

(b) certain aspects of the labelling and packaging of tobacco products including the health 
warnings to appear on unit packets of tobacco products and any outside packaging as well 
as traceability  and security  features that  are applied to  tobacco products  to ensure their 
compliance with that Directive; 

(c) the prohibition on the placing on the market of tobacco for oral use; 

(d) cross-border distance sales of tobacco products; 

(e) the obligation to submit a notification of novel tobacco products; 

(f) the placing on the market  and the labelling of certain products, which are related to 
tobacco products, namely electronic cigarettes and refill containers, and herbal products 
for smoking. 

The Directive aims to facilitate the smooth functioning of the internal market for tobacco 
and related products, taking as a base a high level of protection of human health, especially 
for young people, and to meet the European Union’s obligations under the World Health 
Organisation (WHO) Framework Convention for Tobacco Control (FCTC) to which the 
European Union acceded on 30 June 2005.   

Article 27 of the Tobacco Products Directive empowers the Commission, subject to certain 
conditions,  to  adopt  delegated  acts  referred  to  in  Article 3(2),  Article 3(4),  Article 4(3), 
Article 4(5),  Article 7(5),  Article 7(11),  Article 7(12),  Article 9(5),  Article 10(3)(a), 
Article 10(3)(b),  Article 11(6),  Article 12(3),  Article 15(12),  Article 20(11)  and 
Article 20(12). 

2. LEGAL BASIS 

This  report  is  required  under  Article 27(2)  of  the  Tobacco  Products  Directive,  which 
confers the power on the Commission to adopt delegated acts for a period of 5 years from 
19 May 2014. The Commission is required to draw up a report in respect of the delegation 
of power not later than 9 months before the end of the 5-year period. The delegation of 
power  is  tacitly  extended  for  periods  of  an  identical  duration  unless  the  European 

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OJ L 127, 29.4.2014, p. 1. 

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Parliament or the Council opposes such an extension not later than 3 months before the 
end of each period. 

3. EXERCISE OF THE DELEGATION IN THE CURRENT PERIOD 

The Commission adopted the first report on the exercise of the delegation of powers under 
the Tobacco Products Directive on 8 August 20182. 

During the current 5-year period as per the tacit extension of the delegation of powers, the 
Commission  adopted  one  delegated  act  under  Articles  7(12)  and  11(6)  of  the  Tobacco 
Products Directive. 

Article 7(12)  empowers  the  Commission  to  adopt  delegated  acts  to  withdraw  the 
exemption for a particular tobacco product  category, other than cigarettes and roll-your 
own tobacco, from the prohibitions laid down in Article 7(1) and (7) if there is a substantial 
change of circumstances as established in a Commission report. Similarly, Article 11(6) 
empowers the Commission to withdraw the possibility for Member States to grant labelling 
exemptions for particular categories of tobacco products for smoking, other than cigarettes, 
roll-your-own  tobacco  and  waterpipe  tobacco,  if  there  is  a  substantial  change  of 
circumstances as established in a Commission report for the product category concerned. 

On 15 June 2022, the Commission adopted a report3 that established a substantial change 
of circumstances4 regarding heated tobacco products. The report provides information and 
statistics  on  market  developments.  It  showed  that  there  was  an  increase  of  the  sales 
volumes of heated tobacco products by at least 10 % in at least five Member States and 
that the sales volume of heated tobacco products  at retail level  exceeded 2,5 % of total 
sales of tobacco products at EU level.  

Consequently,  because  of  that  substantial  change  of  circumstances  regarding  heated 
tobacco  products,  the  Commission  adopted  Delegated  Directive  (EU)  2022/2100  of 
29 June  2022  amending  Directive  2014/40/EU  of  the  European  Parliament  and  of  the 
Council  as  regards  the  withdrawal  of  certain  exemptions  in  respect  of  heated  tobacco 
products5 (‘the Delegated Directive’). This Delegated Directive extended the prohibition 
of the placing on the market of tobacco products with a characterising flavour or containing 
flavourings in any of their components such as filters, papers, packages, capsules or any 
technical  features  allowing  modification  of  the  smell  or  taste  of  the  tobacco  products 
concerned  or  their  smoke  intensity,  already  applying  to  cigarettes  and  roll-your-own 
tobacco, to heated tobacco products. On the same grounds, it withdrew the possibility for 
Member States to grant exemptions for heated tobacco products, insofar as they are tobacco 
products for smoking, from certain labelling obligations, namely the obligations to carry 

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Report from the Commission to the European Parliament and the Council on the exercise of the 
power to adopt delegated acts conferred on the Commission pursuant to Directive 2014/40/EU on 
the approximation of the laws and administrative provisions of the Member States concerning the 
manufacture, presentation and sale of tobacco and related products (COM/2018/579 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 (COM/2022/279 final). 
Within the meaning of Article 2(28) of the Tobacco Products Directive. 
OJ L 283, 3.11.2022, p. 4. 

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the information message laid down in Article 9(2) and the combined health warnings laid 
down in Article 10 of the Tobacco Products Directive. 

Before its adoption, the draft Delegated Directive was submitted to the Expert Group on 
Tobacco  Policy6,  which  was  set  up  to  ensure  appropriate  expert  consultation  for  the 
preparation  of  delegated  acts  among  other  things.  The  European  Parliament  and  the 
Council have been systematically invited to this expert group’s meetings. The documents 
relevant to these consultations were sent simultaneously to the European Parliament and 
to  the  Council,  as  provided  for  in  the  Common  Understanding  between  the  European 
Parliament,  the  Council  and  the  Commission  on  Delegated  Acts7.  After  adoption,  the 
Delegated Directive was notified to the European Parliament and to the Council with the 
latter  requesting  an  extension  of  the  deadline  by  2  months.  Neither  the  European 
Parliament nor the Council objected to the Delegated Directive adopted by the Commission 
under  the  Tobacco  Products  Directive  within  the  extended  period  provided  for  in 
Article 27(5) of that Directive. 

4. CONCLUSION 

During  the  current  5-year  period,  the  Commission  adopted  one  delegated  act  based  on 
Articles  7(12)  and  11(6)  of  the  Tobacco  Products  Directive.  In  this  respect,  the 
Commission  has  exercised  the  delegated  powers  conferred  on  by  those  articles  in 
compliance with the objective, scope and content of the delegation. 

As regards the other delegated powers conferred in the Tobacco Products Directive8, the 
preconditions to exercise them have not been met in the current 5-year period.  

The delegation of powers conferred on the Commission pursuant to the Tobacco Products 
Directive  should  be  extended  in  time,  as  set  out  in  Article 27(2)  of  that  Directive,  and 
taking  into  account  that  following  the  first  Commission  report  neither  the  European 
Parliament nor the Council opposed such an extension. The rationale for the delegation has 
not  changed,  and  the  powers  granted  are  essential  to  achieve  the  Tobacco  Products 
Directive’s objective, namely facilitating the smooth functioning of the internal market for 
tobacco and related products, taking as a base a high level of human health protection.  

The  Commission  invites  the  European  Parliament  and  the  Council  to  take  note  of  this 
report. 

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Commission Decision C(2014) 3509 final of 4.6.2014 setting up the group of experts on tobacco 
policy. 
Annex  to  the  Interinstitutional  Agreement  between  the  European  Parliament,  the  Council  of  the 
European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1). 
The first report on the exercise of the delegation of powers under the Tobacco Products Directive 
provided information on the delegated acts adopted under Article 10(3)(b) and Article 15(12). 

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