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
Date: 2018-08-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, approximation of laws, consumer information, delegated legislation, labelling, market approval, powers of the institutions (EU), public health, tobacco, tobacco industry

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 8.8.2018 COM(2018) 579 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 and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products  
 
 
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 

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 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 the Tobacco Products 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; 

in order 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  obligations  of  the  Union  under  the  WHO  Framework 
Convention for Tobacco Control (FCTC).  

Article 27 of the Tobacco Products Directive confers powers on the Commission to adopt 
delegated acts in certain cases referred to therein and subject to the conditions laid down 
in that Article. The Commission is empowered to adopt delegated acts with regard to: 

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the reduction of the maximum emission levels laid down in Article 3(1), where this is 
necessary based on internationally agreed standards (Article 3(2)); 

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OJ L 127, 29.4.2014, p. 1. 

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the integration of standards agreed by parties to the FCTC or by the WHO relating to 
maximum  emission  levels  for  emissions  from  cigarettes  other  than  the  emissions 
referred  to  in  Article  3(1)  and  for  emissions  from  tobacco  products  other  than 
cigarettes into Union law (Article 3(4)); 

the  adaptation  of  the  methods  of  measurement  of  the  tar,  nicotine  and  carbon 
monoxide  emissions,  where  this  is  necessary,  based  on  scientific  and  technical 
developments or internationally agreed standards (Article 4(3)); 

the  integration  of  standards  agreed  by  the  parties  to  the  FCTC  or  by  the  WHO  for 
measurement methods into Union law (Article 4(5)); 

the  determination  of  maximum  content  levels  for  additives  or  combination  of 
additives  that  result  in  a  characterising  flavour,  where  the  content  level  or 
concentration  of  these  additives  or  the  combination  thereof  has  resulted  in 
prohibitions pursuant to Article 7(1) in at least three Member States (Article 7(5)); 

the  setting  of  maximum  content  levels  for  additives,  where  an  additive  or  a  certain 
quantity thereof has been shown to amplify the toxic or addictive effect of a tobacco 
product, and where this has resulted in prohibitions pursuant to Article 7(9) in at least 
three Member States (Article 7(11)); 

the  withdrawal  of  exemptions  for  tobacco  products  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  (Article 
7(12)); 

the adaptation of the wording of the information message laid down in Article 9(2) to 
scientific and market developments (Article 9(5)); 

the adaptation of the text warnings listed in Annex I taking into account scientific and 
market developments  (Article 10(3)(a));  

the establishment and adaptation of the picture library referred to in Article 10(1)(a)  
taking into account scientific and market developments  (Article 10(3) (b)); 

the  withdrawal  of  the  possibility  of  granting  exemptions  for  any  of  the  particular 
product  categories  referred  to  in  Article  11(1)  if  there  is  a  substantial  change  of 
circumstances  as  established  in  a  Commission  report  for  the  product  category 
concerned (Article 11(6)); 

the  adaptation  of  the  wording  of  the  health  warning  laid  down  in  Article  12(1)  to 
scientific developments (Article 12(3)); 

the definition of the key elements of the data storage contracts referred to in Article 
15(8), such as duration, renewability, expertise required or confidentiality, including 
the regular monitoring and evaluation of those contracts (Article 15(12)); 

the  extension  of  a  prohibition  by  at  least  three  Member  States  of  placing  on  the 
market  specific  electronic  cigarettes  or  refill  containers  or  a  type  thereof,  to  all 
Member States, if such an extension is justified and proportionate (Article 20(11)); 

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the  adaptation  of  the  wording  of  the  health  warning  in  Article  20(4)(b)  (Article 
20(12)). 

2. LEGAL BASIS 

This report is required under Article 27(2) of the Tobacco Products Directive. Pursuant to 
that  Article,  the  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  for  a 
period  of  five  years  from  19  May  2014  and  the  Commission  is  required  to  draw  up  a 
report in respect of the delegation of power not later than nine months before the end of 
the five-year period. The delegation of power shall be tacitly extended for periods of an 
identical duration, unless the European Parliament or the Council opposes such extension 
not later than three months before the end of each period.  

3. EXERCISE OF THE DELEGATION 

3.1 Procedural Aspects 

In  the  reporting  period  the  Commission  adopted  two  delegated  acts  based  on  Articles 
10(3)(b) and 15(12) of the Tobacco Products Directive. 

Prior to their adoption, the two draft delegated acts were submitted to the Expert Group 
on  Tobacco  Policy2,  established  inter  alia  to  ensure  appropriate  expert  consultation  for 
the  preparation  of  delegated  acts.  The  European  Parliament  has  been  systematically 
invited  to  the  meetings  of  this  Expert  Group.  The  documents  relevant  to  these 
consultations  were  transmitted  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  Acts3.  After  adoption,  the 
delegated acts were notified to the European Parliament and to the Council. No objection 
to  either  of the delegated acts adopted by the Commission  under the Tobacco Products 
Directive  was  raised  by  the  European  Parliament  or  the  Council  within  the  2  month 
period  provided  for  in  Article  27(5)  of  the  Directive.  In  the  case  of  the  delegated  act 
adopted pursuant to Article 15(12) of the Directive the European Parliament requested an 
extension of the deadline by 2 months. 

3.2 Delegated acts adopted under the Tobacco Products Directive  

3.2.1. Article 10(3)(b) 

Article 10(3)(b) empowers the Commission to adopt delegated acts to establish and adapt 
a  picture  library.  The  pictures  contained  in  that  library  are  an  integral  part  of  the 
combined  health  warning  which  is  required  to  appear  on  each  unit  packet  and  outside 
packaging of tobacco products for smoking placed on the EU market. Accordingly, the 

Commission Decision C(2014) 3509 final of 4.6.2014 setting up the group of experts on tobacco 

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policy.  
3 
European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1). 

Annex to the Interinstitutional Agreement between the European Parliament, the Council of the 

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Commission  adopted  Delegated  Directive  2014/109/EU  of  10  October  2014  amending 
Annex  II  to  Directive  2014/40/EU  of  the  European  Parliament  and  of  the  Council  by 
establishing the library of picture warnings to be used on tobacco products4. In line with 
the delegated powers conferred upon it, the Commission may make use of this delegated 
power in the future to adapt the picture library. 

3.2.2. Article 15(12) 

In  accordance  with  Article  15(1)  and  (5),  Members  States  shall  ensure  that  all  unit 
packets of tobacco products are marked with a unique identifier, in order to enable their 
movements  to  be  recorded  by  all  economic  operators  involved  in  the  trade  of  tobacco 
products,  from  the  manufacturer  to  the  last  economic  operator  before  the  first  retail 
outlet. Article 15(8) requires Member States to ensure that manufacturers and importers 
of tobacco products conclude data storage contracts with an independent third party, for 
the purpose of hosting the data storage facility for all relevant traceability data recorded 
in  this  context.  Article  15(12)  empowers  the  Commission  to  adopt  delegated  acts  to 
define  the  key  elements  of  the  data  storage  contracts,  such  as  duration,  renewability, 
expertise required or confidentiality, including the regular monitoring and evaluation of 
those contracts. To ensure the effective functioning of the traceability system in general 
and the interoperability of the data storage system in particular, the Commission adopted 
Delegated  Regulation  (EU)  2018/573  of  15  December  2017  on  key  elements  of  data 
storage contracts to be concluded as part of a traceability system for tobacco products5.  

3.3 Delegated powers conferred by the following provisions of the Tobacco Products 
Directive that have not been exercised 

3.3.1. Article 3(2) 

Regarding  the  delegated  power  foreseen  under  Article  3(2)  to  decrease  the  maximum 
emission  levels  for  tar,  nicotine  and  carbon  monoxide  based  on  internationally  agreed 
standards,  no  such  new  standard  has  emerged.  The  Commission  has  therefore  not  yet 
made use of this delegated power.  

3.3.2. Article 3(4) 

Regarding  the  delegated  power  foreseen  under  Article  3(4)  to  integrate  into  Union  law 
standards  agreed  by  the  parties  to  the  FCTC  or  by  the  WHO  relating  to  maximum 
emission  levels  for  emissions  from  cigarettes  other  than  the  emissions  referred  to  in 
Article 3(1) and for emissions from tobacco products other than cigarettes, no such new 
standard has emerged. The Commission has therefore not yet made use of this delegated 
power. 

3.3.3. Article 4(3) 

Regarding  the  delegated  power  foreseen  under  Article  4(3)  to  adapt  the  methods  of 
measurement of tar, nicotine and carbon monoxide emissions to scientific and technical 
developments  or  internationally  agreed  standards,  no  developments  or  standards  have 

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OJ L 360, 17.12.2014, p. 22. 
OJ L 96, 16.4.2018, p. 1. 

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emerged  that  would  justify  an  adjustment  for  the  purpose  of  the  Tobacco  Products 
Directive. The Commission has therefore not yet made use of this delegated power. 

3.3.4 Article 4(5) 

Regarding  the  delegated  power  foreseen  under  Article  4(5)  to  integrate  into  Union  law 
standards for measurement methods agreed by the parties to the FCTC or by the WHO, 
no such standards have emerged. The Commission has therefore not yet made use of this 
delegated power. 

3.3.5. Article 7(5) 

Regarding  the  delegated  power  foreseen  under  Article  7(5)  to  set  maximum  content 
levels  for  certain  additives  or  combinations  of  additives  that  result  in  a  characterising 
flavour,  the  necessary  conditions  (prohibitions  pursuant  to  Article  7(1)  in  at  least  three 
Member States) have not been met. The Commission has therefore not yet made use of 
this delegated power. 

3.3.6. Article 7(11) 

Regarding  the  delegated  power  foreseen  under  Article  7(11)  to  set  maximum  content 
levels  for  additives  that  have  been  shown  to  amplify  the  toxic  or  addictive  effects  of  a 
tobacco product, the necessary conditions (prohibitions pursuant to Article 7(9) in at least 
three  Member  States)  have  not  been  met.  The  Commission  has  therefore  not  yet  made 
use of this delegated power.  

3.3.7 Article 7(12) 

Regarding the delegated power foreseen under Article 7(12) to withdraw exemptions for 
certain product categories from the prohibitions provided for under Article 7(1) and (7), 
the  necessary  condition  (a  substantial  change  of  circumstances  as  established  in  a 
Commission report) has not been met. The Commission has therefore not yet made use 
of this delegated power. 

3.3.8 Article 9(5) 

Regarding the delegated power foreseen under Article 9(5) to adapt the general warnings 
and  information  messages  on  tobacco  products  for  smoking  to  scientific  and  market 
developments,  the  Commission  considers  it  premature  to  adapt  the  wording  of  the 
information  message  at  this  point  as  it  considers  the  current  messages  appropriate  and 
effective. The Commission has therefore not yet made use of this delegated power.  

3.3.9 Article 10(3)(a) 

Regarding the delegated power foreseen under Article 10(3)(a) to adapt the text warnings 
listed  in  Annex  I  taking  into  account  scientific  and  market  developments,  the 
Commission considers it premature to adapt the text warnings at this point as it considers 
the  current  messages  appropriate  and  effective.  The  Commission  has  therefore  not  yet 
made use of this delegated power.  

3.3.10 Article 11(6) 

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Regarding the delegated power foreseen under Article 11(6) to withdraw from Member 
States the possibility of granting exemptions for particular categories of tobacco products 
for  smoking  other  than  cigarettes,  roll-your-own  tobacco  and  waterpipe  tobacco,  the 
necessary  condition  (a  substantial  change  of  circumstances  as  established  in  a 
Commission report) has not been met. The Commission has therefore not yet made use 
of this delegated power.  

3.3.11 Article 12(3) 

Regarding the delegated power foreseen under Article 12(3) to adapt the wording of the 
health  warnings  on  smokeless  tobacco  products  to  scientific  developments,  the 
Commission  considers  it  premature  to  adapt  the  wording  of  the  health  warning  as  it 
considers the current message appropriate and effective. The Commission has therefore 
not yet made use of this delegated power.  

3.3.12 Article 20(11) 

Regarding  the  delegated  power  foreseen  under  Article  20(11)  to  prohibit  specific 
electronic  cigarettes  or  refill  containers,  or  types  thereof,  the  necessary  conditions 
(prohibitions of these products on duly justified grounds pursuant to Article 20(11) in at 
least  three  Member  States)  have  not  been  met.  The  Commission  has  therefore  not  yet 
made use of this delegated power.  

3.3.13 Article 20(12) 

Regarding  the  delegated  power  foreseen  under  Article  20(12)  to  adapt  the  health 
warnings  on  electronic  cigarettes  and  refill  containers,  the  Commission  considers  it 
premature to adapt the wording of the health warning of Article 20(4)(b)  as it considers 
the  current  message  appropriate  and  effective.  The  Commission  has  therefore  not  yet 
made use of this delegated power.  

4. CONCLUSION 

The Commission has exercised the delegated powers conferred on it by Article 10(3)(b) 
and Article 15(12) of the Tobacco Products Directive 2014/40/EU in compliance with the 
objective, scope and content of the delegation.  

As  regards  the  other  delegated  powers  conferred,  the  preconditions  for  their  exercise 
have  not  yet  been  met.  The  delegation  of  powers  should  nevertheless  be  extended,  as 
provided  in  Article  27(2)  of  the  Tobacco  Products  Directive.  The  rationale  for  the 
delegation  has  not  changed  and  the  powers  granted  are  essential  for  achieving  the 
objective of the Tobacco Products Directive, 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.  

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