EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down uniform rules for the procedures for determining whether a tobacco 
product has a characterising flavour  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down uniform rules for the procedures for determining whether a tobacco 
product has a characterising flavour  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to D irective 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, and in particular Article 7(3)  thereof,  
Whereas:  
(1) Article 7 (1) of Directive 2014/40/EU provides that the placing on the market of 
tobacco products with a characterising flavour  is to be prohibited .  
(2) Pursuant to Article 7(2) of Directive 2014/40/EU, both Member States and the 
Commission may carry out a procedure in order to determine whether a tobacco 
product has a characterising flavour. In order to ensure that uniform rules are applied 
throughout the  Union, the determination as to whether a product has a characterising 
flavour should be carried out by the Commission where  divergent decisions have been 
taken by Member States  on product s with the same composition  or if there is a risk  of 
divergent decis ions being taken . Member States should be  encouraged to carry out the 
procedure if the product is placed on a limited number of national markets  only.  
(3) Where a Member State (“the initiating Member State”) or the Commission considers 
that a tobacco product might have a characterising flavour, it should request  the 
manufacturer or importer to communicate its assessment as to  whether the product 
concerned  has a characterising flavour. In its reply the manufacturer or importer 
should also set out , where applica ble, the response received from its ultimate parent 
company and indicate , to the extent possible,  whether a product with the same 
composition  is placed on other national markets  of EU Member States . Importers are 
also encouraged to consult the manufacturer.  
(4) If the manufacturer or importer do es not dispute that the product has a characterising 
flavour, it should inform the initiating Member State or the Commission  of the 
measures  taken  in order to  ensure that the product is withdrawn from the mar ket, 
including  the measures  taken in other Member States where product s with the same 
composition  are placed on the market.  
(5) If the manufacturer or importer does not reply or  contests that the  product has a 
characterising flavour, the initiating Member State or the Commission should continue 
the procedure . To this end the advisory panel  may be consulted  and information from 
                                                 
1 OJ L 127, 29.4.2014, p.1.   
EN 3   EN other sources  may be gathered . A time limit  for the submission of the opinion  of the 
advisory panel should be set . Informatio n may also be exchanged with other Member 
States and the Commission.  
(6) Before a decision is taken as to whether a product has a characterising flavour , the 
manufacturer  or importer  of the product should be adequately informed  and should 
have the right to sub mit written observations. Where the advisory panel has been 
consulted , its opinion should be transmitted  to the manufacturer or importer. In its 
written observations  the manufacturer or importer should also indicate , where 
applicable , whether its ultimate parent compan y has been consulted. Importers are also 
encouraged to consult the manufacturer.  
(7) The initiating Member State should submit a draft of its decision to the Commission 
including an English summary of that draft. A copy of those document s should also be 
sent to all other Member States. Where the initiating Member State intends to take a 
decision without having consulted the advisory panel or where it intends to depart 
from the opinion of the advisory panel, it should indicate that intenti on when 
submitting the draft.  
(8) The Commission and the other Member States should be afforded  the opportunity  to 
comment on the draft decision. Where  the advisory panel was not consulted  by the 
initiating Member State , the Commission  may recommend that t he initiating Member 
State consult the advisory panel and submit a new draft decision. Where the initiating 
Member State intends to depart from the opinion of the panel, the Commission should 
be allowed to  request further explanations from that Member State. Where  the 
initiating Member State and the Commission do not agree on the decision to be 
adopted , the Commission should launch its own procedure.  
(9) The Commission should be able to initiate a procedure at any time. Where  the 
Commission launches a procedure , all national procedures concerning product s with 
the same composition  should be terminated . Information already gathered should be 
shared with the Commission.   
(10) In order to avoid parallel procedures and divergent decisions for products with the 
same composit ion, Member States and the Commission should inform each other 
when they initiate a procedure. Where a Member State initiates a procedure, all other 
Member States should  refrain from launching a procedure for product s with the same 
composition . Where procedures concerning product s with the same composition have 
already been initiated in two or more Member States, the Member State in which the 
procedure was initiated first should continue with its procedure.  Member States may 
also agree that another Mem ber State become  the initiating Member State.  All 
procedures initiated in Member States other than the initiating Member State should be 
suspended pending the adoption of the decision by the initiating Member State.  
(11) A common electronic communication m echanism  should be put in place  in order to 
allow efficient  exchange of information  between the Commission and the Member 
States , in particular to avoid parallel procedures  and divergent decisions  concerning 
products with the same composition .  
(12) The Member States and the Commission sh ould make publically available non -
confidential versions of decisions adopted according to this Regulation and should in 
this respect take due account of indications from manufacturers or importers whether 
information provided  is confidential or not.   
EN 4   EN (13) The measures provided for in this Decision are in accordance with the opinion of the 
Committee referred to in Article 25 of Directive 2014/40/EU,  
 
HAS ADOPTED THIS REGULATION:  
 Article 1  
Subject matter  
This Regulation  lays down uni form rules for the procedures for determining whether a 
tobacco product has a characterising flavour.  
Article 2  
Initiation of the procedure  
1.  Where a Member State (“the initiating Member State”) or the Commission considers 
that a tobacco product might have a character ising flavour , it shall request  the 
manufacturer or the importer of the product concerned to provide its assessment as to 
whether  that product  has a characterising flavour .  
2.  The manufacturer or importer shall reply to the request within  a period of four weeks 
from the receipt  of the request referred to in  paragraph 1. In its reply , the 
manufacturer or importer shall also  set out , where applicable,  the response  received 
from its ultimate parent compan y and identify , to the extent possible , any other 
Member States  in which  the same product  has been placed on the market .  
For the purpose of this Regulation , 'same product' means product with the same 
proportion of ingredients in the tobacco blend composition, irrespective of the  brand 
name or  design .  
3.  The initiating Member State shall notify the Commission  and all other Member 
States of the initiation of a procedure as early as possible and at the latest two weeks  
following receipt of the reply by the manufacturer or importer  pursuant to paragraph 
2. 
Where t he Commission has initiated the procedure, it shall notify  all Member States 
of the initiation as early as possible and at the latest two weeks following receipt of 
the reply by the manufacturer or importer pursuant to para graph 2.  
The notification of the initiation of a procedure shall identify , to the extent possible , 
the Member States in which the same product is placed on the market.   
Article 3  
Assessment of the manufacturer or importer  
1.  Where  the manufacturer or importer does not dispute that a tobacco product has a 
characterising flavour, it shall inform the initiating Member State or the Commission 
in its reply submitted pursuant to Article 2(2) .    
The manufacturer or importer  shall inform the initiating Member State or the 
Commission  of the measures  taken  in order to ensure the withdrawal of the product 
from the market concerned . Where  applicable , the manufacturer or importer shall 
also inform them of  the measures taken in other Member States for the same product.    
EN 5   EN The initiating Member State shall transmit  the information referred to in the first and 
the second subparagraphs to the other Member States  and the Commission . Where 
the Commission has initi ated the procedure, it shall transmit  that information to the 
Member States.   
2.  Where the manufacturer or importer does not reply  within the deadline set in Article 
2(2), or disputes  that the product has a characterising flavour, the initiating Member 
State or the Commission shall continue the procedure  in accordance with Articles 4, 
5 and 6 . The manufacturer or importer may continue  to place the product on the 
market  until the  initiating  Member State or the Commission ha s adopted a decision 
determining whether the product has a characterising flavour .  
Article 4 
Gathering of further information and consultation of the advisory panel  
1.  The initiating Member State or the Commission may request further information 
from the manufacturer or importer concerned, gather information from other sources , 
exchange information with other Member States and the Commission  and consult the 
advisory panel established pursuant to  Article 7(4) of Directive 2014/40/EU .  
2. Where a Member Stat e or the Commission consult s the advisory panel , its opinion 
shall be submitted within 12 weeks from the receipt of the request.   
Article 5 
Communication of the assessment and right to submit observations  
1.  Where the initiating Member State or the Commission considers that a product ha s a 
characterising flavour  and intends to adopt a decision to that end , it shall inform the 
manufacturer or importer of its assessment . Where the advisory panel has been 
consulted, its opinion shall  be attached . The manufacturer or importer shall have four 
weeks from the receipt of the assessment to submit written observations. In its 
written observations the manufacturer or importer shall also indicate, where 
applicable,  whether its ultimate parent company has been consulted.  
2.  Where the initiating Member State or the Commission deem s it necessary to gather 
additional information after receipt of the observations  from the manufacturer or 
importer, it shall inform the manufacturer or importer of  the additional information  
gathered  and shall give it the opportunity to submit additional written observations . 
Article 6 
Decision  
1.  Where a Member State has initiated the procedure,  it shall submit its  draft decision  
on whether the product has a chara cterising flavour  to the Commission at the latest 
four weeks before the decision is taken . The draft  decision  shall be  duly reasoned  
considering  the opinion of the advisory panel, where applicable, and other available 
evidence and information  as appropriate .  The Decision  shall be accompanied  by the 
opinion of the advisory panel , where applicable, and by an English summary of the 
draft decision .   
EN 6   EN A copy of th ose documents shall be sent to all Member States , highlighting , to the 
extent possible , in which other Member State s the same product is placed on the 
market .  
2. The Commission and the other Member States may provide comments on the draft 
decision within three weeks of its receipt. Where the initiating Member State has not 
consulted the advisory panel, the Commission may either recommend that that 
Member State consult the advisory panel and submit a new draft decision or itself 
initiate a procedure .  
Where the initiating Member State intends to depart from the opinion of the advisory 
panel  and the Commission does not agree, the Commission  and th at Member State 
shall try to find a  mutually  acceptable solution. Where such a  solution  is not found , 
the Commission shall initiate a procedure . 
3.  The initiating Member State or the Commission shall adopt a decision determining 
whether the product has a characterising flavour . The initiating Member State or the 
Commission shall notify its decision to the manufacturer or importer.  An English 
summary o f the decision shall be made available to the other Member States and the 
Commission, highlighting , to the extent possible,  in which Member State (s) the same 
product is  placed on the market.   
The manufacturer or importer shall inform the initiating Member  State and the 
Commission of the measures taken in order to withdraw the product from the market 
and, where applicable, of the measures taken in other Member States for the same 
product.  
4. The Commission may initiate a procedure at any time. Where  a nati onal procedure 
relating to the same product is pending or terminated , the Commission shall consult 
the Member State concerned before initiati ng the procedure . Information already 
gathered shall be shared with the Commission  upon request . 
Article 7  
Parallel procedures  
1.  Where a Member State has initiated a procedure concerning a product, other Member 
States shall refrain from initiating a parallel procedure concerning the same product.  
Where procedure s concerning the same product have already been initiated  in two or 
more Member States , the Member State in which the  procedure was initiated  first 
shall continue the procedure . That Member State shall be the initiating Member State 
for the purposes of this Regulation.  
By way of derogation from  the s econd subparagraph, Member States in which the 
same product is placed on the market  may agree that a  Member State other than the 
first initiating Member State shall be responsible for  determining, in accordance with 
this Regulation, whether that product ha s a characterising flavour . In this case, t hat 
Member State shall be the initiating Member State for the purposes of this 
Regulation.   
All procedures initiated  in Member States other than the initiating Member State 
shall be suspended pending the adoption of the decision  referred to in Article 6 by 
the initiating Member State . Information already gathered may be exchanged 
between Member States and with the Commi ssion.   
EN 7   EN 2. As soon as  the initiating Member State  has taken a decision, the suspen ded national 
procedures relating to the same product may resume . 
The initiating Member State  shall , as appropriate,  make available to other Member 
States and the Commission, u pon request, all information  gathered during the 
procedure.  
If a Member State where the same product is placed  on the market does not agree 
with the decision of the initiating Member State , it shall communicate its position to 
the Commission . The Commission shall consult the initiating Member State and the 
other Member States where the same product is placed on the market . If, based on 
this co nsultation , there is a risk of diverg ent decisions on the same product, the 
Commission shall initiate a  procedure.  Where  the Commission does not initiate a 
procedure , Member States where the same product is placed on the market may 
initiate procedures.  
3.  Where  the Commission initiates  a procedure  in order to determine if a product has a 
characterising flavour , all pending national procedures concerning the same product  
shall be terminated . The information already gathered by Member States shall be 
communicated to the Commission upon request.  
Article 8 
Communication  mechanism  
A common electronic mechanism  allowing efficient  communication between the Commission 
and the Member States shall be established by the Commission.   
 
Article 9 
Confidential information  
In their communications, manufacturer s and importers shall mark a ll information which they 
consider to be a trade secret or otherwise confidential and shall duly justify their claims. The 
Member States and the Commission shall adequately protect confidential information  
received according to this Regulation.   
 
Article 10 
Publication of decisions  
The Member States and the Commission sh all make publically avail able n on-confidential 
versions of all decisions.  
Article 11 
Entry into force  
This Regulation shall enter into force on the twentieth day  following that of its publication  in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 8   EN Done at Brussels,  
 For the Commission  
 The President  
 […] 
  
[Choose between the  two options, depending on the person who signs.]  
  
 On behalf of the President  
 […] 
 [Position]