EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING DECISION  
of XXX  
laying down the procedure for the establishment and operation of an independent 
advisory panel assisting Member States and the Commission in determining whether 
tobacco products have a characterising flavour  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING DECISION  
of XXX  
laying  down the procedure for the establishment and operation of an independent 
advisory panel assisting Member States and the Commission in determining whether 
tobacco products have 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 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, and in particular Article 7(4) thereof,  
Whereas : 
(1) Article 7 of Directive 2014/40/EU  prohibits the placing on the market of t obacco 
products with a characterising flavour . Uniform rules for the procedures for 
determining whether a tobacco product has a characterising flavour are laid down in 
Commission Implementing Regulation (EU) …/.. of XXX .  
(2) Article 7(4) of Directive 2014/40/EU provides that , when determining whether a 
tobacco product has a characterising flavour, Member States and the Commission may 
consult an independent advisory panel (" the panel "). It further empowers the 
Commission to ado pt implementing act s laying down the procedure for the 
establishment and operation  of that panel .  
(3) The panel  should be composed of highly qualified, specialised and independent 
experts  with relevant expertise in the fields of sensory, statistical and chemi cal 
analysis. They should perform their functions impartially and in the public interest. 
They should be selected on the basis of objective criteria through a public call for 
applications  and be appointed in a personal capacity. The y should have the range of 
skills and expertise necessary for the panel  to be able to perform its functions.   
(4) The panel  should be assisted by a technical group  recruited by means of a public 
procurement procedure. The technical group should carry out sensory and chemical 
assessment s based on a comparison of the smelling properties of the test product with 
those  of a reference group  of products . Sensory , including smelling,  analysis is a n 
established  scientific discipline that applies principles of experimental design and 
statistical analysis to assess and describe perceptions of the human senses , including 
smell , for the purpose of  evaluating consumer product s. It has been found to be a 
suitable method for producing valid, robust, reliable and reproducible results when 
                                                 
1 OJ L 127, 29.4.2014, p.  1.  
EN 3   EN assessing whether a tobacco product has a characterising flavour.  Such analysis  should 
be conducted on the basis of established procedures and produce results  that can be 
presented  on the basis of statistical tools . More d etailed provisions laying down the  
methodology  for establishing the reference group and for differentiating  between the 
test products and the reference group  are to be specified in a separate implementing 
act. Where it is considered  necessary , sensory analysis should be complemented  by 
chemical analysis of the composition of the products.  
(5) In carrying out its advisory functions, t he panel  should examine , as applicable,  data 
provided by the technical group , as well as  any other information at its disposal that it 
may consider relevant , including information obtained as a result of the reporting 
obligations laid down in Article 5 of Directive 2014/40/EU . It should advise the 
Member States and the Commission in a timely manner as to whether it considers that 
the tested products have a char acterising flavour within the meaning of Article  7(1) of 
Directive  2014/40/EU.  
(6) As scientific methods and techniques for determining the existence of a characterising 
flavour may evolve with time and experience gained, it is appropriate for the 
Commission t o monitor developments in the field with a view to assessing whether the 
methodologies  used to carry out such a determination  should be revised.  
(7) The panel  and the process by which it assesses the existence of a characterising 
flavour  should be  protected ag ainst  external  interference from  any entities or 
associations  with an interest in the outcome of its assessment . Confidential  
information should be protected  against inadvertent disclosure . Members of the panel  
and the technical group who can no longer perform their duties or cease to comply 
with the requirements of this Decision should be  replaced .  
(8) The work of the panel  should be based on the principles of a high level of expertise, 
independence and transparency. It should be organised an d conducted in conformity 
with best practice and high scientific standards .  
(9) The panel should contribute effectively to improving the functioning of the internal 
market while ensuring  a high level of public health , in particular by  helping the 
Member States and the Commission to assess tobacco products with a potentially 
characterising flavour. The panel’s activities are necessary to ensure the effective and 
uniform implementation of Directive 2014/40/EU  and the advice provided by the 
member s of the panel is essential to reach  the relevant Union policy objectives. 
Therefore, it is appropriate to provide the panel  with adequate financial support  in the 
form of a special allowance for its members, beyond the reimbursement of their 
expenses.  
(10) Personal data should be collected, processed and published in accordance with 
Regulation (EC) No 45/2001 of the European Parliament and the Council2.  
                                                 
2 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the 
protection of individuals with regard to the processing of personal data by the Community institutions and 
bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).   
EN 4   EN (11) 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 DECISION:  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject matter  
This Decision  lays down the procedure for the establishment and operation of an independent 
advisory panel (‘the panel’) assisting Member States and the Commission in determining 
whether a tobacco product has a characterising flavour.  
Article 2  
Definitions   
For the purpose s of this Decision, ‘test product’ means a product referred to the panel  by a 
Member State  or th e Commission for an opinion as  to whether or not it has a characterising 
flavour within the meaning of Article 7(1) of Directive 2014/40/EU . 
 Article 3  
Tasks  
1. The panel  shall provide opinion s as to whether test product s have  a characterising 
flavour  within the meaning of Article 7(1) of Directive 2014/40/EU . 
2. The opinion shall  be sent to the requesting Member State, where applicable, and to 
the Commission.   
CHAPTER II   
ESTABLISHMENT OF THE INDEPENDENT ADVISORY 
PANEL  
Article 4  
Appointment  
1. The panel  shall consist of six members .  
2. The Director -General for Health and Food Safety acting on behalf  of the 
Commission (‘the Director -General ’) shall appoint  the members of the panel from a 
list of suitable candidates established following publication of a call for applications 
on the Commission ’s website and in the Register of Commission expert groups and 
other similar entities ( ‘Register of expert groups ’). The  members  shall be selected on  
the basis of the ir expertise and experience in the fields of sensory, statistical and 
chemical analysis , and with due regard to the need to ensure independence and 
absence of conflict s of interests.   
3. Persons on  the list  of suitable candidates who are not appointed  to the panel  shall be 
included in a reserve list  of suitable  candidates to replace members whose  
EN 5   EN membership has ceased  in accordance with Article  5(3). The Director -General shall 
ask applicants for their consent before including their names on the reserve list. 
4. The list of  panel  members shall be published i n the Register of  expert groups and  be 
made available on the relevant Commission website.  
 
Article 5  
Terms of office   
1. The members of the panel  shall be  appointed for a renewable term of five years .  
2. If, at the end of a term, the renewal or replacement of the panel has not been 
confirmed, the existing members shall remain in office.  
3. An individual shall cease to be a member  of the panel  if: 
(a) he or she dies or becomes incapacitated to such an extent that he or she is 
incapable of performing his or her functions under this Decision ; 
(b) he or she resigns ;  
(c) the Director -General  suspends his  or her membership  pursuant to paragraph  5, 
in which case he  or she shall cease to be a member for the duration of the 
suspension ; or 
(d) the Director -General  terminates his  or her membership  pursuant to  
paragraph  5. 
4. A member wishing to resign shall notify the Director -General by email or registered 
post, giving  at least six months ’ notice . Where he or she is in a position to execute 
his or her  tasks and a replacement process is ongoing, he or she may , at the request of 
the Director -General , remain in office until  the replace ment is confirmed .  
5. The Director -General  may temporarily suspend or permanently terminate the 
membership  of a member  where it has been found, or there are reasonable grounds to 
consider , that:  
(a) the member no longer complies with , or has acted in breach of , the condition s 
set out in this Decision  or in Article 339 of the Treaty on the Functioning of the 
Europ ean Union;  
(b) the member no longer compl ies with one or more essential conditions set out in 
the call for application s, or with the principles of independence , impartiality 
and confidentiality referred to  in Article 15, or where the member 's conduct or 
position is incompatible with  declarations  made in accordance with  Articles 15 , 
16 and  17; 
(c) the member is incapable of performing his or her tasks under this Decision ; 
(d) other significant factors are putting the functioning of the panel  into question . 
6. Whe re the membership of a member has ceased  in accordance with paragraph 3(a), 
(b) or (d), the Director -General shall appoint a replacement for the remainder of the  
EN 6   EN term.  The Commission shall launch a new call for applications  once the reserve list is 
exploited .  
CHAPTER III  
OPERATION OF THE PANEL   
Article  6 
Election of the Chair and Vice -Chair  
1. At the beginning of each term, the panel  shall elect a Chair and a Vice -Chair from 
among its members. The election shall take place by a simple majority of its total 
member ship. In the event of parity , the Director -General shall select the Chair from 
the members with most votes , on the basis of  an assessment of their qualifications  
and experience . 
2. The term of office of the Chair and Vice -Chair shall coincide with the term of the 
panel  and shall be renewable. Any replacement of the Chair or Vice -Chair shall be 
for the remainder of th e term of the panel . 
Article 7 
Voting rules  
1. The panel  shall take decision s by the majority of members present at the vot e. 
2. Persons who have ceased to be member s or whose membership is temporarily 
suspended  pursuant to  Article 5( 5) shall not be taken into account for the calculation 
of the majority referred to in paragraph 1 . 
3. In the event of parity , the Chair shall have the casting vote . 
Article 8 
Rules of procedure  
1. The panel shall adopt its rules of procedure o n a proposal by and in agreement with 
the Director -General .  
2. The rules of procedure shall ensure that the panel performs its tasks in complia nce 
with the principles of scientific excellence, independence and transparency.  
3. In particular, t he rules of procedure shall provide for:  
(a) the procedure for the election of the Chair and Vice -Chair of the panel , in 
accordance  with Article 6 ; 
(b) application of the principles laid down in Chapter  IV; 
(c) procedures for the adoption of an opinion;  
(d) relations with third parties , including scientific bodies;  
(e) other detailed rules on the functioning of the panel.   
EN 7   EN Article 9 
Advice on  test products   
1. Where the panel  is asked to provide an opinion on a test product,  the Chair of the 
panel  shall inform all members . He or she may appoint a rapporteur from among the 
members to coordinate  the examination of a particular product. The Chair shall 
submit a final report to the Commissi on and, where applicable, the requesting 
Member State.   
2. Where the panel consider s it necessary for the purposes of providing  an opinion , it 
shall  request  input from  the technical group  established in accordance with 
Article  11. In forming its opinion , the panel shall  have regard to the information and 
data obtained from the technical group. It may also have regard to any other 
information  at its disposal that it considers authoritative and  relevant,  including 
information resulting from reporting oblig ations pursuant to Article 5 of Directive 
2014/40/EU.  
3. With respect to the data and information provided by the technical group, the panel  
shall , in particular : 
(a) verify whether the technical group  respected applicable rules  and scientific 
standards;  
(b) assess the data and information , in particular to determine whether they are  
sufficient to reach a  conclusion or whether additional data and information are 
needed ; 
(c) request such clarifications  from the technical group as may be necessary to 
reach a conclus ion. 
4. If the panel considers the data or information to be insufficient or has doubts as to 
whether the applicable rules and standards were respected, it shall  consult the 
Commission and , where applicable , the requesting Member State. Where it is 
considered  necessary, t he panel may ask the technical group to repeat certain tests 
taking into account the panel’s comments . 
5. Where the  panel is satisfied that applicable rules and standards were respected , 
including , where applicable,  following the procedure laid d own in paragraph 4,  and 
that the data and information are sufficient to reach a conclusion, it shall proceed to 
deliver an  opinion in accordance with  paragraph 2 . 
6. The panel shall submit its opinion within three months  of the date of receipt of the 
request or by a  date agreed  with the Commission or the requesting Member State . 
Article 10 
Consultation on other matters   
1. The Commission may consult the panel on other matters relat ing to the determination 
of a characteris ing flavour in accordance with Article 7 of Directive 2014/40/EU . In 
such cases, i t shall decide , in consultation with the Chair , whether to convene a 
meeting or proceed by means of a  written procedure .   
EN 8   EN 2. The Chair  may appoint a rapporteur from among the panel  members to coordinate  
the task. He or she shall submit a final report to the Commission .  
3. In its deliberations, the panel  shall consider, as appropriate, data and information 
provided to it by the technical  group  and other relevant information at its disposal.  
Article 11 
Technical group of sensory and chemical assessors   
1. A technical group of sensory and chemical assessors (the "technical group") shall be 
set up to provide  the panel with  an assessment of the sensory  and, where appropriate , 
chemical properties  of the test product  as part of the procedure laid down in Article 
9(2). The technical group shall be composed of : 
(a) two qualified persons selected on the basis of their knowledge, skills and 
experience in s ensory analysis who shall be responsible for recruitment, 
training and supervision of the sensory assessors;  
(b) sensory assessors recruited on the basis of their olfactory discrimination ability 
and their capacity to perceive, analyse and interpret smells, an d who have 
reached the age of majority as laid down in applicable national legislation ; and  
(c) two persons selected on the basis of their knowledge and skills in chemical and 
laboratory analysis who shall be responsible for the chemical analysis of test 
products.   
2. A public procurement procedure shall be established for the selection of a contractor 
with responsibility for setting up the technical group. The contractor shall have at its 
disposal the minimum technical expertise and equipment as specified in  the call for 
tender, to include the persons referred to in paragraph 2(a) and (c).   
 The call for tender and associated contractual documentation shall specify that the 
technical group is to act independently and is under an obligation to protect 
confide ntial information and personal data. It shall further contain:  
(a) a description of the technical group’s main functions;  
(b) specifications relating to the establishment, management and operation of the 
technical group, including technical specifications applic able to the 
performance of the group's functions;  
(c) specifications concerning the technical expertise and equipment that must be 
available to the contractor;  
(d) specifications relating to the recruitment of sensory assessors. Such 
specifications shall include a  requirement that sensory assessors may only be 
recruited following approval by the Commission of the candidates proposed;  
3. The technical group’s  sensory analysis  shall be based on a comparison of the 
smelling properties  of the test product with those  of a reference group . 
4. The sensory analysis shall be complemented , where necessary , by a chemical 
assessment of the product composition through chemical analyses. This assessment 
shall  be carried out in a manner that produce s accurate, consistent and rep roducible 
results . The process and results of the chemical assessment shall be documented.  
5. The technical group shall  deliver the results of the product testing to the panel  and 
submit a copy to the Commission.   
EN 9   EN 6. The work  of the technical group shall be subject to the limits of the annual budget 
allocated to it by the Commission.  
Article 1 2 
Secretariat  
1. The Commission shall provide a secretariat for the panel  and for all other activities 
relating to the application of this Decision.  
2. The secretariat shall be responsible for providing administrative support to facilitate 
the efficient functioning of the panel  and to monitor compliance with the rules of 
procedure . 
Article 1 3 
Special allowance  
1. The members of the panel  shall be entitled to  a special allowance compensating them 
for their preparatory work and participation, in person or remotely  by electronic 
means, in the meetings of the panel  and other activities relat ing to the application of 
this Decision and organised by the Commission, and for serving as rapporteur on a 
specific question . 
2. The special allowance  shall  consist of a maximum  of EUR 450  in the form of a daily 
unit cost for each full working day. The total allowance shall be calculated and 
rounded up to the amount corresponding  to the nearest half working day.   
3. The Commission shall reimburse t ravel and, where appropriate, subsistence expenses 
incurred by  members and external experts in connection with the panel ’s activities in 
accordance with internal Commission provisions.  
4. All allowances and reimbursements shall be subject to the annual budget allocated to 
the panel by the Commission . 
Chapter IV  
INDEPENDENCE, CONFIDENTIALITY AND 
TRANSPARENCY  
Article 14 
Communication  
1.  The Chair of the panel  shall act as the contact person for the Member States  and the 
Commission . 
2.  The Chair shall immediately report to the Commission  any circumstances that could 
jeopardise the functioning of the panel .  
Article 1 5 
Independence  
1. The members of the panel  shall be appointed in a personal capacity. They shall not 
delegate their responsibilities to any other person. In performing their functions, the y  
EN 10   EN shall respect the principles of independence, impartiality and confidentiality and act 
in the public interest .  
2. Experts apply ing to be appointed as members of the panel shall be required to submit  
a declaration indicating any interest that may compromise or reasonably be perceived 
to compromise their independence, including any relevant circumstances relating to 
their close fami ly members  or partners . Submission of a duly completed declaration 
of interests shall be necessary in order for an expert to be eligible to be appointed as 
a member of the panel. If the Commission concludes that no conflict of interest 
exists, the applicant shall be eligible for appointment , provided he  or she is 
considered to possess the required expertise.  
3. Panel m embers shall promptly inform the Commission if there is any change in the 
information provided  in their declaration , in which case t hey must  immediately  
submit  a new declaration showing  relevant changes .  
4. At each meeting, panel members shall declare any specific interest that may 
compromise or reasonably be perceived to compromise their independence in 
relation to any item on the ag enda.  In such cases, the Chair may request that the 
member concerned withdraw from the meeting  or from parts of the meeting . The 
Chair shall  inform the Commission of such declaration  and actions taken . 
5. The panel m embers shall refrain from having any direct or indirect contact with the 
tobacco industry or its representatives . 
 
Article 1 6 
Confidentiality  and protection of personal data  
1. The panel members shall not divulge information , including commercially sensitive 
or personal data,  acquired as a result of the panel’s work or of other activities relat ing 
to the application of this Decision , even after they have ceased to be members . They 
shall sign a declaration of confidentiality  to this effect .  
2. The panel members s hall comply with the Commission ’s security rules on the 
protecti on of  EU classified and sensitive non -classified information, as set out in 
Commission Decisions (EU, Euratom) 2015/4433 and 2015/4444. Should they fail to 
respect these obligations, the Commission may take all appropriate measures.   
 
Article 1 7  
Commitment   
The panel members of the panel  shall undertake  to contribute actively to the work of the 
panel . They shall si gn a declaration of commitment  to this effect . 
                                                 
3 Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 
17.3.2015, p. 41).   
4 Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU 
classified information (OJ L 72, 17.3.2015, p. 53).    
EN 11   EN Article 1 8  
Transparency  
1. The activities of the panel  shall be carried out with a high level of transparency. The 
Commission shall publish all relevant documents on a dedicated website  and provide 
a link to this website from the register of expert groups . In particular , it shall  make 
available to the public, without undue delay:  
(a) the members’ names;  
(b) the members’ declarations of interests, confidentiality and commitment;  
(c) the panel’s  rules of procedure;   
(d) the opinions adopted by the panel ;  
(e) the agendas and minutes  of the panel’s me etings . 
2. By way of derogation from paragraph 1 , publication shall not be required  where 
disclosure of a document would undermine the protection of a public or private 
interest as defined in Article 4 of Regulation (EC) No 1049/2001  of the European 
Parliamen t and of the Council5. 
CHAPTER V  
FINAL PROVISIONS  
Article 19 
Addresse es 
This Decision is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 Vytenis ANDRIUKAITIS  
 Member of the Commission  
                                                 
5 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding 
public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).