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Commission Implementing Decision (EU) 2016/786 of 18 May 2016 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 (notified under document C(2016) 2921) (Text with EEA relevance)
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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 membership. 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 the term of the panel.
1.For votes in cases other than referred to in Article 6 and Article 8(3)(a), the panel shall only take decisions when at least four members are participating in the vote, one of whom must be either the Chair or the Vice-Chair. Decisions shall be taken by a simple majority.
2.In the event of parity, the person chairing the vote shall have the casting vote.
3.Persons who have ceased to be members 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.
1.The panel shall adopt, and update as appropriate, its rules of procedure on a proposal by and in agreement with the Director-General.
2.The rules of procedure shall ensure that the panel performs its tasks in compliance with the principles of scientific excellence, independence and transparency.
3.In particular, the 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.
1.The panel shall specify and, as appropriate, update the methodology for the technical assessment of test products. The methodology for sensory analysis shall be based on a comparison of the smelling properties of the test product with those of reference products. In developing the methodology, the panel shall take into consideration, as appropriate, input from the technical group referred to in Article 12.
2.The draft methodology, and any subsequent draft update, shall be submitted to the Director-General for approval and shall only become applicable after such approval has been given.
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 Commission and, where applicable, the requesting Member State.
2.Where the panel considers it necessary for the purposes of providing an opinion, it shall request input from the technical group established in accordance with Article 12. 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 obligations 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 conclusion.
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, the 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 down 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 to the Commission and any referring Member States within three months of the date of receipt of the request or by a date agreed with the Commission or the requesting Member State.
1.The Commission may consult the panel on other matters relating to the determination of a characterising flavour in accordance with Article 7 of Directive 2014/40/EU. In such cases, it shall decide, in consultation with the Chair, whether to convene a meeting or proceed by means of a written procedure.
2.The Chair may appoint a rapporteur from among the panel members to coordinate the task and 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.
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 10. The technical group shall be composed of:
(a)two qualified persons selected on the basis of their knowledge, skills and experience in sensory 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, and 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 and include the persons referred to in paragraph 1(a) and (c).
The call for tender and associated contractual documentation shall specify that the technical group is under an obligation to act independently and protect confidential information and personal data. It shall further contain a requirement that each group member return a duly completed declaration of interest before engaging in any work for the technical group. In addition, the call for tender and associated contractual documentation shall contain, at least, the following elements:
(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 applicable 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 the methodology established pursuant to Article 9.
4.The sensory analysis shall be complemented, where appropriate, by a chemical assessment of the product composition through chemical analyses. This assessment shall be carried out in a manner that produces accurate, consistent and reproducible 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 by a date agreed by the panel.
6.The work of the technical group shall be subject to the limits of the annual budget allocated to it by the Commission.
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.
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 relating 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 travel 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.
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