| 20.5.2016 | EN | Official Journal of the European Union | L 131/79 | 20.5.2016 | SL | Uradni list Evropske unije | L 131/79 |
| COMMISSION IMPLEMENTING DECISION (EU) 2016/786 | IZVEDBENI SKLEP KOMISIJE (EU) 2016/786 |
| of 18 May 2016 | z dne 18. maja 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 | o določitvi postopka za ustanovitev in delovanje neodvisnega svetovalnega odbora za pomoč državam članicam in Komisiji pri določanju, ali imajo tobačni izdelki značilno aromo |
| (notified under document C(2016) 2921) | (notificirano pod dokumentarno številko C(2016) 2921) |
| (Text with EEA relevance) | (Besedilo velja za EGP) |
| THE EUROPEAN COMMISSION, | EVROPSKA KOMISIJA JE – |
| Having regard to the Treaty on the Functioning of the European Union, | ob upoštevanju Pogodbe o delovanju Evropske unije, |
| 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/EC (1), and in particular Article 7(4) thereof, | ob upoštevanju Direktive 2014/40/EU Evropskega parlamenta in Sveta z dne 3. aprila 2014 o približevanju zakonov in drugih predpisov držav članic o proizvodnji, predstavitvi in prodaji tobačnih in povezanih izdelkov in razveljavitvi Direktive 2001/37/ES (1) in zlasti člena 7(4) Direktive, |
| Whereas: | ob upoštevanju naslednjega: |
| (1) | Article 7 of Directive 2014/40/EU prohibits the placing on the market of tobacco 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) 2016/779 (2). | (1) | Člen 7 Direktive 2014/40/EU prepoveduje dajanje tobačnih izdelkov z značilno aromo na trg. Enotna pravila glede postopkov za določanje, ali ima tobačni izdelek značilno aromo, so določena v Izvedbeni uredbi Komisije (EU) 2016/779 (2). |
| (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 adopt implementing acts laying down the procedure for the establishment and operation of that panel. | (2) | Člen 7(4) Direktive 2014/40/EU določa, da se lahko države članice in Komisija pri določanju, ali ima tobačni izdelek značilno aromo, posvetujejo z neodvisnim svetovalnim odborom (v nadaljnjem besedilu: odbor). S tem členom se Komisija tudi pooblašča za sprejemanje izvedbenih aktov o določitvi postopka za ustanovitev in delovanje navedenega odbora. |
| (3) | The panel should be composed of highly qualified, specialised and independent experts with relevant expertise in the fields of sensory, statistical and chemical 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. They should have the range of skills and expertise necessary for the panel to be able to perform its functions. | (3) | Odbor bi morali sestavljati visoko usposobljeni, specializirani in neodvisni strokovnjaki s strokovnim znanjem in izkušnjami na področju senzorične, statistične in kemične analize. Svoje naloge bi morali opravljati nepristransko in v javnem interesu. Izbrati bi jih bilo treba na podlagi objektivnih meril z javnim povabilom k oddaji prijav, imenovani pa bi morali biti osebno. Imeti bi morali spretnosti in strokovno znanje, ki so potrebni, da bo lahko odbor opravljal svoje naloge. |
| (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 assessments based on a comparison of the smelling properties of the test product with those of reference products. Sensory, including smelling, analysis is an 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 products. It has been found to be a suitable method for producing valid, robust, reliable and reproducible results when assessing whether a tobacco product has a characterising flavour. Such analysis should be conducted on the basis of an established methodology and produce results using statistical tools. Where it is considered appropriate, sensory analysis should be complemented by chemical analysis of the products. | (4) | Odboru bi morala pomagati tehnična skupina, sestavljena na podlagi postopka oddaje javnega naročila. Tehnična skupina bi morala izvajati senzorične in kemične ocene na podlagi primerjave vonjskih lastnosti preskusnega izdelka z vonjskimi lastnostmi referenčnih izdelkov. Senzorična, med drugim vonjska analiza, je uveljavljena znanstvena disciplina, ki uporablja načela načrta poskusa in statistične analize za oceno in opis zaznav človeških čutov, med drugim vonja, za vrednotenje potrošniškega blaga. Ugotovljeno je bilo, da je metoda primerna za pripravo veljavnih, zanesljivih in ponovljivih rezultatov pri ocenjevanju, ali ima tobačni izdelek značilno aromo. Takšna analiza bi morala biti izvedena na podlagi uveljavljene metodologije in bi morala zagotoviti rezultate z uporabo statističnih orodij. Kadar je primerno, bi morala senzorično analizo dopolnjevati kemična analiza izdelkov. |
| (5) | In carrying out its advisory functions, the 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 characterising flavour within the meaning of Article 7(1) of Directive 2014/40/EU. | (5) | Pri opravljanju svojih svetovalnih nalog bi moral odbor, če je to primerno, preučiti podatke, ki jih je predložila tehnična skupina, ter vse druge informacije, ki jih ima na voljo in za katere meni, da so pomembni, vključno z informacijami, pridobljenimi na podlagi obveznosti poročanja iz člena 5 Direktive 2014/40/EU. Državam članicam in Komisiji bi moral pravočasno svetovati z mnenjem o tem, ali imajo preskušeni izdelki značilno aromo v smislu člena 7(1) Direktive 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 to monitor developments in the field with a view to assessing whether the methodologies used to carry out such a determination should be revised. | (6) | Znanstvene metode in tehnike za določanje obstoja značilne arome se lahko skozi čas in s pridobljenimi izkušnjami spreminjajo, zato je primerno, da Komisija spremlja razvoj na tem področju, da lahko oceni, ali bi bilo treba metodologije za sprejetje takšne odločitve spremeniti. |
| (7) | The panel and the process by which it assesses the existence of a characterising flavour should be protected against external interference from any entities or associations with an interest in the outcome of its assessment. Confidential information should be protected against inadvertent and deliberate 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. | (7) | Odbor in postopek, s katerim ocenjuje obstoj značilne arome, bi morala biti zaščitena pred zunanjimi vplivi vseh subjektov ali združenj, ki jih zanima izid njegove ocene. Zaupni podatki bi morali biti zaščiteni pred nenamernim in namernim razkritjem. Člane odbora in tehnične skupine, ki ne morejo več opravljati svojih nalog ali ne izpolnjujejo več zahtev iz tega sklepa, bi bilo treba nadomestiti. |
| (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 and conducted in conformity with best practice and high scientific standards. | (8) | Delo odbora bi moralo temeljiti na načelih visoke ravni strokovnega znanja, neodvisnosti in preglednosti. Organizirano in vodeno bi moralo biti v skladu z najboljšo prakso in visokimi znanstvenimi standardi. |
| (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 that potentially have a 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 members 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. | (9) | Odbor bi moral učinkovito prispevati k boljšemu delovanju notranjega trga ob hkratnem zagotavljanju visoke ravni javnega zdravja, zlasti s pomočjo državam članicam in Komisiji pri oceni tobačnih izdelkov z morebitno značilno aromo. Dejavnosti odbora so potrebne, da se zagotovi učinkovito in enotno izvajanje Direktive 2014/40/EU in mnenje članov odbora je bistveno za doseganje zadevnih ciljev politike Unije. Zato je poleg povračila stroškov odboru primerno zagotoviti ustrezno finančno podporo v obliki posebnega dodatka za njegove člane. |
| (10) | Personal data should be collected, processed and published in accordance with Regulation (EC) No 45/2001 of the European Parliament and the Council (3). | (10) | Osebni podatki bi se morali zbirati, obdelovati in objavljati v skladu z Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta (3). |
| (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, | (11) | Ukrepi iz tega sklepa so v skladu z mnenjem odbora iz člena 25 Direktive 2014/40/EU – |
| HAS ADOPTED THIS DECISION: | SPREJELA NASLEDNJI SKLEP: |
| CHAPTER I | POGLAVJE I |
| GENERAL PROVISIONS | SPLOŠNE DOLOČBE |
| Article 1 | Člen 1 |
| Subject matter | Predmet urejanja |
| 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 or not a tobacco product has a characterising flavour. | Ta sklep določa postopek za ustanovitev in delovanje neodvisnega svetovalnega odbora (v nadaljnjem besedilu: odbor) za pomoč državam članicam in Komisiji pri določanju, ali ima tobačni izdelek značilno aromo. |
| Article 2 | Člen 2 |
| Definition | Opredelitev pojmov |
| For the purposes of this Decision, ‘test product’ means a product referred to the panel by a Member State or the 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. | V tem sklepu „preskusni izdelek“ pomeni izdelek, ki ga je država članica ali Komisija predložila odboru za pridobitev mnenja o tem, ali ima značilno aromo v smislu člena 7(1) Direktive 2014/40/EU. |
| Article 3 | Člen 3 |
| Tasks | Naloge |
| The panel shall provide opinions as to whether test products have a characterising flavour within the meaning of Article 7(1) of Directive 2014/40/EU. | Odbor izraža mnenja o tem, ali imajo preskusni izdelki značilno aromo v smislu člena 7(1) Direktive 2014/40/EU. |
| CHAPTER II | POGLAVJE II |
| ESTABLISHMENT OF THE INDEPENDENT ADVISORY PANEL | USTANOVITEV NEODVISNEGA SVETOVALNEGA ODBORA |
| Article 4 | Člen 4 |
| Appointment | Imenovanje |
| 1. The panel shall consist of six members. | 1. Odbor sestavlja šest članov. |
| 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 their 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 conflicts of interests. | 2. Generalni direktor za zdravje in varnost hrane v imenu Komisije (v nadaljnjem besedilu: generalni direktor) imenuje člane odbora s seznama primernih kandidatov, ki se pripravi po objavi povabila k oddaji prijave na spletišču Komisije in v registru strokovnih skupin Komisije ter drugih podobnih subjektov (v nadaljnjem besedilu: register strokovnih skupin). Člani so izbrani na podlagi njihovega strokovnega znanja in izkušenj na področju senzorične, statistične in kemične analize ter ob upoštevanju, da je treba zagotoviti neodvisnost in odsotnost nasprotja interesov. |
| 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 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. | 3. Osebe s seznama primernih kandidatov, ki niso bile imenovane v odbor, se vključijo v rezervni seznam primernih kandidatov za nadomestitev članov, katerih članstvo preneha v skladu s členom 5(3). Pred vključitvijo kandidatov na seznam generalni direktor pridobi njihovo soglasje. |
| 4. The list of panel members shall be published in the Register of expert groups and be made available on the relevant Commission website. | 4. Imena članov odbora se objavijo v registru strokovnih skupin Komisije in na zadevnem spletišču Komisije. |
| Article 5 | Člen 5 |
| Terms of office | Mandat |
| 1. The members of the panel shall be appointed for a renewable term of five years. | 1. Člani odbora so imenovani za pet let z možnostjo podaljšanja. |
| 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. | 2. Če na koncu mandata podaljšanje ali nadomestitev odbora ni potrjena, obstoječi člani ostanejo na položaju. |
| 3. An individual shall cease to be a member of the panel if: | 3. Posameznik preneha biti član odbora, če: |
| (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; | (a) | umre ali postane nezmožen za delo v takšnem obsegu, da je nesposoben za opravljanje nalog iz tega sklepa; |
| (b) | he or she resigns; | (b) | odstopi; |
| (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 | (c) | generalni direktor prekine njegovo članstvo v skladu z odstavkom 5, pri čemer njegovo članstvo preneha v času trajanja prekinitve; ali |
| (d) | the Director-General terminates his or her membership pursuant to paragraph 5. | (d) | generalni direktor konča njegovo članstvo v skladu z odstavkom 5. |
| 4. A member wishing to resign shall notify the Director-General by e-mail 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 replacement is confirmed. | 4. Član, ki želi odstopiti, o tem obvesti generalnega direktorja po elektronski pošti ali s priporočeno pošto z vsaj šestmesečnim odpovednim rokom. Če članov položaj dopušča opravljanje nalog in postopek za izbiro nadomestnih članov še poteka, lahko na zahtevo generalnega direktorja ostane na svojem položaju do potrditve nadomestitve. |
| 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: | 5. Generalni direktor lahko začasno ali trajno prekine članstvo člana, če je bilo ugotovljeno ali če obstajajo utemeljeni razlogi za domnevo, da: |
| (a) | the member no longer complies with, or has acted in breach of, the conditions set out in this Decision or in Article 339 of the Treaty on the Functioning of the European Union; | (a) | član ne izpolnjuje več pogojev, določenih v tem sklepu ali v členu 339 Pogodbe o delovanju Evropske unije, ali je te pogoje kršil; |
| (b) | the member no longer complies with one or more essential conditions set out in the call for applications, or with the principles of independence, impartiality and confidentiality referred to in Article 16, or that the member's conduct or position is incompatible with declarations made in accordance with Articles 16, 17 and 18; | (b) | član ne izpolnjuje več enega ali več bistvenih pogojev iz povabila k oddaji prijave ali načel neodvisnosti, nepristranskosti in zaupnosti iz člena 16 ali njegovo ravnanje ali položaj ni v skladu z izjavami, danimi v skladu s členi 16, 17 in 18; |
| (c) | the member is incapable of performing his or her tasks under this Decision; | (c) | član ni sposoben opravljati svojih nalog v skladu s tem sklepom; |
| (d) | other significant factors are putting the functioning of the panel into question. | (d) | je delovanje odbora vprašljivo zaradi drugih pomembnih dejavnikov. |
| 6. Where the membership of a member has ceased in accordance with paragraph 3, the Director-General shall appoint a replacement for the remainder of the term or for the period of the temporary suspension. The Commission shall launch a new call for applications once the reserve list is exhausted. | 6. Ob prenehanju članstva člana v skladu z odstavkom 3 generalni direktor imenuje nadomestnega člana za preostanek mandata ali za obdobje prekinitve. Ko je rezervni seznam prazen, Komisija objavi novo povabilo k oddaji prijave. |
| CHAPTER III | POGLAVJE III |
| OPERATION OF THE PANEL | DELOVANJE ODBORA |
| Article 6 | Člen 6 |
| Election of the Chair and Vice-Chair | Izvolitev predsednika in podpredsednika |
| 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. | 1. Na začetku vsakega mandata odbor izmed svojih članov izvoli predsednika in podpredsednika. Za izvolitev je potrebna navadna večina vsega članstva. V primeru enakega števila glasov generalni direktor izbere predsednika izmed članov z največ glasovi na podlagi ocene njihovih kvalifikacij in izkušenj. |
| 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. | 2. Mandat predsednika in podpredsednika sovpada z mandatom odbora in se lahko podaljša. Vsaka nadomestitev predsednika ali podpredsednika velja za preostanek mandata odbora. |
| Article 7 | Člen 7 |
| Voting rules | Pravila glasovanja |
| 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. | 1. Pri glasovanju, razen v primerih iz člena 6 in člena 8(3)(a), odbor sprejme odločitve, samo če glasujejo vsaj štirje člani, od katerih mora biti eden predsednik ali podpredsednik. Odločitve se sprejmejo z navadno večino. |
| 2. In the event of parity, the person chairing the vote shall have the casting vote. | 2. V primeru enakega števila glasov ima predsedujoči odločilni glas. |
| 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. | 3. Osebe, ki niso več člani ali katerih članstvo je začasno prekinjeno v skladu s členom 5(5), se ne upoštevajo pri izračunu večine iz odstavka 1. |
| Article 8 | Člen 8 |
| Rules of procedure | Poslovnik |
| 1. The panel shall adopt, and update as appropriate, its rules of procedure on a proposal by and in agreement with the Director-General. | 1. Na predlog in po dogovoru z generalnim direktorjem odbor sprejme in po potrebi posodobi svoj poslovnik. |
| 2. The rules of procedure shall ensure that the panel performs its tasks in compliance with the principles of scientific excellence, independence and transparency. | 2. Poslovnik zagotavlja, da odbor izvaja svoje naloge v skladu z načeli znanstvene odličnosti, neodvisnosti in preglednosti. |
| 3. In particular, the rules of procedure shall provide for: | 3. Poslovnik zlasti določa: |
| (a) | the procedure for the election of the Chair and Vice-Chair of the panel, in accordance with Article 6; | (a) | postopek za izvolitev predsednika in podpredsednika odbora v skladu s členom 6; |
| (b) | application of the principles laid down in Chapter IV; | (b) | uporabo načel iz poglavja IV; |
| (c) | procedures for the adoption of an opinion; | (c) | postopke za sprejemanje mnenj; |
| (d) | relations with third parties, including scientific bodies; | (d) | odnose s tretjimi strankami, vključno z znanstvenimi organi; |
| (e) | other detailed rules on the functioning of the panel. | (e) | druga podrobna pravila o delovanju odbora. |
| Article 9 | Člen 9 |
| Methodology | Metodologija |
| 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. | 1. Odbor določi in po potrebi posodobi metodologijo za tehnično ocenjevanje preskusnih izdelkov. Metodologija senzorične analize temelji na primerjavi vonjskih lastnosti preskusnega izdelka z vonjskimi lastnostmi referenčnih izdelkov. Pri oblikovanju metodologije odbor po potrebi upošteva prispevek tehnične skupine iz člena 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. | 2. Osnutek metodologije in vsak naslednji osnutek posodobitve se predloži generalnemu direktorju v odobritev in začne veljati šele po njej. |
| Article 10 | Člen 10 |
| Advice on test products | Svetovanje glede preskusnih izdelkov |
| 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. | 1. Kadar je odbor pozvan k pripravi mnenja o preskusnem izdelku, predsednik odbora o tem obvesti vse člane. Izmed članov lahko imenuje poročevalca, ki bo usklajeval preučitev določenega izdelka. Predsednik predloži končno poročilo Komisiji in, če je primerno, državi članici prosilki. |
| 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. | 2. Če odbor meni, da je za pripravo mnenja potreben prispevek tehnične skupine, ustanovljene v skladu s členom 12, zaprosi zanj. Pri oblikovanju mnenja odbor upošteva informacije in podatke, pridobljene od tehnične skupine. Upošteva lahko tudi vse druge informacije, ki jih ima na voljo in za katere meni, da so zanesljive in ustrezne, vključno z informacijami, ki izhajajo iz obveznosti poročanja v skladu s členom 5 Direktive 2014/40/EU. |
| 3. With respect to the data and information provided by the technical group, the panel shall, in particular: | 3. V zvezi s podatki in informacijami, ki jih je predložila tehnična skupina, odbor zlasti: |
| (a) | verify whether the technical group respected applicable rules and scientific standards; | (a) | preveri, ali je tehnična skupina upoštevala veljavna pravila in znanstvene standarde; |
| (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; | (b) | oceni podatke in informacije, zlasti da presodi, ali zadostujejo za sklepno ugotovitev ali so potrebni dodatni podatki in informacije; |
| (c) | request such clarifications from the technical group as may be necessary to reach a conclusion. | (c) | tehnično skupino zaprosi za pojasnila, če so potrebna za oblikovanje sklepne ugotovitve. |
| 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. | 4. Če odbor meni, da podatki ali informacije niso zadostni, ali dvomi, če so bila upoštevana veljavna pravila in standardi, se posvetuje s Komisijo in po potrebi z državo članico prosilko. Če je potrebno, lahko odbor prosi tehnično skupino za ponovitev nekaterih preskusov ob upoštevanju pripomb odbora. |
| 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. | 5. Če odbor ugotovi – po potrebi tudi v skladu s postopkom iz odstavka 4 –, da so bili veljavna pravila in standardi upoštevani ter da podatki in informacije zadostujejo za sklepno ugotovitev, pripravi mnenje v skladu z odstavkom 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. | 6. Odbor predloži svoje mnenje Komisiji in zadevnim državam članicam v treh mesecih od datuma prejema zahtevka ali do datuma, dogovorjenega s Komisijo ali državo članico prosilko. |
| Article 11 | Člen 11 |
| Consultation on other matters | Posvetovanje o drugih zadevah |
| 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. | 1. Komisija se lahko posvetuje z odborom o drugih zadevah v zvezi z določitvijo značilne arome v skladu s členom 7 Direktive 2014/40/EU. V takih primerih se po posvetovanju s predsednikom odloči, ali bo sklicala sejo ali nadaljevala s pisnim postopkom. |
| 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. | 2. Predsednik lahko za usklajevanje naloge izmed članov odbora imenuje poročevalca in Komisiji pošlje končno poročilo. |
| 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. | 3. Pri posvetovanju odbor po potrebi preuči podatke in informacije, ki mu jih je predložila tehnična skupina, in druge zadevne informacije, ki jih ima na voljo. |
| Article 12 | Člen 12 |
| Technical group of sensory and chemical assessors | Tehnična skupina senzoričnih in kemičnih ocenjevalcev |
| 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: | 1. Da se odboru zagotovi ocena senzoričnih in po potrebi kemičnih lastnosti preskusnega izdelka v okviru postopka iz člena 10, se ustanovi tehnična skupina senzoričnih in kemičnih ocenjevalcev (v nadaljnjem besedilu: tehnična skupina). Tehnično skupino sestavljajo: |
| (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; | (a) | dve usposobljeni osebi, izbrani na podlagi njunega znanja, spretnosti in izkušenj pri senzorični analizi, ki sta pristojni za najemanje, usposabljanje in nadzor senzoričnih ocenjevalcev; |
| (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 | (b) | senzorični ocenjevalci, najeti na podlagi sposobnosti vohalnega razločevanja in sposobnosti zaznavanja, analize in razlage vonjev, ki so polnoletni v skladu z nacionalno zakonodajo, ki se uporablja; in |
| (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. | (c) | dve osebi, izbrani na podlagi njunega znanja in spretnosti na področju kemične in laboratorijske analize, ki sta odgovorni za kemično analizo preskusnih izdelkov. |
| 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). | 2. Za izbor izvajalca za vzpostavitev tehnične skupine se izvede postopek oddaje javnega naročila. Izvajalec ima na voljo minimalno tehnično strokovno znanje in opremo, kakor je določeno v javnem razpisu, in vključi osebe iz odstavka 1(a) in (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: | V javnem razpisu in povezani pogodbeni dokumentaciji je podrobno opredeljeno, da je tehnična skupina dolžna delovati neodvisno ter varovati zaupne informacije in osebne podatke. Javni razpis vsebuje tudi zahtevo, da vsak član skupine pred kakršnim koli delom za tehnično skupino predloži pravilno izpolnjeno izjavo o interesu. Poleg tega javni razpis in povezana pogodbena dokumentacija vsebujeta vsaj naslednje sestavne dele: |
| (a) | a description of the technical group's main functions; | (a) | opis glavnih nalog tehnične skupine; |
| (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; | (b) | določila, ki se nanašajo na vzpostavitev, upravljanje in delovanje tehnične skupine, vključno s tehnično specifikacijo, ki se uporablja za opravljanje njenih nalog; |
| (c) | specifications concerning the technical expertise and equipment that must be available to the contractor; | (c) | določila v zvezi s tehničnim strokovnim znanjem in opremo, ki morajo biti izvajalcu na voljo; |
| (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. | (d) | določila, ki se nanašajo na najemanje senzoričnih ocenjevalcev. V teh določilih je vključena zahteva, da se senzorični ocenjevalci lahko najamejo, šele ko Komisija odobri predlagane kandidate. |
| 3. The technical group's sensory analysis shall be based on the methodology established pursuant to Article 9. | 3. Senzorična analiza tehnične skupine temelji na metodologiji, določeni v skladu s členom 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. | 4. Senzorična analiza se po potrebi dopolni s kemično oceno sestave izdelka s kemičnimi analizami. Ta ocena se opravi tako, da se pridobijo točni, dosledni in ponovljivi rezultati. Proces in rezultati kemične ocene se dokumentirajo. |
| 5. The technical group shall deliver the results of the product testing to the panel by a date agreed by the panel. | 5. Tehnična skupina predloži rezultate preskušanja izdelka odboru do datuma, ki ga je ta določil. |
| 6. The work of the technical group shall be subject to the limits of the annual budget allocated to it by the Commission. | 6. Delo tehnične skupine je omejeno z letnimi proračunskimi sredstvi, ki ji jih dodeli Komisija. |
| Article 13 | Člen 13 |
| Secretariat | Sekretariat |
| 1. The Commission shall provide a secretariat for the panel and for all other activities relating to the application of this Decision. | 1. Komisija zagotovi sekretariat za odbor in vse druge dejavnosti, povezane z uporabo tega sklepa. |
| 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. | 2. Sekretariat zagotavlja upravno podporo za učinkovito delovanje odbora in za nadzor skladnosti s poslovnikom. |
| Article 14 | Člen 14 |
| Special allowance | Posebni dodatek |
| 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. | 1. Člani odbora so upravičeni do posebnega dodatka za pripravljalno delo in sodelovanje, osebno ali na daljavo z elektronskimi sredstvi, na sestankih odbora in pri drugih dejavnostih, povezanih z uporabo tega sklepa, ki jih organizira Komisija, in za poročanje o danem vprašanju. |
| 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. | 2. Posebni dodatek znaša največ 450 EUR v obliki dnevnih stroškov na enoto za vsak polni delovni dan. Skupni dodatek se izračuna in zaokroži do zneska, ki ustreza najbližjemu polovičnemu delovnemu dnevu. |
| 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. | 3. Komisija krije potne stroške in po potrebi stroške bivanja članov in zunanjih strokovnjakov v povezavi z dejavnostmi odbora v skladu z veljavnimi določbami Komisije. |
| 4. All allowances and reimbursements shall be subject to the annual budget allocated to the panel by the Commission. | 4. Vsi dodatki in povračila so odvisni od letnih proračunskih sredstev, ki jih Komisija dodeli odboru. |
| CHAPTER IV | POGLAVJE IV |
| INDEPENDENCE, CONFIDENTIALITY AND TRANSPARENCY | NEODVISNOST, ZAUPNOST IN PREGLEDNOST |
| Article 15 | Člen 15 |
| Communication | Komunikacija |
| 1. The Chair of the panel shall act as the contact person for the Member States and the Commission. | 1. Predsednik odbora je kontaktna oseba za države članice in Komisijo. |
| 2. The Chair shall immediately report to the Commission any circumstances that could jeopardise the functioning of the panel. | 2. Predsednik takoj obvesti Komisijo o kakršnih koli okoliščinah, ki bi lahko ogrozile delovanje odbora. |
| Article 16 | Člen 16 |
| Independence | Neodvisnost |
| 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, they shall respect the principles of independence, impartiality and confidentiality and act in the public interest. | 1. Člani odbora so imenovani osebno. Svojih odgovornosti ne prenašajo na druge osebe. Pri opravljanju nalog spoštujejo načela neodvisnosti, nepristranskosti in zaupnosti ter delujejo v javnem interesu. |
| 2. Experts applying 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 family 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. | 2. Od strokovnjakov, ki se prijavijo za člane odbora, se zahteva predložitev izjave, v kateri navedejo kakršne koli interese, ki bi lahko ogrozili ali za katere upravičeno velja, da bi ogrozili njihovo neodvisnost, vključno z vsemi ustreznimi okoliščinami v zvezi z njihovimi ožjimi družinskimi člani ali partnerji. Predložitev ustrezno izpolnjene izjave o interesih je eden od pogojev za imenovanje strokovnjaka za člana odbora. Če Komisija ugotovi, da ni nasprotja interesov, kandidat izpolnjuje pogoje za imenovanje, če se oceni, da ima zahtevano strokovno znanje. |
| 3. Panel members shall promptly inform the Commission if there is any change in the information provided in their declaration, in which case they must immediately submit a new declaration showing relevant changes. | 3. Člani odbora takoj obvestijo Komisijo o vsaki spremembi informacij iz izjave; v tem primeru morajo nemudoma predložiti novo izjavo, iz katere so razvidne zadevne spremembe. |
| 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 agenda. 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. | 4. Člani odbora na vsakem sestanku izrazijo vse posebne interese, ki bi lahko ogrozili ali za katere upravičeno velja, da ogrožajo njihovo neodvisnost v zvezi s katero koli točko dnevnega reda. V takšnih primerih lahko predsednik zaprosi zadevnega člana, da se ne udeleži sestanka ali delov sestanka. Predsednik obvesti Komisijo o takšni izjavi in sprejetih ukrepih. |
| 5. The panel members shall refrain from having any direct or indirect contact with the tobacco industry or its representatives. | 5. Člani odbora se vzdržijo vseh neposrednih ali posrednih stikov s tobačno industrijo ali njenimi zastopniki. |
| Article 17 | Člen 17 |
| Confidentiality and protection of personal data | Zaupnost in varstvo osebnih podatkov |
| 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 relating to the application of this Decision, even after they have ceased to be members. They shall sign a declaration of confidentiality to this effect. | 1. Člani odbora tudi po prenehanju članstva ne smejo razkriti podatkov, med drugim poslovno občutljivih ali osebnih podatkov, pridobljenih pri delu odbora ali drugih dejavnostih v zvezi z uporabo tega sklepa. K temu se zavežejo s podpisom izjave o zaupnosti. |
| 2. The panel members shall comply with the Commission's security rules on the protection of EU classified and sensitive non-classified information, as set out in Commission Decisions (EU, Euratom) 2015/443 (4) and (EU, Euratom) 2015/444 (5). Should they fail to respect these obligations, the Commission may take all appropriate measures. | 2. Člani odbora spoštujejo varnostna pravila Komisije za varovanje tajnih in občutljivih netajnih podatkov, kakor je določeno v sklepih Komisije (EU, Euratom) 2015/443 (4) in (EU, Euratom) 2015/444 (5). Če teh obveznosti ne spoštujejo, lahko Komisija sprejme vse ustrezne ukrepe. |
| Article 18 | Člen 18 |
| Commitment | Zavezanost |
| The panel members shall undertake to contribute actively to the work of the panel. They shall sign a declaration of commitment to this effect. | Člani odbora se zavežejo, da bodo dejavno prispevali k delu odbora. K temu se zavežejo s podpisom izjave o zavezanosti. |
| Article 19 | Člen 19 |
| Transparency | Preglednost |
| 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: | 1. Dejavnosti odbora se izvajajo ob visoki stopnji preglednosti. Komisija objavi vse relevantne dokumente na namenskem spletišču in navede povezavo do tega spletišča iz registra strokovnih skupin. Zlasti da javnosti brez nepotrebnega odlašanja na voljo: |
| (a) | the members' names; | (a) | imena članov; |
| (b) | the members' declarations of interests, confidentiality and commitment; | (b) | izjave o interesih, zaupnosti in zavezanosti članov; |
| (c) | the panel's rules of procedure; | (c) | poslovnik odbora; |
| (d) | the opinions adopted by the panel pursuant to Article 10; | (d) | mnenja, ki jih je odbor sprejel v skladu s členom 10; |
| (e) | the agendas and minutes of the panel's meetings; | (e) | dnevne rede in zapisnike sestankov odbora; |
| (f) | the methodology established in accordance with Article 9. | (f) | metodologijo, določeno skladno s členom 9. |
| 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 Parliament and of the Council (6). | 2. Z odstopanjem od odstavka 1 se objava dokumenta ne zahteva, kadar bi njegovo razkritje oslabilo varstvo javnega ali zasebnega interesa, kakor je opredeljeno v členu 4 Uredbe Evropskega parlamenta in Sveta (ES) št. 1049/2001 (6). |
| CHAPTER V | POGLAVJE V |
| FINAL PROVISIONS | KONČNE DOLOČBE |
| Article 20 | Člen 20 |
| Addressees | Naslovniki |
| This Decision is addressed to the Member States. | Ta sklep je naslovljen na države članice. |
| Done at Brussels, 18 May 2016. | V Bruslju, 18. maja 2016 |
| For the Commission | Za Komisijo |
| Vytenis ANDRIUKAITIS | Vytenis ANDRIUKAITIS |
| Member of the Commission | Član Komisije |
| (1)
OJ L 127, 29.4.2014, p. 1. | (1) UL L 127, 29.4.2014, str. 1. |
| (2) Commission Implementing Regulation (EU) 2016/779 of 18 May 2016 laying down uniform rules as regards the procedures for determining whether a tobacco product has a characterising flavour (see page 48 of this Official Journal). | (2) Izvedbena uredba Komisije (EU) 2016/779 z dne 18. maja 2016 o določitvi enotnih pravil glede postopkov za določanje, ali ima tobačni izdelek značilno aromo (glej stran 48 tega Uradnega lista). |
| (3) 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). | (3) Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov (UL L 8, 12.1.2001, str. 1). |
| (4) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). | (4) Sklep Komisije (EU, Euratom) 2015/443 z dne 13. marca 2015 o varnosti v Komisiji (UL L 72, 17.3.2015, str. 41). |
| (5) 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). | (5) Sklep Komisije (EU, Euratom) 2015/444 z dne 13. marca 2015 o varnostnih predpisih za varovanje tajnih podatkov EU (UL L 72, 17.3.2015, str. 53). |
| (6) 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). | (6) Uredba Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije (UL L 145, 31.5.2001, str. 43). |
