natgillin/translations-raw huggingface dataset:
Substances other than the ingredients referred to in point (b) of the second subparagraph of paragraph 2 of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture;
zavojčki elektronskih cigaret in posodice za ponovno polnjenje vključujejo navodilo za uporabo z informacijami o:
except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;
navodilih za uporabo in shranjevanje izdelka, vključno z navedbo, da se uporaba izdelka mladim in nekadilcem odsvetuje;
electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use;
kontraindikacijah;
electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.
opozorilih za posebne rizične skupine;
unit packets of electronic cigarettes and refill containers include a leaflet with information on:
morebitnih neželenih učinkih;
instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;
zasvojljivosti in toksičnosti, ter
contra-indications;
kontaktnih podatkih proizvajalca ali uvoznika in kontaktni pravni ali fizični osebi v Uniji;
warnings for specific risk groups;
zavojčki in kakršna koli zunanja embalaža elektronskih cigaret in posodic za ponovno polnjenje:
possible adverse effects;
zajemajo seznam vseh sestavin izdelka v vrstnem redu, padajočem glede na težo, navedbo vsebnosti nikotina v izdelku in dovajanje na odmerek, številko serije ter priporočilo, naj se izdelek hrani izven dosega otrok;
addictiveness and toxicity; and
brez poseganja v točko (i) te točke, ne vsebujejo elementov ali značilnosti iz člena 13, z izjemo člena 13(1)(a) in (c) glede informacij o vsebnosti nikotina in aromatičnih snovi, in
contact details of the manufacturer or importer and a legal or natural contact person within the Union;
navajajo eno od naslednjih zdravstvenih opozoril:
unit packets and any outside packaging of electronic cigarettes and refill containers:
„Izdelek vsebuje nikotin, ki povzroča hudo zasvojenost.
include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;
Nekadilcem se uporaba odsvetuje.“
without prejudice to point (i) of this point, do not include elements or features referred to in Article 13, with the exception of Article 13(1)(a) and (c) concerning information on the nicotine content and on flavourings; and
„Izdelek vsebuje nikotin, ki povzroča hudo zasvojenost.“
carry one of the following health warnings:
Države članice določijo, katero od teh zdravstvenih opozoril se uporabi.
‘This product contains nicotine which is a highly addictive substance.
zdravstvena opozorila ustrezajo zahtevam iz člena 12(2).
It is not recommended for use by non-smokers’.
prepoved objave komercialnih sporočil, namenjenih neposredni ali posredni promociji elektronskih cigaret in posodic za ponovno polnjenje v storitvah informacijske družbe, v tiskanih medijih in drugih natisnjenih publikacijah, z izjemo tistih, ki so namenjene le strokovnim delavcem na področju trgovanja z elektronskimi cigaretami in posodicami za ponovno polnjenje, in publikacij, ki se natisnejo in izdajo v tretjih državah, in niso pretežno namenjene za trg Unije;
‘This product contains nicotine which is a highly addictive substance.’
prepoved objave komercialnih sporočil, namenjenih neposredni ali posredni promociji elektronskih cigaret in posodic za ponovno polnjenje, po radiu;
Member States shall determine which of these health warnings is to be used;
prepoved objave kakršnih koli javnih ali zasebnih prispevkov k radijskim programom, namenjenih neposredni ali posredni promociji elektronskih cigaret in posodic za ponovno polnjenje;
health warnings comply with the requirements specified in Article 12(2).
prepoved objave kakršnih koli javnih ali zasebnih prispevkov k vsem dogodkom, dejavnostim ali za posameznike, namenjenih neposredni ali posredni promociji elektronskih cigaret in posodic za ponovno polnjenje, ki vključujejo več držav članic ali potekajo v več državah članicah ali imajo drug čezmejni učinek;
commercial communications in Information Society services, in the press and other printed publications, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited, except for publications that are intended exclusively for professionals in the trade of electronic cigarettes or refill containers and for publications which are printed and published in third countries, where those publications are not principally intended for the Union market;
prepoved avdiovizualnih komercialnih sporočil, za katere se uporablja Direktiva 2010/13/EU Evropskega parlamenta in Sveta [19], za elektronske cigarete in posodice za ponovno polnjenje.
commercial communications on the radio, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers, are prohibited;
Člen 18 te direktive se uporablja za čezmejno prodajo elektronskih cigaret in posodic za ponovno polnjenje na daljavo.
any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;
Države članice od proizvajalcev in uvoznikov elektronskih cigaret in posodic za ponovno polnjenje zahtevajo, naj pristojnim organom vsako leto predložijo:
any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited;
celovite podatke o obsegu prodaje, posebej za vsako blagovno znamko in posebej za vsako vrsto izdelka;
audiovisual commercial communications to which Directive 2010/13/EU of the European Parliament and of the Council [19] applies, are prohibited for electronic cigarettes and refill containers.
informacije o preferencah različnih skupin potrošnikov, vključno z mladimi, nekadilci in glavnimi tipi obstoječih uporabnikov;
Article 18 of this Directive shall apply to cross-border distance sales of electronic cigarettes and refill containers.
načine prodaje izdelka, in
Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit, annually, to the competent authorities:
povzetke vseh raziskav trga, ki so jih izvedli v zvezi z navedenim, in prevode teh besedil v angleščino.
comprehensive data on sales volumes, by brand name and type of the product;
Države članice spremljajo razvoj trga elektronskih cigaret in trga posodic za ponovno polnjenje, vključno z vsemi dokazi v zvezi s tem, da so lahko prvi izdelek, ki vodi v zasvojenost z nikotinom in kasnejšo tradicionalno uporabo tobaka med mladimi in nekadilci.
information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users;
Države članice zagotovijo, da so informacije, prejete v skladu z odstavkom 2, dane javnosti na voljo na spletni strani.
the mode of sale of the products; and
Države članice na zahtevo vse informacije, prejete v skladu s tem členom, dajo na voljo Komisiji in drugim državam članicam.
executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.
Države članice in Komisija zagotovijo, da se poslovne skrivnosti in druge zaupne informacije obravnavajo zaupno.
Member States shall monitor the market developments concerning electronic cigarettes and refill containers, including any evidence that their use is a gateway to nicotine addiction and ultimately traditional tobacco consumption among young people and non-smokers.
Države članice od proizvajalcev, uvoznikov in distributerjev elektronskih cigaret in posodic za ponovno polnjenje zahtevajo, naj vzpostavijo in vzdržujejo sistem zbiranja informacij o vseh domnevnih škodljivih učinkih na zdravje ljudi.
Member States shall ensure that the information received pursuant to paragraph 2 is made publicly available on a website.
Če kateri koli od teh gospodarskih subjektov meni ali lahko upravičeno sumi, da elektronske cigarete ali posodice za ponovno polnjenje v njegovi posesti, ki naj bi se dale na trg ali so dane na trg, niso varne ali kakovostne ali so kakor koli drugače neskladne s to direktivo, nemudoma sprejme korektivne ukrepe, potrebne, da bi zadevni izdelek ustrezno uskladili s to direktivo ali ga po potrebi umaknili oz. odpoklicali.
Member States shall, upon request, make all information received pursuant to this Article available to the Commission and other Member States.
V tem primeru mora gospodarski subjekt tudi nemudoma obvestiti organe za nadzor trga v državah članicah, kjer je izdelek dan na voljo ali naj bi bil dan na voljo, pri čemer navede zlasti podrobnosti o tveganjih za zdravje ljudi in varnost ter vseh sprejetih korektivnih ukrepov ter rezultate teh ukrepov.
The Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.
Države članice lahko od gospodarskega subjekta zahtevajo tudi dodatne informacije, denimo o varnostnih in kakovostnih vidikih ali kakršnih koli škodljivih učinkih elektronskih cigaret ali posodic za ponovno polnjenje.
Member States shall require manufacturers, importers and distributers of electronic cigarettes and refill containers to establish and maintain a system for collecting information about all of the suspected adverse effects on human health of these products.
Komisija o morebitnih tveganjih za javno zdravje, povezanih z uporabo elektronskih cigaret, ki se lahko ponovno napolnijo, pošlje Evropskemu parlamentu in Svetu poročilo do 20. maja 2016 in po tem datumu, kadar koli je primerno.
Should any of these economic operators consider or have reason to believe that electronic cigarettes or refill containers, which are in their possession and are intended to be placed on the market or are placed on the market, are not safe or are not of good quality or are otherwise not in conformity with this Directive, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with this Directive, to withdraw or to recall it, as appropriate.
Če elektronske cigarete in posodice za ponovno polnjenje izpolnjujejo zahteve iz tega člena in pristojni organ ugotovi ali lahko upravičeno sumi, da bi določena elektronska cigareta ali posodica za ponovno polnjenje ali vrsta le-teh lahko predstavljala resno tveganje za zdravje ljudi, lahko sprejme ustrezne začasne ukrepe.
In such cases the economic operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available or is intended to be made available, giving details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action.
O sprejetih ukrepih nemudoma obvesti Komisijo in pristojne organe drugih držav članic, skupaj z vsemi podpornimi podatki.
Member States may also request additional information from the economic operators, for example on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.
Komisija čim prej po prejemu informacij odloči, ali je začasni ukrep upravičen.
The Commission shall submit a report to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes by 20 May 2016 and whenever appropriate thereafter.
Komisija zadevno državo članico obvesti o svojih zaključkih, da bi ta lahko sprejela primerne nadaljnje ukrepe.
In the case of electronic cigarettes and refill containers that comply with the requirements of this Article, where a competent authority ascertains or has reasonable grounds to believe that specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, could present a serious risk to human health, it may take appropriate provisional measures.
Če se med uporabo prvega pododstavka tega odstavka dajanje določenih elektronskih cigaret ali posodic za ponovno polnjenje ali vrste le-teh na trg iz upravičenih razlogov prepove v vsaj treh državah članicah, se na Komisijo prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 27, s katerimi takšno prepoved razširi na vse države članice, če je takšna razširitev upravičena in sorazmerna.
It shall immediately inform the Commission and the competent authorities of other Member States of the measures taken and shall communicate any supporting data.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 27 za spremembe besedila zdravstvenih opozoril iz odstavka 4(b) tega člena.
The Commission shall determine, as soon as possible after having received that information, whether the provisional measure is justified.
Pri spreminjanju tega zdravstvenega opozorila Komisija zagotovi, da temelji na dejstvih.
The Commission shall inform the Member State concerned of its conclusions to enable the Member State to take appropriate follow-up measures.
Komisija z izvedbenimi akti sprejme skupno obliko uradnega obvestila iz odstavka 2 in tehnične standarde mehanizma za polnjenje iz odstavka 3(g).
Where, in application of the first subparagraph of this paragraph, the placing on the market of specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 27 to extend such a prohibition to all Member States, if such an extension is justified and proportionate.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 25(2).
The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to adapt the wording of the health warning in paragraph 4(b) of this Article.
Člen 21
When adapting that health warning, the Commission shall ensure that it is factual.
Zeliščni izdelki za kajenje
The Commission shall, by means of an implementing act, lay down a common format for the notification provided for in paragraph 2 and technical standards for the refill mechanism provided for in paragraph 3(g).
Na vsakem zavojčku in kakršni koli zunanji embalaži zeliščnega izdelka za kajenje se navede naslednje zdravstveno opozorilo:
These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
„Kajenje tega izdelka škoduje zdravju.“
Article 21
Zdravstveno opozorilo se prikaže na sprednji in zadnji zunanji površini zavojčka in kakršni koli zunanji embalaži.
Herbal products for smoking
Zdravstveno opozorilo mora biti v skladu z zahtevami iz člena 9(4).
Each unit packet and any outside packaging of herbal products for smoking shall carry the following health warning:
Pokrivati mora 30 % ustrezne površine zavojčka in kakršne koli zunanje embalaže.
‘Smoking this product damages your health.’
Zavojčki in kakršna koli zunanja embalaža zeliščnih izdelkov za kajenje ne smejo vsebovati elementov ali značilnosti iz točk (a), (b) in (d) člena 13(1) in navedb, da izdelek ne vsebuje dodatkov ali aromatičnih snovi.
The health warning shall be printed on the front and back external surface of the unit packet and on any outside packaging.
Člen 22
The health warning shall comply with the requirements set out in Article 9(4).
Poročanje o sestavinah zeliščnih izdelkov za kajenje
It shall cover 30 % of the area of the corresponding surface of the unit packet and of any outside packaging.
Države članice od izdelovalcev in uvoznikov zeliščnih izdelkov za kajenje zahtevajo, da njihovim pristojnim organom predložijo seznam vseh sestavin in količine teh sestavin, uporabljenih pri izdelavi teh izdelkov, posebej za vsako blagovno znamko in za vsako vrsto.
Unit packets and any outside packaging of herbal products for smoking shall not include any of the elements or features set out in Article 13(1)(a), (b) and (d) and shall not state that the product is free of additives or flavourings.
Proizvajalci ali uvozniki prav tako obvestijo pristojne organe zadevne države članice, če se sestava izdelka tako spremeni, da vpliva na informacije, predložene na podlagi tega člena.
Article 22
Informacije iz tega člena se predložijo pred dajanjem na trg novega ali spremenjenega zeliščnega izdelka za kajenje.
Reporting of ingredients of herbal products for smoking
Države članice zagotovijo, da so informacije, predložene v skladu z odstavkom 1, dane na voljo javnosti na spletni strani.
Member States shall require manufacturers and importers of herbal products for smoking to submit to their competent authorities a list of all ingredients, and quantities thereof that are used in the manufacture of such products by brand name and type.
Gospodarski subjekti natančno navedejo, katere informacije so po njihovem mnenju poslovna skrivnost.
Manufacturers or importers shall also inform the competent authorities of the Member States concerned when the composition of a product is modified in a way that affects the information submitted pursuant to this Article.
NASLOV IV
The information required under this Article shall be submitted prior to the placing on the market of a new or modified herbal product for smoking.
KONČNE DOLOČBE
Member States shall ensure that the information submitted in accordance with paragraph 1 is made publicly available on a website.
Člen 23
Economic operators shall specify exactly which information they consider to constitute a trade secret.
Nadzor in izvrševanje
TITLE IV
Države članice zagotovijo, da proizvajalci in uvozniki tobačnih in povezanih izdelkov Komisiji in pristojnim organom držav članic v predpisanem roku zagotovijo popolne in točne informacije, ki se zahtevajo v skladu s to direktivo.
FINAL PROVISIONS
Zahtevane informacije mora zagotoviti zlasti proizvajalec, če ima sedež v Uniji.
Article 23
Če ima proizvajalec sedež zunaj Unije, uvoznik pa v Uniji, mora zahtevane informacije prvenstveno zagotoviti uvoznik.
Cooperation and enforcement
Zahtevane informacije morata zagotoviti tako proizvajalec kot uvoznik, če imata oba sedež zunaj Unije.
Member States shall ensure that manufacturers and importers of tobacco and related products provide the Commission and the competent authorities of the Member States with complete and correct information requested pursuant to this Directive and within the time limits set out herein.
Države članice zagotovijo, da se tobačni in povezani izdelki, ki niso v skladu s to direktivo, vključno z izvedbenimi in delegiranimi akti, ki so v njej določeni, ne dajo na trg.
The obligation to provide the requested information shall lie primarily with the manufacturer, if the manufacturer is established in the Union.
Države članice zagotovijo, da se tobačni in povezani izdelki ne dajo na trg, če niso izpolnjene obveznosti poročanja iz te direktive.
The obligation to provide the requested information shall lie primarily with the importer, if the manufacturer is established outside the Union and the importer is established inside the Union.
Države članice določijo pravila o kaznih, ki veljajo za kršitev nacionalnih določb, sprejetih na podlagi te direktive, in sprejmejo vse potrebne ukrepe za zagotavljanje njihovega izvrševanja.
The obligation to provide the requested information shall lie jointly with the manufacturer and the importer if both are established outside the Union.
Določene kazni morajo biti učinkovite, sorazmerne in odvračilne.
Member States shall ensure that tobacco and related products which do not comply with this Directive, including the implementing and delegated acts provided for therein, are not placed on the market.
Morebitne finančne kazni, ki se lahko naložijo za namerne kršitve, so lahko takšne, da izničijo gospodarsko korist, ki se jo je nameravalo pridobiti s kršitvijo.
Member States shall ensure that tobacco and related products are not placed on the market if the reporting obligations set out in this Directive are not complied with.
Pristojni organi držav članic sodelujejo med seboj in s Komisijo, da zagotovijo pravilno uporabo in ustrezno izvrševanje te direktive ter si posredujejo vse informacije, ki so potrebne za enotno uporabo te direktive.
Member States shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures that are necessary to ensure that these penalties are enforced.
Člen 24
The penalties provided for shall be effective, proportionate and dissuasive.
Prosti pretok
Any financial administrative penalty that may be imposed as a result of an intentional infringement may be such as to offset the economic advantage sought through the infringement.
Države članice zaradi pomislekov v zvezi z vidiki, ki jih ureja ta direktiva in ob upoštevanju odstavkov 2 in 3 tega člena ne smejo prepovedati ali omejiti dajanja na trg tobačnih in povezanih izdelkov, ki so v skladu s to direktivo.
The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure the correct application and due enforcement of this Directive and shall transmit to each other all information necessary with a view to applying this Directive in a uniform manner.
Ta direktiva ne vpliva na pravico držav članic, da ohranijo ali uvedejo nadaljnje zahteve, ki veljajo za vse izdelke, dane na njihov trg, v zvezi s standardizacijo embalaže tobačnih izdelkov, če obstajajo upravičeni razlogi z vidika javnega zdravja, pri čemer upoštevajo visoko raven varovanja zdravja ljudi, ki jo zagotavlja ta direktiva.
Article 24
Taki ukrepi morajo biti sorazmerni in ne smejo biti sredstvo za samovoljno diskriminacijo ali prikrito omejevanje trgovine med državami članicami.
Free movement
Komisijo se uradno obvesti o teh ukrepih, skupaj z razlogi za njihovo ohranitev ali uvedbo.
Member States may not, for considerations relating to aspects regulated by this Directive, and subject to paragraphs 2 and 3 of this Article, prohibit or restrict the placing on the market of tobacco or related products which comply with this Directive.
Država članica lahko tudi prepove določeno kategorijo tobačnih ali povezanih izdelkov zaradi posebnih razmer v tej državi članici, kadar so ukrepi upravičeni zato, ker je treba zaščititi javno zdravje, pri čemer se upošteva visoka raven varovanja zdravja ljudi, ki jo zagotavlja ta direktiva.
This Directive shall not affect the right of a Member State to maintain or introduce further requirements, applicable to all products placed on its market, in relation to the standardisation of the packaging of tobacco products, where it is justified on grounds of public health, taking into account the high level of protection of human health achieved through this Directive.
Komisijo se uradno obvesti o takšnih nacionalnih ukrepih, skupaj z razlogi za njihovo uvedbo.
Such measures shall be proportionate and may not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.
Komisija ob upoštevanju visoke ravni varovanja zdravja ljudi, dosežene s to direktivo, v šestih mesecih po prejemu uradnega obvestila v skladu s tem odstavkom nacionalne ukrepe odobri ali zavrne, potem ko preveri, ali so upravičeni, nujni in sorazmerni s svojim ciljem, ali pa so morda sredstvo za samovoljno diskriminacijo ali prikrito omejevanje trgovine med državami članicami.
Those measures shall be notified to the Commission together with the grounds for maintaining or introducing them.
Če Komisija v roku šestih mesecev ne sprejme odločitve, se šteje, da so nacionalni ukrepi odobreni.