natgillin/translations-raw huggingface dataset:
The suitability of the third party, in particular its independence and technical capacities, as well as the data storage contract, shall be approved by the Commission.
Komisija ali države članice lahko v ustrezno utemeljenih primerih proizvajalcem ali uvoznikom dovolijo dostop do shranjenih podatkov, če poslovno občutljive informacije ostanejo ustrezno zaščitene v skladu z ustreznim pravom Unije in nacionalnim pravom.
The third party's activities shall be monitored by an external auditor, who is proposed and paid by the tobacco manufacturer and approved by the Commission.
Gospodarski subjekt, vključen v trgovino s tobačnimi izdelki, ne sme spreminjati ali brisati evidentiranih podatkov.
The external auditor shall submit an annual report to the competent authorities and to the Commission, assessing in particular any irregularities in relation to access.
Države članice zagotovijo, da se osebni podatki obdelujejo le v skladu s pravili in zaščitnimi ukrepi iz Direktive 95/46/ES.
Member States shall ensure that the Commission, the competent authorities of the Member States, and the external auditor have full access to the data storage facilities.
Komisija z izvedbenimi akti:
In duly justified cases the Commission or the Member States may grant manufacturers or importers access to the stored data, provided that commercially sensitive information remains adequately protected in conformity with the relevant Union and national law.
določi tehnične standarde za vzpostavitev in delovanje sistema za prepoznavanje in sledenje, kot je določen v tem členu, vključno z označevanjem posebne identifikacijske oznake, evidentiranjem, posredovanjem, obdelavo in shranjevanjem podatkov ter dostopom do shranjenih podatkov;
Recorded data shall not be modified or deleted by an economic operator involved in the trade of tobacco products.
določi tehnične standarde za zagotavljanje, da so sistemi, ki se uporabljajo za posebno identifikacijsko oznako, in z njo povezane funkcije v celoti medsebojno usklajeni v vsej Uniji.
Member States shall ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 27 za določitev ključnih elementov pogodb o shranjevanju podatkov iz odstavka 8 tega člena, kot so trajanje, podaljšanje, zahtevana strokovna mnenja ali zaupnost, vključno z rednim spremljanjem in ocenjevanjem teh pogodb.
The Commission shall, by means of implementing acts:
Odstavki 1 do 10 se uporabljajo za cigarete in tobak za zvijanje od 20. maja 2019, za druge tobačne izdelke, razen cigaret in tobaka za zvijanje, pa od 20. maja 2024.
determine the technical standards for the establishment and the operation of the tracking and tracing system as provided for in this Article, including the marking with a unique identifier, the recording, transmitting, processing and storing of data and access to stored data;
Člen 16
determine the technical standards for ensuring that the systems used for the unique identifier and the related functions are fully compatible with each other across the Union.
Varnostni element
The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to define the key elements of the data storage contracts referred to in paragraph 8 of this Article, such as duration, renewability, expertise required or confidentiality, including the regular monitoring and evaluation of those contracts.
Države članice zahtevajo, da imajo vsi zavojčki tobačnih izdelkov, ki so dani na trg, poleg posebne identifikacijske oznake iz člena 15 tudi varnostni element, zaščiten pred nedovoljenimi posegi in sestavljen iz vidnih in nevidnih elementov.
Paragraphs 1 to 10 shall apply to cigarettes and roll-your-own tobacco from 20 May 2019 and to tobacco products other than cigarettes and roll-your-own tobacco from 20 May 2024.
Varnostni element je natisnjen ali pritrjen tako, da se ga ne da odstraniti, izbrisati, prekriti ali kakor koli prekiniti, niti z davčnimi znamkami, oznakami cene ali drugimi elementi, določenimi v zakonodaji.
Article 16
Države članice, ki za davčne namene zahtevajo davčne žige ali nacionalne identifikacijske oznake, lahko dovolijo, da se uporabljajo kot varnostni element, če davčni žigi ali nacionalne identifikacijske oznake izpolnjujejo vse tehnične standarde in funkcije iz tega člena.
Security feature
Komisija z izvedbenimi akti določi tehnične standarde za varnostni element in njihovo morebitno izmenično uporabo ter prilagoditev znanstvenemu, tržnemu in tehnološkemu razvoju.
In addition to the unique identifier referred to in Article 15, Member States shall require that all unit packets of tobacco products, which are placed on the market, carry a tamper proof security feature, composed of visible and invisible elements.
Odstavek 1 se uporablja za cigarete in tobak za zvijanje od 20. maja 2019, za druge tobačne izdelke, razen cigaret in tobaka za zvijanje, pa od 20. maja 2024.
The security feature shall be irremovably printed or affixed, indelible and not hidden or interrupted in any form, including through tax stamps and price marks, or other elements imposed by legislation.
POGLAVJE III
Member States requiring tax stamps or national identification marks used for fiscal purposes may allow that they are used for the security feature provided that the tax stamps or national identification marks fulfil all of the technical standards and functions required under this Article.
Tobak za oralno uporabo, čezmejna prodaja tobačnih izdelkov na daljavo in novi tobačni izdelki
The Commission shall, by means of implementing acts, define the technical standards for the security feature and their possible rotation and adapt them to scientific, market and technical developments.
Člen 17
Paragraph 1 shall apply to cigarettes and roll-your-own tobacco from 20 May 2019 and to tobacco products other than cigarettes and roll-your-own tobacco from 20 May 2024.
Tobak za oralno uporabo
CHAPTER III
Brez poseganja v člen 151 Akta o pristopu Avstrije, Finske in Švedske države članice prepovejo dajanje tobaka za oralno uporabo na trg.
Tobacco for oral use, cross-border distance sales of tobacco products and novel tobacco products
Člen 18
Article 17
Čezmejna prodaja tobačnih izdelkov na daljavo
Tobacco for oral use
Države članice lahko prepovejo čezmejno prodajo tobačnih izdelkov potrošnikom na daljavo.
Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Pri preprečevanju takšne prodaje sodelujejo med seboj.
Article 18
Prodajna mesta, vključena v čezmejno prodajo tobačnih izdelkov na daljavo, ne smejo dobavljati teh izdelkov potrošnikom v državah članicah, kjer je takšna prodaja prepovedana.
Cross-border distance sales of tobacco products
Države članice, ki ne prepovedujejo takšne prodaje, od prodajnih mest, ki nameravajo opravljati čezmejno prodajo na daljavo potrošnikom v Uniji, zahtevajo, da se registrirajo tako pri pristojnih organih države članice, v kateri ima prodajno mesto sedež, kot tudi v državi članici, v kateri se nahajajo dejanski ali morebitni potrošniki.
Member States may prohibit cross-border distance sales of tobacco products to consumers.
Prodajna mesta izven Unije se morajo registrirati pri pristojnih organih države članice, v kateri se nahajajo dejanski ali morebitni potrošniki.
Member States shall cooperate to prevent such sales.
Vsa prodajna mesta, ki nameravajo opravljati čezmejno prodajo na daljavo, morajo ob registraciji pristojnim organom predložiti vsaj naslednje informacije:
Retail outlets engaging in cross-border distance sales of tobacco products may not supply such products to consumers in Member States where such sales have been prohibited.
ime ali naziv podjetja in stalni naslov kraja dejavnosti, od koder bodo dobavljeni tobačni izdelki;
Member States which do not prohibit such sales shall require retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State, where the retail outlet is established, and in the Member State, where the actual or potential consumers are located.
datum začetka dejavnosti ponujanja tobačnih izdelkov potrošnikom za čezmejno prodajo na daljavo s storitvami informacijske družbe, kakor so opredeljene v točki 2 člena 1 Direktive 98/34/ES;
Retail outlets established outside the Union shall be required to register with the competent authorities in the Member State where the actual or potential consumers are located.
naslov spletne ali spletnih strani, ki se uporabljajo v ta namen, in vse zadevne informacije, ki so potrebne za identifikacijo spletne strani.
All retail outlets intending to engage in cross-border distance sales shall submit at least the following information to the competent authorities when registering:
Pristojni organi držav članic zagotovijo, da imajo potrošniki dostop do seznama vseh prodajnih mest, ki so v njih registrirana.
name or corporate name and permanent address of the place of activity from where the tobacco products will be supplied;
Pri dajanju tega seznama na voljo države članice zagotovijo, da so izpolnjena pravila in zaščitni ukrepi iz Direktive 95/46/ES.
the starting date of the activity of offering tobacco products for cross-border distance sales to consumers by means of Information Society services, as defined in point 2 of Article 1 of Directive 98/34/EC;
Prodajna mesta lahko začnejo tobačne izdelke za čezmejno prodajo na daljavo dajati na trg šele, ko prejmejo potrdilo o svoji registraciji pri zadevnih pristojnih organih.
the address of the website or websites used for that purpose and all relevant information necessary to identify the website.
Namembne države članice za tobačne izdelke, ki se prodajajo s čezmejno prodajo na daljavo, lahko zahtevajo, da prodajno mesto, ki izdelke dobavlja, imenuje fizično osebo, odgovorno za potrjevanje, da so tobačni izdelki, preden dosežejo potrošnika, skladni z nacionalnimi predpisi, ki so bili v namembni državi članici sprejeti v skladu s to direktivo, če je tako preverjanje potrebno za zagotovitev skladnosti in olajšanje izvrševanja.
The competent authorities of the Member States shall ensure that consumers have access to the list of all retail outlets registered with them.
Prodajna mesta, ki se ukvarjajo s čezmejno prodajo na daljavo, uporabljajo sistem za preverjanje starosti, ki ob prodaji omogoča preverjanje, ali potrošnik, ki kupuje izdelek, izpolnjuje pogoje glede najnižje predpisane starosti, določene v nacionalnem pravu namembne države članice.
When making that list available, Member States shall ensure that the rules and safeguards laid down in Directive 95/46/EC are complied with.
Prodajno mesto ali fizična oseba, imenovana na podlagi odstavka 3, pristojnim organom te države članice zagotovi opis podrobnosti in delovanja sistema za preverjanje starosti.
Retail outlets may only start placing tobacco products on the market via cross-border distance sales when they have received confirmation of their registration with the relevant competent authority.
Prodajna mesta obdelujejo osebne podatke potrošnika samo v skladu z Direktivo 95/46/ES, pri čemer teh podatkov ne razkrijejo proizvajalcu tobačnih izdelkov ali družbam, ki so del iste skupine družb, ali kateri koli drugi tretji strani.
The Member States of destination of tobacco products sold via cross-border distance sales may require that the supplying retail outlet nominates a natural person to be responsible for verifying — before the tobacco products reach the consumer — that they comply with the national provisions adopted pursuant to this Directive in the Member State of destination, if such verification is necessary in order to ensure compliance and facilitate enforcement.
Osebni podatki se ne uporabljajo ali prenesejo za druge namene kot za posamezni nakup.
Retail outlets engaged in cross-border distance sales shall operate an age verification system, which verifies, at the time of sale, that the purchasing consumer complies with minimum age requirements provided for under the national law of the Member State of destination.
To se uporablja tudi, če je prodajno mesto v lasti proizvajalca tobačnih izdelkov.
The retail outlet or natural person nominated pursuant to paragraph 3 shall provide to the competent authorities of that Member State a description of the details and functioning of the age verification system.
Člen 19
Retail outlets shall only process personal data of the consumer in accordance with Directive 95/46/EC and those data shall not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to other third parties.
Uradno obveščanje o novih tobačnih izdelkih
Personal data shall not be used or transferred for purposes other than the actual purchase.
Države članice zahtevajo, da proizvajalci in uvozniki novih tobačnih izdelkov pristojnim organom držav članic predložijo uradno obvestilo o vsakem takem izdelku, ki ga nameravajo dati na zadevni nacionalni trg.
This also applies if the retail outlet forms part of a manufacturer of tobacco products.
Uradno obvestilo se predloži elektronsko šest mesecev pred nameravanim dajanjem na trg.
Article 19
Uradnemu obvestilu se priloži podroben opis zadevnega novega tobačnega izdelka, navodila za njegovo uporabo ter informacije o sestavinah in emisijah, ki se zahtevajo v skladu s členom 5.
Notification of novel tobacco products
Proizvajalci in uvozniki, ki predložijo uradno obvestilo o novem tobačnem izdelku, zadevnim pristojnim organom predložijo tudi:
Member Stes shall require manufacturers and importers of novel tobacco products to submit a notification to the competent authorities of Member States of any such product they intend to place on the national market concerned.
razpoložljive znanstvene študije o toksičnosti, zasvojljivosti in privlačnosti novega tobačnega izdelka, zlasti v zvezi z njegovimi sestavinami in emisijami;
The notification shall be submitted in electronic form six months before the intended placing on the market.
razpoložljive študije, njihove povzetke in tržne raziskave o preferencah različnih potrošniških skupin, vključno z mladimi ter trenutnimi kadilci;
It shall be accompanied by a detailed description of the novel tobacco product concerned as well as instructions for its use and information on ingredients and emissions in accordance with Article 5.
druge razpoložljive in pomembne informacije, vključno z analizo razmerja med tveganji in koristmi izdelka, njegovimi pričakovanimi vplivi na opuščanje uporabe tobaka, njegovimi pričakovanimi vplivi na začetek njegove uporabe in predvidevanji v zvezi z dojemanjem potrošnikov.
The manufacturers and importers submitting a notification of a novel tobacco product shall also provide the competent authorities with:
Države članice zahtevajo, da proizvajalci in uvozniki novih tobačnih izdelkov svojim pristojnim nacionalnim organom pošljejo vse nove ali posodobljene informacije o študijah, raziskavah in druge informacije iz točk (a) do (c) odstavka 1.
available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions;
Države članice imajo pravico od proizvajalcev ali uvoznikov novih tobačnih izdelkov zahtevati, da opravijo dodatne teste ali predložijo dodatne informacije.
available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers;
Države članice dajo Komisiji na voljo vse informacije, ki jih prejmejo na podlagi tega člena.
other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.
Države članice lahko uvedejo sistem za odobritev novih tobačnih proizvodov.
Member States shall require manufacturers and importers of novel tobacco products to transmit to their competent authorities any new or updated information on the studies, research and other information referred to in points (a) to (c) of paragraph 1.
Države članice lahko proizvajalcem in uvoznikom zaračunavajo sorazmerne pristojbine za take odobritve.
Member States may require manufacturers or importers of novel tobacco products to carry out additional tests or submit additional information.
Novi tobačni izdelki, ki so dani na trg, morajo izpolnjevati zahteve iz te direktive.
Member States shall make all information received pursuant to this Article available to the Commission.
Katere določbe te direktive se uporabljajo za nove tobačne izdelke, je odvisno od tega, ali so ti izdelki zajeti v opredelitvi brezdimnega tobačnega izdelka ali tobačnega izdelka za kajenje.
Member States may introduce a system for the authorisation of novel tobacco products.
NASLOV III
Member States may charge manufacturers and importers proportionate fees for that authorisation.
ELEKTRONSKE CIGARETE IN ZELIŠČNI IZDELKI ZA KAJENJE
Novel tobacco products placed on the market shall respect the requirements of this Directive.
Člen 20
Which of the provisions of this Directive apply to novel tobacco products depends on whether those products fall under the definition of a smokeless tobacco product or of a tobacco product for smoking.
Elektronske cigarete
TITLE III
Države članice zagotovijo, da se elektronske cigarete in posodice za ponovno polnjenje dajo na trg le, če so skladne s to direktivo in vso ostalo zadevno zakonodajo Unije.
ELECTRONIC CIGARETTES AND HERBAL PRODUCTS FOR SMOKING
Ta direktiva se ne uporablja za elektronske cigarete in posodice za ponovno polnjenje, za katere je treba pridobiti dovoljenje v skladu z Direktivo 2001/83/ES ali za katere veljajo zahteve iz Direktive 93/42/EGS.
Article 20
Proizvajalci in uvozniki elektronskih cigaret in posodic za ponovno polnjenje predložijo uradno obvestilo pristojnim organom držav članic o kakršnih koli tovrstnih izdelkih, ki jih nameravajo dati na trg.
Electronic cigarettes
Za elektronske cigarete in posodice za ponovno polnjenje, ki so 20. maja 2016 že na trgu, se uradno obvestilo predloži v šestih mesecih od tega datuma.
The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with this Directive and with all other relevant Union legislation.
Za vsako bistveno spremembo izdelka se predloži novo uradno obvestilo.
This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.
Uradno obvestilo glede na to, ali gre za elektronsko cigareto ali posodico za ponovno polnjenje, vsebuje:
Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market.
ime in kontaktne podatke proizvajalca, odgovorno pravno ali fizično osebo v Uniji in po potrebi uvoznika v Unijo;
For electronic cigarettes and refill containers already placed on the market on 20 May 2016, the notification shall be submitted within six months of that date.
seznam vseh sestavin izdelka in emisij, ki nastanejo pri njegovi uporabi, posebej za vsako blagovno znamko in za vsako vrsto, vključno s količinami teh sestavin;
A new notification shall be submitted for each substantial modification of the product.
toksikološke podatke glede sestavin in emisij izdelka, tudi ob segrevanju, pri čemer se zlasti navedejo njihovi učinki na zdravje potrošnikov pri vdihavanju in se med drugim upošteva kakršen koli zasvojevalni učinek;
The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:
podatke o vsebnosti in vnosu nikotina pri uporabi v običajnih okoliščinah ali razmerah, ki jih je mogoče razumno predvideti;
the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;
opis komponent izdelka, po potrebi vključno z mehanizmom za odpiranje in ponovno polnjenje elektronske cigarete ali posodice za ponovno polnjenje;
a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
opis postopka izdelave, vključno s tem, ali vključuje serijsko proizvodnjo in izjavo o tem, da je postopek izdelave skladen z zahtevami iz tega člena;
toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;
izjavo o tem, da sta proizvajalec in uvoznik v celoti odgovorna za kakovost in varnost izdelka pri dajanju na trg in uporabi v običajnih okoliščinah ali razmerah, ki jih je mogoče razumno predvideti.
information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
Če države članice menijo, da so predloženi podatki nepopolni, lahko zahtevajo dopolnitev zadevnih podatkov.
a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
Države članice lahko proizvajalcem in uvoznikom tobačnih izdelkov zaračunajo sorazmerne pristojbine za prejemanje, skladiščenje, obravnavo in analiziranje informacij, ki se jim predložijo.
a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article;
Države članice zagotovijo:
a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.
se tekočina, ki vsebuje nikotin, da na trg le v temu namenjenih posodicah za ponovno polnjenje s prostornino največ 10 ml, v elektronskih cigaretah, ki se lahko zavržejo, ali v polnilih za enkratno uporabo, ter da prostornina polnil ali rezervoarjev ne presega 2 ml;
Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned.
tekočina, ki vsebuje nikotin, vsebuje največ 20 mg/ml nikotina;
Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them.
tekočina, ki vsebuje nikotin, ne vsebuje dodatkov iz člena 7(6);
Member States shall ensure that:
se pri izdelavi tekočine, ki vsebuje nikotin, uporabljajo le zelo čiste sestavine.
nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;
V tekočini, ki vsebuje nikotin, so snovi, razen sestavin iz točke (b) drugega pododstavka odstavka 2 tega člena, prisotne le v sledeh, če so take sledi med izdelavo neizogibne s tehničnega vidika;
the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;
se v tekočini z izjemo nikotina uporabljajo le sestavine, ki v segreti ali nesegreti obliki ne predstavljajo tveganja za zdravje ljudi;
the nicotine-containing liquid does not contain additives listed in Article 7(6);
elektronske cigarete nikotin dovajajo enakomerno ob normalni uporabi;
only ingredients of high purity are used in the manufacture of the nicotine-containing liquid.
elektronskih cigaret in posodic za ponovno polnjenje ne morejo uporabljati otroci in so zaščitene pred nedovoljenimi posegi, lomljenjem in puščanjem ter imajo mehanizem, ki zagotavlja ponovno polnjenje brez puščanja.