| |
| EUROPEAN COMMISSION | EVROPSKA KOMISIJA |
| Brussels, 20.5.2016 | Bruselj, 20.5.2016 |
| COM(2016) 269 final | COM(2016) 269 final |
| REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL | POROČILO KOMISIJE EVROPSKEMU PARLAMENTU IN SVETU |
| on the potential risks to public health associated with the use of refillable electronic cigarettes | o morebitnih tveganjih za javno zdravje v zvezi z uporabo elektronskih cigaret, ki se lahko ponovno napolnijo |
| Background and context | Ozadje |
| Article 20(10) of Directive 2014/40/EU 1 (‘Tobacco Products Directive’ or ‘TPD’) requires the European Commission to 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 (‘e-cigarettes’). At the time of the adoption of the TPD, there were concerns about the risks of refillable e-cigarettes to users and consumers, due to their particular characteristics, which allow users to come into direct contact with refill liquids (‘e-liquids’) containing nicotine and other ingredients which may have adverse health effects. | Člen 20(10) Direktive 2014/40/EU 1 („Direktiva o tobačnih izdelkih“ ali „DTI“) zahteva, da Evropska komisija predloži poročilo Evropskemu parlamentu in Svetu o morebitnih tveganjih za javno zdravje, povezanih z uporabo elektronskih cigaret, ki se lahko ponovno napolnijo („e-cigarete“). V času sprejetja DTI so se pojavljali pomisleki glede tveganj elektronskih cigaret, ki se lahko ponovno napolnijo, za uporabnike in potrošnike, in sicer zaradi njihovih posebnih značilnosti, ki uporabnikom omogočajo, da pridejo v neposredni stik s tekočinami za ponovno polnjenje („e-tekočine“), ki vsebujejo nikotin in druge sestavine s potencialno škodljivimi učinki na zdravje. |
| It should be noted that this report identifies the particular risks that may be associated with refillable e-cigarettes and their refill containers, as requested by the co-legislators. The report does not aim to make comparisons between refillable and other types of e-cigarettes, and does not consider the potential public health impact of e-cigarettes in general (such as initiation, cessation, dual use and long-term health effects). | Opozoriti je treba, da to poročilo opredeljuje posebna tveganja, ki so lahko povezana z e-cigaretami, ki se lahko ponovno napolnijo, in posodicami za njihovo ponovno polnjenje, kot je zahtevano s strani sozakonodajalcev. Cilj poročila ni oblikovanje primerjav med e-cigaretami, ki se lahko ponovno napolnijo, in drugimi vrstami e-cigaret, ter ne upošteva morebitnega splošnega vpliva e-cigaret na javno zdravje (npr. začetek, prenehanje, dvojna uporaba in dolgoročni učinki na zdravje). |
| E-cigarettes are relatively new products on the EU market and evidence concerning their potential risks and benefits is only starting to emerge. At this stage, the Commission and Member States are monitoring scientific evidence, user profiles and market developments regarding all types of e-cigarettes. This evidence will also inform the report on the application of the Tobacco Products Directive to be submitted from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions pursuant to Article 28 of the TPD. 2 | E-cigarete so precej novi proizvodi na trgu EU, dokazi v zvezi z njihovimi morebitnimi tveganji in koristmi pa se šele začenjajo pojavljati. Na tej stopnji Komisija in države članice spremljajo znanstvene dokaze, uporabniške profile in tržne razvoje v zvezi z vsemi vrstami e-cigaret. Ti dokazi bodo upoštevani tudi v poročilu o uporabi direktive o tobačnih izdelkih, ki ga mora Komisija predložiti Evropskemu parlamentu, Svetu, Evropskemu ekonomsko-socialnemu odboru in Odboru regij na podlagi člena 28 direktive o tobačnih izdelkih 2 . |
| This report was prepared with input from the PRECISE study prepared by an external contractor. 3 This study analysed the available scientific literature on health risks of refillable e-cigarettes, data from EU poison centres in eight Member States, and performed chemical analysis on e-cigarette samples. The contractor also conducted a survey amongst the e-cigarette industry to determine what they believed to be the main risks associated with refillable e-cigarettes. The Commission has carefully considered the risks of refillable e-cigarettes identified by Member States and has discussed this report with the Expert Group on Tobacco Policy and the Subgroup on Electronic cigarettes. 4 Information based on discussions with international regulators has also been included in this report. | To poročilo je bilo pripravljeno na podlagi raziskave PRECISE, ki jo je pripravil zunanji izvajalec 3 . Ta raziskava je analizirala razpoložljivo znanstveno literaturo o tveganjih za zdravje e-cigaret, ki se lahko ponovno napolnijo, in podatke iz centrov za zastrupitve EU v osmih državah članicah ter opravila kemijske analize vzorcev e-cigaret. Izvajalec je prav tako izvedel raziskavo znotraj industrije e-cigaret, da bi določil domnevne glavne nevarnosti, povezane z e-cigaretami, ki se lahko ponovno napolnijo. Komisija je skrbno preučila tveganja e-cigaret, ki se lahko ponovno napolnijo, določena s strani držav članic, o tem poročilu pa je razpravljala s strokovno skupino o tobačni politiki in podskupino za elektronske cigarete 4 . V tem poročilu so bile vključene tudi informacije na podlagi razprav z mednarodnimi regulativnimi organi. |
| Regulation of e-cigarettes under the Tobacco Products Directive | Ureditev e-cigaret v okviru direktive o tobačnih izdelkih |
| Article 20 of the TPD sets down a number of safety and quality requirements for nicotine-containing e-cigarettes intended for the consumer market. These consumer e-cigarettes may be disposable, rechargeable with a cartridge or refillable by means of refill containers containing e-liquid. | Člen 20 DTI določa številne zahteve glede varnosti in kakovosti e-cigaret, ki vsebujejo nikotin in so namenjene potrošniškemu trgu. E-cigarete za potrošnike so lahko takšne, da se po uporabi zavržejo ali pa se ponovno napolnijo s pomočjo kartuše ali posodice za ponovno polnjenje, ki vsebuje elektronsko tekočino. |
| Manufacturers and importers must notify their products to Member State competent authorities (Article 20(2)). This notification must include information on ingredients and emissions, toxicological data, information on nicotine doses and uptake, and a description of the device and production processes. Manufacturers must also submit sales data and information on consumer preferences annually to Member States (Article 20(7)). Manufacturers and importers must collect information on suspected adverse effects on human health and take immediate corrective action if they believe their products to be unsafe (Article 20(9)). | Proizvajalci in uvozniki proizvodov morajo svoje izdelke priglasiti pristojnim organom držav članic (člen 20(2)). Priglasitev mora vsebovati informacije o sestavinah in emisijah, toksikološke podatke, informacije o odmerkih nikotina in uporabi ter opis pripomočka in proizvodnih procesov. Proizvajalci morajo vsako leto državam članicam predložiti tudi podatke o prodaji in informacije o preferencah potrošnikov (člen 20(7)). Proizvajalci in uvozniki morajo zbirati informacije o domnevnih škodljivih učinkih na zdravje ljudi in nemudoma sprejeti korektivne ukrepe, če menijo, da njihovi proizvodi niso varni (člen 20(9)). |
| The TPD sets limits on the amount of nicotine in consumer e-cigarettes and refill containers. E-liquids must not contain more than 20 mg/ml nicotine (Article 20(3)(b)), tanks and cartridges must not be larger than 2 ml, and refill containers must not be larger than 10 ml (Article 20(3)(a)). Refill containers and e-cigarettes must also be child-resistant and tamper-proof, and sold with instructions for use and health warnings (Article 20 paragraphs 3(g), 4(a) and (b)). | Direktiva o tobačnih izdelkih določa omejitve glede vsebnosti nikotina v potrošniških e-cigaretah in posodicah za ponovno polnjenje. E-tekočine ne smejo vsebovati več kot 20 mg/ml nikotina (člen 20(3)(b)), rezervoarji in kartuše ne smejo biti večji od 2 ml, posodice za ponovno polnjenje pa ne smejo biti večje od 10 ml (člen 20(3)(a)). Elektronskih cigaret in posodic za ponovno polnjenje ne morejo uporabljati otroci in so zaščitene pred nedovoljenimi posegi, prodajajo pa se skupaj z navodili za uporabo in zdravstvenimi opozorili (člen 20 (3 (g), 4 (a) in (b)). |
| Potential risks to public health | Možna tveganja za javno zdravje |
| The Commission has identified four main risks related to the use of refillable e-cigarettes. These risks are: (1) poisoning from ingesting e-liquids containing nicotine (especially for young children), (2) skin reactions related to dermal contact with e-liquids containing nicotine and other skin irritants, (3) risks associated with home blending and (4) risks due to using untested combinations of e-liquid and device or hardware customisation. | Komisija je opredelila štiri glavna tveganja, povezana z uporabo e-cigaret, ki se lahko ponovno napolnijo. Ta tveganja so: (1) zastrupitev z zaužitjem e-tekočin, ki vsebujejo nikotin (zlasti za mlajše otroke), (2) kožne reakcije, povezane z dermalnim stikom z e-tekočinami, ki vsebujejo nikotin in druge snovi, ki dražijo kožo, (3) tveganja, povezana z mešanjem tekočin na domu in (4) tveganja zaradi uporabe nepreskušenih kombinacij e-tekočin in naprav ali prilagoditve komponent. |
| 1. Accidental ingestion of e-liquid | 1. Nenamerno zaužitje e-tekočine |
| Refillable e-cigarettes and refill containers are, in most cases, open systems that allow direct access to nicotine-containing liquids. Nicotine is an alkaloid found in tobacco plants. It is a stimulant that acts on the parasympathetic nervous system and is the primary cause of addiction to tobacco products. A highly addictive drug, nicotine is also acutely toxic (lethal) by all routes of exposure in high enough doses. | E-cigarete, ki se lahko ponovno napolnijo, in posodice za ponovno polnjenje so v večini primerov odprti sistemi, ki omogočajo neposreden dostop do tekočin z nikotinom. Nikotin je alkaloid, ki se nahaja v rastlinah tobaka. Je poživilo, ki deluje na parasimpatično živčevje in je glavni vzrok za zasvojenost s tobačnimi izdelki. Poleg tega, da je nikotin droga, ki povzroča hudo zasvojenost, je v dovolj visokih odmerkih tudi akutno toksičen (smrtonosen) prek vseh načinov izpostavljenosti. |
| In its opinion on the reclassification of nicotine, the European Chemical Agency’s Committee for Risk Assessment (RAC) considered that 5 mg per kg bodyweight was a justified estimate for the acute toxicity of nicotine through oral exposure. 5 This Acute Toxicity Estimate (ATE) value is in the same order as outlined by Mayer (2014) who estimated the lower limit causing fatal outcomes as 0.5-1 g of ingested nicotine, corresponding to an oral LD50 of 6.5-13 mg per kg bodyweight for humans., 6 7 This translates to 390-780 mg of nicotine for a 60 kg adult and 65-130 mg for a 10 kg child. | V svojem mnenju o prerazvrstitvi nikotina je Odbor za oceno tveganja (RAC) Evropske agencije za kemikalije ocenil, da je 5 mg na kg telesne teže utemeljena ocena akutne toksičnosti nikotina prek oralne izpostavljenosti 5 . Navedena vrednost ocene akutne toksičnosti (ATE) ustreza razvrstitvi, kot jo je navedel Mayer (2014), po kateri spodnja meja povzročanja smrtnih izidov, torej 0,5–1 g zaužitega nikotina, ustreza oralnemu odmerku LD50 v vrednosti 6,5–13 mg na kg telesne teže pri ljudeh., 6 7 Pri odrasli osebi s težo 60 kg to pomeni 390–780 mg nikotina in pri otroku s težo 10 kg 65–130 mg nikotina. |
| Based on the limits set out in the TPD, refillable e-cigarette devices can contain up to 40 mg nicotine and refill containers can hold up to 200 mg nicotine. There is, therefore, a particular risk for young children if they accidently ingest e-liquid especially from a refill container. There have been media reports of lethal poisonings of young children in the US and Israel from e-liquids. 8 | Na podlagi mejnih vrednosti, določenih v DTI, smejo e-cigarete, ki se lahko ponovno napolnijo, vsebovati do 40 mg nikotina, posodice za ponovno polnjenje pa do 200 mg nikotina. Zato obstaja posebno tveganje za mlajše otroke, če nenamerno zaužijejo e-tekočine, še zlasti iz posodic za ponovno polnjenje. Mediji v ZDA in Izraelu so poročali o smrtonosnih zastrupitvah mlajših otrok z e-tekočinami 8 . |
| The PRECISE study commissioned for DG Health and Food Safety analysed 277 cases of nicotine poisoning reported to poison centres in eight EU Member States (Austria, Hungary, Ireland, Lithuania, Netherlands, Portugal, Sweden and Slovenia) from January 2012 to March 2015. 9 They found that 87.3% of cases were related to refill liquids, 0.7% to non-refillable e-cigarettes and 12% to unknown product types (which may partly be explained by their large market share). Of the cases studied, 71.3% related to unintentional poisoning. Overall, 67.5% of cases followed ingestion of e-liquids. In terms of demographics, 33.2% of cases related to children aged five or under, 9.7% related to 6-18 year olds and 57% related to adults over the age of 18. Regarding outcome, 23.7% of cases required hospitalisation and 6.8% had a moderate or major effect. These results are similar to data from US poison centres. 10 | V raziskavi PRECISE, ki jo je naročil Generalni direktorat za zdravje in varnost hrane, je bilo proučenih 277 primerov zastrupitve z nikotinom, ki so bili prijavljeni centrom za zastrupitve v osmih državah članicah EU (Avstrija, Madžarska, Irska, Litva, Nizozemska, Portugalska, Švedska in Slovenija) od januarja 2012 do marca 2015 9 . Ugotovili so, da je bilo 87,3 % primerov povezanih s tekočinami za polnjenje, 0,7 % z elektronskimi cigaretami, ki jih ni mogoče ponovno napolniti, in 12 % z neznanimi vrstami izdelkov (kar je delno mogoče razložiti z njihovim velikim tržnim deležem). 71,3 % preučenih primerov se je nanašalo na nenamerne zastrupitve. Skupno 67,5 % primerov se je zgodilo po zaužitju e-tekočin. 33,2 % primerov je bilo povezanih z otroki, starimi pet let ali manj, 9,7 % primerov se je nanašalo na otroke v starosti 6 do 18 let in 57 % na odrasle osebe, starejše od 18 let. Kar zadeva posledice, je bila v 23,7 % primerov potrebna hospitalizacija, 6,8 % primerov pa je imelo zmerne ali hude učinke. Ti rezultati so podobni podatkom iz ameriških centrov za zastrupitve 10 . |
| Finally, it should also be noted that many different flavours are used in e-liquids; some of which are classified as hazardous to health under the CLP Regulation 11 and warrant further investigation. | Treba je opozoriti tudi na to, da je v e-tekočinah uporabljenih veliko različnih arom, nekatere izmed njih so v okviru uredbe CLP 11 razvrščene kot nevarne za zdravje in zahtevajo dodatno proučitev. |
| How to mitigate risks? | Kako zmanjšati tveganja? |
| In order to mitigate the risk of accidental ingestion of nicotine-containing e-liquids, refill containers and e-cigarette devices should be child-resistant as laid down in Article 20(3)(g). Refillable ecigarettes and their refill containers should also be sold with appropriate instructions for use and storage to prevent accidental ingestion of e-liquid by children or adults and warnings for specific risk groups (Article 20(4)(a)(i) and (iii)). They should also indicate a list of ingredients and be labelled with appropriate health warnings to communicate the potential health risks to consumers (TPD Article 20(4)(b) and the CLP Regulation). The rather high percentage of poisonings involving adults over the age of 18 (57%) also suggests the need to increase awareness amongst citizens on the toxicity of the e-liquids containing nicotine, perhaps through national educational campaigns. | Za zmanjšanje tveganja nenamernega zaužitja e-tekočin, ki vsebujejo nikotin, morajo biti posodice za ponovno polnjenje in e-cigarete varne za otroke, kot je določeno v členu 20(3)(g). E-cigarete, ki se lahko ponovno napolnijo, in posodice za njihovo ponovno polnjenje je treba prodajati skupaj z ustreznimi navodili za uporabo in shranjevanje, da se prepreči nenamerno zaužitje e-tekočin s strani otrok ali odraslih, in opozorili za posebne rizične skupine (člen 20(4)(a) (i) in (iii). Prav tako je na njih treba navesti seznam sestavin in jih označiti z ustreznimi zdravstvenimi opozorili za obveščanje o morebitnih nevarnostih za zdravje potrošnikov (člen DTI 20(4)(b) uredbe CLP). Razmeroma visok delež zastrupitev odraslih oseb nad 18 let (57 %) kaže na to, da je treba povečati ozaveščenost državljanov o toksičnosti e-tekočin, ki vsebujejo nikotin, morda prek nacionalnih izobraževalnih kampanj. |
| In addition to these precautionary requirements, it is also important that other requirements are set for e-cigarettes; such as those laid down in Article 20(3) paragraphs (a) and (b) that ensure that e-liquid containers do not contain excessive levels of nicotine (which could be lethal to children and adults). | Poleg teh previdnostnih zahtev je pomembno, da se za e-cigarete postavijo še druge zahteve, kot so denimo predpisi iz točk (a) in (b) člena 20(3), ki zagotavljajo, da posodice z e-tekočinami ne vsebujejo pretirane količine nikotina (ki bi bile lahko smrtonosne za otroke in odrasle). |
| 2. Dermal contact | 2. Stik s kožo |
| Refillable e-cigarettes require users to refill the device directly with e-liquid, usually using a small bottle or refill container. There is a risk when opening or refilling that e-liquid from refillable e-cigarettes is spilled and comes into contact with the skin. E-liquids contain substances that are toxic through dermal exposure (nicotine) or may be irritating to the skin (propylene glycol and flavours). 12 | Uporabniki e-cigaret, ki se lahko ponovno napolnijo, morajo napravo neposredno napolniti z e-tekočino, običajno s pomočjo stekleničke ali posodice za ponovno polnjenje. Obstaja tveganje, da se e-tekočina iz e-cigaret, ki se lahko ponovno napolnijo, pri odpiranju ali polnjenju razlije in pride v stik s kožo. E-tekočine vsebujejo snovi, ki so strupene, če pridejo v stik s kožo (nikotin) ali pa dražijo kožo (propilenglikol in arome) 12 . |
| In its Opinion on the reclassification of nicotine, the European Chemicals Agency’s Committee for Risk Assessment 13 considered that 70 mg per kg bodyweight was a justified estimate for the acute toxicity of nicotine through dermal exposure. 14 This ATE value is identical to the LD50 derived from animal data, as the lethal dose of nicotine by the dermal route in humans is largely unknown. This would mean that at the concentrations allowed by the TPD, the amount of e-liquid needed to produce an acutely toxic effect through dermal exposure in humans is 35 ml for a small child and 210 ml for a 60kg adult. This is larger than the maximum size of a refill container allowed under the TPD. In their analysis of poison centre data, the PRECISE study also found that 10% of reported cases were related to dermal exposure. | V svojem mnenju o prerazvrstitvi nikotina je Odbor za oceno tveganja Evropske agencije za kemikalije 13 70 mg nikotina na kg telesne teže označil kot utemeljeno oceno akutne toksičnosti pri stiku s kožo 14 . Navedena vrednost ATE je identična vrednosti LD50, pridobljeni iz živalskih podatkov, saj smrtni odmerek nikotina prek dermalne poti pri ljudeh večinoma ni znan. To bi pomenilo, da pri koncentracijah, ki jih dovoljuje DTI, količina e-tekočine, potrebne za nastanek akutno toksičnega učinka ob stiku s kožo, pri ljudeh znaša 35 ml za majhnega otroka in 210 ml za odraslega s težo 60 kg. To je več od največje dovoljene velikosti posodice za ponovno polnjenje v okviru DTI. Raziskava PRECISE je pri analizi podatkov centra za zastrupitve pokazala, da je bilo 10 % prijavljenih primerov povezanih z dermalno izpostavljenostjo. |
| Propylene glycol, a large component of many e-liquids, also appears to have mild irritating and sensitising effects on the skin of humans. 15 Some flavour components have also been self-reported as skin sensitizers or irritants in the European Chemicals Agency’s C&L inventory. 16 | Tudi propilenglikol, ki je pogosta sestavina številnih e-tekočin, ima blage dražilne učinke ter povzroča preobčutljivost človeške kože 15 . V inventarju razvrstitve in označitve Evropske agencije za kemikalije so bile kot povzročitelji preobčutljivosti kože ali dražilne snovi navedene tudi nekatere sestavine arom 16 . |
| How to mitigate risks? | Kako zmanjšati tveganja? |
| In order to mitigate the risk of dermal contact with nicotine-containing e-liquids, refill containers and e-cigarette devices should be child-resistant and protected against leakage (Article 20(3)(g)). They should also be refilled in a manner and be designed in a way that ensures refilling without leakage as laid down in Article 20(3)(g), and specified further by Commission Implementing Decision (EU) 2016/586. 17 Refillable e-cigarettes and their refill containers should also be sold with appropriate instructions for use and storage to ensure that users and others do not accidently come into contact with the e-liquid when handling e-cigarettes and information on possible adverse effects (Article 20(4)(a)(i) and (iv)). E-cigarettes should also be labelled according to the requirements set out in the TPD (Article 20(4)(b)) and those specified under other relevant EU legislation (such as the CLP Regulation). | Da bi zmanjšali tveganje dermalnega stika z e-tekočinami, ki vsebujejo nikotin, morajo biti posodice za ponovno polnjenje in e-cigarete varne za otroke in zaščitene pred puščanjem (člen 20(3)(g)). Prav tako jih je treba napolniti in oblikovati na način, ki zagotavlja ponovno polnjenje brez puščanja, kakor je določeno v členu 20(3)(g), in podrobneje določeno z Izvedbenim sklepom Komisije (EU) 2016/586 17 . E-cigarete, ki se lahko ponovno napolnijo, in posodice za njihovo ponovno polnjenje je treba prodajati skupaj z ustreznimi navodili za uporabo in shranjevanje, da bi se izognili nenamernemu stiku uporabnikov in drugih oseb z e-tekočinami pri ravnanju z e-cigaretami, in informacijami o možnih škodljivih učinkih (člen 20(4)(a) (i) in (iv)). Poleg tega morajo biti e-cigarete označene v skladu z zahtevami iz DTI (člen 20(4)(b)) in zahtevami, določenimi v skladu z drugo ustrezno zakonodajo EU (kot je uredba CLP). |
| 3. Mixing or customisation of liquids | 3. Mešanje ali prilagoditev tekočin |
| Unlike disposable or rechargeable e-cigarettes, refillable e-cigarettes allow users more flexibility to determine the e-liquid used in their devices. Although the majority of users purchase e-liquids pre-blended, some users prefer to blend their own e-liquid at home by purchasing ingredients separately (home blending or self-mixing). 18 Refillable e-cigarettes may also allow users to ‘customise’ their e-liquid according to personal preferences by, for example, mixing flavours. There are a number of risks associated with these practices. | Za razliko od e-cigaret za enkratno uporabo ali takih, ki za polnjenje uporabljajo kartuše, elektronske cigarete s tekočino za ponovno polnjenje uporabnikom omogočajo več prožnosti pri določanju, katero e-tekočino bodo uporabili v svoji napravi. Čeprav večina uporabnikov kupi vnaprej zmešane e-tekočine, nekateri uporabniki raje zmešajo svojo lastno e-tekočino doma ter sestavine kupijo ločeno (mešanje na domu ali lastne mešanice) 18 . E-cigarete, ki se lahko ponovno napolnijo, uporabnikom omogočajo tudi, da svoje e-tekočine prilagodijo glede na osebno izbiro, na primer z mešanjem arom. S temi praksami je povezana vrsta tveganj. |
| Firstly, home blending requires that users purchase high-concentration nicotine. E-liquid is, for example, sold in 50 ml bottles containing 72 mg/ml nicotine (3.6g of nicotine per bottle). 19 As outlined previously, there are risks to users and others if high concentrations of nicotine liquid are stored at home and handled inappropriately. There is also a risk that consumers do not dilute the solution correctly resulting in much higher nicotine concentrations than intended in the final e-liquids. Although the TPD introduces maximum nicotine concentration levels for e-cigarettes (e-liquids must not contain more than 20 mg/ml nicotine) and limits the volume of refill containers (they must not be larger than 10 ml), there is a risk that home blending may also allow users to circumvent the limits set for e-cigarettes in the TPD (through the purchase of high concentration nicotine or nicotine in powdered form if not adequately controlled by Member States). | Mešanje na domu od uporabnika zahteva, da kupuje nikotin z visoko koncentracijo. E-tekočino je, na primer, mogoče kupiti v 50 ml stekleničkah, ki vsebujejo po 72 mg/ml nikotina (3.6 g nikotina na stekleničko) 19 . Kot že omenjeno, je shranjevanje visokih koncentracij nikotinske tekočine na domu ob neustreznem ravnanju povezano s tveganji za uporabnike in ostale osebe. Obstaja tudi nevarnost, da potrošniki ne bi pravilno razredčili raztopine, kar bi imelo za posledico veliko višje koncentracije nikotina v končni tekočini kot načrtovano. Čeprav DTI uvaja najvišji prag vsebnosti nikotina v e-cigaretah (e-tekočine ne smejo vsebovati več kot 20 mg/ml nikotina) in omejuje prostornino posodic za ponovno polnjenje (ne smejo biti večje od 10 ml), obstaja tveganje, da bi mešanje na domu uporabnikom omogočalo izogibanje omejitvam za e-cigarete, določenim v DTI (z nakupom visoke koncentracije nikotina ali nikotina v prahu, če to s strani držav članic ni ustrezno nadzorovano). |
| The TPD requires manufacturers or importers to submit data on toxicological studies (Article 20(2)(c)) and to ensure that only high-purity ingredients are used in e-liquids(Article 20(3)(d)). Home blending would mean that untested e-liquids with inappropriate ingredients could continue to be used by consumers. | DTI od proizvajalcev in uvoznikov zahteva, da predložijo podatke o toksikoloških raziskavah (člen 20(2)(c)) in zagotovijo, da so v e-tekočinah uporabljene samo sestavine z visoko čistostjo (člen 20(3)(d)). Mešanje na domu bi pomenilo, da bi lahko potrošniki še naprej uporabljali nepreskušene e-tekočine z neprimernimi sestavinami. |
| Secondly, many of the flavours currently in use in e-liquids have not been tested for use in e-liquids and it is not known if they are safe for inhalation. There is evidence emerging that some flavours are not safe when used in e-cigarettes. 20 One concern is that refillable e-cigarettes will allow users to continue to use untested or unsafe flavours. Users could also potentially mix flavours with unknown effects (either through home-blending or adding additional flavours to purchased e-liquids (‘customising’)). The health risks of second-hand exposure of vapour from such self-mixed e-liquids are also unknown. 21 | Poleg tega veliko arom, ki se trenutno uporabljajo v e-tekočinah, ni bilo preskušenih za uporabo v e-tekočinah in ni znano, ali so varne za vdihavanje. Obstajajo dokazi, da uporaba nekaterih arom v elektronskih cigaretah ni varna 20 . Ena izmed težav je, da bodo elektronske cigarete, ki se lahko ponovno napolnijo, uporabnikom omogočile, da nadaljujejo z uporabo nepreskušenih ali nevarnih arom. Uporabniki bi lahko potencialno ustvarili mešanice arom z neznanimi učinki (prek mešanja na domu ali z dodajanjem arom kupljenim e-tekočinam – „prilagajanje“). Prav tako niso znana tveganja za zdravje pasivne izpostavljenosti hlapom iz tovrstnih lastnih mešanic e-tekočin 21 . |
| An additional concern is that refillable e-cigarettes may be used with illegal substances such as tetrahydrocannabinol (THC). In a study of 3,847 students in the United States, 5.4% had used e-cigarettes to vaporise cannabis. Of those that had ever used e-cigarettes, 18% had used them to vaporise cannabis. 22 | Dodatna težava je, da se lahko e-cigarete, ki se lahko ponovno napolnijo, uporabljajo z nedovoljenimi snovmi kot na primer tetrahidrokanabinol (THC). Raziskava s 3 847 študenti iz Združenih držav je pokazala, da je 5,4 % vprašanih e-cigarete uporabljalo za uparjevanje konoplje. Izmed tistih, ki so e-cigarete uporabljali že prej, jih je 18 % uporabljalo za uparjevanje konoplje 22 . |
| How to mitigate risks? | Kako zmanjšati tveganja? |
| In order to mitigate the risks associated with home blending or e-liquid customisation, Member States should ensure that manufacturers and importers respect the limits on nicotine concentration set by the TPD. The TPD does not allow e-liquids of concentrations higher than 20 mg/ml or in containers larger than 10 ml. Similarly, high-concentration liquid or powdered nicotine for other purposes, such as industrial use, should not be easily accessible for consumer purchase. If they do not already do so, Member States should also consider regulating or limiting the sale of such solutions or powders. Authorities should also ensure that oils or liquids with THC or other illicit substances are not sold to consumers in Member States where they are not allowed. | Za zmanjšanje tveganj, povezanih z mešanjem na domu ali prilagoditvijo e-tekočin, bi morale države članice zagotoviti, da proizvajalci in uvozniki spoštujejo omejitve koncentracije nikotina, ki jih določa DTI. DTI ne dovoljuje e-tekočin s koncentracijami, višjimi od 20 mg/ml, ali v posodicah, večjih od 10 ml. Prav tako nakup visoko koncentrirane tekočine ali nikotina v prahu za druge namene (npr. industrijsko uporabo), ne bi smel biti enostavno dostopen potrošnikom. Prav tako bi morale države članice premisliti o urejanju ali omejitvi prodaje takšnih raztopin ali praškov, če tega še niso storile. Oblasti bi prav tako morale zagotoviti, da se olja ali tekočine s THC-jem ali drugimi prepovedanimi snovmi ne prodajajo potrošnikom v državah članicah, v katerih niso dovoljene. |
| Member States should also monitor notifications and conduct research on the toxicological profile of e-liquids and emissions as regards flavours and the mixing of flavours in notified products. Member States should carefully monitor evidence on the health risks of flavours. As additional evidence emerges, it may be justified for Member States to prohibit certain flavours for use in e-liquids (as outlined in Recital 47 of the TPD, the responsibility for adopting rules on flavours remains with the Member States). | Države članice bi morale tudi spremljati obvestila in opravljati raziskave o toksikološkem profilu e-tekočin in emisij glede arom in mešanja arom v priglašenih izdelkih. Države članice bi morale skrbno nadzorovati dokaze o zdravstvenih tveganjih arom. Če se pojavijo dodatni dokazi, bodo lahko države članice upravičeno prepovedale nekatere arome za uporabo v e-tekočinah (kot je opisano v uvodni izjavi 47 DTI, odgovornost za sprejetje pravil v zvezi z aromami ostaja v pristojnosti držav članic). |
| 4. Use of e-liquids with untested devices and hardware customisation | 4. Uporaba e-tekočin z nepreskušenimi napravami in personalizacija komponent |
| Refillable e-cigarettes allow users to mix and match e-liquid and devices and to customise their devices by purchasing components separately and ‘building’ their own device (also known as hardware customisation). 23 | E-cigarete, ki se lahko ponovno napolnijo, uporabnikom omogočajo mešanje in dopolnjevanje e-tekočin in naprav ter personaliziranje svojih naprav s kupovanjem posamičnih sestavnih delov in „gradnjo“ lastne naprave (znano tudi kot personalizacija komponent) 23 . |
| Studies have also shown that if e-liquid is heated to higher temperatures, an increase in toxic emissions is observed. 24 | Raziskave so pokazale tudi, da se pri segrevanju e-tekočin na visoke temperature povečajo toksične emisije 24 . |
| There is a risk therefore that the combination of device and e-liquid chosen by users will not have been adequately tested, in particular as regards the safety of the emissions produced. Hardware customisation may further mean that users boost e-cigarettes with powerful batteries, increasing the amount of toxic emissions, although it should be noted that vapour heated to a very high temperature may not be palatable to users. | Zato obstaja tveganje, da kombinacija naprave in e-tekočine, izbrane s strani uporabnikov, ne bi bila ustrezno preskušena, zlasti glede varnosti nastalih emisij. Personalizacija komponent lahko poleg tega pomeni, da uporabniki e-cigarete opremijo z vzdržljivimi baterijami, s čimer se poveča količina toksičnih emisij, čeprav okus hlapov, segretih na zelo visoko temperaturo, uporabnikom verjetno ne bo ustrezal. |
| There is also a risk to users if untested or inappropriate components are used, such as leaching of metals into the e-liquid or battery explosions. 25 According to Article 20(2)(e) to (g) of the TPD, manufacturers and importers must include a description of the components used, the production process and a declaration that they bear full responsibility for the safety and quality of the products they place on the market. | Poleg tega obstaja tveganje za uporabnike v primeru, da so uporabljene nepreskušene ali neustrezne komponente, saj lahko pride do izpiranja kovin v e-tekočino ali do eksplozije baterije 25 . V skladu s členom 20(2)(e) do (g) DTI morajo proizvajalci in uvozniki izdelke opremiti z opisom uporabljenih sestavnih delov, proizvodnim postopkom in izjavo, da nosijo polno odgovornost za varnost in kakovost izdelkov, ki jih dajo na trg. |
| How to mitigate risks? | Kako zmanjšati tveganja? |
| Member States should ensure when enforcing the TPD that manufacturers and importers of e-cigarettes do not sell untested components and that all notified components have undergone appropriate tests to ensure they are safe. Member States should also ensure that when manufacturers and importers notify information on e-liquids they consider the conditions under which they can reasonably be expected to be used by consumers. | Države članice morajo pri izvrševanju DTI zagotoviti, da proizvajalci in uvozniki e-cigaret ne prodajajo nepreskušenih komponent in da so vsi priglašeni sestavni deli prestali ustrezne preskuse za zagotovitev varnosti. Države članice morajo tudi zagotoviti, da proizvajalci in uvozniki ob objavi informacij na e-tekočinah presodijo tudi pogoje, pod katerimi se lahko upravičeno pričakuje, da se bodo uporabljale s strani potrošnikov. |
| Member States should also ensure that notifications received under the TPD accurately reflect whether particular components or devices have the potential to significantly affect the quality of the emissions produced or increase their toxicity depending on the way in which they are used. Member States should also ensure that when measures are taken on dangerous products posing a risk to the health and safety of consumers they are notified through the Rapid Alert System for dangerous non-food products (‘RAPEX’) 26 , allowing other countries that may find the same product in their national markets to take the necessary measures to prevent the further sale of the dangerous product. | Prav tako morajo države članice zagotoviti, da obvestila, prejeta v okviru zahtev iz DTI, natančno odražajo, ali lahko določene komponente ali naprave znatno vplivajo na kakovost nastalih emisij oziroma glede na način uporabe povečajo njihovo toksičnost. Države članice bi morale zagotoviti tudi, da se sprejeti ukrepi glede nevarnih proizvodov, ki predstavljajo resno tveganje za zdravje in varnost potrošnikov, priglasijo prek sistema hitrega obveščanja za nevarne neprehrambene proizvode („RAPEX“) 26 , kar drugim državam, ki bi lahko enak proizvod našle na svojih nacionalnih trgih, dovoljuje, da sprejmejo potrebne ukrepe, s katerimi preprečijo nadaljnjo prodajo nevarnega izdelka. |
| Conclusions | Sklepi |
| The use of refillable electronic e-cigarettes, and the potential exposure to e-liquids containing nicotine in high concentrations, may pose risks to public health. In the context of current scientific knowledge, the measures relating to refillable e-cigarettes provided for in the TPD and secondary legislation, 27 combined with national regulation, provide an adequate and proportionate framework for the mitigation of such risks. This does not, however, preclude the need for further study of these products and their safety for consumers (in particular concerning poisoning from accidental ingestion of e-liquid and the hazard profile of flavours). There is also a need for raised awareness amongst citizens of the toxicity of the eliquids containing nicotine, which could potentially be achieved through national educational campaigns. | Uporaba elektronskih cigaret, ki se lahko ponovno napolnijo, in morebitna izpostavljenost e-tekočinam, ki vsebujejo nikotin v visokih koncentracijah, lahko pomeni tveganje za javno zdravje. Glede na trenutna znanstvena spoznanja ukrepi v zvezi z e-cigaretami, ki se lahko ponovno napolnijo, iz DTI in sekundarne zakonodaje 27 , skupaj z nacionalno zakonodajo zagotavljajo ustrezen in sorazmeren okvir za zmanjšanje teh tveganj. To pa ne pomeni, da ni treba poskrbeti za nadaljnje preučevanje teh proizvodov in njihove varnosti za potrošnike (zlasti v zvezi z zastrupitvami zaradi nenamernega zaužitja e-tekočin in profila nevarnosti o aromah). Prizadevati si je treba tudi za večjo osveščenost državljanov glede toksičnosti e -tekočin, ki vsebujejo nikotin, kar je mogoče doseči z nacionalnimi izobraževalnimi kampanjami. |
| Member States and the Commission should carefully monitor the market of refillable e-cigarettes, as well as the notifications received under Article 20(2) of the TPD. Further research on certain aspects of e-cigarettes relevant to refillables, such as emissions testing and the safety of flavours or mixtures of flavours, should also be carried out. Additional research on these topics would benefit all users of e-cigarettes (disposable, rechargeable and refillable). | Države članice in Komisija morajo skrbno spremljati trg e-cigaret, ki se lahko ponovno napolnijo, kakor tudi uradna obvestila, ki jih prejemajo v skladu s členom 20(2) DTI. Prav tako je treba izvesti nadaljnje raziskave o nekaterih vidikih e-cigaret v zvezi z e-cigaretami, ki se lahko ponovno napolnijo, kot so preskušanje emisij in varnost arom ali mešanic arom. Dodatne raziskave na teh področjih bi koristile vsem uporabnikom e-cigaret (za enkratno uporabo ali tistih, ki se lahko ponovno napolnijo s pomočjo kartuše ali tekočine za polnjenje). |
| (1) | (1) |
| 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 (OJ L 127, 29.04.2014, p. 1). . | Direktiva 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 (UL L 127, 29.4.2014, str. 1). |
| (2) | (2) |
| Article 28(1) of the TPD requires that ‘no later than five years from 20 May 2016, and whenever necessary thereafter, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the application of this Directive.’. | Člen 28(1) direktive o tobačnih izdelkih določa, da „Komisija najpozneje pet let po 20. maju 2016 in kadar koli je potrebno po tem datumu Evropskemu parlamentu, Svetu, Evropskemu ekonomsko-socialnemu odboru in Odboru regij predloži poročilo o uporabi te direktive“. |
| (3) | (3) |
| EAHC/2013/Health/17: Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe (PRECISE). | EAHC/2013/Health/17: Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe (PRECISE) („Morebitna tveganja elektronskih cigaret in njihove tehnične specifikacije v Evropi (PRECISE)“). |
| (4) | (4) |
| Commission Decision of 4 June 2014 setting up the group of experts on tobacco policy, C(2014) 3509 final. | Sklep Komisije z dne 4. junija 2014 o ustanovitvi skupine strokovnjakov za tobačno politiko, C (2014) 3509 final. |
| (5) | (5) |
| The European Chemicals Agency’s Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and labelling at EU level of Nicotine (ISO). Adopted 10 September 2015. http://echa.europa.eu/documents/10162/f9510930-4e5e-45ff-bb3a-888cefaf6592 . | Mnenje Odbora za oceno tveganja Evropske agencije za kemikalije (RAC), ki predlaga usklajeno razvrščanje in označevanje nikotina na ravni EU (ISO). Sprejeto 10. septembra 2015. http://echa.europa.eu/documents/10162/f9510930-4e5e-45ff-bb3a-888cefaf6592 . |
| (6) | (6) |
| The LD50 value is a dose that, when administered to animals in an acute toxicity test, is expected to cause death in 50% of the treated animals in a given period. | Vrednost LD50 je odmerek, za katerega se predvideva, da pri živalih v preskusu akutne toksičnosti predvidoma povzroči smrt pri 50 % obravnavanih živali v danem obdobju. |
| (7) | (7) |
| Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch Toxicol 2014;88:5-7. | Mayer B. „How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century.“ („Koliko nikotina je dovolj, da ubije človeka? Povezovanje splošno sprejetega smrtnega odmerka in vprašljivih poskusov na lastni koži v devetnajstem stoletju.“) Arch Toxicol 2014; 88:5–7. |
| (8) | (8) |
| http://www.nydailynews.com/news/national/1-year-old-n-y-boy-dies-ingesting-liquid-nicotine-article-1.2045532 and http://www.timesofisrael.com/police-investigating-toddler-death-from-nicotine-overdose/ . | http://www.nydailynews.com/news/national/1-year-old-n-y-boy-dies-ingesting-liquid-nicotine-article-1.2045532 in http://www.timesofisrael.com/police-investigating-toddler-death-from-nicotine-overdose/ . |
| (9) | (9) |
| EAHC/2013/Health/17: Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe (PRECISE). | EAHC/2013/Health/17: Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe (PRECISE) („Morebitna tveganja elektronskih cigaret in njihove tehnične specifikacije v Evropi (PRECISE)“). |
| (10) | (10) |
| Vakkalanka, J.P et al. Epidemiological trends in electronic cigarette exposures reported to U.S. Poison Centers. Clinical Toxicology, 2014;52(5): p. 542-548. | Vakkalanka, J.P et al. Epidemiological trends in electronic cigarette exposures reported to U.S. Poison Centers („Epidemološki trendi pri izpostavljenosti elektronskim cigaretam, predstavljeni ameriškim centrom za zastrupitve“). Clinical Toxicology, 2014;52(5): str. 542–548. |
| (11) | (11) |
| Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353 31.12.2008, p. 1). | Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi, o spremembi in razveljavitvi direktiv 67/548/EGS in 1999/45/ES ter spremembi Uredbe (ES) št. 1907/2006 (UL L 353, 31.12.2008, str. 1) |
| (12) | (12) |
| Presentation by European Chemical Agency (ECHA) to the Subgroup on Electronic cigarettes on 14 March 2016. | Predstavitev Evropske agencije za kemikalije (ECHA) podskupini o elektronskih cigaretah z dne 14. marca 2016. |
| (13) | (13) |
| http://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment . | http://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment . |
| (14) | (14) |
| The European Chemicals Agency’s Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and labelling at EU level of Nicotine (ISO). Adopted 10 September 2015. http://echa.europa.eu/documents/10162/f9510930-4e5e-45ff-bb3a-888cefaf6592 . | Mnenje Odbora za oceno tveganja Evropske agencije za kemikalije (RAC), ki predlaga usklajeno razvrščanje in označevanje nikotina na ravni EU (ISO). Sprejeto 10. septembra 2015. http://echa.europa.eu/documents/10162/f9510930-4e5e-45ff-bb3a-888cefaf6592 . |
| (15) | (15) |
| Health Council of the Netherlands. Propylene glycol (1.2-Propanediol); Health based recommended occupational exposure limit. The Hague: Health Council of the Netherlands, 2007; publication no. 2007/02OSH. | Nizozemski Svet za zdravje. Propilenglikol (propan-1,2-diol); Mejna vrednost izpostavljenosti na delovnem mestu, ki je še priporočljiva za zdravje. Haag Nizozemski Svet za zdravje, 2007; objava št. 2007/02OSH. |
| (16) | (16) |
| http://echa.europa.eu/eu/information-on-chemicals/cl-inventory-database . | http://echa.europa.eu/eu/information-on-chemicals/cl-inventory-database . |
| (17) | (17) |
| Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes (OJ L 101, 16.4.2016, p. 15) | Izvedbeni sklep Komisije (EU) 2016/586 z dne 14. aprila 2016 o tehničnih standardih za mehanizem za ponovno polnjenje elektronskih cigaret (UL L 101, 16.4.2016, str. 15) |
| (18) | (18) |
| According to the Industry Organisation ECITA, home blending is limited to less than 5% of the market, http://ec.europa.eu/health/tobacco/docs/ev_20131122_mi_en.pdf . . | Glede na obrtno organizacijo ECITA je mešanje na domu omejeno na manj kot 5 % trga, http://ec.europa.eu/health/tobacco/docs/ev_20131122_mi_en.pdf . |
| (19) | (19) |
| https://www.totallywicked-eliquid.com/50 ml-titanium-ice-72 mg-unflavoured-3-bottle-multipack.html . . | https://www.totallywicked-eliquid.com/50 ml-titanium-ice-72 mg-unflavoured-3-bottle-multipack.html . |
| (20) | (20) |
| Barrington-Trimis, J.L et al..Flavorings in electronic cigarettes: an unrecognised respiratory health hazard? Jama, 2014. 312(23): p. 2493-4. | Barrington-Trimis, J.L et al. Flavorings in electronic cigarettes: an unrecognised respiratory health hazard? („Arome v elektronskih cigaretah: nepriznana nevarnost za zdravje dihalnih poti?“) Jama, 2014. 312(23): str. 2493–4. |
| (21) | (21) |
| US CDC Letter of Evidence on e-cigarettes to N.C. Department of Health and Human Services. http://www.tobaccopreventionandcontrol.ncdhhs.gov/Documents/CDC-LetterofEvidenceonElectronicNicotineDeliverySystemsNorthCarolina-April2015.pdf . | US CDC Letter of Evidence on e-cigarettes to N.C. Department of Health and Human Services („Pismo ameriškega Centra za kontrolo bolezni in preventivo (CDC) Ministrstvu Severne Karoline za zdravje in socialno skrb o dokazih, povezanih s cigaretami“). http://www.tobaccopreventionandcontrol.ncdhhs.gov/Documents/CDC-LetterofEvidenceonElectronicNicotineDeliverySystemsNorthCarolina-April2015.pdf . |
| (22) | (22) |
| Morean et al. High School Students’ Use of Electronic Cigarettes to Vaporize Cannabis. Pediatrics 2015;136:4. | Morean et al. High School Students’ Use of Electronic Cigarettes to Vaporize Cannabis („Uporaba elektronskih cigaret za uparjevanje konoplje pri srednješolcih“). Pediatrics 2015; 136: 4. |
| (23) | (23) |
| Individual e-cigarette components can easily be purchased and configured together to make customised devices (e.g. http://www.amazon.co.uk/ecigarette-eshisha/b?ie=UTF8&node=3787506031 ). | Posamezne sestavne dele e-cigaret je mogoče enostavno kupiti in sestaviti skupaj (npr. http://www.amazon.co.uk/ecigarette-eshisha/b?ie=UTF8&node=3787506031 ). |
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| Geiss, O., et al., Correlation of volatile carbonyl yields emitted by e-cigarettes with the temperature of the heating coil and the perceived sensorial quality of the generated vapours. Int. J. Hyg. Environ. Health. 2016. 219(3): p.268-277, http://dx.doi.org/10.1016/j.ijheh.2016.01.004. | Geiss, O., et al., Correlation of volatile carbonyl yields emitted by e-cigarettes with the temperature of the heating coil and the perceived sensorial quality of the generated vapours („Korelacija volatilnih emisij karbonilnih snovi iz e-cigaret s temperaturo grelca ter zaznana senzorična kakovost nastalih hlapov“). Int. J. Hyg. Environ. Health. 2016. 219(3): str. 268–277, http://dx.doi.org/10.1016/j.ijheh.2016.01.004. |
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| Brown CJ, et al. Electronic cigarettes: product characterization and design considerations. Tob Control 2014;23:ii4–ii10. doi:10.1136/tobaccocontrol-2013-051476. | Brown CJ, et al. Electronic cigarettes: product characterization and design considerations („Elektronske cigarete: opis izdelka in različni dizajni“). Tob Control 2014; 23: II.4 – II.10. doi:10.1136/tobaccocontrol-2013-051476. |
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| http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm. | http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm. |
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| Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes (OJ L 101, 16.4.2016, p. 15) | Izvedbeni sklep Komisije (EU) 2016/586 z dne 14. aprila 2016 o tehničnih standardih za mehanizem za ponovno polnjenje elektronskih cigaret (UL L 101, 16.4.2016, str. 15). |
