REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the potential risks to public health associated with the use of refillable electronic cigarettes
Date: 2016-05-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, consumer information, labelling, product safety, public health, safety standard, tobacco industry, toxic substance

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 20.5.2016  COM(2016) 269 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the potential risks to public health associated with the use of refillable electronic cigarettes  
 
 
 
 
 
Background and context 

Article  20(10)  of  Directive  2014/40/EU1  (‘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. 

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). 

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 

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. 

Regulation of e-cigarettes under the Tobacco Products Directive 

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. 

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 

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). . 
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.’. 
3 EAHC/2013/Health/17: Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe 
(PRECISE). 
4 Commission Decision of 4 June 2014 setting up the group of experts on tobacco policy, C(2014) 3509 final. 

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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)). 

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)). 

Potential risks to public health 

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. 

1. Accidental ingestion of e-liquid 

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. 

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.,67 This 
translates to 390-780 mg of nicotine for a 60 kg adult and 65-130 mg for a 10 kg child. 

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 

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, 

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. 
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. 
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. 
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/. 

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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 

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 Regulation11 and warrant further investigation. 

How to mitigate risks? 

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 
e-cigarettes  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. 

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). 

2. Dermal contact 

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 

In  its  Opinion  on  the  reclassification  of  nicotine,  the  European  Chemicals  Agency’s  Committee  for 
Risk  Assessment13  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 

9 EAHC/2013/Health/17: Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe 
(PRECISE). 
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. 
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). 
12 Presentation by European Chemical Agency (ECHA) to the Subgroup on Electronic cigarettes on 14 March 2016. 
13 http://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment . 
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. 

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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. 

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 

How to mitigate risks? 

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). 

3. Mixing or customisation of liquids 

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. 

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). 

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. 
16 http://echa.europa.eu/eu/information-on-chemicals/cl-inventory-database. 
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) 
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. . 
19 https://www.totallywicked-eliquid.com/50 ml-titanium-ice-72 mg-unflavoured-3-bottle-multipack.html. . 

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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. 

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 

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 

How to mitigate risks? 

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. 

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). 

4. Use of e-liquids with untested devices and hardware customisation 

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 

20 Barrington-Trimis, J.L et al..Flavorings in electronic cigarettes: an unrecognised respiratory health hazard? Jama, 2014. 
312(23): p. 2493-4. 
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 . 
22 Morean et al. High School Students’ Use of Electronic Cigarettes to Vaporize Cannabis. Pediatrics 2015;136:4. 
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).  

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Studies  have  also  shown  that  if  e-liquid  is  heated  to  higher  temperatures,  an  increase  in  toxic 
emissions is observed.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. 

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. 

How to mitigate risks? 

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. 

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. 

Conclusions 

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 e-liquids containing nicotine, which could potentially be achieved through national 
educational campaigns. 

24 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. 
25 Brown CJ, et al. Electronic cigarettes: product characterization and design considerations. Tob Control 2014;23:ii4–ii10. 
doi:10.1136/tobaccocontrol-2013-051476. 
26 http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm. 
27 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) 

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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). 

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