The Commission has identified four main risks related to the use of refillable e-cigarettes and reported their comments in a document entitled: Potential risks to public health. According to the authors, these risks are:
- Poisoning from ingesting e-liquids containing nicotine (especially for young children),
- Skin reactions related to dermal contact with e-liquids containing nicotine and other skin irritants,
- Risks associated with home blending and
- Risks due to using untested combinations of e-liquid and device or hardware customisation
The report states that measures relating to refillable e-cigarettes provided for in the TPD and secondary legislation, combined with national regulation, provide an adequate and proportionate framework for the mitigation of such risks.
Recommendations to Member States
The authors request 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). 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.
They also point out the need for raised awareness amongst citizens of the toxicity of the e-liquids containing nicotine, which could potentially be achieved through national educational campaigns.
The report recommends to Member States and to the Commission itself to carefully monitor the market of refillable e-cigarettes.
The report that was a request from the EU Parliament, in agreement with the provisions of the EU TPD’s Article 20. Its role was to evaluate the risks linked to nicotine e-liquid of refillable cigarettes. The authors of the report did not include the intrinsic risk of vaping to only focus on what they judge harmful in the refillable hardware.
The Potential Risks from Electronic Cigarettes and their Technical Specifications in Europe (PRECISE) that served as a base to the report’s manuscript was ordered by the Commission to “an external contractor” who evaluated the “available scientific litterature”. A survey amongst the e-cigarette industry is included to the report to determine what they believed to be the main risks associated with refillable e-cigarettes.
This report has been discussed with the Expert Group on Tobacco Policy and the Subgroup on Electronic cigarettes set up June 2014.
1. Accidental ingestion of e-liquid
The report says that nicotine, a highly addictive drug, is also acutely toxic (lethal) by all routes of exposure in high enough doses.
277 cases of nicotine poisoning were identified being reported to poison centres in eight EU Member States (Austria, Hungary, Ireland, Lithuania, Netherlands, Portugal, Sweden and Slovenia) from January 2012 to March 2015:
- 71.3% related to unintentional poisoning.
- 67.5% of cases followed ingestion of e-liquids
- 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. The report notices that results are similar to data from US poison centres. It adds that among the many different flavours used in e-liquids the authors report that some are classified as hazardous to health under the CLP Regulation.
2. Dermal contact
The Commission poses 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 (larger than the maximum size of a refill container allowed under the TPD).
Propylene glycol is identified by the report to have mild irritating and sensitising effects on the skin of humans.
3. Mixing or customisation of liquid
Home blending requires that users purchase high-concentration nicotine. The report identifies risks to users and others if high concentrations of nicotine liquid are stored at home and handled inappropriately but and a risk that consumers do not dilute the solution correctly resulting in much higher nicotine concentrations than intended in the final e-liquids.
Home blending would mean that untested e-liquids with inappropriate ingredients could continue to be used by consumers, which is in contradiction with the purpose of the TPD.
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. Refillable e-cigarettes will allow users to continue to use untested or unsafe flavours. Health risks of second-hand exposure of vapour may occur from such self-mixed e-liquids.
Finally, refillable e-cigarettes may be used with illegal substances such as tetrahydrocannabinol (THC)
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
If e-liquid is heated to higher temperatures, an increase in toxic emissions is observed. Additionally, purchasing components separately and ‘building’ one’s own device 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 a risk to users if untested or inappropriate components are used.