Electronic Cigarettes – a health and environment issue: developing healthy measures
The use of e-cigarettes spreads rapidly. The EU “Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) identified e-cigarettes as one of the “emerging health and environmental issues” in 2018.
By contrast, the regulatory framework is not fit for the purpose and is hardly in the position to protect users (“vapers”). The EU Tobacco Directive (Directive 2014/40/EU) lays down some rules for ingredients and emissions of tobacco products including e-cigarettes, as well as rules for labelling.
However, only nicotine-containing products are covered. Apart from nicotine and some generic bans (e.g. to use CMRs) it does not stipulate any substance specific limits of ingredients in e-liquids or in emissions.
Some national standards and guidelines on e-cigarettes and e-liquids exist (UK, FR) which do contain normative provisions regarding chemical substances including limits. These documents are a valuable starting point for establishing clear-cut protective substance specific rules. Currently, European normative documents are under development in a technical committee of CEN (CEN/TC 437 “Electronic cigarettes and e-liquids”) which was established in 2015.
At present it remains unclear whether it will define thresholds for substances or substance exclusions. Against this background ANEC developed the present paper. Based on several studies commissioned by one of its members a proposal was prepared addressing substances in e-liquids (solvents, contaminants and flavours) as well as substances formed (degradation products) or released (from materials) during vaping.
Suggested thresholds are based on existing air quality standards as well as appropriate “derived no-effect levels” (DNELs) for inhalation exposure notified by manufacturers or importers in the context of the registration procedure required by the European chemicals regulation REACH.
Literature data show that maximum measured data would often exceed the proposed limits. Conversely, it is also clear that many products could pass. Unfortunately, this does not hold true for the main solvents used (propylene glycol, glycerine) the measured values are considerably higher than the suggested limits. Even though the (known) associated health effects (essentially respiratory irritation) have been considered as mild and transient some risk assessors have warned that there is a risk of damage to the respiratory tract (particularly in heavy vapers).
It must be borne in mind that there may be several ingredients present in e-liquids or substances formed during vaping with irritating effects. The (combined) long-term effects of such exposures are not known. This issue requires further thought and debate. Hence, ANEC does not propose thresholds for solvents at this stage.
Raising standards for consumers E-cigarettes and e-liquids – Limits for chemicals – Basis for discussion Ref: ANEC-PT-2019-CEG-005 4 Apart from that the paper contains proposals for limits for 39 substances in e-liquids (3 metallic contaminants and 36 flavours). In addition, there are also limits for 7 substances in emissions (3 metallic contaminants and 4 degradation products).
The suggestions in the present paper are intended to stimulate a debate on the need to establish clear-cut substance specific rules for e-cigarettes and e-liquids (with or without containing nicotine). In the long run it may be preferable to adopt a positive list of allowed flavours rather than setting thresholds for hundreds or even thousands of substances (which might be a mission impossible).
Leave a Reply