The European Union (EU) Tobacco Products Directive was passed in 2014 and started to be implemented in 2016. Article 20 of the TPD focuses on the regulation of e-cigarettes and includes provisions aiming to harmonize the safety and quality specifications for e-cigarettes.
Article 20 of the Directive has brought forward specific regulations with regard to the reporting of ingredients, emissions, quality control in production and potential design parameters that could mitigate risk.6
Additionally, a commission implementing decision (EU) 2015/2183 of 24 November 2015 that establishes a common format for the notification of electronic cigarettes and refill containers (notified under document C(2015) 8087) and the commission implementing decision (EU) 2016/586 of 14 April 2016 regarding technical standards for the refill mechanism of electronic cigarettes (notified under document C(2016) 2093) are also to be implemented within the year.
The main objective of EUREST-PLUS is to monitor and evaluate the impact of the current TPD within the context of the WHO Framework Convention on Tobacco Control (FCTC) ratification at a European level. These objectives are addressed through five integrated research-oriented work packages (WP) in this HORIZON2020 project.
How we are adressing this research gap
Cohort study of smokers/vapers in 6 EU MS
In WP2 and WP3 we will evaluate how the implementation of the TPD relative to e-cigarettes will influence smokers and e-cigarette users and allow us to model the dynamics behind potential transitions between different types of products. For this to be done we will create a cohort study of adult smokers in 6 EU MS (Germany, Greece, Hungary, Poland, Romania, and Spain; total n=6000) in a pre- vs. post-TPD study design (WP2 and WP3).
Population use and assessment in 28 EU MS
WP5 aims to asses support for TPD implementation and FCTC policies across 28 EU Member States through a secondary analysis of the Special Eurobarometer Tobacco Survey’s. Within this secondary analyses we will evaluate associations between socio-demographic and personal parameters and specific policy determinants with regards to e-cigarette use and experimentation.
Through these analyses interesting outcomes are identified. For instance, a recent article of our research team which presented the two-year trends and predictors of e-cigarette use in 27 EU MS based on the two past EU Eurobarometer indicated that although the perception of harmfulness of the e-cigarettes increased from 27.1% in 2012 to 51.6% in 2014, an increase of the ever e-cigarette use prevalence was also recorded (from 7.2% in 2012 to 11.6% in 2014), (Filippidis et al., 2016). It is also worth noting that current e-cigarette users were more likely to have started using e-cigarettes because they perceived it as a mean of quitting smoking (aOR=2.82; 95% CI 1.99 to 3.99), or as a mean to circumvent smoking bans (aOR=1.54; 95% CI 1.19 to 2.00), (Filippidis et al., 2016).
Product sampling and analysis
Regarding WP6, the main aim is to assess the labeling/packaging practices, the technical design/safety features and chemical composition of e-cigarettes before the implementation of Article 20 of the TPD and then re-evaluate these same parameters after the adoption of the TPD so as to assess compliance to TPD provisions. A sub-parameter of the labeling/packaging practices is also to evaluate package descriptors and marketing practices of such products.
Some of the parameters noted under the current TPD are the following:
- refill volume <10ml in vials, TPD,Art20,3(a)
- nicotine content <20mg/ml, TPD,Art20,3(b)
- Liquid does not contain additives listed in Article 7(6), TPD,Art20,3(c), TPD,Art20,7(6)
- child proof, TPD,Art20,3(g)
- tamper proof, TPD,Art20,3(g)
- breakage resistant, TPD,Art20,3(g)
- leakage resistant, TPD,Art20,3(g)
- inclusion of a leaflet, , TPD,Art20,4(a)
- list of ingredients, TPD,Art20,4(bi)
- health warnings, public/private contributions, TPD,Art20,4(biii)
- cross-border distance sales of electronic cigarettes and refill containers, TPD,Art20,6
- refill mechanism requirements, Implementing Decision, 2016/586, Art2,1 (a)
- refill mechanism requirements, Implementing Decision, 2016/586, Art2,1 (b)
- refilling instructions, Implementing Decision, 2016/586, Art2
Chemical composition of e-cigarettes will be analyzed via:
Gas Chromatography-Mass spectrometry (GC-MS), Liquid Chromatography-Mass spectrometry (LC- MS) and Solid Phase Micro Extraction (SPME) techniques.