Kommentteja sähkösavukkeista komission tieteelliselle neuvostolle 27.10.2020 Toimitimme Euroopan komission terveyttä ja ympäristöä koskevalle tieteelliselle komitealle kommentteja sen sähkösavukkeita koskevasta alustavasta näkemyksestä. Korostimme lausunnossamme sitä, kuinka sähkösavukkeiden turvallisuutta ei vielä tiedetä ja kuinka erityisiä huolia liittyy makuihin, mahdollisiin metalleihin sekä pienhiukkasiin. Erityisen tärkeää on huomioida se, että makuaineiden turvallisuutta on tutkittu lähinnä suun kautta nautittuina, ei kuumennettuina ja hengitettyinä. Lisäksi olisi tärkeä kiinnittää enemmän huomiota sähkösavukkeiden ja tavanomaisten tupakkatuotteiden yhteiskäyttöön, joka on yleistä. On välttämätöntä miettiä, millä EU-tason toimilla nuoria voitaisiin paremmin suojata sähkösavukkeilta, koska ne vetoavat erityisesti nuoriin. Alla voit lukea koko lausuntomme. 6.3 European Regulatory Framework The high number of notifications on attempts to put products on the market limits seriously the member states’ ability to keep updated which products have entered the market, to ensure that information on the notifications is accurate and sufficient, as well as to ensure that products that have entered the market are safe (Ollila 2019). It is obviously even less clear on what bases the e-cigarette produces or importers give their assurance in the notification that the product in question is safe when heated and inhaled. Based on the SCHEER preliminary opinion the following conclusions can be drawn: The safety of e-cigarettes is not yet well known, especially concerning the flavours, possible metals and ultrasmall particles. This is further complicated by the emerge of new types of devices and increased power. A precautionary approach, especially as regards adolescents’ health should be taken. E-cigarettes appeal strongly to adolescents, and youth appealing flavours play a significant role in that appeal. Serious considerations on EU-level measures to improve protection of youth from e-cigarettes should be considered. These considerations should include stricter regulation on youth appealing flavours, including considering banning flavours other than that of tobacco, as well as forbidding advertising, including in social media, and implementing display ban. The regulation of device types and power should also be considered at EU level. As e-cigarettes are often used together with conventional tobacco products, the health effects of concomitant use deserve more attention in the final SCHEER opinion. The existing notification scheme without resources to study the notification information, and even more so the accuracy of the information of the products intended for the market, do not ensure the safety of the e-cigarettes in the market. EU level measures to ensure safety should considered. 6.4 Chemical ingredients in e-liquids The study notes the high number of e-cigarette linked notifications that each member state receives (Table 1). As is mentioned (p 24) based on the study in the Netherlands by Havermans et al 2019, the number of marketed e-liquids can be extremely high in individual member state. Furthermore, the composition of the e-liquids have been shown to differ from the list of ingredients in the labels (Han et al 2014). 6.5.2 Exposure assessment The preliminary SHCEER opinion deserves to be commended on its through review of the existing scientific and other literature on e-cigarettes and their safety, it remains somewhat unclear, how well the SCHEER opinion captures all major risks involved, as not all the ingredients are known, flavours, metals and ultrasmall particles are not part of the risk assessment. Flavours are known to significantly affect the toxity of e-cigarettes (see for example Leigh et al 2016). It is alarming is that the safety of flavours has in most cases been tested only for per oral use, not when heated and inhaled ( see also Stratton et al 2018), although it is clear that heating results in new chemical compounds. It has been earlier postulated that especially sweet flavours would cause irritation in mouth and respiratory track (for example Lerner et al 2015). While it is understandable that it is not possible to give a scientific opinion on the health effects of the ultrasmall particles, as there was no available data, this is also concerning, as it has been postulated that the ultrasmall particles can be especially harmful as they can enter especially deep in the lung tissue and further from there to the rest of the body. While the device type and power level remain largely unregulated in EU, the opinion notes that later generation models can be used at much higher power and newest pod-mods contains nicotine salts enabling users to consume increased levels of nicotine. 6.6 Role in the initiation of smoking (particularly focusing on young people) The SCHEER opinion concludes that flavours are a crucial factor for the adolescents to initiate e-cigarette use. Furthermore it is noted that adolescents like tobacco flavour less that sweet and other “youth-appealing” flavours, while concurrent or ex-smokers like also tobacco flavour. There is clear evidence that e-cigarettes serve as a gateway for smoking. It is clear from the SCHEER preliminary opinion that use of e-cigarettes has increased markedly among adolescents and that youth appealing flavours play a critical role in initiation. Findings also from a Finnish longitudinal youth study suggest that experimentation with nicotine e-cigarettes serves as a gateway to subsequent use of conventional cigarettes as well as nicotine e-cigarettes (Kinnunen et al. 2019). The data in the opinion shows that among the flavours that appeal to smokers is tobacco flavour, a flavour not appealing to adolescents without a history of smoking. Tobacco flavour is among the flavours appealing to smokers, but it is not appealing to non-smoking adolescents. It is furthermore clear from the opinion that e-cigarettes are not very successful as a cessation tool for smokers. 6.7 Role of electronic cigarettes in the cessation of traditional tobacco 19 smoking and dual use As e-cigarettes are often used together with conventional tobacco products, it would have been good to include more profound assessment of the impacts of concomitant use, as there are some indications that dual use may be markedly more harmful that use of either type of the product alone (Talal et al 2018). References Stratton K, Kwan LY, Eaton DL. Public health consequences of e-cigarettes. A consensus study report of the National academies of sciences, engineering and medicine. USA: The National Academic Press, 2018 Hahn J, Monakhova YB, Hengen J, et al. Electronic cigarettes: overview of chemical composition and exposure estimation. Tob Induc Dis 2014;12:23 Ollila E. See you in court. Obstacles to enforcing the ban on electronic cigarette flavours and marketing in Finland. Tob Control 2019:0:1-6. doi:10.1136/tobaccocontrol-2019-0055260 Leigh NJ, Lawton RI, Hershberger PA, et al. Flavourings significantly affect inhalation toxicity of aerosol generated from electronic nicotine delivery systems (ends). Tob Control 2016;25:ii81–7. Lerner CA, Sundar IK, Yao H, et al. Vapors produced by electronic cigarettes and e-juices with flavorings induce toxicity, oxidative stress, and inflammatory response in lung epithelial cells and in mouse lung. PLoS One 2015;10:e0166732. Kinnunen JM, Ollila H, Minkkinen J, Lindfors PL, Timberlake DS, Rimpelä AH. Nicotine matters in predicting subsequent smoking after e-cigarette experimentation: A longitudinal study among Finnish adolescents. Drug Alcohol Depend. 2019 Aug 1;201:182-187. doi: 10.1016/j.drugalcdep.2019.04.019. Epub 2019 Jun 19. PMID: 31238240. Talal Alzahrani, Ivan Pena, Nardos Temesgen,Stanton A. Glantz. Association Between Electronic Cigarette Use and Myocardial Infarction. Am J Prev Med 2018; Published online ahead of print 22-AUG-2018 DOI information: 10.1016/j.amepre.2018.05.004.