Scheer Report - Was steckt dahinter Teil 11

Hallo Liebe Leser,

Heute kommt der elften Teil der Anmerkungen zum Scheer Report. Also die Dinge die mir zum Scheer Report aufgefallen ist und welche man als Anregung für eine Mail an die Abgeordneten mitnehmen kann.

Vorab liste ich Euch wie schon im vorigen Teil alle bisherigen Artikel dieser Serie auf:

Wie auch im Teil vorher werde ich mich nur auf die Bereiche im Scheer Report beschränken, welche nicht explicit in den vorigen Artikeln behandelt wurden, es sei denn ich habe neue Anmerkungen dazu gefunden. Daher fangen wir auch mit Seite 46 des Scheer Reportes an.

SCHEER Preliminary Opinion on electronic cigarett

6.5.4 Human evidence for health impacts of electronic cigarettes

The health impacts of electronic cigarette’s use are still difficult to be established due to the lack of long-term data from epidemiological studies or clinical trials. However, since 2016, the World Health Organization (WHO) has already noted that, while electronic cigarettes might be “less harmful” than conventional cigarettes, electronic cigarettes still “are harmful to health and are not safe”. Therefore, WHO suggested to “deter electronic cigarette
https://www.who.int/fctc/cop/cop7/FCTC_COP_7_11_EN.pdf
promotion to non-smokers and young people; prohibit unproven health claims about electronic cigarettes; prevent/Bar/Ban involvement of the tobacco industry in the marketing and promoting of e- cigarettes”. Although, electronic cigarettes are relatively new in terms of exposure to humans, and more research is needed over a longer period of time, there is large scientific body of studies suggesting that electronic cigarettes’ use can pose various health risks to the user; e.g., acute or chronic cardiovascular disease (CVD) problems, can irritate the lungs, as well as induce other symptoms, like cough, chest pain, nausea, vomiting, or diarrhea, and sometimes fatigue, fever, or even weight loss (Thirión-Romero et al., 2019). In this section, a brief summary of studies regarding health impacts of electronic cigarettes on human is presented. ...

Cardiovascular diseases

The most consistent evidence regarding the effect of electronic cigarettes on human health concerns cardiovascular diseases. In November 2019, the European Heart Network (EHN) published a position document regarding the cardiovascular consequences of electronic cigarette’s use. The EHN concluded that there is mixed evidence for the effects of electronic cigarettes on the cardiovascular system from short-term exposure. In particular, it was noted that “while some studies have found a higher risk compared to smoking combustible tobacco cigarettes, short-term electronic cigarette use is likely less harmful to the cardiovascular system than smoking conventional cigarettes”, whereas, the long-term effects on the cardiovascular system are still unknown due to the lack of relevant data. However, the authors underlined that, despite the fact that there is “no evidence” this should not be interpreted as no effect, and findings from recent studies suggest that use may pose a higher risk than so far assumed. The EHN underlined the need for longitudinal studies to elucidate long-term effects of electronic cigarette use on the cardiovascular system and whether electronic cigarette use is less hazardous to cardiovascular health than conventional cigarette smoking in the longer term. Finally, EHN recommends that health professionals should inform patients and the public of the risks related to electronic cigarette use. The United States Food and Drug Administration (FDA) has also highlighted the adverse health impacts of electronic cigarette use (Chen, 2013). The detrimental acute effects of electronic cigarette use on cardio-metabolic features include adverse vascular and cardiac impacts (including effects on blood pressure and heart rate) (Qasim et al., 2017). Based on the evidence available to date, the individual and interactive effects of flavour and additives used in electronic cigarettes collectively detrimentally impact CVD health, including the propagation of increased heart rate and increased diastolic blood pressure, posing users at elevated subsequent risk for manifesting CVD. The underlying pathophysiological mechanisms remain to be elucidated, however, it has been hypothesized that via sympathetic nervous stimulation, as well as endothelial cell dysfunction and oxidative stress (Higashi et al., 2009, Moheimani et al., 2017), (atomized) nicotine impacts
http://www.ehnheart.org/images/EHN_e-cigarettes_final_final.pdf vasculature (Zhang et al., 2018) and arterial stiffness (Vlachopoulos et al., 2016) similarly to conventional tobacco smoking, ultimately inducing hypertension (Moheimani et al., 2017), a well-established CVD risk factor. While due to lag time effects robust evidence remains limited to date, it is hypothesized that these risks are anticipated be highest among the most susceptible populations, including children and adolescents. Specifically, the detrimental health impacts of electronic cigarette use on cardio-metabolic features, including effects on blood pressure and heart rate (Qasim et al., 2017) are hypothesized to result via the effects of atomized nicotine on the sympathetic nervous system, inducing cardiac arrhythmias and elevated blood pressure (Moheimani et al., 2017), as well as adverse long-term adverse impacts on vasculature (Zhang et al., 2018) similar to those of conventional tobacco smoking, such as arterial stiffness (Vlachopoulos et al., 2016). Furthermore, electronic cigarette use is also associated with key underlying pathophysiological mechanisms implicated in CVD onset and progression, including endothelial cell dysfunction and oxidative stress (Higashi et al., 2009, Moheimani et al., 14 2017) similar to that of tobacco smoking, including rapid surges in the number of circulating endothelial progenitor cells (Antoniewicz et al., 2016), ultimately inducing vascular injury.

Nicotine remains a very important toxin present in electronic cigarette. Most of the cardiovascular effects demonstrated in humans are consistent with the known sympathomimetic effects of nicotine. Acute exposure to (high amounts) of inhaled nicotine may cause dizziness, nausea, or vomiting. Following (acute) exposure to the electronic cigarette with nicotine, there was a significant shift in cardiac sympathovagal balance towards sympathetic predominance. The decrease in high-frequency component and the increases in the low-frequency component and the low-frequency to high-frequency ratio were significantly greater following exposure to nicotine containing electronic cigarette use. The acute sympathomimetic effect of nicotine containing electronic cigarette can possibly be associated with increased cardiac risk populations with and without known cardiac disease. (Moheimani et al., 2017).
Recent findings demonstrate that volatile liquids containing nicotine may induce adverse cardiovascular effects attributed to its toxic impact on myocardial cells. Most electronic cigarettes containing nicotine have a basic pH > 9, which seems to enhance the dosage of nicotine delivered (Stepanov and Fujioka, 2015). Even so, electronic cigarette users exposed to 11 mg/mL of nicotine content in e-liquids had increased cardiac output and heart rate (Farsalinos et al., 2014). Regular electronic cigarette use with nicotine containing liquid is associated with a shift towards sympathetic predominance in heart rate and associated variability (Moheimani et al., 2017, Franzen et al., 2018), as well as vascular calcification and impaired vascular function (Babic et al., 2019), leading to prolonged elevated systolic blood pressure (Franzen et al., 2018).

Lung diseases

Short-term use of an electronic cigarette has acute effects on airways physiology and respiratory symptoms in COPD smokers, asthmatic smokers, “healthy” smokers and healthy never smokers. Evidence arising from both experimental and observational studies, support that electronic cigarette use may induce pulmonary toxicity, which is anticipated to emerge as a major public health concern (Chun et al., 2017, Jankowski et al., 2017). Specifically, studies in both, animal models and human populations demonstrate that acute electronic cigarette use triggers oxidative stress and increased airflow resistance (Vardavas et al., 2012), either by increased mucin secretion via altered neutrophil related pathways (Reidel et al., 2018) and/or by damage of epithelial airway cells which lead to persistent inflammation and secretion of mediators (namely defensins and matrix metalloproteinases) inducing lung tissue destruction (Chen et al., 2019). Diminished pulmonary function is hence anticipated, particularly among susceptible populations. In fact, electronic cigarette use in adolescents has been associated with the presence of asthma (Clapp and Jaspers, 2017). Furthermore, studies in cell lines of human epithelial lung and fibroblast cell lines revealed that the aforementioned cell lines are sensitive to electronic cigarette exposure, inducing production of ROS and pro‐inflammatory cytokines, apoptosis, and necrosis (Chen 17 et al., 2019), all hallmarks for tumor growth and development. However, the effects of long-term use particularly in relation to lung cancer remain to be determined in epidemiological investigations (Chun et al., 2017, Murthy, 2017).

Other health effects

There are also some indications about electronic cigarette use and other health problems. In a recent systematic review conducted among 18 investigations, the carcinogenic potential of electronic cigarettes and the occurrence of head and neck cancers was revealed, albeit with a low level of evidence. Moreover, within this context, findings from several investigations reviewed corroborated that electronic cigarette use induces DNA damage via increased oxidative stress, with most profound effects being associated with flavoured e-liquid use (Flach et al., 2019). It is apparent that as the long-term health effects of electronic cigarettes remain for the most part unknown to date, further investigations regarding their impacts upon both pulmonary and other health systems are urgently needed (Klein et al., 2019).

Few studies have reviewed actual use of electronic cigarettes in pregnant women. In particular, in a survey conducted in 316 pregnant women from a University of Maryland prenatal clinic, 13% of participants reported prior or current use of electronic cigarettes, and 0.6% reported current daily use (Mark et al., 2015). When analysing by various potential confounders, authors found that those who had ever used electronic cigarettes (ever-users) were slightly older and more likely to identify as white when compared to never-users, whereas no health effects were reported. In another study Ashford et al. (2016) administered a survey to 194 current or former female tobacco users (101 whom were pregnant) at a University of Kentucky. Of the pregnant participants, 22.7% were current electronic cigarette users and 37.6% were former users; again, no health effects were reported. Moreover, in a report commissioned by Public Health England, it was reported lack of evidence on the prevalence of using electronic cigarettes in pregnancy in England, the effects of using electronic cigarettes on smoking during pregnancy and following childbirth, as well as on the effects of using electronic cigarettes on maternal health or pregnancy outcomes.

Yuan et al., (2015) reviewed clinical and preclinical data concerning sensitivity of the adolescent brain to nicotine. They reported that nicotine exposure in adolescence and the subsequent aberrant activation of nAChRs can lead to persisting changes in neuronal signalling which may have potentially severe consequences for teen addiction, cognition, and emotional regulation. Sailer et al. studied the impact of nicotine replacement therapies (NRT) and electronic nicotine delivery systems (ENDS) on fatal brain development. In case of NRT it was concluded that NRT during pregnancy cannot be considered as a safe alternative to conventional tobacco smoking. Currently, no studies assessing ENDS safety
during pregnancy are available, but there are some studies in vitro and on animal models with positive results. ENDS were linked to impaired placental trophoblast function, diminished alveolar cell proliferation and postnatal lung growth (Sailer et al., 2019).

A recent epidemiological study by Pham et al. (2020) explored the association between electronic cigarette use and adverse mental health status. The cross-sectional analysis was conducted in Canada using data from the 2015 and 2016 (n=53,050). The association between electronic cigarette use and mental health was found to be modified by smoking status and sex in most of the epidemiological models. The effect was somewhat more pronounced in non-smoking electronic cigarettes users, and in female electronic cigarette users, who tended to have higher odds of adverse mental health than male users. The study relied on respondent self-report, and the cross-sectional nature and thus, does not allow us to clarify the direction of this association. Therefore, authors concluded that electronic cigarettes as a possible risk factor for mental health and the potentially harmful effects of second-hand aerosols should be clarified using future longitudinal studies.

The oral cavity is the initial point of contact of electronic cigarette smoke and the first affected system in humans. Oral health depends on an intricate balance in the interactions between oral bacteria and the human immune system. Emerging evidence from subjects with periodontitis as well as periodontaly healthy subjects demonstrates that electronic cigarette use is associated with a compositional and functional shift in the oral microbiome, with an increase in opportunistic pathogens and virulence traits. Dysbiosis of oral microbial communities underlies the etiology of periodontitis, caries, and oral cancer.

Electronic cigarette nicotine poisonings

Another potential health effect associated with the use of electronic cigarettes is poisoning from ingestion of e-liquid containing nicotine, particularly by young children (European Commission, 2016). Within the context of electronic cigarettes, the concern lies within the high concentration of liquid nicotine contained within devices, which at high doses can substantiate the risk of severe toxicity that may result in neurological and neuromuscular harm, respiratory failure and even death (Bassett et al., 2014; Dinakar and O’Connor, 2016; Eggleston et al., 2016). A number of case reports and reports from poison centres have documented incidents of unintentional exposure to e-liquids, including among young children(Chang and Rostron, 2019; Eggleston et al., 2016; Maessen et al., 2020; CI Vardavas et al., 2017) and in rare cases resulting in fatality (Eggleston et al., 2016). Notably, among the 148 cases of acute intoxication due to exposures to e-cigarettes reported to the Czech Toxicological Information Centre over a 7-year period (2012-2018), more than 60% were in the group of children below 12 years (Obertova et al., 2020). The main route of exposure was ingestion of e-liquid contained in cartridges or refillable tanks, which were not characterized by a childproof fastening and opening mechanism.
Among those above the age of 10 years, nicotine intoxication from e-liquids has primarily occurred by way of a suicide attempt, rather than unintentional ingestion (Maessen et al., 2020; Park and Min, 2018). The level of nicotine that may produce acute toxicity has been estimated by the European Chemical Agency’s Committee for Risk Assessment to be 5 mg per kg bodyweight (RAC, 2015). The most frequently reported symptoms of nicotine intoxication include vomiting, tachycardia, headache. In addition to ingestion, route of exposure can also be via ocular, dermal, or inhalation. In a study evaluating nicotine poisonings (n=277) reported to poison centres in eight European Union (EU) Member States (Austria, Hungary, Ireland, Lithuania, Netherlands, Portugal, Sweden and Slovenia) from 2012-2015, the most frequent symptoms reported were vomiting, nausea and dizziness, similar results are reported for the US (Chang and Rostron, 2019; Chatham-Stephens et al., 2014; Vardavas et al., 2017). The majority of cases were unintentional (71.3%), related to refillable electronic cigarettes (87.3%), with exposures primarily via ingestion (54.%), followed by 28.6% inhalation, 9% ocular and 7.9% dermal (Vardavas et al., 2017). While respiratory exposure was more frequent among paediatric patients, ocular exposure was more frequent among adults (Vardavas et al., 2017). These parallel findings from the UK, in which 36.4% of the exposure incidents (2007-2013) were for children ages 4 and younger

(Thomas et al., 2014) and from the US indicating that 50% of cases were among children (Chatham-Stephens et al., 2014). Medical outcomes were minor in effect (53.8%) or no effect at all (39.4%), with 6.3% moderate effects, and 1 case of a major clinical outcome. No deaths were reported. While presenting symptoms at the poisoning centres are characteristic of nicotine, they may potentially also be attributable to other ingredients in electronic cigarette liquids, namely flavours, which contain substances identified as respiratory irritants (see also 6.5.3 and table 7) (Girvalaki et al., 2018; Vardavas et al., 72017).

In order to mitigate the potential risks of electronic cigarette poisonings, the EU Tobacco Products Directive (TPD) 2014/40/EU (European Parliament and the Council of the European Union, 2014), along with Commission Implementing Decisions EU 2016/586 (2016) (Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes (notified under document C(2016) 2093), 14 n.d.) and EU 2015/2183 (2015)(Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers (notified under document C(2015) 8087), n.d.), sets forth standards for electronic cigarette product safety, packaging, and reporting. Specifically, EU TPD Article 20 stipulates a maximum limit for e-liquid refill volumes (≤10 mL) and nicotine content of the vial (≤20 mg/mL), as well as requires the existence of child-resistant fastening and a tamper-proof system. A study evaluating compliance with the EU TPD parameters before and after its implementation, among the most commonly used electronic cigarette refill products in nine European countries found that there was general compliance for child resistant packaging and the product’s nicotine content and volume after TPD implementation (Girvalaki et al., 2019). 25

Health effects related to second-hand exposure to aerosol from electronic cigarettes

Particularly in relation to cardiovascular and other health effects of passive smoking secondary to electronic cigarettes use, it has been documented that the complete blood counts of otherwise naïve passive smokers are not affected by such exposures (Flouris et al., 2013). Additionally, despite high levels of carbonyl emissions as reported in several studies above, limited impacts on cardiovascular and/or other health outcomes have been documented (Farsalinos and Gillman, 2017). However, a limited number of studies (Ballbe et al., 2014, Flouris et al., 2013), mimicking real-life situations, regarding the impacts of passive smoking due to electronic cigarettes currently exists (Shearston et al., 2019), evaluating primarily the effects upon airborne nicotine levels, serum cotinine, lung function, complete blood counts and inflammatory marker levels (Shearston et al., 2019). Of these, solely a single study which evaluates the effects of regular passive smoking exposure due to electronic cigarettes within the home, demonstrating increased levels of ambient air nicotine and biomarkers of nicotine (Ballbe et al., 2014).
Although the database on the long-term consequences of second-hand exposure to electronic cigarettes on human health is not reach, it is well established that passive smoking detrimentally impacts cardiovascular health, with recent meta-analyses revealing that such exposure increases CVD risk by 23% (Lv et al., 2015), including ischemic and coronary heart disease risk by 25-30% (He et al., 1999, Dunbar et al., 2013, Law et al., 1997). It is hypothesized that passive smoking CVD risk in a non-linear dose-effect relationship, detrimentally impacting health event even at low exposure levels (Argacha et al., 2018), as a result of nicotinic stimuli on both the sympathetic system and vascular oxidative stress (Barnoya and Glantz, 2005, Whincup et al., 2004). Surprisingly, particularly in relation to cardiovascular and other health effects of passive smoking secondary to electronic cigarettes, the authors found that the complete blood counts of otherwise naïve passive smokers are not affected by such exposures (Flouris et al., 2013). Additionally, despite high levels of carbonyl emissions as reported in several studies above, limited impacts on cardiovascular and/or other health outcomes have been documented (Farsalinos and Gillman, 2017). However, it is noteworthy that to date data on the longterm consequences of passive smoking of electronic cigarettes on human health are lacking (Hiemstra and Bals, 2016).

Indoor electronic cigarette use can lead to deposition of aerosol components on surfaces. In a recent review Díez-Izquierdo et al (2018) analysed the reported concentration of nicotine, nitrosamines and/or cotinine as components of third-hand smoke (THS) in indoor dust. The reported THS concentrations could be linked to harmful effects on cells, in animal models, and in people including children. However, the authors concluded, that only speculations can be made on the long-term effects of these exposures (Díez-Izquierdo et al., 2018).

Health effects of electronic cigarette use on young populations, children and adolescents

With regard to the health effects of electronic cigarette use in children and adolescents, these are associated with the particular ingredients of electronic cigarettes liquids most often preferred by this population group. Specifically, as aforementioned, apart from nicotine, e-liquids have an array of flavours, strengths, and types; particularly with regard to added flavours, a recent systematic review of 66 investigations revealed that consumers prefer flavoured electronic cigarettes. Preferences varied by age, gender, and smoking history, with several flavours being perceived as having diminished risk of harm from electronic cigarettes use (Zare et al., 2018). It is noteworthy that adolescents (Zare et al., 2018) (along with young adults (Harrell et al., 2017a, Harrell et al., 2017b) were most likely to initiate use with flavoured types, while young adults were observed to prefer menthol and/or other sweet flavours (Zare et al., 2018). As such, use of flavoured volatile liquids may pose a gateway for electronic cigarettes use, which may be later escalated to nicotine use, particularly among vulnerable populations such as children and adolescents (Harrell et al., 2017a, Harrell et al., 2017b). Most guilefully, though, those with the sweetest taste (namely strawberry and/or cinnamon) and most likely to be readily adopted by younger populations as they are erroneously presumed to be less harmful (Pepper et al., 2016), were found to be of highest toxicity (Leigh et al., 2016, Pisinger and Dossing, 2014, Bahl et al., 2012). Specifically, liquid flavours were found to be highly cytotoxic to human embryonic and mouse neural stem cells, as well as human pulmonary fibroblasts, inducing alterations in gene expression (Pisinger and Dossing, 2014, Bahl et al., 2012). However, the long-term effects of such exposure on health, particularly during pivotal developmental periods (namely pregnancy and childhood), remain to be elucidated (De Long et al., 2014) and are not predictable based on currently available data (Tierney et al., 2016). Hence, these adverse health effects are upheld to be highest among susceptible populations, such as children and adolescents, who based on market date most frequently utilize electronic cigarettes containing potentially harmful chemicals, such as sweet flavours and additives.

In addition, with regard to the respective effects of passive smoking secondary to electronic cigarettes use, there exists a complete paucity of evidence regarding the acute and long term effects of passive smoking secondary to electronic cigarettes on cardiovascular and other health outcomes in children and adolescents. Therefore, further research investigations are urgently mandated for evaluating the effects of passive smoking induced by electronic cigarettes use in susceptible populations, particularly such as children and adolescents who may be regularly exposed within their home environments.

Electronic cigarettes and injuries due to burns and explosions

As additional health effects, electronic cigarette use can be the cause of injuries due to burns and explosions. Reports of spontaneous explosions and/or fires of electronic cigarettes have been reported, and cases are predominantly attributed to the malfunction of lithium-ion batteries – a risk that can be substantially mitigated through appropriate legislative action. Electric, thermal or mechanical damage to lithium-ion batteries (via 56 persistent over-charging, over-heating or crushing, respectively) can result in the erosion of integral safety features (Nicoll et al., 2016). Such damage can trigger a hazardous short circuit, initiating a ‘‘thermal runaway’’ reaction whereby internal battery overheating causes a battery fire or explosion, and subsequent burn and blast injuries. Injury mechanisms associated in explosions related to the use of electronic cigarettes, include thermal burns with flames, blasts lesions secondary to the explosion, chemical burns caused by the leakage of corrosive lithium ion compounds following explosion, Nicoll et al., 2016) and thermal burns without flames (overheating) (Serror et al., 2018). These mechanisms may be single or associated. Electronic cigarette explosion injuries can be classified as direct and indirect injuries (Patterson et al., 2017). Direct injuries result directly from the explosion of the device. These mainly include localized hand injuries, face injuries (head and neck), waist/groin injuries, as well as inhalation injuries from using the device. Hand injuries, including severe burns, loss of digits or high-pressure injection of e-liquids, (Foran et al., 12 2017) occur when the electronic cigarette device explodes while being held by the victim or while being kept in their pocket (and the hand is used to extinguish the fire) Serror et al., 2018, Patterson et al., 2017). Face injuries occur when the electronic cigarette is being held up to the face for inhalation. These can include ocular and oral/maxillofacial trauma due to thermal, chemical and blunt force injuries. Ocular injuries may cause significant and permanent visual impairment due to injuries to the cornea, conjunctiva and anterior segment and permanent fovea damage and visual loss due to choroidal rupture following an explosion (Khairudin et al., 2016). The directionality of blasts toward the upper and posterior oral cavity and palate may cause fractures, burns, lacerations, dental injuries (including dental avulsion and fractures), as well as cranial injuries (Archambeau et al., 2016). Inhalation injuries include upper airway injuries and irritation resulting from direct flash or explosion of the electronic cigarette device (Archambeau et al., 2016; Patterson et al., 2017). Waist/groin injuries occur when the electronic cigarette device is stored in the victims’ pant pocket and ignites the victims clothing, resulting in deep burns in the pelvic area. The majority of burns occur when the device explodes while stored in the users pocket, making the groin and genital area the most commonly affected area of the body in reported cases (Serror et al., 2018; Toy et al., 2017; Brownson et al., 2016; Hassan et al., 2016; Arnaout et al., 2017). Indirect electronic cigarette explosion injuries occur as a consequence of fire when the device ignites and causes a house or car fire, causing subsequent flame burn injuries and inhalation injuries (Patterson et al., 2017). The pattern and severity of electronic cigarette related injuries depend on the status of the device (charging, in- use, stored) and it's positioning relative to the user. Severe injuries are more likely when the electronic cigarette device is in the victim’s mouth, in very close proximity to their face, or in a pocket (U.S. Fire Administration, 2017). Additionally, explosion enerates a relatively concentrated area of direct thermal injury, creating an entryway into the skin for toxic chemicals and introducing chemical burns. The quantity of toxic chemicals that are subsequently introduced into the lesions varies, and the amounts that would cause permanent toxic injury is unknown (Kite et al., 2016).

Safety Gate notification for electronic cigarette and related products from 2012 to 2020

By searching for the key-work ‘electronic cigarette’ on the Rapid Alert System for dangerous non-food products (now called Safety Gate, once known as RAPEX), which is the EU rapid alert system notifying Member states about risks to the health and safety of consumers (excluding pharmaceutical and medical devices), entries were found. They come from 14 different MS, indicating that the potential risk is spread all over Europe. Considering the country of origin of the notified products, excluding a few ’unkown’, almost 50% was from 49 China, 1 form the United States and the rest from EU MS.

Electric shock (n=7) due the following defect: The insulation is not sufficient, and a user may come into contact with live parts and receive and electric shock.
Electric shock/fire (n=2) due the following defect: The electrical insulation is inadequate: beside the electric shock, generation of fire is also considered possible.
Burn/fire/injuries (n=1) due the following defect: An external short circuit can occur in the battery, leading to an internal temperature and pressure increase. The battery and the device it is used for can consequently explode, releasing shrapnel and 3 or/leading to a fire
The products did not comply with the requirements of the Low Voltage Directive and the relevant European standard EN 60335 EN 60960 and EN 62133-2 and their withdrawal from the market was established, in some cases paralleled by a recall of the products from end 7 users.
The remaining entries are classified as risks coming from ‘chemical products’ and generally refers to e-liquid content. In two cases the product was considered not compliant due to the lack of a child-proof fastening and opening mechanism, independently form the content and for that reason they were withdrawn from the market. However, the lack of child-proof fastening and opening mechanism was described also for other products, for which the e-14 liquid composition was also not compliant. All the other cases (n= 42) did not comply with the requirements of the TPD. The risk was connected to different causes, listed below:
an excessive amount of nicotine: values ranged from 23.5 up to very high ones (100-150 and 250 mg/ml were the highest values). The content was declared in the label. The products did not comply with the requirements of the TPD
nicotine content was wrongly declared in the label (e.g. labelled as <20mg/ml, while 21 actually containing >20 mg/ml). Beside TPD, the products did not comply with the Regulation on the classification, labelling and packaging of substances and mixtures (CLP)
the presence of nicotine was not reported on the labelling, although the liquid contained nicotine. The products did not comply with TPD and CLP
The product contains an excessive volume of liquid, which contains nicotine.
The product lacks the adequate labelling and warnings. The product does not comply with the CLP Regulation
In two cases, the products were considered to be misleading for consumers since they can be mistaken for foodstuff. Indeed, one of them refers to a drink both in respect of packaging and in terms of organoleptic characteristics, i.e. intense aroma of cocoa, while a second one has a label depicting fruits. So beside being not compliant with CLP, the products did not comply with the requirements of Directive 34 87/357/EEC on products which, appearing to be other than they are, endanger the health or safety of consumers.

Overall, the risk was associated mainly to nicotine content, especially if the user, due to inadequate safety label bearing risk-related indications, has no information about safe and correct use of the product, e.g. how to properly dilute the product and avoid the dangers incurred when the product comes into contact with the skin or if it is ingested.

Conclusions for poisoning and injuries due to burns and explosion
For both poisoning and injuries due to burns and explosion, the evidence for the intrinsic capability to cause health problems is strong, but the incidence is quite low: only few case reports are available, the collection of injury events has not yet foreseen by the EU IDB, and the notifications to the Rapid Alert System for dangerous non-food products not compliant with the ralted regulations are limited. Therefore, the related risk is low.

Conclusion and weight of evidence consideration
There is moderate, but growing level of evidence from human data suggesting that electronic cigarette use has harmful health effects, especially but not limited to the cardiovascular system. However, more studies, in particular on long-term health effects, are needed. For acute health effects, only one valuable clinical study was identified. Pulmonary changes such as increased airway resistance and decreased airway conductance were observed in healthy volunteers. If assessed in cohort studies, acute effects of electronic cigarette use are mouth/throat irritation, and cough and is reported by a subgroup of users, this effect seems not to be related to the nicotine content and the overall incidence was low. The weight-of-evidence is moderate for local irritative damage to the respiratory tract of electronic cigarette users.

In addition, with regard to the respective effects of second-hand exposure of children and adolescents secondary to electronic cigarettes use, the weight of evidence cannot be established as there exists a complete paucity of evidence regarding the acute and longterm effects on cardiovascular and other health outcomes in this group. Therefore, further research investigations are urgently mandated for evaluating the effects induced by electronic cigarettes use in susceptible populations, particularly such as children and adolescents who may be regularly exposed within their home environments.

6.5.5 Risk assessment

In this section the results of exposure assessments will be compared to the results of dose-response analyses, such as PoDs and human limit values, for substances in the aerosol of 18 electronic cigarettes.

Given the numerous substances potentially present in aerosol from electronic cigarettes, the SCHEER prioritized for the risk assessment (Section 6.5.5.1). The preferred approach for the risk assessment will be explained in Section 6.5.5.2. Risk assessments will be presented based on simulations and based on measured concentrations for electronic cigarette users.

6.5.5.1 Prioritisation for risk assessment

Prioritisation was performed based on the concentrations measured in aerosol (section 6.5.2.3, table 5) and the hazards and human health impacts identified (section 6.5.3 and 30 6.5.4). In addition, a comparison is made to the list of compounds recommended to be measured in aerosol of electronic cigarettes according to the tobacco and electronic cigarette industry dominated CEN for the purpose of regulatory submission under the TPD (CEN, 2018) and to the list of the European Association for the Co-ordination of Consumer Representation in Standardisation (ANEC, 2019). The CEN-list includes nicotine, in situ formed formaldehyde, acrolein, acetaldehyde and the hardware related metals cadmium, chromium, iron, lead, mercury, nickel, titanium and aluminium. ANEC (2019) addressed substances in e-liquids (solvents, contaminants and flavours) as well as substances formed (degradation products) or released (from materials) during electronic cigarette use. Priority was given to substances frequently found in screened literature, substances with highest measured concentrations and substances with identified (low) thresholds.

It is noted that the composition of the aerosols as measured only match with the lists of top ingredients in liquids as presented in Annex 2 (present in > 10% liquids) for nicotine, carrier liquids, ethyl acetate and ethanol. The latter two compounds were not quantified. Other ingredients on the list, present in liquid in concentrations > 1 mg/ml and detected in aerosols, were: acetoin, diacetyl, and acetylpropionyl. None of the other listed ingredients were quantified in aerosols. Comparing the list of table 5 with the CEN-list and the ANEC-list it can be concluded that table 5 is the most comprehensive list. However, it is noted that CEN additionally lists iron, mercury, titanium and aluminium.

The focus of the risk assessment will be on the organic substances

Um diesen gesamten Textblock werde ich nun meine weiteren Gedanken mit Euch, meine Leser teilen. Wie immer werde ich dabei die einzelnen Textpassagen seperat markieren. Dieses dient de Übersicht meiner Gedankengänge. (Die zu einigen Teilen schon in vorigen Artikeln dieser Serie erwähnt wurden und in anderen Teilen neu sind.)

The health impacts of electronic cigarette’s use are still difficult to be established due to the lack of long-term data from epidemiological studies or clinical trials. However, since 2016, the World Health Organization (WHO) has already noted that, while electronic cigarettes might be “less harmful” than conventional cigarettes, electronic cigarettes still “are harmful to health and are not safe”. Therefore, WHO suggested to “deter electronic cigarette
https://www.who.int/fctc/cop/cop7/FCTC_COP_7_11_EN.pdf
promotion to non-smokers and young people; prohibit unproven health claims about electronic cigarettes; prevent/Bar/Ban involvement of the tobacco industry in the marketing and promoting of e- cigarettes”. Although, electronic cigarettes are relatively new in terms of exposure to humans, and more research is needed over a longer period of time, there is large scientific body of studies suggesting that electronic cigarettes’ use can pose various health risks to the user; e.g., acute or chronic cardiovascular disease (CVD) problems, can irritate the lungs, as well as induce other symptoms, like cough, chest pain, nausea, vomiting, or diarrhea, and sometimes fatigue, fever, or even weight loss (Thirión-Romero et al., 2019). In this section, a brief summary of studies regarding health impacts of electronic cigarettes on human is presented. ...

Hier habe ich nur eine Anmerkung. Ich habe bereits in vorigen Artikeln die Neutralität der WHO zur E-Zigarette mehrfach bezweifelt. Was hat also ein Text der als Framingmaterial gedacht ist, in einer wissentschaftlichen Abhandlung zu suchen?

Cardiovascular diseases
The most consistent evidence regarding the effect of electronic cigarettes on human health concerns cardiovascular diseases. In November 2019, the European Heart Network (EHN) published a position document regarding the cardiovascular consequences of electronic cigarette’s use. The EHN concluded that there is mixed evidence for the effects of electronic cigarettes on the cardiovascular system from short-term exposure. In particular, it was noted that “while some studies have found a higher risk compared to smoking combustible tobacco cigarettes, short-term electronic cigarette use is likely less harmful to the cardiovascular system than smoking conventional cigarettes”, whereas, the long-term effects on the cardiovascular system are still unknown due to the lack of relevant data. However, the authors underlined that, despite the fact that there is “no evidence” this should not be interpreted as no effect, and findings from recent studies suggest that use may pose a higher risk than so far assumed. The EHN underlined the need for longitudinal studies to elucidate long-term effects of electronic cigarette use on the cardiovascular system and whether electronic cigarette use is less hazardous to cardiovascular health than conventional cigarette smoking in the longer term.....Recent findings demonstrate that volatile liquids containing nicotine may induce adverse cardiovascular effects attributed to its toxic impact on myocardial cells. Most electronic cigarettes containing nicotine have a basic pH > 9, which seems to enhance the dosage of nicotine delivered (Stepanov and Fujioka, 2015). Even so, electronic cigarette users exposed to 11 mg/mL of nicotine content in e-liquids had increased cardiac output and heart rate (Farsalinos et al., 2014). Regular electronic cigarette use with nicotine containing liquid is associated with a shift towards sympathetic predominance in heart rate and associated variability (Moheimani et al., 2017, Franzen et al., 2018), as well as vascular calcification and impaired vascular function (Babic et al., 2019), leading to prolonged elevated systolic blood pressure (Franzen et al., 2018)....

Lung diseases

Short-term use of an electronic cigarette has acute effects on airways physiology and respiratory symptoms in COPD smokers, asthmatic smokers, “healthy” smokers and healthy never smokers. Evidence arising from both experimental and observational studies, support that electronic cigarette use may induce pulmonary toxicity, which is anticipated to emerge as a major public health concern (Chun et al., 2017, Jankowski et al., 2017). Specifically, studies in both, animal models and human populations demonstrate that acute electronic cigarette use triggers oxidative stress and increased airflow resistance (Vardavas et al., 2012), either by increased mucin secretion via altered neutrophil related pathways (Reidel et al., 2018) and/or by damage of epithelial airway cells which lead to persistent inflammation and secretion of mediators (namely defensins and matrix metalloproteinases) inducing lung tissue destruction (Chen et al., 2019). Diminished pulmonary function is hence anticipated, particularly among susceptible populations. In fact, electronic cigarette use in adolescents has been associated with the presence of asthma (Clapp and Jaspers, 2017). Furthermore, studies in cell lines of human epithelial lung and fibroblast cell lines revealed that the aforementioned cell lines are sensitive to electronic cigarette exposure, inducing production of ROS and pro‐inflammatory cytokines, apoptosis, and necrosis (Chen 17 et al., 2019), all hallmarks for tumor growth and development. However, the effects of long-term use particularly in relation to lung cancer remain to be determined in epidemiological investigations (Chun et al., 2017, Murthy, 2017).

Hier fallen mir gleich mehrere Dinge auf.

Die Wirkung von Nikotin wurde bisher immer mit der Wirkung von Coffein verglichen. Sofern es sich um neutrale Bewertungen verhielt. Es ist nachgewiesen das Nikotin in Abwesenheit von MAO-Hemmern nicht suchterzeugend ist, ebenso wie nachgewiesen wurde das Nikotin nicht krebserregend ist.
Hat irgendjemand schon mal daran gedacht, das der Rauch einer Pyro das Problem ist. Ich meine wirklich der Rauch und nicht die enthaltenen "Nervengifte"
Hat irgendjemand mal daran gedacht, das der Mensch a) keine Maus ist, b) ein funktionierendes Abwehrsystem gegen eindringendes Fremdmaterial (egal ob lebende oder tote Materie) hat.
Hat jemand bei den Tests mal daran gedacht, das ein lebender Organismus mehr ist als ein Zellhaufen?

Nicotine remains a very important toxin present in electronic cigarette. Most of the cardiovascular effects demonstrated in humans are consistent with the known sympathomimetic effects of nicotine. Acute exposure to (high amounts) of inhaled nicotine may cause dizziness, nausea, or vomiting. Following (acute) exposure to the electronic cigarette with nicotine, there was a significant shift in cardiac sympathovagal balance towards sympathetic predominance. The decrease in high-frequency component and the increases in the low-frequency component and the low-frequency to high-frequency ratio were significantly greater following exposure to nicotine containing electronic cigarette use. The acute sympathomimetic effect of nicotine containing electronic cigarette can possibly be associated with increased cardiac risk populations with and without known cardiac disease. (Moheimani et al., 2017).

Okay, hier kommen wir mal zu grundlegendem in der Biochemie. Abbaugeschwindigkeit, Bioverfügbarkeit und die daraus sich ergebene "Halbwertzeit" im Körper. Hierzu empfehle ich wieder den Artikel von mir: Nikotin - das tödliche Suchtgift . Insbesondere die von mir verlinkten Videos von Prof. Bernd Mayer. Die Mengen die dazu oral oder inhalativ aufgenommen werden müssten sind einfach absurd hoch. Vorher hätten besagten Menschen schon Kopfschmerzen und würden über den Weg der Selbsttiatration bereits die Dampfe beiseite legen.

Other health effects
There are also some indications about electronic cigarette use and other health problems. In a recent systematic review conducted among 18 investigations, the carcinogenic potential of electronic cigarettes and the occurrence of head and neck cancers was revealed, albeit with a low level of evidence. Moreover, within this context, findings from several investigations reviewed corroborated that electronic cigarette use induces DNA damage via increased oxidative stress, with most profound effects being associated with flavoured e-liquid use (Flach et al., 2019). It is apparent that as the long-term health effects of electronic cigarettes remain for the most part unknown to date, further investigations regarding their impacts upon both pulmonary and other health systems are urgently needed (Klein et al., 2019).

Mir ist keine Studie bekannt die bisher belegen konnte das es negative Auswirkungen durch Bestandteile des Aerosols für die Menschen gibt welche den Dampf direkt einatmen. Eher das Gegenteil. )18

Electronic cigarette nicotine poisonings
Another potential health effect associated with the use of electronic cigarettes is poisoning from ingestion of e-liquid containing nicotine, particularly by young children (European Commission, 2016)....

WTF!! Nikotin-Shots müssen in kindersicheren Behältern verkauft werden. Die E-Zigarette selber hat in Kinderhand nichts zu suchen. Eltern die dampfen haben die gesetzliche Fürsorgepflicht gegenüber ihren Kindern. Was zum Geier hat dieses vorgeschobene Kinder-und Jugendschutzargument in dieser Diskussion überhaupt verloren. Sorry das ist kein Argument, das ist nicht mal nen Einwand, das nennt sich Vorwand. Hier wird ein Punkt angesprochen der eigentlich schon lange geklärt ist wenn man geltende Gesetze umsetzt.

Electronic cigarettes and injuries due to burns and explosions
As additional health effects, electronic cigarette use can be the cause of injuries due to burns and explosions. Reports of spontaneous explosions and/or fires of electronic cigarettes have been reported, and cases are predominantly attributed to the malfunction of lithium-ion batteries – a risk that can be substantially mitigated through appropriate legislative action. Electric, thermal or mechanical damage to lithium-ion batteries (via 56 persistent over-charging, over-heating or crushing, respectively) can result in the erosion of integral safety features (Nicoll et al., 2016). Such damage can trigger a hazardous short circuit, initiating a ‘‘thermal runaway’’ reaction whereby internal battery overheating causes a battery fire or explosion, and subsequent burn and blast injuries. Injury mechanisms associated in explosions related to the use of electronic cigarettes, include thermal burns with flames, blasts lesions secondary to the explosion, chemical burns caused by the leakage of corrosive lithium ion compounds following explosion, Nicoll et al., 2016) and thermal burns without flames (overheating) (Serror et al., 2018)....Conclusions for poisoning and injuries due to burns and explosion
For both poisoning and injuries due to burns and explosion, the evidence for the intrinsic capability to cause health problems is strong, but the incidence is quite low: only few case reports are available, the collection of injury events has not yet foreseen by the EU IDB, and the notifications to the Rapid Alert System for dangerous non-food products not compliant with the ralted regulations are limited. Therefore, the related risk is low.

Ab hier wird mein Hals richtig dick. Was hier beschrieben wird sind Schäden die nicht durch die E-Zigarette an sich entstehen sondern durch die verwendeten Akkus. Ich suche immer noch eine Fall in dem eine E-Zigarette explodiert ist, und es KEIN Anwenderfehler war. Ein solcher Fall ist derzeit nicht veröffentlicht worden

Conclusion and weight of evidence consideration
There is moderate, but growing level of evidence from human data suggesting that electronic cigarette use has harmful health effects, especially but not limited to the cardiovascular system. However, more studies, in particular on long-term health effects, are needed. For acute health effects, only one valuable clinical study was identified. Pulmonary changes such as increased airway resistance and decreased airway conductance were observed in healthy volunteers. If assessed in cohort studies, acute effects of electronic cigarette use are mouth/throat irritation, and cough and is reported by a subgroup of users, this effect seems not to be related to the nicotine content and the overall incidence was low. The weight-of-evidence is moderate for local irritative damage to the respiratory tract of electronic cigarette users.

In addition, with regard to the respective effects of second-hand exposure of children and adolescents secondary to electronic cigarettes use, the weight of evidence cannot be established as there exists a complete paucity of evidence regarding the acute and longterm effects on cardiovascular and other health outcomes in this group. Therefore, further research investigations are urgently mandated for evaluating the effects induced by electronic cigarettes use in susceptible populations, particularly such as children and adolescents who may be regularly exposed within their home environments.

Jeder Stoff den wir dem menschlichen Körper zuführen hat Auswirkungen. Und noch mal die Wirkungsweise von Nikotin ähnelt dem des Coffeins. Als nächstes kommt dann eine Reglementierung wieviel Coffein.... Lassen wir das lieber. Ansonsten kommen die da oben noch auf dumme Gedanken. Das es keine Second-Hand-Emissonen gibt wurde bereits mehrfach in den anderen Teilen nachgewiesen. Daher gehe ich darauf hier auch nicht weiter ein.

Fazit

Ich habe heute mal bewusst mehr Rohmaterial as dem Scheer Report verwendet. Zum einen weil, diese Punkte alle sehr eng verzahnt sind. Zum anderen weil ich denke, das diese Serie mit 11 Teilen doch schon einen gewissen Umfang erreicht hat.

Irgendwann möchten wir ja auch alle das Gesamtwerk mal näher betrachten können. Aber ich muss sagen das es mit mehr Material auch nicht besser wird. Wenn man die Zusammenhänge liest. Eher wird es für mich grausiger. Also jeder Dampfer der jetzt noch sagt, das wäre alles Schwarzmalerei. Der möge doch bitte mal alle Artikel in Folge lesen. Meine Anmerkungen alleine reichen da schon aus.

in diesem Sinne

Seid Achtsam