Ingredients
Ingredients are all substances and components that are part of a finished product. This includes tobacco, additives, flavours as well as paper, filter, ink, capsules and glue.
The use of the ingredients in tobacco and related products such as e-cigarettes containing nicotine are subject to regulations of the European and German tobacco legislation.
Use of Additives
The manufacturing of tobacco products is strictly regulated. All additives that are harmful in unburned form or that have a carcinogenic or mutagenic effect are prohibited. Substances that could increase addiction and facilitate inhalation or nicotine intake must not be used.
Substances that might give the impression of health benefits and that are associated with energy and vitality, such as caffeine or taurine, are also prohibited.
Flavourings must not be used in filters, papers, packaging, capsules or other components of cigarettes.
Reporting Obligations
All ingredients of a product, their quantities and the associated toxicological data must be reported by the manufacturers to the competent authorities. This also includes information about the tobacco itself and certain smoke components.
The authorities are notified when the composition of a product is changed or before a new tobacco product will be launched. The information is submitted electronically to the national authorities via a European portal and in a standardised format (
BVL).
Interested consumers can find the ingredients of a product on the websites of our member companies and the German Ministry of Food and Agriculture ( BMEL) as the authorities have a duty to supply information.
Priority Additives
Specific additives for cigarettes and fine cut are subject to more detailed reporting obligations and are to be assessed in more detail for being used in tobacco products. Cigarette manufacturers established a consortium for assessing the priority list of additives (carob bean, cocoa, diacetyl, fenugreek, fig, geraniol, glycerol, guaiacol, guar gum, liquorice, maltol, menthol, propylene glycol, sorbitol, titanium dioxide) and commissioned comprehensive studies for their toxicological assessment. The results of these studies were submitted to the authorities on 1 July 2018. In assessing this data, the individual EU member states are supported by a European working group - led by the Dutch National Institute for Public Health and the Environment (RIVM) and supported by the German Federal Institute for Risk Assessment (BfR) (). At the same time, three publications on the results of the consortium were put up for discussion by the academic community (LINK PubMed Publikationen).
“Characteristic Flavours”
Since 2016, cigarettes and fine cut have not been allowed to have any flavour other than tobacco. They must not smell or taste, for example, fruity, sweet or of vanilla. The reason for this ban: Tobacco products should not be attractive to children and adolescents due to their aroma.
An advisory panel and a technical group have been set up at the European level to implement this ban. Since 2016, these groups have been working on suitable methods and procedures for the sensory and chemical assessment of tobacco products.
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Menthol Ban
Since 20 May 2020, it is prohibited to sell menthol cigarettes in Europe as well as in Germany.
While “characteristic flavours” in cigarettes and fine cut have already been prohibited since May 2016, menthol products were exempt from the regulation until 2020. Menthol cigarettes have a market share of over 3% in some EU countries and the consumer should be given a longer transition period. However, small quantities of menthol may still be used as an aroma component in cigarettes and fine cut in other EU countries.
Compared to other European countries, Germany has even gone a step further: The use of menthol has been prohibited for all smoking tobacco categories since 20 May 2020, even in small quantities (Annex 1, Tobacco Product Ordinance). This ban in Germany is not only based on the “characteristic aroma”, but on the suspicion that menthol may facilitate the inhalation and the absorption of nicotine in smoke. The result of this national solo was that many flavours had to be changed in Germany.
The BVTE regrets that menthol cigarettes have now disappeared in Germany - products with a decade-long tradition, which were mainly preferred by older smokers. We also disapprove of the complete ban on menthol as a flavour in Germany because not all available scientific data confirms the criticisms of menthol.
In Europe and particularly in Germany, the production of e-cigarettes is subject to strict legal requirements.
Limitation of Nicotine Content
In the EU, liquids may contain a maximum of 20 mg / ml nicotine. Liquids that contain nicotine may not exceed a volume of 10 ml. This is different in the United States. In the US market, there are no maximum values and quantitative limits for nicotine in e-cigarettes and liquids. In the US, some products have a nicotine content of over 55 mg / ml.
The use of certain flavours and other ingredients in nicotine-containing liquids of e-cigarettes is prohibited according to Appendix 2 of the Tobacco Product Ordinance. This includes, for example, additives that are associated with energy and vitality (e.g. caffeine or taurine), or vitamins or other substances that could be suggestive of health benefits. In addition, ingredients with CMR properties (carcinogenic, mutagenic, and toxic to reproduction) and other toxic ingredients are prohibited.
Use of Ingredients
Apart from nicotine, only ingredients of high purity and of no risk to human health may be used for the production of liquids and e-cigarettes.
For e-cigarettes, all additives that are harmful in unburned form or have a carcinogenic or mutagenic effect, may enhance addiction, have a stimulating and vitalizing effect or facilitate inhalation or nicotine absorption are prohibited. Vitamins and substances that could give the impression of health benefits and are associated with energy and vitality, such as caffeine or taurine, are also prohibited.
Labelling Obligations
In addition to warnings, the packaging and outer packaging of e-cigarettes and refill cartridges must also show a variety of information for the consumer such as the ingredients used, the nicotine content and the nicotine release per dose. You will find a compilation on the website of the Federal Office of Consumer Protection and Food Safety ( BVL).
Reporting Obligations
All ingredients of a product, their quantities and the associated toxicological data must be reported by the manufacturers to the competent authorities. This also includes information about the tobacco and certain smoke components. With this official notification, the manufacturers assume full responsibility for the quality and safety of the product.
The authorities are always notified when the composition of a product is changed or before a new tobacco product will be launched. The information is submitted electronically to the national authorities in a standardised format.
Equal Regulations for All Liquids
So far all regulations for e-cigarettes only refer to products containing nicotine. The strict requirements do not apply to liquids that do not contain nicotine or that are mixed by the consumers themselves. A current bill of the Federal Government wants to close this gap for Germany. Then the same strict rules will apply to all liquids intended to be used in e-cigarettes, at least on the German market.
The equal legal status and strict rules including for the production of nicotine-free liquids enhance consumer protection and increase the security of e-cigarettes. We therefore expressly welcome the statutory project.
Stringent legal requirements for the ingredients in liquids are important in order to minimize the health risks for consumers and avoid events as they occurred in the United States last year. From mid-2019 on, the prevalence of lung diseases increased among consumers of vaping products. In a relatively short period, over 2,000 people fell ill and more than 60 people in the United States died as a result.
On their website, the US Centers for Disease Control and Prevention ( CDC) informs about the outbreak of the pulmonary disease (LINK). It mainly affected consumers of illicit or contaminated THC-containing liquids (THC = tetrahydrocannabinol) in so-called „e-joints”. The primary suspect substance is vitamin E acetate, which was probably used as an extender in THC-containing oils. So far, no case of this mysterious lung disease is known in Germany and Europe because the use of THC-containing liquids and the use of vitamins in liquids are categorically prohibited in Germany.
E-Cigarette: Distrust and Ignorance Prevail
The German Federal Institute for Risk Assessment ( BfR) surveyed how Germans rate and perceive the e-cigarette. The result shows that distrust and ignorance prevail ( BfR-Verbraucher-Monitor-Spezial (in german)). Over 60% of the population perceive the health risks of e-cigarettes as higher than or the same as tobacco cigarettes. Only 6% of Germans are of the opinion that e-cigarettes are less harmful than tobacco products.
In its press release from 7 April 2020, however, the BfR points out, “that the consumption of conventional cigarettes involves a significantly higher health risk than the consumption of e-cigarettes”.
The potential of e-cigarettes as a possible reduced-risk alternative for smokers should be sufficiently explained in the evaluation of the product.
Overall, the aerosol inhaled by the consumer is less complex than tobacco smoke: It contains both qualitatively and quantitatively less toxic substances than tobacco smoke. The English Department of Health and Social Care believes that e-cigarettes are around 95% safer than smoked tobacco and they can help smokers to quit. ( Link)
Flavouring bans in e-cigarettes require proper scientific assessment and should be openly discussed with all stakeholders
Since the beginning of the corona pandemic, health policy has increasingly interfered with the individual's freedom of choice and enacted regulations that extend into the closest family circle. Scientific arguments were often the basis for far-reaching measures that shaped our everyday lives for months. However, trust in the objectivity and expertise of scientific assessments is an important prerequisite for accepting restrictions or bans. This requirement applies not only to the fight against the pandemic, but to all areas of health protection - including flavouring bans in e-cigarettes.
Compared to infection control, e-cigarettes are perhaps not the most important health policy issue at the moment.But here, too, the question applies to what extent governments may intervene in the decisions of individuals to protect their health. On 28 December 2021, the BfR published in its statement 043/2021 the recommendation to ban menthol, safrole and sucralose in e-liquids. For the first time since 2015, menthol, an important flavouring substance, which is contained in many, perhaps even most, e-liquids, is again being targeted by the risk assessment. But is this recommendation rally meant to protect human health? Or put it another way, does the federal government really believe that inhaling or swallowing menthol can lead to serious illness? Unfortunately, the real intention behind flavouring bans is possibly to limit the acceptance of e-cigarettes through new restrictions in order to force risk-reduced products out of the market. The DKFZ had formulated its claims in no uncertain terms: E-cigarettes and tobacco heaters should disappear from Germany by 2040.
A sensible policy would be the best way to create new confidence. The newly elected federal government stipulated in its coalition agreement to base health policy decisions on current scientific findings. In conflict-prone fields such as e-cigarettes and "Tobacco Harm Reduction", science should therefore fulfil this responsibility with particular care and evaluate the state of scientific knowledge in an objective and balanced manner. The current BfR statement did not meet these standards. The actual assessment of menthol comprises only a few lines and refers to just six literature references. It is hard to imagine that the assessments in this fragmentary text actually initiated the the proposal to ban menthol. The recommendation itself is awkwardly formulated, formalistic and cloistered, perhaps authors doubted it themselves.
Menthol, of all things, was proposed as a candidate for ban because of health risks, although the substance has been used safely in food, consumer products and medicines for decades. In its assessments, the BfR refers to systemic symptoms, i.e. disease indications that are supposed to occur independently of inhalation intake. If this argumentation is really taken seriously by the BMEL, menthol would first have to be banned in toothpaste and cough sweets, among other things.
As an association, we have carefully examined the statement. Our examination demonstrated considerable technical deficiencies that call the core statements into question. The major conclusions of the BfR can neither be justified by the studies nor by the references listed. Central statements are not substantiated and consequently, scientifically worthless. This applies in particular to the alleged role of menthol in the development of respiratory diseases and the triggering of severe systemic symptoms in mice.
We had already sent our summarized critique to the BMEL and the BfR in January and hope that a discussion on this will take place in the near future. The protection of vapers from avoidable health risks is also an important issue for us. However, the proposed menthol ban appears rather as a matter of principle to put further restrictions on e-cigarettes. Unfortunately, concerns are raised again that science is used to create confusion rather than clarity. The BfR has accompanied the development of e-cigarettes from the beginning and gained a better and more balanced understanding. This led to a growing acceptance in the vaping community. Hopefully, thistrust will not be gambled away carelessly.
“Using the Potential of the E-Cigarette!”
Online Symposium with Prof. Heino Stöver "Interim Results on E-Cigarettes: ” What we know and must do“ on 27 May 2020 (Frankfurt University of Applied Sciences)
The scientists who took part in the symposium agreed that the chances provided by e-cigarettes to promote smoking cessation are massively underestimated in Germany. They asked politicians to recognize this potential and to take the next step.
Ute Mons, formerly from the German Cancer Research Center, supported a balanced and differentiated risk communication with smokers in Germany. In Great Britain, the discussion and the factual and sober assessment of the possibilities of e-cigarettes to promote smoking cessation are much further.
In the discussion about e-cigarettes, emotionality should be minimized and, at the same time, scientific arguments should be corroborated. Health authorities should assume their responsibilities and ensure that adult smokers can make informed decisions about potentially less harmful tobacco and nicotine products.