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.
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.
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).
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.
Publikationen zu Prioritätszusatzstoffen:
- Regulatory Toxicology and Pharmacology Volume 104, June 2019, Pages 29-38
- Regulatory Toxicology and Pharmacology Volume 104, June 2019, Pages 84-97
- Regulatory Toxicology and Pharmacology Volume 104, June 2019, Pages 163-199
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.
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).
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)
“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 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.