The National Centre on Addiction and Doping of Istituto Superiore di Sanità (CNDD-ISS) participated in the three years (2017-2020) project Joint Action on Tobacco Control (JATC 1) (https://jaotc.eu/our-mission/) funded by the European Commission, and under the coordination of the Hellenic Cancer Society – Greece .
The Tobacco Product Directive (TPD), (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0040&from=IT), entered into force on 19 May 2014 and became applicable in the EU Member States (EU MS) on 20 May 2016 (in Italy entered into force in January 2016 and it is available from https://www.gazzettaufficiale.it/eli/gu/2016/01/18/13/sg/pdf), with the aim to contribute in the reduction of tobacco-related deaths and illnesses, in line with the implementation of the WHO Framework Convention on Tobacco Control (FCTC) that lays down rules governing the manufacture, presentation and sale of tobacco and related products, including cigarettes, roll your own tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco, electronic cigarettes, novel tobacco and herbal products for smoking (https://apps.who.int/iris/bitstream/handle/10665/42811/9241591013.pdf).
The JATC has been strongly supported, as the European Region has one of the highest proportions of deaths attributable to tobacco with an estimated 16% of all deaths (nearly 50% of smokers die 14 years earlier) compared to the global average of 12%. In addition to the health risks, tobacco use and dependence has a major impact on society and health care system economically and in terms of morbidity and mortality.
The JATC is based on the collaboration between European Commission (EC) and the EU MS with the objective of supporting the implementation of TPD in all 28 MS (UK left in January 2020), and improving the protection of European public health.
Core of JATC's activities was the European Union Common Entry Gate (EU-CEG), the European database on tobacco and e-cigarette products, which is the common reporting format for submitting data on ingredients contained in tobacco and related products and public disclosure of the data.
The participating countries in the JATC were 23, while the collaborating partners were from 9 countries.
The JATC consisted of 9 Work Packages (WP):
- WP1 Coordination of the action
- WP2 Dissemination
- WP3 Evaluation of the action
- WP4 Integration into national policies and sustainability
- WP5 EU Common Entry Gate (EU-CEG) data extraction and handling
- WP6 Tobacco product evaluation
- WP7 E-cigarette product evaluation
- WP8 Laboratory verification, collaboration and analyses
- WP9 Additives subject to enhanced reporting obligations
CNDD-ISS participated in the activities of WP6, WP7, WP9 and later also in WP4 as coordinator for the last 10 months of the project.
Work Package 6 Tobacco Product Evaluation
WP6 aimed at handling the aspects pertinent to tobacco product data handling collected by EU MS in light of the obligations of the TPD. Among the activities, a questionnaire was prepared to collect the responses of EU MS regulatory authorities on key TPD issues or issues addressed by JATC such as: sustainability, EU-CEG and tobacco products reporting, laboratory testing and priority additives.
Two reports regarding the analysis of data in the EU-CEG relating to tobacco products were prepared. The results of these activities have been published in a specific section of the JATC website (https://jaotc.eu/useful-material-2/) and in the following article Tobacco products in the European Union Common Entry Gate (EU-CEG): A tool for monitoring the EU tobacco products directive published in the Tobacco Prevention & Cessation journal, available from:
http://www.tobaccopreventioncessation.com/pdf-145501-72869?filename=Tobacco%20products%20in%20the.pdf
Work Package 7 E-cigarette product evaluation
WP7 aimed at supporting the EU MS activities in ensuring that electronic cigarettes and refill containers are only placed on the market if they comply with the TPD (i.e. carrying out data analysis in EU-CEG as regards to electronic cigarettes and refill liquids).
CNDD-ISS was leader of Task 4.2 Support the EU MS in the development of a system for the reporting of information on suspected adverse effects on human health in line with TPD Art. 20 (9). Specifically, a reporting form was prepared for suspected adverse effects on human health following the use of electronic cigarettes and refill liquids in line with Article 20 (9) of the TPD, with the contribution of the partners of WP7. The form is described in the report D7.4 Report on a proposed format for the reporting of adverse effects (available at this link https://jaotc.eu/wp-content/uploads/2021/02/WP7-D7.4-Report -on-a-proposed-system-for-the-reporting-of-adverse-effects.pdf), where two slightly different versions of the form are reported, one for economic operators and one for competent authorities.
The protocol (or guidance document) of the system for reporting adverse effects has been published in the final report of the activities of WP4 (available from https://jaotc.eu/wp-content/uploads/2022/03/D4.2_Sustainability_plan.pdf) and later in the following article Reporting system of suspected adverse effects from electronic cigarettes and refill liquids in Europe, published in Tobacco Prevention & Cessation journal available from http://www.tobaccopreventioncessation.com/pdf-143331-70350.
Work Package 9 Additives subject to enhanced reporting obligations
WP9 aimed at evaluating the data submitted with regards to enhanced reporting obligations under TPD Art. 6 which shall apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list outlined in the Commission Implementing Decision 2016/787.
An independent review panel was appointed in in order to evaluate the industry dossier and studies on priority additives in tobacco products (TPD Article 6 p.4), and to facilitate the peer review process through discussion and definition of tasks, roles and evaluation strategy.
The industry reports on toxicity, dependence and attractiveness of additives subject to enhanced reporting obligations (Carob bean, Cocoa, Diacetyl, Fenugreek, Fig, Geraniol, Glycerol, Guaiacol, Guar gum, Licorice, Maltol, Menthol, Propylene Glycol, Sorbitol, Titanium Dioxide) were reviewed by the 10 independent scientific experts and the other WP9 partners. The main findings of the peer review (described in the D9.3 Reporting on the peer review of the enhanced reporting information on priority additives available from https://jaotc.eu/wp-content/uploads/2021/04/D9.3-Report-on-the-peer-review-of-the-enhanced-reporting-information-on-priority-additives.pdf), were the followings:
- insufficient quality of industry reports (not comprehensive) for which regulation should not be based solely on them
- many of the priority additives and/or their pyrolysis products, are flavorings and/or sweeteners (carob bean, cocoa, diacetyl, fenugreek, fig, geraniol, glycerol, guaiacol, guar gum, licorice, maltol, menthol, sorbitol) that modify the flavor of cigarettes, making them more palatable and attractive
- the combustion of sugars produces carbonyls, some of which enhance the addictive effects of nicotine through the mechanism of inhibition of monoamine oxidase
- for guar gum and sorbitol, industry data show significantly increased carbonyl levels
- additives may increase attractiveness and the risk for addiction or harm by promoting smoke inhalation and continuation of tobacco product use
- there is strong evidence that menthol (and its analogs such as geraniol) facilitates inhalation by activating the cooling receptor TRPM8
- titanium dioxide is classified as “carcinogen category 2” as of September 9th 2021
Although nicotine and its pharmacological effects are central to sustaining tobacco product use, they are insufficient to support product acceptance. Sensory stimuli attributable to flavours are particularly critical to product acceptance, reducing subjective measures of cravings and withdrawal, even in the absence of nicotine. A primary example of such an additive is menthol. Menthol is 1 of the 15 priority additives for tobacco products that were subject to further evaluation within the TPD, based on the data that these additives may (1) contribute to toxic, addictive or carcinogenic, mutagenic or reprotoxic properties of cigarettes and roll-your-own (RYO) tobacco, (2) may result in a characterising flavour, or (3) may facilitate inhalation or nicotine uptake (European Tobacco Products Directive (TPD): current impact and future steps available from https://tobaccocontrol.bmj.com/content/31/2/198).
Even when menthol cannot be tasted, the substance makes it easier to inhale tobacco smoke. This is one of the key outcomes of Work Package 9 of the Joint Action on Tobacco Control. Menthol makes smoking more attractive for young and novice smokers who are not yet used to inhaling sharp, pungent tobacco smoke. There is strong evidence for this effect in independent literature, but not in the reports submitted by tobacco manufacturers.
Since May 2020, tobacco products containing a characterizing menthol flavor are prohibited in the EU. However, menthol may still be added in low amounts, which do not lead to a characteristic flavor. According to the European Tobacco Products Directive, manufacturers of tobacco products are required to disclose to the Member States which additives they use in tobacco products. The manufacturers also had to provide additional information about, among other things, the harmful and addictive effects of 15 priority additives, including menthol. The reports about the priority additives have been reviewed by a group of independent experts, in Work Package 9.
The tobacco companies conclude in their report that low amounts of menthol do not facilitate inhalation of tobacco smoke. However, the WP 9 experts found strong evidence for such an effect in independent literature. Their advice is therefore to ban the addition of menthol in tobacco products in any amount. Some countries, such as Germany, have already banned menthol and similar substances due to the fact that they facilitate smoke inhalation.
The main conclusion of the WP9 experts is that the reports that were submitted by tobacco manufacturers are of insufficient quality. For example, various relevant independent studies have not been included in the reports, as was the case for menthol. In addition, the WP9 experts found limitations in the research methods and statistical analyzes used by the tobacco manufacturers. The WP9 experts therefore question the scientific validity of the industry reports. They recommend that the outcomes and conclusions of the industry report should therefore not be used by Member States to guide policy (Menthol facilitates inhalation of tobacco smoke, even when you can’t taste it! Available from https://jaotc.eu/news/).
The results and conclusions of the review work of the independent panel of WP9 have been published in the journal Tobacco Prevention & Cessation and are available at the following links:
http://www.tobaccopreventioncessation.com/pdf-151529-76874
http://www.tobaccopreventioncessation.com/pdf-150361-76877
As a result of these conclusions, proposals have recently been made to revise the TPD regarding ingredient bans (Tobacco companies’ exploitation of loopholes in the EU ban on menthol cigarettes: a case study from Denmark, available from https://tobaccocontrol.bmj.com/content/tobaccocontrol/early/2022/03/20/tobaccocontrol-2021-057213.full.pdf): “To be efficient, bans on flavoured tobacco products should prohibit menthol and other ingredients with flavour properties, as ingredients. Consequently, authorities are not placed in a position to prove whether a flavour is characterising. Banning menthol as an ingredient will also end tobacco companies’ use of menthol for its pharmacological effects. Internal tobacco industry documents reveal that even subliminal levels of menthol may decrease the harshness of tobacco smoking by making the smoke more ‘smooth’ and that these properties appeal to novice smokers. Other ingredients that have the potential to mask the irritating effect of tobacco smoke, such as ingredients that produce a cooling effect, should also be banned. Moreover, legislation should encompass all tobacco products to avoid the substitution of one product with another. To be comprehensive, the legislation should also prohibit flavoured tobacco accessories and filter modifications which may enable tobacco companies to circumvent the flavour ban.
These recommendations should be considered in the revision of the EU TPD. The revised TPD should at least make it clear that member states may go beyond the directive provisions to protect public health.
Efficient legislation should also prohibit distinctive features, colours, and brand descriptors on tobacco packets and the tobacco products itself that connote cooling effects or flavours other than the flavour of tobacco. Accordingly, the implementation of plain packaging of tobacco products can support a menthol ban. A comprehensive ban on tobacco marketing is also essential to avoid the marketing of tobacco products exempt from the ban. Finally, it is recommended that a menthol ban is supported by the prohibition of descriptions of tobacco product sensation in both online and physical stores”.
Work Package 4 Integration into national policies and sustainability
CNDD-ISS led WP4, which aimed at supporting MS and international public health institutions for the continuation and sustainability of post-JATC activities, at national or European level, through some sustainability proposals outlined in 8 guidance documents prepared by WP4 partners. Several partners were both authors and reviewers, while others were solely reviewers. The documents produced aim to promote some practices to be integrated into national and international health research and to develop policies with the aim of preventing the consumption of tobacco and nicotine, and to mitigate the consequences of health risks due to the consumption of tobacco and nicotine.
The final Deliverable of WP4 (D4.2 Sustainability plan, including scenarios for long-term sustainability available from https://jaotc.eu/wp-content/uploads/2022/03/D4.2_Sustainability_plan.pdf) included the following documents related to the activities of WP 6, 7, 8, and to the TPD:
- Guidance document on how to clean and handle EU-CEG data, by Hellenic Cancer Society, provides a starting framework that can be used for assessing the completeness of the EU-CEG database and aid EU MS regulator interpretation of the data
- Guidance to reporting system of suspected adverse effects (AE) for electronic cigarettes and refill liquids, by ISS, aims at providing the necessary steps and modalities that each MS should follow if involved in the development of a system for the reporting of suspected adverse effects (AE) on human health for electronic cigarettes and refill liquids
- Guidance to the checklist for e-cig compliance to the TPD, by Estonian Health Board, supports economic operators and regulators on the assessment of electronic cigarette and refill container products against legislative requirements
- Laboratory analysis related to tobacco and nicotine products, by Istituto per le Ricerche Farmacologiche Mario Negri of Italy, is a guidance intended to facilitate approved independent laboratories in developing all necessary capacities (technologies, knowledge and expertise) to react to new demands from national competent authorities in order to cover verification needs in a homogeneous approach, within MS
- Guidance to recommendations for treating electronic cigarette and heated tobacco product dependence, by Semmelweis University, provides a recommendation and guidance for incorporating the treatment of e-cigarette and HTP dependence in guidelines for treating tobacco dependence and supporting smoking cessation (article available from http://www.tobaccopreventioncessation.com/pdf-142961-69727)
- General guidance on mapping actors in the field of electronic cigarettes, by Semmelweis University, provides a guide on how to identify national authorities and other organizations as well as stakeholders with e-cigarette-related legislative and scientific competences
- The Tobacco Data Lake: An IT system to monitor and perform economic analyses of tobacco and nicotine products, by Semmelweis University, highlights the concept of a novel complex tobacco IT system, a Tobacco Data Lake, and its potential in developing and performing economic analysis on all products under the TPD, including novel tobacco products
- Certain legislative aspects of national measures to implement TPD with regards to e-cigarettes and heated tobacco products, by Semmelweis University, aims to help national legislators and authorities to implement provisions of the TPD, with particular regard to the specificities of e-cigarettes and novel tobacco products
The sustainability proposals in the guidance documents concerned actions such as: a proportion of tobacco taxes might be allocated to tobacco control programs; to establish a sustainable fee for tobacco laboratories (FTL), using aliquots of the contribution to the costs for EU-CEG that will ensure the sustainability of independent EU laboratories; to collect EU-CEG maintenance fee that can partially cover the costs of the activities mentioned in the guidance documents and generally support the implementation of the TPD
In general, tobacco control policies outlined in the TPD were gradually implemented across the 27 EU MS (and the UK at that time), supported by central policy actions, European projects such as the Joint Action on Tobacco Control and by EU MS regulators’ efforts.
JATC 1 ended in December 2020, and the second three-year project (2021-2024) JATC 2 (Joint Action on strengthening cooperation between interested Member States and the Commission in the area of Tobacco Control) is currently underway.
