The participation of Istituto Superiore di Sanità in the Joint Action on Tobacco Control| Tabaccologia

Article

The National Centre on Addiction and Doping of Istituto Superiore di Sanità (ISS) participated in the three years (2017-2020) project Joint Action on Tobacco Control (JATC) funded by the European Commission, and under the coordination of the Hellenic Cancer Society – Greece [1].

The Tobacco Product Directive (TPD) entered into force on 19 May 2014 [2] and became applicable in the EU Member States (EU MS) on 20 May 2016, 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 [3].

The JATC was 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.

ISS participated in the activities of WP6, WP7, WP9 and later also in WP4 as coordinator for the last 10 months of the project.

In WP6, which aimed to handle aspects pertinent to tobacco product data handling collected by EU MS in light of the obligations of the TPD, ISS contributed as a reviewer of the questionnaire 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 (Task 1.1).

In WP7, which aimed to support the EU MS activities in ensuring that electronic cigarettes and refill containers are only placed on the market if they comply with the TPD, ISS reviewed the Checklist for e-cigarette product compliance to the TPD (Task 4.1), and held the coordination 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, ISS prepared a draft of a format for the reporting of suspected adverse effects (AE) on human health following the use of electronic cigarettes and refill liquids in line with Article 20(9) of the TPD, which was reviewed by WP7 partners. The form is described in the report D 7.4 Report on a proposed format for the reporting of adverse effects, where two versions of the form are reported: one for economic operators and one for competent authorities.

ISS also participated in WP9, which aimed to evaluate 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.

ISS collaborated in the creation of an independent review panel in charge of evaluating industry dossier and studies on priority additives in tobacco products (TPD Article 6 p.4), and facilitating the peer review process through discussion and definition of tasks, roles and evaluation strategy. ISS then contributed to the scientific review of 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), together with the 10 independent scientific experts and the other WP9 partners. The main findings of the peer review (described in the D 9.3 Reporting on the peer review of the enhanced reporting information on priority additives), were the followings:

1. insufficient quality of industry reports (not comprehensive) for which regulation should not be based solely on them;
2. 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;
3. additives may increase the risk for addiction or harm by promoting smoke inhalation and continuation of tobacco product use;
4. there is strong evidence that menthol (and its analogs such as geraniol) facilitates inhalation by activating the cooling receptor TRPM8;
5. titanium dioxide is classified as “carcinogen category 2” as of September 9th 2021.

Finally ISS coordinated 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) included the following documents related to the activities of WP 6, 7, 8, and to the TPD:

1. 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;
2. 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;
3. 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;
4. 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;
5. 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;
6. 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;
7. 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;
8. 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.

References

1. Joint Action on Tobacco Control.Publisher Full Text
2. Official Journal of the European Union. European Tobacco Product Directive 2014/40/EU. Directive of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC.Publisher Full Text
3. World Health Organization (WHO). World Health Organization Geneve; 2003. Publisher Full Text