Atti del XXIII Convegno Nazionale Tabagismo e Servizio Sanitario Nazionale
Pubblicato: 2021-08-31

Tobacco products and electronic cigarettes database

Ufficio 8 - Promozione della salute e prevenzione e controllo delle malattie cronico-degenerative Direzione generale della prevenzione sanitaria Ministero della Salute, Roma

Various regulatory measures originate the database containing all notifications of tobacco products and electronic cigarettes that want to be marketed by producers and distributors.

The main one is the European Tobacco Products Directive (ETPD) 2014/40/UE, which states that six months before marketing tobacco products (article 5), electronic cigarettes and refill liquids (article 21), producers and importers must notify member states providing a variety of information.

The details of sending methods and the information to be sent were then defined by two European Union (EU) implementing decisions, one for tobacco products (2015/2186) and one for electronic cigarettes and refill liquids (2015/2183), while the management of the database, run by the European Commission towards each single member state, was regulated by a Service Level Agreement (SLA). All these measures were then implemented in Italy with specific decrees.

The stakeholders involved in the management and use of the database are: the Directorate-General for Health and Food Safety (DG SANTE), which created the computer system, manufacturers and importers of tobacco products and electronic cigarettes and refill liquids, and then the competent authorities of the various member states (for Italy the Ministry of Health and Agenzia delle Dogane).

The system provides a central archive called Common Entry Gate (EU-CEG) which receives notifications from manufacturers and importers, which stores them on an offline server for security reasons and then sorts them in 27 national archives (one for each member state) to which are accessed only by persons authorized by the competent authority.

One of the aspects that made the management and use of this database complicated was the discord that arose between the need to make the information contained in the database public and the need to protect the trade secrets of manufacturers and importers.

In fact, Article 5 of the TPD provides that “Member States shall make the information submitted publicly available on a website. In making this information available to the public, Member States take due account of the need to protect trade secrets. Member States ask manufacturers and importers to specify, when submitting, the information they consider trade secrets”.

The Commission also describes the criteria for which certain information on flavorings, additives and ingredients other than additives cannot be considered trade secrets or confidential information.

Essentially, some thresholds are defined (different for each type of product) above which the presence of that aroma, ingredient or additive must be made public; studies on toxicity or on the ability to induce addiction can never be considered trade secrets.

This issue was explored by the Joint Action on tobacco products funded by the Commission in which 22 other member states participated together with Italy. Working group 5 of the Joint Action has prepared a report in which information is given on what is considered sensitive and, in their opinion, can be included in three groups:

  1. Public information that can be disclosed to all (for example the length of the product which can be measured by anyone);
  2. Conditionally public information that can be disclosed only based on certain criteria (for example the launch date of the product which can be found on the website but must only be published after it happened);
  3. Confidential information that must not be disclosed as a trade secret (e.g. information on product recall that could benefit competitors).

The TPD also requires member states to make the information contained in the European Union Common Entry Gate (EU-CEG) database available to all through a website. Thanks to the collaboration with the ISS, Italy was one of the first states to publish the website , website financed through three CCM projects for a total value of only 85,000 euros in 5 years.

What information does the EU-CEG database include?

The database, accessible only to the competent authorities through a secure network, is divided into two macro areas: tobacco products the first and electronic cigarettes and refill liquids the second. The database immediately displays a list of all the products present, which can be ordered and downloaded and, for each of them, notification details are accessible.

Each notification includes 6 groups of information, all linked by the product identification code:

  1. Information on the notifier (name, address, VAT number, etc.);
  2. Product information (type, length, weight, etc.);
  3. Information on how the product is presented (brand name, package type, launch date, etc.);
  4. Information on tobacco ingredients (leaf, drying, quantity, etc.);
  5. Information on other ingredients;
  6. Information on emissions (tar, nicotine, CO2). For each of these categories the notifier must attach various studies and reports (especially as regards the ingredients).

Some numbers

As of December 31st 2020, there were almost four thousand notifications of tobacco products (3,937) sent by 110 producers and importers. As regards the type of notification, in the first place there is the updating of periodic information (33.6%) followed by notifications of a new product (23.4%).

Notifications of e-cigarettes and refill liquids are 12 times more numerous (48,634), sent by 733 manufacturers and importers. The main type is the notification of a new product (30.5%) followed by the updating of periodic information (17.3%) and corrections to existing notifications (17.2%).

Among the types of tobacco products notified in the first place there are cigars, with 1,809 notifications (45.9%), followed by cigarettes (24.5%) and surprisingly by waterpipe tobacco (6.4%). In this regard it must be said that data concern notifications sent by producers that do not necessarily coincide with the products on the market, as the products may have been notified but not placed on the market yet.

For electronic cigarettes, the most notified products are refill containers or cartridges (69.3%) followed by refillable e-cigarette devices (7.7%) and tanks/atomizers/coils (7.5%).

Working group 7 of the Joint Action on tobacco products conducted, at the end of 2019, a study to verify the compliance of the notifications of electronic cigarettes with the forecasts of the TPD on the data of various European countries.

Concerning Italy the study found that there is substantial compliance (at least as declared by the manufacturers) regarding the volume and capacity of the containers (max 10 ml) and of the cartridges with refill liquid (max 2 ml) with only 55 non-compliant products out of 27,816 (0.2%); differently, regarding the volume and capacity of the tanks/atomizers/coils of electronic cigarettes the non-compliant results were 1,434 out of 6,740 (21.3%), more than 1 in five non-compliant with a median capacity equal to 4,5 ml, more than double that is allowed (2 ml). As for the nicotine concentration declared by the producers (Table 1), there seems to be a substantial conformity of the notified products, as only 54 notifications (0.2%) report a concentration higher than the permitted one (20 mg/ml).

The working group then analyzed the ingredients contained in the e-cig liquids (Table 2); among the 24,387 notifications that reported the presence of at least one ingredient, the average of the declared ingredients was 16, even though some notifications even reported 120.

As an indicator of the low quality of notifications, we can consider that over 5,000 notifications (18.2%) do not report the presence of even one ingredient. Among the most used ingredients there are propylene glycol, contained in 97.4% of the notified products, followed by glycerol (92.6%), nicotine (90.2%), vanilla (40.8%), water (35.9%), and ethyl butyrate (33.2%).

In conclusion, the construction and maintenance of the EU-CEG database by the European Commission allows member states to verify compliance with the rules of the TPD of tobacco products and electronic cigarettes and refill liquids, possibly in the 6 months between notification and placing on the market. The database also gives the possibility to analyze the type, quantities and characteristics of the ingredients contained for each type of product. Finally, it is possible to analyze the temporal trends for each individual brand (type of product, mix of ingredients, presence of additives and flavors, sales data, etc.).

However, the database has still many limitations, first of all the fact that the information sent is self-referenced by the producers and distributors: it should be checked on a sample basis on the products actually on the market. The large size of the database, combined with the confidentiality of some information, makes it difficult to use, especially since access is exclusively reserved to the competent authorities on a secure network, not accessible to everyone. The database was then built to verify the products contained and regulated by the TPD which dates back to 2014, and therefore all the products recently released on the market, such as devices of heated tobacco or products containing nicotine salts, are then excluded from the notification - and therefore from the controls.

Figures and tables

NOTIFICATORE 2016 2017 2018 2019 2020 Totale
Importatore 47 181 64 73 186 551 110 notificatori, 15 importatori, 95 produttori
Produttore 71 172 202 372 2.569 3.386
Totale 118 353 266 445 2.755 3.937
Tabella 1.Notifica e notificatore: tabacco.
TIPO DI NOTIFICA 2016 2017 2018 2019 2020 Totale
Aggiornamento delle informazioni periodiche (per esempio, vendite, quantità degli ingredienti) 4 28 87 1.205 1.324
Notifica di un nuovo prodotto 109 107 169 196 340 921
Aggiunta a una notifica già esistente (per esempio, mercato nazionale) 34 13 104 395 546
Rimozione di una notifica (incluso il ritiro del prodotto) 4 4 18 346 372
Correzioni di errori a una notifica già esistente 3 171 14 14 145 347
Modifica delle informazioni già notificate che NON hanno portato a un nuovo prodotto ID 3 17 9 277 306
Modifica sostanziale delle informazioni già notificate che hanno portato a un nuovo prodotto ID 6 30 21 17 47 121
TOTALE 118 353 266 445 2.755 3.937
NOTIFICATORE 2016 2017 2018 2019 2020 Totale
Importatore 1.210 3.264 2.112 2.468 1.750 10.804 733 notificatori, 72 importatori, 661 produttori
Produttore 6.843 9.029 4.455 12.034 5.469 37.830
Totale 8.053 12.293 6.567 14.502 7.219 48.634
Tabella 2.Notifica e notificatore: e-cig.
TIPO DI NOTIFICA 2016 2017 2018 2019 2020 Totale
Notifica di un nuovo prodotto 875 3.663 1.368 4.066 4.843 14.815
Aggiornamento delle informazioni periodiche (per esempio, vendite, quantità degli ingredienti) o prodotto 2.397 2.494 1.843 1.620 91 8.445
Correzioni di errori a una notifica già esistente 2.106 2.532 1.037 2.119 594 8.388
Aggiunta a una notifica già esistente (per esempio, mercato nazionale) 475 1.447 835 3.063 666 6.486
Rimozione di una notifica (incluso il ritiro del prodotto) 1.556 1.339 866 1.335 404 5.500
Modifica delle informazioni già notificate che NON hanno portato a un nuovo prodotto ID 636 724 561 2.267 599 4.787
Modifica sostanziale delle informazioni già notificate che hanno portato a un nuovo prodotto ID 8 94 57 32 22 213
TOTALE 8.053 12.293 6.567 14.502 7.219 48.634

Affiliazioni

Lorenzo Spizzichino

Ufficio 8 - Promozione della salute e prevenzione e controllo delle malattie cronico-degenerative Direzione generale della prevenzione sanitaria Ministero della Salute, Roma

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