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Directorate-General for Health and Food Safety

Health programme 2015

Study on the development of a EU common reporting format for

submission of data on ingredients contained in tobacco and related products, and disclosure of the

collected data to the public

Final Report

European Regulatory Science on Tobacco Consortium (EUREST)

Consumers, Health, Agriculture and Food Executive Agency

Edited by C Vardavas & P Behrakis

EUREST Consortium

11/2015



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Directorate D Health systems and products

Unit D.4 Substances of human origin and Tobacco control

E-mail: [email protected]

European Commission

B-1049 Brussels

European Commission B-1049 Brussels



Study on the development of a EU common reporting

format for submission of data on ingredients contained in

tobacco and related products

and disclosure of the collected data to the public

European Regulatory Science on Tobacco (EUREST)

Consortium

Led by the Biomedical Research Foundation of the Academy of Athens (BRFAA) in partnership with the European Network on

Smoking and Tobacco Prevention (ENSP)



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LEGAL NOTICE

This report was produced under the EU Health Programme (2008-2013) in the frame of a service contract

with the Consumers, Health, Agriculture and Food Executive Agency (Chafea) acting on behalf of the European

Commission.

The content of this report represents the views of EUREST and is its sole responsibility; it can in no way be

taken to reflect the views of the European Commission and/or Chafea or any other body of the European

Union.

The European Commission and/or Chafea do not guarantee the accuracy of the data included in this report,

nor do they accept responsibility for any use made by third parties thereof.

More information on the European Union is available on the Internet (http://europa.eu).

Luxembourg: Publications Office of the European Union, 2015

ISBN 978-92-9200-680-8

doi:10.2818/30286

European Union, 2015

http://europa.eu.int/citizensrights/signpost/about/index_en.htm#note1#note1

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Contents

1. ABSTRACT .................................................................................................................................... 6

2. EXECUTIVE SUMMARY ............................................................................................................ 7

3. RESUME EXECUTIF ................................................................................................................. 13

4. INTRODUCTION AND BACKGROUND .............................................................................. 20

5. OVERALL METHODOLOGY .................................................................................................... 21

6. FINDINGS AND METHODS PER WORK-PACKAGE ....................................................... 22

6.1 WP1 Detailed Methods and Results 22

6.1.1. Introduction 22

6.1.2 Methodological approach 22

6.1.3 Synopsis of EU-MS responses 23

6.1.4 Synopsis of Tobacco Industry Stakeholder feedback 25

6.1.5 Synopsis of E-Cigarette Industry Stakeholder responses 26

6.1.7 Synopsis of the International Experience 27


6.2.1 Introduction 28

6.2.3. Data Dictionary and its scientific justification. 30



6.3.2 Methodological Approach 33

6.4. WP4 Detailed Methods and Results 34


6.4.2 Methodological Approach 34

6.4.3 Synopsis of tobacco industry stakeholder feedback 35

6.4.4 Synopsis of e-cigarette industry stakeholder feedback 36

6.4.5. Cost/benefit analysis 37

7. CONCLUSIONS ......................................................................................................................... 42

8. ANNEXES ........................................................................................................................................

ANNEX A. Data dictionary for the proposed common EU reporting format for

tobacco products

ANNEX B. Data dictionary for the proposed common EU notification format for

electronic cigarettes and refill containers

ANNEX C: Data dictionary technical justification document

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1. ABSTRACT

The objective of the EUREST (European Regulatory Science on Tobacco) project was to

provide the Commission with a study concerning the development of an common reporting

format for submission of data on ingredients contained in tobacco and related products in

the EU and disclosure of the collected data to the public as laid down the provisions of the

Tobacco Products Directive (TPD). To address this objective, four work packages (WPs) were

designed.

The first WP aimed at providing an overview of the experience of regulators and stakeholders

with the current and previous reporting formats and mechanisms, for which a questionnaire

assessment was performed and supplemented by an evaluation of the status quo of

reporting formats in other non EU areas. Within WP2, through the triangulation of a) the

utilisation of the knowledge of the strengths and weaknesses of the current and previous

EU reporting formats, b) the evaluation of global best practices and potential public health

impact and c) the provisions of the TPD articles, we designed data dictionaries, which

propose a structure for the information to be requested. As the provisions of the TPD cover

both tobacco products and e-cigarettes with different reporting and notification obligations,

two separate data dictionaries were designed. Subsequently, in WP3, a pilot submission

system platform was developed that outlined the structure and key associations between

variables within each data dictionary. Finally in WP4 a qualitative evaluation of the cost

benefit projections for the proposed reporting format was performed.

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2. EXECUTIVE SUMMARY

One key aspect of the current Tobacco Products Directive (2014/40/EU) (TPD)1, which

the EUREST project specifically addresses, is the development of an EU common

reporting format for submission of data on ingredients contained in tobacco and

related products and disclosure of the collected data to the public. Indeed, the current

TPD stipulates that Member States (MS) require manufacturers and importers of

tobacco products to report on the ingredients used in such products, the ground for

their inclusion and relevant toxicological information. The TPD seeks to further

harmonise the approach on ingredients regulation in the context of the internal

market and to rationalise the reporting system for manufacturers and importers. In

this sense, it provides for a common and standardised electronic reporting format for

all Member States for the reporting of tobacco ingredients (Article 5), including both

tobacco leaf and additives (TPD Article 2(18)). The TPD also provides for a common

electronic notification format for electronic cigarettes and refill containers (Article 20).

In order to make the TPD fully operational and to keep up with future trends in the

tobacco sector, delegated and implementing powers are foreseen to amend or

supplement the basic act and to give effect or 'shape the rules' laid down in the basic

act. Accordingly, the Commission shall, by means of implementing acts, lay down

the common format for the submission and the making available of the required

information on tobacco products (Article 5(5)), as well as the common format for the

notification of the required information on e-cigarettes and refill containers (Article

20(13)).

The project was comprised of four work packages, which provide an opportunity for

both original data collection as also internal feedback between WPs, as outlined below

WP1: Assessed experience with current and previous reporting formats

WP2: Developed the common reporting format

WP3: Developed the pilot submission platform

WP4: Collected feedback and performed basic cost/benefit projections

The final and main deliverables of the EUREST project include a) two data dictionaries

that incorporate the domains to be reported within the common reporting format for

tobacco products and common notification format for e-cigarettes respectively and

b) the pilot submission platform that is built on the aforementioned data dictionaries

and facilitates the electronic submission of the data.

1 Directive 2014/40/EU 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. Available from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:127:TOC

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Summary of WP1

The objective of WP1 was to perform a critical appraisal and deliver an assessment

of the experience with a) the current reporting format based on the Practical Guide

implemented in 2007, and b) current and previous submission mechanisms used by

manufacturers to submit information to regulators at the EU MS level. To address

this objective an active data collection process was initiated during which

questionnaires were sent out to all 28 EU MS, a sample of Stakeholders from the

industry as well as non-governmental organisations (NGOs) within the European

Network for Smoking and Tobacco Prevention (ENSP).

The key take home points brought forward with regards to the current status quo

on the reporting of information by the industry to regulators were the following:

Submission process

Envelopes with combined paper/CD submissions were the most common

method of receiving submissions, with the majority of information within the

CDs. Only a few EU MS were receiving submissions through an online portal.

The aforementioned current process was rated as relatively unsatisfactory

with regards to the EU MS ability to check the data, access the data, perform

data extraction and perform comparisons with the data. EU MS indicated that

the implementation of an online submission platform would substantially

improve the capacity of EU MS to address the above functions.

The EU MS noted that submissions from the industry are received from

multiple parties including the headquarters, if it is an international company,

and external parties (i.e. laboratories, legal offices)

The majority of the EU MS noted that the submission mechanism, in its

current form, does not allow them to perform comparisons of ingredient data

either across time or across companies. This was attributed to the difficulties

in merging the different files and categories.

Most of the EU MS would be in favour of a common data depository to allow

the sharing of data, including a centralised data submission service.

Reporting format

Absolute adherence to Table 1-Product Information, of the common reporting

format for the submission of tobacco products ingredient information to

regulators2 as provided in the practical guide of 2007, was present in only a

percentage of EU MS

Both EU MS and stakeholders noted a gap in the ability to report unique

products, a gap that is still uncovered despite the existence of multiple

product recognition types, indicating the need to develop/design a new EU

wide reporting number for unique tobacco products.

Both EU MS and stakeholders provided suggestions on how to improve the

component categories of the tables of the common reporting format, including

a more detailed breakdown of product categories and new product functions.

Ingredients within tobacco products were reported with the use of multiple

parameters including the Chemical Abstract Service (CAS) number, common

name or FEMA format (Flavor and Extract Manufacturers Association of the

2 Reporting on tobacco product ingredients. PRACTICAL GUIDE Brussels, 31 May 2007. Available at:http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/practical_guidance_en.pdf

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United States). Industry stakeholders noted their preference towards the use

of the CAS number as the primary ingredient registration number.

Industry stakeholders noted that within Table 1 the information provided is

not analytically derived but based more on upstream information provided

to them by suppliers.

Table 2-Toxicological data of the common reporting format, is currently not

used to full extent by regulators due to a lack of time indicating the

importance of generating predefined flagged parameters during

toxicological reporting.

E-cigarettes were addressed separately during the data collection process due to the

fact that no reporting format is currently in place. Key points of their feedback

included the following:

Stakeholders noted the multiple types of products on the market that would

have to be reported and also the multiple types of hardware combinations,

especially for modifiable electronic cigarettes. All these parameters would

need to be taken into consideration when reporting a unique product.

E-cigarette stakeholders noted that to some extent liquids from providers are

also used, while quality control testing is performed by a number of

stakeholders, especially for ingredients that may be of greater risk.

The large number of existing e-cigarette products, and their combinations, on

the EU market must be taken into account in the evaluation and reporting of

emissions. As there is no standard for measuring these emissions, each

company currently uses different testing protocols.

Modifications to the existing Table 1- ingredient information would be

necessary so as to facilitate the reporting of e-cigarette ingredients (i.e. in

ingredient categories, function etc.)

International best practices from Canada, Brazil and the US were also assessed in

WP1 so as to identify what other aspects are routinely reported and of public health

importance - by the industry to regulators outside the EU. Such areas included, but

were not limited to, the way submissions are performed, fees and expenses, the

flagging of priority additives, design parameters and ingredient/emission analyses.

Summary of WP2

The aim of WP2 was to develop a new

common reporting/notification format for

electronic reporting, by manufacturers and

importers of tobacco products. This should

allow for the reporting of ingredients and

quantities thereof, used in the manufacture

of the tobacco products, herbal products for

smoking and electronic cigarettes (including

refill containers) by brand name and type, as

well as their emissions and yields to national

regulators so as to monitor and evaluate

products and assess their potential impact

on public health.

Within WP2, through the triangulation of a) the utilisation of the knowledge of the

WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

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strengths and weaknesses of the current and previous EU reporting formats as

collected through WP1, b) the potential public health importance of reporting specific

parameters of tobacco products and c) the provisions of the TPD, we designed

parameters which outline the information to be requested under the proposed EU

common reporting/notification format.

As the articles of the TPD cover both tobacco products and e-cigarettes with different

reporting/notification obligations, two separate data dictionaries were designed

for these products. These two data dictionaries, which are presented in detail within

ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report, were

supported by a detailed assessment of the rationale behind the inclusion of each of

the parameters included (ANNEX C)

The data dictionaries are the main outcome of all work performed under the

framework of this specific tender as they present proposed EU common

reporting/notification formats for submission of data on ingredients contained in

tobacco products and e-cigarettes and their refills. Ultimately the aim of the two data

dictionaries is to provide background documents that can be consulted to understand

what information is to be requested in the common reporting/notification formats,

for both tobacco products and e-cigarettes. In general the data dictionaries were

comprised of specific domains, which correspond to different categories of

information that is to be reported/notified. These domains include:

a. Submitter Characteristics. This functional domain provides regulators with a

clear picture of who is submitting the product information, with the use of a

submitter-ID, which is a unique ID provided to each submitter of products

so as to chart the association between multiple companies that may market

identical products under different names. This Submitter ID is provided within

an offline procedure.

b. Product Submission and Description. Within this domain, the notion of a

Product-ID is brought forward which is used as the key to identify unique

products (products with a specific combination of ingredients and design

parameters) and to monitor product changes and the flow of uploading of new

information to the central reporting system. This key would also include

information on the submitter, the year and the product version. Hence by

changing the information within this Product ID one can monitor product

development and the flow of information towards regulators. For instance a

modification to a recipe or alteration of a reported design feature would lead

to a change of this product ID for tobacco or e-cigarettes products as the

product itself would not be the same. On the other hand a submission of new

information/data on an existing product (including a change in the external

packaging) NOT leading to a modification in recipe or design would not change

the product ID, but update the product version number. Within this section

product design/ingredients were separated from product external

presentation (packaging) to allow for the reporting of products that are

identical (as defined above) in different types of packages, without the need

to perform multiple product submissions for each external presentation.

c. Description of Ingredients (tobacco and additives): These two domains

consist of the variables related to the reporting of tobacco leaf and additives.

Details on a number of parameters related to tobacco parts used in tobacco

products are requested here as well as their relative concentrations within the

final product. With regards to additives, an important aspect within this

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domain is the ability to monitor their potential fluctuation, within a specific

production timeframe a key aspect in tobacco product monitoring. This

section additionally contains detailed toxicological information for the

regulator, in the form of an easy to use checklist.

d. Emissions: This domain covers the reporting of emissions for tobacco

products as also for e-cigarettes. As no current emission protocol for e-

cigarettes exists, EUREST suggests testing the product for which information

is being submitted with a separate compatible product (hardware or liquid).

e. Product specific domains. The final section of the data dictionary is modified

according to the product which is being reported. Within this section product

specific parameters are requested.

Summary of WP3

Subsequently, in WP3 a pilot submission system platform was developed outlining

the structure and key associations between variables as outlined in the data

dictionaries produced during WP2. In short, WP3 was comprised of 4 consecutive

phases as follows

a) An inception phase: During which the translation of the data dictionaries into the

tangible requirements for an electronic platform were produced. During this phase,

the main entities, action types, use cases and functional requirements were outlined

and agreed upon. The main outcome of this phase was the Use Case document.

b) The design phase: The design of the pilot electronic platform included the

translation of the requirements as gathered in the analysis, to detailed technical

specifications for the final product. The main deliverable of this phase was the Data

Model. The data model organizes the variables of the data dictionary and

standardizes how these data elements relate to each other, hence determining the

structure of the presented data.

c) Implementation: This is the phase that the pilot electronic platform was developed

according to the design which was produced during the previous phase.

Implementation was based on Oracle/ Computer industry specific and technical best

practices and standards to produce a deliverable that is covering all requested

requirements and can be considered as a high end application. The final result of the

implementation phase was the User Guide.

d) Testing: The final stage of the process for creating the EUREST electronic reporting

system was the testing and optimization of the functional product. Based on

predefined test cases, the pilot product was delivered internally for testing of the

various use cases.

The deliverable of WP3 was the verified Application in its official format.

Summary of WP4

The overall aim of WP4 was to provide feedback on the ongoing processes developed

within the previous work packages as also to perform a qualitative cost benefit

assessment of the proposed reporting/notification format and submission

mechanism.

Two aspects of research were performed under WP4. The first aspect was to perform

a data collection activity to obtain feedback on draft working versions of the data

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dictionary from a convenience sample of e-cigarette and tobacco industries. The

results of these questionnaires were critically appraised by EUREST experts and

constructive comments were incorporated into the data dictionaries of WP2. The

second aspect of WP4 was to perform a basic qualitative assessment of the cost

effectiveness of the proposed solution, with feedback also from EU MS. Key

conclusions of this process include:

The slightly increased administrative burden resulting from the increased

number of parameters that would be requested would nevertheless be

substantially less than if the current status quo of CD/paper submissions

continued, with the prerequisite that the submission process across Member

States could be unified to the extent possible.

In light of the above central submission system, costs that are foreseeable

are those related to the facilitation of an IT system at a national level and

include hardware and software costs as also costs for IT personnel to staff

the system.

The administrative burden for national regulators and the Commission from

the adoption of a common reporting/notification format and accompanying IT

submission system is proportionate compared to the obtainable benefits for

the internal market and public health.

Industry costs would be of two types, one related to the one-off costs of

setting up of the system and one related to the recurring costs, both of which

were regarded as limited if the submission process across Member States

could be unified as mentioned above and if solutions for both SMEs (e.g.

pdf/web submissions) and large system to system XML batch uploading for

larger submitters are provided.

Parameters deployed in the data dictionaries would potentially save time and

costs for both the regulators and the industry. Such parameters include the

use of a common product IDs across EU MS, the ability to transfer information

between products of the same industry.

Finally the proposed common reporting/notification format would significantly

increase the information on tobacco product/e-cigarette constituents, design

parameters and characteristics that would fuel product regulatory science both

at a European level and aid the protection of European public health.

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3. RESUME EXECUTIF

Un des aspects cl de la Directive actuelle (2014/40/EU) relative aux produits du tabac

(TPD)3, qui fait lobjet du projet EUREST, est le dveloppement en commun dun modle

europen de transmission de donnes sur les ingrdients contenus dans le tabac et produits

associs et la publication auprs du grand public de ces donnes recueillies. En effet, la TPD

actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs

de produits du tabac la dclaration des ingrdients utiliss dans leurs produits, les raisons

pour leur utilisation et les informations relatives leur toxicit. La TPD rvise vise

harmoniser encore plus lapproche de rglementation des ingrdients dans le contexte du

march intrieur et rationaliser le systme de dclaration des fabricants et des importateurs.

En ce sens, elle prvoit un modle commun et standardis de dclaration lectronique,

destin tous les Etats membres pour la dclaration des ingrdients du tabac (Article 5), y

compris les feuilles de tabac et les additifs (TPD Article 2(18)). La TPD prvoit aussi un

modle commun de notification lectronique pour les cigarettes lectroniques et les flacons

de recharge (Article 20).

Afin de permettre la TPD rvise dtre compltement oprationnelle et jour avec les

nouvelles tendances dans le secteur du tabac, il est prvu que les pouvoirs dlgus et

dexcution changent ou compltent lacte de base et donnent effet ou faonnent les rgles

inscrites dans lacte de base. Ainsi, la Commission doit, travers des actes dexcution,

tablir un modle commun pour la dclaration et mettre disposition les informations

requises lis aux produits du tabac (Article 5(5)), ainsi que le modle commun pour la

notification des informations requises des cigarettes lectroniques et flacons de recharge

(Article 20(13)).

Le projet est compos de quatre tches de travail (WP), qui permettent le recueil de donnes

ainsi que lchange interne des informations entre les diffrents WPs, tel que le montre le

schma ci-dessous.

WP1 : Evaluation de lexprience avec les modles de notification actuels et passs

WP2 : Dveloppement dun modle commun de dclaration

WP3 : Dveloppement de la plateforme test pour la transmission

3 Directive 2014/40/EU 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. Available from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:127:TOC

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WP4 : Recueil des commentaires et ralisation des analyses de lvaluation de cot

par rapport aux avantages

Les lments livrables les plus importants et dfinitifs du projet EUREST sont : a) deux

dictionnaires de donnes comprenant les champs dclars dj inclus dans le modle

commun de dclaration des produits du tabac et le modle commun de notification des

cigarettes lectroniques et ; b) la plateforme test de transmission, construite partir des

dictionnaires de donnes prcdemment cits et simplifiant la transmission lectronique des

informations.

Rsum du WP1

Lobjectif du WP1 est dtablir une analyse critique et fournir une valuation de lexprience

: a) du modle actuel de dclaration bas sur le Guide Pratique mis en application en 2007

et, b) des mcanismes actuels et passs utiliss par les fabricants pour soumettre les

informations aux instances de rglementation au niveaux des EM europens. Afin datteindre

cet objectif, un processus actif de recueil de donnes a t initi, durant lequel un

questionnaire fut envoy tous les 28 EM europens, un chantillon de les intervenants de

l'industrie ainsi que les organisations non-gouvernementales (ONG) du rseau de lENSP

(European Network for Smoking and Tobacco Prevention).

Les points cls retenir concernant la situation actuelle de dclaration des informations de

lindustrie aux instances de rglementation sont :

Processus de transmission

Les transmissions par enveloppes comprenant des papiers et CD taient le plus

souvent utilises, avec la majorit des informations grave sur des CDs. Seulement

une poigne dEM recevaient les informations par des portails onlines.

Le processus actuel susmentionn fut considr comme insatisfaisant en ce qui

concerne la possibilit des EM europens vrifier les informations, y accder,

extraire les donnes et effectuer des comparatifs. Les EM europens ont dclar

que la mise en place dun systme de dclaration online pourrait considrablement

amliorer leur capacit rgler les problmes prcdemment cits.

Les EM europens ont not que les dclarations reues de lindustrie provenaient de

diverses parties, y compris des siges sociaux, lorsquil sagissait dentreprises

internationales, et aussi des acteurs externes, telles que des laboratoires et des

services juridiques.

La majorit des EM europens ont remarqu que le processus de notification tel quel,

ne leur permettait pas deffectuer des analyses comparatives de diffrentes donnes

des ingrdients, sur un lapse de temps ou entre les entreprises. Ceci est d la

difficult de fusionner les diffrents fichiers et catgories.

La plupart des EM europens seraient favorables une banque de donnes

commune, ce qui permettrait lchange de donnes, y compris un service central de

transmission de donnes.

Modle de dclaration

Adhsion absolue au tableau 1 Information sur le produit, du modle de

transmission dinformation sur les ingrdients des produits du tabac aux instances

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de rglementation4, comme prvu dans le Guide Pratique de 2007, ntait respecte

que dans un pourcentage des EM europens.

Les EM europens ainsi que les parties intresses ont remarqu limpossibilit de

dclarer des produits uniques, une impossibilit non rgle malgr lexistence de

multiples moyens de reconnaissance des produits, ce qui indique un besoin de

dvelopper/concevoir un nouveau numro uniques de transmission pour les produits

du tabac au niveau europen.

Les ingrdients contenus dans les produits du tabac sont dclars travers

lutilisation de paramtres multiples, y compris le numro du Chemical Abstract

Service (CAS), nom commun ou bien le numro FEMA (Flavour and Extract

Manufacturers Association des Etats-Unis). Les intervenants de lindustrie ont

exprim leur prfrence pour lutilisation du numro de CAS en tant que numro

principal denregistrement des ingrdients.

Les intervenants de lindustrie ont expliqu que dans le tableau 1, les informations

fournies nont pas t tablies de manire analytique mais plutt bases sur des

informations en amont , qui leur a t communiques par les fournisseurs.

Tableau 2 les donnes toxicologiques du modle commun de dclaration ne sont

actuellement pas utilises dans leur potentiel maximal par les instances de

rglementation, d un manque de temps, ce qui indique limportance de gnrer

des paramtres signals prdfinis lors de la dclaration toxicologique.

Les cigarettes lectroniques ont t abordes sparment pendant le processus de collecte

des donnes, en raison de labsence actuelle dun modle de notification. Les points cls de

leurs commentaires sont :

Les parties intresses ont remarqu les nombreux types de produits sur le march

qui doivent tre dclars, et les nombreux types de saccessoires, notamment pour

les cigarettes lectroniques modifiables. Tous ces paramtres doivent tre pris en

considration lors que la dclaration dun produit unique.

Les parties intresses des cigarettes lectroniques ont remarqu que jusqu un

certain point, les liquides des fournisseurs sont aussi utiliss, alors que les contrles

de qualit sont effectus par les parties intresses, et notamment pour les

ingrdients qui comporteraient des risques plus levs.

Le nombre lev de produits de cigarettes lectroniques, et leur combinaison, sur le

march europen doit tre pris en compte dans lanalyse et la communication des

donnes dmission. Comme il ny a pas de critres pour mesurer ces missions,

chaque entreprise utilise actuellement des protocoles danalyse diffrents.

Changements dans le tableau 1 existant des informations sur les ingrdients

seraient ncessaires afin de faciliter le dclaration des ingrdients contenus dans les

cigarettes lectroniques (telles que les catgories dingrdients, leurs fonctions, etc.)

Des pratiques exemplaires du Canada, du Brsil et des Etats-Unis ont aussi t values

dans le WP1 afin didentifier dautres lments systmatiquement dclars et tant dune

importance pour la sant publique par lindustrie aux instances de rglementation en

dehors de lUnion Europenne. Ces lments comprenaient entre autres, la faon dont les

4 Transmission d'informations sur les ingrdients des produits du tabac. GUIDE PRATIQUE Bruxelle, 31 Mai 2007. Disponible: http://health.belgium.be/internet2Prd/groups/public/@public/@dg4/documents/ie2divers/19071572_fr.pdf

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dclarations sont faites, les taxes et les frais, le signalement des additifs prioritaires, les

paramtres de design et les analyses des ingrdients/missions.

Rsum du WP2

Le but du WP2 est de dvelopper un nouveau modle

commun de dclaration/notification pour la dclaration

lectronique des fabricants et des importateurs de

produits du tabac. Ceci doit permettre la dclaration

des ingrdients et des quantits utiliss dans la

fabrication des produits du tabac, des produits fumer

base de plantes et des cigarettes lectroniques (y

compris les flacons de recharge), par marque et par

type, ainsi que leurs missions et teneurs, aux

instances de rglementation nationales, afin de

contrler et dvaluer les produits, et analyser leur

impact ventuel sur la sant publique.

Dans le WP2, travers la triangulation de a) lutilisation des connaissances des forces et

faiblesses des modles europens actuels et passs, recueillis grce au WP1, b) limportance

potentielle pour la sant publique de dclarer des paramtres spcifiques des produits du

tabac et c) les dispositions de la TPD, nous avons labor des paramtres qui soulignent les

informations requises travers cette proposition de modle commun europen de

dclaration et notification.

Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes

lectroniques avec des obligations de dclaration/notification diffrentes, deux

dictionnaires distincts de donnes ont t conus pour ces produits. Ces deux

dictionnaires de donnes, prsents de manire dtaille en ANNEXE A (produits du tabac)

et ANNEXE B (cigarettes lectroniques) de ce rapport, ont t tays par une valuation

approfondie des raisons pour la prise en compte de chaque paramtre utilis (ANNEXE C).

Les dictionnaires de donnes sont les rsultats principaux du travail effectu dans le cadre

de cet appel doffre, puisquils proposent des modles communs europens de

dclaration/notification pour la transmission de donnes sur les ingrdients contenus dans

les produits du tabac et les cigarettes lectroniques et leurs recharges.

Le but final des deux dictionnaires de donnes est de fournir des documents de rfrence

qui peuvent tre consults et permettent de comprendre quelles informations doivent tre

exiges dans les modles commun de dclaration/notification, pour les produits du tabac

ainsi que les cigarettes lectroniques. De manire gnrale, les dictionnaires de donnes

ont t constitus par des domaines spcifiques, qui correspondent des catgories

dinformations tre dclares/notifies. Ces domaines comprennent :

a) Les caractristiques de lauteur de la transmission (le transmetteur). Ce domaine

fonctionnel permet aux instances de rglementation davoir une ide prcise de qui

a effectu la transmission des informations du produit, laide dun submitter-ID

( identifiant-transmetteur ), unique chaque personne qui dclare/notifie un

produit, afin de visualiser les liens entre les entreprises multiples qui commercialisent

un produit identique avec des noms diffrents. Ce Submitter-ID est gnr travers

une procdure offline.

WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donnes

Pertinance sur la Sant Publique

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b) La transmission et la description des produits. Sous ce domaine, la notion dun

Product-ID ( Identifiant-Produit ) est mise en avant et utilise comme la cl

pour identifier les produits uniques (produits avec une mlange spcifique

dingrdients et de paramtres de design) et pour contrler les changements

effectus sur produits et le flux dinformations tlcharges dans le systme central

de transmission. Cette cl comprendrait aussi des informations sur le transmetteur,

lanne et la version du produit. Cest pourquoi en changeant les informations dans

ce Product-ID, il est possible de suivre le dveloppement des produits et le flux

dinformations destines aux instances de rglementation. Par exemple, un

changement dans la recette ou une modification dans les caractristiques de design

rsulterait un changement du Product-ID pour les produits du tabac ou les

cigarettes lectroniques, puisque le produit en lui-mme ne serait le mme. Dun

autre ct, une transmission de donnes/informations nouvelles sur un produit dj

existant (y compris un changement au niveau du packaging externe) SANS donner

lieu une modification de la recette ou du design, ne changerait pas le Product-ID,

mais mettrait jour le numro de version du produit. Dans cette section, le design

et les ingrdients du produit ont t spars de la prsentation externe du produit

(packaging) afin de permettre la dclaration des produits identiques (comme

dfinis prcdemment) dans diffrents types de packaging, sans avoir besoin de faire

des dclarations de produits multiples pour chaque paquet externe.

c) La description des ingrdients (tabac et additifs). Ces deux domaines sont composs

de variables associs la dclaration des feuilles de tabac et des additifs. Des dtails

sur le nombre de paramtres associs aux parties du tabac utilises dans les produits

du tabac sont demands ici, ainsi que leurs concentrations relatives dans le produit

fini. En ce qui concerne les additifs, un aspect important dans ce domaine est la

possibilit de contrler leurs fluctuations potentielles, pendant un dlai de production

spcifique un aspect essentiel dans le contrle des produits du tabac. Cette partie

contient galement des informations toxicologiques dtailles pour les instances de

rglementation, sous la forme dune checklist facile utiliser.

d) Les missions. Ce domaine aborde la dclaration des missions des produits du

tabac, ainsi que des cigarettes lectroniques. Comme il nexiste actuellement pas de

protocole pour les cigarettes lectroniques, EUREST propose de tester le produit pour

lequel les informations sont transmises avec un produit compatible distinct

(accessoire ou liquide).

e) Les domaines spcifiques au produit. La dernire partie du dictionnaire des donnes

est modifie selon le produit qui est dclar. Dans ce chapitre, des paramtres

spcifiques des produits sont exigs.

Rsum du WP3

Dans le WP3, une plateforme test dun systme de transmission a t dveloppe, en

prcisant la structure et les principales associations entre les variables, ainsi soulign dans

les dictionnaires donnes gnrs lors du WP2. En un mot, le WP3 comprenait les 4 tapes

conscutives suivantes :

a) Une phase de dmarrage : Durant laquelle les dictionnaires de donnes ont t traduits

en des besoins concrets pour la plateforme lectronique. Au cours de cette tape, les

principales caractristiques, les types dactions, les cas dutilisation et les exigences

fonctionnelles ont t dfinis et convenus. La principale ralisation de cette phase fut

le document sur les cas dutilisation.

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b) La phase de conception : La conception de la plateforme lectronique test comprenait

la traduction des exigences ainsi recueillies dans l analyse, en caractristiques

techniques dtaills pour le produit final. Le rsultat principal de cette phase cest le

Model de Donnes . Le modle de donnes classe les variables de chaque

dictionnaire de donnes et normalise les lments de donnes les uns avec les autres,

do le besoin de dterminer la structure des donnes prsentes.

c) La mise en uvre : Cest ltape o la plateforme lectronique test est dveloppe selon

le design labor dans ltape prcdente. La mise en uvre fut base sur les

meilleures pratiques et rfrences spcifiques et techniques de lindustrie

informatique/Oracle, afin dobtenir un produit qui rponde toutes les exigences et qui

soit considr comme un programme de trs haut niveau. Le dernier rsultat de la

phase de mise en uvre est le Mode dEmploi.

d) La phase de test : La dernire tape dans le processus de cration dun systme de

notification lectronique EUREST est la phase de test et doptimisation du produit

fonctionnel. A partir de tests prdfinis, le produit test fut livr en interne pour tester

les diffrents cas dutilisation.

Llment livrable du WP3 est lapplication vrifi dans son format officiel.

Rsum du WP4

Le but gnral du WP4 tait de fournir des retours sur le processus de dveloppement au

sein des tches de travail prcdents, ainsi queffectuer une valuation cot/bnfices du

modle de dclaration/notification et du mcanisme de transmission.

Deux aspects de recherche ont t effectus par le WP4. Le premier aspect tait de recueillir

des donnes afin de dobtenir des commentaires sur les versions provisoires des

dictionnaires de donnes dun chantillon de commodit dindustries du tabac et de

cigarettes lectroniques. Les rsultats de ces questionnaires furent analyss de manire

critique par des experts dEUREST et des commentaires constructifs furent incorpors dans

les dictionnaires de donnes du WP2. Le second aspect du WP4 tait deffectuer une analyse

qualitative de base du rapport cot/efficacit de la solution propose, avec les commentaires

des EM europens. Les principales conclusions de ce processus sont :

La lgre augmentation des frais administratifs, lis laugmentation du nombre de

paramtres exigs, mais considrablement moins que le systme actuel si les

transmissions continuent tre effectues par CD/papier, condition que le

processus de transmission entre les tats membres soit unifi autant que possible.

Compte tenu du systme central de transmission ci-dessus, les cots prvisibles sont

ceux lis la mise en place dun systme informatique au niveau national et

comprennent les cots de matriel et de logiciels, ainsi que les cots du personnel

informatique, employ pour le systme.

Les frais administratifs pour les instances de rglementation nationales et la

Commission, partir de ladoption du modle commun de dclaration/notification

et le systme de transmission informatique qui laccompagne, sont proportionnels

comparativement aux bnfices engendrs pour le march interne et la sant

publique.

Les cots pour lindustrie seraient de deux sortes : le premier tant li des frais

ponctuels pour la mise en place du systme et lautre li des cots rcurrents, tous

deux peuvent tre minimaliss si le processus de transmission entre les tats

membres est unifi, comme prcdemment mentionn, et si les solutions sont

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prvues aussi bien pour les PME (par exemple PDF/transmission web) que pour les

gros transmetteur (les grands systmes et systme XML de tlchargement en lot).

Les paramtres dploys dans les dictionnaires de donnes vont potentiellement

faire gagner du temps et de largent aussi bien pour les instances de rglementation

que lindustrie. De tels paramtres impliquent lutilisation de Product-ID communs

dans les tats membres europens, la possibilit de transfrer les informations entre

les produits de la mme industrie.

Et enfin, le modle de dclaration/notification commun suggr augmenterait

considrablement les informations sur les composants dans les produits du

tabac/cigarettes lectroniques, concevrait des paramtres et caractristiques qui

alimenterait les sciences rglementaires des produits au niveau europen, tout en

aidant la protection de la sant publique europenne.

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4. INTRODUCTION AND BACKGROUND

The objective of this project was to provide the Commission with a study which will

propose a common mandatory format and a pilot submission platform for electronic

reporting of ingredients and emissions by manufacturers to national authorities and

mechanisms for their dissemination to the general public as laid down the provisions

of the TPD. The TPD foresees a common electronic reporting format for all Member

States or the reporting of tobacco information from the industry to the regulators

and then to the general public. Comprehensive information on ingredients and

emissions to assess, addictiveness, toxicity and potential characterising flavours of

these products and the risks to health associated with their consumption should allow

Member States and the Commission to exercise their legal obligations to facilitate

the internal market and obtain a high level of public health.

The TPD outlines the prerequisite to submit information on ingredients (article 5),

including both tobacco leaf and additives. Moreover, article 5(6) requires

manufacturers and importers to submit internal and external studies available to

them on market research and preferences of various consumer groups, including

young people and current smokers, as well as executive summaries of any market

surveys they carry out when launching new products. Manufacturers and importers

are also required to report the sales volume data per product. In addition article 6

foresees that more detailed information needs to be provided for additives put on a

priority list. Similarly to the reporting of tobacco products, the TPD also provides the

framework, via Article 20(2), for the reporting of parameters related to electronic

cigarettes and their refill containers.

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5. OVERALL METHODOLOGY

Overall Approach

Through a cyclic process there was a specific amount of feedback between individual work

packages of the EUREST tender, as outlined in the Figure 2 below. Specifically, the

information collected from WP1 supported the development of WP2 and WP3 draft

documents and deliverables, while the feedback process of WP4 provided information that

enriched the deliverables of WP2 and WP4.

While presented in detail within the next chapter, in short, the methodological approach

used throughout the EUREST tender was as follows:

WP1: Experience with current and previous reporting formats

Questionnaire assessment to EU MS regulators and stakeholders

Researcher evaluation of the status quo of reporting formats in other areas

WP2: Development of the common reporting format

Researcher evaluation of information collected in WP1

Researcher evaluation of best practices applied.

Researcher review of domains with direct relevance to public health.

Internal EUREST group evaluation.

WP3: Development of the pilot submission platform

IT development of the structure and prerequisites needed to develop the pilot

submission system platform.

IT development of the key associations between aspects to be reported.

WP4: Feedback process and basic cost/benefit projections

Questionnaire feedback assessment from EU MS regulators and stakeholders

Qualitative evaluation of the cost/benefit of each aspect included with a focus on the

impact on European public health

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6. FINDINGS AND METHODS PER WORK-PACKAGE

6.1 WP1 Detailed Methods and Results

6.1.1. Introduction

The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of

the experience with 1) the current reporting format based on the Practical Guide

implemented in 2007, and 2) current and previous submission mechanisms used by

manufacturers to submit information to EU MS regulators. This was complimented by a

critical appraisal of the evidence and the assessment of existing formats and international

experience.

This aim was addressed through the combination of four questionnaire assessments:

One to European Union Member State regulators(EU MS)

One to tobacco industry stakeholders (TIS)

One to e-cigarette industry stakeholders (ECIS)

One to Non-governmental organisations (NGOs)

In addition to the above, in depth interviews were performed with selected EU MS

regulators, while experts within the EUREST consortium from non-EU countries provided

insight and their experience with established reporting formats implemented in their

jurisdiction.

6.1.2 Methodological approach

In order to record the experience with the current reporting format and submission

mechanisms, regulators in all 28 EU MS were contacted and provided with a questionnaire.

This questionnaire covered the EU MS experience with the current reporting mechanism

(Domain 1 of the questionnaire), current reporting format (Domain 2), its current utility

(Domain 3) for which additional information to improve its utility was requested (Domain

4). Finally Domain 5 of the questionnaire covered experience with the reporting format

developed by the Electronic Model Tobacco Control (EMTOC) project for those that had

experience with that electronic submission system.

EU MS feedback

Overall, regulators from 24 of the 28 MS (86%) responded to our data collection request.

During the procedure of data synthesis, regulators from three MS of the 24 that agreed to

participate were contacted additionally via phone and provided in-depth responses which

provided further details to their written responses.

Industry feedback

The rationale behind this activity was to obtain information from TIS and ECIS on mainly

technical information that would aid the development of the new reporting format and

electronic submission platform. For this purpose a structured questionnaire was also created

and sent to a convenience sample of TIS and ECIS that operate in EU MS. This questionnaire

requested information on current protocols and analyses (Domain 1), methods of

constituent identification (Domain 2), aspects of unique product identification (Domain 3),

trade secrets and market information (Domain 4) and an area for other comments.

A total of 11 TIS provided feedback, 9 out of 15 initially contacted and two more which

offered to respond to the questionnaire. With regards to ECIS 8 were contacted, of which 5

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responded, however additional requests during the data collection process were made from

an additional 6 ECIS, 4 of which provided feedback. In total 10 ECIS returned a completed

questionnaire, the responses of which were evaluated.

NGO Feedback

For this purpose of obtaining information from non-governmental organization (NGO) which

are active in tobacco control, a limited NGO data collection activity was performed among

member organisations of the European Network for Smoking and Tobacco Prevention

(ENSP). Responses were received from 6 NGOs, who were invited to provide their feedback

on a number of aspects related to the relationship between access and use of data released

to the general public.

6.1.3 Synopsis of EU-MS responses

1. Combined Paper/CD submissions were the most common method of receiving

information on tobacco product ingredients in 2013, with electronic submissions (via

email or EMTOC) the second most common reporting method. While three EU MS

had approximately 50% of submissions in paper only format, the majority of EU MS

received >80% of their submissions via CDs. CDs were commonly password

protected.

2. With regards to comparing the perceptions of EU MS on their ability to check the

data, access the data, perform data extraction and perform comparisons with the

data, a specific trend across EU MS was noted, with the highest scores noted for the

EMTOC submission platform> by email submissions > CD submissions > combined

paper/CD submissions > paper submissions. Overall in all cases the EMTOC

submission platform, as the only online submission system, scored higher than all

other mechanisms in all of the domains noted.

3. Among EU MS using the EMTOC submission platform, specific domains of utility were

assessed. Positive aspects of the EMTOC system included the collection of

comparable data in an electronic format, a high level of security, mass upload

capacity (XML), and the fact that the system forces the user to complete all fields.

Drawbacks of the EMTOC submission platform that were noted include the complexity

of obtaining annually a smart card, its administrative and technical needs,

maintenance aspects and financial costs, its limited use throughout the EU and its

inability to produce predefined reports. These issues would need to be addressed in

an updated submission platform.

4. With regards to product submissions to EU MS, the majority of MS stated that tables

of ingredient data and supporting files that the industry submits are completed by

the international headquarters of each industry. However tables and supporting files

are also directly sent to them by external parties (i.e. laboratories) on behalf of the

industry. Legal offices were also mentioned. This broad spectrum of users verifies

the need to be able to document and record the details of these submitting parties,

via a central submission office.

5. Absolute adherence to Table 1-Product Information, of the common reporting format

for the submission of tobacco products ingredient information to regulators5 as

5 Reporting on tobacco product ingredients. PRACTICAL GUIDE Brussels, 31 May 2007. Available at:http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/practical_guidance_en.pdf

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provided in the practical guide of 2007, was present in 10/24 of EU MS that

responded, with the majority noting that while most companies comply with Table 1

data submissions for their products, some gaps exist. Blank responses within specific

columns and/or submissions in non-tabular format were identified as potential issues

to be addressed in a potential updating of the reporting format or submission

platform. With regards to the submission language of Table 1 data, the majority of

submissions were in English with some, albeit limited, evidence of intra-EU language

submissions.

6. With regards to component categories of Table 1, discrepancies in the reporting of

Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity

values (Table 1- Column 14) were often non consistently reported across companies

while the numbers provided were not always accompanied by any methodology of

how they are were defined. With regards to Ingredient Functions (Table 1 - Column

15), potentially additional functions were proposed for inclusion.

7. The most commonly used format of ingredient submissions in Table 1 either included

a Chemical Abstract Service (CAS) registration number or was only of CAS

registration format. The most common reporting format after CAS was of FEMA

format (Flavor and Extract Manufacturers Association of the United States).

8. With regards to the utility of Table 1 data, 12/18 of EU MS reported that they were

able to use the ingredient data from the industry. On the contrary the majority had

never compared ingredient data either between products or between years. Notably,

issues of time and resources were brought up as the rationale behind this gap, an

issue which may be addressed when developing a new reporting format and

submission mechanism. The aspect of lack of time or expertise corroborates the need

to develop an electronic reporting platform that would be user friendly and provide

automated reports for easy data extraction and immediate use in regulatory

processes.

9. With regards to Table 2-Toxicological information data of the common reporting

format for the submission of tobacco products ingredient information to regulators,

the vast majority of submitted files were in English language, with a number of EU

MS reporting that they never received any supporting information. Moreover, it was

noted that the information submitted is too technical, or not easily accessible,

readable and user friendly. A consensus was that most EU MS do not seem to be

requesting this data, or regard it as too complicated for use in daily regulatory

activities.

10. Notably, 13/17 of EU MS were not able to use the supporting toxicological data

submitted to them (Table 2). The lack of time, resources or capacities to utilize this

data was noted. Specific counter options were suggested for the easier submission

and use of data. Based on the feedback from EU MS, the current running hypothesis

is that this data should also be coded into specific, easier to use formats (i.e.

checkboxes for CMR properties).

11. With regards to publicly available Table 3 data, 15/20 EU MS reported that the data

for Table 3 is available on the web for the general public however only 7/20 MS

reported that the results that are uploaded are in a process able or searchable

format, with 8/20 reporting that data is uploaded in a static format such as a pdf or

picture file. This warrants the need to develop user access for the public, where they

should be able to log-on and obtain downloadable versions of the publicly available

information, in a searchable format.

12. Overall EUREST asked EU MS to provide their feedback on how they would wish to

receive Table 1 data, with all EU MS responding that it should be via electronic only

submissions with a number of MS requesting a centralized data submission system

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and joint EU database. EU MS requested changes in the way Table 2 data is reported

to them and which aspects it should cover, while solutions for the collection of sales

and market data were also noted. These suggestions were taken into account during

the formulation of the proposed new common reporting format and electronic

submission platform.

13. Finally, EU MS were almost all in favour of sharing data across the EU, with the

exception of two MS (one of which reported organizational constraints) indicating a

significant alignment to the common goal of the TPD across the EU MS.

6.1.4 Synopsis of Tobacco Industry Stakeholder feedback

1. Overall, 11 TIS provided feedback, 10 companies and one association.

2. Specific product types were proposed based on the new requirements of the TPD

including the addition of Cigarillos, Chewing tobacco, Nasal tobacco, Oral tobacco,

Electronic cigarettes, Novel tobacco products, Herbal products for smoking.

3. New ingredient functions were proposed for a number of ingredient categories, while

others were requested to be removed based on changes to the TPD. Corrections were

proposed, especially for cigars and cigarillos.

4. With regard to reporting of ingredient quantities, the TIS reported that these

quantities are not analytically derived and are mainly based on the suppliers

disclosures multiplied with the application rate in production.

5. Batch modification due to deliberate changes were reported to be performed on a

number of products per year, with the percentage of modifications that exceeded a

5% change in ingredient quantity, were identified to be fewer. Batch-related

maintenance activities were reported by a number of TIS.

6. Importantly, the best practice for the reporting of ingredients as noted by the TIS

was the use of the CAS number as the primary ingredient registration number. As

certain discrepancies were noted in the reporting of CAS numbers, or due to their

inexistence for certain semi-refined natural commodities, the CAS number was

recommended to be complemented by an ingredient name and a secondary

ingredient registration number. The issue of how to handle multiple CAS numbers

was also noted, as was the potential role of the existing EMTOC-Ingredient ID.

7. With regards to identification formats that would aid unique product identification,

multiple formats were mentioned, none however were of universal form. Most

formats were either for internal use only or did not allow for comparisons between

products or years. The UPC, EAN, GTIN, SKU numbers were approaches outlined to

be of interest.

8. Tobacco leaf parameters were all regarded as trade secrets, similarly sales and

market data studies were also regarded as trade secrets and should be available only

to regulators.

9. As to the TIS experience with the current submission mechanism, most TIS had

experience in multiple mechanisms, including, CD, CD/paper and EMTOC. Smaller

industries were more experiences in paper only submissions.

10. The EMTOC reporting mechanism was assessed separately. Overall EMTOC scored

highly on almost all domains, with a number of exceptions in a few cases. The scoring

was very similar to the scoring of MS in range (with the exception that the TIS

requested domains were more technically oriented, while MS domains were utility

oriented).

11. EMTOC was regarded overall as user friendly and inexpensive. While accessing

overall EMTOC was noted as easy, the registration process was noted as potentially

an area that may be improved. This aspect was brought forward also by the EU MS.

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With regards to data protection, while the transmission of data was generally

regarded as secure, the TIS mentioned concerns with regards to potential mistakes

in uploading public files and the fact that a number of legal files have not been

finalized or accepted by relevant parties.

12. With regards to EMTOCs technical infrastructure, the ability to perform XML uploads

was perceived very positively, however the maximum upload able file size was noted

as an area in need of updating.

6.1.5 Synopsis of E-Cigarette Industry Stakeholder responses

1. The list of ECIS, while a convenience list and in not a comprehensive list of

manufacturers, did indicate the broad types and design features of the products

marketed in the EU. Notably, the ECIS also brought forward that existence of a

plethora of combinations of products when one takes into account the number of e-

cigarettes (hardware) and the number of compatible e-cigarette liquids, and the

different combinations of each of the above. Especially for modifiable (MOD) e-

cigarettes the reporting of the ability to alter airflow, the voltage, the battery, the

programming and the flavors were all aspects noted as essential to aid unique

product identification.

2. Almost all ECIS reported that they perform chemical and toxicological assessment of

their products while EUREST toxicologists noted that appropriate chemical evaluation

methods were reported by the industry.

3. Some manufacturers do not manufacture the liquid themselves but purchase it from

external suppliers (which EUREST notes is similar to the process that conventional

cigarette manufacturers purchase leaf of composite materials from external suppliers

too).

4. Overall chemical assessment is performed on a range of substances, with a focus on

those that as indicated by the literature may be produced by the thermal degradation

and on those substances that may be of significant concern to users.

5. The ECIS noted that testing may also be performed to evaluate product stability and

leaching due to the storage processes, an aspect which should also be evaluated and

potentially reported as part of quality control in all phases of production.

6. ECIS perform routine production and quality control on their products on a broad

range of aspects and this should not be difficult to be reported to regulators. Specific

production control guidelines do exist in the industry and are noted by ECIS to be

implemented.

7. It is possible that the number of chemical analyses, especially for MOD products,

may be especially complex and this may affect the reporting of the emissions of

these products.

8. Multiple emission protocols are used by ECIS, which would make the reporting of

emissions very complex for e-cigarettes. This has the unfortunate result that

emission data between companies, under the current status quo, is not comparable.

The development of such standardized protocols, test and procedures is needed so

as to be able to perform any homogenous reporting.

9. ECIS noted that valuating nicotine dosing in the liquid is easy to perform, while

nicotine dosing in emissions would be a complex process. Nicotine pharmacokinetic

studies have been performed only by a small number of ECIS and on a limited scale.

10. Specific terms were proposed by ECIS for the updating of the existing reporting

format so that it may also allow for the reporting of e-cigarettes. These terms have

been included in the data dictionary and are based on the existing ingredient

categories with a number of new additions.

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11. ECIS noted that there are substantial differences in design characteristics of e-

cigarettes which may be reported. Such aspects include the Battery type, voltage,

wattage, delivery and recharge requirements, Product Size and weight, Battery

charge capacity, Thread fitting, Variable or fixed voltage etc. These variables would

also allow for unique product identification, especially for MODs. These indexes

reflect also the plethora of products available in the EU market

12. With regards to the reporting of market and sales data, while this data is collected

by some ECIS, EUREST was not provided with an example so as to be able to assess

if the market research data collected can be reported to regulators in a format other

than a single pdf file. This approach was incorporated into the proposed reporting

format. With regards to sales data, the majority of ECIS noted that the best way for

it to be reported would be the total number of units for different product types

13. As with the TIS, ECIS were strongly in favour of the use of the CAS number for the

reporting of ingredients to regulators. This was substantially different from the

response to the potential use of the European Community Number, the IUPAC

number or the FL number, which may be necessary though for the reporting of

ingredients that are extracts of natural sources.

14. With regards to product identification, as with the TIS, the ECIS indicated no

universal identification code that could be used for product recognition, even though

most ECIS noted that they use an identification system, with the UPC code noted as

the most commonly used in tandem with an internal production code.

15. Other aspects that were brought forward include the rationale for the inclusion of

safety parameters related to the use and disposal of electrical circuitry.

6.1.6 Synopsis of Non-Governmental organization Feedback

1. Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to

the national regulators, but have not seen any publicly available data.

2. Only one NGO reported that they had access to the publicly available data. None

reported that they were able to use it though.

3. Of more interest was the perceived value of being able to download the publicly

available raw constituent list of all tobacco products which was perceived as relatively

useful, however the importance of including e-cigarettes was stressed.

4. Moreover the feedback from the NGOs indicated that information on additives and

flavors should be included in reports to the public, while if they were to choose

between obtaining raw data of the publicly available information or reports on

predefined aspects, in most cases raw data was noted as the preferred method of

receipt.

6.1.7 Synopsis of the International Experience

Within WP1 an active data collection process with EUREST international experts from Canada

and the US was performed and assessed domains that were perceived either to be of direct

interest to the reporting format, or to the submission mechanism. Information on the

current reporting process in Brazil was also evaluated as available in the general domain.

Overall, each international reporting format and process has its own strengths that were

assessed for potential inclusion in the proposed new EU common reporting format within

the context of the TPD.

An overview of the reporting formats implemented in other countries across the globe

indicates that the proposed EU reporting format will be a substantial departure from the

status quo, especially for e-cigarettes and refill liquids at the time this was assessed, as

outlined in the reporting prerequisites of the three aforementioned countries.

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We synthesize the international experience as follows:

Data submission in all countries is performed electronically either via CD or through

an online submission system.

Fees are organized in the US and Brazil to cover running expenses. This is not done

in Canada. The US approach provides a detailed methodology for the attribution of

fees.

Detailed information on the laboratories, manufacturers and importers should be

collected, an issue that is not extensively collected in the current EU reporting

format.

International experience notes that detailed and extensive toxicity testing may have

limited applied use, effort should be made to make this information as easy to use

and understand- as possible. Regulators seem to find this information of limited use

in its current file only format. This verifies EURESTs working hypothesis to note the

necessity to adopt checkboxes and selected checklists that would complement pdf

file collection.

In line with the above, other reporting formats highlight separately those

constituents which they deem as important to public health, an approach that may

be applicable in an EU reporting format. i.e. flagging a priority toxicant list or priority

additive list.

Identifying unique products was an issue noted by all other reporting formats.

Multiple methods are used with all evaluated noted to incorporate the dual use of a

text area and the provision of a product identifier (i.e. the SKU or the UPC number).

No specific system was deemed as ideal.

Chemical substances seem to be reported inconsistently, however the three

aforementioned international reporting formats do note the use of CAS numbers as

a prerequisite, often accompanied by again a text box. This aspect may be

applicable to the EU reporting mechanism and was strongly supported by MS and

Industry responses. EUREST experts verified the importance of the CAS as the best

practice in chemical reporting.

Information on filter specifications and other design elements is often collected, that

can be related to smoking intensity.

Ingredient analyses can contain mean and standard deviation of result analyses.

Canada includes also the 95% C.I. for emission analyses, not on ingredient

quantities.

Information on tobacco ingredient part can include the leaf type, the cure method

and the existence of expanded and/or reconstituted tobacco.

An example of the package is often collected, even if only in electronic format.

E-cigarettes are not included in any other reporting format. Hence this will be a

completely novel area that the TPD will need to address.

6.2 WP2 Detailed Methods and Results

6.2.1 Introduction

The aim of WP2 was to develop a new common reporting format for electronic reporting, by

manufacturers and importers of tobacco products. This should allow for the reporting of

ingredients and quantities thereof, used in the manufacture of the tobacco products, herbal

products for smoking and electronic cigarettes (including refill containers) by brand name

and type, as well as their emissions and yields to national regulators so as to monitor and

evaluate products and assess their potential impact on public health.

6.2.2 Methodological approach

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WP2 was based on the combination of evidence available from three sources that included:

1. The synthesis of the data collected in WP1 through the questionnaires and interviews

with regards to the reporting requirements and processes of the European Directive

2001/376and the practical guide on reporting on tobacco product ingredients published

on 31 May 20077.

2. A selected evaluation of the scientific evidence for each of the aspects brought forward

and discussed. In addition, relevant legal, technical and background documents, with

regard to ingredient reporting and disclosure, from within the EU and at international

level were considered. This search strategy was complemented by a snowball data

collection through the evaluation of the references of those documents and the provision

of additional files from EUREST counterparts that would provide the scientific justification

to the regulatory options brought clearly forward in the wording of the TPD. Other

relevant legal, technical and background documents, with regard to ingredient reporting

and disclosure, from within the EU and at international level were also considered.

3. The wording and contextual interpretation of the Articles of the TPD8.

As significant differences exist between e-cigarettes/refill liquids and tobacco products

regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill

liquids is a novel aspect of the TPD, special emphasis was placed on the development of a

notification format for these products. Hence, the EUREST consortium opted to approach

separately the issue of a notification format for these products and thus the final deliverables

of WP2 were two separate Data Dictionaries, which include the variables and their

description where possible- that EUREST proposes should be included in the common

notification format. The aim of these two data dictionaries is to provide a background

document that can be consulted to understand what information is to be requested in the

common reporting format, for both tobacco products and e-cigarettes. These data

dictionaries hence become central documents of WP2 as it outlines and describes what

information the common reporting format would request, the values that each response

would take, what the data item practically means in real-world terms and where a data item

fits in the structure of a submission mechanism (i.e. a flowchart process within which some

variables may be requested based on the response to previous questions, an area developed

in WP3).

The Data dictionary for tobacco products and the data dictionary for e-cigarettes including

their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B

respectively). Within these data dictionaries after each item is numbered (column 1) it is

given a descriptive name field (column 2), a brief textual description is provided

description (column 3), the data type is identified (column 4), white list terms are noted

(column 5), possible predefined values are listed (column 6), mandatory and non-

6Directive 2001/37/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products, OJ L 194, 18.7.2001 7http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/practical_guidance_en.pdf 8Directive 2014/40/EU 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. Available from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:127:TOC

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:127:TOC

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mandatory items for reporting are identified (column 7), and their confidential vs. public

visibility (column 8).

6.2.3. Data Dictionary and its scientific justification.

The data dictionaries are the epitome of all work performed under the framework of this

specific tender as it presents the new proposed EU common reporting format for submission

of data on ingredients contained in tobacco products and e-cigarettes and their refills and

related products and disclosure of the collected data to the regulators and public. In addition,

the TPD also requires special reporting for herbal products for smoking and novel tobacco

products. While not covered by the common format, we must state that it could be practical

for specific variables within the common reporting format to be used.

A more technical and scientific justification of the terms to be included within the data

dictionary is provided in Annex C , however below we provide an overview of the main

domains included within the data dictionaries and their rationale.

The data dictionaries are comprised of a number of common domains and also domains that

are specific to each type of product regulated under the TPD. The key domains include:

a) Submitter characteristics (Section 2.2)

Within this introductory and functional domain the aim was to collect the necessary

information that would provide the regulators with a clear picture of the associations

between the manufacturer/importer and potential affiliate, subsidiary and primary

companies so as to be able to chart the association between multiple companies that may

market identical products under different names. This domain sets the scene and describes

these associations, so that the products reported below can be assessed appropriately. The

key to this domain is the Submitter ID, an identification number that would be unique for

each submitter and would be provided centrally by the administrator.

B1) Product Submission and Description (Section 2.3A)

This section of the data dictionary contains information on three key variables of the data

dictionary on which all subsequent variable are dependant: i) the type of actual product for

which the submission is taking place ii) the type of submission and iii) its tobacco product

ID (TP-ID) or e-cigarette ID respectively (EC-ID). These IDs contain inherent information

such as the submitter ID, the year the product was first marketed, and the product version

number (attributed by the submitter the first time the product is submitted. This centrally

provided ID will allow regulators to identify identical products in multiple markets and allow

for the creation of a complete list of all tobacco products within the EU market, an important

aspect of tobacco product monitoring

An important aspect is the monitoring of changes that take place after a product is placed

on the market. This is monitored through the introduction of a variable that monitors the

submission type, which would allow based on the perform activity to either request a new

TP-ID or update the version of the TP-ID. An important point that EUREST stresses is that

in principle any substantial modification to a recipe or alteration of a reported design feature

would lead to a change within the Product ID. On the other hand a submission of new

information/data on an existing product NOT leading to a substantial modification in recipe

or design would not change the product ID, but update the product version number (so as

to reflect the current status and to allow for product monitoring).

B2) Product Submission and Description (Section 2.3B) product presentation

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The need to develop a new method for identifying and coding unique tobacco

products/electronic cigarettes in an orderly fashion was outlined by the activities of WP1,

which indicated that the current status quo was to report the product by its brand name