Study on the development of a EU common reporting format ...

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 amp P Behrakis

EUREST Consortium

112015



EUROPEAN COMMISSION


Directorate D mdash Health systems and products

Unit D4 mdash Substances of human origin and Tobacco control

E-mail SANTE-D4-SOHO-and-TOBACCO-CONTROLeceuropaeu

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)



Europe Direct is a service to help you find answers

to your questions about the European Union

Freephone number ()

00 800 6 7 8 9 10 11

() The information given is free as are most calls (though some operators phone boxes or hotels may charge you)

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 andor Chafea or any other body of the European

Union

The European Commission andor 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 (httpeuropaeu)

Luxembourg Publications Office of the European Union 2015

ISBN 978-92-9200-680-8

doi10281830286

copy European Union 2015

EUROPEAN COMMISSION



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

61 WP1ndash Detailed Methods and Results 22

611 Introduction 22

612 Methodological approach 22

613 Synopsis of EU-MS responses 23

614 Synopsis of Tobacco Industry Stakeholder feedback 25

615 Synopsis of E-Cigarette Industry Stakeholder responses 26

617 Synopsis of the International Experience 27

62 WP2 Detailed Methods and Results 28

621 Introduction 28

623 Data Dictionary and its scientific justification 30


631 Introduction 33

632 Methodological Approach 33


641 Introduction 34


643 Synopsis of tobacco industry stakeholder feedback 35

644 Synopsis of e-cigarette industry stakeholder feedback 36

645 Costbenefit 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

EUROPEAN COMMISSION

6


Health programme

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

EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY

One key aspect of the current Tobacco Products Directive (201440EU) (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 costbenefit 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 201440EU 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 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC

EUROPEAN COMMISSION

8


Health programme

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 ldquotake homerdquo 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 paperCD 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 (ie 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 developdesign 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 athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf

EUROPEAN COMMISSION

9


Health programme

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 ldquoupstreamrdquo 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 ldquoflaggedrdquo 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 (ie 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 ndash 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 ingredientemission analyses

Summary of WP2

The aim of WP2 was to develop a new

common reportingnotification 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

EUROPEAN COMMISSION

10


Health programme

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 reportingnotification format

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

reportingnotification 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

reportingnotification 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 reportingnotification 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 reportednotified 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

ldquosubmitter-IDrdquo 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

ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo 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

informationdata 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 designingredients 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

EUROPEAN COMMISSION

11


Health programme

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

production timeframe ndash 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 lsquoData

Modelrsquo 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 lsquoApplicationrsquo 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 reportingnotification 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

EUROPEAN COMMISSION

12


Health programme

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 CDpaper 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 reportingnotification 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 (eg

pdfweb 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 reportingnotification format would significantly

increase the information on tobacco producte-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

EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF

Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac

(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele

europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits

associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD

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

de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons

pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave

harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du

marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs

En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique

destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y

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

modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons

de recharge (Article 20)

Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les

nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et

drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo

inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution

eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations

requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la

notification des informations requises des cigarettes eacutelectroniques et flacons de recharge

(Article 20(13))

Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees

ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le

scheacutema ci-dessous

WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes

WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration

WP3 Deacuteveloppement de la plateforme test pour la transmission


EUROPEAN COMMISSION

14


Health programme

WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct

par rapport aux avantages

Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux

dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele

commun de deacuteclaration des produits du tabac et le modegravele commun de notification des

cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des

dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des

informations

Reacutesumeacute du WP1

Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience

a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007

et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les

informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre

cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un

questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de

lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP

(European Network for Smoking and Tobacco Prevention)

Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de

lrsquoindustrie aux instances de reacuteglementation sont

Processus de transmission

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

souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement

une poigneacutee drsquoEM recevaient les informations par des portails onlines

Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui

concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave

extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute

que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement

ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes

Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de

diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises

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

services juridiques

La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel

ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees

des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la

difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories

La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees

commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de

transmission de donneacutees

Modegravele de deacuteclaration

Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de

transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances

EUROPEAN COMMISSION

15


Health programme

de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee

que dans un pourcentage des EM europeacuteens

Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de

deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de

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

deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits

du tabac au niveau europeacuteen

Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers

lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract

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

Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont

exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero

principal drsquoenregistrement des ingreacutedients

Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations

fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des

informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs

Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont

actuellement pas utiliseacutees dans leur potentiel maximal par les instances de

reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer

des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique

Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte

des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de

leurs commentaires sont

Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute

qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour

les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en

consideacuteration lors que la deacuteclaration drsquoun produit unique

Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un

certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles

de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les

ingreacutedients qui comporteraient des risques plus eacuteleveacutes

Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le

marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des

donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions

chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents

Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients

seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les

cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)

Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees

dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune

importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en

dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les

4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf

EUROPEAN COMMISSION

16


Health programme

deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les

paramegravetres de design et les analyses des ingreacutedientseacutemissions


Le but du WP2 est de deacutevelopper un nouveau modegravele

commun de deacuteclarationnotification pour la deacuteclaration

eacutelectronique des fabricants et des importateurs de

produits du tabac Ceci doit permettre la deacuteclaration

des ingreacutedients et des quantiteacutes utiliseacutes dans la

fabrication des produits du tabac des produits agrave fumer

agrave base de plantes et des cigarettes eacutelectroniques (y

compris les flacons de recharge) par marque et par

type ainsi que leurs eacutemissions et teneurs aux

instances de reacuteglementation nationales afin de

controcircler et drsquoeacutevaluer les produits et analyser leur

impact eacuteventuel sur la santeacute publique

Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et

faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance

potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du

tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les

informations requises agrave travers cette proposition de modegravele commun europeacuteen de

deacuteclaration et notification

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

eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux

dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux

dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)

et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation

approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)

Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre

de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de

deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans

les produits du tabac et les cigarettes eacutelectroniques et leurs recharges

Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence

qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre

exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac

ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees

ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories

drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent

a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine

fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui

a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo

(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un

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

un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers

une proceacutedure offline

WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees

Pertinance sur la Santeacute Publique

EUROPEAN COMMISSION

17


Health programme

b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo

Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo

pour identifier les produits uniques (produits avec une meacutelange speacutecifique

drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements

effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central

de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur

lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans

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

drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un

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

reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les

cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun

autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave

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

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

mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design

et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit

(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme

deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire

des deacuteclarations de produits multiples pour chaque paquet externe

c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes

de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails

sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits

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

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

possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production

speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie

contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de

reacuteglementation sous la forme drsquoune checklist facile agrave utiliser

d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du

tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de

protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour

lequel les informations sont transmises avec un produit compatible distinct

(accessoire ou liquide)

e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees

est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres

speacutecifiques des produits sont exigeacutes


Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en

preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans

les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes

conseacutecutives suivantes

a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits

en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les

principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences

fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut

le document sur les cas drsquoutilisation

EUROPEAN COMMISSION

18


Health programme

b) La phase de conception La conception de la plateforme eacutelectronique test comprenait

la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques

techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le

laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque

dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres

drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees

c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon

le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les

meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie

informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui

soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la

phase de mise en œuvre est le Mode drsquoEmploi

d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de

notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit

fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester

les diffeacuterents cas drsquoutilisation

Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel


Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au

sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du

modegravele de deacuteclarationnotification et du meacutecanisme de transmission

Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir

des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des

dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de

cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere

critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans

les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse

qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires

des EM europeacuteens Les principales conclusions de ce processus sont

La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de

paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les

transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le

processus de transmission entre les eacutetats membres soit unifieacute autant que possible

Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont

ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et

comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel

informatique employeacute pour le systegraveme

Les frais administratifs pour les instances de reacuteglementation nationales et la

Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification

et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels

comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute

publique

Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais

ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous

deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats

membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont

EUROPEAN COMMISSION

19


Health programme

preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les

gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)

Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement

faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation

que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs

dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre

les produits de la mecircme industrie

Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait

consideacuterablement les informations sur les composants dans les produits du

tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui

alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en

aidant agrave la protection de la santeacute publique europeacuteenne

EUROPEAN COMMISSION

20


Health programme

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

EUROPEAN COMMISSION

21


Health programme

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 costbenefit projections

Questionnaire feedback assessment from EU MS regulators and stakeholders

Qualitative evaluation of the costbenefit of each aspect included with a focus on the

impact on European public health

EUROPEAN COMMISSION

22


Health programme

6 FINDINGS AND METHODS PER WORK-PACKAGE

61 WP1ndash Detailed Methods and Results

611 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

612 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

EUROPEAN COMMISSION

23


Health programme

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

613 Synopsis of EU-MS responses

1 Combined PaperCD 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 gt80 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 platformgt by email submissions gt CD submissions gt combined

paperCD submissions gt 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 (ie 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


EUROPEAN COMMISSION

24


Health programme

provided in the practical guide of 2007 was present in 1024 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 andor 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 1218 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 1317 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 (ie

checkboxes for CMR properties)

11 With regards to publicly available Table 3 data 1520 EU MS reported that the data

for Table 3 is available on the web for the general public however only 720 MS

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

format with 820 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

EUROPEAN COMMISSION

25


Health programme

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

614 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 CDpaper 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

EUROPEAN COMMISSION

26


Health programme

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 EMTOCrsquos 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

615 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 ldquoquality controlrdquo 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

EUROPEAN COMMISSION

27


Health programme

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 ldquototal number of units for different product typesrdquo

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

616 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

617 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

EUROPEAN COMMISSION

28


Health programme

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 ndash

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

in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the

necessity to adopt ldquocheckboxesrdquo 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 ie 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

ldquotextrdquo area and the provision of a product identifier (ie 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 ldquotextrdquo 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 ldquobest

practicerdquo 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 CI 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 andor 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

62 WP2 Detailed Methods and Results

621 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


EUROPEAN COMMISSION

29


Health programme

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

2001376and 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-cigarettesrefill 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 ldquoData Dictionariesrdquo which include the variables ndashand 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 (ie 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 ldquofieldrdquo (column 2) a brief textual description is provided

ldquodescriptionrdquo (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 200137EC 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 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU 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 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC

EUROPEAN COMMISSION

30


Health programme

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

visibility (column 8)

623 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 22)

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

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

between the manufacturerimporter 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 ldquoSubmitter IDrdquo an identification number that would be unique for

each submitter and would be provided centrally by the administrator

B1) Product Submission and Description (Section 23A)

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

informationdata 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 23B) ndash product presentation

EUROPEAN COMMISSION

31


Health programme

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

productselectronic 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 ndash

information which was neither homogenously coded nor written Keeping in mind that there

will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data

Dictionary within this section (23B) information on product name and product brand

subtype name are maintained from the current reporting format It was noted that in some

cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie

dimensions weight filter etc)- are marketed in different product presentations (ie external

packaging) which would lead to a significant increase in reporting burden if reported

individually (per presentationpackaging) Moreover regulators would benefit from a deeper

understanding and reporting of the relationship between a product and its presentation while

from a public health perspective the ingredient quantities and product design parameters

are related to constituent uptake in comparison to outside product presentation With the

above in mind EUREST introduced the notion of allowing one unique product (unique recipe

and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple

product presentations

Per presentation a list of parameters is to be reported with regards to potential product

launch date package types sale volume market data a picture of the outside packaging

of the product etc

c) Description of Ingredients Tobacco (Section 23B)

A significant departure from the current status quo is the inclusion of information on tobacco

leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and

the reporting of tobacco types would provide the regulators and the public significant

information with regards to the main ingredient in these products Information would include

the tobacco part type a description of what it entails its source leaf type cure method and

quantity While regulators would obtain an in-depth analysis of the constituents EUREST

notes that it is imperative that the public also receive information on the tobacco parts

included within tobacco products above a certain threshold as handled for additives While

it was not possible to conclude within the framework of this tender on what would be the

optimal cut-off for such a confidential vs public reporting we believe that it should be at the

05 level as for additives

Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow

the same motive as other ingredients (ie additives) and would be reported (by quantity

per above characteristic ie part typegtleaf typegtcure method) For instance a specific part

type with the same leaf type but with two cure methods would be reported separately

d) Description of ingredients Additives and other substanceselements (Section 25)

This section is an expansion of Table 1 and Table 2 of the current reporting format outlined

in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient

added is reported separately for each of the product components or materials to which it is

included It was noted however in the current format that no specific identifier of chemical

substances was used while often different language names were also used for the same

chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS

number as the key unique identifier of chemical substances followed by other reporting

numbers if available to the submitter

EUROPEAN COMMISSION

32


Health programme

An important issue that EUREST raises in WP2 and in this section of the data dictionary is

the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may

fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco

leaf This led to the development of two parallel parameters product recipe and product

measured quantity within a standardised timeframebatch This is based on the hypothesis

that a manufacturer will make a product based on certain recipe specifications which are

known before the product is created Subsequently should the manufacturer adjust the

added concentrations of additives to adjust for potential variations then the measured

values should also be provided to the regulator Hence the regulator would then be aware

of the concentrations (with min and max ranges) of ingredients in products on the EU market

and be able to monitor the additives within tobacco products One important issue that this

raises is that of what would be the framework of such a standardised batch or time period

for which the submitter should collect and statistically analyse the final batches It was not

possible to conclude on what would be the ideal reporting period but EUREST suggests that

an annual reporting period may be adequate and accommodate both small and larger batch

production companies without it becoming a burden to regulators

This section also included in coded format an updated version of Table 2 of the current

reporting format which was evaluated to be currently of limited use to regulators due to its

complexity EUREST proposes in light of the above to accommodate an easier checkbox

system for regulators utilising the current model and CLPREACH classifications This would

be complemented by the uploading of complete files on CMR properties which would be

available should the regulator wish to evaluate the toxicity more in depth Within the

toxicological grading we must note that EUREST removed reference to the use of the GRAS

system which refers to the toxicity during ingestion not inhalation

e) TNCO and other emissions (Section 26)

This section of the data dictionary is specific to product emissions The functionality to allow

for TNCO emissions is provided as also the ability for additional emission testing should it

be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled

with detail and was a complex issue due to the absence of testing standards emission

protocols or priority emission constituents to evaluate To address this gap and until a

standard is adopted that meets the EC requirements EUREST proposed that e-cigarette

liquids and products should be tested not on theoretical testbeds or with test bed liquids

but with real market products

With regards to the emissions to be tested for e-cigarettes EUREST proposes that those

constituents which can be tested for in the liquid phase should be tested as such as the

absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl

propionyl) in the liquid would mean that they would not be identifiable in the emissions

Emission testing in this case would include testing for formaldehyde acetylaldehyde

acrolein heavy and trace metals and total aerosol production These emissions of e-

cigarettes and their refill liquids have the highest relevance to public health via direct or

passive exposure to e-cigarette vapour

f) Domains related to specific products

The data dictionary concludes with domains for specific products An example of information

requested for a specific product include design parameters of cigarettes (filter ventilation

characterising flavour etc) information on pH and nicotine for smokeless tobacco and

information in nicotine content within roll your own tobacco

EUROPEAN COMMISSION

33


Health programme

For e-cigarettes this includes a detailed description of design parameters that would aid in

unique product identification and also includes hardware parameters including substantial

information on the voltage wattage and battery parameters which may be potentially

linked under certain conditions to the production of toxic substances It is important to

note that within the reporting format for e-cigarettes parameters related to the declaration

of child and tamper proof status and the related design parameters quality and safety

issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production

conformity and non-risk under normal conditions of use are all requested as detailed in the

data dictionary (ANNEX B) and the technical justification document (Annex C)


631 Introduction

The aim of WP3 was to develop the framework for the creation of an efficient platform for

the submission of data from manufacturers or importers to EU MS regulators Hence the

overall scope of WP3 was to develop the necessary files for the implementation of a large

scale submission system and to develop a pilot IT submission platform that could be used

for the submission and handling of such data The overall goal was focused on the fact that

the submission platform should be designed to be secure user friendly and useful to all

partners involved This utility would greatly increase the benefits it could provide to

regulators industry and subsequently to NGOs and EU citizens

632 Methodological Approach

The development of the pilot electronic platform for data submission was based on a well-

established system development lifecycle (SDLC) consisting of the following phases

1 Analysis-inception

2 Design Elaboration

3 Implementation ndash Construction

4 Testing

Analysis ndash Inception

This main scope of this phase was to finalize and to extract the detailed requirements for

the pilot electronic platform Its main purpose in this particular project was to standardize

the information extracted by Work Packages 1 and 2 The gathering of the requirements

was based on workshops interviews and guided discussions targeting to translate the

analysis of WP1 and WP2 to tangible requirements for an electronic platform During this

analysis the following information were collected

The main entities of the application such as the tobacco product electronic

cigarette manufacturer laboratory and ingredient

The use cases that need to be served by the electronic platform along with their

respective actors

Additional functional and non-functional requirements (such as security

requirements)

The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData

Dictionaryrsquo

Design - Elaboration

EUROPEAN COMMISSION

34


Health programme

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 deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3

is substantially based on the variables noted in the data dictionaries as outlined in WP2

taking into account not only their description but also the relationship between variables

For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model

was developed The EUREST 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

The Data Model document provides a technical representation of how the Database of the

lsquoReporting platformrsquo is structures including the following information Tables Attributes

Constraints Relationships Business Rules

Implementation ndash Construction

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 and technical

best practices and standards (such as W3C standards) with the aim to produce a deliverable

that covers all requested requirements

The pilot electronic platform for data submission was developed to provide the following

featuresfunctionalities in summary

Use and profile management for the various stakeholders

Submission and manufacturers management

Products and ingredients management (additive ingredients tobacco ingredients

emissions product presentation sales data review data)

The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of

the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to

execute the various functionalities provided by the system

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 purpose of this

phase was to ensure the quality of the end-product (Quality of Service - QoS)

The deliverable of this phase was the verified lsquoApplicationrsquo in its official format


641 Introduction

WP4 is very closely tied to the previous work packages to the extent that it essentially is

integrated throughout the formulation of the proposed reporting format (WP2) and design

mechanisms of actual data submission and disclosure within the electronic reporting system

(WP3) As previously outlined 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 format and submission

mechanism


EUROPEAN COMMISSION

35


Health programme

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 dictionary from

a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative

assessment of the cost effectiveness of the proposed solution

With regards to the questionnaire process two structured questionnaires were developed

that included domains on multiple aspects of WP2 and WP3 that included Issues specific to

the proposed draft notification format introduced through Directive 201440EU (Domain

1) evaluation of the administrative and economic impact of implementing the proposed

draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an

area for the submission of other issuescomments (Domain 4)

All communications with stakeholders were performed only in writing via a dedicated email

account and fully documented No communication through any other venue was facilitated

Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report

completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which

12 ECIS returned a completed report

With regards to the costbenefit analysis approach this was performed through the

combination of stakeholder feedback EUREST expert consultation and a supplementary

review of information available taking into account that a number of aspects of the proposed

data dictionary for which a conclusion cannot be reached would impact the overall cost of

its implementation

643 Synopsis of tobacco industry stakeholder feedback

1 With respect to the reporting of variables under the domain of tobacco types tobacco

part types a significant number of TIS mentioned that the types of tobacco part leaf

types and cure methods are comprehensive with minor addition and suggestions

brought forward

2 With respect to the ingredient quantity fluctuation responses included that either

the ingredient quantities fluctuate substantially in their products while others noted

that they work with specific recipes

3 TIS were asked to define their interpretation of the proposed aspect of a standardized

batch for which ingredient quantities should be measured and then compared with

the quantities reported There was no conclusive response from the stakeholders

with regards to either the size or the timeframe that would define a standardized

batch

4 TIS considered a number of items noted within the data dictionary as trade secrets

with a focus on market and sales data as also certain ingredient information below a

certain cut-off

5 With regards to the administrative and economic impact of implementing the

proposed draft notification format TIS indicated that the redevelopment and

reprogramming of IT systems in order to accommodate new requirements will result

in significantly large development cost

6 All TIS stated that they cannot provide any indication of cost at this stage until the

data dictionary is clearly defined the system and process identified eg the cost

associated with one centralised harmonised system would be significantly less than

multiple portals

7 There were significant different opinions between TIS on the implementation of fees

related to the implementation and adherence to the system

8 With regards to issues related to the submission mechanism TIS deemed that the

following key features are of significant importance to them

EUROPEAN COMMISSION

36


Health programme

ndash One centralised IT system with one single authority as the owner of the IT-

system

ndash Security aspects such as Secure Connection Data Segregation Access Control

Process Requirements Electronic Signature

ndash Technical support such as HelpdeskSupport Functions Correction possibilities

Audit Trail Language requirements Speed Adequate bandwidth of the

connection

ndash Utility Acceptance by and within the EU Member States Dissemination of

Information for public purposes etc

644 Synopsis of e-cigarette industry stakeholder feedback

1 The majority of ECIS indicated the broad types and design features of the products

marketed in the EU The types suggested by EUREST where in most cases regarded

as satisfactory It is worth noting that ECIS referred that there are product types

that do not fit within the mentioned categories and they recommend additional

product types that were related to the handling of e-cigarette components that do

not contain liquid but are of more hardware design

2 A significant number of ECIS noted the existence of a plethora of products that which

are identical from a constituent and design perspective which however marketed with

different presentations ECIS corroborated that an ability to register products that

differ only by presentation type would results in efficiency savings

3 Almost all ECIS reported that the e-submission of the annual data and information

would be potentially helpful for them Issues that were requested to take into account

included the needs of SME the timeframe between now and the implementation of

such a reporting system Overall it was noted that if implemented appropriately it

would result in the harmonisation across EU MS in relation to the reporting

requirements enabling a single submission across Member States including only in

one language

4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS

stated that all potential ingredient functions have been included As the table

provided was the generic table for all products a number of the functions were not

applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo

should be replaced by the term ldquoexcipientrdquo

5 With respect to the emission test product EC-ID a significant number of ECIS

responded that the wording of the approach is understandable but a clarification

should be made about what would be the best- selling product that is used for

testing whether is the best-selling in the EU or the best-selling product in EU for a

particular company This was taken into account in the wording of the relative data

dictionary by EUREST

6 ECIS brought forward a number of aspects related to the emissions protocol and

emission substances that will be assessed for each product It was stated that a

number of potential emission products if not within the e-liquid would subsequently

not be in the emissions (TSNAs impurities) hence ECIS suggested that for those

that can be eliminated and verified to be non-existent in the e-liquid that emission

testing should not be performed Most ECIS brought forward the issue of temperature

as a modulator of emissions Clarifications on some of the proposed emissions were

made which were taken into account during the WP2 feedback process

7 With regards to the emission protocols it was noted that multiple emission protocols

are used by ECIS which would make the reporting of emissions very complex for e-

cigarettes ECIS noted the need to create standards for emission testing

EUROPEAN COMMISSION

37


Health programme

8 ECIS responded that there is a range of items in the relative data dictionary for e-

cigarettes and their refill liquids which they regard as confidential and of trade secret

with a focus on those about the description of ingredients contained in products the

emissions as well as sales and market research data in order to mitigate the risk of

disclosure of confidential information Specifically some ECIS also noted that the

composition of flavourings to be considered of intellectual property Threshold levels

for these cut-offs were suggested


proposed draft notification format ECIS indicated that any pharmacokinetic nicotine

uptake study conducted in a clinical setting will result in significantly large

development costs which may be prohibitive for most SME Almost all ECIS stated

that it is too early to provide any estimation about the costs Regarding the

administrative impact ECIS indicated that administrative burden will be significant

based on the detailed level of the information requested

10 With regards to the IT system ECIS deemed that the following key features to be in

significant importance

ndash Centralized system for all EU Member States System with central Ownership and

Management

ndash Data security High protection from unauthorized accesses

Organizationindividual log in and account tracking of submission progress with

a saveable online platform

ndash Correction possibilities Helpdesk functions Language requirements Capability

of CSV XML API spreadsheet and bulk uploading Support for users with queries

related to the IT system

ndash It is worth noting that ECIS indicated to avoid the need for expensive and

complex software and systems considering the needs of small companies

645 Costbenefit analysis

6451 Technical feasibility and sustainability of the funding model

According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers

and importers of tobacco products proportionate fees for receiving storing handling

analysing and publishing the information submitted to them pursuant to this Articlerdquo While

Article 20(2) outlines that ldquoMember States may charge manufacturers and importers

proportionate fees for receiving storing handling and analysing the information submitted

to themrdquo

With this in mind EUREST performed an exploratory qualitative evaluation of the types of

funding models that could be used to support the regulatory process

Three different types of funding systems were evaluated by EUREST an outline of which is

provided below

a) A flat rate fee system for which the user is subject to a flat rate for usage of the

submission system This flat rate would include all costs related to the handling of the data

as outlined in TPD Art5(8)

b) A staggered fee system relative to the number of products that the

manufacturersubmitter markets in the EU MS While this would be directly proportionate

to the relative ldquouserdquo of the IT system for reporting this approach comes with two main

drawbacks Firstly it may disproportionately impact SME who may have a more diverse

portofolio of products in comparison to larger enterprises This is especially the case for

manufacturers and importers of e-cigarette liquids who based on EUREST research may

EUROPEAN COMMISSION

38


Health programme

market more than 100 products Secondly this is not proportionate to the market share of

the product and its impact on consumers

c) A staggered fee system according to which the fee paid by each submitter is related to

the overall share of the product type in the market (ie cigarette vs roll your own vs pipe

etc) and proportionate to the percentage share of the product within the product type The

US FDA has implemented such an approach EUREST perceives that such a funding model

would be potentially applicable within EU MS subject to certain prerequisites that include

but may not be limited to the fact that the EU MS would have to obtain detailed information

on the value of the total tobacco market in their MS and be aware of the proportionate

percentage of each industry to the whole While a potentially more complex procedure in

comparison to either a flat rate or staggered system EUREST perceives that a weighted fee

system would be the most appropriate

EUROPEAN COMMISSION

39


Health programme

6452 Administrative burden for national regulators the Commission and non-

industry stakeholders

Administrative burden to national regulators and the Commission would be related to time

needed to handle and process the information through the reporting obligations outlined in

the proposed common reporting format This would potentially translate into increased

personnel time should in depth analyses of the submitted data be performed if submission

of this information would take place under the current status quo as identified in WP1 (a

combination of paper submissions CD-ROMS and EMTOC files) Importantly the above

administrative burden would be substantially less than what is currently requested should a

central submission system be coordinated In light of the above 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 Moreover we must

stress that the administrative burden for national regulators and the Commission from the

adoption of a common reporting format and IT submission system is minor compared to the

obtainable benefits for the internal market and public health

6453 AdministrativeCompliance costs for the industry

Through WP4 we performed a limited evaluation of the administrativecompliance costs for

the industry so as to adopt the new TPD for the reporting of ingredients for both large

companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was

contacted the vast majority noted that the exact administrative and compliance costs for

the industry would be based on the final requirements and hence estimations performed

now would not reflect necessarily the final costs However some key points were noted and

evaluated The overview of the administrative and compliance costs for the industry as

evaluated by EUREST is as follows

There are two main types of costs one related to the one-off costs of setting up of

the system and one related to the recurring costs

One off cost settings included the costs to set up the IT requirements and time

needed to perform the submission both of which were regarded as limited in the

case of a central submission system that could facilitate pdfweb submissions for

SMEs and large system to system XML batch uploading for larger submitters

Aspects that would reduce further the economic burden of stakeholders would be the

use of the following technical aspects suggested by EUREST

o The reporting of a product (identical products) to the system using a product

ID which can be referenced

o The ability to submit under one submission the same products that use only

a different packaging presentation

o The aspect that a number of reported variables for each product may be

common between products of the same submitter (ie toxicity reporting for

ingredients) which should be entered once into the system and then ldquocarried

acrossrdquo the system within the same submitter environment

o Mass xml batch uploading would substantially reduce the coststime for

reporting

Administrative burden issues would be limited and also based on the feedback from

stakeholders as part of WP4 substantially smaller when compared to potential

toxicology andor emission testing The main aspect brought forward here was that

the administrative requirements of each submitter (by number of products markets

etc) would be directly associated with the administrative requirements (in

EUROPEAN COMMISSION

40


Health programme

timepersonnel) which would include the cost for receiving storing handling

analyzing and publishing of the information per productmanufacturer

For the reporting in particular of ingredients within e-cigarettes and their refill

mechanisms laboratory costs would be a significant aspect of the costs for a

submitter and would be either covered with the use of in-house facilities or the

subcontracting of external laboratories If a submitter was to pursue the

development of an in-house laboratory the setup costs would be larger while

subcontracting of laboratory testing would lead to lower initial however longer

recurring costs for the submitter

Emission testing for the case of e-cigarettes and their refill mechanisms would be

a source of significant cost which would be substantially lower if performed as part

of a liquid analysis Hence potential emission constituents that could be evaluated as

non-existent in the e-liquid may be measured only in liquid form However so as to

protect consumer and public health emissions which may have an impact on health

must be measured for each product on the EU Market

EUREST has proposed the aspect of recipe vs measured quantities within tobacco

products This would allow for the more appropriate monitoring of the change of

constituents within tobacco products and allow for detailed tobacco product

monitoring with potential benefits for the internal market and public health However

the costs related to these reporting requirements would be significantly dependant

on the timeframe and size of each proposed ldquostandardised batch period

6454 Utility of data for the regulators and the EU citizens from a public health

perspective

While the main objective of the new common reporting format is to improve the functioning

of the internal market it also represents important benefits to public health

The key elements of the new reporting format and the electronic data platform which

correspond with the final text of the TPD provide an unprecedented opportunity to increase

the detail of information that is available to the regulators and the general public This

increased information will enable regulators to monitor product development constituents

and toxicity and also will enable people to take informed decisions for both tobacco products

as noted in the current format and e-cigarettes for the first time With these facts in mind

the information to be reported by the industry to regulators would have a significant impact

on European Public Health around the below domains

Regulators and the public would have a clear picture of the potential carcinogenic

mutagenic or reprotoxic (CMR) properties that any constituent may have including their

REACH (19072006) and potential CLP classification (12722008) Should an ingredient

not have any known CMR properties this too will be reported

Regulators and the public above a quantity threshold would for the first time receive

information on the tobacco plant derived constituents of tobacco products This would

include for example further information on the tobacco leaf type the existence of

expanded or reconstituted tobacco

Regulators and the public would be provided with information on product specific

emissions design characteristics that may impact the productrsquos CMR properties

addictiveness or potential characterising flavour(s) As product design playrsquos an

important role in product use and experimentation the monitoring of these design

elements would provide crucial information to regulators implementing EU or national

legislations related to tobacco control

EUROPEAN COMMISSION

41


Health programme

Specific design parameters would be noted for certain tobacco products Due to their

direct association with constituent uptake regulators and the public would benefit from

the understanding

Finally the proposed common reporting format would significantly increase the

information on tobacco product constituents design parameters and characteristics that

if linked appropriately with population based data could lead to a broad range of novel

associations that would fuel tobacco product regulatory science both at a European level

and globally

With regards to e-cigarettes in particular

It would reveal to regulatory authorities the exact ingredients within each marketed

liquid along with information on their potential addictive or toxic characteristics This

knowledge would allow regulators to better evaluate existing and emerging products and

ensure that what is on the market is of high quality composition The general public will

also benefit from greater knowledge of the ingredients of e-liquids

To date knowledge on the emissions of e-cigarettes is limited and identified within

selected reports and scientific manuscripts the results of which may be difficult for

regulators and the public to assess Within the proposed reporting format relevant

emissions (via direct or passive exposure to e-cigarette vapour) are to be provided

As e-cigarettes and their refill liquids constitute an emerging and constantly changing

product category the notification process will give a ldquoheads uprdquo to regulators of new

products about to enter the market that include also information on e-cigarette design

parameters

The above are especially important as the EU is taking a global lead on the regulation of e-

cigarettes Consumers and regulators should therefore be in a position to benefit from the

increased information on this emerging product that will be required

EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS

Overall the activities performed throughout the current project had the overall aim to

support 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

To reach this objective the EUREST consortium applied a number of research methods to

understand the current status quo in the EU to assess aspects that need to be addressed

in a new reporting format and to subsequently develop two central documents the Data

Dictionaries for tobacco products and E-cigarettesrefills respectively These two

documents which were described in detail within this final report and its accompanying

annexes have been designed to be useful to regulators understand stakeholder

requirements be cost effective in adopting the aspects outlined in the TPD and finally to

provide a framework for the disclosure of important information to regulators and the

general public

Moreover within the EUREST project these two data dictionaries were also built into a

functional pilot electronic platform for data submission that was designed to assess the

interrelations between data fields requested so as to ensure that they would be functional

when applied in practice through a commonly designed web portal for the submission of

information

Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary

update the format for the submission and dissemination of the information on ingredients

dissemination to the general public Hence in light of the above the work performed within

the EUREST project may provide input to the work on implementing acts

EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products




Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products

1 Introduction

Objectives of this document

The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data

model of the submission platform

Reference documents

This section lists the applicable and referenced documents

Ref Name

Available from httpeur-lexeuropaeulegal-

contentENTXTuri=OJL2014127TOC Directive 201440EU 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 200137EC

httpeceuropaeuhealthph_determinantslife_styleTob

accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE

httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No

12722008 on classification labelling and packaging (CLP) of substances and mixtures

Version 40 November 2013

httpeur-lexeuropaeulegal-

contentENTXTPDFuri=CELEX32008R1272ampfrom=EN

Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16

December 2008 on classification labelling and packaging of substances and mixtures

amending and repealing Directives 67548EEC and 199945EC and amending

Regulation (EC) No 19072006

EUROPEAN COMMISSION


Health programme

Annex A ndash2

Explanation of the data types

Definition of the data types used in this dictionary

Name Definition Example

String Alphanumeric values limited to 1000 characters Abcd 1234

Decimal Number values decimal allowed 1 22 333

Integer Rounded number values no decimal numbers 1 22 333

File Files as provided in pdf form XXXXXpdf

Date Text corresponding to the following format DDMMYYYY

22032012

List element Must be only one of the values present in the Values column

Boolean Boolean value 0 (falsedisabled)

1(trueenabled)

Reporting types

There are multiple types of mandatoryoptional fields in the current system as noted in the table below

Type Explanation

System generated (AUTO) The variables are automatically generated by the software system in each MS

Mandatory (M) These variables must be completed to successfully submit the report

Optional (O) These are to be completed on an optional basis to aid product reporting

Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)

M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is

information that is not product specific

CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs

EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists

The following table contains certain white lists used for the validation of fields

Data Type Description Regular expression

Phone

Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters

[[0-9][+] [()]]

Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-

]+)(([a-z]23))$

Name String (100)

Identifier Numeric with no decimal characters (Maximum 10 digits)

Description long Alphanumeric maximum 1000 characters

Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center

Five digit identifier eg 02565

Tobacco Product

identifier (TP-ID)

Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN

e 02565-2015-00230

UPCidentifier 12 Digit Numeric

EANidentifier Up to 13 Digit Numeric

SKU identifier Numeric

GTINidentifier Numeric

CAS identifier Numeric

FEMA identifier 4 digit Numeric with the following format NNNN NNNN

Food Additive

identifier

5 digit Alphanumeric eg E1402 or E160

FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933

EC identifier Unique 7 digit identifier written as NNN-NNN-N

where N represents integers NNN-NNN-N

Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2

2 Data Dictionary

21 Application User Characteristics

Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log

on to the reporting platform

22 Submitter characteristics

The submitter is either the manufacturer or importer responsible for the submitted data

Item

Field Comments Data Type Control Type

White list

Reporting Visibility

210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)

String Text M

220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below

String Text M

230 Submitter_SME Verification if the Submitter or parent company if

it exists is an SME as defined in EU recommendation 2003361

List

element

Dropdown M

240 Submitter_VAT The VAT number of the Submitter of the product String Text M

245 Submitter_Type Indication whether the submitter is a

manufacturer or importer

List

element

Dropdown M

250 Submitter_Address The address of the Submitter associated with the

VAT

String Text M

260 Submitter_Country The country of the Submitter in which the company is based

List element

Dropdown M

270 Submitter_Phone The business phone of the Submitter with international codes

String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5

280 Submitter_Email The business email address of the Submitter Only functional addresses should be used

String Text Email M

290 Submitter_Has_Parent_Company

Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory

2100 Submitter_Has_Subsidiary_company

Checkbox if the submitter has a subsidiary company

Boolean Checkbox F (it makes all information in 22b below mandatoryndash

multiple entries

possible)

2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)

Boolean Checkbox F (it makes information in 22c mandatory)

22A ManufacturerImporter Parent company characteristics

Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables

Item Field Comments Data Type Control Type

White list


291 Submitter_Parent_ID The Submitter ID of the parent company should

one exist

String Text F

292 Submitter_Parent_Name Official name of the parent company String Text F

293 Submitter_Parent_Address

The address of the parent company String Text F

294 Submitter_Parent_Count

ry

The country in which the parent company is based List element Dropdown F

295 Submitter_Parent_Phone The business phone of the parent company with international codes

String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6

296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used

String Text Email F

22B ManufacturerImporter Subsidiary company characteristics

Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables


White list


2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company

should one exist

String Text F

2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F

2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F

2104 Submitter_Subsidiary_Country The country in which the subsidiary company

is based

List element Dropdown F

2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company

with international codes

String Text Phone F

2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7

22C Enterer reporting on behalf of the submitter


Item

Field Comments Data Type Control

Type

White

list


2201 Submitter_Principal_ID The Submitter ID of the company on whose

behalf the submission takes place (so called

Principal)

String Text F

2202 Submitter_Principal_Name Official name of the principal company String Text F

2203 Submitter_Principal_Address The address of the principal company String Text F

2204 Submitter_Principal_Country The country in which the principal company is

based


2205 Submitter_Principal_Phone The business phone of the principal company


String Text Phone F

2206 Submitter_Principal_Email The business email address of the principal

company Only functional addresses should be

used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8

23 Product Submission and Description ndash Part A

Item


White list


301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a

complete list of the possible actions types

List element Dropdown M

303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy

Date System Generated

AUTO

304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version


AUTO

310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID

number- year- product numberrdquo (NNNNN-NNNN-

NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter

as is provided centrally by the administrative office

ldquoyearrdquo is that within which the product was first reported

ldquonumberrdquo is a unique number given to each product by the submitter when first reported

String Text TP-ID M (following the specified

rules)

314 Tobacco_Product_ID_Other_Exist

Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If

checked then Item 315 become mandatory

Boolean Checkbox M

315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9

product in other MS Each additional TP_ID is separated with semicolons ()

320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types


330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and

cigarettes)

331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm

Decimal Text F (M for cigars cigarillos and cigarettes)

332 Product_Weight Weight of one unit of product including the specified

moisture for one unit of product and expressed in

mg

Decimal Text M

333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a

unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all

loose products is 1 g including the moisture content and expressed in mg

Decimal Text M

375 Product_Manufacturer_Identification

If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described

String Text F (M if submitted by an importer)

385 Product_Production_Multipl

e_Sites

Dropdown if the product in the current presentation is

produced in multiple sites


386 Product_Production_Site_Address

The complete address of the sites where product production is completed

String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10

340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties

File File browser

F (M for cigarettes and RYO tobacco)

341 Product_Filter Existence of a filter in the product Boolean Checkbox M

342 Product_Filter_Length Length of the product filter in mm Decimal Text F

23 Product Submission and Description ndash Part B

Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance

if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of

presentation

Item


White list


321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip

tion Long

M

322 Product_Brand_subtype_name

The product ldquosubtype namerdquo as marketed in the MS String Text Description Long

M

323 Tobacco

Product_launch_date

Date on which the submitter plans to launchlaunched

the product on the market

Date text M

350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form

The picture should be clear enough to view details and aid in unique product identification

File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11

391 Product_Package_ Picture_File

The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification

File File browser

O

360 Product_Multiple_Presentation

A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B


370 Product_internal_Number The Internal manufacturing ID used by the company

for recognition of the product

String Text M

At least one must be reported consistently for ALL submissions

made by a single submitter

371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text

372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product

String Text

373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product

String Text

374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product

String Text

380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list


390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33


3100 Product_Package_Units The number of individual units of product in the package

Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT

package contains individual units ie bits or pouches)

3105 Product_Package_Net_Weight

Net Weight of the product contained within one

package in g

Decimal Text F (M for SLT (if it is loose) finecut RYO

EUROPEAN COMMISSION


Health programme

Annex A ndash12

and waterpipe tobacco)

3110 Product_Maximum_Sales_Price

The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported

Decimal Text O

3115 Product_Sales_Volume Information on annual sales volume of the reported

product in the country at the submitter level To be

reported in sticks for cigarettes cigars and cigarillos

or in kilograms for oral and fine cut tobacco

Decimal Text M

3120 Product_Other_Market_Data Other market data that may be available to the submitter

String Text O

3130 Product_Market_Research_File

The relevant pdf document of internal and external studies on market research and preferences of various

consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they

carry out when launching new products if available to the submitter

File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13

24 Description of Ingredients Tobacco

Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product

or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used

in the product similar to how other ingredients are reported

Item


White list


410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately

List element

Dropdown M

411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section

String Text F

412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco

File File browser

F if Item 410 2 3 or 4

413 Tobacco_Part_Manufactured_Source

The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources

must be reported separately one by one

String Text F Item 410 is 2 3 or 4

420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list

of tobacco leaf types

List element

Dropdown M

421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section

String Text F

430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table

36 of the Reference Data section for a complete list

List

element

Dropdown M

431 Tobacco_Leaf_Cure_Method_Other

The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14

440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by

leaf cure method leaf type and part type

Decimal Text M

25 Description of ingredients Additives and other substanceselements

Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or

related products including paper filter ink capsules and adhesivesrdquo

Item


White list


510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in

Table 37 of the Reference Data section

List element

Dropdown M

511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if

the response to Item 510 is ldquootherrdquo

String Text F (M if response to

Item510 is ldquootherrdquo)

520 Ingredient_Name Chemical name of the ingredient String Text M

521 Ingredient_CAS The CAS registry number used to identify the ingredient

String Text CAS Identifier

M

522 Ingredient_CAS_Additional The additional CAS registry numbers provided For

each additional CAS number provided to the

system the system will provide a field for an

additional CAS (up to 10 additional CAS can be

uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15

523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association

(FEMA) 4 digit reference number of ingredient if

one has been granted for the ingredient In the

case of multiple FEMA numbers they are to be

separated by semicolons ()

String Text FEMA identifier

F

If a CAS

does not exist reporting at least one is mandatory and to be

reported in the following order of importance FEMAgtAdditivegtFLgtEC

524 Ingredient_Additive_Number If the ingredient is a food additive its food additive

number should be stated using the ldquoE numberrdquo

noted in Commission Regulation (EU) No

11302011 and Regulation (EC) No 13332008

String Text Food Additiv

e

Identifier

525 Ingredient_FL_Number European flavouring (FL) number of ingredient if

one has been granted for the ingredient based on

the commission Implementing Regulation (EU) No

8722012

String Text FL identifi

er

526 Ingredient_EC_Number European Community (EC) number if one has been

granted for the ingredient (This is also known as

the EC No EINECS No and EC)

String Text EC identifi

er

530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does

fluctuate A response of YES would make items 550 551 552 553 mandatory

Boolean Checkbox M

540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in

Item 510 above preferably in descending order of weight

Decimal Text M

541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should

declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower

Decimal Text F (M if 530 is Yes)

EUROPEAN COMMISSION


Health programme

Annex A ndash16

542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should

declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs


550 Ingredient_Measured_Mean_Qu

antity

The measured mean (average) weight of the

ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch

Decimal Text F (M if

530 is Yes)

551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period


552 Ingredient_Measured_Min_Leve

l The measured (actual) lower value of the quantity

of that ingredient added to one unit of the product

within each standardized batch during the previous

reporting period This corresponds with the

minimal value recorded


530 is

Yes)

553 Ingredient_Measured_Max_Level

The measured upper value of the weight quantity

of that ingredient included during the previous


maximal value recorded during the previous

reporting period


560 Ingredient_Function Function of the ingredient The ingredient functions

are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()

Multivalue Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash17

561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo

String Text F

570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo

List element

Dropdown M

571 Ingredient_Priority_Additive_Fil

es

Pdf files of the report which shall include an

executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo

File File

browser

F

580 Ingredient_Unburnt_Status Dropdown on the existence of information if the

ingredient in unburnt status is characterised by any

known type of toxicity or has CMR properties

Selection to be defined as in Table 39

List element

Dropdown M

590 Ingredient_REACH_Registration Notification if the ingredient has been registered

under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances

Responses Yes Full Yes Intermediate Yes NONS No not registered

List

element

Dropdown M

5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified

(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database

List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18

5110 Ingredient_CLP_Acute_Tox_Oral

Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

F based on response to 5109

Reminder all fields that are flagged with a symbol (ie M or

F) are

automatically completed by the system once submitted for the first

time by the manufacturer

5111 Ingredient_CLP_Acute_Tox_Der

mal

Ingredient Classification with regards to acute

dermal toxicity based on Regulation (EC) No 12722008

List

element

Dropdown Tox_C

ode

5112 Ingredient_CLP_Acute_Tox_Inhalation

Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

5113 Ingredient_CLP_Skin_CorrosiveIrritant

Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

5114 Ingredient_CLP_Eye_DamageIrritation

Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

5115 Ingredient_CLP_Respiratory_Sensitisation

Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

5116 Ingredient_CLP_Skin_Sensitisation

Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No

12722008

List element

Dropdown Tox_Code

5117 Ingredient_CLP_MutagenGenotox

Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No

12722008

List element

Dropdown Tox_Code

5119 Ingredient_CLP_Reproductive_Tox

Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008

List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19

5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the

dropdown list provided

List element

Dropdown Tox_Code

5121 Ingredient_CLP_STOT_Description

Reference to the specific organ(s) affected in text format based on the above classification

String Text

5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration

toxicity based on Regulation (EC) No 12722008

List

element

Dropdown Tox_C

ode

5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses

List element

Dropdown M

5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and

intact transfer of an ingredient to smoke or

Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products

Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity

Boolean Checkbox FM

5141 Ingredient_Tox_CMR Existence of any CMR related study including but

not limited to

In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties

Assays to determine the effect of the ingredient

on the reproductive system and its potential to cause birth defects

Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on

Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20

either inhalation or dermal exposure for the latter)

5142 Ingredient_Tox_CardioPulmonary

Existence of In vitro and in vivo assays to evaluate

the toxicological effects of the ingredient on the

heart blood vessels or respiratory tract

Boolean Checkbox FM

5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence

Boolean Checkbox FM

5144 Ingredient_Tox_Other Existence of any other toxicological data not stated

above

Boolean Checkbox FM

5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will

be available

File File browser

FM

26 TNCO and other emissions

Note These variables are not mandatory for all tobacco products

Item

Field Comments Data Type

Control Type

White list


610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243

Decimal Text F (M for cigarettes)

611 Emission_Nicotine Nicotine yield according to the ISO standard 10315

with the accuracy measurements determined in accordance with ISO standard 8243


612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243


EUROPEAN COMMISSION


Health programme

Annex A ndash21

620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and

communicated to the commission In case of multiple entries they should be separated by semi- columns ()

String Text F (M for cigarettes)

630 Emission_Other_Available Filter variable for notification of the existence or not

of information on other emissions and their levels

List element

Dropdown

M

631 Emission_Methods_File Pdf file on the production and measurement methods

used to assess the emissions The file should contain

substantial information for the regulator to

understand and duplicate if necessary the emission

test and also include where the emission testing took

place

File File

browser

F

640 Emission_Name Chemical name of the emissions produced during the

testing of the product

String Text F

641 Emission_CAS The individual emissionrsquos Chemical Abstract Service

(CAS) registry number

CAS

Identifie

r

F

642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number

not exist

String Text F

643 Emission_Quantity The quantity of the emission produced during the

process of using the product

Numeric Text F

644 Emission_Units The units in which the emission is measured String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash22

27 Cigarette specific

The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo

Item


Control Type

White list


710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)

Boolean Checkbox M

722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M

723 Cigarette_Filter_Drop_Pressure_Closed

Drop of Pressure with closed vents (mmH2O) Decimal Text M

724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M

28 Smokeless (Oral-nasal-chewing) specific

The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo

OR ldquoChewing tobaccordquo

Item


Control Type

White list


810 Smokeless_pH The pH of the product Decimal Text M

820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O

830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M

840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O

850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach

String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23

29 Novel Tobacco Products

The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo

Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File

Pdf file on the RiskBenefit analysis of the product its

expected effects on cessation of tobacco

consumption its expected effects on initiation of

tobacco consumption and predicted consumer

perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)

920 Novel_Contain_Tobac

co

Identification if the novel tobacco product contains

tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)

210 Fine cut - Pipe tobacco specific

The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo

Field Field Comments Data

Type

Control

Type

White

List

Reporting Visibili

ty

1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the

loose product per unit

Decimal Text M

1020 Finecutpipe_Unionised_Nicotine_Con

tent

Unionised nicotine content of

the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24

212 Other tobacco products not specifically mentioned

These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements

as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products

3 Reference Data

31 Type of submission

32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo

4 Roll your own tobacco

5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco

15 Herbal product for smoking

16 Novel tobacco product

Value Name

1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)

2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID

version)

3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation

(Update of TP-ID version)

4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name

1 Flip top box square corner

2 Flip top box bevel corneroctagonal

3 Flip top box rounded corner

4 Shoulder hinged box

5 Soft pack

6 Pouch with flap

7 Bucket (Cylindrical or cuboid)

8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin

22 Standing pouch roll-fold

23 Slide lid box

24 Flow wrap

25 Folding pouch

26 ShellHull amp Slide box

27 Multi-pack display

EUROPEAN COMMISSION


Health programme

Annex A ndash26

34 Tobacco Part Type

35 Tobacco Leaf type

36 Tobacco Leaf Cure Method

Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf

2 Manufactured ndash Cut stems

3 Manufactured - Reconstituted tobacco

4 Manufactured - Expanded tobacco

5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other

8 Unspecified (less than 30 is identifiable to one leaf type)

EUROPEAN COMMISSION


Health programme

Annex A ndash27

37 Ingredient Category

Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)

4 side seam adhesive (burnt )

5 inks used on cigarette paper (burnt)

6 filtration material (unburnt)

7 filter overwrap (unburnt)

8 filter adhesive (unburnt)

9 tipping paper and tipping paper inks (unburnt)

10 Adhesive (unburnt)

11 Adhesive (burnt)

12 tips (unburnt)

13 Pouch material (unburnt)

14 paper (unburnt)

15 Other (unburnt)

38 Ingredient Function

Value Name

1 Addictive Enhancer

2 Adhesive

3 Binder

4 Carrier

5 Colour

6 Combustion Modifier

7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28

39 Ingredient Unburnt Status

310 Toxicological Data Available

11 Filtration Material

12 Flavour andorTaste Enhancer

13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative

17 Solvent - Processing Aid

18 Reduced Ignition Propensity Agent

19 Sizing Agent

20 Smoke Enhancer

21 Smoke Colour Modifier

22 Smoke Odour Modifier

23 Wrapper

24 Water-Wetting Agents

25 Viscosity Modifier

26 Other

Value Name

0 No available information on the ingredientrsquos toxicity in unburnt form

1 Not toxic and without CMR properties in unburnt form

2 Identified as toxic and or with CMR properties in unburnt form

Value Name

1 No toxicological data available

2 Toxicological data is available but not new

3 New toxicological data has been obtained since the last reporting period

EUROPEAN COMMISSION


Health programme

Annex B - 1

Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers

1 Introduction

11 Objectives of this documents

The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within

the data model of the submission platform

12 Reference documents

Ref Name




States concerning the manufacture presentation and sale of tobacco and related

products and repealing Directive 200137EC

httpeceuropaeuhealthph_determinantslife_styleT

obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE

httpechaeuropaeudocuments1016213562clp_en

pdf

Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No









EUROPEAN COMMISSION


Health programme

Annex B -2

13 Explanation of the data types








22032012


Boolean Boolean value A pop up box asking for a tick-box for yes

0 (falsedisabled) 1(trueenabled)

14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]

Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-

]+)(([a-z]23))$

Name String(100)


Descriptionlong Alphanumeric maximum 1000 characters



Electronic cigarette

identifier (EC-ID)

Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN

e 02565-15-00230







Food Additive

identifier


FL identifier 7 digit numeric with the following format

NNNNNN eg 13093 or 09933

EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers

NNN-NNN-N

Tox_Code Maximum 2 digits One numeric one capital character

eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item

Field Comments Data Type Control Type White list

Reporting Visibility1

210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)

String Text M

220 Submitter Name Official name of the submitter at the MS level

as linked to the VAT number requested below

String Text M

230 Submitter_SME Verification if the Submitter or parent

company if it exists is an SME as defined in EU recommendation 2003361


240 Submitter_VAT The VAT number of the Submitter of the product

String Text M

241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer


250 Submitter_Address The address of the Submitter associated with

the VAT

String Text M

1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)

EUROPEAN COMMISSION


Health programme

Annex B -5



270 Submitter_Phone The business phone of the Submitter with

international codes

String Text Phone M


String Text Email M


Checkbox if the submitter has a parent company It makes all information in 2b below

mandatory

Boolean Checkbox M

2100 Submitter_Has_Subsidiary_Company

Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible

Boolean Checkbox M


Boolean Checkbox M



Item



291 Submitter_Parent_ID The Submitter ID of the parent company should one exist

String Text F


293 Submitter_Parent_Address The address of the parent company String Text F

EUROPEAN COMMISSION


Health programme

Annex B -6

294 Submitter_Parent_Country The country in which the parent company is based



String Text Phone F

296 Submitter_Parent_Email The business email address of the parent

company Only functional addresses should be used

String Text Email F

22B ManufacturerImporter subsidiary company characteristics


Item



2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company

should one exist

String Text F

2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F

2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F

2104 Submitter_Subsidiary_Country The country in which the affiliate company is based


2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes

String Text Phone F

2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item



2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called

Principal)

String Text F



2204 Submitter_Principal_Country The country in which the principal company is based


2205 Submitter_Principal_Phone The business phone of the principal company with international codes

String Text Phone F

2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8

23A Product Submission and Description ndash Part A

Item



301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types


303 Submission_Start_Date The submission date will be calculated by the

system when the user submits the product Date will have the following format ddmmyyyy

Date System

Generated

AUTO

304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action

that would lead to a change of the EC-ID version


AUTO

310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID

number- year- product numberrdquo (NNNNN-NN-

NNNNN)

ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office

ldquoyearrdquo is that within which the product was first reported (2 digits)

ldquonumberrdquo is a unique number given to each

product by the submitter when first reported

String Text EC-ID AUTO

314 E-cigarette_Product_ID_Other_Exist

Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory

Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9

315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other

Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()

String Text F

320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference

Data section which provides a list of product

types


325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in

mg

Decimal Text M

326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in

ml

Decimal Text M

375 Product_Manufacturer_Identifi

cation

If the submitter is NOT the manufacturer of the

product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described

String Text F if

submitted by an importer

350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification

File File browser M

385 Product_Production_Multiple_S

ites

Dropdown if the product in the current

presentation is produced in multiple sites

List element Dropdown


The address of the sites where product production is completed This Item is repeated for each product production site

String Text

EUROPEAN COMMISSION


Health programme

Annex B -10

23B Product Submission and Description ndash Part B



presentation

Item

Field Comments Data Type Control Type White

list


321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the

MS

String Text Descript

ionLong

M

322 Product_Brand_Subtype_name

The product ldquosubtype namerdquo (if one exists) as marketed in the MS

String Text DescriptionLong

M

360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is

the ldquokeyrdquo to product description Part B (the

ldquothirdrdquo level of detail)


361 E-cigarette_launch_date The date on which the submitter plans to

launchlaunched the product on the market

Date Text M

370 Product_Manufacturer_Number

The internal manufacturing ID used by the company for recognition of the product

String Text M At least one must be reported consistently for ALL

submissions made by a single submitter

371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product

String Text

372 Product_EAN_Number The EAN-13 or EAN-8 (European Article

Number) for the product

String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11

374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product

String Text

380 Product_National_Market The Member state for which the product

information below is being provided


391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification

File File browser M

3100 Product_Package_Units The number of individual units of product in the

package

Decimal Text M

3102 Product_CLP_Classification Overall Product classification as a mixture of

substances based on Regulation (EC) No

12722008 and as described in the ldquoGuidance

on the Application of the CLP Criteriardquo This

takes into account collectively the potential

toxicity at the ldquoproduct levelrdquo


EUROPEAN COMMISSION


Health programme

Annex B -12

23C Product Submission of annual data ndash Part C

Item



3106 Product_Annual_Reporting_Section

Verification if the submitter would like also to

submit their annual information noted in TPD

Art207 via the current submission system

Checking this box activates the below

reporting requirements

Boolean Checkbox F

3115 Product_Sales_Volume Information on annual sales volume of the

reported product in the country at the

submitter level Sales volume reporting to be

reported in pieces (for devices) andor ml (for

e-liquids)

Numeric Text F if 3105 is yes

3117 Product_Mode_Of_Sales Relevant pdf document describing the mode

of sale of the products

File File browser F if 3105 is yes AND

3125 is Option 3

3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter

String Text F if 3105 is yes

3125 Product_Market_Research_Available

Existence of market data available See Table 33 of the Reference Data section for responses

List element Dropdown F if 3105 is yes

3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups

including young people non-smokers and the main types of current uses and if available

to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section


3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13

24 Description of ingredients contained in the product

Item

Field Comments Data Type Control Type White list Reporting

Visibility




M

522 Ingredient_CAS_Additional The additional CAS registry numbers

provided For each additional CAS number

provided to the system the system will

provide a field for an additional CAS (up to 10

additional CAS can be uploaded)

String Text F

523 Ingredient_FEMA_Number Flavour and Extract Manufacturers

Association (FEMA) 4 digit reference number

of ingredient if one has been granted for the

ingredient In the case of multiple FEMA

numbers they are to be separated by

semicolons ()


If a CAS does not exist reporting

at least one is

mandatory and to be reported in the following order of

importance

FEMAgtAdditivegtFLgtEC

524 Ingredient_Additive_Number If the ingredient is a food additive its food

additive number should be stated using the

ldquoE numberrdquo noted in Commission Regulation

(EU) No 11302011 and Regulation (EC) No

13332008

String Text Food Additive Identifier

525 Ingredient_FL_Number European flavouring (FL) number of

ingredient if one has been granted for the

ingredient based on the commission

Implementing Regulation (EU) No 8722012

String Text FL identifier

EUROPEAN COMMISSION


Health programme

Annex B -14

526 Ingredient_EC_Number European Community (EC) number if one

has been granted for the ingredient (This is

also known as the EC No EINECS No and

EC)

String Text EC identifier

540 Ingredient_Recipe_Quantity The weight of the ingredient included in one

unit of product in mg according to recipe Ingredients should be listed in descending order of weight

Decimal Text M

560 Ingredient_Function Function of the ingredient The ingredient

functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()


561 Ingredient_Function_Other The function of the ingredient in text format if


String Text F

580 Ingredient_Unburnt_Status Dropdown on the existence of information if

the ingredient in unburnt status is

characterised by any known type of toxicity

or has CMR properties Selection to be

defined as in Table 35


590 Ingredient_REACH_Registration

Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH

status can be identified via the public domain through the site httpechaeuropaeuinformation-on-

chemicalsregistered-substances



EUROPEAN COMMISSION


Health programme

Annex B -15

5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-

chemicalscl-inventory-database



Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories

List element Dropdown Tox_Code F based on response to 5109

5111 Ingredient_CLP_Acute_Tox_Dermal

Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories

List element Dropdown Tox_Code

5112 Ingredient_CLP_Acute_Tox_In

halation


inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories



Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric

format as Categories



Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories


5115 Ingredient_CLP_Respiratory_S

ensitisation

Ingredient Classification with regards to

respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories


5116 Ingredient_CLP_Skin_Sensitisa

tion

Ingredient Classification with regards to skin

sensitisation based on Regulation (EC) No


EUROPEAN COMMISSION


Health programme

Annex B -16

12722008 Responses are in alphanumeric format as Categories

5117 Ingredient_CLP_MutagenGen

otox

Ingredient Classification with regards

mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories



12722008 Responses are in alphanumeric




Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories


5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are

selected from the dropdown list provided Responses are in numeric format as Categories




String Text

5122 Ingredient_CLP_Aspiration_Tox

Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)

No 12722008 Responses are in numeric format as Categories


5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for

potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17

5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and

intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an

ingredient that transfers intact into the emissions andor studies to identify any breakdown products

Studies on the effect of addition of an

ingredient to the test article on emission

composition and toxicity

Boolean Checkbox FM

5141 Ingredient_Tox_CMR Existence of any CMR related study including

but not limited to In vitro toxicological assays to evaluate

potential genotoxic and cytotoxic

properties Assays to determine the effect of the

ingredient on the reproductive system and its potential to cause birth defects

Assays to determine whether the

ingredient affects the tumorigenic properties of the product (The analyses

should be based on either inhalation or dermal exposure for the latter)

Boolean Checkbox FM


Existence of In vitro and in vivo assays to

evaluate the toxicological effects of the

ingredient on the heart blood vessels or

respiratory tract

Boolean Checkbox FM

5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie

whether the ingredient promotes dependence

Boolean Checkbox FM

5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above

Boolean Checkbox FM

5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of

File File browser FM

EUROPEAN COMMISSION


Health programme

Annex B -18

consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available

25 Emissions

Item

Field Comments Data Type Control Type White list Reporting Visibility

615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided

Decimal Text M

625 Emission_Protocol_Type The type of protocol used for the production of

e-cigarette emissions In the absence of

agreed standardsprotocols emissions

measuring should be performed for both the

recommended medium range wattage and the

recommended under normal use maximum

wattage

After a unified standardprotocol for emission

measuring has been approved by the EC the

stakeholders will have to repeat the tests using

the standardised protocol and to submit this

information to the competent authorities


631 Emission_Methods_File Pdf file on the production and measurement

methods used to assess the emissions The

file should contain substantial information for

the regulator to understand and duplicate if

necessary the emission test and also include

where the emission testing took place

File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19

640 Emission_Name Name of the emissions produced during the

testing of the product selected from a

dropdown list in Reference Table 37

List Element Dropdown M

643 Emission_Quantity The quantity of the emission produced during

the process of using the product

Numeric Text M

644 Emission_Units Unit in which the emission is measured List Element Dropdown M

26 E-cigarette specific

Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility

1110 E-Cigarette_Description Description of the e-cigarette or refill container to

facilitate unique product identification including a

description of the individual parts (componentse-

liquid)

String Text M M

1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank

size for cartridgescartomisers or for refill container

actual volume when placed on the market)

Decimal Text M M

1116 E-

cigarette_Nicotine_Concentrat

ion

The nicotine concentration of the liquid in the e-

cigarette or refill container in mgml

Decimal Text M M

1120 E-Cigarette_Battery_Type Description of the type of battery used including its

chemical composition (type)

String Text M NA

1121 E-

Cigarette_Battery_Type_Capa

city

Indication of the battery capacity in mAh Decimal Text M NA

EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-

Cigarette_VoltWatt_Adjustab

le

Verification that the e-cigarette is either

voltagewattage adjustable Responses are as noted

in Table 37 of the Reference Section data

List

element

Dropdown M NA

1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to

Item1121 is ldquo3rdquo or ldquo4rdquo

Decimal Text F NA

1131 E-

Cigarette_Voltage_Lower_Ran

ge

Lower voltage obtainable if response to Item1121

is ldquo1rdquo or ldquo2rdquo

Decimal Text F NA

1132 E-

Cigarette_Voltage_Upper_Ran

ge

Upper voltage obtainable if response to Item1121


Decimal Text F NA

1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if

response to Item1121 is ldquo2rdquo or ldquo4rdquo

Decimal Text F NA

1141 E-

Cigarette_Wattage_Lower_Ra

nge

Lower wattage obtainable if response to Item1121


Decimal Text F NA

1142 E-

Cigarette_Wattage_Upper_Ra

nge

Upper wattage obtainable if response to Item1121


Decimal Text F NA

1150 E-

Cigarette_Airflow_Adjustable

Indication if the airflow of the e-cigarette is

adjustable

Boolean Checkbox M NA

1160 E-Cigarette_Wick_Changeable Indication that the consumer may

adjustalterreplace the wick

Boolean Checkbox M O

1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the

e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21

1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the

atomiser

String Text M O

1190 E-

Cigarette_Nicotine_DoseUpta

ke_File

Pdf document for the nicotine dosinguptake studies

This file must include

1) Evidence from internal or published studies with

regards to nicotine dosing and uptake that the

manufacturerimporter is aware of

2) Total nicotine delivery per device or refill

container that is provided in the vapour assuming a

100 uptake by the consumer

File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof

Declaration that the product is child resistant and

tamper proof is protected against breakage and

leakage and have a mechanism that ensures refilling

without leakage (where applicable)

Boolean Checkbox M M

11110 E-Cigarette_Production _File Pdf file with the description of the final production

process including series production

File File

Browser

M M

11120 E-

Cigarette_Production_Confor

mity

Declaration that the production process ensures

conformity (including but not limited to information

on series production)


11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer

bear full responsibility for the quality and safety of

the product when used under normal or reasonably

foreseeable conditions


11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are

used in the manufacture of the liquid This include at

the minimum the following

String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22

The diluents shall comply to the requirements of the European Pharmacopeia

Nicotine should comply to the requirements of the European Pharmacopeia

Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid

11123 E-cigarette_Non_Risk Declaration that the product does not pose

reasonably foreseeable risk to human health under

normal conditions of use (with the exception for its

nicotine content)


11124 E-

cigarette_Consistent_Dosing

Declaration of nicotine dosing at consistent levels

during product use and across batches under normal

or reasonably foreseeable conditions

String Text M M

11124 E-

cigarette_Consistent_Dosing_

Methods

Relevant PDF file describing how they ensure

consistent dosing in the absence of an agreed

standardprotocol

File File

Browser

11130 E_Cigarette_OpeningRefill

_File

Pdf file with the description of the opening and refill

mechanism where applicable

File File

Browser

M for

refillable e-

cigarettes

M

11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the

leaflet of information for consumers that will include

Instructions for use and storage of the product

including a reference that the product is not

recommended for use by young people and non-

smokers contra-indications warnings for specific

risk groups possible adverse effects addictiveness

and toxicity and contact details of the manufacturer

or importer and a legal or natural contact person

within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name

10 Electronic cigarette ndash Disposables including disposable kits

11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits

12 Electronic cigarette ndash Rechargeable refillable including assembly kits

13 Electronic cigarette - Refill container containing e-liquid

14 Other components of electronic cigarettes intended to contain e-liquid

33 Marketing Data Available

Value Name

1 No marketing data available

2 Marketing data is available but not new

3 New marketing data has been obtained since the last reporting period

Value Name

1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)

2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)

3 Submission of new informationdata on an existing product leading to a

modificationaddition at the level of product presentation (Update of EC-ID version)

4 Cancellation of the product

EUROPEAN COMMISSION


Health programme

Annex B -24


NOTE This list also includes functions for other regulated products


Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name

1 Nicotine in vapour

2 Ethylene glycol

3 Diethylene glycol

4 Carbonyl Formaldehyde

5 Carbonyl Acetaldehyde

6 Carbonyl Acrolein

7 Carbonyl Crotonaldehyde

8 TSNA NNN

9 TSNA NNK

10 Trace metal Cadmium

11 Trace metal Chromium

12 Trace metal Copper

13 Trace metal Lead

14 Trace metal Nickel

15 Trace metal Arsenic

16 Trace metal Mercury

17 Trace metal Tin

18 Trace metal Silicon

19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene

23 Flavour ingredients Diacetyl

24 Flavour ingredients Acetyl Propionyl

25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26

38 E-Cigarette VoltageWattage Adjustable

Value Name

1 Yes voltage and wattage adjustable

2 Yes only voltage adjustable

3 Yes only wattage adjustable

4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1

Annex C Data Dictionary Technical Justification Document

1 Introduction

In this ANNEX we provide a description and scientific and regulatory justification of all terms

included in the data dictionary This is directly linked to the Data Dictionaries in Annex A

and Annex B and is complimentary to these documents This working document provides

the insight into the EUREST train of thought and its processes and is not based on a

separate review of the literature

We separate the variables initially based on those that are requested for all products

and secondly for those requests that are product specific (ie specific to e-cigarettes

smokeless tobacco cigars or cigarettes etc)

System generated variables are not discussed as they are internal to the system and

not modifiable but allow for the linkage of domains

The variables included here are based on the understanding that an offline process

will initiate the submission of the data and the registration of the submitter After

registration the submitter would be provided with appropriate log-in access

The document should be read with the data dictionary open so as to facilitate its

reading

All responses that the submitter will provide are to be in numeric format unless

explicitly stated otherwise in the data dictionary This is done so as to receive data

that can be merged into one common dataset (string columns canrsquot be merged) and

to avoid language issues and spelling mistakes The importance of such a merge

dataset of all information submitted within or across EU MS canrsquot be stressed enough

as it is this activity that will allow for the monitoring of product changes and product

evolution across the EU

String responses with multiple variables have each variable separated with a

semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The

breakdown of such string variables into numeric responses would at this stage make

the reporting format extremely complicated In a future revision such string

variables should be transformed into categorical variables that would allow for the

data to be merged

Variable description

Application User Characteristics

The data that was requested here through this table is now collected through an offline

procedure Once the submitter (or a third person authorized to act on behalf of the

submitter) has been authorized and approved then heshe will be provided with the

necessary information to log on to the reporting system and upload the necessary

information

2a Fields related to submitter characteristics

Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type

Submitter_Address Submitter_Country Submitter_Phone Submitter_Email

Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company

Submitter_Appoints_enterer In these fields the submitter characteristics and contact

information must be submitted It is likely that some of this information must also be

EUROPEAN COMMISSION


Health programme

Annex C - 2

requested during the offline registration procedure of the submitter The submitter is either

the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)

the obligation to provide the requested information shall lie primarily with the manufacturer

if the manufacturer is established in the Union The obligation to provide the requested

information shall lie primarily with the importer if the manufacturer is established outside

the Union and the importer is established inside the Union The obligation to provide the

requested information shall lie jointly with the manufacturer and the importer if both are

established outside the EU

2b ManufacturerImporter Parent company characteristics

This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is

checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo

ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo

ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo

2c ManufacturerImporter subsidiary company characteristics

This information is requested once the Item 2100

(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following

data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo

ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo

ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo

2d Enterer reports on behalf of the submitter

This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is

checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo

ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo

ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo

3a Product Submission and Description ndash Part A

Submission_Type This variable requests from the submitter the type of submission that

they wish to perform Users will have the ability to perform a submission of a new product

to update data on an existing product to correct data on an existing product leading to a

modification addition at the level of product presentation or to perform a submission

cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the

system of the type of data that will be submitted so that the system domains are linked

appropriately It is mainly a functional parameter mandatory for all products and based on

TPD 5(1) and 20(2)

New product submission including a submission of a product modification in declared

recipe or design (New Product-ID number)

Submission of new informationdata on an existing product NOT leading to a

modification in recipe or design (Update of Product-ID version)

Submission of new informationdata on an existing product leading to a

modificationaddition at the level of product presentation (Update of Product-ID

version)

Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo

which is to be calculated by the system when the user submits the product (Date will have

the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents

EUROPEAN COMMISSION


Health programme

Annex C - 3

the date between two versions of the same product as generated by the system whenever

the user performs an action that would lead to a change of the product ID (TP or EC) version

Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is

given to each product This is the common key between different submission versions of the

same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-

product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One

for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence

of one common number or identification code throughout the globe for such products this

ID is suggested to be used as a ldquoKEYrdquo in the variable list

With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical

design and recipe that is marketed in the EU using a different Product-ID The field of

ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked

Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design

characteristics) is marketed in another EU MS The submitter reports which other

Product_IDs exist for this identical product in other MS Each additional ID is separated with

semicolons () Updating this field does not interfere with the product number but it changes

the product version

Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each

specific product is reported In this field the submitter must state the product for which

heshe will be submitting data This list is based on the existing categories of the current

EU reporting format with the addition of product types noted by i) the articles of the TPD

ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the

Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo

ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo

ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing

reporting format and the new TPD articles Based on the response provided to this item

specific columns of the common reporting format are then requested to be completed Based

on the submitter response to this question the appropriate reporting format variables are

then provided

Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two

measurements which describe the average total length of the product unit and its average

diameter (measured at the point with maximal diameter) are expressed in mm These

variables help identify the actual product and aid in stratifying the reporting These two

factors are noted in the Brazilian reporting format but are not in the current EU reporting

format The inclusion of these two parameters allows for a) unique product identification

and potential stratification of products by their length (regular king long ultra-long) or

their diameter (slim vs non slim)

Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable

ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified

moisture which is expressed in mg This variable is requested for all products as part of a)

unique product identification and b) issues related to ingredient dosing A unit of product is

one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose

products is 1 g including the moisture content and expressed in mg This weight includes

the moisture content and it is expressed in mg These two aspects were retained from the

current reporting format however are selectively applied based on the TPD requirements

EUROPEAN COMMISSION


Health programme

Annex C - 4

Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-

liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml

respectively

Product_Manufacturer_Identification If the submitter is not the manufacturer of the

product then here he she would state the official company name of the manufacturer of

the product and other information that would aid the identification of the manufacturer

Should multiple companies produce the same product this should be described

Product_Production_Multiple_Sites and Product_Production_Site_Address This section

defines if the product in the current presentation is produced in multiple sites and the

complete address of the sites where product production is completed The Item

ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site

Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a

pdf file as the relative technical document setting out a general description of the additives

used and their properties

ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and

manufacturing characteristics of the filter if one exists

Product_Market_Research_Available (only for electronic cigarette and refill containers) This

variable provides information about the existence of market data available and is requested

to select one of the options available in reference table 312 of the Data Dictionary

3b Product Submission and Description ndash Part B

Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the

product and the brand subtype name of the product as they are marketed in the MS for

which the data are submitted The variable of the product brand name was assessed to be

beneficial and was retained from the current reporting format

Product_Launch_Date This is the date that the submitter plans to launch the product on to

the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo

above as the submission start date must precede the date during which the product will

enter the market

ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable

ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The

picture should be clear enough to view details and aid in unique product identification This

would allow for the collection of an ldquoactualrdquo example of the final marketed product This

information is not collected in the current reporting format however is routine practice in

both the Canadian and Brazilian reporting formats who actually request a sample to be sent

to the central regulators As this process would probably lead to an overflow of actual

products collected at either a national or EU level and would encompass certain purchase

and shipment costs we propose that if part of the reporting this information be provided

in the form of a picture file that would aid individual product identification by MS and EU

regulators Moreover the provision of a picture of the product package

ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the

final marketed product This information is not collected in the current reporting format

however is routine practice in both the Canadian and Brazilian reporting formats who

actually request a sample to be sent to the central regulators As this process would probably

lead to an overflow of products collected at either a national or EU level and would

encompass certain purchase and shipment costs we propose that if part of the reporting

EUROPEAN COMMISSION


Health programme

Annex C - 5

this information be provided in the form of a picture file that would aid individual product

identification by MS and EU regulators

Product_Multiple_Presentation Based on the number of multiple presentations reported in

Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each

individual presentation For instance if a company reports that they have 5 types of

presentation for a product then the info below would be completed five times once for each

type of presentation This will allow the regulator to see if other presentations of the same

product are available EUREST proposes to increase the number of attributes that will be

collected with regards to product design characteristics as this would allow for the easier

identification-and comparison- of products between MS

Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number

Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are

used to be able to ensure the unique identification of the product These 4 parameters are

closely linked to each other to allow for the introduction of a product ID Based on the

research from the TIS and the ECIS no unique identification system is used throughout the

industry with each company using one or more of the above identification systems

Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly

used however we cannot verify with certainty that this is the appropriate approach

Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping

Unit) or the internal manufacturer number Hence the current working hypothesis is that a

combination of product identifiers will be needed to verify the individuality of the products

Specifically we will request the industry to report at least one of the above parameters ndashin

a consistent manner For each of the parameters above specific rules are identified to

ensure that the submission system will recognize only codes of valid format for each of the

reporting types

Product_National_Market The member state for which the product information below is

being provided The EU MS is selected from a dropdown list

Product_Package_Type (only for tobacco products) Products_Package_Units These fields

refer to the monitoring of the external packaging of the product and identification of the

product unit The collection of this information will aid in unique product identification and

issue which has not been addressed and canrsquot be addressed comprehensively under the

current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is

requested to select one of the options available in Reference Table 33 of the Data

Dictionary This information is requested in the Canadian and Brazilian reporting formats

Product_Package_Net_Weight (only for tobacco products) The variable

ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one

package which is expressed in g (without packaging)

Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable

defines the overall product classification as a mixture of substances based on Regulation

(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo

This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo

Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the

current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo

is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators

assess market trends ldquoMember States shall also require manufacturers and importers to

report their sales volumes per brand and type reported in sticks or kilograms and per

Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported

EUROPEAN COMMISSION


Health programme

Annex C - 6

in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such

information in a predefined electronic format could be optionally requested by Member

States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require

manufacturers and importers of electronic cigarettes and refill containers to submit

annually to the competent authorities (i) comprehensive data on sales volumes by brand

name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is

not trade secrets or unknown and are often adhoc requested by the MS regulatory office for

tobacco These aspects were also noted by MS as aspects of interest to collect More

importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product

identification Based on TPD 5(6)

Product_Other_Market_Data Other market data that may be available to the submitter

Product_Market_Research_File This variable was not requested in the current EU reporting

format however is now clearly stated in the TPD 5(6) ldquoMember States shall require

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 relating to ingredients and emissions as well as executive summaries of

any market surveys they carry out when launching new productsrdquo While in WP1 MS

reported that this information would be useful the TIS again noted that this would be a

trade secret and hence not available to the general public Evaluating a few examples

provided by Stakeholders and based on internal document reviews and the examples

applied in the Canadian format we suggest that this information is not broken down into

individual variables (ie date sample size methodology etc) but collected in the form of

a common pdf file

4 Product Submission of annual data ndash Part C (Only for e-cigarettes)

If the submitter would like also to submit their annual information via the current submission

system they are to check a box which will activate the following reporting requirements

ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo

ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo

ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD

20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes

and refill containers to submit annually to the competent authorities comprehensive data

on sales volumes by brand name and type of the product information on the preferences

of various consumer groups including young people non-smokers and the main types of

current users the mode of sale of the products and executive summaries of any market

surveys carried out in respect of the above including an English translation thereofrdquo

5 Tobacco ingredient description

As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance

or element present in a finished tobacco product or related products including paper filter

ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco

ingredientrdquo used in the product similar to how other ingredients are reported

Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of

tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide

some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has

been prepared solely by mechanical processing that involves no chemical additive or

substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco

stems in the product Reconstituted tobacco refers to a mixture created by reclaiming

remnants of virgin tobacco remaining after manufacture-elements that would otherwise be

EUROPEAN COMMISSION


Health programme

Annex C - 7

wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has

been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for

tobacco ingredients that do not fall under this category for which a string variable is

provided ldquoTobacco_Part_Type_Otherrdquo

Tobacco_Part_Description_File This variable includes a pdf file which includes the overall

description of the manufactured part type in the recipe The description provides detailed

information on the quantitative and qualitative consistency of the manufactured tobacco

This also includes a brief description of the process used (ie paper vs cast slurry) if any

ingredients react together during processing and if so under what conditions Moreover any

other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are

also to be described This is complimentary to the detailed information provided through

Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430

(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types

included in the reconstituted or expanded tobacco One pdf file should be uploaded for each

time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured

tobacco types used in a quantity below a certain percentage of the total tobacco content

one summary file may be submitted for these types as long as the total percentage of these

unreported manufactured tobacco types does not exceed a ceiling amount of the total

tobacco content The level for both these percentages still needs to be defined before

implementation in practice Based on TPD 5(1a) ldquoMember States shall require

manufacturers and importers of tobacco products to submit to their competent authorities

the following information by brand name and type (a) a list of all ingredients and quantities

thereof used in the manufacture of the tobacco products in descending order of the weight

of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)

ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a

finished tobacco product or related products including paper filter ink capsules and

adhesivesrdquo

Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the

manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple

sources must be reported separately one by one Based on TPD 5(1a)

Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined

in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types

A number of commonly used leaf types were noted as based on the Canadian reporting

format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified

(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned

For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the

ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the

other rarer types that may be used in production This is a string variable Based on TPD

5(1a)

Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to

the cure method used for the leaf specific numeric responses are provided in Reference

table 37 (Air fire steam sun flue other) These are obtained from the literature and the

other international reporting formats As noted also in the US reporting format the cure

method is justified by the fact that it is needed to identify tobacco derived materials as these

factors change the tobacco composition by altering endogenous constituents (eg Sugars)

and in some circumstances add exogenous constituents (eg partially pyrolised organic

matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for

the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the

EUROPEAN COMMISSION


Health programme

Annex C - 8

other name description of the cure method This is a string variable and is based on TPD

Art5 1(a)

Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the

combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)

- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of

weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting

format Tobacco related ingredients would be listed for each tobacco part type (and leaf

typecure method when referring top tobacco leaf where applicable) with each new tobacco

related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each

separate combination would have a different quantity in a different ldquorowrdquo similar to how non

tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect

of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that

tobacco part ingredients should be provided to the general public as general tobacco

ingredients are handled (using a cut-off to separate confidential from public information)

This variable is based on TPD Art5 1(a)


As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any

substance or element present in a finished tobacco product or related products including

paper filter ink capsules and adhesivesrdquo

Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable

ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the

actual product or in its emissions The current EU reporting format prerequisites were

updated with suggestions brought forward my MS and TIS which requested some changes

with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such

as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also

compared with the list of the US reporting format to assess the ability to identify common

classifications between the reporting of the EU and the US New categories were added

based on the MS Industry and expert evaluation of the existing categories The complete

list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo

option is provided for ingredients that do not fall to this category (Item 510) for which a

string variable is provided Based on TPD 5(1a) and TPD 20(2)

Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional

Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number

Ingredient_EC_Number The combination of these ingredient identifiers allow for unique

ingredient identification Initially we would like to describe how we concluded that these

variables should be requested and subsequently we explain how these variables are

practically reported These fields are used to identify the individual ingredients within a

product and allow for comparisons of ingredients between products The current system

allows for the reporting of either an ingredient name for submission or a CAS FEMA

Additive FL or EC number As noticeable the CoE number was removed from the list of

potential ingredient numbers used in the due to its limited usage and transition to the FL

number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the

chemical name of the ingredient (which would help ingredient classification in case of

multiple CAS numbers) The FEMA variable is deemed as the second most important

ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion

of semi processed natural ingredients that do not have a CAS number (ie coffee bean

extract) We conclude that due to that the CoE number being replaced by the FL number

(which is used primarily and specifically for flavouring substances) and the similarity with

EUROPEAN COMMISSION


Health programme

Annex C - 9

the FEMA number (that only evaluates substances for GRAS that are used to formulate

flavors to be added to human foods and not for flavor ingredients for use in tobacco

products e-cigarettes or other products that involve routes of exposure other than

ingestion) the most appropriate registration number used for identification of substances

in tobacco and cigarette products is the CAS number This is based on the feedback from

the MS the TIS and the ECIS that noted that the majority (in some cases 100) of

ingredients have a CAS number which all parties (and EUREST experts) noted that would

cover almost completely ingredient identification This is also the identifier suggested in the

Canadian and US format and was also noted in the current reporting format

Important facts about the CAS number

i A common misperception is that CAS numbers are unique EUREST would like to

stress that they are not CAS Registry Numbers may not be unique to chemical

structures or MDL numbers

ii It consists of 89 million organic and inorganic substances and 65 million sequences

a number far greater than other proposed registration numbers and with a

continuous daily update of approximately 15000 new substances

iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups

by hyphens The first part of the number starting from the left has 2 to 7 digits

the second part has 2 digits The final part consists of a single check digit CAS

Numbers hence use the format xxxxxxx-yy-z

iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example

suppliers may use the CAS Registry Number for a parent compound to describe a

modified substance (eg salt or hydrate) Although imprecise the use of an

unmodified parent compounds CAS Registry Number is not erroneous when

describing the modified compound This basis is applied in the EUREST reporting

format

Practically the submitter must notify the system if the ingredient has one multiple or no

CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply

that the CAS number does not exist and then it is mandatory for them to submit at least

one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS

numbers the unmodified parent CAS number is to be used while the secondary CAS

numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the

secondary CAS numbers are to be written in string format separated by a semicolumn ()

between CAS numbers This method will allow the assessment of the secondary CAS

numbers at the stage of data analysis These variables are based on TPD 5(1a)

Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the

ingredient quantity does fluctuate A response of YES would make the subsequent items

(550 551 552 553) mandatory as detailed below

Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in

one unit of product in mg according to recipe Ingredients should be listed for each category

mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of

weight Practically this means a new entry for each ingredient reported separately for each

category This same method will be applied for all products within the proposed common

reporting format including e-cigarettes

Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)

These two variables provide the min and the max levels of an ingredient according to recipe

When the declared quantity of the additive fluctuates the manufacturer should declare

lowest and upper range in weight (mg) of the specific ingredient in one unit of the product

EUROPEAN COMMISSION


Health programme

Annex C - 10

The actual weight used for production of individual standardized batches should be always

within the reported range

Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides

the measured mean (average) weight of the ingredient in mg that was added to one unit of

the product during the previous reporting period This ldquomeasured mean quantity is to be

calculated based on the average of the quantity of that ingredient added within each

standardized batch

Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived

standard deviation of the mean quantity of ingredient added to one unit of the product

within each standardized batch during the previous reporting period

Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco

products) These two variables provide the measured (actual) lower and upper values of

the weight quantity of that ingredient added to one unit of the product within each

standardized batch during the previous reporting period These correspond with the minimal

and maximal values recorded

Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo

defines the function of the ingredient The ingredient functions are given in Table 39 of the

Reference Data section with their code and definition If an ingredient has multiple functions

all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo

option is provided as a response to Item 560 that does not fall under this category for

which a string variable ldquoIngredient_Function_Otherrdquo is provided

Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a

priority additive (Responses include Yes no not published yet) This is based on TPD

Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses

will be ldquonot published yetrdquo The rationale behind this classification is to request from the

submitter to flag the ingredients that will be in the priority list as for them they will have to

provide (when implemented) comprehensive studies that would examine their toxicity

flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2

Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf

files of the report which shall include an executive summary and a comprehensive overview

compiling the available scientific literature on that additive and summarising internal data

on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6

p4

Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence

on the toxicity of the ingredient or this ingredient has CMR properties This variablewas

retained as is from the current format however its responses were altered from string

format to numeric responses which would allow for easier database handling Responses

include

No available information on the ingredientrsquos toxicity in unburnt form

Not toxic and without CMR properties in unburnt form

Identified as toxic and or with CMR properties in unburnt form

Ingredient_REACH_Registration This variable refers to the registration under Regulation

(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable

ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration

separated CLP classification is also to be further assessed

EUROPEAN COMMISSION


Health programme

Annex C - 11

The REACH registration is comprehensive and would report the ingredientrsquos toxicological

information The complete list of responses is available in the document ldquoGeneral

Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo

Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf

Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified

(12722008) and is in the CampL Inventory (A yes vs no response)

Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal

Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant

Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation

Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox

Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT

Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables

provide information about the toxicity of the ingredients and if these ingredients have been

CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity

acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage

irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity

specific target organ toxicity accordingly The responses are in alphanumeric format The

variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text

format based on the above classification The secondary effects should be noted these are

also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo

provides the ingredient classification with regards to aspiration toxicity based on Regulation

(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data

are based on TPD 5(2) and 20(2)

Ingredient_Tox_Data This variable describes the existence of toxicological data available

for either as an individual substance or as part of a mixture and in burnt or unburnt form

The complete list of potential responses is as follows

No toxicological data available

Toxicological data is available but not new

New toxicological data has been obtained since the last reporting period

Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the

chemistry andor toxicity of emissions including but not limited to

Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to

smoke or

Studies to evaluate the proportion of an ingredient that transfers intact into the

emissions andor studies to identify any breakdown products

Studies on the effect of addition of an ingredient to the test article on emission


Ingredient_Tox_CMR The variable describes the existence of any CMR related study

including but not limited to


Assays to determine the effect of the ingredient on the reproductive system and its

potential to cause birth defects

Assays to determine whether the ingredient affects the tumorigenic properties of the

product (The analyses should be based on either inhalation or dermal exposure for

the latter)

Ingredient_Tox_CardioPulmonary This variable provides information about the existence of

in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart

blood vessels or respiratory tract

EUROPEAN COMMISSION


Health programme

Annex C - 12

Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of

the ingredient ie whether the ingredient promotes dependence

Ingredient_Tox_Other This variable provides the existence of any other toxicological data

not stated above

Ingredient_ToxAddictive_File This variable includes files related to the relevant

toxicological data above in items (5140-5144) referring in particular to their effects on

the health of consumers and taking into account inter alia any addictive effects as referred

to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied

by the relevant toxicological data regarding the ingredients in burnt or unburnt form as

appropriate referring in particular to their effects on the health of consumers and taking

into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own

tobacco a technical document setting out a general description of the additives used and

their properties shall be submitted by the manufacturer or importer Other than for tar

nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers

and importers shall indicate the methods of measurement of emissions used Member States

may also require manufacturers or importers to carry out studies as may be prescribed by

the competent authorities in order to assess the effects of ingredients on health taking into

account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf

file upload will be available

7 Emissions

Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the

emission of Tar according to the ISO standard 4387 with the accuracy measurements

determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1

of the TPD

Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines

the nicotine yield according to the ISO standard 10315 with the accuracy measurements

determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of

the TPD

Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines

theCO yield according to the ISO standard 8454 with the accuracy measurements

determined in accordance with ISO standard 8243 This variable is defined in Articles Art3

p1 amp Art4 p1 of the TPD

Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to

measure each of the above TNCO emissions from the list of the laboratories used by

manufacturers and communicated to the commission and is based on Based on TPD 4(2)

In case of multiple entries they should be separated by semi-colons () This is a string

variable

Emission_Other_Available (for tobacco products) This variable notifies the existence or not


Emission_Methods_File This variable requests a pdf file on the production and

measurement methods used to assess the emissions The file should contain substantial

information for the regulator to understand and duplicate if necessary the emission test and

also include where the emission testing took place Based on Art20 2(b) for e-cigarettes

and Art4(4) and Art5 p1(c) and p3 for other tobacco products

EUROPEAN COMMISSION


Health programme

Annex C - 13

Emission_Name This variable defines the chemical name of the emissions produced during

the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3

Emission_CAS Emission_IUPAC These variables allow emission identification The variable

ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry

number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of

absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes

this is based on Art 20

Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the

quantity of the emission produced during the process of using the product and the variable

ldquoEmission_Unitsrdquo defines the units in which the emission is measured

Emission variables that are specific to e-cigarettes based on Art 20(2b) include

Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product

selected in accordance with the below criteria

Electronic cigarettes placed on the market in one piece (eg disposables) or as an

assembly kit (device and e-liquid together eg electronic cigarettes sold together

with an exchangeable cartridge or with a refill container) should be tested ldquoas isas

a unitrdquo and this EC-ID be reported

Each e-liquid placed on the market as a separately purchasable item (eg refill

containers or cartridges that can be used for more than one device) should be tested

at least with one hardware device with which it is compatible (the EC-ID of which

should be reported in 615)

Each hardware device placed on the market as a separately purchasable item should

be tested at least with one e-liquid with which it is compatible (the EC-ID of which

is to be reported in 615)

If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-

liquid the company should test with a compatible best-selling (in volume) hardware

device or e-liquid (preferably from their own company or from the EU market) If

the company does not have at its disposal precise sales information the company

should use the best estimation available and perform testing with that compatible

hardwareliquid

Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable

defines the type of protocol used for the production of e-cigarette emissions It has been

noted that

In the absence of agreed standardsprotocols emissions measuring should be

performed for both the recommended medium range wattage and the recommended

under normal use maximum wattage All other settings (ie airflow puffing etc) are

to be described within the next item Item 631 (methods)

After the unified standardsprotocols for emission measuring have been developed

the stakeholders will have to repeat the tests using the standardised protocol and to

submit this information to the competent authorities Based on TPD 20(2)

EUROPEAN COMMISSION


Health programme

Annex C - 14


Cigarette characterising flavour This classifies the cigarette as having a characterizing

flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct

descriptionrdquo column of the current reporting format

Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed

Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing

characteristics of the cigarette filter Some of these aspects were included in the

ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently

in the Brazilian and Canadian reporting formats also These parameters allow for the

evaluation of two aspects a) unique product identification (as aforementioned such

examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that

may impact smoking intensity smell and taste and hence are covered under Article 7(7) of

the TPD ldquoMember States shall prohibit the placing on the market of tobacco products

containing flavourings in any of their components such as filters papers packages capsules

or any technical features allowing modification of the smell or taste of the tobacco products

concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter

characteristics impact smell taste and smoking intensity hence the necessity to collect such

information Practically this also should be reported so as to assess issues of identifying

products that are manipulated or have a characterising flavour


Based on the definition of Smokeless tobacco in the TPD the following three categories were

used Oral tobacco Chewing tobacco Tobacco for nasal use

Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless

_Unionised_Nicotine_Content These variables present the basic chemical analyses of a

smokeless tobacco product and are based on what is requested in other international

formats (USA Canada) The scientific basis for the inclusion of these variables is the fact

that these chemical attributes are directly related and influence nicotine availability and

product texture

Smokeless_Analysis_Methods This variable provides a brief text description of the methods

used to measure the above variables including references to more detailed information on

the approach This is a string variable


Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit

analysis of the product its expected effects on cessation of tobacco consumption its

expected effects on initiation of tobacco consumption and predicted consumer perception

Based on TPD 19 (1c)

Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains

tobacco

11 RYO-Fine cut - Pipe tobacco specific

The following information is available only for products that have the ldquoProduct_Typerdquo (Item

320) to ldquoFinecutrdquo OR ldquoPipe Tobacco

FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These

attributes provide the total nicotine content of the loose product per unit and the unionized

nicotine content of the loose content

EUROPEAN COMMISSION


Health programme

Annex C - 15


E-Cigarette_Description This variable provides a string response for the submitter to

describe the e-cigarette or refill container so as to aid unique product identification A

description of the individual parts of the e-cigarette or refill liquid is also to be provided

E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for

cartridgescartomisers or for refill container actual volume when placed on the market) This

is based under the clause of unique product identification Based on TPD 20(3)

E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The

nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component

description as defined in TPD 20 (2b)

E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-

cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery

under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description

of the components of the productrdquo As e-cigarettes are an evolving device we already have

seen product changes in the types of batteries used over the past few years and we envisage

that this will be an area of significant research and product trialerror as battery output is

directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its

emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical

composition of the battery and any other information that may help identify unique

batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that

will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided

in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides

an indication of the battery capacity in mAh

E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-

cigarette_Voltage_Upper_Range E-cigarette_Wattage E-

cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of

these parameters allows us to assess multiple aspects of the e-cigarette including a) unique

product identification-as mentioned in the Interim report there are thousands of

combinations of MOD type cigarettes with one of the most important aspects the battery

that powers the device B) As battery output is directly related to atomizer temperature ndash

which is in turn related to the production of harmful emissions such as Carbonyl compounds-

collecting as much information on battery type is important The ECIS noted that this

information is important both for emission creation and for unique product identification and

should be collected in the new reporting format Overall as responses can be provided in

number format the inclusion of these parameters will help regulators assess the role of

battery changes of MOD e-cigarettes and the association between battery output and

emissions Again these parameters are based on component description as defined in TPD

20 (2e)

E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery

oriented parameters these two variables collect further information on modifiable e-

cigarettes Market research has indicated that some MODS also allow the ability to change

airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick

(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo

as defined in TPD 20 (2e) and allow for unique product identification

E-cigarette_Microprocessor Certain newer versions including MODS but also disposables

use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are

EUROPEAN COMMISSION


Health programme

Annex C - 16

sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should

also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product

identification

E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring

(coil) in the atomiser

E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and

uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While

effort was made to assess if the actual methods for nicotine dosing could be noted in numeric

format this was not deemed scientifically justifiable as there is no scientific base for a

standardized methodology of assessing nicotine dosing provided with each puff as each e-

cigarette manufacturer and the plethora of published scientific evidence indicate multiple

puffing regimes and methods of assessing dosing a fact verified by the feedback from the

ECIS Hence in this case it is premature to identify one method that will be used across the

industry hence we conclude that a file should be uploaded by each industry With regards

to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no

standardized methodology in the published literature to assess nicotine uptake

(pharmokinetics) which also may be disproportionate relative to the reporting

requirements hence we conclude that a file should be uploaded in this instance In both

cases (dosing vs uptake) a detailed file must include

Evidence from internal or published studies with regards to nicotine dosing and

uptake that the manufacturerimporter is aware of

Total nicotine delivery per device or refill container that is provided in the vapour

assuming a 100 uptake by the consumer

E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the

submitter has to provide his declarations Checking this box means that they declare that

their products are child and tamper proof they have childproof caps as defined in TPD

Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected

against breakage and leakage and have a mechanism that ensures refilling without leakage

(where applicable) Technical specifications for this are currently being worked on by the

industry and by standardization committees however the final specifications to be adopted

would be based on the implementing acts of the TPD

E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request

the description of the production process including whether it involves or not series

production and a declaration checkbox that it confirms to the requirements of Article 20 of

the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence

to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also

production country

E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter

must bear full responsibility for the quality and safety of the product based on TPD 20 (2)

with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full

responsibility for the quality and safety of the product when placed on the market and used

under normal or reasonably foreseeable conditionsrdquo

E-cigarette_High_Purity This variable declares that only ingredients of high purity are used

in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should

be of pharmaceutical quality while the purity levels of the other ingredients are to be

provided This parameter is defined in TPD 20 (2g) This include at the minimum the

following

EUROPEAN COMMISSION


Health programme

Annex C - 17

bull The diluents shall comply with the requirements of the European Pharmacopeia

bull Nicotine should comply with the requirements of the European Pharmacopeia

bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl

propionyl in the liquid

E-cigarette_Non_Risk This variable declares that the product does not pose reasonably

foreseeable risk to human health under normal conditions of use(with the exception for its

nicotine content) as defined in TPD 20 (2g)

E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-

cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during

product use and across batches under normal or reasonably foreseeable conditions A

relevant PDF file describing how they ensure consistent dosing in the absence of an agreed

standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo

E_Cigarette_OpeningRefill _File With this variable a file is provided related to the

description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of

the components of the product including where applicable the opening and refill

mechanism of the electronic cigarette or refill containersrdquo As standards for these refill

mechanisms are being developed EUREST envisages that this will be an area of significant

product evolution in the near future

E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers

must upload a file of the scanned file of the leaflet of information for consumers that will

include Instructions for use and storage of the product including a reference that the

product is not recommended for use by young people and non-smokers contra-indications

warnings for specific risk groups possible adverse effects addictiveness and toxicity and

contact details of the manufacturer or importer and a legal or natural contact person within

the Union This was preferred to the submission of multiple text boxes as this way the

regulator will have a copy of what is received by consumers Based on TPD 20(4)


These products are included in the proposed common reporting format with variables

included in the above tables based on their reporting requirements as outlined in the TPD ndash

hence no other specific wording terminology will be applied These include cigars cigarillos

water pipe tobacco amp herbal products

EUROPEAN COMMISSION


Health programme

Annex C - 18

HOW TO OBTAIN EU PUBLICATIONS

Free publications

bull one copy

via EU Bookshop (httpbookshopeuropaeu)

bull more than one copy or postersmaps

from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)

from the delegations in non-EU countries

(httpeeaseuropaeudelegationsindex_enhtm)

by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)

or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)

Priced publications

bull via EU Bookshop (httpbookshopeuropaeu)

Priced subscriptions

bull via one of the sales agents of the Publications Office of the European Union

(httppublicationseuropaeuothersagentsindex_enhtm)

EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286



EUROPEAN COMMISSION


Directorate D mdash Health systems and products

Unit D4 mdash Substances of human origin and Tobacco control

E-mail SANTE-D4-SOHO-and-TOBACCO-CONTROLeceuropaeu

European Commission

B-1049 Brussels

European Commission B-1049 Brussels








Consortium







Freephone number ()

00 800 6 7 8 9 10 11


LEGAL NOTICE



Commission



Union





ISBN 978-92-9200-680-8

doi10281830286


EUROPEAN COMMISSION



Contents

1 ABSTRACT 6







611 Introduction 22







621 Introduction 28



631 Introduction 33



641 Introduction 34





7 CONCLUSIONS 42

8 ANNEXES


tobacco products




EUROPEAN COMMISSION

6


Health programme

1 ABSTRACT






designed














EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY





















20(13))













EUROPEAN COMMISSION

8


Health programme

Summary of WP1











Submission process


















Reporting format




percentage of EU MS












EUROPEAN COMMISSION

9


Health programme
































Summary of WP2













on public health


WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

EUROPEAN COMMISSION

10


Health programme


















































EUROPEAN COMMISSION

11


Health programme












Summary of WP3




phases as follows




















various use cases


Summary of WP4




mechanism



EUROPEAN COMMISSION

12


Health programme















the system



















EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF






















(Article 20(13))








EUROPEAN COMMISSION

14


Health programme








informations
























services juridiques











EUROPEAN COMMISSION

15


Health programme












































EUROPEAN COMMISSION

16


Health programme













































WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees


EUROPEAN COMMISSION

17


Health programme
















































EUROPEAN COMMISSION

18


Health programme










































publique





EUROPEAN COMMISSION

19


Health programme













EUROPEAN COMMISSION

20


Health programme
























EUROPEAN COMMISSION

21


Health programme


Overall Approach
























EUROPEAN COMMISSION

22


Health programme



611 Introduction






experience









jurisdiction










EU MS feedback





Industry feedback










EUROPEAN COMMISSION

23


Health programme




NGO Feedback













protected



























EUROPEAN COMMISSION

24


Health programme








submissions



















processes








activities

















EUROPEAN COMMISSION

25


Health programme





submission platform






























be of interest



to regulators








oriented)




EUROPEAN COMMISSION

26


Health programme
























too)










implemented



these products













EUROPEAN COMMISSION

27


Health programme




































receipt













EUROPEAN COMMISSION

28


Health programme






fees



format






file collection




additive list















quantities







621 Introduction








EUROPEAN COMMISSION

29


Health programme





on 31 May 20077


























in WP3)








EUROPEAN COMMISSION

30


Health programme













































EUROPEAN COMMISSION

31


Health programme




















of the product etc


























EUROPEAN COMMISSION

32


Health programme















































EUROPEAN COMMISSION

33


Health programme











631 Introduction















4 Testing











respective actors


requirements)


Dictionaryrsquo


EUROPEAN COMMISSION

34


Health programme



























Testing







641 Introduction







mechanism


EUROPEAN COMMISSION

35


Health programme




















its implementation





brought forward








batch



certain cut-off








multiple portals





EUROPEAN COMMISSION

36


Health programme


system





connection




















one language























EUROPEAN COMMISSION

37


Health programme


















Management
















to themrdquo




provided below










EUROPEAN COMMISSION

38


Health programme













EUROPEAN COMMISSION

39


Health programme










































reporting






EUROPEAN COMMISSION

40


Health programme























perspective

























EUROPEAN COMMISSION

41


Health programme



the understanding





and globally














parameters




EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS




to the public









general public





information





EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products





1 Introduction




Reference documents


Ref Name

















EUROPEAN COMMISSION


Health programme

Annex A ndash2









22032012



1(trueenabled)

Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String (100)





Tobacco Product

identifier (TP-ID)


e 02565-2015-00230







Food Additive

identifier






2 Data Dictionary






Item


White list



String Text M


String Text M



List

element

Dropdown M




List

element

Dropdown M


VAT

String Text M


List element

Dropdown M


String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5


String Text Email M






multiple entries

possible)






White list



one exist

String Text F





ry



String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6


String Text Email F




White list



should one exist

String Text F




is based




String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7



Item


Type

White

list




Principal)

String Text F




based




String Text Phone F



used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8


Item


White list







AUTO



AUTO








rules)




Boolean Checkbox M


String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9





cigarettes)





mg

Decimal Text M




Decimal Text M





e_Sites






String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10


File File browser







presentation

Item


White list



tion Long

M



M

323 Tobacco

Product_launch_date



Date text M



File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11



File File browser

O






String Text M





String Text


String Text


String Text










package in g


EUROPEAN COMMISSION


Health programme

Annex A ndash12




Decimal Text O





Decimal Text M


String Text O





File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13





Item


White list



List element

Dropdown M


String Text F


File File browser








List element

Dropdown M


String Text F



List

element

Dropdown M



String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14



Decimal Text M




Item


White list




List element

Dropdown M








M





uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15







F

If a CAS








e

Identifier




8722012


er





er



Boolean Checkbox M



Decimal Text M




EUROPEAN COMMISSION


Health programme

Annex A ndash16





antity




530 is Yes)










530 is

Yes)






reporting period





EUROPEAN COMMISSION


Health programme

Annex A ndash17


String Text F


List element

Dropdown M


es



File File

browser

F





List element

Dropdown M




List

element

Dropdown M



List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18



List element

Dropdown Tox_Code



F) are




mal



List

element

Dropdown Tox_C

ode



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code


12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19



List element

Dropdown Tox_Code



String Text



List

element

Dropdown Tox_C

ode


List element

Dropdown M





Boolean Checkbox FM


not limited to





Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20






Boolean Checkbox FM


Boolean Checkbox FM


above

Boolean Checkbox FM


be available

File File browser

FM



Item


Control Type

White list









EUROPEAN COMMISSION


Health programme

Annex A ndash21






List element

Dropdown

M






place

File File

browser

F



String Text F



CAS

Identifie

r

F


not exist

String Text F



Numeric Text F


EUROPEAN COMMISSION


Health programme

Annex A ndash22



Item


Control Type

White list



Boolean Checkbox M








Item


Control Type

White list







String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23



Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File





perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)


co


tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)




Type

Control

Type

White

List

Reporting Visibili

ty



Decimal Text M


tent


the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24




3 Reference Data


32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo


5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco



Value Name



version)



4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name





5 Soft pack

6 Pouch with flap


8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin


23 Slide lid box

24 Flow wrap

25 Folding pouch



EUROPEAN COMMISSION


Health programme

Annex A ndash26




Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf




5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other


EUROPEAN COMMISSION


Health programme

Annex A ndash27


Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)








11 Adhesive (burnt)

12 tips (unburnt)


14 paper (unburnt)

15 Other (unburnt)


Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28





13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

Value Name




Value Name




EUROPEAN COMMISSION


Health programme

Annex B - 1


1 Introduction





Ref Name









pdf










EUROPEAN COMMISSION


Health programme

Annex B -2









22032012




14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String(100)






identifier (EC-ID)


e 02565-15-00230







Food Additive

identifier





NNN-NNN-N


eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item




String Text M



String Text M





String Text M




the VAT

String Text M


EUROPEAN COMMISSION


Health programme

Annex B -5




international codes

String Text Phone M


String Text Email M



mandatory

Boolean Checkbox M



Boolean Checkbox M


Boolean Checkbox M



Item




String Text F



EUROPEAN COMMISSION


Health programme

Annex B -6




String Text Phone F



String Text Email F



Item




should one exist

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item




Principal)

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8


Item







Date System

Generated

AUTO




AUTO



NNNNN)








Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9



String Text F



types



mg

Decimal Text M


ml

Decimal Text M


cation



String Text F if



File File browser M


ites






String Text

EUROPEAN COMMISSION


Health programme

Annex B -10




presentation

Item


list



MS


ionLong

M




M







Date Text M






String Text



String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11


String Text





File File browser M


package

Decimal Text M








EUROPEAN COMMISSION


Health programme

Annex B -12


Item









Boolean Checkbox F





e-liquids)





3125 is Option 3










3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13


Item


Visibility




M






String Text F






semicolons ()



at least one is


importance






13332008







EUROPEAN COMMISSION


Health programme

Annex B -14




EC)




Decimal Text M






String Text F













EUROPEAN COMMISSION


Health programme

Annex B -15











halation












ensitisation





tion




EUROPEAN COMMISSION


Health programme

Annex B -16



otox
















String Text






potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17







Boolean Checkbox FM









Boolean Checkbox FM





respiratory tract

Boolean Checkbox FM



Boolean Checkbox FM


Boolean Checkbox FM



EUROPEAN COMMISSION


Health programme

Annex B -18


25 Emissions

Item



Decimal Text M







wattage













File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19







Numeric Text M



Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility




liquid)

String Text M M




Decimal Text M M

1116 E-


ion



Decimal Text M M



String Text M NA

1121 E-


city


EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-


le




List

element

Dropdown M NA



Decimal Text F NA

1131 E-


ge



Decimal Text F NA

1132 E-


ge



Decimal Text F NA



Decimal Text F NA

1141 E-


nge



Decimal Text F NA

1142 E-


nge



Decimal Text F NA

1150 E-



adjustable






e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21


atomiser

String Text M O

1190 E-


ke_File









File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof








File File

Browser

M M

11120 E-


mity













String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22







nicotine content)


11124 E-





String Text M M

11124 E-


Methods



standardprotocol

File File

Browser


_File



File File

Browser

M for

refillable e-

cigarettes

M










within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name







Value Name




Value Name






EUROPEAN COMMISSION


Health programme

Annex B -24




Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name


2 Ethylene glycol

3 Diethylene glycol



6 Carbonyl Acrolein


8 TSNA NNN

9 TSNA NNK




13 Trace metal Lead




17 Trace metal Tin


19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene



25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26


Value Name




4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1


1 Introduction















reading













data to be merged







information







EUROPEAN COMMISSION


Health programme

Annex C - 2

































TPD 5(1) and 20(2)







version)




EUROPEAN COMMISSION


Health programme

Annex C - 3

















the product version












then provided

















EUROPEAN COMMISSION


Health programme

Annex C - 4



respectively

























enter the market


















EUROPEAN COMMISSION


Health programme

Annex C - 5

























reporting types























EUROPEAN COMMISSION


Health programme

Annex C - 6























a common pdf file

























EUROPEAN COMMISSION


Health programme

Annex C - 7



























adhesivesrdquo












5(1a)










EUROPEAN COMMISSION


Health programme

Annex C - 8


Art5 1(a)















































EUROPEAN COMMISSION


Health programme

Annex C - 9


























format























EUROPEAN COMMISSION


Health programme

Annex C - 10







standardized batch


























p4





include








EUROPEAN COMMISSION


Health programme

Annex C - 11

































smoke or












the latter)




EUROPEAN COMMISSION


Health programme

Annex C - 12




not stated above
















7 Emissions




of the TPD




the TPD









variable








EUROPEAN COMMISSION


Health programme

Annex C - 13






























hardwareliquid



noted that








EUROPEAN COMMISSION


Health programme

Annex C - 14




























product texture










tobacco







EUROPEAN COMMISSION


Health programme

Annex C - 15






































20 (2e)









EUROPEAN COMMISSION


Health programme

Annex C - 16



identification


































production country










following

EUROPEAN COMMISSION


Health programme

Annex C - 17
































EUROPEAN COMMISSION


Health programme

Annex C - 18


Free publications

bull one copy








Priced publications





EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286








Consortium







Freephone number ()

00 800 6 7 8 9 10 11


LEGAL NOTICE



Commission



Union





ISBN 978-92-9200-680-8

doi10281830286


EUROPEAN COMMISSION



Contents

1 ABSTRACT 6







611 Introduction 22







621 Introduction 28



631 Introduction 33



641 Introduction 34





7 CONCLUSIONS 42

8 ANNEXES


tobacco products




EUROPEAN COMMISSION

6


Health programme

1 ABSTRACT






designed














EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY





















20(13))













EUROPEAN COMMISSION

8


Health programme

Summary of WP1











Submission process


















Reporting format




percentage of EU MS












EUROPEAN COMMISSION

9


Health programme
































Summary of WP2













on public health


WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

EUROPEAN COMMISSION

10


Health programme


















































EUROPEAN COMMISSION

11


Health programme












Summary of WP3




phases as follows




















various use cases


Summary of WP4




mechanism



EUROPEAN COMMISSION

12


Health programme















the system



















EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF






















(Article 20(13))








EUROPEAN COMMISSION

14


Health programme








informations
























services juridiques











EUROPEAN COMMISSION

15


Health programme












































EUROPEAN COMMISSION

16


Health programme













































WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees


EUROPEAN COMMISSION

17


Health programme
















































EUROPEAN COMMISSION

18


Health programme










































publique





EUROPEAN COMMISSION

19


Health programme













EUROPEAN COMMISSION

20


Health programme
























EUROPEAN COMMISSION

21


Health programme


Overall Approach
























EUROPEAN COMMISSION

22


Health programme



611 Introduction






experience









jurisdiction










EU MS feedback





Industry feedback










EUROPEAN COMMISSION

23


Health programme




NGO Feedback













protected



























EUROPEAN COMMISSION

24


Health programme








submissions



















processes








activities

















EUROPEAN COMMISSION

25


Health programme





submission platform






























be of interest



to regulators








oriented)




EUROPEAN COMMISSION

26


Health programme
























too)










implemented



these products













EUROPEAN COMMISSION

27


Health programme




































receipt













EUROPEAN COMMISSION

28


Health programme






fees



format






file collection




additive list















quantities







621 Introduction








EUROPEAN COMMISSION

29


Health programme





on 31 May 20077


























in WP3)








EUROPEAN COMMISSION

30


Health programme













































EUROPEAN COMMISSION

31


Health programme




















of the product etc


























EUROPEAN COMMISSION

32


Health programme















































EUROPEAN COMMISSION

33


Health programme











631 Introduction















4 Testing











respective actors


requirements)


Dictionaryrsquo


EUROPEAN COMMISSION

34


Health programme



























Testing







641 Introduction







mechanism


EUROPEAN COMMISSION

35


Health programme




















its implementation





brought forward








batch



certain cut-off








multiple portals





EUROPEAN COMMISSION

36


Health programme


system





connection




















one language























EUROPEAN COMMISSION

37


Health programme


















Management
















to themrdquo




provided below










EUROPEAN COMMISSION

38


Health programme













EUROPEAN COMMISSION

39


Health programme










































reporting






EUROPEAN COMMISSION

40


Health programme























perspective

























EUROPEAN COMMISSION

41


Health programme



the understanding





and globally














parameters




EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS




to the public









general public





information





EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products





1 Introduction




Reference documents


Ref Name

















EUROPEAN COMMISSION


Health programme

Annex A ndash2









22032012



1(trueenabled)

Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String (100)





Tobacco Product

identifier (TP-ID)


e 02565-2015-00230







Food Additive

identifier






2 Data Dictionary






Item


White list



String Text M


String Text M



List

element

Dropdown M




List

element

Dropdown M


VAT

String Text M


List element

Dropdown M


String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5


String Text Email M






multiple entries

possible)






White list



one exist

String Text F





ry



String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6


String Text Email F




White list



should one exist

String Text F




is based




String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7



Item


Type

White

list




Principal)

String Text F




based




String Text Phone F



used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8


Item


White list







AUTO



AUTO








rules)




Boolean Checkbox M


String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9





cigarettes)





mg

Decimal Text M




Decimal Text M





e_Sites






String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10


File File browser







presentation

Item


White list



tion Long

M



M

323 Tobacco

Product_launch_date



Date text M



File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11



File File browser

O






String Text M





String Text


String Text


String Text










package in g


EUROPEAN COMMISSION


Health programme

Annex A ndash12




Decimal Text O





Decimal Text M


String Text O





File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13





Item


White list



List element

Dropdown M


String Text F


File File browser








List element

Dropdown M


String Text F



List

element

Dropdown M



String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14



Decimal Text M




Item


White list




List element

Dropdown M








M





uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15







F

If a CAS








e

Identifier




8722012


er





er



Boolean Checkbox M



Decimal Text M




EUROPEAN COMMISSION


Health programme

Annex A ndash16





antity




530 is Yes)










530 is

Yes)






reporting period





EUROPEAN COMMISSION


Health programme

Annex A ndash17


String Text F


List element

Dropdown M


es



File File

browser

F





List element

Dropdown M




List

element

Dropdown M



List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18



List element

Dropdown Tox_Code



F) are




mal



List

element

Dropdown Tox_C

ode



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code


12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19



List element

Dropdown Tox_Code



String Text



List

element

Dropdown Tox_C

ode


List element

Dropdown M





Boolean Checkbox FM


not limited to





Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20






Boolean Checkbox FM


Boolean Checkbox FM


above

Boolean Checkbox FM


be available

File File browser

FM



Item


Control Type

White list









EUROPEAN COMMISSION


Health programme

Annex A ndash21






List element

Dropdown

M






place

File File

browser

F



String Text F



CAS

Identifie

r

F


not exist

String Text F



Numeric Text F


EUROPEAN COMMISSION


Health programme

Annex A ndash22



Item


Control Type

White list



Boolean Checkbox M








Item


Control Type

White list







String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23



Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File





perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)


co


tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)




Type

Control

Type

White

List

Reporting Visibili

ty



Decimal Text M


tent


the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24




3 Reference Data


32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo


5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco



Value Name



version)



4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name





5 Soft pack

6 Pouch with flap


8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin


23 Slide lid box

24 Flow wrap

25 Folding pouch



EUROPEAN COMMISSION


Health programme

Annex A ndash26




Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf




5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other


EUROPEAN COMMISSION


Health programme

Annex A ndash27


Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)








11 Adhesive (burnt)

12 tips (unburnt)


14 paper (unburnt)

15 Other (unburnt)


Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28





13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

Value Name




Value Name




EUROPEAN COMMISSION


Health programme

Annex B - 1


1 Introduction





Ref Name









pdf










EUROPEAN COMMISSION


Health programme

Annex B -2









22032012




14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String(100)






identifier (EC-ID)


e 02565-15-00230







Food Additive

identifier





NNN-NNN-N


eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item




String Text M



String Text M





String Text M




the VAT

String Text M


EUROPEAN COMMISSION


Health programme

Annex B -5




international codes

String Text Phone M


String Text Email M



mandatory

Boolean Checkbox M



Boolean Checkbox M


Boolean Checkbox M



Item




String Text F



EUROPEAN COMMISSION


Health programme

Annex B -6




String Text Phone F



String Text Email F



Item




should one exist

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item




Principal)

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8


Item







Date System

Generated

AUTO




AUTO



NNNNN)








Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9



String Text F



types



mg

Decimal Text M


ml

Decimal Text M


cation



String Text F if



File File browser M


ites






String Text

EUROPEAN COMMISSION


Health programme

Annex B -10




presentation

Item


list



MS


ionLong

M




M







Date Text M






String Text



String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11


String Text





File File browser M


package

Decimal Text M








EUROPEAN COMMISSION


Health programme

Annex B -12


Item









Boolean Checkbox F





e-liquids)





3125 is Option 3










3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13


Item


Visibility




M






String Text F






semicolons ()



at least one is


importance






13332008







EUROPEAN COMMISSION


Health programme

Annex B -14




EC)




Decimal Text M






String Text F













EUROPEAN COMMISSION


Health programme

Annex B -15











halation












ensitisation





tion




EUROPEAN COMMISSION


Health programme

Annex B -16



otox
















String Text






potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17







Boolean Checkbox FM









Boolean Checkbox FM





respiratory tract

Boolean Checkbox FM



Boolean Checkbox FM


Boolean Checkbox FM



EUROPEAN COMMISSION


Health programme

Annex B -18


25 Emissions

Item



Decimal Text M







wattage













File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19







Numeric Text M



Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility




liquid)

String Text M M




Decimal Text M M

1116 E-


ion



Decimal Text M M



String Text M NA

1121 E-


city


EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-


le




List

element

Dropdown M NA



Decimal Text F NA

1131 E-


ge



Decimal Text F NA

1132 E-


ge



Decimal Text F NA



Decimal Text F NA

1141 E-


nge



Decimal Text F NA

1142 E-


nge



Decimal Text F NA

1150 E-



adjustable






e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21


atomiser

String Text M O

1190 E-


ke_File









File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof








File File

Browser

M M

11120 E-


mity













String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22







nicotine content)


11124 E-





String Text M M

11124 E-


Methods



standardprotocol

File File

Browser


_File



File File

Browser

M for

refillable e-

cigarettes

M










within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name







Value Name




Value Name






EUROPEAN COMMISSION


Health programme

Annex B -24




Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name


2 Ethylene glycol

3 Diethylene glycol



6 Carbonyl Acrolein


8 TSNA NNN

9 TSNA NNK




13 Trace metal Lead




17 Trace metal Tin


19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene



25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26


Value Name




4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1


1 Introduction















reading













data to be merged







information







EUROPEAN COMMISSION


Health programme

Annex C - 2

































TPD 5(1) and 20(2)







version)




EUROPEAN COMMISSION


Health programme

Annex C - 3

















the product version












then provided

















EUROPEAN COMMISSION


Health programme

Annex C - 4



respectively

























enter the market


















EUROPEAN COMMISSION


Health programme

Annex C - 5

























reporting types























EUROPEAN COMMISSION


Health programme

Annex C - 6























a common pdf file

























EUROPEAN COMMISSION


Health programme

Annex C - 7



























adhesivesrdquo












5(1a)










EUROPEAN COMMISSION


Health programme

Annex C - 8


Art5 1(a)















































EUROPEAN COMMISSION


Health programme

Annex C - 9


























format























EUROPEAN COMMISSION


Health programme

Annex C - 10







standardized batch


























p4





include








EUROPEAN COMMISSION


Health programme

Annex C - 11

































smoke or












the latter)




EUROPEAN COMMISSION


Health programme

Annex C - 12




not stated above
















7 Emissions




of the TPD




the TPD









variable








EUROPEAN COMMISSION


Health programme

Annex C - 13






























hardwareliquid



noted that








EUROPEAN COMMISSION


Health programme

Annex C - 14




























product texture










tobacco







EUROPEAN COMMISSION


Health programme

Annex C - 15






































20 (2e)









EUROPEAN COMMISSION


Health programme

Annex C - 16



identification


































production country










following

EUROPEAN COMMISSION


Health programme

Annex C - 17
































EUROPEAN COMMISSION


Health programme

Annex C - 18


Free publications

bull one copy








Priced publications





EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286





Freephone number ()

00 800 6 7 8 9 10 11


LEGAL NOTICE



Commission



Union





ISBN 978-92-9200-680-8

doi10281830286


EUROPEAN COMMISSION



Contents

1 ABSTRACT 6







611 Introduction 22







621 Introduction 28



631 Introduction 33



641 Introduction 34





7 CONCLUSIONS 42

8 ANNEXES


tobacco products




EUROPEAN COMMISSION

6


Health programme

1 ABSTRACT






designed














EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY





















20(13))













EUROPEAN COMMISSION

8


Health programme

Summary of WP1











Submission process


















Reporting format




percentage of EU MS












EUROPEAN COMMISSION

9


Health programme
































Summary of WP2













on public health


WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

EUROPEAN COMMISSION

10


Health programme


















































EUROPEAN COMMISSION

11


Health programme












Summary of WP3




phases as follows




















various use cases


Summary of WP4




mechanism



EUROPEAN COMMISSION

12


Health programme















the system



















EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF






















(Article 20(13))








EUROPEAN COMMISSION

14


Health programme








informations
























services juridiques











EUROPEAN COMMISSION

15


Health programme












































EUROPEAN COMMISSION

16


Health programme













































WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees


EUROPEAN COMMISSION

17


Health programme
















































EUROPEAN COMMISSION

18


Health programme










































publique





EUROPEAN COMMISSION

19


Health programme













EUROPEAN COMMISSION

20


Health programme
























EUROPEAN COMMISSION

21


Health programme


Overall Approach
























EUROPEAN COMMISSION

22


Health programme



611 Introduction






experience









jurisdiction










EU MS feedback





Industry feedback










EUROPEAN COMMISSION

23


Health programme




NGO Feedback













protected



























EUROPEAN COMMISSION

24


Health programme








submissions



















processes








activities

















EUROPEAN COMMISSION

25


Health programme





submission platform






























be of interest



to regulators








oriented)




EUROPEAN COMMISSION

26


Health programme
























too)










implemented



these products













EUROPEAN COMMISSION

27


Health programme




































receipt













EUROPEAN COMMISSION

28


Health programme






fees



format






file collection




additive list















quantities







621 Introduction








EUROPEAN COMMISSION

29


Health programme





on 31 May 20077


























in WP3)








EUROPEAN COMMISSION

30


Health programme













































EUROPEAN COMMISSION

31


Health programme




















of the product etc


























EUROPEAN COMMISSION

32


Health programme















































EUROPEAN COMMISSION

33


Health programme











631 Introduction















4 Testing











respective actors


requirements)


Dictionaryrsquo


EUROPEAN COMMISSION

34


Health programme



























Testing







641 Introduction







mechanism


EUROPEAN COMMISSION

35


Health programme




















its implementation





brought forward








batch



certain cut-off








multiple portals





EUROPEAN COMMISSION

36


Health programme


system





connection




















one language























EUROPEAN COMMISSION

37


Health programme


















Management
















to themrdquo




provided below










EUROPEAN COMMISSION

38


Health programme













EUROPEAN COMMISSION

39


Health programme










































reporting






EUROPEAN COMMISSION

40


Health programme























perspective

























EUROPEAN COMMISSION

41


Health programme



the understanding





and globally














parameters




EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS




to the public









general public





information





EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products





1 Introduction




Reference documents


Ref Name

















EUROPEAN COMMISSION


Health programme

Annex A ndash2









22032012



1(trueenabled)

Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String (100)





Tobacco Product

identifier (TP-ID)


e 02565-2015-00230







Food Additive

identifier






2 Data Dictionary






Item


White list



String Text M


String Text M



List

element

Dropdown M




List

element

Dropdown M


VAT

String Text M


List element

Dropdown M


String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5


String Text Email M






multiple entries

possible)






White list



one exist

String Text F





ry



String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6


String Text Email F




White list



should one exist

String Text F




is based




String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7



Item


Type

White

list




Principal)

String Text F




based




String Text Phone F



used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8


Item


White list







AUTO



AUTO








rules)




Boolean Checkbox M


String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9





cigarettes)





mg

Decimal Text M




Decimal Text M





e_Sites






String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10


File File browser







presentation

Item


White list



tion Long

M



M

323 Tobacco

Product_launch_date



Date text M



File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11



File File browser

O






String Text M





String Text


String Text


String Text










package in g


EUROPEAN COMMISSION


Health programme

Annex A ndash12




Decimal Text O





Decimal Text M


String Text O





File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13





Item


White list



List element

Dropdown M


String Text F


File File browser








List element

Dropdown M


String Text F



List

element

Dropdown M



String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14



Decimal Text M




Item


White list




List element

Dropdown M








M





uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15







F

If a CAS








e

Identifier




8722012


er





er



Boolean Checkbox M



Decimal Text M




EUROPEAN COMMISSION


Health programme

Annex A ndash16





antity




530 is Yes)










530 is

Yes)






reporting period





EUROPEAN COMMISSION


Health programme

Annex A ndash17


String Text F


List element

Dropdown M


es



File File

browser

F





List element

Dropdown M




List

element

Dropdown M



List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18



List element

Dropdown Tox_Code



F) are




mal



List

element

Dropdown Tox_C

ode



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code


12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19



List element

Dropdown Tox_Code



String Text



List

element

Dropdown Tox_C

ode


List element

Dropdown M





Boolean Checkbox FM


not limited to





Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20






Boolean Checkbox FM


Boolean Checkbox FM


above

Boolean Checkbox FM


be available

File File browser

FM



Item


Control Type

White list









EUROPEAN COMMISSION


Health programme

Annex A ndash21






List element

Dropdown

M






place

File File

browser

F



String Text F



CAS

Identifie

r

F


not exist

String Text F



Numeric Text F


EUROPEAN COMMISSION


Health programme

Annex A ndash22



Item


Control Type

White list



Boolean Checkbox M








Item


Control Type

White list







String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23



Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File





perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)


co


tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)




Type

Control

Type

White

List

Reporting Visibili

ty



Decimal Text M


tent


the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24




3 Reference Data


32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo


5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco



Value Name



version)



4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name





5 Soft pack

6 Pouch with flap


8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin


23 Slide lid box

24 Flow wrap

25 Folding pouch



EUROPEAN COMMISSION


Health programme

Annex A ndash26




Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf




5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other


EUROPEAN COMMISSION


Health programme

Annex A ndash27


Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)








11 Adhesive (burnt)

12 tips (unburnt)


14 paper (unburnt)

15 Other (unburnt)


Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28





13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

Value Name




Value Name




EUROPEAN COMMISSION


Health programme

Annex B - 1


1 Introduction





Ref Name









pdf










EUROPEAN COMMISSION


Health programme

Annex B -2









22032012




14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String(100)






identifier (EC-ID)


e 02565-15-00230







Food Additive

identifier





NNN-NNN-N


eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item




String Text M



String Text M





String Text M




the VAT

String Text M


EUROPEAN COMMISSION


Health programme

Annex B -5




international codes

String Text Phone M


String Text Email M



mandatory

Boolean Checkbox M



Boolean Checkbox M


Boolean Checkbox M



Item




String Text F



EUROPEAN COMMISSION


Health programme

Annex B -6




String Text Phone F



String Text Email F



Item




should one exist

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item




Principal)

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8


Item







Date System

Generated

AUTO




AUTO



NNNNN)








Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9



String Text F



types



mg

Decimal Text M


ml

Decimal Text M


cation



String Text F if



File File browser M


ites






String Text

EUROPEAN COMMISSION


Health programme

Annex B -10




presentation

Item


list



MS


ionLong

M




M







Date Text M






String Text



String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11


String Text





File File browser M


package

Decimal Text M








EUROPEAN COMMISSION


Health programme

Annex B -12


Item









Boolean Checkbox F





e-liquids)





3125 is Option 3










3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13


Item


Visibility




M






String Text F






semicolons ()



at least one is


importance






13332008







EUROPEAN COMMISSION


Health programme

Annex B -14




EC)




Decimal Text M






String Text F













EUROPEAN COMMISSION


Health programme

Annex B -15











halation












ensitisation





tion




EUROPEAN COMMISSION


Health programme

Annex B -16



otox
















String Text






potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17







Boolean Checkbox FM









Boolean Checkbox FM





respiratory tract

Boolean Checkbox FM



Boolean Checkbox FM


Boolean Checkbox FM



EUROPEAN COMMISSION


Health programme

Annex B -18


25 Emissions

Item



Decimal Text M







wattage













File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19







Numeric Text M



Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility




liquid)

String Text M M




Decimal Text M M

1116 E-


ion



Decimal Text M M



String Text M NA

1121 E-


city


EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-


le




List

element

Dropdown M NA



Decimal Text F NA

1131 E-


ge



Decimal Text F NA

1132 E-


ge



Decimal Text F NA



Decimal Text F NA

1141 E-


nge



Decimal Text F NA

1142 E-


nge



Decimal Text F NA

1150 E-



adjustable






e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21


atomiser

String Text M O

1190 E-


ke_File









File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof








File File

Browser

M M

11120 E-


mity













String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22







nicotine content)


11124 E-





String Text M M

11124 E-


Methods



standardprotocol

File File

Browser


_File



File File

Browser

M for

refillable e-

cigarettes

M










within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name







Value Name




Value Name






EUROPEAN COMMISSION


Health programme

Annex B -24




Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name


2 Ethylene glycol

3 Diethylene glycol



6 Carbonyl Acrolein


8 TSNA NNN

9 TSNA NNK




13 Trace metal Lead




17 Trace metal Tin


19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene



25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26


Value Name




4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1


1 Introduction















reading













data to be merged







information







EUROPEAN COMMISSION


Health programme

Annex C - 2

































TPD 5(1) and 20(2)







version)




EUROPEAN COMMISSION


Health programme

Annex C - 3

















the product version












then provided

















EUROPEAN COMMISSION


Health programme

Annex C - 4



respectively

























enter the market


















EUROPEAN COMMISSION


Health programme

Annex C - 5

























reporting types























EUROPEAN COMMISSION


Health programme

Annex C - 6























a common pdf file

























EUROPEAN COMMISSION


Health programme

Annex C - 7



























adhesivesrdquo












5(1a)










EUROPEAN COMMISSION


Health programme

Annex C - 8


Art5 1(a)















































EUROPEAN COMMISSION


Health programme

Annex C - 9


























format























EUROPEAN COMMISSION


Health programme

Annex C - 10







standardized batch


























p4





include








EUROPEAN COMMISSION


Health programme

Annex C - 11

































smoke or












the latter)




EUROPEAN COMMISSION


Health programme

Annex C - 12




not stated above
















7 Emissions




of the TPD




the TPD









variable








EUROPEAN COMMISSION


Health programme

Annex C - 13






























hardwareliquid



noted that








EUROPEAN COMMISSION


Health programme

Annex C - 14




























product texture










tobacco







EUROPEAN COMMISSION


Health programme

Annex C - 15






































20 (2e)









EUROPEAN COMMISSION


Health programme

Annex C - 16



identification


































production country










following

EUROPEAN COMMISSION


Health programme

Annex C - 17
































EUROPEAN COMMISSION


Health programme

Annex C - 18


Free publications

bull one copy








Priced publications





EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286

EUROPEAN COMMISSION



Contents

1 ABSTRACT 6







611 Introduction 22







621 Introduction 28



631 Introduction 33



641 Introduction 34





7 CONCLUSIONS 42

8 ANNEXES


tobacco products




EUROPEAN COMMISSION

6


Health programme

1 ABSTRACT






designed














EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY





















20(13))













EUROPEAN COMMISSION

8


Health programme

Summary of WP1











Submission process


















Reporting format




percentage of EU MS












EUROPEAN COMMISSION

9


Health programme
































Summary of WP2













on public health


WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

EUROPEAN COMMISSION

10


Health programme


















































EUROPEAN COMMISSION

11


Health programme












Summary of WP3




phases as follows




















various use cases


Summary of WP4




mechanism



EUROPEAN COMMISSION

12


Health programme















the system



















EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF






















(Article 20(13))








EUROPEAN COMMISSION

14


Health programme








informations
























services juridiques











EUROPEAN COMMISSION

15


Health programme












































EUROPEAN COMMISSION

16


Health programme













































WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees


EUROPEAN COMMISSION

17


Health programme
















































EUROPEAN COMMISSION

18


Health programme










































publique





EUROPEAN COMMISSION

19


Health programme













EUROPEAN COMMISSION

20


Health programme
























EUROPEAN COMMISSION

21


Health programme


Overall Approach
























EUROPEAN COMMISSION

22


Health programme



611 Introduction






experience









jurisdiction










EU MS feedback





Industry feedback










EUROPEAN COMMISSION

23


Health programme




NGO Feedback













protected



























EUROPEAN COMMISSION

24


Health programme








submissions



















processes








activities

















EUROPEAN COMMISSION

25


Health programme





submission platform






























be of interest



to regulators








oriented)




EUROPEAN COMMISSION

26


Health programme
























too)










implemented



these products













EUROPEAN COMMISSION

27


Health programme




































receipt













EUROPEAN COMMISSION

28


Health programme






fees



format






file collection




additive list















quantities







621 Introduction








EUROPEAN COMMISSION

29


Health programme





on 31 May 20077


























in WP3)








EUROPEAN COMMISSION

30


Health programme













































EUROPEAN COMMISSION

31


Health programme




















of the product etc


























EUROPEAN COMMISSION

32


Health programme















































EUROPEAN COMMISSION

33


Health programme











631 Introduction















4 Testing











respective actors


requirements)


Dictionaryrsquo


EUROPEAN COMMISSION

34


Health programme



























Testing







641 Introduction







mechanism


EUROPEAN COMMISSION

35


Health programme




















its implementation





brought forward








batch



certain cut-off








multiple portals





EUROPEAN COMMISSION

36


Health programme


system





connection




















one language























EUROPEAN COMMISSION

37


Health programme


















Management
















to themrdquo




provided below










EUROPEAN COMMISSION

38


Health programme













EUROPEAN COMMISSION

39


Health programme










































reporting






EUROPEAN COMMISSION

40


Health programme























perspective

























EUROPEAN COMMISSION

41


Health programme



the understanding





and globally














parameters




EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS




to the public









general public





information





EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products





1 Introduction




Reference documents


Ref Name

















EUROPEAN COMMISSION


Health programme

Annex A ndash2









22032012



1(trueenabled)

Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String (100)





Tobacco Product

identifier (TP-ID)


e 02565-2015-00230







Food Additive

identifier






2 Data Dictionary






Item


White list



String Text M


String Text M



List

element

Dropdown M




List

element

Dropdown M


VAT

String Text M


List element

Dropdown M


String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5


String Text Email M






multiple entries

possible)






White list



one exist

String Text F





ry



String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6


String Text Email F




White list



should one exist

String Text F




is based




String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7



Item


Type

White

list




Principal)

String Text F




based




String Text Phone F



used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8


Item


White list







AUTO



AUTO








rules)




Boolean Checkbox M


String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9





cigarettes)





mg

Decimal Text M




Decimal Text M





e_Sites






String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10


File File browser







presentation

Item


White list



tion Long

M



M

323 Tobacco

Product_launch_date



Date text M



File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11



File File browser

O






String Text M





String Text


String Text


String Text










package in g


EUROPEAN COMMISSION


Health programme

Annex A ndash12




Decimal Text O





Decimal Text M


String Text O





File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13





Item


White list



List element

Dropdown M


String Text F


File File browser








List element

Dropdown M


String Text F



List

element

Dropdown M



String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14



Decimal Text M




Item


White list




List element

Dropdown M








M





uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15







F

If a CAS








e

Identifier




8722012


er





er



Boolean Checkbox M



Decimal Text M




EUROPEAN COMMISSION


Health programme

Annex A ndash16





antity




530 is Yes)










530 is

Yes)






reporting period





EUROPEAN COMMISSION


Health programme

Annex A ndash17


String Text F


List element

Dropdown M


es



File File

browser

F





List element

Dropdown M




List

element

Dropdown M



List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18



List element

Dropdown Tox_Code



F) are




mal



List

element

Dropdown Tox_C

ode



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code


12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19



List element

Dropdown Tox_Code



String Text



List

element

Dropdown Tox_C

ode


List element

Dropdown M





Boolean Checkbox FM


not limited to





Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20






Boolean Checkbox FM


Boolean Checkbox FM


above

Boolean Checkbox FM


be available

File File browser

FM



Item


Control Type

White list









EUROPEAN COMMISSION


Health programme

Annex A ndash21






List element

Dropdown

M






place

File File

browser

F



String Text F



CAS

Identifie

r

F


not exist

String Text F



Numeric Text F


EUROPEAN COMMISSION


Health programme

Annex A ndash22



Item


Control Type

White list



Boolean Checkbox M








Item


Control Type

White list







String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23



Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File





perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)


co


tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)




Type

Control

Type

White

List

Reporting Visibili

ty



Decimal Text M


tent


the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24




3 Reference Data


32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo


5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco



Value Name



version)



4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name





5 Soft pack

6 Pouch with flap


8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin


23 Slide lid box

24 Flow wrap

25 Folding pouch



EUROPEAN COMMISSION


Health programme

Annex A ndash26




Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf




5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other


EUROPEAN COMMISSION


Health programme

Annex A ndash27


Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)








11 Adhesive (burnt)

12 tips (unburnt)


14 paper (unburnt)

15 Other (unburnt)


Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28





13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

Value Name




Value Name




EUROPEAN COMMISSION


Health programme

Annex B - 1


1 Introduction





Ref Name









pdf










EUROPEAN COMMISSION


Health programme

Annex B -2









22032012




14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String(100)






identifier (EC-ID)


e 02565-15-00230







Food Additive

identifier





NNN-NNN-N


eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item




String Text M



String Text M





String Text M




the VAT

String Text M


EUROPEAN COMMISSION


Health programme

Annex B -5




international codes

String Text Phone M


String Text Email M



mandatory

Boolean Checkbox M



Boolean Checkbox M


Boolean Checkbox M



Item




String Text F



EUROPEAN COMMISSION


Health programme

Annex B -6




String Text Phone F



String Text Email F



Item




should one exist

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item




Principal)

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8


Item







Date System

Generated

AUTO




AUTO



NNNNN)








Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9



String Text F



types



mg

Decimal Text M


ml

Decimal Text M


cation



String Text F if



File File browser M


ites






String Text

EUROPEAN COMMISSION


Health programme

Annex B -10




presentation

Item


list



MS


ionLong

M




M







Date Text M






String Text



String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11


String Text





File File browser M


package

Decimal Text M








EUROPEAN COMMISSION


Health programme

Annex B -12


Item









Boolean Checkbox F





e-liquids)





3125 is Option 3










3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13


Item


Visibility




M






String Text F






semicolons ()



at least one is


importance






13332008







EUROPEAN COMMISSION


Health programme

Annex B -14




EC)




Decimal Text M






String Text F













EUROPEAN COMMISSION


Health programme

Annex B -15











halation












ensitisation





tion




EUROPEAN COMMISSION


Health programme

Annex B -16



otox
















String Text






potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17







Boolean Checkbox FM









Boolean Checkbox FM





respiratory tract

Boolean Checkbox FM



Boolean Checkbox FM


Boolean Checkbox FM



EUROPEAN COMMISSION


Health programme

Annex B -18


25 Emissions

Item



Decimal Text M







wattage













File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19







Numeric Text M



Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility




liquid)

String Text M M




Decimal Text M M

1116 E-


ion



Decimal Text M M



String Text M NA

1121 E-


city


EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-


le




List

element

Dropdown M NA



Decimal Text F NA

1131 E-


ge



Decimal Text F NA

1132 E-


ge



Decimal Text F NA



Decimal Text F NA

1141 E-


nge



Decimal Text F NA

1142 E-


nge



Decimal Text F NA

1150 E-



adjustable






e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21


atomiser

String Text M O

1190 E-


ke_File









File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof








File File

Browser

M M

11120 E-


mity













String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22







nicotine content)


11124 E-





String Text M M

11124 E-


Methods



standardprotocol

File File

Browser


_File



File File

Browser

M for

refillable e-

cigarettes

M










within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name







Value Name




Value Name






EUROPEAN COMMISSION


Health programme

Annex B -24




Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name


2 Ethylene glycol

3 Diethylene glycol



6 Carbonyl Acrolein


8 TSNA NNN

9 TSNA NNK




13 Trace metal Lead




17 Trace metal Tin


19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene



25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26


Value Name




4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1


1 Introduction















reading













data to be merged







information







EUROPEAN COMMISSION


Health programme

Annex C - 2

































TPD 5(1) and 20(2)







version)




EUROPEAN COMMISSION


Health programme

Annex C - 3

















the product version












then provided

















EUROPEAN COMMISSION


Health programme

Annex C - 4



respectively

























enter the market


















EUROPEAN COMMISSION


Health programme

Annex C - 5

























reporting types























EUROPEAN COMMISSION


Health programme

Annex C - 6























a common pdf file

























EUROPEAN COMMISSION


Health programme

Annex C - 7



























adhesivesrdquo












5(1a)










EUROPEAN COMMISSION


Health programme

Annex C - 8


Art5 1(a)















































EUROPEAN COMMISSION


Health programme

Annex C - 9


























format























EUROPEAN COMMISSION


Health programme

Annex C - 10







standardized batch


























p4





include








EUROPEAN COMMISSION


Health programme

Annex C - 11

































smoke or












the latter)




EUROPEAN COMMISSION


Health programme

Annex C - 12




not stated above
















7 Emissions




of the TPD




the TPD









variable








EUROPEAN COMMISSION


Health programme

Annex C - 13






























hardwareliquid



noted that








EUROPEAN COMMISSION


Health programme

Annex C - 14




























product texture










tobacco







EUROPEAN COMMISSION


Health programme

Annex C - 15






































20 (2e)









EUROPEAN COMMISSION


Health programme

Annex C - 16



identification


































production country










following

EUROPEAN COMMISSION


Health programme

Annex C - 17
































EUROPEAN COMMISSION


Health programme

Annex C - 18


Free publications

bull one copy








Priced publications





EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286

EUROPEAN COMMISSION

6


Health programme

1 ABSTRACT






designed














EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY





















20(13))













EUROPEAN COMMISSION

8


Health programme

Summary of WP1











Submission process


















Reporting format




percentage of EU MS












EUROPEAN COMMISSION

9


Health programme
































Summary of WP2













on public health


WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

EUROPEAN COMMISSION

10


Health programme


















































EUROPEAN COMMISSION

11


Health programme












Summary of WP3




phases as follows




















various use cases


Summary of WP4




mechanism



EUROPEAN COMMISSION

12


Health programme















the system



















EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF






















(Article 20(13))








EUROPEAN COMMISSION

14


Health programme








informations
























services juridiques











EUROPEAN COMMISSION

15


Health programme












































EUROPEAN COMMISSION

16


Health programme













































WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees


EUROPEAN COMMISSION

17


Health programme
















































EUROPEAN COMMISSION

18


Health programme










































publique





EUROPEAN COMMISSION

19


Health programme













EUROPEAN COMMISSION

20


Health programme
























EUROPEAN COMMISSION

21


Health programme


Overall Approach
























EUROPEAN COMMISSION

22


Health programme



611 Introduction






experience









jurisdiction










EU MS feedback





Industry feedback










EUROPEAN COMMISSION

23


Health programme




NGO Feedback













protected



























EUROPEAN COMMISSION

24


Health programme








submissions



















processes








activities

















EUROPEAN COMMISSION

25


Health programme





submission platform






























be of interest



to regulators








oriented)




EUROPEAN COMMISSION

26


Health programme
























too)










implemented



these products













EUROPEAN COMMISSION

27


Health programme




































receipt













EUROPEAN COMMISSION

28


Health programme






fees



format






file collection




additive list















quantities







621 Introduction








EUROPEAN COMMISSION

29


Health programme





on 31 May 20077


























in WP3)








EUROPEAN COMMISSION

30


Health programme













































EUROPEAN COMMISSION

31


Health programme




















of the product etc


























EUROPEAN COMMISSION

32


Health programme















































EUROPEAN COMMISSION

33


Health programme











631 Introduction















4 Testing











respective actors


requirements)


Dictionaryrsquo


EUROPEAN COMMISSION

34


Health programme



























Testing







641 Introduction







mechanism


EUROPEAN COMMISSION

35


Health programme




















its implementation





brought forward








batch



certain cut-off








multiple portals





EUROPEAN COMMISSION

36


Health programme


system





connection




















one language























EUROPEAN COMMISSION

37


Health programme


















Management
















to themrdquo




provided below










EUROPEAN COMMISSION

38


Health programme













EUROPEAN COMMISSION

39


Health programme










































reporting






EUROPEAN COMMISSION

40


Health programme























perspective

























EUROPEAN COMMISSION

41


Health programme



the understanding





and globally














parameters




EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS




to the public









general public





information





EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products





1 Introduction




Reference documents


Ref Name

















EUROPEAN COMMISSION


Health programme

Annex A ndash2









22032012



1(trueenabled)

Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String (100)





Tobacco Product

identifier (TP-ID)


e 02565-2015-00230







Food Additive

identifier






2 Data Dictionary






Item


White list



String Text M


String Text M



List

element

Dropdown M




List

element

Dropdown M


VAT

String Text M


List element

Dropdown M


String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5


String Text Email M






multiple entries

possible)






White list



one exist

String Text F





ry



String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6


String Text Email F




White list



should one exist

String Text F




is based




String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7



Item


Type

White

list




Principal)

String Text F




based




String Text Phone F



used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8


Item


White list







AUTO



AUTO








rules)




Boolean Checkbox M


String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9





cigarettes)





mg

Decimal Text M




Decimal Text M





e_Sites






String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10


File File browser







presentation

Item


White list



tion Long

M



M

323 Tobacco

Product_launch_date



Date text M



File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11



File File browser

O






String Text M





String Text


String Text


String Text










package in g


EUROPEAN COMMISSION


Health programme

Annex A ndash12




Decimal Text O





Decimal Text M


String Text O





File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13





Item


White list



List element

Dropdown M


String Text F


File File browser








List element

Dropdown M


String Text F



List

element

Dropdown M



String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14



Decimal Text M




Item


White list




List element

Dropdown M








M





uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15







F

If a CAS








e

Identifier




8722012


er





er



Boolean Checkbox M



Decimal Text M




EUROPEAN COMMISSION


Health programme

Annex A ndash16





antity




530 is Yes)










530 is

Yes)






reporting period





EUROPEAN COMMISSION


Health programme

Annex A ndash17


String Text F


List element

Dropdown M


es



File File

browser

F





List element

Dropdown M




List

element

Dropdown M



List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18



List element

Dropdown Tox_Code



F) are




mal



List

element

Dropdown Tox_C

ode



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code


12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19



List element

Dropdown Tox_Code



String Text



List

element

Dropdown Tox_C

ode


List element

Dropdown M





Boolean Checkbox FM


not limited to





Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20






Boolean Checkbox FM


Boolean Checkbox FM


above

Boolean Checkbox FM


be available

File File browser

FM



Item


Control Type

White list









EUROPEAN COMMISSION


Health programme

Annex A ndash21






List element

Dropdown

M






place

File File

browser

F



String Text F



CAS

Identifie

r

F


not exist

String Text F



Numeric Text F


EUROPEAN COMMISSION


Health programme

Annex A ndash22



Item


Control Type

White list



Boolean Checkbox M








Item


Control Type

White list







String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23



Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File





perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)


co


tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)




Type

Control

Type

White

List

Reporting Visibili

ty



Decimal Text M


tent


the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24




3 Reference Data


32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo


5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco



Value Name



version)



4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name





5 Soft pack

6 Pouch with flap


8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin


23 Slide lid box

24 Flow wrap

25 Folding pouch



EUROPEAN COMMISSION


Health programme

Annex A ndash26




Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf




5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other


EUROPEAN COMMISSION


Health programme

Annex A ndash27


Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)








11 Adhesive (burnt)

12 tips (unburnt)


14 paper (unburnt)

15 Other (unburnt)


Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28





13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

Value Name




Value Name




EUROPEAN COMMISSION


Health programme

Annex B - 1


1 Introduction





Ref Name









pdf










EUROPEAN COMMISSION


Health programme

Annex B -2









22032012




14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String(100)






identifier (EC-ID)


e 02565-15-00230







Food Additive

identifier





NNN-NNN-N


eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item




String Text M



String Text M





String Text M




the VAT

String Text M


EUROPEAN COMMISSION


Health programme

Annex B -5




international codes

String Text Phone M


String Text Email M



mandatory

Boolean Checkbox M



Boolean Checkbox M


Boolean Checkbox M



Item




String Text F



EUROPEAN COMMISSION


Health programme

Annex B -6




String Text Phone F



String Text Email F



Item




should one exist

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item




Principal)

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8


Item







Date System

Generated

AUTO




AUTO



NNNNN)








Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9



String Text F



types



mg

Decimal Text M


ml

Decimal Text M


cation



String Text F if



File File browser M


ites






String Text

EUROPEAN COMMISSION


Health programme

Annex B -10




presentation

Item


list



MS


ionLong

M




M







Date Text M






String Text



String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11


String Text





File File browser M


package

Decimal Text M








EUROPEAN COMMISSION


Health programme

Annex B -12


Item









Boolean Checkbox F





e-liquids)





3125 is Option 3










3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13


Item


Visibility




M






String Text F






semicolons ()



at least one is


importance






13332008







EUROPEAN COMMISSION


Health programme

Annex B -14




EC)




Decimal Text M






String Text F













EUROPEAN COMMISSION


Health programme

Annex B -15











halation












ensitisation





tion




EUROPEAN COMMISSION


Health programme

Annex B -16



otox
















String Text






potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17







Boolean Checkbox FM









Boolean Checkbox FM





respiratory tract

Boolean Checkbox FM



Boolean Checkbox FM


Boolean Checkbox FM



EUROPEAN COMMISSION


Health programme

Annex B -18


25 Emissions

Item



Decimal Text M







wattage













File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19







Numeric Text M



Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility




liquid)

String Text M M




Decimal Text M M

1116 E-


ion



Decimal Text M M



String Text M NA

1121 E-


city


EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-


le




List

element

Dropdown M NA



Decimal Text F NA

1131 E-


ge



Decimal Text F NA

1132 E-


ge



Decimal Text F NA



Decimal Text F NA

1141 E-


nge



Decimal Text F NA

1142 E-


nge



Decimal Text F NA

1150 E-



adjustable






e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21


atomiser

String Text M O

1190 E-


ke_File









File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof








File File

Browser

M M

11120 E-


mity













String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22







nicotine content)


11124 E-





String Text M M

11124 E-


Methods



standardprotocol

File File

Browser


_File



File File

Browser

M for

refillable e-

cigarettes

M










within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name







Value Name




Value Name






EUROPEAN COMMISSION


Health programme

Annex B -24




Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name


2 Ethylene glycol

3 Diethylene glycol



6 Carbonyl Acrolein


8 TSNA NNN

9 TSNA NNK




13 Trace metal Lead




17 Trace metal Tin


19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene



25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26


Value Name




4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1


1 Introduction















reading













data to be merged







information







EUROPEAN COMMISSION


Health programme

Annex C - 2

































TPD 5(1) and 20(2)







version)




EUROPEAN COMMISSION


Health programme

Annex C - 3

















the product version












then provided

















EUROPEAN COMMISSION


Health programme

Annex C - 4



respectively

























enter the market


















EUROPEAN COMMISSION


Health programme

Annex C - 5

























reporting types























EUROPEAN COMMISSION


Health programme

Annex C - 6























a common pdf file

























EUROPEAN COMMISSION


Health programme

Annex C - 7



























adhesivesrdquo












5(1a)










EUROPEAN COMMISSION


Health programme

Annex C - 8


Art5 1(a)















































EUROPEAN COMMISSION


Health programme

Annex C - 9


























format























EUROPEAN COMMISSION


Health programme

Annex C - 10







standardized batch


























p4





include








EUROPEAN COMMISSION


Health programme

Annex C - 11

































smoke or












the latter)




EUROPEAN COMMISSION


Health programme

Annex C - 12




not stated above
















7 Emissions




of the TPD




the TPD









variable








EUROPEAN COMMISSION


Health programme

Annex C - 13






























hardwareliquid



noted that








EUROPEAN COMMISSION


Health programme

Annex C - 14




























product texture










tobacco







EUROPEAN COMMISSION


Health programme

Annex C - 15






































20 (2e)









EUROPEAN COMMISSION


Health programme

Annex C - 16



identification


































production country










following

EUROPEAN COMMISSION


Health programme

Annex C - 17
































EUROPEAN COMMISSION


Health programme

Annex C - 18


Free publications

bull one copy








Priced publications





EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286

EUROPEAN COMMISSION

7


Health programme

2 EXECUTIVE SUMMARY





















20(13))













EUROPEAN COMMISSION

8


Health programme

Summary of WP1











Submission process


















Reporting format




percentage of EU MS












EUROPEAN COMMISSION

9


Health programme
































Summary of WP2













on public health


WP1 feedback

TPD Articles

Data Dictionaries

Public Health

relevance

EUROPEAN COMMISSION

10


Health programme


















































EUROPEAN COMMISSION

11


Health programme












Summary of WP3




phases as follows




















various use cases


Summary of WP4




mechanism



EUROPEAN COMMISSION

12


Health programme















the system



















EUROPEAN COMMISSION

13


Health programme

3 RESUME EXECUTIF






















(Article 20(13))








EUROPEAN COMMISSION

14


Health programme








informations
























services juridiques











EUROPEAN COMMISSION

15


Health programme












































EUROPEAN COMMISSION

16


Health programme













































WP1 Commentaires

Articles de la TPD

Dictionnaire des

Donneacutees


EUROPEAN COMMISSION

17


Health programme
















































EUROPEAN COMMISSION

18


Health programme










































publique





EUROPEAN COMMISSION

19


Health programme













EUROPEAN COMMISSION

20


Health programme
























EUROPEAN COMMISSION

21


Health programme


Overall Approach
























EUROPEAN COMMISSION

22


Health programme



611 Introduction






experience









jurisdiction










EU MS feedback





Industry feedback










EUROPEAN COMMISSION

23


Health programme




NGO Feedback













protected



























EUROPEAN COMMISSION

24


Health programme








submissions



















processes








activities

















EUROPEAN COMMISSION

25


Health programme





submission platform






























be of interest



to regulators








oriented)




EUROPEAN COMMISSION

26


Health programme
























too)










implemented



these products













EUROPEAN COMMISSION

27


Health programme




































receipt













EUROPEAN COMMISSION

28


Health programme






fees



format






file collection




additive list















quantities







621 Introduction








EUROPEAN COMMISSION

29


Health programme





on 31 May 20077


























in WP3)








EUROPEAN COMMISSION

30


Health programme













































EUROPEAN COMMISSION

31


Health programme




















of the product etc


























EUROPEAN COMMISSION

32


Health programme















































EUROPEAN COMMISSION

33


Health programme











631 Introduction















4 Testing











respective actors


requirements)


Dictionaryrsquo


EUROPEAN COMMISSION

34


Health programme



























Testing







641 Introduction







mechanism


EUROPEAN COMMISSION

35


Health programme




















its implementation





brought forward








batch



certain cut-off








multiple portals





EUROPEAN COMMISSION

36


Health programme


system





connection




















one language























EUROPEAN COMMISSION

37


Health programme


















Management
















to themrdquo




provided below










EUROPEAN COMMISSION

38


Health programme













EUROPEAN COMMISSION

39


Health programme










































reporting






EUROPEAN COMMISSION

40


Health programme























perspective

























EUROPEAN COMMISSION

41


Health programme



the understanding





and globally














parameters




EUROPEAN COMMISSION

42


Health programme

7 CONCLUSIONS




to the public









general public





information





EUROPEAN COMMISSION

43


Health programme

8 ANNEXES


tobacco products





1 Introduction




Reference documents


Ref Name

















EUROPEAN COMMISSION


Health programme

Annex A ndash2









22032012



1(trueenabled)

Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex A ndash3

White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String (100)





Tobacco Product

identifier (TP-ID)


e 02565-2015-00230







Food Additive

identifier






2 Data Dictionary






Item


White list



String Text M


String Text M



List

element

Dropdown M




List

element

Dropdown M


VAT

String Text M


List element

Dropdown M


String Text Phone M

EUROPEAN COMMISSION


Health programme

Annex A ndash5


String Text Email M






multiple entries

possible)






White list



one exist

String Text F





ry



String Text Phone F

EUROPEAN COMMISSION


Health programme

Annex A ndash6


String Text Email F




White list



should one exist

String Text F




is based




String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash7



Item


Type

White

list




Principal)

String Text F




based




String Text Phone F



used

String Text Email F

EUROPEAN COMMISSION


Health programme

Annex A ndash8


Item


White list







AUTO



AUTO








rules)




Boolean Checkbox M


String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash9





cigarettes)





mg

Decimal Text M




Decimal Text M





e_Sites






String Text M

EUROPEAN COMMISSION


Health programme

Annex A ndash10


File File browser







presentation

Item


White list



tion Long

M



M

323 Tobacco

Product_launch_date



Date text M



File File

browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash11



File File browser

O






String Text M





String Text


String Text


String Text










package in g


EUROPEAN COMMISSION


Health programme

Annex A ndash12




Decimal Text O





Decimal Text M


String Text O





File File browser

M

EUROPEAN COMMISSION


Health programme

Annex A ndash13





Item


White list



List element

Dropdown M


String Text F


File File browser








List element

Dropdown M


String Text F



List

element

Dropdown M



String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash14



Decimal Text M




Item


White list




List element

Dropdown M








M





uploaded)

String Text F

EUROPEAN COMMISSION


Health programme

Annex A ndash15







F

If a CAS








e

Identifier




8722012


er





er



Boolean Checkbox M



Decimal Text M




EUROPEAN COMMISSION


Health programme

Annex A ndash16





antity




530 is Yes)










530 is

Yes)






reporting period





EUROPEAN COMMISSION


Health programme

Annex A ndash17


String Text F


List element

Dropdown M


es



File File

browser

F





List element

Dropdown M




List

element

Dropdown M



List

element

Dropdown M

EUROPEAN COMMISSION


Health programme

Annex A ndash18



List element

Dropdown Tox_Code



F) are




mal



List

element

Dropdown Tox_C

ode



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



List element

Dropdown Tox_Code



12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code


12722008

List element

Dropdown Tox_Code



List element

Dropdown Tox_Code

EUROPEAN COMMISSION


Health programme

Annex A ndash19



List element

Dropdown Tox_Code



String Text



List

element

Dropdown Tox_C

ode


List element

Dropdown M





Boolean Checkbox FM


not limited to





Boolean Checkbox FM

EUROPEAN COMMISSION


Health programme

Annex A ndash20






Boolean Checkbox FM


Boolean Checkbox FM


above

Boolean Checkbox FM


be available

File File browser

FM



Item


Control Type

White list









EUROPEAN COMMISSION


Health programme

Annex A ndash21






List element

Dropdown

M






place

File File

browser

F



String Text F



CAS

Identifie

r

F


not exist

String Text F



Numeric Text F


EUROPEAN COMMISSION


Health programme

Annex A ndash22



Item


Control Type

White list



Boolean Checkbox M








Item


Control Type

White list







String Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash23



Ite

m

Field Comments Data

Type

Control

Type

White

list


910 Novel_ Risk

Benefit_File





perception

File File

browser

O (M if the

submitter uses

this system to

report their

product)


co


tobacco

Boolea

n

Checkbo

x

O (M if the

submitter uses

this system to

report their

product)




Type

Control

Type

White

List

Reporting Visibili

ty



Decimal Text M


tent


the loose content

Decimal Text O

EUROPEAN COMMISSION


Health programme

Annex A ndash24




3 Reference Data


32 Product Type

Value Name

1 Cigarette

2 Cigar

3 Cigarillo


5 Pipe tobacco

6 Waterpipe tobacco

7 Oral tobacco

8 Nasal tobacco

9 Chewing tobacco



Value Name



version)



4 Cancellation

EUROPEAN COMMISSION


Health programme

Annex A ndash25

33 Product Package

Value Name





5 Soft pack

6 Pouch with flap


8 Cuboid can

9 BlockFoil pack

10 Cylinder cardcan

11 Standing pouch

12 Folding box

13 Carton box

14 Hinged box

15 Hinged tin

16 Flip top pack

17 Single tube tin

18 Bundle

19 Multi cigar tube

20 Cylinder tin

21 Round tin


23 Slide lid box

24 Flow wrap

25 Folding pouch



EUROPEAN COMMISSION


Health programme

Annex A ndash26




Value Name

1 Air

2 Fire

3 Steam

4 Sun

5 Flue

6 Other

Value Name

1 Tobacco leaf




5 Other

Value Name

1 Virginia

2 Burley

3 Oriental

4 Maryland

5 Kentucky

6 Dark

7 Other


EUROPEAN COMMISSION


Health programme

Annex A ndash27


Value Name

1 tobacco (burnt)

2 Tobacco (unburnt)

3 paper (burnt)








11 Adhesive (burnt)

12 tips (unburnt)


14 paper (unburnt)

15 Other (unburnt)


Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component

EUROPEAN COMMISSION


Health programme

Annex A ndash28





13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

Value Name




Value Name




EUROPEAN COMMISSION


Health programme

Annex B - 1


1 Introduction





Ref Name









pdf










EUROPEAN COMMISSION


Health programme

Annex B -2









22032012




14 Reporting types


Type Explanation








EUROPEAN COMMISSION


Health programme

Annex B -3

15 White lists



Phone


[[0-9][+] [()]]


]+)(([a-z]23))$

Name String(100)






identifier (EC-ID)


e 02565-15-00230







Food Additive

identifier





NNN-NNN-N


eg 1A 0 1 2

EUROPEAN COMMISSION


Health programme

Annex B - 4

2 Data Dictionary






Item




String Text M



String Text M





String Text M




the VAT

String Text M


EUROPEAN COMMISSION


Health programme

Annex B -5




international codes

String Text Phone M


String Text Email M



mandatory

Boolean Checkbox M



Boolean Checkbox M


Boolean Checkbox M



Item




String Text F



EUROPEAN COMMISSION


Health programme

Annex B -6




String Text Phone F



String Text Email F



Item




should one exist

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -7



Item




Principal)

String Text F






String Text Phone F


String Text Email F

EUROPEAN COMMISSION


Health programme

Annex B -8


Item







Date System

Generated

AUTO




AUTO



NNNNN)








Boolean Checkbox M

EUROPEAN COMMISSION


Health programme

Annex B -9



String Text F



types



mg

Decimal Text M


ml

Decimal Text M


cation



String Text F if



File File browser M


ites






String Text

EUROPEAN COMMISSION


Health programme

Annex B -10




presentation

Item


list



MS


ionLong

M




M







Date Text M






String Text



String Text


String Text

EUROPEAN COMMISSION


Health programme

Annex B -11


String Text





File File browser M


package

Decimal Text M








EUROPEAN COMMISSION


Health programme

Annex B -12


Item









Boolean Checkbox F





e-liquids)





3125 is Option 3










3125 is Option 3

EUROPEAN COMMISSION


Health programme

Annex B -13


Item


Visibility




M






String Text F






semicolons ()



at least one is


importance






13332008







EUROPEAN COMMISSION


Health programme

Annex B -14




EC)




Decimal Text M






String Text F













EUROPEAN COMMISSION


Health programme

Annex B -15











halation












ensitisation





tion




EUROPEAN COMMISSION


Health programme

Annex B -16



otox
















String Text






potential responses


EUROPEAN COMMISSION


Health programme

Annex B -17







Boolean Checkbox FM









Boolean Checkbox FM





respiratory tract

Boolean Checkbox FM



Boolean Checkbox FM


Boolean Checkbox FM



EUROPEAN COMMISSION


Health programme

Annex B -18


25 Emissions

Item



Decimal Text M







wattage













File File browser M

EUROPEAN COMMISSION


Health programme

Annex B -19







Numeric Text M



Item

Field Comments Data

Type

Control

Type

Reporting

for e-

cigarettes

Reporting

for e-

cigarette

refill

container

Visibility




liquid)

String Text M M




Decimal Text M M

1116 E-


ion



Decimal Text M M



String Text M NA

1121 E-


city


EUROPEAN COMMISSION


Health programme

Annex B -20

1122 E-


le




List

element

Dropdown M NA



Decimal Text F NA

1131 E-


ge



Decimal Text F NA

1132 E-


ge



Decimal Text F NA



Decimal Text F NA

1141 E-


nge



Decimal Text F NA

1142 E-


nge



Decimal Text F NA

1150 E-



adjustable






e-cigarette


EUROPEAN COMMISSION


Health programme

Annex B -21


atomiser

String Text M O

1190 E-


ke_File









File File

Browser

M M

11100 E_Cigarette

_Child_Tamper_Proof








File File

Browser

M M

11120 E-


mity













String Text M M

EUROPEAN COMMISSION


Health programme

Annex B -22







nicotine content)


11124 E-





String Text M M

11124 E-


Methods



standardprotocol

File File

Browser


_File



File File

Browser

M for

refillable e-

cigarettes

M










within the Union

File File

Browser

O O

EUROPEAN COMMISSION


Health programme

Annex B -23

3 Reference Data


32 Product Type

Value Name







Value Name




Value Name






EUROPEAN COMMISSION


Health programme

Annex B -24




Value Name




Value Name


2 Adhesive

3 Binder

4 Carrier

5 Colour


7 Casing

8 Fibre

9 Filler

10 Filter Component



13 Humectant

14 pH Modifier

15 Plasticiser

16 Preservative



19 Sizing Agent

20 Smoke Enhancer



23 Wrapper



26 Other

EUROPEAN COMMISSION


Health programme

Annex B -25


Value Name




37 Emission Name

Name


2 Ethylene glycol

3 Diethylene glycol



6 Carbonyl Acrolein


8 TSNA NNN

9 TSNA NNK




13 Trace metal Lead




17 Trace metal Tin


19 VOC Toluene

20 VOC Benzene

21 VOC 13-Butadiene

22 VOC Isoprene



25 Other

EUROPEAN COMMISSION


Health programme

Annex B -26


Value Name




4 No un-adjustable

EUROPEAN COMMISSION


Health programme

Annex C - 1


1 Introduction















reading













data to be merged







information







EUROPEAN COMMISSION


Health programme

Annex C - 2

































TPD 5(1) and 20(2)







version)




EUROPEAN COMMISSION


Health programme

Annex C - 3

















the product version












then provided

















EUROPEAN COMMISSION


Health programme

Annex C - 4



respectively

























enter the market


















EUROPEAN COMMISSION


Health programme

Annex C - 5

























reporting types























EUROPEAN COMMISSION


Health programme

Annex C - 6























a common pdf file

























EUROPEAN COMMISSION


Health programme

Annex C - 7



























adhesivesrdquo












5(1a)










EUROPEAN COMMISSION


Health programme

Annex C - 8


Art5 1(a)















































EUROPEAN COMMISSION


Health programme

Annex C - 9


























format























EUROPEAN COMMISSION


Health programme

Annex C - 10







standardized batch


























p4





include








EUROPEAN COMMISSION


Health programme

Annex C - 11

































smoke or












the latter)




EUROPEAN COMMISSION


Health programme

Annex C - 12




not stated above
















7 Emissions




of the TPD




the TPD









variable








EUROPEAN COMMISSION


Health programme

Annex C - 13






























hardwareliquid



noted that








EUROPEAN COMMISSION


Health programme

Annex C - 14




























product texture










tobacco







EUROPEAN COMMISSION


Health programme

Annex C - 15






































20 (2e)









EUROPEAN COMMISSION


Health programme

Annex C - 16



identification


































production country










following

EUROPEAN COMMISSION


Health programme

Annex C - 17
































EUROPEAN COMMISSION


Health programme

Annex C - 18


Free publications

bull one copy








Priced publications





EUROPEAN COMMISSION


Health programme

Annex C - 19

EB-0

4-1

5-4

06-E

N-N

doi10281830286

Study on the development of a EU common reporting format ...

Documents

Transcript of Study on the development of a EU common reporting format ...