SIST-TP CEN/TR 17236:2018
(Main)Electronic cigarettes and e-liquids - Constituents to be measured in the aerosol of vaping products
Electronic cigarettes and e-liquids - Constituents to be measured in the aerosol of vaping products
This European Technical Report gives a list of constituents of interest proposed for measurement in the aerosol for the purpose of regulatory submission under the Directive 2014/40/EU (TPD) [2] , for:
— prefilled products such as disposable e-cigarettes and refill cartridges;
— e-liquids sold in refill containers;
— the following categories of hardware: coils or other heater elements of the vaping product, atomisers, rebuildable atomisers and all open tank or dripper products with inbuilt atomisers, including clearomisers.
This list is not intended to be comprehensive but rather, it represents the default minimum requirement. Depending on the device/liquid combination and the toxicological assessment other substances might have to be measured as well.
Elektronische Zigaretten und Liquids für elektronische Zigaretten - Inhaltsstoffe, die im Aerosol von Verdampfungsprodukten gemessen werden
Cigarettes électroniques et e-liquides - Composants dont la teneur est à mesurer dans l’aérosol des produits de vapotage
Le présent Rapport technique européen fournit une liste de composants d'intérêt dont le dosage dans l’aérosol est proposé en vue de soumettre une notification aux autorités réglementaires au sens de la Directive 2014/40/UE sur les produits du tabac (TPD) [2], concernant :
— les produits pré-remplis tels que les cigarettes électroniques et les cartouches de recharge jetables ;
— les e-liquides vendus dans un flacon de recharge ;
les catégories suivantes de matériel : résistances ou autres éléments chauffants du dispositif de vapotage, atomiseurs, atomiseurs reconstructibles et tous les réservoirs ouverts ou produits de type Dripper avec atomiseurs intégrés, y compris les clearomiseurs.
La présente liste ne prétend pas être exhaustive, mais présente les exigences minimales par défaut. En fonction de la combinaison dispositif/liquide et de l'évaluation toxicologique, d'autres substances peuvent également devoir faire l'objet d'un mesurage.
Elektronske cigarete in e-tekočine - Sestavine, ki jih je treba meriti v aerosolu inhalacijskih proizvodov
To evropsko tehnično poročilo podaja seznam sestavin, predlaganih za merjenje v aerosolu za namene regulativne predložitve v skladu z direktivo 2014/40/EU (TPD) [2], za:
– predhodno polnjene izdelke, kot so elektronske cigarete za enkratno uporabo in polnilne kartuše;
– elektronske tekočine, ki se prodajajo v polnilnih vložkih;
– naslednje kategorije sestavnih delov: tuljave ali druge grelne elemente inhalacijskega izdelka, uparjalnike, obnovljive uparjalnike in vse izdelke z odprtim rezervoarjem ali razdelilnikom za kapljanje z vgrajenimi uparjalniki, vključno z uparjalniki Clearomiser.
Ta seznam ni izčrpen, temveč predstavlja privzeto minimalno zahtevo. Glede na kombinacijo naprave/tekočine in toksikološko oceno je morda treba izmeriti še druge snovi.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TP CEN/TR 17236:2018
01-december-2018
(OHNWURQVNHFLJDUHWHLQHWHNRþLQH6HVWDYLQHNLMLKMHWUHEDPHULWLYDHURVROX
LQKDODFLMVNLKSURL]YRGRY
Electronic cigarettes and e-liquids - Constituents to be measured in the aerosol of vaping
products
Cigarettes électroniques et e-liquides - Composants dont la teneur est à mesurer dans
l’aérosol des produits de vapotage
Ta slovenski standard je istoveten z: CEN/TR 17236:2018
ICS:
65.160 7REDNWREDþQLL]GHONLLQ Tobacco, tobacco products
RSUHPD and related equipment
SIST-TP CEN/TR 17236:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TP CEN/TR 17236:2018
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SIST-TP CEN/TR 17236:2018
CEN/TR 17236
TECHNICAL REPORT
RAPPORT TECHNIQUE
September 2018
TECHNISCHER BERICHT
ICS 65.160
English Version
Electronic cigarettes and e-liquids - Constituents to be
measured in the aerosol of vaping products
Cigarettes électroniques et e-liquides - Composants Elektronische Zigaretten und Liquids für elektronische
dont la teneur est à mesurer dans l'aérosol des Zigaretten - Inhaltsstoffe, die im Aerosol von
produits de vapotage Verdampfungsprodukten gemessen werden
This Technical Report was approved by CEN on 4 June 2018. It has been drawn up by the Technical Committee CEN/TC 437.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 17236:2018 E
worldwide for CEN national Members.
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Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Mandate . 4
5 What is the purpose of the emissions reporting? . 4
5.1 General . 4
5.2 TPD guidance . 5
5.3 Hardware versus e-liquids. 5
6 Existing regulatory guidance on compounds to be measured . 5
6.1 TPD . 5
6.2 European Commission guidance . 5
6.3 Member State guidance . 6
6.4 Existing voluntary standards/specification . 6
6.5 FDA . 6
7 Recommended compounds to be measured in vaping aerosol . 7
7.1 Aerosol versus e-liquid . 7
7.2 Overall mass of aerosol yield and nicotine . 8
7.3 Thermal degradation products . 8
7.4 Hardware specific emissions . 9
8 Recommendation . 9
Bibliography . 11
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European foreword
This document (CEN/TR 17236:2018) has been prepared by Technical Committee CEN/TC 437
“Electronic cigarettes and e-liquids”, the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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1 Scope
This document gives a list of constituents of interest proposed for measurement in the aerosol for the
purpose of regulatory submission under the Directive 2014/40/EU (TPD) [2], for
— prefilled products such as disposable e-cigarettes and refill cartridges,
— e-liquids sold in refill containers,
— the following categories of hardware: coils or other heater elements of the vaping product, atomisers,
rebuildable atomisers and all open tank or dripper products with inbuilt atomisers, including
clearomisers.
This list is not intended to be comprehensive but rather, it represents the default minimum requirement.
Depending on the device/liquid combination and the toxicological assessment other substances might
have to be measured as well.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
4 Mandate
TPD requires:
— “Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification
to the competent authorities of the Member States“ […] ”The notification shall, depending on whether
the product is an electronic cigarette or a refill container, contain the following information:”[…];
— “(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by
brand name and type, including quantities thereof”.
5 What is the purpose of the emissions reporting?
5.1 General
There can be many reasons to measure constituents in vaping aerosol. Different purposes will focus on
different constituents to be measured and different aerosol generation protocols under which to measure
them. TPD requires submission of data across the range of vaping products in order to allow comparisons
between products, analogous to the required tar/nicotine/carbon monoxide measurements required for
cigarettes under the TPD. This requires:
a) constituents to be measured that can reasonably be expected to be present in all vaping products;
b) measurement under a standardised machine vaping regime to allow comparisons. This regime
should be consumer relevant.
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5.2 TPD guidance
One of the purposes of the TPD is to help safeguard consumer safety. This would suggest emissions of
interest should be selected based on risk, i.e. a combination of inherent hazards and absolute abundance
in aerosol.
TPD definition: “‘emissions’ means substances that are released when a tobacco or related product is
consumed as intended,…”. (Emphasis added.) The proposal should thus address emissions of potential
toxicological concern, that can be expected when the products are used as intended, i.e. where the
products allow choice (e.g. of e-liquid, coil type, wattage and air flow settings, etc.), the interest is in
emissions that are produced when the compatible choices are made.
5.3 Hardware versus e-liquids
By mass, the bulk of the aerosol from vaping products are components that were present in the e-liquid
and have been aerosolised unchanged. Besides the e-liquid ingredients, this could include a small
contribution from e-liquid contaminants, potential reaction products between ingredients and potential
degradation products over time. Given the added aspects introduced by aerosolising the e-liquid (e.g.
choice of vaping device, machine vaping regime, analytical collection challenges), such compounds are
more appropriately measured in the e-liquid than in the aerosol.
Additionally some constituents in the aerosol derive from the hardware, i.e. from the materials the
different device parts are made of. These are thus hardware specific and measurement of them is relevant
to that hardware, not to e-liquids. The TPD already recognises that information submitted can differ
between e-liquids and hardware: “The notification shall, depending on whether the product is an
electronic cigarette or a refill container, contain the following information: …”
Another source of aerosol constituents is the thermal degradation products of the e-liquid that are
created from the aerosolisation process. These are dependent on the combination of e-liquid and
hardware used and should thus be measured for both vaping hardware and e-liquids, but with the
product combination clearly defined.
6 Existing regulatory guidance on compounds to be measured
6.1 TPD
The TPD itself contains no specifics on which emissions should be measured for vaping products.
However, assuming that emission measurement for cigarettes and vaping products will serve similar TPD
purposes, it is relevant to note that “emission levels” for cigarettes, as per paragraph 11 of the preamble,
refers to the tar, nicotine and carbon monoxide yields. This suggests an interest in a measure of the overall
aerosol yield, in nicotine in aerosol and in the main, high abundance, acute toxicant present in the aerosol
of all cigarettes.
6.2 European Commission guidance
No specific guidance form the European Commission exists. However, the TPD data dictionary electronic
cigarettes [3] makes provision for the potential notification of a number of named emissions (reference
data 10.4 in the data dictionary), listed in Table 1. The compounds have been sorted based on their most
likely source of origin if they were to be found in the vaping aerosol. Some could arise from more than
one source of origin and therefore appear in more than one row.
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6.3 Member State guidance
One of the Member States, the UK, has published guidance on the emissions to be measured and notified
under the TPD. This guidance was discussed with the other Member States [4]. The guidance with regards
to the emissions to be measured for notification is based on the toxicologically most important emissions
expected to be present across the range of vaping products and indicates additional metals could be
included, depending on the construction and the material composition of the hardware. This guidance is
included in Table 1.
6.4 Existing voluntary standards/specification
Regulatory guidance exists in the form of the BSI PAS 54115 [6], a voluntary British Public Available
Specification that covers the emissions to be measured in vaping products. The BSI PAS 54115
recommendations are essentially the same as those taken over by the MHRA and these guidances have
therefore been combined in Table 1. An additional voluntary French Experimental Standard,
AFNOR XP D90-300-3 [5], has therefore also been included in Table 1.
6.5 FDA
The final published FDA deeming regulations indicates the FDA still needs to decide on what constituents
in aerosol should be reported on and exempts vapi
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