EN 17746:2023

Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences within a single e-cigarette

This document specifies the method for the determination of nicotine delivery consistency of an electronic cigarette over the duration of use of e-liquid in the reservoir or a battery charge.
This document:
-   defines the equipment to be used;
-   specifies the preparation of the e-cigarette samples for testing;
-   specifies the aerosol generation process;
-   specifies the analytical method;
-   specifies the determination of the test result.
This document does not seek to demonstrate whether there is consistency of nicotine delivery between e-cigarettes. The latter is the aim of a separate method under development, EN 17634 Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences of a number of e-cigarettes of identical type [1]. Two separate methods have been developed to determine consistency of nicotine delivery, pending regulatory clarity on the Tobacco Products Directive's requirement to "deliver nicotine doses at consistent levels" [2].

Elektronische Zigaretten und E-Liquids - Bestimmung der gleichmäßigen Abgabe von Nikotin über definierte Zugsequenzen einer Anzahl von E-Zigaretten identischen Typs

Dieses Dokument legt ein Verfahren zur Bestimmung der gleichmäßigen Abgabe von Nikotin zwischen E Zigaretten (Geräte, Verbrauchsmaterialien und Kombinationen) fest.
Dieses Dokument:
-   legt die anzuwendenden Geräte fest;
-   legt die Vorbereitung der zu untersuchenden Proben fest;
-   legt den Sammelvorgang von Aerosolen fest;
-   legt das Analysenverfahren fest.
Es werden geeignete Probenahmeverfahren beschrieben, um Ergebnisse innerhalb einer einzelnen Produktionscharge zu erhalten und um eine chargenübergreifende Probenahme durchzuführen.
Ziel des Verfahrens nach diesem Dokument ist es nicht, nachzuweisen, ob eine Gleichmäßigkeit zwischen den zu Beginn und den gegen Ende einer Tankfüllung oder Batterieladung durchgeführten Zügen vorliegt. Letzteres ist das Ziel eines anderen Verfahrens, das mit EN 17746, Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der gleichmäßigen Abgabe von Nikotin über definierte Zugsequenzen innerhalb einer einzelnen E-Zigarette[1], entwickelt wird. Zwei unterschiedliche Verfahren wurden entwickelt, um die gleichmäßigen Abgabe von Nikotin zu bestimmen, bis Rechtsklarheit über die Festlegung der Richtlinie über Tabakerzeugnisse besteht, dass "Nikotindosen auf einem gleichmäßigen Niveau abgegeben werden"[2].

Cigarettes électroniques et e-liquides - Détermination de la constance de délivrance de la nicotine lors de séquences de bouffées définies avec une seule e-cigarette

Le présent document spécifie la méthode de détermination de la constance de délivrance de la nicotine par une cigarette électronique pendant la durée d’utilisation du e liquide dans le réservoir ou pendant une charge de batterie.
Le présent document :
—   définit l’équipement à utiliser ;
—   spécifie la préparation des échantillons de e cigarettes pour les essais ;
—   spécifie le processus de génération de l’aérosol ;
—   spécifie la méthode d’analyse ;
—   spécifie la détermination du résultat d’essai.
Ce document ne cherche pas à démontrer s’il y a une constance de délivrance de la nicotine entre les e cigarettes. Cette dernière fait l’objet d’une méthode séparée en cours d’élaboration, l’EN 17634 Cigarettes électroniques et e liquides — Détermination de la constance de délivrance de la nicotine lors de séquences de bouffées définies avec plusieurs e cigarettes identiques [1]. Deux méthodes séparées ont été mises au point pour déterminer la constance de délivrance de la nicotine, en attendant la clarification réglementaire de l’exigence de la Directive sur les produits du tabac stipulant de « libérer les doses de nicotine de manière constante » [2].

Elektronske cigarete in e-tekočine - Ugotavljanje konsistentnosti porazdelitve nikotina v določenem zaporedju vdihavanja pri eni e-cigareti

Ta dokument določa metodo za določanje konsistentnosti porazdelitve nikotina ene
elektronske cigarete [1].
Ta dokument:
opredeljuje opremo, ki jo je treba uporabljati;
določa pripravo vzorcev e-cigaret za preskušanje;
določa postopek zbiranja aerosolov;
določa analitično metodo;
opredeljuje določanje rezultata preskusa.

General Information

• Status: Published
• Publication Date: 16-May-2023
• ICS: 65.160 - Tobacco, tobacco products and related equipment
• Technical Committee: CEN/TC 437 - Electronic cigarettes and e-liquids
• Drafting Committee: CEN/TC 437/WG 4 - Requirements and test methods for emissions
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-May-2023
• Due Date: 14-Jul-2022
• Completion Date: 17-May-2023
• Ref Project: SIST EN 17746:2023 - Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences within a single e-cigarette

Overview

EN 17746:2023 (CEN) specifies a standardized laboratory method to determine nicotine delivery consistency over defined puff sequences within a single electronic cigarette. The method assesses how consistently one device delivers nicotine as its e-liquid reservoir is consumed or its battery discharges. It defines equipment, sample preparation, aerosol generation, analytical measurement and calculation of test results - but does not compare consistency between multiple devices of the same model (that is addressed in EN 17634).

Key topics and technical requirements

• Scope: Measure nicotine delivery consistency for a single e‑cigarette across its period of use (e‑liquid or battery life).
• Apparatus & analytical method: Use apparatus and nicotine analysis in accordance with EN ISO 24199 (GC method) and vaping conditions per ISO 20768.
• Sample preparation:
  • Minimum test sample: at least 5 e‑cigarettes (2 to determine puffs/sequence, 3 to assess consistency), with recommended spare units.
  • Follow device-specific instructions: unopened disposables, fully charged rechargeable batteries, specified e‑liquids or EN 17375 reference liquids for open systems.
• Preliminary checks: leakage, battery function, priming (first 5 puffs to waste if no instructions), and pre‑vaping weighing to 1 mg.
• Aerosol collection & sequencing:
  • Create sequences of puffs and collect aerosol collected mass (ACM) on traps; determine nicotine per sequence.
  • Recommended puffs/sequence based on per‑puff ACM:
    • ≤ 15 mg/puff → 20 puffs/sequence

    • 15–30 mg/puff → 10 puffs/sequence

    • 30 mg/puff → 5 puffs/sequence

  • Repeat sequences until refill or exhaustion criteria (or 75% of added e‑liquid consumed by mass loss); discard the last sequence and any sequences affected by battery depletion.
• Result calculation: Determine nicotine (mg) per sequence and apply statistical procedures to quantify delivery consistency.

Practical applications and users

EN 17746:2023 is targeted to:

• Test laboratories performing routine analytical vaping and nicotine quantification.
• Manufacturers and product development teams for quality control, design validation and product consistency checks.
• Regulatory bodies and notified bodies assessing claims about nicotine delivery stability.
• Researchers studying device performance and user exposure.

Typical uses include product specification verification, batch release testing, comparative R&D studies, and preparing evidence for regulatory compliance or due diligence.

Related standards

• EN ISO 24199 - nicotine determination (GC method)
• ISO 20768 - routine analytical vaping machine conditions
• EN 17375 - reference e‑liquids
• EN 17634 - consistency testing across multiple e‑cigarettes

Keywords: EN 17746:2023, electronic cigarettes, e‑liquids, nicotine delivery consistency, aerosol collected mass, vaping machine, ISO 20768, EN ISO 24199.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2023
Elektronske cigarete in e-tekočine - Ugotavljanje konsistentnosti porazdelitve
nikotina v določenem zaporedju vdihavanja pri eni e-cigareti
Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over
defined puff sequences within a single e-cigarette
Elektronische Zigaretten und Liquids für elektronische Zigaretten - Bestimmung der
Konsistenz der Nikotinabgabe über definierte Zugsequenzen innerhalb einer einzelnen
E-Zigarette
Cigarettes électroniques et e-liquides - Détermination de la constance de délivrance de
la nicotine lors de séquences de bouffées définies avec une seule e-cigarette
Ta slovenski standard je istoveten z: EN 17746:2023
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 17746
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2023
EUROPÄISCHE NORM
ICS 65.160
English Version
Electronic cigarettes and e-liquids - Determination of
nicotine delivery consistency over defined puff sequences
within a single e-cigarette
Cigarettes électroniques et e-liquides - Détermination Elektronische Zigaretten und E-Liquids - Bestimmung
de la constance de délivrance de la nicotine lors de der gleichmäßigen Abgabe von Nikotin über definierte
séquences de bouffées définies avec une seule e- Zugsequenzen einer Anzahl von E-Zigaretten
cigarette identischen Typs
This European Standard was approved by CEN on 10 March 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17746:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Principle . 6
5 Apparatus . 6
6 Sampling . 6
7 Generation of aerosol collected mass for determination of consistency of nicotine
delivery . 6
7.1 Sample preparation for analytical vaping . 6
7.1.1 General . 6
7.1.2 Disposable e-cigarettes . 6
7.1.3 Rechargeable E-cigarettes . 6
7.1.4 Refillable E-cigarettes. 6
7.2 Preliminary tests before vaping . 7
7.3 Vaping and collection of aerosol collected mass . 7
7.3.1 Vaping plan . 7
7.3.2 Collection of the aerosol . 7
7.3.3 Setting up the vaping machine . 7
7.3.4 Procedure for vaping run . 7
7.4 Determination of nicotine . 8
7.5 Determination of nicotine delivery consistency . 9
8 Test report . 9
Bibliography . 11
European foreword
This document (EN 17746:2023) has been prepared by Technical Committee CEN/TC 437 “Electronic
cigarettes and e-liquids”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2023, and conflicting national standards shall
be withdrawn at the latest by November 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United
Kingdom.
1 Scope
This document specifies the method for the determination of nicotine delivery consistency of an
electronic cigarette over the duration of use of e-liquid in the reservoir or a battery charge.
This document:
— defines the equipment to be used;
— specifies the preparation of the e-cigarette samples for testing;
— specifies the aerosol generation process;
— specifies the analytical method;
— specifies the determination of the test result.
This document does not seek to demonstrate whether there is consistency of nicotine delivery between
e-cigarettes. The latter is the aim of a separate method under development, EN 17634 Electronic
cigarettes and e-liquids — Determination of nicotine delivery consistency over defined puff sequences of a
number of e-cigarettes of identical type [1]. Two separate methods have been developed to determine
consistency of nicotine delivery, pending regulatory clarity on the Tobacco Products Directive's
requirement to "deliver nicotine doses at consistent levels" [2].
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 17375, Electronic cigarettes and e-liquids — Reference e-liquids
EN ISO 24199, Vapour products — Determination of nicotine in vapour product emissions — Gas
chromatographic method (ISO 24199)
ISO 20768, Vapour products — Routine analytical vaping machine — Definitions and standard conditions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/ui
— IEC Electropedia: available at https://www.electropedia.org/
3.1
electronic cigarette
e-cigarette
product, that vaporises e-liquid to generate an inhalable aerosol carried by air drawn through the device
by the user
Note 1 to entry: Electronic cigarette is also referred to as e-cig, vapour product, personal vapouriser or
ENDS/ENNDS.
Note 2 to entry: Electronic cigarette differs from tobacco products in that they do not contain tobacco.
3.2
e-liquid
base liquid, which may or may not contain nicotine and/or additives, intended for transformation into an
aerosol by an electronic cigarette
3.3
vaped until exhaustion
aerosol generation via vaping machine until a pre-determined endpoint
3.4
open system
electronic cigarette where the user fills a reservoir with e-liquid
3.5
aerosol collected mass
ACM
mass of aerosol collected on an aerosol trapping system from the operation of a vapour product by a
routine analytical vaping machine after a defined number of puffs
Note 1 to entry: Routine analytical vaping machine is described in ISO 20768.
3.6
vaping
action of generating an aerosol with an airflow from an electronic cigarette
3.7
aerosol
system of colloidal particles suspended in gas by the use of an e-cigarette
Note 1 to entry: Vapour is a generally accepted, but scientifically incorrect, term for aerosol.
3.8
nicotine
(S)-3-(1-methyl-2-pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature
under No CAS: 54-11-5
3.9
clearomizer
e-liquid reservoir with in-built atomizer
3.10
e-liquid cartridge
e-liquid container that can be loaded directly into an e-cigarette, which can be disposable
3.11
coil
resistive component of the atomiser
Note 1 to entry: Coils are made of metal, ceramic, or other resistive materials.
3.12
sequence
defined number of puffs for aerosol generation
4 Principle
The test specimens are vaped until exhaustion (of battery or e-liquid) on a routine analytical vaping
machine
...