prCEN/TS 17633

General principles and requirements for testing for quality and nicotine levels of e-liquids

This document specifies the quality testing of e-liquids for vaping products in their fully produced form (“finished e-liquid”), whether containing nicotine or not. It is also applicable to testing of e-liquids when extracted from prefilled cartridges and similar e-liquid presentations to consumers.
This document is intended to be read in conjunction with CEN documents WI 00437001, General principles for manufacturing, filling and holding e-liquids for prefilled containers or products, and WI 00437023, E-liquid Ingredients.
NOTE   Testing for undesirable constituents is outside the scope of this document because their presence in final e-liquid is limited by controls at the ingredient level. The maximum level of undesirable constituents is set in the ingredient specification and monitored by testing at a frequency determined appropriate by the manufacturer.

Allgemeine Grundsätze und Anforderung für die Prüfung der Qualität und des Nikotingehalts von E-Liquids

Dieses Dokument legt die Qualitätsprüfung von E Liquids für Dampfprodukte in ihrer vollständig hergestellten Form ("fertiges E-Liquid") fest, unabhängig davon, ob diese Nikotin enthalten oder nicht. Es ist auch anwendbar auf die Prüfung von E-Liquids, wenn diese aus vorgefüllten Kartuschen extrahiert werden, und ähnliche Präsentationen von E-Liquids für Verbraucher.
Dieses Dokument ist dafür vorgesehen, in Verbindung mit den CEN Dokumenten WI 00437001, General principles for manufacturing, filling and holding e-liquids for prefilled containers or products sowie WI 00437023, E liquid Ingredients, gelesen zu werden.
ANMERKUNG   Die Prüfung auf unerwünschte Bestandteile fällt nicht in den Anwendungsbereich dieses Dokuments, da deren Anwesenheit im endgültigen E-Liquid durch Kontrollen des Gehalts von Inhaltsstoffen begrenzt ist. Der Höchstgehalt an unerwünschten Bestandteilen wird in der Spezifikation hinsichtlich der Inhaltsstoffe festgelegt und durch Prüfen bei einer vom Hersteller festgelegten Häufigkeit überwacht.

Principes généraux et exigences pour les essais de qualité et la détermination de la teneur en nicotine des e-liquides

Le présent document spécifie les essais de qualité auxquels sont soumis les e-liquides pour produits du vapotage à l’état fini (« e-liquide fini »), qu’ils contiennent ou non de la nicotine. Il est également applicable aux essais qui sont conduits sur les e-liquides extraits de cartouches préremplies ou disponibles sous d’autres présentations similaires pour les consommateurs.
Ce document est destiné à être lu conjointement avec les documents du CEN WI 00437001, Principes généraux pour la fabrication, le remplissage et la conservation des e-liquides pour produits ou conteneurs préremplis (General principles for manufacturing, filling and holding e-liquids for prefilled containers or products), et WI 00437023, Ingrédients des e-liquides (E-liquid Ingredients).
NOTE   Les essais de détection de composés indésirables ne relèvent pas du domaine d’application du présent document car leur présence dans le e-liquide final est limitée par les contrôles effectués sur les ingrédients. La teneur maximale en composés indésirables est fixée dans la spécification des ingrédients et surveillée lors d’essais réalisés à une fréquence déterminée par le fabricant.

Splošna načela in zahteve za preskušanje kakovosti in ravni nikotina v e-tekočinah

General Information

• Status: Not Published
• 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 3 - Requirements and test methods for e-liquids
• Current Stage: 3099 - Dispatch of ENQ draft to CMC - Consensus building
• Due Date: 11-Jan-2022
• Completion Date: 11-Jan-2022
• Ref Project: oSIST prEN 17633:2021 - General principles and requirements for testing for quality and nicotine levels of e-liquids

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN 17633:2021
01-april-2021

Splošna načela in zahteve za preskušanje kakovosti in ravni nikotina v e-tekočinah

General principles and requirements for testing for quality and nicotine levels of e-liquids

Allgemeine Grundsätze und Anforderung für die Prüfung der Qualität und des
Nikotingehalts von E-Liquids

Principes généraux et exigences pour les essais de qualité et la détermination de la

teneur en nicotine des e-liquides
Ta slovenski standard je istoveten z: prEN 17633
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
oSIST prEN 17633:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17633:2021
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oSIST prEN 17633:2021
DRAFT
EUROPEAN STANDARD
prEN 17633
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2021
ICS 65.160
English Version
General principles and requirements for testing for quality
and nicotine levels of e-liquids

Principes généraux et exigences pour les essais de Allgemeine Grundsätze und Anforderung für die

qualité et la détermination de la teneur en nicotine des Prüfung der Qualität und des Nikotingehalts von E-

e-liquides Liquids

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 437.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17633:2021 E

worldwide for CEN national Members.
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prEN 17633:2021 (E)
Contents Page

European foreword ............................................................................................................................................ 3

Introduction .......................................................................................................................................................... 4

1 Scope .......................................................................................................................................................... 5

2 Normative references .......................................................................................................................... 5

3 Terms and definitions ......................................................................................................................... 5

4 General requirements ......................................................................................................................... 7

5 Compounds of interest ........................................................................................................................ 7

6 E-liquids testing ..................................................................................................................................... 7

7 Technical records ............................................................................................................................... 10

Bibliography ....................................................................................................................................................... 11

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oSIST prEN 17633:2021
prEN 17633:2021 (E)
European foreword

This document (prEN 17633:2021) has been prepared by Technical Committee CEN/TC 437 “Electronic

cigarettes and e-liquids”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
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prEN 17633:2021 (E)
Introduction

E-liquid is a term describing liquid either prefilled in vaping products, or available in other forms so that

consumers can fill the reservoirs or soak the wicking material of vaping products. E-liquids may or may

not contain nicotine. In either case, they generally contain glycerol and/or propylene glycol together with

additional flavouring components. E-liquids are intended to be aerosolised for inhalation by the user.

This document establishes the general principles and requirements for the testing of quality and nicotine

levels in e-liquids for vaping products in their fully produced state.

The recommendations given in this document are relevant to the vast majority of product types currently

available, as well as to those that will be developed. Not all elements of these recommendations will apply

to every type of product, but the definitions may be used to identify recommendations for specific

products within the product sector.

This document can provide state of the art guidance for the testing of e-liquids for quality and nicotine

level; however, in cases where national regulations currently exist, said regulations take precedence over

this document.
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1 Scope

This document specifies the quality testing of e-liquids for vaping products in their fully produced form

(“finished e-liquid”), whether containing nicotine or not. It is also applicable to testing of e-liquids when

extracted from prefilled cartridges and similar e-liquid presentations to consumers.

This document is intended to be read in conjunction with CEN documents WI 00437001, General

principles for manufacturing, filling and holding e-liquids for prefilled containers or products, and

WI 00437023, E-liquid Ingredients.

NOTE Testing for undesirable constituents is outside the scope of this document because their presence in final

e-liquid is limited by controls at the ingredient level. The maximum level of undesirable constituents is set in the

ingredient specification and monitored by testing at a frequency determined appropriate by the manufacturer.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

WI 00437001, General principles for manufacturing, filling and holding e-liquids for prefilled containers

or products

ISO 20714:2019, E-liquid — Determination of nicotine, propylene glycol and glycerol in liquids used in

electronic nicotine delivery devices — Gas chromatographic method
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:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
e-liquid

base liquid, which may or may not contain nicotine and/or ingredients, intended for transformation into

an aerosol by an electronic cigarette
3.2
vaping product

product that vapourises e-liquid to generate an inhalable aerosol carried by air drawn through the device

by the user

Note 1 to entry: Vaping products also referred to as electronic cigarette, e-cig, vapour product, personal vapouriser

or ENDS/ENNDS.

Note 2 to entry: Vaping products differ from tobacco products in that they do not contain tobacco.

In preparation.
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3.3
nicotine

(S)-3-(1-methyl-2-pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature

under n° CAS: 54-11-5
3.4
e-liquid cartridge

e-liquid container that can be loaded directly into an e-cigarette, which can be disposable

3.5
compound
individual chemical substance that usually has a unique CAS#
3.6
constituent
individual chemical substance within an ingredient
3.7
ingredient
any compound or mixture of compounds intentionally included in an e-liquid
EXAMPLE Vegetable glycerol, propylene glycol, nicotine, flavourings
3.8
flavouring
ingredient that imparts smell and/or taste
3.9
manufacturer

any entity which manufactures a product or has a product designed or manufactured, and/or markets

that product under their name or trademark
3.10
product batch

products manufactured in a defined production schedule and specified volume from identified

components/base ingredients according to the batch specification
3.11
batch specification

document itemizing the inputs and processes for manufacturing a specific product batch that can be used

for batch traceability purposes
3.12
release specification
...