SIST EN 17633:2022

General principles and requirements for testing of quality and nicotine levels of electronic cigarette 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 concernant les essais relatifs à la qualité et aux teneurs en nicotine des liquides pour cigarettes électroniques

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 vsebnosti nikotina v tekočinah za elektronske cigarete

Ta dokument določa preskušanje kakovosti e-tekočin za uparjalnike v njihovi polno proizvedeni obliki (»končna e-tekočina«) z nikotinom ali brez njega. Uporablja se tudi za preskušanje e-tekočin, pridobljenih iz predhodno polnjenih kartuš, in podobnih e-tekočin, ki so na voljo potrošnikom.
Ta dokument je treba brati skupaj z dokumentoma CEN WI 00437001, Splošna načela za proizvodnjo, polnjenje in shranjevanje e-tekočin za predhodno polnjene vsebnike ali proizvode ter WI 00437023, Sestavine e-tekočin.
OPOMBA:   Preskušanje neželenih sestavin ne spada na področje uporabe tega dokumenta, ker je njihova prisotnost v končni e-tekočini omejena z nadzorom na ravni sestavin. Največja raven neželenih sestavin je določena v specifikaciji za sestavine in se preskuša s pogostostjo, za katero proizvajalec meni, da je ustrezna.

General Information

• Status: Published
• Public Enquiry End Date: 07-Apr-2021
• Publication Date: 05-Oct-2022
• ICS: 65.160 - Tobacco, tobacco products and related equipment
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 22-Sep-2022
• Due Date: 27-Nov-2022
• Completion Date: 06-Oct-2022
• Ref Project: CEN/TS 17633:2022 - General principles and requirements for testing of quality and nicotine levels of electronic cigarette liquids

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 17633:2022
01-november-2022
Splošna načela in zahteve za preskušanje kakovosti in vsebnosti nikotina v
tekočinah za elektronske cigarete

General principles and requirements for testing of quality and nicotine levels of electronic

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

Principes généraux et exigences concernant les essais relatifs à la qualité et aux teneurs

en nicotine des liquides pour cigarettes électroniques
Ta slovenski standard je istoveten z: CEN/TS 17633:2022
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
SIST EN 17633:2022 en,fr,de

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

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SIST EN 17633:2022
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SIST EN 17633:2022
CEN/TS 17633
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
September 2022
TECHNISCHE SPEZIFIKATION
ICS 65.160
English Version
General principles and requirements for testing of quality
and nicotine levels of electronic cigarette liquids

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

relatifs à la qualité et aux teneurs en nicotine des Prüfung der Qualität und des Nikotingehalts von E-

liquides pour cigarettes électroniques Liquids

This Technical Specification (CEN/TS) was approved by CEN on 1 August 2022 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to

submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS

available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in

parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17633:2022 E

worldwide for CEN national Members.
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SIST EN 17633:2022
CEN/TS 17633:2022 (E)
Contents Page

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

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

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

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

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

4 General requirements ......................................................................................................................... 6

5 Ingredients .............................................................................................................................................. 7

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

7 Technical records ................................................................................................................................. 9

Bibliography ....................................................................................................................................................... 10

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SIST EN 17633:2022
CEN/TS 17633:2022 (E)
European foreword

This document (CEN/TS 17633:2022) 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.

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 announce this Technical Specification: 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.
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SIST EN 17633:2022
CEN/TS 17633:2022 (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 can or cannot

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.

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 can be used to identify recommendations for specific

products within the product sector.

The content is applicable to manufacturers and distributors in Europe and forms a guide for regulators,

enforcement authorities and commercial operators in the area. It is also applicable to consultancies,

laboratories and testing houses engaged in or advising on, the manufacturing of e-liquids and e-liquid

components.

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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SIST EN 17633:2022
CEN/TS 17633:2022 (E)
1 Scope

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

produced form, i.e. “finished e-liquid”, at the point of manufacture, whether containing nicotine or not.

This document is intended to be read in conjunction with EN 17647 and EN 17648.

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 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 17647, General principles for manufacturing, filling and holding e-liquids for prefilled containers or

products

ISO 20714, 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 https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
e-liquid

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

into an aerosol by a vaping product
3.2
finished e-liquid

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

into an aerosol by a vaping product

Note 1 to entry: Finished e-liquid can refer to bulk e-liquid stored in large volume vessels prior to final filling into

individual refill containers or e-liquid that has been filled into refill containers or cartridges.

3.3
vaping product

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

by the user

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

vaporizer or ENDS/ENNDS.

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

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SIST EN 17633:2022
CEN/TS 17633:2022 (E)
3.4
nicotine

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

under CAS RN® 54-11-5
3.5
e-liquid cartridge

e-liquid container that can be loaded directly into a vaping product, which can be disposable

3.6
compound
individual chemical substance that usually has a unique CAS RN®
3.7
constituent
individual chemical substance within an ingredient
3.8
ingredient
any compound or mixture of compounds intentionally included in an e-liquid
EXAMPLES Vegetable glycerol, propylene glycol, nicotine, flavourings.
3.9
flavouring
ingredient that imparts smell and/or taste
3.10
manufacturer

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

that product under their name or trademark
4 General requirements
4.1 E-liquids testing
E-liquids testing (analysis)
...

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.

---------------------- Page: 1 ----------------------
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.
---------------------- Page: 3 ----------------------
oSIST prEN 17633:2021
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

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
oSIST prEN 17633:2021
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.
---------------------- Page: 6 ----------------------
oSIST prEN 17633:2021
prEN 17633:2021 (E)
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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oSIST prEN 17633:2021
prEN 17633:2021 (E)
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
...