EN 17648:2022

SLOVENSKI STANDARD
01-september-2022
Sestavine e-tekočin
E-liquid ingredients
Inhaltsstoffe von E-Liquids
Ingrédients des e-liquides
Ta slovenski standard je istoveten z: EN 17648:2022
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 17648
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 65.160
English Version
E-liquid ingredients
Ingrédients des e-liquides Inhaltsstoffe von E-Liquids
This European Standard was approved by CEN on 27 June 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17648:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 6
3.1 Terms and definitions . 6
3.2 Abbreviations . 7
4 Ingredient suppliers’ selection . 8
4.1 Disclosure of e-liquid / flavouring formulation . 8
4.2 Supply chain requirements . 8
4.3 Change notifications . 8
5 Ingredient requirements . 9
5.1 Ingredient functions . 9
5.2 Ingredient quality . 9
5.3 Ingredient exclusion criteria . 10
5.4 Toxicological risk assessment . 12
6 Finished e-liquid requirements . 13
6.1 E-liquid integrity . 13
6.2 E-liquid related emission requirements . 14
6.3 E-liquid related product information requirements . 14
Annex A (informative) Compounds that should not be used as ingredients in e-liquids . 17
Annex B (informative) Undesirable constituents . 18
Bibliography . 20

European foreword
This document (EN 17648:2022) 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 February 2023, and conflicting national standards shall
be withdrawn at the latest by February 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, Turkey and the United
Kingdom.
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 or nicotine salts. 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 related to ingredients used in e-
liquids and e-liquid components to ensure an appropriate level of consumer safety.
The content is applicable to producers 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 planning to be engaged in, the safety evaluation of e-liquids
and e-liquid components.
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 on ensuring the consumer safety of e-liquid
ingredients. Note that as a matter of course, in cases where national regulations currently exist, said
regulations take precedence over this document.
1 Scope
This document describes requirements related to ingredients used in e-liquids and e-liquid components.
This document:
— specifies ingredient purity and related supply chain requirements;
— specifies ingredient exclusion criteria based on function and toxicological properties;
— specifies the need for a toxicological risk assessment and provides guidance on the content of this as
well as specifying competency requirements for those responsible for it;
— specifies nicotine content versus label claim over shelf life and performance characteristics of the
analytical method used to measure the nicotine;
— specifies pH limits for the e-liquid;
— provides guidance on the measuring of emissions;
— specifies certain ingredient-related product labelling;
— provides guidance on ingredients that should not be used in e-liquids;
— provides guidance on maximum levels in finished e-liquid for certain undesirable constituents that
may occur in natural extracts used as flavourings.
This document does not apply to packaging, vaping devices or refill container materials/ingredients.
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.
CEN/TR 17236, Electronic cigarettes and e-liquids - Constituents to be measured in the aerosol of vaping
products
CEN/TS 17633 , General principles and requirements for testing for quality and nicotine levels of electronic
cigarette liquids
EN 17647, General principles for manufacturing, filling and holding e-liquids for prefilled containers or
products
EN ISO 20714, E-liquid - Determination of nicotine, propylene glycol and glycerol in liquids used in
electronic nicotine delivery devices - Gas chromatographic method (ISO 20714)

Under preparation. Stage at the time of publication: FprCEN/TS 17633:2022.
3 Terms, definitions and abbreviations
3.1 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
3.1.1
base e-liquid
diluents, that form the bulk or entirety of an e-liquid
3.1.2
compound
individual chemical substance, that usually has a unique CAS RN number
3.1.3
constituent
individual chemical substance within an ingredient
3.1.4
diluent
liquid used in the e-liquid to dilute nicotine and/or flavourings and/or to form the aerosol
3.1.5
e-liquid
base liquid, which may or may not contain nicotine and/or nicotine salts and/or other ingredients,
intended for transformation into an aerosol by a vaping device
3.1.6
e-liquid component
mixture or ingredient placed on the market, intended for use in e-liquids
3.1.7
flavouring
ingredient that imparts smell and/or taste
Note 1 to entry: A flavouring can be a substance, e.g. vanillin or a mixture of several substances, e.g. lime oil.
3.1.8
ingredient
compound or mixture of compounds intentionally included in an e-liquid
EXAMPLES glycerol, propylene glycol, nicotine, flavourings.
3.1.9
producer
manufacturer of any e-liquid-containing product, e-liquid component, e-liquid ingredient or related
packaging or accompanying documents (e.g. leaflet), supplied to a consumer, whereby the manufacturer,
by importing and/or putting his name, trademark or other distinguishing feature on the product presents
himself as the entity legally responsible for the item within the relevant jurisdiction
3.1.10
refill container
refill bottle
receptacle containing an e-liquid, which can be used to refill a vaping device
3.1.11
solvent
substance, ordinarily a liquid, in which other materials dissolve to form a solution
3.2 Abbreviations
For the purposes of this document, the following abbreviations apply.
Carc Carcinogenic
CAS RN CAS Registry Number
CoE number Number of a material listed in the Council of Europe's reports on chemically defined
flavouring substances and natural sources of flavourings
CLP Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on
classification, labelling and packaging of substances and mixtures
CMR Carcinogenic, mutagenic and/or reprotoxic
ECHA European Chemicals Agency
E-number A code number preceded by the letter E (for Europe), denoting food additives
numbered in accordance with EU directives
EP European Pharmacopoeia
FEMA Flavor and Extract Manufacturers Association of the United States
FLAVIS European Union flavouring information system
FL-number FLAVIS number
GRAS Generally recognized as safe
IARC International Agency for Research on Cancer
IOFI International Organization of the Flavor Industry
JECFA Joint FAO/WHO Expert Committee on Food Additives
Lact. Lactation
Muta. Mutagenic
NTP National Toxicology Program
Repr. Reprotoxic
Resp. sens Respiratory sensitizer
TPD Tobacco Products Directive
USP United States Pharmacopeia
4 Ingredient suppliers’ selection
4.1 Disclosure of e-liquid / flavouring formulation
The e-liquid producer shall ensure they receive full disclosure of all ingredients used in the finished e-
liquid or e-liquid component, including of any flavouring pre-mixes that may be used in the production
of an e-liquid. Disclosure information is pivotal for proper risk assessment (see 5.4) and control over
potential constituents of concern (see 5.3 and Annex B).
The e-liquid disclosure shall consist of the list of individual ingredients, including their use level or
appropriate concentration ranges tha
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