E-liquid ingredients

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.

Inhaltsstoffe von E-Liquids

Dieses Dokument beschreibt Anforderungen in Bezug auf Inhaltsstoffe, die in E Liquids und E Liquid Komponenten verwendet werden.
Dieses Dokument:
- gibt Anforderungen an die Reinheit von Inhaltsstoffen und die diesbezügliche Lieferkette an;
- gibt Ausschlusskriterien für Inhaltsstoffe auf der Grundlage der Funktion und der toxikologischen Eigenschaften an;
- gibt die Notwendigkeit einer toxikologischen Risikobewertung an, stellt eine Leitlinie für deren Inhalt bereit und beschreibt die Anforderungen an die Kompetenz derer, die für diese Risikobewertung verantwortlich sind;
- gibt den Nikotingehalt im Vergleich zur Angabe der Haltbarkeitsdauer auf dem Etikett an, sowie die Leistungsfähigkeit des Analyseverfahrens, das zur Messung des Nikotingehalts angewendet wird;
- gibt pH Wert Grenzen für das E Liquid an;
- stellt eine Anleitung zur Messung von Emissionen bereit;
- gibt bestimmte auf Inhaltsstoffe bezogene Produktkennzeichnungen an;
- stellt eine Leitlinie zu Inhaltsstoffen, die nicht in E Liquids verwendet werden sollten bereit;
- stellt eine Leitlinie zu Höchstgehalten bestimmter unerwünschter Bestandteile im fertigen E Liquid bereit, die sich durch die Verwendung von natürlichen Aroma-/Geschmacksstoffextrakten ergeben können.
Dieses Dokument ist nicht anzuwenden für Verpackungen, Verdampfungsgeräte oder Werkstoffe/Inhaltsstoffe von Nachfüllbehältern.

Ingrédients des e-liquides

Le présent document décrit les exigences relatives aux ingrédients utilisés dans les e-liquides et aux composants des e-liquides.
Ce document :
   spécifie les exigences relatives à la pureté des ingrédients ainsi qu’à leur chaîne d’approvisionnement ;
   spécifie les critères d’exclusion des ingrédients selon leur fonction ou leurs propriétés toxicologiques ;
   stipule la nécessité de procéder à une appréciation du risque toxicologique, fournit des recommandations concernant le contenu de cette évaluation et spécifie enfin des exigences relatives aux compétences des personnes responsables de cette évaluation ;
   spécifie la teneur en nicotine réelle par rapport à celle mentionnée sur l’étiquette, tout au long de la durée de conservation du e-liquide, et spécifie également les caractéristiques de performance de la méthode d’analyse utilisée pour mesurer la teneur en nicotine ;
   spécifie les limites du pH des e-liquides ;
   fournit des recommandations concernant le mesurage des émissions ;
   précise l’étiquetage à apposer sur le produit en fonction de certains ingrédients ;
   fournit des recommandations relatives aux ingrédients qu’il convient de ne pas utiliser dans les e liquides ;
   fournit des recommandations relatives aux concentrations maximales de certains composants indésirables présents dans les e-liquides prêts à l’emploi, qui peuvent être retrouvés dans les extraits naturels utilisés comme substances aromatisantes.
Le présent document ne s’applique pas aux emballages, aux dispositifs de vapotage ou aux matériaux/ingrédients constituant les récipients de recharge.

Sestavine e-tekočin

Dokument se uporablja za e-tekočine in koncentrate arom, neposredno dobavljene porabniku za uporabo v e-tekočinah, ki so namenjeni proizvodnji aerosola za vdihavanje v elektronskih cigaretah in podobnih pripomočkih, ki proizvajajo paro. Uporablja se za e-tekočine in koncentrate, namenjene porabniku, z nikotinom ali brez.  
Standard določa minimalne varnostne in tehnične zahteve za izbiro oziroma upravljanje sestavin za e-tekočine in koncentrate arom ter nekatere zahteve za ocenjevanje tveganja v zvezi s sestavinami in podatke o proizvodu za pripravljene e-tekočine/koncentrate arom, kadar so ti izdelki namenjeni uporabi v elektronskih cigaretah, ki se uporabljajo in vzdržujejo na način, ki ga predpiše proizvajalec.
Ta dokument se ne uporablja za materiale embalaže, naprav ali polnilnih posod.

General Information

Status
Published
Publication Date
02-Aug-2022
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
03-Aug-2022
Due Date
17-Oct-2022
Completion Date
03-Aug-2022
Ref Project
SIST EN 17648:2022 - E-liquid ingredients

Overview

EN 17648:2022 - published by CEN - establishes European best-practice requirements for e-liquid ingredients and e-liquid components. The standard sets out ingredient purity, supply‑chain and traceability rules, ingredient exclusion criteria, and toxicological risk assessment requirements to help ensure consumer safety for liquids intended to be aerosolised in vaping products. EN 17648:2022 does not apply to packaging, vaping devices or refill container materials.

Key topics and technical requirements

  • Ingredient disclosure and supplier selection
    • Full ingredient disclosure (including flavouring pre‑mixes), identification (CAS RN, FL‑number where available) and concentration ranges to support risk assessment.
    • Traceability: unique batch coding for ingredients and finished e‑liquid; supplier change notifications.
  • Ingredient purity and quality
    • Diluents (glycerol, propylene glycol) and nicotine must meet recognised pharmaceutical standards; supporting certificates of analysis/conformity are required.
  • Ingredient functions and exclusion
    • E‑liquids are expected to contain diluents, flavourings and optionally nicotine/nicotine salts. Ingredients added solely as preservatives or colorants are not permitted; inclusion of other functional additives (e.g., antioxidants) must be justified toxicologically.
  • Toxicological risk assessment
    • A toxicological risk assessment is required for ingredients and finished e‑liquids, with guidance on content and competency requirements for those performing assessments.
  • Analytical and performance requirements
    • Requirements for measuring nicotine content vs label claim over shelf life, and performance characteristics of analytical methods used.
    • pH limits for e‑liquids and guidance on measuring aerosols/emissions from vaping products.
  • Labelling and undesirable constituents
    • Ingredient‑related product labelling requirements and guidance on ingredients that should not be used (Annex A).
    • Guidance on maximum levels for undesirable constituents from natural extracts (Annex B).

Applications and who uses it

  • E‑liquid manufacturers and ingredient suppliers - to design compliant formulations, maintain supplier controls and demonstrate traceability and quality.
  • Distributors and importers - to verify supplier documentation and support market surveillance.
  • Regulators and enforcement authorities - as a harmonised reference for ingredient safety expectations.
  • Testing laboratories, consultancies and toxicologists - for guidance on required analyses, toxicological assessments and method performance.
  • Quality and compliance teams - for building product labelling, change control and supply‑chain procedures.

Related standards

  • EN 17647 - manufacturing, filling and holding e‑liquids
  • EN ISO 20714 - GC method for nicotine, PG and glycerol
  • CEN/TS 17633 (general testing principles) and CEN/TR 17236 (aerosol constituents) - referenced for testing and emissions guidance

Keywords: EN 17648:2022, e-liquid ingredients, CEN standard, toxicological risk assessment, ingredient purity, nicotine testing, pH limits, e-liquid labelling, supply chain traceability.

Frequently Asked Questions

EN 17648:2022 is a standard published by the European Committee for Standardization (CEN). Its full title is "E-liquid ingredients". This standard covers: 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.

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.

EN 17648:2022 is classified under the following ICS (International Classification for Standards) categories: 65.160 - Tobacco, tobacco products and related equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

You can purchase EN 17648:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.

Standards Content (Sample)


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 that are sufficient to inform the risk assessment.
Where the ingredients are individual compounds, there shall be sufficient information to unambiguously
identify the specific chemical entity, including stereochemistry information where applicable (typically
ensured through identification of appropriate CAS RN and/or FL-number).
Where ingredients consist of extracts of natural raw materials, the producer shall obtain information on
the presence and maximum levels of any toxicologically undesirable constituents as identified in Annex B,
if the presence of constituents listed in Annex B is suspected based on scientific literature. Sufficient
information to perform the toxicological assessment (see 5.3) typically includes identification numbers
such as CAS RN, FEMA, JECFA CoE, E-numbers and/or FL-numbers. These numbers generally provide
some information on the plant botanical name, the plant part used, and/or the extraction process used
which allows the main constituents in the composition of the mixture to be characterized through
available literature, where required in the toxicological risk assessment.
If insufficient compositional information is available from the identification information provided by the
supplier, for the toxicological risk assessment to support the proposed level of use of the ingredient in
the e-liquid, chemical analysis may be used to help identify and/or quantify compounds within the
ingredient to further inform the risk assessment.
4.2 Supply chain requirements
All e-liquid ingredients shall be supplied with a unique batch code. The producer’s own unique batch code
for the finished e-liquid shall ensure traceability back to these individual ingredient batch codes.
For all e-liquid ingredients relevant certificates of analysis and/or certificate of conformity
demonstrating compliance with the purity requirement specified in 5.2 shall be made available to the
producer.
To ensure sufficient quality in the supply chain, ingredient suppliers accredited for food flavouring or
pharmaceutical ingredient production should be used.
4.3 Change notifications
Producers shall ensure their ingredient supply chain informs them of any changes to the supplied
ingredients that can affect the composition and/or quality of the ingredients. This can include, but is not
restricted to, changes to manufacturing processes, changes to geographical origin(s) of the raw materials
used to produce natural extracts, changes to recommended storage conditions and shelf life. The
producer shall ensure they have appropriate documentation to demonstrate the modified ingredients
still meet the purity requirements as specified in 5.2. Any such changes shall result in a new unique batch
number, both for the modified ingredient and the finished e-liquid.
5 Ingredient requirements
5.1 Ingredient functions
E-liquids are expected to consist of only diluent(s) and optionally flavouring(s), nicotine and/or nicotine
salts. Substances whose only function is as a preservative or to impart colour to an e-liquid or subsequent
aerosol intentionally, shall not be added to e-liquids.
NOTE E-liquids can end up having a colour due to ingredients that have other functions and can change colour
over time.
Preservatives may be present as constituents from ingredients, but then their level in the finished e-liquid
needs to be taken into account in the toxicological risk assessment. If there are exceptional reasons why
other ingredients might be required, such as antioxidants or others, their inclusion shall be justified,
taking into account their toxicological profile and all risk-benefit considerations.
5.2 Ingredient quality
All diluents forming the base e-liquid, as well as the nicotine used in e-liquids shall meet appropriate
pharmaceutical standards.
Only nicotine meeting recognized pharmaceutical specifications shall be used. Supporting
documentation shall include certificate(s) of analysis and/or certificate(s) of conformity. If nicotine salts
are used as either an ingoing ingredient, or formed in situ, the nicotine used to form the nicotine salts
shall be of the before mentioned recognized pharmaceutical grade quality and the acid added shall be
equivalent to, or of better quality than European or US food grade quality, with supporting documentation
including certificate(s) of analysis and/or certificate(s) of conformity.
Only propylene glycol (CAS RN 57-55-6) meeting recognized pharmaceutical specifications shall be used
as a diluent . Supporting documentation shall include certificate(s) of analysis and/or certificate(s) of
conformity. Where EP propylene glycol is used, an additional requirement is that the level of di-ethylene
glycol contamination shall be controlled to ensure it does not exceed a mass fraction of 0,1 %.
Only glycerol (CAS RN 56-81-5) meeting recognized pharmaceutical specifications shall be used as a
diluent . Supporting documentation shall include certificate(s) of analysis and/or certificate(s) of
conformity.
Where water is used as diluent, its specifications shall be equivalent to, or better than, European or US
pharmaceutical specifications for purified water or water for injection . Supporting documentation shall
include certificate(s) of analysis and/or certificate(s) of conformity.
Only ethanol meeting recognized pharmaceutical specifications shall be used as a diluent . Supporting
documentation shall include certificate(s) of analysis and/or certificate(s) of conformity.
Flavourings are usually supplied in a solvent. The specifications for such flavouring solvents shall be
equivalent to, or better than European or US food grade specifications, with supporting documentation
including certificate(s) of analysis and/or certificate(s) of conformity. For clarities' sake, if the flavouring
solvent is the same compound that is also used as a diluent in the same e-liquid, the proportion added as

For example: nicotine meeting the requirements specified in the European Pharmacopoeia (EP), Nicotine
Monograph, or those specified in the United States Pharmacopeia (USP), Nicotine Monograph.
For example: propylene glycol meeting the requirements specified in the EP Propylene glycol Monograph, or those
specified in the USP, Propylene Glycol Monograph.
For example: glycerol meeting either the EP Glycerol Monograph or the USP, Glycerin Monograph.
For example: meeting the requirements of either the Purified Water for Injection Monograph or the Purified Water
Monograph from either the EP or the USP.
For example: meeting the requirements of the EP Ethanol (96 percent) or Anhydrous Ethanol Monographs, or the
USP Ethanol absolute Monograph.
a diluent shall meet recognized pharmaceutical specifications as described above, whereas the flavouring
solvent proportion can meet food grade specifications.
Except for tobacco extracts, only flavourings, whether natural or artificial, that are also authorized for use
in food shall be used.
Examples of these are the flavouring agents listed on the following lists:
— Annex 1 of European Food Regulation EU 1334/2008;
— Substances Added to Food Inventory of the United States;
— FEMA GRAS listings;
— IOFI Global Reference List of Natural Complex Substances / Natural Flavouring Complexes.
NOTE The European Union list of flavouring substances can also be consulted in the form of the Food
Flavourings Database - FLAVIS.
All flavourings, except for tobacco extract, shall be of equivalent quality, or better than, European or US
food grade quality.
For tobacco extracts, the following families of compounds that can be concentrated in the extraction
processes, shall be considered in the toxicological risk assessment (5.4) that is required to support the
use of the extract as an ingredient in the finished e-liquid:
— Tobacco specific nitrosamines (TSNA’s), specifically N-nitrosonornicotine (NNN), nicotine-derived
nitrosamine ketone (NNK), N-nitrosoanatabine (NAT) and N-nitrosoanabasine (NAB);
— Cyclic aromatic hydrocarbons, such as phenol and methylphenols (o-, m- and p-cresol) and polycyclic
aromatic hydrocarbons, such as benzo[a]pyrene;
— Metals (Nickel, Lead, Cadmium, Chromium, Arsenic, Mercury);
— Pesticides;
— Nicotine-relevant alkaloids.
Any other potential ingredients in the finished e-liquid shall be at least of European food grade purity or
equivalent or higher.
5.3 Ingredient exclusion criteria
Ingredients with the hazard classification listed in Table 1 shall not be used in e-liquids.
Table 1 — European Union CMR and respiratory sensitization classifications
Classification
Hazard Hazard
class and
Code Warning of danger text
category
Class Category code
Category 1A Muta. 1A
May Cause genetic defects < exposure
H340
route >
Germ cell Category 1B Muta. 1B
mutagenicity
Suspected of causing genetic
Category 2
Muta. 2 H341 defects < exposure route >
Category 1A Carc. 1A
H350 May cause cancer < exposure route >
Category 1B Carc. 1B
Carcinogenicity
Suspected of causing cancer < exposure
Category 2
Carc. 2 H351 route >
May damage fertility or the unborn
Category 1A H360
Repr. 1A child < exposure route >
H360F May damage fertility < exposure route >
May damage the unborn child < exposure
H360D
route >
May damage fertility. May damage the
H360FD
unborn child < exposure route >
Category 1B Repr. 1B
Reproductive
May damage fertility. Suspected of
Toxicity
H360Fd damaging the unborn child < exposure

route >
May damage the unborn child. Suspected
H360Df
of damaging fertility <
...

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The EN 17648:2022 standard presents a comprehensive framework for evaluating and regulating the ingredients used in e-liquids, ensuring a higher level of consumer safety. Its scope clearly defines the quality and safety specifications surrounding ingredient purity, which is critical in maintaining the integrity of e-liquid products. By establishing stringent supply chain requirements, this standard effectively enhances transparency and accountability among manufacturers. One of the key strengths of EN 17648:2022 is its focus on ingredient exclusion criteria based on function and toxicological properties. This ensures that e-liquids are crafted without harmful components, prioritizing public health. Moreover, the requirement for a thorough toxicological risk assessment underscores the standard's commitment to consumer safety and positions it as a vital regulatory measure within the vaping industry. The standard also addresses nicotine content comprehensively, specifying the correlation between nicotine levels and label claims over the product’s shelf life. This aspect is essential for promoting accurate consumer information and reinforcing trust in e-liquid products. Additionally, the defined pH limits for e-liquids contribute to ensuring optimal product quality, which is a significant factor for user experience and safety. Another notable feature is the guidance on measuring emissions, which is critical for assessing the safety and efficacy of e-liquids during use. The standard's emphasis on ingredient-related product labeling aligns with the increasing consumer demand for transparency in product composition. By outlining specific guidance on ingredients that should not be included in e-liquids, the EN 17648:2022 enhances product safety and quality assurance. Finally, the designation of maximum levels for undesirable constituents in natural extracts used as flavorings reflects a nuanced understanding of balancing flavor appeal while maintaining safety standards. Overall, EN 17648:2022 serves as a pivotal document that reinforces best practices in the e-liquid industry, fostering a safe environment for both manufacturers and consumers alike, while directly addressing urgent consumer safety considerations.

Die Norm EN 17648:2022 stellt einen wichtigen Rahmen für die Anforderungen an die Inhaltsstoffe von E-Liquids und Komponenten von E-Liquids bereit. Diese Norm umfasst wesentliche Aspekte der Inhaltsstoffqualität und -sicherheit, die für die Herstellung von E-Liquids entscheidend sind. Ein zentrales Merkmal dieser Norm ist die Festlegung von Reinheitsanforderungen und den damit verbundenen Anforderungen an die Lieferkette, was sicherstellt, dass die verwendeten Inhaltsstoffe von höchster Qualität sind und gesundheitliche Risiken minimiert werden. Zu den Stärken der EN 17648:2022 gehört die spezifische Ausschlusskriterien für Inhaltsstoffe, die auf deren Funktionen und toxikologischen Eigenschaften basieren. Dies sorgt dafür, dass potenziell schädliche Substanzen von vornherein ausgeschlossen werden, was zu einer höheren Sicherheit für die Verbraucher führt. Die Norm fordert zudem eine toxikologische Risikoabschätzung und bietet eine umfassende Anleitung, um die Kompetenz der dafür Verantwortlichen zu gewährleisten. Dies ist besonders relevant, da es einen strukturierten Ansatz zur Beurteilung von Gesundheitsrisiken im Zusammenhang mit E-Liquids fördert. Ein weiterer bedeutender Aspekt ist die Spezifikation des Nikotingehalts im Vergleich zu den Deklarationen auf dem Etikett über die Haltbarkeit und die Leistungsmerkmale der verwendeten analytischen Methoden. Dies gewährleistet, dass Verbraucher präzise Informationen über die Inhaltsstoffe erhalten und dass Hersteller transparente und vertrauenswürdige Produkte anbieten. Die Norm gibt zudem pH-Grenzen für E-Liquids vor, was für die Stabilität und Qualität der Produkte von Bedeutung ist. Zudem enthält sie Richtlinien zur Messung von Emissionen, was hilft, die Umwelt- und Gesundheitsauswirkungen von E-Liquid-Dampf zu bewerten. Die Vorschriften für die Produktbeschriftung in Bezug auf Inhaltsstoffe und die Empfehlungen zu Inhaltsstoffen, die in E-Liquids nicht verwendet werden sollten, fördern zusätzlich die Transparenz und Verantwortung in der Branche. Darüber hinaus befasst sich die Norm mit maximalen Gehalten an unerwünschten Bestandteilen in fertigen E-Liquids, die aus natürlichen Extrakten verwendet werden, was den Verbraucherschutz weiter erhöht. Insgesamt ist die EN 17648:2022 eine relevante und umfassende Norm, die nicht nur zu einer erhöhten Produktsicherheit beiträgt, sondern auch Vertrauen in die E-Liquid-Industrie schafft.

SIST EN 17648:2022は、電子タバコ用リキッドの成分に関する重要な標準文書です。この標準の主な範囲は、電子リキッドに使用される成分の要件を定義することであり、成分の純度とサプライチェーン要件に関する明確な指針を提供しています。 この標準の強みの一つは、成分の機能や毒物学的特性に基づく除外基準を明示している点です。これにより、消費者や製造者が安全性を確保するための重要な基準を理解できるようになります。また、毒物学的リスク評価の必要性について説明し、その内容に関するガイダンスを提供している点も大きな特徴です。リスク評価を担当する者の能力要件についても明示されており、専門的な知識の重要性を強調しています。 さらに、ニコチンの含有量については、ラベル表記との整合性、保存期間、分析手法の性能特性に関する具体的な指針を示しているため、消費者に対する透明性が向上します。pH制限や排出量の測定に関するガイダンスも含まれており、品質管理の面での包括的なアプローチが評価されます。 製品のラベリングに関しても、成分に関連する一定の基準を確立しており、消費者保護の観点からも極めて重要です。また、自然抽出物を使用したフレーバリングにおける望ましくない成分の最大許容量に関する指針も、製品の品質維持に寄与しています。 一方で、パッケージングや vaping デバイス、リフィルコンテナの材料や成分には適用されないため、これらの領域に関しては別の規定が必要になる点に留意が必要です。 全体として、SIST EN 17648:2022は、電子リキッドの安全性と品質を確保するための包括的な標準であり、業界内での重要なリファレンスとなるでしょう。

표준 문서 SIST EN 17648:2022는 전자 담배 액상 성분과 관련된 요구 사항을 명확히 하고 있어 매우 중요합니다. 이 문서는 전자 액상에 사용되는 성분의 순도 및 물류 공급망 요구 사항을 명시하며, 전자 담배 산업에서 품질 보증 및 안전성을 확보하는 데 기여합니다. 성분의 기능 및 독성 특성에 기반한 제외 기준을 설정함으로써, 불필요한 성분의 사용을 줄이고, 소비자의 건강을 보호하는 데 중점을 두고 있습니다. 또한, 독성 위험 평가의 필요성을 명시하고 이와 관련된 지침을 제공하여, 해당 평가를 수행하는 전문가의 역량 요구 사항까지 규정하고 있습니다. 이러한 조치는 전자 액상의 안전성을 높이는 중요한 요소로 작용합니다. 니코틴 함량과 레이블 주장 간의 일관성을 보장하기 위해, 저장 수명 및 분석 방법의 성능 특성에 대한 요구 사항도 명확히 하고 있습니다. pH 한계값 설정은 소비자와 제품의 안전성을 모두 고려한 것으로, 전자 액상을 사용하는 모든 사용자에게 필수적인 요소라 할 수 있습니다. 또한, 배출 측정 기준에 대한 지침을 제공하여, 전자 흡입기를 사용할 때 발생할 수 있는 위험 요소를 체계적으로 관리하도록 돕습니다. 문서는 최종 전자 액상에서 특정 바람직하지 않은 성분의 최대 허용 수준에 대한 지침도 포함하고 있어, 자연 추출물을 향료로 사용할 때 나타날 수 있는 문제를 미리 예방하는 데 기여합니다. 이러한 측면에서 SIST EN 17648:2022는 전자 담배 제품의 품질 향상 및 소비자 안전 증대에 매우 중요한 역할을 합니다. 다만, 이 표준은 포장, 흡입 장치 또는 리필 용기 재료/성분에는 적용되지 않으므로, 해당 분야에서 따로 검토가 필요할 것입니다. 이러한 명확한 경계 설정은 문서의 적용 범위를 더욱 분명히 하여, 제작자와 소비자 모두가 직면할 수 있는 다양한 문제들을 해결할 수 있도록 하고 있습니다.

La norme SIST EN 17648:2022 sur les ingrédients des e-liquides constitue un document fondamental pour l'industrie du vapotage. Son champ d'application est clair et précis, se concentrant uniquement sur les exigences concernant les ingrédients utilisés dans les e-liquides et leurs composants. L'un des points forts de cette norme est qu'elle établit des critères de pureté des ingrédients ainsi que des exigences liées à la chaîne d'approvisionnement, garantissant ainsi la sécurité et la qualité des produits. De plus, elle définit des critères d'exclusion des ingrédients en fonction de leur fonction et de leurs propriétés toxicologiques, ce qui témoigne d'une approche proactive pour protéger les consommateurs. La nécessité d'une évaluation des risques toxicologiques est également un aspect clé. La norme fournit des orientations sur le contenu de cette évaluation, ainsi que sur les exigences de compétence pour les personnes chargées de la réaliser, renforçant ainsi la responsabilité des acteurs de l'industrie. En ce qui concerne la conformité au contenu en nicotine, le document spécifie la relation entre la teneur en nicotine et les déclarations étiquetées sur la durée de conservation, ainsi que les caractéristiques de performance des méthodes analytiques utilisées pour sa mesure, ce qui améliore la confiance des consommateurs dans les produits. Les limites de pH fixées pour les e-liquides, ainsi que les directives concernant la mesure des émissions, sont des ajouts appréciables pour la préservation de la santé publique. De plus, la norme aborde explicitement l'étiquetage des produits en rapport avec certains ingrédients, garantissant une transparence accrue pour les utilisateurs. Enfin, elle offre des conseils sur les ingrédients à éviter dans les e-liquides et fixe des niveaux maximaux pour certains constituants indésirables pouvant survenir dans les extraits naturels utilisés comme arômes. Cela montre une volonté claire d'encadrer l'utilisation de composants potentiellement nocifs. En résumé, la norme SIST EN 17648:2022 clarifie et renforce les exigences liées aux ingrédients des e-liquides, apportant des recommandations essentielles qui garantissent la sécurité et l'intégrité des produits sur le marché. Sa pertinence dans l'industrie actuelle du vapotage ne peut être sous-estimée, car elle promeut des pratiques responsables et sûres.