SIST EN 17648:2022
(Main)E-liquid ingredients
E-liquid ingredients
The document is applicable to e-liquids, as well as flavour concentrates supplied directly to the consumer for use in e-liquids, intended for the production of aerosol for consumption by inhalation in electronic cigarettes and similar vapour producing devices. It is applicable to eliquids and concentrates intended for the consumer either with or without nicotine content.
The standard specifies the minimum safety and technical requirements for the selection and control of ingredients for e-liquids and flavour concentrates, as well as some ingredient-related risk assessment and product information requirements for the finished e-liquid/flavour concentrate, when the products are to be used in electronic cigarette devices operated and maintained in the manner prescribed by the manufacturer.
The document is not applicable to packaging, device or refill container materials.
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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 17648:2022
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
SIST EN 17648:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 17648:2022
---------------------- Page: 2 ----------------------
SIST EN 17648:2022
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.
---------------------- Page: 3 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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
2
---------------------- Page: 4 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN 17648:2022
EN 17648:2022 (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 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.
4
---------------------- Page: 6 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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
1
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)
1
Under preparation. Stage at the time of publication: FprCEN/TS 17633:2022.
5
---------------------- Page: 7 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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
6
---------------------- Page: 8 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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
7
---------------------- Page: 9 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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.
8
---------------------- Page: 10 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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.
2
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
3
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
4
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
5
pharmaceutical specifications for purified water or water for injection . Supporting documentation shall
include certificate(s) of analysis and/or certificate(s) of conformity.
6
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
2
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.
3
For example: propylene glycol meeting the requirements specified in the EP Propylene glycol Monograph, or those
specified in the USP, Propylene Glycol Monograph.
4
For example: glycerol meeting either the EP Glycerol Monograph or the USP, Glycerin Monograph.
5
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.
6
For example: meeting the requirements of the EP Ethanol (96 percent) or Anhydrous Ethanol Monographs, or the
USP Ethanol absolute Monograph.
9
---------------------- Page: 11 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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.
10
---------------------- Page: 12 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
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 < exposure route >
Suspected of damaging fertility or the
Category 2 Repr. 2
H361 unborn child
Lactating Lact. H362 May cause harm to breast-fed children
Sensitization of
Respiratory
the respiratory May cause allergy or asthma symptoms
Sensitizers Resp. Sens 1 H334
tract (or the or breathing difficulties if inhaled
Category 1
a
skin )
< exposure route > = state route of exposure if it is conclusively proven that no other routes of
exposure cause the hazard.
a
Skin sensitization is mentioned in brackets because the official CLP hazard class wording combines respiratory
and skin sensitization, and they are then distinguished at the hazard category level. For the purposes of this table,
only the respiratory sensitizers, not skin sensitizers (H317) are meant.
11
---------------------- Page: 13 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
STOT category 1 (lung) classified ingredients should not be used, unless a robust risk assessment of its
use in the finished e-liquid, that includes appropriate data and is documented in a toxicological risk
assessment (see 5.4) supports the concentration used.
In addition, ingredients are also considered unsuitable for use if they have been identified as any of the
following:
— classified as “Carcinogenic to humans” (Group 1), “Probably carcinogenic to humans” (Group 2a) or
“Possibly carcinogenic to humans” (Group 2b) by IARC;
— identified by the United States National Toxicology Program (NTP) as either “Known” or “Reasonably
Anticipated To Be” human carcinogens;
— listed in Part A of Annex III of the European Parliament and the Council Regulation (EC) No
1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and
certain food ingredients with flavouring properties for use in and on foods, and its updates;
— being psychotropic, other than nicotine;
NOTE A list of psychotropic substances under international control has been established by the UN
Commission on Narcotic Drugs, where schedules 1 and 2 list the drugs and substances under international
control [CND, 2021].
— the only exception to the above is if scientific data has become available after the evaluation or was
not taken into account during the evaluation, by the relevant scientific expert group that resulted in
the inclusion of the compound in the lists mentioned above, that has demonstrated the mechanism
of action for the specified toxic end point is not relevant to humans. In that case the ingredient can
be used but the documented toxicological risk assessment determining the supportable
concentration in e-liquid shall include a scientific justification for its use despite its presence on one,
or more, of the above lists (see 5.4);
— oils and fats (mineral or vegetable) shall not form part of the base e-liquid, not as a diluent or in
another function;
— certain compounds should not be used as ingredients in e-liquids. They may however be present as
impurities and as such their levels should be controlled in line with the toxicological risk assessment
for the finished e-liquid. A non-exhaustive list is included in Annex A;
— toxicologically undesirable constituents can be naturally present in flavourings. The presence of
those undesirable constituents in the finished e-liquid shall be kept as low as possible, through
controlling their limited presence in natural flavourings and/or by limiting the inclusion level of
natural flavourings containing undesirable constituents in the e-liquid. Guidance on maximum levels
for some of these undesirable constituents in the finished e-liquid is provided in Annex B;
— additionally, nicotine shall not be added as an ingredient in e-liquids where the product information
indicates this is a nicotine-free e-liquid.
5.4 Toxicological risk assessment
Use level of each ingredient shall be supported by a toxicological risk assessment to ensure its safe use in
a finished e-liquid. A toxicological risk assessment report supporting each commercial e-liquid stock
keeping unit shall be established and available upon request. It shall be revised at least every 5 years to
include critical new data on ingredients hazard or on product use patterns, until one shelf life period after
the last product has been manufactured.
NOTE 1 A single toxicological risk assessment can support various stock keeping units.
12
---------------------- Page: 14 ----------------------
SIST EN 17648:2022
EN 17648:2022 (E)
The toxicological risk assessment shall consider both the potential hazards associated with the ingredient
and its expected exposure to the consumer in order to determine the supportable level of ingredient use.
In addition, potential thermal degradation of the ingredient due to the aerosolization process shall be
considered.
NOTE 2 Particularly for ingredients used at higher levels, measurement of potential degradation products under
vaping relevant conditions would also be expe
...
SLOVENSKI STANDARD
oSIST prEN 17648:2021
01-junij-2021
Sestavine e-tekočin
E-liquid ingredients
Inhaltsstoffe von E-Liquids
Ingrédients des e-liquides
Ta slovenski standard je istoveten z: prEN 17648
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
oSIST prEN 17648:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN 17648:2021
---------------------- Page: 2 ----------------------
oSIST prEN 17648:2021
DRAFT
EUROPEAN STANDARD
prEN 17648
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2021
ICS 65.160
English Version
E-liquid ingredients
Ingrédients des e-liquides Inhaltsstoffe von E-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 17648:2021 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 5
3.1 Terms and definitions . 5
3.2 Abbreviations . 7
4 Ingredient suppliers’ selection . 7
4.1 Disclosure of e-liquid / flavour formulation . 7
4.2 Supply chain requirements . 8
4.3 Change notifications . 8
5 Ingredient requirements . 8
5.1 Ingredient functions . 8
5.2 Ingredient quality . 9
5.3 Undesirable constituents . 10
5.4 Ingredient exclusion criteria . 11
5.5 Toxicological risk assessment . 13
6 Finished e-liquid requirements . 14
6.1 E-liquid integrity . 14
6.2 E-liquid related emission requirements . 15
6.3 E-liquid related product information requirements . 15
Annex A (informative) Compounds not to be used as ingredients in e-liquids . 18
Bibliography . 19
2
---------------------- Page: 4 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
European foreword
This document (prEN 17648:2021) 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 Enquiry.
3
---------------------- Page: 5 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (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 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.
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 on ensuring the consumer safety of e-liquid
ingredients; however, in cases where national regulations currently exist, said regulations take
precedence over this document.
4
---------------------- Page: 6 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
1 Scope
This document specifies requirements related to ingredients used in e-liquids and e-liquid components.
It does not cover packaging, vaping device 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
prEN 17647:2021, General principles and requirements, for filling and holding e-liquids for vaping
products, including containers and cartridges
prEN 17633:2021, General principles and requirements for testing for quality and nicotine levels of e-liquids
ISO 20714, E-liquid — Determination of nicotine, propylene glycol and glycerol in liquids used in electronic
nicotine delivery devices — Gas chromatographic method
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 http://www.electropedia.org/
• ISO Online browsing platform: available at http://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 have a unique CAS#
3.1.3
constituent
individual chemical substance within an ingredient
3.1.4
contaminant
unwanted and unintended substance or material
3.1.5
diluent
solvent used in the e-liquid to dilute nicotine and/or flavourings and/or to form the aerosol
5
---------------------- Page: 7 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
3.1.6
e-liquid
base liquid, which may or may not contain nicotine and/or other ingredients, intended for transformation
into an aerosol by an electronic cigarette
3.1.7
e-liquid component
mixture or ingredient supplied directly to the consumer, intended for use in e-liquids
3.1.8
flavouring
ingredient that imparts smell and/or taste
3.1.9
ingredient
compound or mixture of compounds intentionally included in an e-liquid
EXAMPLE VG, PG, nicotine, flavourings
3.1.10
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, who, by importing and/or
putting his name, trade mark or other distinguishing feature on the product presents himself as the entity
legally responsible for the item within the relevant jurisdiction
3.1.11
refill container
receptacle containing an e-liquid, which can be used to refill a vaping device
Note 1 to entry: Also called refill bottle.
6
---------------------- Page: 8 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
3.2 Abbreviations
Carc carcinogenic
CAS Chemical Abstracts Service registration 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
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 Reasearch 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 Repiratory sensitizer
TPD Tobacco Products Directive
USP United States Pharmacopeia
4 Ingredient suppliers’ selection
4.1 Disclosure of e-liquid / flavour formulation
The e-liquid producer shall ensure they receive full disclosure of all ingredients used in the final 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 5.5) and control over potential
constituents of concern (see 5.3).
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 and/or FL-number).
7
---------------------- Page: 9 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
Where ingredients consist of extracts of natural raw materials, disclosure information shall include the
presence and maximum levels of any toxicologically undesirable constituents as identified in 5.3.
Sufficient information to perform the toxicological assessment (see 5.5) typically includes identification
numbers such as CAS, FEMA, JECFA CoE 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.
Where ingredients consist of mixtures of individual compounds and/or extracts of raw materials, the
disclosure information described above for each of the individual compounds and/or extracts of raw
materials in the mixture, shall be provided. 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 the
main constituents of the natural extract 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 final e-liquid shall ensure traceability back to these individual ingredient batch codes.
All e-liquid ingredients shall be accompanied by the relevant certificates of analysis and/or certificate of
conformity demonstrating compliance with the purity requirement specified in 5.2.
To ensure sufficient quality in the supply chain, it is recommended to use ingredient suppliers accredited
for food flavour or pharmaceutical ingredient production.
4.3 Change notifications
Producers shall ensure their ingredient supply chain informs them of any changes to the supplied
ingredients that may affect the composition and/or quality of the ingredients. This includes, but is not
restricted to, changes to manufacturing process, changes to geographical origin(s) of the raw ingredients
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 final e-liquid.
5 Ingredient requirements
5.1 Ingredient functions
E-liquids are expected to consist of only diluent(s) and optionally flavouring(s) and nicotine. 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 may end up having a colour due to ingredients that have other functions and may change colour
over time.
Preservatives may be present as constituents from ingredients, but then their final level 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.
8
---------------------- Page: 10 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
5.2 Ingredient quality
All solvents forming the base e-liquid, as well as the nicotine used in e-liquids shall meet appropriate
pharmaceutical standards.
1)
Only nicotine of recognized pharmaceutical grade 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.
2)
Only propylene glycol (2,3-propanediol) of recognized pharmaceutical grade 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 0,1 %w/w.
3)
Only glycerol (1,2,3-propanetriol) of recognized pharmaceutical grade 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, it shall be equivalent to, or of better quality than European or US
4)
pharmaceutical grade quality purified water or water for injection . Supporting documentation shall
include certificate(s) of analysis and/or certificate(s) of conformity.
5)
Only ethanol of recognized pharmaceutical grade 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 solvent(s) used for these products 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.
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 shall be of equivalent quality, or better than, European or US food grade quality.
1)
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.
2)
For example: propylene glycol meeting the requirements specified in the EP Propylene glycol Monograph, or those
specified in the USP, Propylene Glycol Monograph.
3)
For example: glycerol meeting either the EP Glycerol Monograph or the USP, Glycerin Monograph.
4)
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.
5)
For example, meeting the requirements of the EP Ethanol (96 percent) Monograph, Anhydrous Ethanol or the
USP, Ethanol absolute Monograph.
9
---------------------- Page: 11 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
For tobacco extracts, the following families of compounds that can be concentrated in the extraction
processes, shall be considered in the toxicological risk assessment (5.5) that is required to support the
use of the extract as an ingredient in the final product:
• 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 added to the final product shall be at least of European food grade purity
or equivalent or higher.
5.3 Undesirable constituents
Certain toxicologically undesirable constituents that can be naturally present in flavourings, are listed in
Table 1. The presence of those undesirable constituents in the final e-liquid shall be kept as low as
possible, through controlling their limited presence in natural flavourings and/or by limiting the
inclusion level of natural flavourings containing undesirable constituents in the e-liquid. Maximum levels
of these undesirable constituents in the final e-liquid shall be limited to the maximum levels listed in
Table 1.
10
---------------------- Page: 12 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
Table 1 — Maximum levels of certain undesirable constituents in the final e-liquid
Compound CAS number(s) Maximum level in final e-
liquid in mg/kg
Beta-asarone 5273–86–9 1
1-Allyl-4-methoxybenzene, 140–67–0 10
Also known as estragol
Hydrocyanic acid 74–90–8 35
Menthofuran 494–90–6 200
17957–94–7
80183–38–6
4-Allyl-1,2-dimethoxy-benzene, 93–15–2 1
Also known as methyleugenol
Pulegone 89–82–7 20
Quassin 76–78–8 0,5
1-Allyl-3,4-methylene dioxy 94–59–7 1
benzene, also known as safrole
Teucrin A 12798–51–5 2
Thujone (alpha and beta) 76231–76–0 0,5
546–80–5
471–15–8
Coumarin 91–64–5 5
NOTE Attention is drawn to the ingredient exclusion requirements related to ingredient hazard classifications
in 5.4 and that undesirable constituents presenting CMR properties, when present above certain levels, can result
6)
in the classification of the natural flavouring .
Based on the above requirements, maximum levels of these undesirable constituents shall be set in the
ingredient specifications for all flavourings that are known to potentially contain these undesirable
constituents.
5.4 Ingredient exclusion criteria
Ingredients with the hazard classification listed in Table 2 shall not be used in e-liquids.
6)
e.g. presence of methyl eugenol (CAS# 93-15-2, considered as Muta2 H341 and Carc2 H351) should be below 1%
in natural flavourings such as rose oil.
11
---------------------- Page: 13 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
Table 2 — European Union CMR and respiratory sensitization classifications
Classification
Hazard- Hazard
class
and Code Warning of danger text
categor
Class Category y code
Muta.
Category 1A
1A
May Cause genetic defects < exposure
H340
route >
Germ cell Muta.
Category 1B
mutagenicity 1B
Suspected of causing genetic
Category 2
Muta 2 H341 defects < exposure route >
Category 1A Carc. 1A H350 May cause cancer < exposure route >
Carcinogenicity
Suspected of causing
Category 2
Carc. 2 H351 cancer < exposure route >
May damage fertility or the unborn
Category 1A H360
Repr. 1A child < exposure route >
May damage fertility < exposure
H360F
route >
May damage the unborn
H360D
child < exposure route >
H360F May damage fertility. May damage the
D 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.
H360Df Suspected of damaging
fertility < exposure route >
Suspected of damaging fertility or the
Category 2 Repr. 2
H361 unborn child
Lactating Lact. H362 May cause harm to breast-fed children
Sensitization of
Respiratory May cause allergy or asthma
the respiratory Resp.
Sensitisers H334 symptoms or breathing difficulties if
tract (or the Sens 1
Category 1 inhaled
a
skin )
< exposure route > = state route of exposure if it is conclusively proven that no other routes of
exposure cause the hazard.
a
Skin sensitization is mentioned in brackets because the official CLP hazard class wording combines
respiratory and skin sensitization and they are then distinguished at the hazard category level. For the
purposes of this table, only the respiratory sensitisers, not skin sensitisers (H317) are meant.
12
---------------------- Page: 14 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
STOT category 1 (lung) classified ingredients should not be used, unless a robust risk assessment of its
use in the final e-liquid, that includes appropriate data and is documented in a Toxicological Risk
Assessment (see 5.5) supports the concentration used.
In addition, ingredients are also considered unsuitable for use if they have been identified as any of the
following:
• classified as “Carcinogenic to humans” (Group 1), “Probably carcinogenic to humans” (Group 2a) or
“Possibly carcinogenic to humans” (Group 2b) by IARC
• identified by the United States National Toxicology Program (NTP) as either “Known” or “Reasonably
Anticipated To Be” human carcinogens
• listed in Part A of Annex III of the European Parliament and the Council. Regulation (EC) No
1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and
certain food ingredients with flavouring properties for use in and on foods, and its updates.
• being psychotropic, other than nicotine
NOTE A list of psychotropic substances under international control has been established by the UN
Commission on Narcotic Drugs, where schedules 1 and 2 list the drugs and substances under international control
(https://www.unodc.org/unodc/en/commissions/CND/conventions.html).
• The only exception to the above is if scientific data has become available after the evaluation by the
relevant scientific expert group that resulted in the inclusion of the compound in the lists mentioned
above, that has demonstrated the mechanism of action for the specified toxic end point is not relevant
to humans. In that case the ingredient can be used but the documented toxicological risk assessment
determining the supportable concentration in e-liquid shall include a scientific justification for its
use despite its presence on one, or more, of the above lists (see 5.5).
• Oils and fats (mineral or vegetable) shall not be used as diluent or in any other way form part of the
base e-liquid.
• Certain compounds should not be used as ingredients in e-liquids. They may however be present as
impurities and as such their levels should be controlled in line with the toxicological risk assessment
for the final e-liquid. A non-exhaustive list is included in the annex.
• Additionally, nicotine shall not be added as an ingredient in e-liquids where the product information
indicates this is a nicotine-free e-liquid.
5.5 Toxicological risk assessment
Use level of each ingredient shall be supported by a toxicological risk assessment to ensure its safe use in
a final e-liquid. A Toxicological Risk Assessment report supporting each commercial e-liquid stock
keeping unit shall be established and available upon request. It shall be revised at least every 5 years to
include critical new data on ingredients hazard or on product use patterns.
NOTE 1 A single TRA can support various stock keeping units.
The toxicological risk assessment shall consider both the potential hazards associated with the ingredient
and its expected exposure to the consumer in order to determine the supportable level of ingredient use.
In addition, potential thermal degradation of the ingredient due to the aerosolization process shall be
considered.
13
---------------------- Page: 15 ----------------------
oSIST prEN 17648:2021
prEN 17648:2021 (E)
NOTE 2 Particularly for ingredients used at higher levels, measurement of potential degradation products under
vaping relevant conditions would also be expected to support the risk assessment. The potential for degradation
will depend on the ingredient properties as well as the vaping device in which it is being used. As a practical guide,
for less volatile ingredients, levels above 0,1 % can be considered higher use levels in this context.
Ingredient hazard characterization includes a thorough literature review of publicly available
toxicological data, with special attention on key end points related to inhalation exposure route.
Exposure assessment shall consider the intended concentration of ingredients, their transfer into aerosol
in the aerosolisation process, as well as an estimation of high e-liquid consumption.
The consumption estimate should be established by knowledge of consumer product behaviour,
including at least the 90th percentile of the daily dose distribution curve. In case the ingredient transfer
rate is not measured, a conservative default assumption of 100 % transfer should be used
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.