SIST EN 17648:2022

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
• Public Enquiry End Date: 30-Jun-2021
• Publication Date: 23-Aug-2022
• ICS: 65.160 - Tobacco, tobacco products and related equipment
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 10-Aug-2022
• Due Date: 15-Oct-2022
• Completion Date: 24-Aug-2022
• Ref Project: 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.

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 <
...