National foreword

This British Standard is the UK implementation of EN 17648:2022.

The UK participation in its preparation was entrusted to Technical Committee CH/437, Electronic Cigarettes & E-liquids.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2022.

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, Turkey and United Kingdom.

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

3 Terms, definitions and abbreviations

3.1 Terms and definitions

3.2 Abbreviations

4 Ingredient suppliers’ selection

4.1 Disclosure of e-liquid / flavouring formulation

4.2 Supply chain requirements

4.3 Change notifications

5 Ingredient requirements

5.1 Ingredient functions

5.2 Ingredient quality

5.3 Ingredient exclusion criteria

5.4 Toxicological risk assessment

6 Finished e-liquid requirements

6.1 E-liquid integrity

6.2 E-liquid related emission requirements

6.3 E-liquid related product information requirements

Bibliography

BS EN 17648:2022

E-liquid ingredients

Current

Published:

30 Sep 2022