CEN/TC 437 - Electronic cigarettes and e-liquids

This document:
—   defines a vaping regime for products suitable for use for a specific user inhalation behaviour: the direct to lung inhalation;
—   defines the parameters, technical requirements and standard conditions for a vaping machine for direct to lung vaping products;
—   specifies technical requirements of vaping devices suitable to be tested under this regime;
—   specifies the conditions under which this regime is suitable for use.

This document defines terms, symbols and units of measurement related to electronic cigarettes and e-liquids in order to harmonize the terminology.

This document specifies the method for the determination of nicotine delivery consistency of an electronic cigarette over the duration of use of e-liquid in the reservoir or a battery charge.
This document:
-   defines the equipment to be used;
-   specifies the preparation of the e-cigarette samples for testing;
-   specifies the aerosol generation process;
-   specifies the analytical method;
-   specifies the determination of the test result.
This document does not seek to demonstrate whether there is consistency of nicotine delivery between e-cigarettes. The latter is the aim of a separate method under development, EN 17634 Electronic cigarettes and e-liquids - Determination of nicotine delivery consistency over defined puff sequences of a number of e-cigarettes of identical type [1]. Two separate methods have been developed to determine consistency of nicotine delivery, pending regulatory clarity on the Tobacco Products Directive's requirement to "deliver nicotine doses at consistent levels" [2].

This document specifies a method for the determination of nicotine delivery consistency between e-cigarettes (devices, consumables and combinations).
This document:
-   defines the equipment to be used;
-   specifies the preparation of the samples for testing;
-   specifies the aerosol collection process;
-   specifies the analytical method.
Suitable sampling procedures are described for obtaining results from within a single production batch, as well as for sampling across batches.
The method in this document does not seek to demonstrate whether there is consistency between puffs generated at the start or nearer the end of a tank fill or battery charge. The latter is the aim of a separate method under development, EN 17746 Electronic cigarettes and e-liquids — Determination of nicotine delivery consistency over defined puff sequences within a single e-cigarette [1]. Two separate methods have been developed to determine consistency of nicotine delivery, pending regulatory clarity on the Tobacco Products Directive's requirement to "deliver nicotine doses at consistent levels" [2].

This document establishes the general principles for manufacturing, filling and holding e-liquids for prefilled containers or products.
FprCEN/TS 17633 and FprEN 17648 are intended to be used in conjunction with this document.

This document specifies an analytical method to quantify nicotine of collected vapour product emissions by gas chromatography.

This document specifies a method of measurement of the masses of e-liquid vaporised and the aerosol collected from vapour product(s).
It does not specify the vapour product(s), the vapour product(s) operational settings or, e-liquid to be used.
NOTE       Application of this document can be required as a preliminary step for subsequent analyses.

This document specifies a method for the determination of the amount of selected carbonyl compounds (formaldehyde and acetaldehyde) as their 2,4-dinitrophenylhydrazones in vapour product emissions using reversed phase liquid chromatography coupled with ultraviolet or diode array detector (LC-UV or LC-DAD).
This document does not include the analysis of other carbonyl compounds, such as acrolein and crotonaldehyde, due to previous work indicated issues associated with stability of these compounds in the e-liquid solutions that were used to evaluate method performance[4].

This document specifies the manufacturing quality testing of e-liquids for vaping products in their fully produced form "finished e-liquid" at the point of manufacture, whether containing nicotine or not.
This document is intended to be read in conjunction with FprEN 17647 and FprEN 17648.
NOTE   Testing for undesirable constituents is outside the scope of this document because their presence in final e-liquid is limited by controls at the ingredient level. The maximum level of undesirable constituents is set in the ingredient specification and monitored by testing at a frequency determined appropriate by the manufacturer.

This document describes requirements related to ingredients used in e-liquids and e-liquid components.
This document:
- specifies ingredient purity and related supply chain requirements;
- specifies ingredient exclusion criteria based on function and toxicological properties;
- specifies the need for a toxicological risk assessment and provides guidance on the content of this as well as specifying competency requirements for those responsible for it;
- specifies nicotine content versus label claim over shelf life and performance characteristics of the analytical method used to measure the nicotine;
- specifies pH limits for the e-liquid;
- provides guidance on the measuring of emissions;
- specifies certain ingredient-related product labelling;
- provides guidance on ingredients that should not be used in e-liquids;
- provides guidance on maximum levels in finished e-liquid for certain undesirable constituents that may occur in natural extracts used as flavourings.
This document does not apply to packaging, vaping devices or refill container materials/ingredients.

This document:
—          defines the parameters and specifies the standard conditions for a vaping machine for vapour products (as defined in 3.1);
—          specifies technical requirements for the machine for routine analytical vaping, conforming with the standard conditions stated within Clause 4;
—          does not specify the vapour product, the vapour product operation or the liquid to be used;
—          does not specify the means for aerosol trapping, subsequent sample preparation or analyses of components in the trapped aerosol.

This document specifies an analytical method to quantify the nicotine, propylene glycol and glycerol content in e-liquids by gas chromatography.

This document specifies reference e-liquids to be used to test emissions generated by electronic cigarettes [1].
This document applies to the reference e-liquids to be used when an electronic cigarette is sold empty, without an e-liquid, and where the product information or instructions for use are not specific in terms of the compositional characteristics of the e-liquid to be used with the device.

This document is applicable to electronic cigarettes and similar vapour producing devices intended for the production of aerosol from e-liquids for consumption by inhalation. It is applicable to devices intended for use with or without nicotine content in the aerosol produced. This standard is also applicable to e-liquid containers, filling mechanisms and accessories, electrical and other, intended for use with electronic cigarettes and similar vapour producing devices.
This standard specifies the minimum safety and technical requirements for electronic cigarette devices, e-liquid containers, and associated accessories when operated and maintained in the manner prescribed by the manufacturer.

This document gives a list of constituents of interest proposed for measurement in the aerosol for the purpose of regulatory submission under the Directive 2014/40/EU (TPD) [2], for
- prefilled products such as disposable e-cigarettes and refill cartridges,
- e-liquids sold in refill containers,
- the following categories of hardware: coils or other heater elements of the vaping product, atomisers, rebuildable atomisers and all open tank or dripper products with inbuilt atomisers, including clearomisers.
This list is not intended to be comprehensive but rather, it represents the default minimum requirement. Depending on the device/liquid combination and the toxicological assessment other substances might have to be measured as well.

This document specifies to the producers of e-liquid the information that should be provided on the outside packaging, unit packets, product information leaflet, or online content that is supplied with a vaping product. The scope of this document is limited to vaping products, cartridges, prefilled containers, and accessories.
This document is intended to be read in conjunction with CEN document EN 17648, E-liquid Ingredients.