1 Scope

This document is applicable to electronic cigarettes and similar vapour producing devices intended to produce aerosol from e-liquids for consumption by inhalation. It is applicable to devices intended for use with e-liquids. This document is also applicable to e-liquid containers.

This document:

• specifies the considerations and approach required to establish levels of extractable and leachable substances in vaping products, e-liquid cartridges, and e-liquid refill containers;

• specifies a risk-based approach to enable manufacturers to understand the risk associated with the levels of extractable and leachable substances;

• describes an approach to toxicological risk assessment that contributes to an understanding of whether leachable compound levels are within acceptable limits over the anticipated shelf life of the product;

• builds on the requirements of CEN/TS 17287:2019, 5.1 [10] Material (migration) by detailing an analytical and toxicological approach to establish that “no e-liquid contact material shall transfer constituents into the e-liquid at levels that endanger human health”

• does not consider that substances may also transfer directly to the user via direct contact with components as this consideration is included in CEN/TS 17287;

• does not specify all testing necessary to establish the shelf life of products.