1 Scope
This PAS specifies requirements for the composition, manufacture and testing of tobacco-free
oral nicotine pouches through:
-
a) requirements for ingredients and materials;
-
b) limits for nicotine contents, pH characteristics and water activity of the pouches; and
-
c) product information and labelling.
This document also provides guidance on suitable test methods for measurement of nicotine
content, pH and water activity.
This PAS is applicable to pre-portioned, tobacco-free oral nicotine pouches exclusively
intended for oral use by placing them between the gum and buccal mucosa for a period
of time, to facilitate uptake of the nicotine via the oral mucosa, followed by disposal
of the pouch after use.
This PAS is intended for manufacturers, importers, distributers and retailers involved
in the production and sale of tobacco-free oral nicotine pouches, and for use in laboratories
and testing houses engaged in measurements of these pouches.
The PAS does not cover:
-
• pre-portioned, tobacco-free oral nicotine pouches in which the nicotine is not of natural origin;
-
• smokeless tobacco products, such as moist snuff, tobacco oral pouches, snus, nasal snuff, chewing tobacco or any other tobacco-containing smokeless tobacco products;
-
• licensed medicinal nicotine products, such as nicotine replacement therapies (NRT);
-
• products that are subject to an authorization requirement under Directive 2001/83/EC (Community code relating to medicinal products for human use) [3] or to the requirements set out in Directive 93/42/EEC (Medical Device Directive) [4]; or
-
• inhaled-nicotine products, such as cigarettes, other combusted tobacco products, tobacco-heating products or e-cigarettes.
The PAS does not provide a method for assessing the health risks or potential reduced
health risks of tobacco-free oral nicotine pouches.
This PAS is intended for use in the UK.