This draft East African Standard prescribes the requirements, methods of test and sampling for pre-portioned nicotine pouches exclusively intended for oral use by placing them between the gum and buccal mucosa for a period, to facilitate uptake of the nicotine via the oral mucosa, followed by disposal of the pouch after use.
Note: this includes products such as white pouched nicotine products that are used by placing them under the upper lip for a period, before disposal.
This draft East African standard does not cover:
1. pre-portioned, tobacco-free oral nicotine pouches in which the nicotine is not of natural origin;
2. smokeless tobacco products, such as moist snuff, tobacco oral pouches, snus, nasal snuff, chewing tobacco or any other tobacco-containing smokeless tobacco products;
3. Nicotine-Containing, Tobacco-Free Oral Products that are licensed medicinal nicotine products, such as nicotine replacement therapies (NRT);
4. products that are subject to an authorization requirement under Directive 2001/83/EC (Community code relating to medicinal products for human use) or to the requirements set out in Directive 93/42/EEC (Medical Device Directive) ;
5. or inhaled-nicotine products, such as cigarettes, other combusted tobacco products, tobacco-heating products or e-cigarettes;
6. method for assessing the health risks or potential reduced health risks of tobacco-free oral nicotine pouches.
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