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This document establishes limits for nicotine content and pH, and specifies requirements for ingredients and materials, and product information and labelling for nicotine-containing, tobacco-free oral products not intended for medicinal use. This document is applicable to pre-portioned, nicotine-containing, tobacco-free oral products exclusively intended for oral use, and for uptake of the nicotine via the oral mucosa. NOTE This includes products such as white pouched nicotine products that are used by placing them under the upper lip for a period of time, before disposal. This document also gives guidelines for: — analytical methods for measuring: — nicotine content; — pH, as well as certain aspects of toxicological risk assessments.