Regulations
In Great Britain (GB), nicotine pouches are regulated under the General Product Safety Regulations 2005 SI 2005/1803 (GPSR) and the Classification, Labelling and Packaging (CLP) Regulation 1272/2008, as retained in UK law.
CURRENT REGULATIONS
Pouch Requirements
Nicotine pouches must meet the requirements of the GPSR and CLP before they can be sold in GB. There is currently no need to notify authorities in advance. As long as the product meets these standards, it can be placed on the market.
The upcoming Tobacco and Vapes Bill could provide more specific requirements and restrictions for nicotine containing products.
PROVISIONS
The CLP Regulation
Communicate Product Hazards Clearly
Explain How to
Stay Safe
Classify the Products Hazards
Include a Unique Formula Identifier (UFI)
Notify Poison
Centres
PURPOSE
The GPSR
Ensure Products are Safe for Consumer Use
All products must be safe when used under normal or reasonably foreseeable conditions. This can be shown by demonstrating that the product meets recognised national safety standards and codes of practice. For nicotine pouches, this means confirming that all ingredients, packaging, and labelling comply with relevant safety requirements.
Provide Clear Instructions for Use and Disposal
Consumers must be given clear guidance on how to use and dispose of the product safely. These instructions help ensure responsible use and supports proper waste disposal.
Communicate Potential Risks Clearly
Products must display appropriate warnings and safety information on the packaging. This helps consumers understand any potential risks associated with use, especially important for vulnerable groups such as children, pregnant women, and older adults.
Maintain Product Traceability
Each product should include a batch or lot number and the contact details of the producer or importer. This allows the product to be traced if there are safety concerns or recalls. In Northern Ireland, a designated responsible person or entity must be identified. They are accountable for ensuring the product meets all applicable safety standards.
Regulation 2023/988 [EU GPSR], which specifically applies in Northern Ireland, mandates the requirement of a Responsible Person/Entity based within NI or the EU/EEA who is accountable for ensuring the product meets EU safety requirements.
Manufacturers/importers based outside the EU/EEA or NI must therefore appoint a Responsible Person/Entity and the details of the RP must be listed on the product packaging and/or product leaflet.
PURPOSE
The GPSR
Ensure Products are Safe for Consumer Use
All products must be safe when used under normal or reasonably foreseeable conditions. This can be shown by demonstrating that the product meets recognised national safety standards and codes of practice. For nicotine pouches, this means confirming that all ingredients, packaging, and labelling comply with relevant safety requirements.
Provide Clear Instructions for Use and Disposal
Consumers must be given clear guidance on how to use and dispose of the product safely. These instructions help ensure responsible use and supports proper waste disposal.
Communicate Potential Risks Clearly
Products must display appropriate warnings and safety information on the packaging. This helps consumers understand any potential risks associated with use, especially important for vulnerable groups such as children, pregnant women, and older adults.
Maintain Product Traceability
Each product should include a batch or lot number and the contact details of the producer or importer. This allows the product to be traced if there are safety concerns or recalls. In Northern Ireland, a designated responsible person or entity must be identified. They are accountable for ensuring the product meets all applicable safety standards.
Regulation 2023/988 [EU GPSR], which specifically applies in Northern Ireland, mandates the requirement of a Responsible Person/Entity based within NI or the EU/EEA who is accountable for ensuring the product meets EU safety requirements.
Manufacturers/importers based outside the EU/EEA or NI must therefore appoint a Responsible Person/Entity and the details of the RP must be listed on the product packaging and/or product leaflet.
ROBUST PRE-MARKETING TESTING REGIME
Testing Requirements
A comprehensive testing regime should be performed before placing the product on the market to demonstrate that it matches the claims on the label. A robust quality control testing regime should also be completed to ensure consistency between different batches. This includes:
- Nicotine Content (mg of nicotine per pouch or per gram)
- Nicotine Release % (amount of nicotine released from the pouch over a specified amount of time)
- Average Pouch Mass (total average mass per pouch)
- Water Activity (Measure of free water available in the product, a measure of <0.6 (aw) is important to demonstrate a low amount of microbe reproduction)
- Propylene Glycol and Glycerol (Excessive amounts of these can cause irritation)
- Tobacco-Specific Nitrosamines (These should be not be present in a nicotine pouch product)
- Metals (Lead, Arsenic, Nickel, Chromium etc., metals may be present due to impurities during the manufacturing process)
- pH (A higher pH can cause discomfort in some users)
