Testing & Regulations
CURRENT REGULATIONS
Pouch Requirements
In the UK, nicotine pouches are only regulated by general safety and packaging laws – such as the CLP Regulation and the General Product Safety Regulations (GPSR) – and not by any specific rules for nicotine products.
These products must meet the requirements of the CLP and GPSR before they can be legally sold. However, there is currently no requirement to notify authorities before placing them on the market. As long as a producer can confirm their product meets these rules, it can be sold in the UK.
The upcoming Tobacco and Vapes Bill which will in time provide more specification requirements and restrictions for nicotine pouch products.
PROVISIONS
The CLP Regulation
Labelling the product with the appropriate Hazard Pictograms (such as the ‘Skull and Crossbones’ or ‘Exclamation mark’ pictograms).
Labelling the product with the appropriate Signal Word (either Warning or Danger).
Labelling the product with the appropriate Hazard Statements (such as ‘Toxic if swallowed.’ ‘May cause an allergic skin reaction.’ hazard statements).
Such as ‘Keep out of reach of children.’, ‘IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feel unwell.’, ‘Rinse mouth.’
Nicotine plays the largest role in the classification of a nicotine pouch product, given nicotine in its pure form is an extremely toxic and dangerous substance.
The content of nicotine will determine if the product has an Acute Toxicity classification of Category 3 or 4, dependent upon the concentration of nicotine in the product. (A lower category Acute Toxicity classification indicates a more toxic product; Category 3 is more harmful than Category 4).
The UFI code acts as a reference which can be quoted to Poison Centres, where it provides a direct link to information about the contents of the product (mixture).
This aids professionals at poison centres to make appropriate treatment recommendations in case of exposure to the hazards of the product (mixture) and during emergencies.
Application of the UFI code to the product label is optional in GB, but mandatory in NI.
The UFI code is assigned to the product (mixture) during a PCN.
The information provided to the national poison centre via a PCN enables the professionals to provide necessary and crucial information in case of exposure to the hazards of the product or during an emergency.
PURPOSE
The GPSR
Ensure that products intended for, or likely to be used by consumers, are safe under normal or reasonably foreseeable conditions of use.
This can be achieved by demonstrating the product conforms to national standards and product safety codes.
Provide instructions on product usage and disposal.
There is an emphasis in the GPSR on providing the consumer with instructions on correct use and disposal of the product.
Communicate risks of product usage
There is an emphasis on clear communication of risks through appropriate labelling and warnings, particularly towards categories of consumers most likely at risk by using this product such as the elderly, pregnant women, underage people etc.
Relevant information must be provided to the consumer so that they may assess the risks inherent with the product and take necessary precautions.
Ensure traceability
There is an emphasis in the GPSR on product traceability, this can be met by labelling the product with a batch number and the contact details of the producer.
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 that products intended for, or likely to be used by consumers, are safe under normal or reasonably foreseeable conditions of use.
This can be achieved by demonstrating the product conforms to national standards and product safety codes.
Provide instruction on product usage and disposal.
There is an emphasis in the GPSR on providing the consumer with instructions on correct use and disposal of the product.
Communicate risks of product usage
There is an emphasis on clear communication of risks through appropriate labelling and warnings, particularly towards categories of consumers most likely at risk by using this product such as the elderly, pregnant women, underage people etc.
Relevant information must be provided to the consumer so that they may assess the risks inherent with the product and take necessary precautions.
Ensure traceability
There is an emphasis in the GPSR on product traceability, this can be met by labelling the product with a batch number and the contact details of the producer.
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.
REQUIREMENTS
Producers
Before placing a nicotine pouch product on the market, producers should ensure that:
ROBUST PRE-MARKETING TESTING REGIME
Testing Requirements
A comprehensive pre-market testing regime should ideally be performed to demonstrate that the product adheres to and matches label claims. A robust quality control testing regime should also be implemented to ensure consistency between batches of product.
- Nicotine Content (mg of nicotine per pouch or per g)
- Nicotine Release % (% of nicotine released from the pouch over a specified amount of time)
- Average Pouch Mass (total average mg per pouch)
- Water Activity (Measure of free water available in the product, a measure of <0.6 (aw) is important to demonstrate non-proliferation of microbes)
- Major Components (Propylene Glycol, Glycerol, etc.)
- Tobacco-Specific Nitrosamines (These should be no detectable TSNAs in a nicotine pouch product)
- Metals (Lead, Aluminium, Tim, Nickel, Chromium etc. metals may be present due to impurities during the manufacturing process.)
- pH
