The TPD is legislation that regulates the production and sale of tobacco and nicotine related products.
In 2014, the European Commission added electronic cigarettes and E-Liquid into the TPD under their own section (Article 20) within the document which basically classified them as tobacco products. To be governed by the TPD, an E-Liquid must contain nicotine and therefore products intended for use in e-cigarettes that contain no nicotine (zero nic), such as ‘shortfills’, are exempt from the TPD. It is our opinion that the regulations will be extended in the near future to include these products.
The TPD was written into UK Law in 2016 (The Tobacco and Related Products Regulations 2016 – known as the TRPR) and became effective on 20th May 2016.
QCIG welcomes this legislation as control and regulation has been long overdue in our industry. The basic premise of the TPD is to provide consumers with safe, consistent and high quality vaping products.
In short, the TPD regulates the production, quality control, ingredients and marketing of e-cigarettes and related products – E-Liquid being classified as a related product.
The Basic requirements of the TPD
- Manufactures and importers are required to submit technical documentation to the relevant authority in the countries in which they intend to sell their products for each of their products (SKUs). The regulatory authority in the UK is the MHRA. The requirements for this technical documentation are:
- The use of high quality components (ingredients)
- The exclusion of certain banned components that are known to be harmful.
- Manufacture in a ‘clean’ environment.
- A full toxicological risk assessment (TRA) must be prepared for each e-liquid flavour.
- A nicotine-containing e-liquid can have a maximum strength of 20mg/ml.
- Refill bottles are limited to a maximum size of 10ml and pre-filled tanks and cartridges are limited to 2ml.
- Advertising is heavily restricted though you are allowed to advertise in your own retail shop.
- There are some restrictions on cross border sales.
- Manufactures and retailers are required to share market data and trends with the relevant authorities.
- Member states may ban individual products once robust data becomes available.
- The documentation must contain addresses, descriptions and declarations.
- The full chemical composition must be declared.
- A complete toxicological analysis must be provided for each component.
- All compliant products and components must have full traceability and accountability and this is detailed in our Production section.
- Our technical documentation and toxicological tests were conducted and prepared by Adact Medical Ltd, who are one of the leading E-Liquid specialists in the world. They submitted over 50% of all UK submissions to the MHRA.
- To be able to make a submission to a relevant authority, a manufacturer must register with the European Commission and obtain a ‘submitter ID’, which becomes part of the ECID of every product. QCIG’s submitter ID is 00001, which means we were the first manufacturer worldwide to become a registered manufacturer.
- The sale of any product in the UK to the general public is also policed by Trading Standards. (Please also see our separate section on Trading Standards). Their main requirements relating to nicotine containing products are:
- The product complies with the TPD
- The labelling of such products conforms to the latest CLP standard.