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Tobacco Products Directive (TPD) Compliance

Much debate has taken place about the controversial TPD amendments to the eCigarette and Vaping Industry.

This is a brief Q&A on what it means for the industry and how it may affect you.

What is the Tobacco Products Directive (TPD)?

The TPD was first introduced by the European Commission in 2001 to improve product quality and public safety around the sales of tobacco-based products.

In 2014, the European Commission revised the TPD to include the regulation of eCigarettes across the European Union.

From 20 May 2016, eCigarettes and associated products will be regulated in Europe under Article 20 of the TPD (2014/40/EU).

It states that EU countries will have to comply with the new regulations including the supply of eCigarettes and eLiquids. This includes imports into the EU.

The regulations specifically address the following:

  • All nicotine-containing liquids, eCigarette kits & accessories must meet required standards and information submitted to the MHRA (Medicines and Healthcare Regulatory Agency) as a notification (not authorisation).
  • Variable-voltage and variable-wattage products i.e. Batteries/li>
  • Testing includes ingredient analysis, nicotine dosage, vapour emissions and uptake studies on eLiquids.
  • eLiquid refill containers (bottles) not to exceed 10ml
  • Atomisers (tanks) not to exceed 2.0ml capacity
  • Dripper bottles do not comply with TPD regulations and will be discontinued.
  • Maximum nicotine content of 20mg/per ml (2.0%)
  • All new products will require a 6 months’ notice period prior to launch
  • Restrictions on marketing and advertising
  • product packaging must not attract minors
  • product names must not sound playful
  • must not make any health claims

All devices must be tested (with and without nicotine) on all settings under normal usage conditions.

The new regulations came into effect as of May 2016 with full compliance required by May 2017. iBreathe is required to submit all its products to the MHRA by November 2016.

Any products not notified or not compliant must be withdrawn from public sale by May 2017.

How will the new regulations affect me?

Will I be able to sell iBreathe eCigarettes and eLiquid or do I need a special licence?

No. The responsibility lies with the manufacturer i.e. iBreathe to ensure all products comply with TPD regulations.

Are your products going to be regulated as medicines, hindering my ability to sell them?


Will I still be able to buy all of your current product range?

Yes and No. The products that can and can’t be sold is still being reviewed. Once definitive guidelines have been put into place, we will inform all our customers. Rest assured, any products that are sold by iBreathe will fully comply with the TPD.

What happens to my stock if it is not TPD Compliant?

As of 20th May, a 12 months grace period has come into effect for this transition to take place. You are able to continue selling all iBreathe products up until 19th May 2017.

Will your eLiquid be changing?

Our unique eLiquid formulations will remain unchanged, so the flavours you have come to know and love will taste the same. However, we will no longer be able to sell nicotine strengths greater than 2% (20mg/ml).

Glass dripper bottles do not meet the new requirements and will also be discontinued from the 19th May 2017. Whilst the overall manufacturing cost and time will increase, iBreathe is still committed to providing the same level of excellence that you have come to expect from our brand.