E-cigarette Regulations

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Are you ready for the Tobacco Products Directive?

 

The Tobacco Products Directive 2014/40/EU lays down the rules for the manufacture, presentation and sale of e-cigarettes.  It came into effect on 20th May 2016.

A number of restrictions are placed on products such as a limit on nicotine concentration (≤20 mg/ml) and tank volume (≤2 ml).  Also, under the new rules a pre-market notification is required. Certain information on the product must be submitted to the authorities at least 6 months before a product can be placed on the market.  The information to be submitted includes administrative, quality and safety data and will require emissions testing by an analytical laboratory and a toxicological assessment.

The new regulations have a significant impact on business, bringing new costs and major changes in operations.


Read more on the TPD Regulations


How can we help?

We offer a range of services to help companies prepare for the regulations, including:

  • E-cigarette testing: we help source a cost-effective e-cigarette testing laboratory, while ensuring minimum testing requirements are met
  • Notifications: we can prepare and submit notifications for e-cigarettes and e-liquids on your behalf.
  • Toxicological assessment: we advise on the toxicological requirements and can provide a toxicology expert
  • TPD compliance: we will review your product to check it is TPD compliant
  • Manufacturing standards: we provide an insight into the manufacturing standards before they are published

Read our regulatory notes on Article 20 of the Tobacco Products Directive.

In the absence of guidance…

With e-cigarette regulation still in development, there are few official guidelines and no official standards. Where guidance is lacking, pharmaceutical regulatory guidelines can be used as a model. Our knowledge and experience in pharmaceutical regulatory affairs combined with knowledge on the latest developments in e-cigarette regulation allows us to help manufacturers prepare early.