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May 20, 2016

Innokin Endura T18 ready for TPD notification

Link: Endura T18
Innokin is very proud to announce that the Endura T18E (European Version) Complete Vaping System is prepared and ready for notification as soon as the European Commission submission portal opens on May 20th 2016.

Innokin has been working closely with Nerudia in a strategic partnership in order to achieve full compliance with the EU Tobacco Products Directive and to lead the way in creating safer vaping  technologies.

Innokin and the Nerudia science team worked closely together to design and implement a rigorous new vaporizer/ecig testing protocol to ensure more than just compliance. The T18E tank emissions were tested in a way which emulates real life as we are not only testing for compliance; we are testing because we have a responsibility to our consumers.

In order to ensure full compliance and maximum harm reduction the T18E aerosol was carefully and intensively studied and tested for a range of possible toxins as well as potentially harmful metals. The Endura T18E was tested with the most advanced scientific testing procedures available which have been fully validated.  For safety, the levels of carbonyls detected have been multiplied to estimate the “daily dose”, 500 inhalations in a day have been taken to be a maximum foreseeable vaping regime. A 12 mg/ml nicotine concentration unflavoured commercially available e-liquid was used in testing.

T18E tanks were tested at the start, middle, and end of a simulated day of vaping to collect a range of data and the mean result was calculated. No metals were detected. A mean nicotine dose of 940 µg/10 inhalations was determined.

For nicotine and carbonyls, a validated LC-MS method was used. For metals, a validated ICP-MS method was used. Both of these techniques are sensitive enough to quantify levels well below that which would be expected to have any physiological impact.

The following metals were assessed in the emissions from the Endura T18E:

  • Lithium
  • Cobalt
  • Lead
  • Mercury
  • Iron
  • Copper
  • Selenium
  • Nickel
  • Aluminium
  • Chromium
  • Vanadium
  • Arsenic
  • Molybdenum
  • Antimony
  • Barium
  • Cadmium
  • Tin

Background levels were analysed and subtracted. No metals were detected above the reporting thresholds. The reporting level has been derived by taking 50% of the permitted daily exposure stated in ICH Q3D.

Of the six carbonyl compounds assessed, only three were detected, all in extremely low amounts. There are no official “limits” for the levels of carbonyl emissions produced by electronic cigarettes, however to put the results in context they have been compared to the United States Department of Labor Occupational Safety & Health Administration’s (OSHA) permitted exposure levels. The lowest levels found in the OSHA literature have been used.

  • Acetaldehyde
    • Detected at 0.01 % of ACGIH (American Conference of Governmental Industrial Hygienists)
  • Acrolein
    • Detected at 0.75 % of NIOSH (National Institute for Occupational Safety and Health)
  • Formaldehyde
    • Detected at 167 % of NIOSH

Crotonaldehyde, propionaldehyde and butyraldehyde were not detected.

The level of formaldehyde in 500 inhalations from the Innokin T18E device compares favourably to other environmental sources of formaldehyde.

Low levels of Formaldehyde are common in modern life and it is all around us. Formaldehyde is released by many different materials including fabrics, furniture and insulation and it occurs naturally and is produced by most living organisms. There are also low levels of Formaldehyde in beers, wines and spirits.

Therefore it is important to compare this result to levels of formaldehyde in the environment:

Endura T18 Vape pen-TPD

  • Household cleaner and plug in air freshener data from Norgaard et al, Ozone initiated VOC and particle emissions from a cleaning agent and an air freshener: Risk assessment of acute airway effects. Environment International, Volume 68, July 2014, Pages 209–218.
  • House conventional and low VOC build data from Hult et al, Formaldehyde and Acetaldehyde exposure mitigation in US residences: In home measurements of ventilation control and source control. Indoor Air, Volume 25 issue 5, 2014, page 523-525.
  • Example metropolitan area data from Jurvelin J et al, Personal exposure levels and micro-environmental concentrations of formaldehyde and acetaldehyde in the Helsinki metropolitan area, Finland.
  • Lowest limit found in literature was NIOSH at 0.016 ppm 8 hour time weighted average. This has been converted to daily mg using 0.012 m3/min respiratory rate, light intensity for a 21 to <31 year old (Exposure Factors Handbook, USEPA, 2011)

Nerudia has worked with Innokin and provided key information and guidance on the requirements for TPD and has provided guidance on what is needed in terms of the packaging and user manual contents and warnings for each of the main European markets. The Endura T18E is ready for regulations and we are ready for May 20th, 2016 and the TPD. For advice on how Nerudia can assist with TPD compliance please contact compliance@nerudia.com.

Wholesalers and distributors can continue to sell the internationally bestselling Endura T18E with confidence, safe in the knowledge that it is 100% compliant with the new regulations.

For more information on the Endura T18E visit http://www.innokin.com/vaporizers/endura/ or contact regulatory@innokin.com

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