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E-cigarettes

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Requirements for E-Cigarettes in the Tobacco Products Directive (TPD)

Following the implementation of EU’s Tobacco Products Directive (TPD) on 20 May 2016 new requirements are set for importers and manufacturers of e-cigarettes. An overall requirement is that product notification must be made for e-cigarette products that contain nicotine. Notifications must be made before 20 November 2016, in order for the products to remain legally on the market.

A notification must contain information about:

  • Ingredients
  • Emissions
  • Nicotine dose
  • Toxicological data for ingredients
  • Description of components and manufacturing process
  • Declaration (liability)

There are also requirement for instruction manual and labelling, and physical and chemical restrictions, such as volume, nicotine content, additives, purity, health risk, constant nicotine doses in use, and child resistance.

 

Eurofins offer

Eurofins Product Testing offers all required tests and evaluations, and we also offer to handle the registration with EU’s Central Entry Gate.

Consultancy

  • Review of technical documentation and labelling
  • Toxicological evaluation of ingredients
  • Product registration

Testing of Electrical Parts

Tests applicable to the charger during the charging phase

  • Directive 2014/30/EU – Electromagnetic Compatibility (EMC)
    • Test and Report according to standards EN 61000-3-2, EN 61000-3-3, EN 61000-6-1, EN 61000-6-3, EN 55014-1, EN 55014-2
  • Directive 2014/35/EU – Low Voltage (LVD)
    • Electrical Safety Tests and Report according to standards EN 60335-1, EN 60335-2-29
    • Electromagnetic Field (EMF) testing and Report according to EN 62233

Testing of Non-Electrical Parts

  • Nicotine content (GC/FID following the draft method ISO/DIS 20714)
  • Nicotine doses in use (Method based on AFNOR XP D90-300-3, but updated according to the proceedings of the international standardization work)
  • Emissions in use (Method based on AFNOR XP D90-300-3, but updated according to the proceedings of the international standardization work. Standard test method include emissions of nicotine, VOC’s, carbonyl compounds, nitrosoamines, and heavy metals)

Additional optional related tests

  • Screening for prohibited substances (GC/MS)
  • Purity of ingredients  (Selected analyses for impurities like diacetyl, aldehydes, glycols etc.)
  • Child resistance (Methods based on the existing standard for toys EN 71)
  • Resistance to manipulation, damage and leakage of liquids (Methods based on the existing standard for toys EN 71)

Other Chemical Services (applicable to the whole product)

  • Restriction of Hazardous Substances in EEE products (Directive 2011/65/EU (RoHS)
  • REACH Regulation (EC) No 1907/2006 - Annex XVII Restrictet Substances (Cadmium, PAHs, Nickel, Organotins, lead, etc…)
  • REACH Regulation (EC) No 1907/2006 - Candidate List of Substances of Very High Concern (SVHC)
  • Persistent Organic Pollutants Regulation (EC) No 850/2004 (Short Chain Chlorinated Paraffins SCCP,…)
  • Heavy metals content (Hg, Cd, Pb) (Battery Directive 2006/66/EC)
  • Packaging Waste Heavy metals content in packaging (Directive 94/62/EC)

Case study

For more information please contact.

Christopher Lilholm

Business Development Manager
E: christopherlilholm@eurofins.com 

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