E-liquids and e-cigarettes

Compliance with the Tobacco Product Directive/2014/40/EU, i.e. TPD2. As of 20 May 2016, a new tobacco product directive came in force within the EU market. It imposes an obligation to register (notify) electronic cigarettes and liquids used to fill them, the so-called e-liquids, on the manufacturers and importers of these products.

The registration in the EU-CEG (European Common Entry Gate) system requires the provision of the following information:

  • the composition of the product before it is converted into aerosol, with special regard to the composition of aromas and the dose of nicotine (e-liquids and e-cigarettes)
  • the toxicological data of the ingredients of the product (e-liquids and e-cigarettes)
  • the results of the so-called emission tests, i.e. the composition of the vapours of the product after it is converted into aerosol, with special regard to the nicotine content per drag; the content of carbonyl compounds, volatile organic compounds, heavy metals and nitrosamines (e-liquids and e-cigarettes)
  • the description of the product and the manufacturing process (e-liquids and e-cigarettes)
  • the capacity of the atomizer (e-cigarettes)
  • the composition of the heater (e-cigarettes)
  • the repetitiveness of the nicotine dose in an air volume unit – when dragging on the cigarette (e-cigarettes)
  • the accuracy of the voltage applied on the heater (e-cigarettes)
E-liquids and e-cigarettes
E-liquids and e-cigarettes

Moreover, electronic nicotine delivery systems (ENDS) and liquids used to fill them should meet additional requirements:

  • the right classification, labelling of the product and packaging in accordance with the CLP (Classification, Labelling, Packaging) Regulation
  • the right documentation in the form of safety data sheets in accordance with the REACH regulation
  • the right protection against access by children

 

Apart from the TPD2, CLP and REACH requirements, the manufacturers and importers are required to comply with the regulations applicable in the country where the products will be sold. Therefore, when registering the products in EU-CEG, it is necessary to have the results of tests, data from the producers of raw materials, as well as comprehensive knowledge on both Community and domestic legislation.

Comprehensive analysis with documentation

The Spark-Lab Laboratory offers comprehensive services for manufacturers and importers of ENDS and e-liquids. The laboratory develops techniques and analytical methods based on the requirements of ISO 17025:2018 and ISO 20768:2018. So far, the Laboratory has tested more than 4000 products from the Clients from Poland, Great Britain, Germany, the Netherlands, Italy, Belgium, and Greece. The range of services offered by Spark-Lab includes:

  • testing ENDS and e-liquids in accordance with TPD2
  • creating or verifying classification and labelling in accordance with CLP
  • creating or verifying safety data sheets in accordance with REACH
  • making available the toxicological data of the ingredients of the product
  • registration on the Common Entry Gate (EU-CEG) platform
  • PMTA tests for exporters to the American market
  • qualitative and quantitative tests of aromas if there is no data on the raw material
  • technical consultation in the event of the incompatibility of ingredients of the product or production problems
  • participating in research and development projects regarding new ENDS products and liquids used to fill them