Eurofins provides comprehensive, third-party testing for electronic cigarettes (e-cigs) and e-cigarette liquids in accordance with the European Union’s Tobacco Products Directive (TPD – 2014/40/EU). So-called “vape” or “vaping” products represent a new and rapidly expanding segment within product testing, and our laboratory continually works to adapt our methods according to the latest developments in the field.
The Tobacco Products Directive
The TPD places limits on the sale and marketing of tobacco-related products in EU member states. Recent updates to the TPD have established the first EU-wide regulations on e-cigarette hardware and liquid that contains nicotine.
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
The requirements for electronic cigarettes imposed by the directive include limits for nicotine concentration levels, rules for packaging and labeling, and child-resistant guidelines. The TPD also requires that manufacturers and importers of vape products submit ingredient, emissions, and toxicological data to authorities in relevant member states using a digital platform called the EU Common Entry Gate (EU-CEG). See the European Commission’s webpage on the TPD for more information.
A notification must contain information about:
- Nicotine dose
- Toxicological data for ingredients
- Description of components and manufacturing process
- Declaration (liability)
There is also requirements for instruction manual and labeling, and physical and chemical restrictions, such as volume, nicotine content, additives, Cannabidiol, purity, health risk, constant nicotine doses in use, and child resistance.
Comprehensive e-cig testing
Eurofins is an independent, ISO 17025-accredited European laboratory. Our expertise in nicotine-based product testing draws on 30 years of collective knowledge and experience from a global organization of more than 40,000 employees distributed worldwide in over 600 locations.
For all types of e-cigarettes products, we can offer packaged solutions with every analytical method needed for a complete test. The methods that we use not only ensure that you can fulfill all the requirements necessary for getting your products on the market, they also help you to conduct a high level of quality control.
Eurofins specialists can assist you in every step of the process, including with initial screenings to determine the different substances present in new products. They make sure your product data is accurate and submitted through the EU-CEG for mandatory reporting to national authorities. Our laboratory is also able to provide general TPD guidance and check that your labeling complies with the directive.
Eurofins Product Testing offers all required tests and evaluations, and we also offer to handle the registration with EU’s Central Entry Gate.
- Review of technical documentation and labeling
- 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, nitrosamines, and heavy metals)
Additional optional related tests
- Screening for prohibited substances (GC/MS)
- The 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)
- Testing of Cannabidiol content and concentrations related to vape products and e-liquids.
- Testing against the presence of THC in Cannabidiol vape oil related to e-liquids.
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 Restricted 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)
As regulations governing e-cigarettes are relatively new and are expected to continue changing, many importers and manufacturers have been left with questions about their testing obligations. Eurofins has therefore endeavored to offer clear guidance to the industry, with credible reporting services at competitive prices.
Efuma ApS, a leading European wholesaler of vaping products based in Denmark, turned to Eurofins for help in meeting compliance with TPD requirements. Efuma selected Eurofins because of an international reputation for offering reliable quality assurance, and they have seen clear benefits from the partnership.
“If the testing has been done by Eurofins, the respective EU and national agencies know the results will be reliable,” says Efuma co-founder Jimmy Mortensen. “And as a company, we can be sure we’re putting safe, high-quality products out on the market.”
For more information please contact.
Business Development Manager