Tobacco Products Directive (TPD) 2014/40/EU
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.
So-called “vape” or “vaping” products represent a new and rapidly expanding segment within product testing and our laboratories continually work to adapt our methods according to the latest developments. The TPD 2014/40/EU places limits on the sale and marketing of tobacco-related products in EU member states and represents the first EU-wide regulations on e-cigarette hardware and nicotine containing liquids.
TPD 2014/40/EU notification requirements
The Tobacco Products Directive (TPD) came into force on 20th May 2016, bringing with it new requirements for both importers and manufacturers of electronic cigarettes (e-cigarettes) plus an overall requirement that product notification must be made for e-cigarette products containing nicotine.
The requirements for electronic cigarettes imposed by the TPD directive include limits for nicotine concentration levels, rules for packaging and labeling, and child-resistant guidelines. The TPD also requires manufacturers and importers of vape products to 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:
- Nicotine dose
- Toxicological data for ingredients
- Description of components and manufacturing process
- Declaration (liability)
There are also requirements for:
- Instruction manual and labeling
- physical and chemical restrictions such as volume, nicotine content, additives, Cannabidiol, purity, health risk
- Constant nicotine doses in use
- Child resistance
We Offer Comprehensive E-cigarette Testing* **
Eurofins has independent, ISO 17025 accredited laboratories. Our expertise in nicotine-based product testing draws on 30 years of collective knowledge and experience from a global organization to help you gain compliance with all the applicable European Directives.
For all types of e-cigarettes products, we 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 initial screenings to determining the substances present in new products. We make sure your product data is accurate and submitted through the EU-CEG for mandatory reporting to national authorities and can provide general TPD guidance including verifying whether your labeling is compliant.
E-cigarette testing we can perform
Eurofins Product Testing offers all required tests and evaluations, and can handle the registration with EU Common Entry Gate.
- Review of technical documentation and labeling
- Toxicological evaluation of ingredients
- Product registration
Testing of electrical parts
Tests applicable to the charger:
- Electromagnetic Compatibility (EMC) Directive 2014/30/EU
- Tests and reports for compliance with IEC 61000 series and EN 55014-1 and EN 55014-2 standards
- Low Voltage Directive (LVD) 2014/35/EU
- Electrical Safety Tests and Report for compliance with IEC 60335-1 and IEC 60335-2-29 standards
- Electromagnetic Field (EMF) testing and reports 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; e.g. Cadmium, PAHs, Nickel, Organotins, lead
- 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. Being specialist in the field, Eurofins is able to offers clear guidance to industry through our expert and testing services.
*Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC.
**The regulations and standards above are not a full list of those within our capabilities; please enquire on a case by case basis.
For more information about please contact our e-cigarette competence center Eurofins Product Testing in Denmark, or if only for electrical testing of an e-cigarette charger your local Eurofins Electrical and Electronic (E&E) laboratory.