The EU TPD regulation for electronic cigarettes was introduced in 2016 to ensure minimum safety and quality standards of the products to protect the consumers, and to protect children from getting injured by these products, and from starting to use them. If you are uncertain whether your e-cigarette fulfils all requirements, we offer to assess the compliance of your product.
The requirements for electronic cigarettes imposed by the TPD include certain rules for packaging and labelling. It must contain country-specific health warnings and safety precautions while certain elements are banned, e.g., promotional elements and elements and features that make it look like a food or cosmetic product.
Additionally, the e-cigarette product must have a leaflet containing information about the product, warnings, possible adverse effects, addictiveness, toxicity etc. We can help make sure the labelling and leaflet contains the right elements for any European language you could wish. Alternatively, we can provide you with all mandatory labelling and packaging information.
The TPD stipulates restriction on the maximum volume capacity for the e-cigarette liquid tank. Measuring this volume is not straight-forward due to the complexity of the product, the coil and the opening mechanism. We have the test method in-house to determine and document that the tank volume capacity fulfill the TPD requirements.
We can assess and ensure that your product is child- and tamperproof, including that your e-cigarette and packaging does not appeal to children, that it is secured by a sufficient fastenings and opening mechanisms, and is protected against breakage and leakage under mechanical stress.
If you must notify your product under TPD, we can also be of assistance, both when it comes to the initial notification process and the annual sales data reporting.
3 STEPS TO SUCCESS!
1. If your electronic cigarette includes an e-liquid, we evaluate each ingredient to check if all substances (CAS numbers) are suitable for vaping – both from a human health and from a regulatory perspective. If no liquid is included, continue to step 2.
The price per liquid (SKU) is 79 USD (up to 20 substances). This assessment should be done before you consider any other analysis or notification.
2. We need to know your expected markets, your role and responsibility, the expected sales volumes etc. Based on this we can estimate the extent of the process and your cost for regulatory compliance
The price varies from 0 to 2000 USD per SKU depending on product type and regulatory requirements. The price of each service we provide, will be detailed in the quotation
3. We conduct all required laboratory testing, either in our in-house laboratory facility or using external contract laboratories. We generate technical files and dossiers and submit notifications and registrations to relevant competent authorities. We also provide you with required labelling details and safety data sheets in any European language of interest.
WHAT WE DO
