Our roadmap to a successful TPD notification
The Tobacco Products Directive, or TPD, was initially introduced in 2001 to regulate tobacco products and protect consumers within the European Union, with e-cigarettes (and any other ENDS products) added to the regulations in 2014. This meant that any e-cigarette manufacturer now had to submit a TPD notification in order to sell their products in the EU. To help you through the process, we’ve created a roadmap which will result in a successful TPD notification.
TPD regulations and restrictions
Below is a summary of the restrictions in place within the European Union under TPD when selling ENDS products:
- The ENDS tank size must not exceed 2ml
- E-liquid bottle volume must not exceed 10ml
- The maximum nicotine (freebase) concentration of e-liquid must not exceed 20mg per ml
- Certain additives including ones that are harmful, create an impression of health benefit or are associated with energy are prohibited
- Products must be shown to deliver nicotine consistently
- E-cigarettes and refill containers must be in a child-resistant enclosure
- E-cigarettes and refill containers must be in a tamper resistant enclosure
- E-liquids and e-cigarettes must have a mechanism for refilling without leakage (e.g. nozzle)
If that sounds overwhelming, don’t worry. At Inter Scientific, we provide a fully inclusive TPD notification service which covers all of the requirements to notify your products with a quick turnaround time, keeping you fully informed through the process. This includes toxicological reports, product testing, packaging reviews and submitting the information collected to the EU Common Entry Gate to generate your notification.
Here’s a breakdown of our TPD notification process, so you can rest assured that your e-cigarette products are compliant with the EU laws.
In order to successfully notify a product under TPD, products must be tested to ensure that they are reasonably safe and that they deliver a consistent level of nicotine. We’ll ask you to send us samples of each product you will be submitting a notification for so we can carry out the required tests.
For e-liquids, testing is typically performed in conjunction with a test e-cigarette taking a representative sample of product aerosol and analyzing for the following chemicals;
Nicotine dose consistency will be determined by testing three or more blocks of inhalation, or ‘doses’ across a tank fill with the aim of demonstrating no significant change across the tank.
For e-cigarettes, in addition to the above-mentioned testing for e-liquids, the aerosol of the device will also be tested for metals content.
Once the products have been tested, our laboratory team will compile an emissions report and nicotine report, as well as a metals analysis to ensure the quality and stability of the product.
A part of the TPD notification, each ingredient in your product will need to be subject to a toxicological review in order to ensure that it is safe to be sold to the public and does not contain any prohibited ingredients.
In order for our team to complete these toxicology reports, we will need to know the ingredients included in each product so we can review them in relation to the following toxicological factors:
- Reproductive health toxicity
- Emissions toxicity
- Cardiopulmonary toxicity
- Any other known toxicological information
Packaging Submission and review
Finally, we’ll review your packaging. The packaging of e-cigarette products must include:
- A list of ingredients in descending order
- Indication of nicotine content
- Nicotine delivery per dose
- Batch number
- Keep product out of reach of children warning
- Health warning, typically; ‘This product contains nicotine which is a highly addictive substance’ of a specific size, e.g 30% of the largest two surfaces of packaging.
We’ll ask you to submit the packaging you use for your products, including artwork, to fully review and ensure that it is compliant with the TPD regulations.
Successful TPD notification generation
Once the above work has been carried out, we’re ready to assemble the information to create your TPD notification so it can be placed on the market in EU countries.
Our average turnaround time for this process is two weeks, and products may be placed on the market six months after the TPD notification is received.
Contact us today to learn how we can help you to achieve a successful TPD notification and get your e-cigarette products on the European market.