Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 concerns the manufacture, presentation and sale of tobacco and related products.
Part of the directive is dedicated to vaping and it sets several obligations for manufacturers and importers, such as:
-The maximum concentration of nicotine in e-liquid is fixed at 20 mg/ml;
-The maximum packaging volumes are limited to 10ml for e-liquid refill bottles and to 2ml to cartridge;
-A notification (both devices and liquid refills) must be submitted at least 6 months before a new product is placed on the market;
-Producers must notify in every State they intend to sell their products through a European Portal;
-Deadline notification for products already on sale is scheduled for November 20th, 2016;
-Cross border advertising could be prohibited (it’s up to every Member State to set the norm);
-Sales report must be submitted to each Member State.
The TPD-II sets out that Member States may charge proportionate fees for receiving, storing, handling and analysing the information submitted.
|COUNTRY||NOTIFICATION FEE||ANNUAL FEE|
|Austria||Waiting for response from the authority||Waiting for response from the authority|
|Belgium||165 € PER PRODUCT||No FEES envisaged
(Only notification FEE)
|Bulgaria||No FEES envisaged||No FEES envisaged|
|Croatia||Waiting for response from the authority||Waiting for response from the authority|
|Czech Republic||No FEES envisaged||Waiting for response from the authority|
|Denmark||Approx. 4946€ per product (36,900 krone per product)||Approx. 2159 € per product (14,700 krone per product) for annual maintenance of the notification.|
|Estonia||No FEES envisaged||No FEES envisaged|
|Finland||150€ per notification||The authority is not able to give any estimation on when the invoices will be sent.|
|France||295€ per product notification||120€ per product it shall be payed before 31st march of the year following the year o|
|Germany||No FEES envisaged||Waiting for response from the authority|
|Greece||56€ PER PRODUCT||Waiting for response from the authority|
(To be confirmed from the authority)
|Electronic cigarette by brand name and strength, HUF 475,000 (approx. 1543 €).
Refill bottles by brand name and strength, HUF 475,000 (approx. 1543 €).
Electronic device on the market by brand name, HUF 475,000 (approx. 1543 €).
Changes with regard to filing electronic cigarette brand name and strengths of each, HUF 306,000 (approx. 995 €).
Changes with regard to reporting refill bottle brand name and strength, HUF 306,000 (approx. 995 €).
Electronic device change notifications in respect of brand name, HUF 306,000 (approx. 995 €).
Fees must be paid to the National Institute of Pharmacy and Health Food (OGYE), account number: 10032000-00290050
|Request forwarded to competent authority|
|Ireland||No FEES envisaged||We are waiting for answers from Authorities|
|Italy||Not decided yet||Not decided yet|
|Latvia||€121.96 per product for the first time notification||€75,69|
|Lithuania||No FEES envisaged||No FEES envisaged|
|Luxemburgo||5.000€ PER PRODUCT||No FEES envisaged|
|Malta||No FEES envisaged||No FEES envisaged|
|Netherlands||€ 44,85 per new or modified product||Clients will receive an invoice for the notifications made before 20 November 2016 in the summer of 2017.|
|Poland||Medium-sized enterprises - 2137,85 pln (approx. 490€)
Small and micro- enterprises 1282,71 pln (approx. 295€)
other enterprises 4275,69 pln (approx. 980€).
|The manufacturer or importer shall pay the annual fee into the bank account indicated by the Inspector, within 14 days of receiving the instruction to pay, for receiving, storing, handling, analyzing and publishing information on tobacco products submitted.|
(To be confirmed from the authority)
|No FEES envisaged
(Only annual FEE)
|Electronic cigarettes and refill containers: 1000 euros.
The Taxes are 50% reduced if each notified product each year is less than 10.
|Romania||Waiting for response from the authority||Waiting for response from the authority|
|Slovakia||No FEES envisaged||No FEES envisaged|
|Slovenia||Law Consultation||Law Consultation|
|Spain||Legisalative approval process||Legislative approval process|
|Sweden||Waiting for response from the authority||Waiting for response from the authority|
|United Kingdom||150£ (approx. 175€)
80£ (approx. 94€) sustantial notification
|60£ (approx 70 euro) per product to be paid by 1st April|