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Directive

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
Cyprus Unknown Unknown
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
Hungary
(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.
Portugal
(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€) initial notification
80£ (approx. 94€) sustantial notification
60£ (approx 70 euro) per product to be paid by 1st April

MEMBER STATES THAT HAVE ALREADY TRANSPOSED THE DIRECTIVE 2014/40/EU

Updated: November 2016

Directive transposed
Direttive is being transposed
Directive non transposed