The Tobacco Products Directive (TPD) is a directive of the European Union which lays down the the rules governing the manufacture, presentation and sale of tobacco and related products. The TPD is aiming to improve the function of the market for tobacco and related products, while achieving public health objectives.
Each TPD Member States has transposed it into specific national transpositions: the obligations required of producers and importers to market a product are different in the each single national markets.
The Notification of TPD obliges manufacturers and importers to transmit to the Member States a wide range of information, from the formulation to commercial and production data, passing through toxicological dossiers of each ingredient and specific chemical analysis, with a particular attention to nicotine.
The submitter declares the conformity of the products with regard to the safety criteria established by the legislation. A notified product is not automatically authorized for sale, but rather exposes the notifier to the verification of what has been communicated to the authorities: Member States reserve six months from receipt of the notification to study the relative dossier, with particular attention to the danger of the products.
Before marketing the product, it is necessary to wait until the end of these six months period or, in some Member States, till the receipt of a communication from the competent Authorities.
Individual Member States may require fees for receiving, storing and managing the notified data and also for their annual update.
Product Compliance as below:
·E-liquid nicotine concentration is limited to 20 mg/ml (2%)
·E-liquid capacity of Tanks/Cartridges cannot be more than 2 ml
·E-liquid volume of bottles cannot be more than 10 ml
·Products (including devices and bottles) must be child-proof and tamper-proof
·Bottle possess securely attached nozzle at least 9 mm long
·Flow control of bottle emits no more than 20 drops of refill liquid per minute
PACKAGING AND LABELING
To comply with the TPD, electronic cigarettes and refill containers must show safety mechanisms such as child-proof structure, warranty seal, protection against breakage, anti-loss mechanism, recharging mechanism.
Furthermore, illustrative leaflets, unit packs and any external packaging must include specific information like list of ingredients, health warnings, etc. Also follow the obligations (size, font, etc.) defined by the TPD and its national transpositions.
* A warning shall appear on 2 largest surfaces of the unit packet and any outside packaging and cover >30% of the surface of the unit packet.
The TPD provides for restrictions on how vaping products are promoted, by prohibiting commercial communications via radio, audiovisual and print, with the exception of that reserved exclusively for professionals.