TPD-II 2018-07-18T15:44:36+00:00

TPD-II Directive

TPD-II stands for Tobacco Products Directive and deals with the requirements that vaping products must meet to be marketed in the Member States of the European Union.

The Tobacco Product Directive (TPD-II) was issued in 2014 by the European Union to regulate the processing, presentation and sale of tobacco products and related products, including vaping products, in order to guarantee consumers high levels of quality and safety.

It has been transposed by each Member States into specific national transpositions: the obligations required of producers and importers to market a product are therefore different in the each single national markets.

The European Commission has defined eight types of vaping products including hardware and e-liquid.

The TPD-II regulates the design of the product under different profiles, from formulation to packaging, defines the rules to be followed in terms of sales, notification and declarations of conformity.

NOTIFICATION PROCESS

Notification is one of the pillars of the TPD-II; it 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 dangerousness 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.

Lists of notified products

The TPD-II requires that the competent authorities of the Member States publish via web some of the information collected through the notification process, selected with due regard to the need to protect the trade secrets of the producers.

By accessing the institutional links shown here, it is possible to view the lists of notified products made available to date by the Member States.

RESTRICTION ON FORMULATION

The TPD-II places a ceiling on the nicotine content of e-liquid, and defines a list of banned substances, known as blacklist, that can not be used in the formulation.

In the national transcription, some Member States have integrated the TPD-II blacklist with additional substances, defining more restrictive lists of prohibited products.
By clicking the links here below, it’s possible to view institutional documents published by the relevant authorities. Contact us for support about it.

National blacklists

PACKAGING AND LABELING

To comply with the TPD-II, electronic cigarettes and refill containers must show safety mechanisms such as child-proof closure, warranty seal, protection against breakage, anti-loss mechanism, recharging mechanism allowed by the 2016/586 EU Implementing Decision of the European Commission.

Furthermore, illustrative leaflets, unit packs and any external packaging must include specific information (eg list of ingredients, health warnings, etc.) according to the obligations (size, font, etc.) defined by the TPD-II and its national transpositions.

SALE

The TPD-II provides for restrictions on how vaping products are sponsored, for example by prohibiting commercial communications via radio, audiovisual and print, with the exception of that reserved exclusively for professionals.

Cross-border distance sales are also regulated.