Binding Decision Published on the Refill Mechanisms of E-cigarettes

Hong Kong and Chinese mainland sellers of electronic cigarettes (e-cigarettes) may like to know that the European Commission has adopted a Decision (2016/586) on technical standards for the refill mechanism of e-cigarettes. This decision has come about in addition to Directive 2014/40/EU harmonising Member States’ rules on the manufacture, presentation and sale of tobacco and related products, including e-cigarettes. Hong Kong traders familiar with EU law will note that this Decision is binding on all Member States.

Electronic cigarettes are being marketed globally, with the number of ‘vapers’ (e-cigarette users) growing exponentially. When the user inhales, the solution is vaporised – hence the term vaping - and nicotine is imbibed without tar and toxins. This, according to vapers and the product’s supporters, is the crucial difference between electronic and traditional cigarettes.

The rise of the e-cigarette has been spectacular, with several brands being made in mainland China for export to the EU. Due to the rapid spread of e-cigarettes (especially among those who want to stop smoking and switch to a less harmful alternative), the Directive was introduced to harmonise EU standards.

Hong Kong traders in the business of selling e-cigarettes must ensure that their product complies with the new Decision in addition to the requirements of the Directive.

The new Decision provides technical standards for the refill mechanism of electronic cigarettes. Hong Kong sellers should note that Article 2(1) of the Decision states that Member States must ensure that refillable e-cigarettes and refill containers can only be placed on the EU market if the refilling mechanism meets either of the following conditions:

(a) it entails the use of a refill container possessing a securely attached nozzle at least 9 mm long, which is narrower than, and slots comfortably into, the opening of the tank of the electronic cigarette with which it is used, and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected to atmospheric pressure alone at 20 °C ± 5 °C.

(b) it operates by means of a docking system which only releases refill liquids into the tank of the electronic cigarette when the electronic cigarette and refill container are connected.

In addition, refillable e-cigarettes and refill containers with refill mechanisms set out above must also include the appropriate instructions on refilling, including diagrams as set out in Article 2 (2) of the Decision in accordance with Article 20 (4)(a)(i) of the Directive.

If the refill mechanism is in accordance with (a) above, the instructions for use must indicate the width of the nozzle or width of the opening of the tank in the instructions for use in a manner that enables consumers to identify the compatibility of refill containers and electronic cigarettes.

If the refill mechanism is in accordance with (b) above, the instructions for use must specify the types of docking system with which such electronic cigarettes and refill containers are compatible.

The Decision also states that the Commission will consider information provided by stakeholders on alternative mechanisms to ensure leakage-free refilling of e-cigarettes, and is therefore open to amending this Decision accordingly.

The other salient harmonising features for e-cigarettes, set out primarily in Article 20 of the Directive, are as follows:

• Manufacturers and importers of e-cigarettes and refill containers must submit a notification to the national competent authority of each Member State where any such products are to be placed on the market. The notification must contain a variety of information, including contact details, list of ingredients, toxicological data and a description of the production process. Thereafter, certain information must also be submitted on an annual basis.

• Nicotine-containing liquid may only be placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges. Moreover, the cartridges or tanks must not exceed a volume of 2 ml. Notably, the nicotine content in liquid must not contain nicotine in excess of 20 mg/ml.

• E-cigarettes must be child- and tamper-proof, be protected against breakage or leakage, and have a mechanism that ensures refilling can be carried out without leakage.

• There are also several information requirements. Unit packets and refill containers must include a leaflet with information on, among others, instructions for use, contra-indications, warnings for any specific risks, any adverse effects, and addictiveness and toxicity. Furthermore, packaging must contain a list of all ingredients, nicotine content and delivery per dose, as well as carry a health warning about nicotine being highly addictive.

• Any and all advertising of e-cigarettes to EU consumers (whether online or otherwise) is to be banned. Moreover, Member States may prohibit the cross-border distance sales of e-cigarettes to consumers.

Hong Kong traders with business interests in e-cigarettes must ensure their products meet the technical requirements set out in the Decision before placing their product on the EU market. This is in addition to the obligations that were established by the Directive.

Please click on the following links to view the Decision 2016/586 and the Directive 2014/40/EU.