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Health and Safety Requirements for E-Cigarettes Rolled out EU-Wide

On 20 May 2016, all EU Member States were required to implement the EU’s Tobacco Products Directive (Directive 2014/40/EU). Its measures regulate the production and placing on the market of tobacco products, with the aim of reducing the number of tobacco users in the EU, and discouraging young people from taking up smoking. Hong Kong sellers of, among other such products, electronic cigarettes (e-cigarettes) will also find themselves affected by this law.

Directive 2014/40/EU, published on 29 April 2014, is felt to be ambitious: while it has revised (by toughening up) the provisions on tobacco cigarettes in comparison to its 2001 predecessor (Directive 2001/37/EC), the new law adds novel provisions on tobacco-related products, including e-cigarettes.

While e-cigarettes are generally considered as providing a “nicotine hit” to the lungs but without tar and toxins – this being the crucial difference between electronic and traditional cigarettes – there are still those who remain wary or opposed to the product. That being said,  the rise of the e-cigarette has been visible, with several brands being made in mainland China for export to the EU.

Hong Kong sellers should note that where a Member State legislates that a national authorisation is required for e-cigarettes to be sold on its territory, manufacturers or importers will become subject to a time-consuming and extremely costly procedure under Directive 2001/83/EC regulating medicines. Furthermore, whether or not flavours (e.g. chocolate, vanilla or tobacco flavours) will be allowed in e-cigarettes will also be left up to each Member State to decide.

That said, traders will be relieved to hear that Directive 2014/40/EU fully allows, in principle, the marketing of e-cigarettes, whether they are disposable (i.e. single use), rechargeable (with a single-use cartridge), or refillable (by means of a refill container). The other salient harmonising features for e-cigarettes, set out primarily in Article 20 of Directive 2014/40/EU, 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 which ensures that 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.  

An additional safeguard measure was also inserted into Article 20 of Directive 2014/40/EU. It stipulates that where a competent authority ascertains or has reasonable grounds to believe that specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, could present a serious risk to human health, it may take appropriate provisional measures. It must immediately inform the European Commission and the competent authorities of other Member States of the measures taken. The Commission will then determine, as soon as possible, whether the provisional measure is justified. If the specific product or product-type is prohibited by at least three Member States, the Commission may decide to extend the prohibition to all Member States.

Pursuant to Article 30 of Directive 2014/40/EU, Member States may allow certain products not in compliance with the Directive to be placed on the market until 20 May 2017. These include electronic cigarettes or refill containers manufactured or released for free circulation before 20 November 2016.

Please click on the following link to examine Directive 2014/40/EU. Hong Kong traders may also wish to examine the Commission’s press release of 20 May 2016, titled 10 key changes for tobacco products sold in the EU.

Content provided by Picture: HKTDC Research
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