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June 2017

On 20 May 2016, Article 20 of the Tobacco Products Directive 2014/40/EU ("TPD") introduced new laws for nicotine-containing electronic cigarettes and refill containers for electronic cigarettes marketed as consumer products.¹ However, the transitional provisions of the TPD allowed Member States to permit a run-off period until 20 May 2017 for non-compliant electronic cigarettes and refill containers, provided that they were manufactured or released for free circulation before 20 November 2016. As those transitional arrangements have now come to an end, retailers will no longer be able to sell any electronic cigarettes or refill containers that do not comply with the TPD.

The requirements of the TPD include:

• A notification requirement. Manufacturers and importers of electronic cigarettes and refill containers are required to submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification must be submitted in electronic form six months before the intended placing on the market.² A new notification must be submitted for each substantial modification of the product.
• Volume and nicotine concentration limits. Nicotine-containing liquid (i.e. 'e-liquids') can only be placed on the market in dedicated refill containers not exceeding a volume of 10 ml. For disposable electronic cigarettes or single use cartridges, the cartridges or tanks must not exceed a volume of 2 ml. The nicotine concentration (strength) must not exceed 20 mg/ml.
• Purity and quality requirements. Only ingredients of high purity can be used in the manufacture of nicotine-containing liquid. Electronic cigarettes must deliver nicotine at consistent levels under normal conditions of use. Certain additives are also prohibited.
• Packaging requirements. Electronic cigarettes and refill containers must be child- and tamper-proof and protected against breakage and leakage and have a mechanism that ensures refilling without leakage.
• Labelling requirements and warnings. Unit packets of electronic cigarettes and refill containers must include a leaflet which includes (among other things): instructions for use and storage, contraindications, warnings for specific risk groups, possible adverse effects, addictiveness and toxicity, and contact details of the manufacture or importer. Packaging must contain (among other things): a list of ingredients in descending order of weight, nicotine content and delivery per dose, batch number, and a recommendation to keep the product out of reach of children. Packaging must also contain one of the obligatory health warnings.
• Monitoring and reporting requirements. Manufacturers, importers and distributers of electronic cigarettes and refill containers are required to establish and maintain a system for collecting information about all of the suspected adverse effects on human health. If a manufacturer, importer or distributer considers or has reason to believe that such products are not safe, not of good quality, or do not otherwise conform with the requirements of the TPD, then they must take immediate corrective action to bring the product into conformity or withdraw or recall it, as appropriate. In such cases, the market surveillance authorities of the Member State where the product is marketed or intended to be marketed must be informed.

The TPD was implemented in the UK through the Tobacco and Related Products Regulations 2016 (SI 2016/507). The Medicine and Healthcare products Regulatory Agency ("MHRA") is the UK's competent authority for the notification scheme and it is responsible for implementing the majority of the provisions under Article 20 TPD. The MHRA has published further guidance to assist manufacturers, importers and retailers on its website.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

1 The TPD does not apply to electronic cigarettes and refills authorised as medicinal products or medical devices

2 Article 20(2) sets out the information required in the notification. The relevant Information is submitted through a European Union Common Entry Gate (EU-CEG) notification portal. More information on EU-CEG can be found on the European Commission's website.

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