Notification of electronic cigarettes and refill containers

Article 20 of the EU Tobacco Products Directive (Directive 2014/40/EU) governs electronic cigarettes and refill containers through a notification regime, not premarket authorisation. A manufacturer or importer notifies each member state's competent authority via the EU Common Entry Gate (EU-CEG) six months before placing a product on the market — and may sell only once that standstill has run from a complete notification. The notification must contain, by brand name and type, the ingredients and emissions with quantities, toxicological data including when heated, nicotine dosing, a device-design description, the production process, and a full-responsibility declaration. Article 20(3) caps nicotine at 20 mg/ml, refill containers at 10 ml, and tanks and cartridges at 2 ml, and requires child- and tamper-resistant, leak-protected designs. Each substantial modification is a fresh notification with a fresh standstill.