2.

Manufacturers and importers of electronic cigarettes and refill containers shall 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 shall be submitted in electronic form six months before the intended placing on the market. For electronic cigarettes and refill containers already placed on the market on 20 May 2016, the notification shall be submitted within six months of that date. A new notification shall be submitted for each substantial modification of the product. The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information: the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union; a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof; toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect; information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions; a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers; a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article; a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions. Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned. Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.