Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers (notified under document C(2015) 8087) (Text with EEA relevance)

This Decision establishes a common format for the notification of information on electronic cigarettes and refill containers.

1 Member States shall ensure that manufacturers and importers of electronic cigarettes and refill containers submit information referred to in Article 20(2) of Directive 2014/40/EU, including modifications and withdrawal from the market, in accordance with the format provided for in the Annex.

2 Member States shall ensure that manufacturers and importers of electronic cigarettes and refill containers submit the information referred to in paragraph 1 by means of a common entry gate for data submission.

Member States shall be entitled to use data storage services offered by the Commission to comply with their obligations under Article 20(2) of Directive 2014/40/EU provided they have signed a service level agreement with the Commission.

Before submitting information to Member States for the first time pursuant to this Decision, the manufacturer or importer shall apply for an identification number (Submitter ID) generated by the operator of the common entry gate. The manufacturer or importer shall, upon request, submit a document providing company identification and authentication of activities in accordance with the national legislation where the company is established. The Submitter ID shall be used for all subsequent submissions and in all subsequent correspondence.

1 Based on the Submitter ID referred to in Article 4, the manufacturer or importer shall assign an E-Cigarette ID (EC-ID) for each product to be notified.

2 When submitting information on products with the same composition and design, manufacturers and importers shall, to the extent possible, use the same EC-ID, in particular where data are submitted by various members of a group of companies. This shall apply regardless of brand, subtype and the number of markets on which they are placed.

3 Where the manufacturer or importer is not able to ensure that the same EC-ID is used for products with the same composition and design, it shall at least provide, in so far as possible, the different EC-ID that were assigned to such products.

1 In their submission, manufacturers and importers shall mark all information which they consider to be a trade secret or otherwise confidential and shall, upon request, duly justify their claims.

2 In using the data transmitted for applying Directive 2014/40/EU and Regulation (EC) No 1049/2001 of the European Parliament and of the Council , the Commission shall, in principle, not consider the following information to be confidential or amount to a trade secret: (a) ingredients used in quantities above 0,1 % of the final formulation of the liquid; (b) studies and data submitted according to Article 20(2) of Directive 2014/40/EU, in particular on toxicity and addictiveness. Where those studies are linked to specific brands, the explicit and implicit references to the brand shall be removed and the redacted version shall be accessible.

This Decision is addressed to the Member States.