Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the submission and making available of information on tobacco products (notified under document C(2015) 8162) (Text with EEA relevance)

This Decision establishes a common format for the reporting and making available of information on ingredients and emissions of tobacco products and on sales volumes.

1 Member States shall ensure that manufacturers and importers of tobacco products submit information on ingredients, emissions and sales volumes referred to in Article 5 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 tobacco products submit the information referred to in paragraph 1 by means of a common electronic 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 5(7) of Directive 2014/40/EU provided they have signed a service level agreement with the Commission.

Before submitting information to Member States in accordance with this Decision for the first time, 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 a Tobacco Products ID (TP-ID) for each product to be reported.

2 When submitting information on products with the same composition and design, manufacturers and importers shall, to the extent possible, use the same TP-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 TP-ID is used for products with the same composition and design, it shall at least provide, in so far as possible, the different TP-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 When using the information transmitted for the purposes of 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 a trade secret: (a) for all tobacco products, inclusion and quantity of additives other than flavourings; (b) for all tobacco products, inclusion and quantity of ingredients other than additives used in quantities above 0,5 % of the total tobacco product unit weight; (c) for cigarettes and roll-your-own tobacco, inclusion and quantity of individual flavourings used in quantities above 0,1 % of the total tobacco product unit weight; (d) for pipe tobacco, cigars, cigarillos, smokeless tobacco products and all other tobacco products inclusion and quantity of individual flavourings used in quantities above 0,5 % of the total tobacco product unit weight; (e) studies and data submitted according to Article 5(3) 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.