EN Official Journal of the European Union L 309/15

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)

THE EUROPEAN COMMISSION,

Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1), and in particular Article 20(13) thereof,

Whereas:

(1) Directive 2014/40/EU provides that manufacturers and importers of electronic cigarettes and refill containers are to submit to the competent authorities of the Member States concerned a notification of any such products which they intend to place on the market or which are already placed on the market on 20 May 2016. The information should be submitted 6 months before the intended placing on the market of new or substantially modified products. The format for that notification should be laid down.

(2) The experience gained and the knowledge acquired with existing formats for the reporting of tobacco ingredients, where relevant, should be taken into account when developing the format.

(3) A common electronic notification format for submission of information on electronic cigarettes and refill containers should allow Member States and the Commission to process, compare, analyse and draw conclusions from the information received. The data will also provide a basis for assessing health impacts associated with these products.

(4) A common electronic entry gate for submission of data is essential to ensure uniform application of the notification obligations set out in Directive 2014/40/EU. In particular, a common entry gate facilitates and harmonises the submission of data from the manufacturer or importer to the Member States. Streamlining the submission process also reduces administrative burden for manufacturers, importers and national regulators and facilitates comparison of data. To facilitate multiple uploads, a repository might be established at the level of the common entry gate to allow for references to non-confidential documents. The common entry gate should foresee tools for submission of information which are adequate both for companies which have comprehensive IT solutions in place (system to system submissions) and for companies which have no such solutions, in particular small and medium sized companies. Companies will be provided with a submitter identification number which should be used for all submissions by this company.

(5) Member States should be free to make the tools for submission of information laid down in this Decision available for submission of information required under Article 20(7) of Directive 2014/40/EU. The tools could also facilitate submission of other information on electronic cigarettes and refill containers pursuant to Article 20. Manufacturers and importers should be encouraged to keep data provided to Member States up-to-date. To facilitate comparison within the Union, Member States should encourage manufacturers and importers to submit updates during the first half of the subsequent calendar year. When sales data is reported under this format it should relate to the calendar year.

(6) When resubmitting data, including correcting errors in an earlier submission, the information should be provided through the common entry gate.

(7) In order to ensure the quality and comparability of data submitted, Member States should, where applicable, encourage manufacturers and importers to use agreed standards or testing methods. In the absence of agreed Union or international standards or testing methods, manufacturers and importers should clearly describe in their notifications the measurement methods used and should ensure that they are reproducible.

(8) In order to limit the administrative burden and ensure comparability between reported data, Member States should encourage manufacturers and importers to select compatible items when testing components of electronic cigarettes and refill containers placed on the market as separate items.

(9) Whilst the full responsibility for gathering, verifying, analysing as appropriate, storing and disseminating the data collected in accordance with this Decision lies with the Member States, they should have the possibility to store the data submitted to them at Commission facilities. The service offered by the Commission should provide Member States with technical tools to facilitate compliance with their obligations under Article 20 of Directive 2014/40/EU. The Commission will develop a standard service level agreement for this purpose. The Commission should keep an off-line copy of the data submitted through the common entry gate for the purpose of applying Directive 2014/40/EU.

(10) When submitting information on products with the same composition and design, manufacturers and importers should, to the extent possible, use the same product identification number, regardless of brand and subtype or whether they are placed on the market in one or more Member States.

(11) It is appropriate to lay down rules concerning the treatment of confidential data by the Commission in order to ensure the greatest possible transparency of product information for the general public, whilst ensuring that due account is taken of trade secrets. The legitimate expectation of consumers to have access to adequate information on the content of products they intend to consume should be weighed against manufacturers' interests of protecting recipes of their products. Having regard to those competing interests, data that could reveal ingredients used in small quantities in specific products should, in principle, be kept confidential.

(12) Personal data should be processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council (2) and of Regulation (EC) No 45/2001 of the European Parliament and of the Council (3).

(13) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

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

Article 2

Format for notification

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.

Article 3

Storage of data

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.

Article 4

Identification number of the data submitter

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.

Article 5

Identification number of the product

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.

Article 6

Confidential data and disclosure of data

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 (4), 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.

Article 7

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 24 November 2015. For the Commission Vytenis ANDRIUKAITIS Member of the Commission

(1) OJ L 127, 29.4.2014, p. 1.

(2) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

(3) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

(4) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).