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Commission Implementing Regulation (EU) 2016/779 CHAPTER IV — DETERMINATION

Article 9–Article 11 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Coordination before a decision is taken by a Member State

Article 9

1.   The initiating Member State shall, on the basis of the information at its disposal, including any information obtained in accordance with Articles 6, 7 and 8, as applicable, prepare a draft decision as to whether or not the product is to be regarded as having a characterising flavour prohibited under Article 7(1) of Directive 2014/40/EU. The draft decision shall be reasoned, having due regard to the opinion of the panel, where applicable, and other available information as appropriate. The initiating Member State shall submit that draft decision to the Commission and the other Member States. It shall also submit the opinion of the panel, in case the panel was consulted, and provide details, to the extent possible, of any other Member States in which the same product has been placed on the market. The final decision may only be adopted after a period of four weeks has elapsed since the submission of the draft decision. That period may be extended by agreement between the initiating Member State and the Commission. 2.   The Commission and the other Member States may provide comments on the draft decision within a period of three weeks from the submission of the draft decision. Any objections to the conclusion reached in the draft decision shall be duly justified. 3.   The initiating Member State shall consider the comments received. In the event of divergence as to whether or not a product has a characterising flavour, the initiating Member State, the other Member States and the Commission, as applicable, shall endeavour to reach consensus. In the absence of consensus, where it is considered necessary to ensure the uniform application of Article 7(1) of Directive 2014/40/EU, the Commission shall initiate the procedure in accordance with Article 3(1). The initiation of the procedure by the Commission in accordance with the first subparagraph shall not affect the entitlement of the initiating Member State to proceed to adopt a decision prohibiting the product on the basis of Article 7(1). In that case, the initiating Member State shall notify the decision to the manufacturer or importer. It shall also submit a copy of the decision to the other Member States and the Commission, as appropriate, highlighting, to the extent possible, the Member State(s) in which the same product is placed on the market. Once the Commission has adopted its decision, the Member State shall immediately take any measures necessary to ensure that its national law complies with that decision. 4.   In the event that the Member States and Commission have not submitted objections in respect of the draft decision of the initiating Member State, that State shall adopt the decision and notify it to the manufacturer or importer. A copy shall be made available to the other Member States and the Commission, as appropriate, highlighting, to the extent possible, the Member State(s) in which the same product is placed on the market.

Decision by the Commission

Article 10

1.   Where the manufacturer or importer has informed the Commission that it does not dispute that a tobacco product has a characterising flavour, or where the manufacturer has not provided a reply in accordance with Article 4(2), the Commission shall, having due regard to information available at its disposal including any additional information or data obtained under Article 7, adopt a decision pursuant to Article 7(2) of Directive 2014/40/EU on whether or not a product has a characterising flavour. 2.   Where on the basis of Article 6(2), the Commission has proceeded to carry out an in-depth investigation in accordance with Articles 7 and 8, it shall, on the basis of the information obtained as a result of that investigation, adopt a decision pursuant to Article 7(2) of Directive 2014/40/EU on whether or not a product has a characterising flavour.

Parallel procedures

Article 11

1.   As soon as the initiating Member State has adopted a decision, the suspended national procedures relating to the same product may resume. If a Member State where the same product is placed on the market does not agree with the decision of the initiating Member State, it shall communicate its position to the Commission. The Commission shall consult the initiating Member State and the other Member States where the same product is placed on the market. If, based on this consultation, it is considered necessary to ensure the uniform application of Article 7(1) of Directive 2014/40/EU, the Commission shall initiate a procedure in accordance with Article 3(1). 2.   Where the Commission has taken a decision, all Member States shall ensure that the decision is adequately implemented.

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Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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