1.   Where a Member State (‘the initiating Member State’) or the Commission considers that a tobacco product might have a characterising flavour, it may initiate the procedure for determining whether a tobacco product has a characterising flavour. A Member State may also request the Commission to initiate a procedure.

2.   The Commission may initiate the procedure referred to in paragraph 1 even where one or more procedures were initiated or concluded by one or more Member States, in particular, when it is necessary to ensure the uniform application of Article 7 of Directive 2014/40/EU.

1.   The initiating Member State or the Commission shall inform the manufacturer and importer of the product of its view that a tobacco product might have a characterising flavour and request the manufacturer or the importer to provide its assessment.

2.   The manufacturer or importer shall reply to and submit its written observations to the request within a period of four weeks from the receipt of the request referred to in paragraph 1, or by another date agreed with the initiating Member State or the Commission as applicable. In its reply, the manufacturer or importer shall identify, to the extent possible, any other Member States in which the same product has been placed on the market. The manufacturer shall also set out the views of its parent company, where applicable. The importer shall also set out the views of the manufacturer.

3.   The manufacturer or importer shall, in its reply under paragraph 2, indicate if it considers that same products placed on the market in other Member States have different flavours in one or more of the Member States concerned. In such a case, the manufacturer or importer shall set out the grounds upon which this claim is based.

1.   Where the procedure has been initiated by a Member State, that State shall notify the Commission and all other Member States of the initiation of the procedure without delay.

Where the Commission has initiated the procedure, it shall inform all the Member States of such initiation without delay.

The initiating Member State or the Commission shall communicate the information received from the manufacturer or importer in accordance with Article 4(2) to the other Member States and, where applicable, the Commission.

2.   Where a Member State has initiated a procedure, other Member States shall refrain from initiating a parallel procedure concerning the same product. Where procedures concerning the same product have already been initiated in two or more Member States, only the Member State in which the procedure was initiated first shall continue the procedure. By way of derogation, Member States concerned may agree that another Member State shall act as initiating Member State. All procedures initiated in Member States other than the initiating Member State shall be suspended pending the adoption of the decision by the initiating Member State.

3.   Where the Commission has initiated a procedure all Member States shall refrain from initiating procedures and, except insofar as provided for in the second subparagraph of Article 9(3), all pending national procedures shall cease.

4.   Information already gathered shall be exchanged between Member States and with the Commission, upon request.

1.   Where the manufacturer or importer does not dispute that a tobacco product has a characterising flavour, it shall inform the initiating Member State or the Commission accordingly in its reply submitted pursuant to Article 4(2).

Where, in its reply, the manufacturer or importer has not disputed that a tobacco product has a characterising flavour, or where it has failed to provide a reply in accordance with Article 4(2), the initiating Member State or the Commission, as applicable, may proceed to make a determination in accordance with Article 9 or 10 respectively in cases where it considers that the information at its disposal is sufficient to make a determination.

Insofar as the Member State or the Commission considers it necessary to obtain further information in order to be able to make a conclusive determination on whether the product has a characterising flavour, it may gather further information in accordance with Article 7 before making a determination in accordance with Article 9 or 10.

2.   Where the manufacturer or importer disputes that the product has a characterising flavour, the initiating Member State or the Commission shall continue the procedure in accordance with Articles 7 and 8.

1.   The initiating Member State or the Commission may request further information from the manufacturer or importer concerned, to be provided within a time limit to be specified in the request. It may also request information from other sources, exchange information with other Member States and, where applicable, the Commission and consult the independent advisory panel (hereafter the ‘panel’) established pursuant to Commission Implementing Decision (EU) 2016/786 (2).

2.   Where the panel is consulted, it shall submit its opinion within the time-frame applicable under Article 10(6) of Implementing Decision (EU) 2016/786.

1.   Where, on the basis of Article 6(2), the initiating Member State or the Commission has carried out further investigation under Article 7, and where having due regard to information obtained from that investigation, the initiating Member State or the Commission considers that a product has a characterising flavour it shall, before adopting a decision, provide the manufacturer or importer with an opportunity to submit written observations.

The Member State or the Commission shall provide the manufacturer or importer with a summary of the grounds upon which the proposed decision is to be adopted. Where the panel was consulted, its opinion shall be made available to the manufacturer or importer. The manufacturer or importer shall have four weeks to submit its observations. That time limit may be extended by agreement with the initiating Member State or the Commission as applicable. In its observations the manufacturer shall also indicate, where applicable, whether its parent company has been consulted. The importer shall indicate whether the manufacturer has been consulted.

2.   Where the initiating Member State or the Commission deems it necessary to gather additional information after receipt of the observations from the manufacturer or importer, it shall provide the manufacturer or importer with the additional information gathered and shall give it the opportunity to submit additional written observations.

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.

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.

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.

1.   In their communications, manufacturers and importers may request that certain information be kept confidential on the grounds that it constitutes a trade secret or is otherwise commercially sensitive. In such case, they shall clearly identify the information concerned and set out the reasons justifying their request.

2.   Where the request is considered justified, the Member States and the Commission shall ensure that the information received on the basis of this regulation is adequately protected. All communication of such information shall take place using mechanisms that permit the secure transmission of confidential information.