Initiation by a Member State or the Commission
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.
Initial request to the manufacturer or importer
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.
Initial coordination
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.
Assessment of the manufacturer or importer
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
