4. Manufacturers or importers shall establish a report on the results of these studies. That report shall include an executive summary, and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive.

Manufacturers or importers shall submit these reports to the Commission and a copy thereof to the competent authorities of those Member States where a tobacco product containing this additive is placed on the market at the latest 18 months after the additive concerned has been included in the priority list pursuant to paragraph 1. The Commission and the Member States concerned may also request supplementary information from manufacturers or importers regarding the additive concerned. This supplementary information shall form part of the report.

The Commission and the Member States concerned may require these reports to be peer reviewed by an independent scientific body, in particular as regards their comprehensiveness, methodology and conclusions. The information received shall assist the Commission and Member States in taking the decisions pursuant to Article 7. The Member States and the Commission may charge manufacturers and importers of tobacco products proportionate fees for those peer reviews.

5. Small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC(18) shall be exempted from the obligations pursuant to this Article, if a report on that additive is prepared by another manufacturer or importer.

Article 7

Regulation of ingredients

1. Member States shall prohibit the placing on the market of tobacco products with a characterising flavour.

Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, for example sugar to replace sugar that is lost during the curing process, provided those additives do not result in a product with a characterising flavour and do not increase to a significant or measureable degree the addictiveness, toxicity or the CMR properties of the tobacco product.

Member States shall notify the Commission of the measures taken pursuant to this paragraph.

2. The Commission shall, at the request of a Member State, or may, on its own initiative, determine by means of implementing acts whether a tobacco product falls within the scope of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).

3. The Commission shall adopt implementing acts laying down uniform rules for the procedures for determining whether a tobacco product falls within the scope of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).

4. An independent advisory panel shall be established at Union level. Member States and the Commission may consult this panel before adopting a measure pursuant to paragraphs 1 and 2 of this Article. The Commission shall adopt implementing acts laying down the procedures for the establishment and operation of this panel.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).

5. Where the content level or concentration of certain additives or the combination thereof has resulted in prohibitions pursuant to paragraph 1 of this Article in at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 27 to set maximum content levels for those additives or combination of additives that result in the characterising flavour.