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.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.