Directive 2014/40/EU of the European Parliament and of the CouncilShow full title

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.

6. Member States shall prohibit the placing on the market of tobacco products containing the following additives:

(a) vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;

(b) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;

(c) additives having colouring properties for emissions;

(d) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake; and

(e) additives that have CMR properties in unburnt form.

7. Member States shall prohibit the placing on the market of tobacco products containing flavourings in any of their components such as filters, papers, packages, capsules or any technical features allowing modification of the smell or taste of the tobacco products concerned or their smoke intensity. Filters, papers and capsules shall not contain tobacco or nicotine.

8. Member States shall ensure that the provisions and conditions laid down in Regulation (EC) No 1907/2006 are applied to tobacco products as appropriate.

9. Member States shall, on the basis of scientific evidence, prohibit the placing on the market of tobacco products containing additives in quantities that increase the toxic or addictive effect, or the CMR properties of a tobacco product at the stage of consumption to a significant or measureable degree.

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

10. The Commission shall, at the request of a Member State, or may, on its own initiative, determine by means of an implementing act whether a tobacco product falls within the scope of paragraph 9. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2) and shall be based on the latest scientific evidence.

11. Where an additive or a certain quantity thereof has been shown to amplify the toxic or addictive effect of a tobacco product, and where this has resulted in prohibitions pursuant to paragraph (9) 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. In this case, the maximum content level shall be set at the lowest maximum level that led to one of the national prohibitions referred to in this paragraph.

12. Tobacco products other than cigarettes and roll-your-own tobacco shall be exempted from the prohibitions laid down in paragraphs 1 and 7. The Commission shall adopt delegated acts in accordance with Article 27 to withdraw that exemption for a particular product category, if there is a substantial change of circumstances as established in a Commission report.

13. The Member States and the Commission may charge proportionate fees to manufacturers and importers of tobacco products for assessing whether a tobacco product has a characterising flavour, whether prohibited additives or flavourings are used and whether a tobacco product contains additives in quantities that increase to a significant and measurable degree the toxic or addictive effect or the CMR properties of the tobacco product concerned.

14. In the case of tobacco products with a characterising flavour whose Union-wide sales volumes represent 3 % or more in a particular product category, the provisions of this Article shall apply from 20 May 2020.

15. This Article shall not apply to tobacco for oral use.