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

Article 6 Priority list of additives and enhanced reporting obligations

1. In addition to the reporting obligations laid down in Article 5, enhanced reporting obligations shall apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list. The Commission shall adopt implementing acts laying down and subsequently updating such a priority list of additives. This list shall contain additives:

(a) for which initial indications, research, or regulation in other jurisdictions exist suggesting that they have one of the properties set out in points (a) to (d) of paragraph 2 of this Article; and

(b) which are amongst the most commonly used additives by weight or number according to the reporting of ingredients pursuant to paragraphs 1 and 3 of Article 5.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). A first list of additives shall be adopted by 20 May 2016 and shall contain at least 15 additives.

2. Member States shall require manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive that is included in the priority list provided for in paragraph 1, to carry out comprehensive studies, which shall examine for each additive whether it:

(a) contributes to the toxicity or addictiveness of the products concerned, and whether this has the effect of increasing the toxicity or addictiveness of any of the products concerned to a significant or measurable degree;

(b) results in a characterising flavour;

(c) facilitates inhalation or nicotine uptake; or

(d) leads to the formation of substances that have CMR properties, the quantities thereof, and whether this has the effect of increasing the CMR properties in any of the products concerned to a significant or measurable degree.

3. Those studies shall take into account the intended use of the products concerned and examine in particular the emissions resulting from the combustion process involving the additive concerned. The studies shall also examine the interaction of that additive with other ingredients contained in the products concerned. Manufacturers or importers using the same additive in their tobacco products may carry out a joint study when using that additive in a comparable product composition.

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(1) shall be exempted from the obligations pursuant to this Article, if a report on that additive is prepared by another manufacturer or importer.

(1)

Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).