TITLE II

TOBACCO PRODUCTS
CHAPTER I

Ingredients and emissions

Maximum emission levels for tar, nicotine, carbon monoxide and other substances
Article 3
1
The emission levels from cigarettes placed on the market or manufactured in the Member States (‘maximum emission levels’) shall not be greater than:
a
10 mg of tar per cigarette;
b
1 mg of nicotine per cigarette;
c
10 mg of carbon monoxide per cigarette.
2
The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to decrease the maximum emission levels laid down in paragraph 1, where this is necessary based on internationally agreed standards.
3
Member States shall notify the Commission of any maximum emission levels they set for emissions from cigarettes other than the emissions referred to in paragraph 1 and for emissions from tobacco products other than cigarettes.
4
The Commission shall adopt delegated acts in accordance with Article 27 to integrate standards agreed by the parties to the FCTC or by the WHO relating to maximum emission levels for emissions from cigarettes other than the emissions referred to in paragraph 1 and for emissions from tobacco products other than cigarettes into Union law.

Measurement methods
Article 4
1
The tar, nicotine and carbon monoxide emissions from cigarettes shall be measured on the basis of ISO standard 4387 for tar, ISO standard 10315 for nicotine, and ISO standard 8454 for carbon monoxide.
The accuracy of the tar, nicotine and carbon monoxide measurements shall be determined in accordance with ISO standard 8243.
2
The measurements referred to in paragraph 1 shall be verified by laboratories which are approved and monitored by the competent authorities of the Member States.
Those laboratories shall not be owned or controlled directly or indirectly by the tobacco industry.
Member States shall communicate to the Commission a list of approved laboratories, specifying the criteria used for approval and the methods of monitoring applied, and shall update that list whenever any change is made. The Commission shall make those lists of approved laboratories publicly available.
3
The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to adapt the methods of measurement of the tar, nicotine and carbon monoxide emissions, where this is necessary, based on scientific and technical developments or internationally agreed standards.
4
Member States shall notify the Commission of any measurement methods they use for emissions from cigarettes other than the emissions referred to in paragraph 3 and for emissions from tobacco products other than cigarettes.
5
The Commission shall adopt delegated acts in accordance with Article 27 to integrate standards agreed by the parties to the FCTC or by the WHO for measurement methods into Union law.
6
Member States may charge manufacturers and importers of tobacco products proportionate fees for the verification of the measurements referred to in paragraph 1 of this Article.

Reporting of ingredients and emissions
Article 5
1
Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities the following information by brand name and type:
a
a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products, in descending order of the weight of each ingredient included in the tobacco products;
b
the emission levels referred to in Article 3(1) and (4);
c
where available, information on other emissions and their levels.
For products already placed on the market that information shall be provided by 20 November 2016.
Manufacturers or importers shall also inform the competent authorities of the Member States concerned, if the composition of a product is modified in a way that affects the information provided under this Article.
For a new or modified tobacco product the information required under this Article shall be submitted prior to the placing on the market of those products.
2
The list of ingredients referred to in point (a) of paragraph 1 shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in the tobacco products concerned. That list shall also indicate the status of the ingredients, including whether they have been registered under Regulation (EC) No 1907/2006 of the European Parliament and of the Council as well as their classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council .
3
The list referred to in point (a) of paragraph 1 shall also be accompanied by the relevant toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, referring in particular to their effects on the health of consumers and taking into account, inter alia, any addictive effects.
Furthermore, for cigarettes and roll-your-own tobacco, a technical document setting out a general description of the additives used and their properties, shall be submitted by the manufacturer or importer.
Other than for tar, nicotine and carbon monoxide and for emissions referred to in Article 4(4), manufacturers and importers shall indicate the methods of measurement of emissions used. Member States may also require manufacturers or importers to carry out studies as may be prescribed by the competent authorities in order to assess the effects of ingredients on health, taking into account, inter alia, their addictiveness and toxicity.
4
Member States shall ensure that the information submitted in accordance with paragraph 1 of this Article and of Article 6 is made publicly available on a website. The Member States shall take the need to protect trade secrets duly into account when making that information publicly available. Member States shall require manufacturers and importers to specify, when submitting the information pursuant to paragraph 1 of this Article and Article 6, the information which they consider to constitute trade secrets.
5
The Commission shall, by means of implementing acts, lay down and, if necessary, update the format for the submission and the making available of information referred to in paragraphs 1 and 6 of this Article and Article 6. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
6
Member States shall require manufacturers and importers to submit internal and external studies available to them on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions, as well as executive summaries of any market surveys they carry out when launching new products. Member States shall also require manufacturers and importers to report their sales volumes per brand and type, reported in sticks or kilograms, and per Member State on a yearly basis starting from 1 January 2015. Member States shall provide any other sales volume data that is available to them.
7
All data and information to be provided to and by Member States under this Article and under Article 6 shall be provided in electronic form. Member States shall store the information electronically and shall ensure that the Commission and other Member States have access to that information for the purposes of applying this Directive. Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.
8
Member States may charge manufacturers and importers of tobacco products proportionate fees for receiving, storing, handling, analysing and publishing the information submitted to them pursuant to this Article.

Priority list of additives and enhanced reporting obligations
Article 6
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 shall be exempted from the obligations pursuant to this Article, if a report on that additive is prepared by another manufacturer or importer.

Regulation of ingredients
Article 7
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.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 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).