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| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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. ", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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.", | |
| "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. ", | |
| "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.", | |
| "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.", | |
| "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. ", | |
| "Member States shall ensure that the provisions and conditions laid down in Regulation (EC) No 1907/2006 are applied to tobacco products as appropriate.", | |
| "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, 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.", | |
| "This Article shall not apply to tobacco for oral use.", | |
| "Each unit packet of a tobacco product and any outside packaging shall carry the health warnings provided for in this Chapter in the official language or languages of the Member State where the product is placed on the market.", | |
| "Health warnings shall cover the entire surface of the unit packet or outside packaging that is reserved for them and they shall not be commented on, paraphrased or referred to in any form.", | |
| "Member States shall ensure that the health warnings on a unit packet and any outside packaging are irremovably printed, indelible and fully visible, including not being partially or totally hidden or interrupted by tax stamps, price marks, security features, wrappers, jackets, boxes, or other items, when tobacco products are placed on the market.", | |
| "The health warnings shall in no way hide or interrupt the tax stamps, price marks, tracking and tracing marks, or security features on unit packets.", | |
| "Images of unit packets and any outside packaging targeting consumers in the Union shall comply with the provisions of this chapter.", | |
| "Each unit packet and any outside packaging of tobacco products for smoking shall carry one of the following general warnings:‘Smoking kills – quit now’or‘Smoking kills’", | |
| "Each unit packet and any outside packaging of tobacco products for smoking shall carry the following information message:‘Tobacco smoke contains over 70 substances known to cause cancer.’", | |
| "For cigarette packets and roll-your-own tobacco in cuboid packets the general warning shall appear on the bottom part of one of the lateral surfaces of the unit packets, and the information message shall appear on the bottom part of the other lateral surface.", | |
| "The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to adapt the wording of the information message laid down in paragraph 2 to scientific and market developments.", | |
| "The Commission shall, by means of implementing acts, determine the precise position of the general warning and the information message on roll-your-own tobacco marketed in pouches, taking into account the different shapes of pouches.", | |
| "The unit packets and any outside packaging shall not suggest economic advantages by including printed vouchers, offering discounts, free distribution, two-for-one or other similar offers.", | |
| "The elements and features that are prohibited pursuant to paragraphs 1 and 2 may include but are not limited to texts, symbols, names, trademarks, figurative or other signs.", | |
| "Unit packets of roll-your-own tobacco shall have a cuboid or cylindrical shape, or the form of a pouch.", | |
| "Member States shall ensure that all natural and legal persons engaged in the supply chain of tobacco products maintain complete and accurate records of all relevant transactions.", | |
| "Recorded data shall not be modified or deleted by an economic operator involved in the trade of tobacco products." | |
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