Activities of Holger KRAHMER related to 2012/0366(COD)
Plenary speeches (1)
Manufacture, presentation and sale of tobacco and related products (debate)
Amendments (85)
Amendment 61 #
Proposal for a directive
Recital 2
Recital 2
(2) In its reports of 2005 and 2007 on the application of Directive 2001/37/EC, submitted in accordance with Article 11 of that Directive, the Commission identified areas in which further action was considered useful. In 2008 and 2010 the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) provided scientific advice to the Commission on smokeless tobacco products and tobacco additiveingredients. In 2010 a broad stakeholder consultation took place, which was followed by targeted stakeholder consultations and accompanied by studies by external consultants. Member States were consulted throughout the process. The European Parliament and the Council repeatedly called on the Commission to review and update Directive 2001/37/EC.
Amendment 92 #
Proposal for a directive
Recital 14
Recital 14
(14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additiveingredients integrated in the filter of cigarettes as well as additiveingredients colouring the tobacco smoke. Without harmonisation, the obstacles on the internal market are expected to increase in the coming years taking into account the implementation of the FCTC and its guidelines and considering experience gained in other jurisdictions outside the Union. The guidelines on Articles 9 and 10 FCTC call in particular for the removal of ingredients that increase palatability, create the impression that the tobacco products have health benefits, are associated with energy and vitality or have colouring properties.
Amendment 102 #
Proposal for a directive
Recital 15
Recital 15
(15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people. Measures introducing unjustified differences of treatment between flavoured cigarettes (e.g. menthol and clove cigarettes) should be avoided.
Amendment 107 #
Proposal for a directive
Recital 16
Recital 16
(16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additiveingredients altogether, but obliges the manufactures to reduce the additiveingredient or the combination of additiveingredients to such an extent that the additiveingredients no longer result in a characterising flavour. The use of additiveingredients necessary for manufacturing of tobacco products should be allowed, as long as they do not result in a characterising flavour. The Commission should ensure uniform conditions for the implementation of the provision on characterising flavour. Independent panels should be used by the Member States and by the Commission to assist in such decision making. The application of this Directive should not discriminate between different tobacco varieties.
Amendment 113 #
Proposal for a directive
Recital 17
Recital 17
Amendment 113 #
Proposal for a directive
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
Amendment 122 #
Proposal for a directive
Recital 18
Recital 18
(18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobaccotobacco for oral use which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.
Amendment 123 #
Proposal for a directive
Article 2 – paragraph 1 – point 30
Article 2 – paragraph 1 – point 30
(30) '‘substantial change of circumstances'’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 120% in at least 10the 10 biggest sales volume Member States based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 Member States for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;
Amendment 134 #
Proposal for a directive
Recital 22
Recital 22
(22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined health warnings are more effective than text-only warnings. In this light combined health warnings should become mandatory throughout the Union and cover significant and visible parts of the packet surface. A minimum size should be set for all health warnings to ensure their visibility and effectiveness.
Amendment 139 #
Proposal for a directive
Recital 23
Recital 23
Amendment 217 #
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed or irremovably affixed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 219 #
Proposal for a directive
Recital 38
Recital 38
(38) In order to make this Directive fully operational and to keep up with technical, scientific and international developments in tobacco manufacture, consumption and regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union shouldmay be delegated to the Commission, in particular in respect of adopting and adapting maximum yields for emissions and their measurement methods, setting maximum levels for ingredients that increase toxicity, addictiveness or attractiveness, the use of health warnings, unique identifiers and security features in the labelling and packaging, defining key elements for contracts on data storage with independent third parties, reviewing certain exemptions granted to tobacco products other than cigarettes, roll-your- own tobacco and smokeless tobacco products and reviewing the nicotine levels for nicotine containing products. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 235 #
Proposal for a directive
Recital 41
Recital 41
(41) Member States should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this Directive, provided they are compatible with the Treaty and do not jeopardise the full application of this Directive. Accordingly, Member States could, for instance, maintain or introduce provisions providing standardisation of packaging of tobacco productsbe able to introduce more stringent provisions for tobacco products, which they deem necessary to protect public health, provided that those provisions are compatibledo not fall within the Treaty, with WTO obligations and do not affect the full applicatscope of the provisions of this Directive. A prior notification is required for technical regulations pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for If tobacco products or related products fulfil the requirements of this Directive, Member States may neither provision of information in the field of technical standards and regulations and on rules on Information Society servicehibit nor restrict the import, sale or consumption of such products.
Amendment 249 #
Proposal for a directive
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) be positioned at the toplower edge of the unit packet and any outside packaging, and in the same direction as any other information appearing on the packaging;
Amendment 261 #
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
Amendment 271 #
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) '‘characterising flavour'’ means a distinguishable aromasweet, fruity or confectionery-type aroma differing from tobacco or a taste other thandistinguishable from tobacco, resulting from an additive flavouring or combination of additives, including but not limited to fruit, spice, herb, alcohol, cflavourings, which is observable upon intended use of the tobacco product. For the purposes of this definition, it is assumed that tobacco andy, menthol or vanilla observable before or upon intended use of the tobacco product;do not have a sweet, fruity or confectionery-type taste.
Amendment 285 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
The general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging. The text warnings listed in Annex I shall be rotated in such a way as to guarantee their regular appearance. These warnings shall be printed or affixed on the other most visible surface of the unit packet and any outside packaging.
Amendment 287 #
Proposal for a directive
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
Amendment 295 #
Proposal for a directive
Article 10 – paragraph 4 – point b
Article 10 – paragraph 4 – point b
(b) centred in the area in which they are required to be printed or affixed, parallel to the top edge of the unit packet and any outside packaging;
Amendment 297 #
Proposal for a directive
Article 10 – paragraph 4 – point c
Article 10 – paragraph 4 – point c
(c) surrounded by a black border not less than 3 mm and not more than 43 mm in width inside the surface reserved for the text of the warning.
Amendment 298 #
Proposal for a directive
Article 2 – paragraph 1 – point 13
Article 2 – paragraph 1 – point 13
(13) 'flavouring' means an additiveingredient that imparts aroma and/or taste;
Amendment 302 #
Proposal for a directive
Article 2 – paragraph 1 – point 18
Article 2 – paragraph 1 – point 18
(18) '‘ingredient'’ means an additive,y substance, apart from tobacco (leaves and other natural, processed or unprocessed parts of tobacco plants including expanded and reconstituted tobacco), as well as any substance, which is used in the making or preparation of a tobacco product, including paper, filter, inks, capsules and adhesives, and is present in a finished tobacco product, including paper, filter, inks, capsules and adhesivesin modified form;
Amendment 307 #
Proposal for a directive
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) be printed or affixed on the two largest surfaces of the unit packet and any outside packaging;
Amendment 314 #
Proposal for a directive
Article 2 – paragraph 1 – point 19
Article 2 – paragraph 1 – point 19
(19) '‘maximum level'’ or '‘maximum yield'’ means the maximum content or emission, including 0, of a substance in a tobacco product measured in grams;
Amendment 314 #
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
Amendment 318 #
Proposal for a directive
Article 2 – paragraph 1 – point 22
Article 2 – paragraph 1 – point 22
(22) 'nicotine-containing product' means a product usable for consumption by consumers via inhalation, ingestion or in other forms and to which nicotine is either added durwhich neither contaings the manufacturing process or self-administered by the user before or during consumptionobacco nor is a medicinal product within the meaning of Directive 2001/83/EC;
Amendment 319 #
Proposal for a directive
Article 2 – paragraph 1 – point 23
Article 2 – paragraph 1 – point 23
(23) 'novel‘low-risk tobacco product'’ means a tobacco product other than a cigarette, roll-your-own tobacco, pipe tobacco, water-pipe tobacco, cigar, cigarillo, chewing tobacco, nasal tobacco or tobacco for oral use placed on the market after entry into force of this Directivewhich has been developed or is marketed as a product posing a lower level of risk or which, according to the manufacturer’s claims, is less harmful;
Amendment 330 #
Proposal for a directive
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Prohibited elements and features may include but are not limited to texts, symbols, names, trade marks, figurative or other signs, misleading colours, inserts or other additional material such as adhesive labels, stickers, onserts, scratch-offs and sleeves or relate to the shape of the tobacco product itself. Cigarettes with a diameter of less than 7.5 mm shall be deemed to be misleading.
Amendment 335 #
Proposal for a directive
Article 2 – paragraph 1 – point 30
Article 2 – paragraph 1 – point 30
(30) 'substantial change of circumstances' means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 120% in at least 10 Member States based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 Member States for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;
Amendment 336 #
Proposal for a directive
Article 13
Article 13
Amendment 361 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 374 #
Proposal for a directive
Article 14 – paragraph 10
Article 14 – paragraph 10
10. Tobacco products other thanhe application of paragraph 1 to 8 shall for cigarettes and roll-your-own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5gin 3 years and for all other tobacco products 7 years following the date referred to in paragraph 1 of Article 25.
Amendment 384 #
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards, where available, and based on scientific evidence and on the yields notified by Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar, nicotine and carbon monoxide fixed in paragraph 1.
Amendment 404 #
Proposal for a directive
Article 4 – paragraph 3
Article 4 – paragraph 3
Amendment 410 #
Proposal for a directive
Article 4 – paragraph 4
Article 4 – paragraph 4
Amendment 418 #
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 1
Article 5 – paragraph 1 – subparagraph 1
Member States shall require manufacturers and importers of tobacco products to submit annually to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 424 #
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products. The list shall indicate their status, including whether the ingredients have been registered under 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) as well as their classification under 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. The list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients of the tobacco product concerned in burnt or unburnt form as appropriate, referring in particular to their effects on health of consumers and taking into account, inter alia, any addictive effects. The list shall be established in descending order of the weight of each ingredient included in the product. Other than for tar, nicotine and carbon monoxide in connection with cigarettes and for emissions referred to in Article 4 paragraph 4, the manufacturers and importers shall indicate the measurement methods used. Member States may also require manufacturers or importers to carry out other tests as may be laid down by the competent national authorities in order to assess the effects of substances on health, taking into account, inter alia, their addictiveness and toxicity.
Amendment 430 #
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 439 #
Proposal for a directive
Article 5 – paragraph 6 a (new)
Article 5 – paragraph 6 a (new)
6a. Manufacturers of tobacco products other than cigarettes and roll-your-own tobacco shall be exempt from the requirement to provide information on emissions and yields until such time as an appropriate measuring method has been developed at Union level.
Amendment 472 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Member States shall not prohibit the use of additiveingredients which are essential for the manufacture of tobacco products, as long as the additiveuse of those ingredients does not result in a product with a characterising flavour.
Amendment 488 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
Amendment 503 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 513 #
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
Amendment 528 #
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
Amendment 572 #
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco productstobacco for oral use shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
Amendment 574 #
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
Amendment 594 #
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of non-transparent wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 624 #
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
Amendment 638 #
Proposal for a directive
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. Each unit packet and any outside packaging of tobacco for smoking shall carry combined health warnings. The combined health warnings shall:
Amendment 645 #
Proposal for a directive
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) be comprised of a text warning listed in Annex I and a corresponding colour photograph specified in the picture library;
Amendment 650 #
Proposal for a directive
Article 9 – paragraph 1 – point a b (new)
Article 9 – paragraph 1 – point a b (new)
(ab) Member States may request authorisation to use health warnings comprised of a text warning listed in Annex I and a corresponding colour photograph specified in the picture library.
Amendment 667 #
Proposal for a directive
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) cover 750 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 686 #
Proposal for a directive
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) be positioned at the bottopm edge of the unit packet and any outside packaging, and in the same direction as any other information appearing on the packaging;
Amendment 703 #
Proposal for a directive
Article 9 – paragraph 1 – point g
Article 9 – paragraph 1 – point g
Amendment 739 #
Proposal for a directive
Article 9 – paragraph 3 – point c
Article 9 – paragraph 3 – point c
Amendment 751 #
Proposal for a directive
Article 9 – paragraph 3 – point d
Article 9 – paragraph 3 – point d
Amendment 774 #
Proposal for a directive
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. In the case of packets whose most visible surface has an area exceeding 75 cm², the warnings referred to in paragraphs 2 and 3 must cover an area of at least 22.5 cm² on each surface. That area shall be increased to 24 cm² for Member States with two official languages and 26.25 cm² for Member States with three official languages.
Amendment 776 #
Proposal for a directive
Article 10 – paragraph 4 – point a
Article 10 – paragraph 4 – point a
(a) printed in black Helvetica bold type on a white background. The warnings may also be affixed in the form of irremovable labels. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;
Amendment 781 #
Proposal for a directive
Article 10 – paragraph 4 – point c
Article 10 – paragraph 4 – point c
(c) surrounded by a black border not less than 3 mm and not more than 43 mm in width inside the surface reserved for the text of the warning.
Amendment 785 #
Proposal for a directive
Article 10 – paragraph 5
Article 10 – paragraph 5
Amendment 813 #
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
Amendment 840 #
Proposal for a directive
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Prohibited elements and features may include but are not limited to texts, symbols, names, trade marks, figurative or other signs, misleading colours, inserts or other additional material such as adhesive labels, stickers, onserts, scratch-offs and sleeves or relate to the shape of the tobacco product itself. Cigarettes with a diameter of less than 7.5 mm shall be deemed to be misleading.
Amendment 875 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of roll-your- own tobacco shall have the form of a pouch, i.e. a rectangular pocket with a flap that covers the opening. The flap of the pouch shall cover at least 70% of the front of the packet. A unit packet of cigarettes shall include at least 20 cigarettes. A unit packet of roll-your-own tobacco or a unit pack of ‘make your own’ tobacco shall contain tobacco weighing at least 40 g.
Amendment 889 #
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
Amendment 902 #
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
Amendment 919 #
Proposal for a directive
Article 13 – paragraph 4
Article 13 – paragraph 4
Amendment 1012 #
Proposal for a directive
Article 14 – paragraph 10
Article 14 – paragraph 10
10. Tobacco products other than cigarettes and roll-your-own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 510 years following the date referred to in paragraph 1 of Article 25.
Amendment 1111 #
Proposal for a directive
Title 2 – chapter 5 – title
Title 2 – chapter 5 – title
Amendment 1114 #
Proposal for a directive
Article 17 – title
Article 17 – title
Notification of novelreduced-risk tobacco products
Amendment 1121 #
Proposal for a directive
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Member States shall require that manufacturers and importers of reduced- risk tobacco products notify the competent authorities of Member States of any novelsuch tobacco product they intend to place on the markets of the Member States concerned. The notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as any proposed labelling, instructions for use, details of the product’s composition, the manufacturing process and associated controls and information on ingredients and emissions in accordance with Article 5. The manufacturers and importers notifying a novelreduced-risk tobacco product shall also provide the competent authorities in question with:
Amendment 1127 #
Proposal for a directive
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) available scientific studies on toxicity, addictivenessevidence of positive or negative effects, toxicity and attraddictiveness of the product, in particular as regards its ingredients and emissions;
Amendment 1128 #
Proposal for a directive
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) available studies and market research on how consumers perceive and use the product, including its labelling, and on preferences of various consumer groups, including young people and
Amendment 1133 #
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Member States shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point (a) to (c) of paragraph 1. Member States shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information. Member States shall make available to the Commission all information received pursuant to this Article. Member States shall be entitled to introduce an authorisation system and charge a proportionate feeprocedure, including the conditions for authorisation of reduced-risk tobacco products, and charge a proportionate fee. The conditions for authorisation shall stipulate, in particular, the requirements for scientific risk assessment and for the evidence- based demonstration of reduced risk and the provisions pursuant to subparagraphs (a) to (c) of paragraph 1, as well as the requirements for the manufacturing process, controls and market surveillance after a product has been placed on the market. Member States shall also stipulate the requirements for labelling, packaging and measuring, including methods for measuring tar, nicotine and carbon monoxide as well as the special additional ingredients used in reduced-risk tobacco products. Member States shall report to the Commission on these conditions of authorisation.
Amendment 1138 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. NovelLower-risk tobacco products placed on the market shall respect the requirements set out in this Directive, with the exception of Articles 4, 6, 7, 8, 9, 10, 12 and 13, which are to be adapted by the Member States to take into account lower-risk products. The provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point (29) of Article 2 or tobacco for smoking in point (33) of Article 2.
Amendment 1160 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nicotine-containing products may only be placed on the market if they were authorised pursuant to the simplified registration procedure under Articles 14 and 15 of Directive 2001/83/EC:
Amendment 1181 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
a) products for absorption with a nicotine level exceeding 2 mg per unit, or
Amendment 1194 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
b) products for inhalation with a nicotine concentration exceeding 4 mg per ml or
Amendment 1207 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
c) products whose intended use results in a mean maximum peak plasma concentration exceeding 425 ng of nicotine per ml.
Amendment 1212 #
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
Amendment 1227 #
Proposal for a directive
Article 18 – paragraph 3 – introductory part
Article 18 – paragraph 3 – introductory part
Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1 shall carry the following health warning:
Amendment 1249 #
Proposal for a directive
Article 18 – paragraph 5 a (new)
Article 18 – paragraph 5 a (new)
5a. No later than two years from the date specified in Article 25 paragraph 1, the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on whether to propose further legislation on the placing on the market of nicotine containing products not authorised pursuant to Directive 2001/83/EC. In the report, the Commission shall indicate in particular the features which should be considered in the light of developments in scientific and technical knowledge, including the development of internationally agreed rules and standards on products, paying special attention to: (a) standards for the manufacture and supply of nicotine containing products; (b) the appropriate minimum age of sale and purchase for nicotine containing products; (c) consumer information requirements; (d) advertising and communication in line with the harm reduction potential of the products, including the use of science based product claims; (e) the need to ensure availability of nicotine containing products to consumers of tobacco products. With a view to drafting the report the Commission, assisted by scientific and technical experts, shall analyse usage and consumption patterns of nicotine containing products.
Amendment 1311 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. However, a Member State may maintain more stringent national provisions, applicable to all products alike, in areas covered by the Directive, on grounds of overriding needs relating to the protection of public health. A Member State may also introduce more stringent provisions, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. Such national provisions shall be notified to the Commission together with the grounds forThis Directive shall not affect the right of Member States, in accordance with the Treaty, to maintaining or introducing them. The Commission shall, within six months from the date of receiving the notification, approve or reject the provisions after having verified, taking into account the high level of health protection achieved through this Directive, whether or not they are justified,e more stringent provisions with respect to tobacco products which they deem necessary andto proportionate to their aim and whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between the Member States. In the absence of a decision by the Commtect public health, provided these provisions do not fall within the scope of the provission within this period the national provisions shall be deemed to be appros of this Directived.
Amendment 1318 #
Proposal for a directive
Article 24 – paragraph 3
Article 24 – paragraph 3
Amendment 1331 #
Proposal for a directive
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
a) tobacco productscigarettes and roll-your-own tobacco;
Amendment 1336 #
Proposal for a directive
Article 26 – paragraph 1 – point c
Article 26 – paragraph 1 – point c
c) herbal products for smoking. Member States may allow tobacco products other than cigarettes and roll- you-own tobacco that do not comply with the provisions of this Directive until [Date of entry into force + 42 months].