58 Amendments of Salvador SEDÓ i ALABART related to 2012/0366(COD)
Amendment 32 #
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 and menthol, 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 avoided36 .
Amendment 44 #
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 tobacco 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. The Commission should carefully monitor the use of water-pipe tobacco by young people as there is increasing evidence of their use beyond the traditional, older market;
Amendment 54 #
Proposal for a directive
Recital 23
Recital 23
(23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’, ‘slim’, names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed through appropriate packaging and labelling of such products and by informing consumers about its harmfulness, so that the consumer is fully aware of the consequences of consumption of the product.
Amendment 70 #
Proposal for a directive
Recital 34
Recital 34
(34) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use42 provides a legal framework to assess the quality, safety and efficacy of medicinal products including n. Nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account other than the tobacco products covered by this directive should be regulated under the niupcotmine content of the product in question. Subjecting all nicotine-containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilledg review of the pharmaceutical package with the purpose of informing and protecting consumers. The revision may include provisions allowing to market nicotine containing products with lower risk and a positive risk/benefit balance and which can help consumers to quit smoking as consumer products, provided they feature an adapted health warning.
Amendment 101 #
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited towith the exception of menthol, including fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 119 #
Proposal for a directive
Article 2 – paragraph 1 – point 23 a (new)
Article 2 – paragraph 1 – point 23 a (new)
(23a) "Tobacco products with lower risk" means a tobacco product that is designed and marketed to reduce the risks of smoking compared to conventional tobacco products, especially cigarettes, which is placed on the market after the entry into force of this Directive.
Amendment 161 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products with a characterising flavourdditives that give a dominant flavour that differs from that of tobacco, taking the provisions of paragraph 2 into account.
Amendment 167 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product with a characterising flavour.
Amendment 171 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
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, based on scientific evidence. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.
Amendment 172 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
Amendment 175 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 182 #
Proposal for a directive
Article 6 – paragraph 4 – point a
Article 6 – paragraph 4 – point a
a) vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards, or
Amendment 183 #
Proposal for a directive
Article 6 – paragraph 4 – point b
Article 6 – paragraph 4 – point b
b) caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality, or
Amendment 184 #
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Member States shall prohibit the use of flavouringsthe additives indicated in paragraphs 1 and 4 in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity. Filters and capsules shall not contain tobacco.
Amendment 194 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
Member States shall, based on scientific evidence, restrict or, if appropriately justified, prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreci measurable manner at the stage of consumption the toxic or addictive effect of a tobacco product.
Amendment 199 #
Proposal for a directive
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 204 #
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. , at the request of a Member State or on its own initiative, be able to determine by means of delegated acts whether or not to withdraw this exemption if there is a substantial change of circumstances involving an increase in sales volume by product category of at least 20% in the ten largest Member State markets by volume. Those delegated acts shall be adopted in accordance with the examination procedure referred to in Article 21 and shall not apply in the case of new tobacco products regulated in Article 17.
Amendment 216 #
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. In order to ensure their graphic integrity and visibility, and without prejudice to the labelling provisions in Article 10 and 11, 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 wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 220 #
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message shall cover 50% of the surface on which they are printed.
Amendment 234 #
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 262 #
Proposal for a directive
Article 9 – paragraph 1 – point g
Article 9 – paragraph 1 – point g
Amendment 263 #
Proposal for a directive
Article 9 – paragraph 1 – point g – point i
Article 9 – paragraph 1 – point g – point i
(i) height: not less than 6450 mm;
Amendment 281 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
Tobacco for smoking other than cigarettes and roll-your-own tobacco shall be exempted from the obligations to carry the information message laid down in Article 8(2) and the combined health warnings in Article 9in Articles 8 and 9. Each unit packet of tobacco for smoking other than cigarettes and roll- your-own tobacco shall carry the general text warning "Smoking kills / Smoking kills – Stop now". In addition to the general text warning specified in Article 8(1), each unit packet and any outside packaging of these products shall carry a text warning listed in Annex I. The general text warning specified in Article 8(1) shall include a reference to the cessation services in accordance with Article 9(1)(b).
Amendment 283 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
The general text warning shall be printed on the most visible surface of the unit packet and any outside packaging with the exception of transparent packaging used in retail sales. 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 on the other most visible surface of the unit packet and any outside packaging with the exception of transparent packaging used in retail sales.
Amendment 287 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The text warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging, with the exception of transparent packaging used in retail sales. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.
Amendment 288 #
Proposal for a directive
Article 10 – paragraph 3 – subparagraph 1 a (new)
Article 10 – paragraph 3 – subparagraph 1 a (new)
In the case of unit packets whose most visible surface exceeds 75 cm2, the warnings referred to in paragraphs 2 and 3 shall 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 to 26.25 cm2 for Member States with three official languages.
Amendment 290 #
Proposal for a directive
Article 10 – paragraph 4 – introductory part
Article 10 – paragraph 4 – introductory part
4. The general text warning and the text warning referred to in paragraph 1 shall be:
Amendment 292 #
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 be displayed by means of stickers, provided that such stickers cannot be removed. 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 proportionart of the area set aside for the text required;
Amendment 296 #
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 irremovably affixed, parallel to the top edge of the unit packet and any outside packaging;
Amendment 300 #
Proposal for a directive
Article 10 – paragraph 5
Article 10 – paragraph 5
Amendment 313 #
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 317 #
Proposal for a directive
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
Amendment 333 #
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 334 #
Proposal for a directive
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. Paragraph 2 shall not apply to trademarks that existed as at 19 December 2012.
Amendment 338 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
Amendment 341 #
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 cuboid or cylindrical shape, or 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 shall contain tobacco weighing at least 420 g.
Amendment 344 #
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
Amendment 353 #
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
Amendment 362 #
Proposal for a directive
Article 13 – paragraph 4
Article 13 – paragraph 4
Amendment 364 #
Proposal for a directive
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. The unique identifier referred to in paragraph 1 shall allow determining:
Amendment 384 #
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potential consumer is located. All retail outlets intending to engage in cross- border distance sales shall submit at least the following information to the competent authorities:prohibit cross- border distance sales.
Amendment 385 #
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 386 #
Proposal for a directive
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 387 #
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
Amendment 388 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 389 #
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
Amendment 390 #
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 391 #
Proposal for a directive
Article 16 – paragraph 5
Article 16 – paragraph 5
Amendment 395 #
Proposal for a directive
Article 17 – title
Article 17 – title
Amendment 397 #
Proposal for a directive
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Member States shall conduct a market approval system for tobacco products with a lower risk which shall be carried out for a reasonable fee. Member States shall require that manufacturers and importers of tobacco products notify the competent authorities of Member States of any novel tobacco products and for all tobacco products with a lower risk they intend to place on the markets of the Member States concerned. The notif by means of an application. This application 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, all proposed labelling, conditions of use, the product composition, manufacturing and control processes as well as information on ingredients and emissions in accordance with Article 5. The manufacturers and importers notifying a novel tobacco productapplying for a marketing authorization for tobacco products with a lower risk shall also provide the competent authorities in question with:
Amendment 399 #
Proposal for a directive
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) availablerelevant scientific studies on the toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions;
Amendment 400 #
Proposal for a directive
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) available studies and market research on the perception and use of the product including labelling by consumers as well as to the preferences of various consumer groups, includingespecially young people and
Amendment 401 #
Proposal for a directive
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
Amendment 402 #
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 1make available to the Commission all information received pursuant to this Article. Member States shall be entitabled to require tobacco manufactureradopt packaging and labelling rules for 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 feeall new tobacco products authorised as reduced-risk products which may differ from the requirements laid down by this Directive, and they shall notify the Commission of these rules.
Amendment 407 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. NExcept where authorised under the provisions of paragraph 2 of this Article, novel tobacco products placed on the market shall respect the requirements set out in this Directive. 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 444 #
Proposal for a directive
Article 22 – paragraph 2
Article 22 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(48(4), 9(3), 11(3), 14(9), 18(2) and 18(5) shall be conferred on the Commission for an indeterminate period of time from [Office of Publications: please insert the date of the entry into force of this Directive].
Amendment 453 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(48(4), 9(3), 11(3), 14(9), 18(2) and 18(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 461 #
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(48(4), 9(3), 11(3), 14(9), 18(2) and 18(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.