41 Amendments of Pilar DEL CASTILLO VERA 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 63 #
Proposal for a directive
Recital 29
Recital 29
(29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use38 prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition39 . The prohibitioHowever, the ban ofn the sale of oral tobacco should be maintained in order to prevent the introduction to the internalobacco products for oral use, should not affect historically traditional tobacco products for oral use, marketing of a product that is addictive, has adverse health effects and is attractive to young peoplewhich may be allowed by individual Member States. For other smokeless tobacco products that are not produced for the mass market, a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use.
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 110 #
Proposal for a directive
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
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 121 #
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 volume Member States´ markets 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 510 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 139 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 159 #
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 providing dominant flavour different from tobacco according to the provisions of paragraph 2.
Amendment 168 #
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 173 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 192 #
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 adequately 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 197 #
Proposal for a directive
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 205 #
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, at request of a Member State or on its own initiative, may determine through implementing acts to withdraw this excemption if there is a substantialignificant change ofin circumstances as established in a Commission reportinvolving an increase in sales volume by product category, at least 20 % in the ten largest markets by volume of the Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21; they shall not apply in the case of novel products as referred to in Article 17.
Amendment 207 #
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, and 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 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 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 250 #
Proposal for a directive
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) be positioned at the top edge of the unit packet and any outside packaging, and in the same direction as any other information appearing on the packaging;
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 284 #
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 irremovably affixed on the other most visible surface of the unit packet and any outside packaging.
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 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 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 363 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Member States shall ensure that all unit packets of tobacco products shall be marked with a unique, safe and impossible to duplicate identifier. In order to ensure their integrity, unique identifiers shall be irremovably printed/affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or by the opening of the packet. In relation to products manufactured outside the Union the obligations laid down in this Article apply only to those destined to or placed on the Union market.
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 369 #
Proposal for a directive
Article 14 – paragraph 8
Article 14 – paragraph 8
8. In addition to the unique identifier referred to in paragraph 1, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or other elements mandated by legislation.
Amendment 375 #
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 377 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. This ban shall, however, not affect traditional tobacco products for oral use, which may be allowed by individual Member States.
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 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 408 #
Proposal for a directive
Title III, title
Title III, title
Amendment 411 #
Proposal for a directive
Article 18
Article 18