BETA

53 Amendments of Bogdan Kazimierz MARCINKIEWICZ related to 2012/0366(COD)

Amendment 32 #
Proposal for a directive
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 .
2013/05/28
Committee: ITRE
Amendment 35 #
Proposal for a directive
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 or the traditional flavour of 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.
2013/05/28
Committee: ITRE
Amendment 40 #
Proposal for a directive
Recital 16
(16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products shouldall 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.
2013/05/28
Committee: ITRE
Amendment 44 #
Proposal for a directive
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;
2013/05/28
Committee: ITRE
Amendment 49 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 54 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 55 #
Proposal for a directive
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 by packaging and labelling such products appropriately and by informing consumers of their harmfulness, so that they are fully aware of the consequences of using such products.
2013/05/28
Committee: ITRE
Amendment 63 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 66 #
Proposal for a directive
Recital 31
(31) All tobacco products have the potential to cause mortality, morbidity and disability and their consumption should be contained. It is therefore important to monitor developments as regards novel tobacco products. A notification obligation for novel tobacco products should be put on manufacturers and importers, without prejudice to the power of the Member States to ban or to authorise them. The Commission should monitor the developments and submit a report 5 years after the date of transposition of this Directive, in order to assess whether amendments to this Directive are necessary. Children and young people must be educated, as this is the simplest and most effective way of preventing young people from starting to smoke. Consideration should also be given to creating a fund financed by the manufacturers of tobacco products, which would be used to fund anti-smoking campaigns. Member States should harmonise the legal age for purchasing tobacco products at 18.
2013/05/28
Committee: ITRE
Amendment 70 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 100 #
Proposal for a directive
Article 2 – paragraph 1 – point 4
4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or the traditional flavour of menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
2013/05/28
Committee: ITRE
Amendment 157 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products with a characterising flavour other than the traditional flavour of menthol, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness.
2013/05/28
Committee: ITRE
Amendment 166 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 190 #
Proposal for a directive
Article 6 – paragraph 5
5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness. Filters and capsules shall not contain tobacco.
2013/05/28
Committee: ITRE
Amendment 207 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 216 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 234 #
Proposal for a directive
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;
2013/05/28
Committee: ITRE
Amendment 250 #
Proposal for a directive
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;
2013/05/28
Committee: ITRE
Amendment 263 #
Proposal for a directive
Article 9 – paragraph 1 – point g – point i
(i) height: not less than 6450 mm;
2013/05/28
Committee: ITRE
Amendment 284 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 296 #
Proposal for a directive
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;
2013/05/28
Committee: ITRE
Amendment 300 #
Proposal for a directive
Article 10 – paragraph 5
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22, to withdraw the exemption laid down in paragraph 1 if there is a substantial change of circumstances as established in a Commission report.
2013/05/28
Committee: ITRE
Amendment 313 #
Proposal for a directive
Article 11 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the requirements in paragraphs 1 and 2 taking into account scientific and market developments.
2013/05/28
Committee: ITRE
Amendment 317 #
Proposal for a directive
Article 12 – paragraph 1 – point c
(c) refers to flavour, taste, any flavourings or other additives or the absence thereof;deleted
2013/05/28
Committee: ITRE
Amendment 318 #
Proposal for a directive
Article 12 – paragraph 1 – point c
(c) refers to flavour, taste, any flavourings or other additives or the absence thereof;deleted
2013/05/28
Committee: ITRE
Amendment 333 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 334 #
Proposal for a directive
Article 12 – paragraph 2 a (new)
2a. Paragraph 2 shall not apply to trademarks that existed as at 19 December 2012.
2013/05/28
Committee: ITRE
Amendment 353 #
Proposal for a directive
Article 13 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to define more detailed rules for the shape and size of unit packets in so far as these rules are necessary to ensure the full visibility and integrity of the health warnings before the first opening, during the opening and after reclosing of the unit packet.
2013/05/28
Committee: ITRE
Amendment 362 #
Proposal for a directive
Article 13 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to make either cuboid or cylindrical shape mandatory for unit packets of tobacco products other than cigarettes and roll-your-own tobacco if there is a substantial change of circumstances as established in a Commission report.
2013/05/28
Committee: ITRE
Amendment 363 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 377 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 384 #
Proposal for a directive
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.
2013/05/28
Committee: ITRE
Amendment 385 #
Proposal for a directive
Article 16 – paragraph 1 – point a
(a) name or corporate name and permanent address of the place of activity from where the tobacco products are supplied;deleted
2013/05/28
Committee: ITRE
Amendment 386 #
Proposal for a directive
Article 16 – paragraph 1 – point b
(b) the starting date of the activity of offering tobacco products for cross-border distance sales to the public by means of information society services;deleted
2013/05/28
Committee: ITRE
Amendment 387 #
Proposal for a directive
Article 16 – paragraph 1 – point c
(c) the address of the website/-s used for that purpose and all relevant information necessary to identify the website.deleted
2013/05/28
Committee: ITRE
Amendment 388 #
Proposal for a directive
Article 16 – paragraph 2
2. The competent authorities of the Member States shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in Directive 95/46/EC Retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant Member States.deleted
2013/05/28
Committee: ITRE
Amendment 389 #
Proposal for a directive
Article 16 – paragraph 3
3. If it is necessary in order to ensure compliance and facilitate enforcement, Member States of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this Directive in the Member State of destination.deleted
2013/05/28
Committee: ITRE
Amendment 390 #
Proposal for a directive
Article 16 – paragraph 4
4. Retail outlets engaged in distance sales shall be equipped with an age verification system, which verifies at the time of sale, that the purchasing consumer respects the minimum age foreseen under the national legislation of the Member State of destination. The retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system.deleted
2013/05/28
Committee: ITRE
Amendment 391 #
Proposal for a directive
Article 16 – paragraph 5
5. Personal data of the consumer shall only be processed in accordance with Directive 95/46/EC and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties. Personal data shall not be used or transferred beyond the purpose of this actual purchase. This also applies if the retail outlet forms part of a manufacturer of tobacco products.deleted
2013/05/28
Committee: ITRE
Amendment 400 #
Proposal for a directive
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
2013/05/28
Committee: ITRE
Amendment 408 #
Proposal for a directive
Title III, title
NON TOBACCO PRODUCTSdeleted
2013/05/28
Committee: ITRE
Amendment 411 #
Proposal for a directive
Article 18
Article 18 Nicotine-containing products 1. The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC: (a) products with a nicotine level exceeding 2 mg per unit, or (b) products with a nicotine concentration exceeding 4 mg per ml or (c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations granted to nicotine- containing products pursuant to Directive 2001/83/EC. 3. 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: This product contains nicotine and can damage your health. 4. The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10(4). In addition, it shall: (a) be printed on the two largest surfaces of the unit packet and any outside packaging; (b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages. 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position, format, layout, design and rotation of the health warnings.deleted
2013/05/28
Committee: ITRE
Amendment 414 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
2013/05/28
Committee: ITRE
Amendment 416 #
Proposal for a directive
Article 18 – paragraph 1 – point a
(a) products with a nicotine level exceeding 2 mg per unit, ordeleted
2013/05/28
Committee: ITRE
Amendment 420 #
Proposal for a directive
Article 18 – paragraph 1 – point b
(b) products with a nicotine concentration exceeding 4 mg per ml ordeleted
2013/05/28
Committee: ITRE
Amendment 423 #
Proposal for a directive
Article 18 – paragraph 1 – point c
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.deleted
2013/05/28
Committee: ITRE
Amendment 426 #
Proposal for a directive
Article 18 – paragraph 1 a (new)
1a. Member States shall introduce a ban on the use of nicotine-containing products in public places.
2013/05/28
Committee: ITRE
Amendment 427 #
Proposal for a directive
Article 18 – paragraph 1 b (new)
1b. Member States shall introduce a minimum age for purchasing nicotine-containing products.
2013/05/28
Committee: ITRE
Amendment 430 #
Proposal for a directive
Article 18 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations granted to nicotine- containing products pursuant to Directive 2001/83/EC.
2013/05/28
Committee: ITRE
Amendment 432 #
Proposal for a directive
Article 18 – paragraph 3 – subparagraph 1
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: This product contains nicotine and can damage your health.deleted
2013/05/28
Committee: ITRE
Amendment 433 #
Proposal for a directive
Article 18 – paragraph 4
4. The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10(4). In addition, it shall: (a) be printed on the two largest surfaces of the unit packet and any outside packaging; (b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.deleted
2013/05/28
Committee: ITRE
Amendment 435 #
Proposal for a directive
Article 18 – paragraph 5
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position, format, layout, design and rotation of the health warnings.
2013/05/28
Committee: ITRE
Amendment 480 #
Proposal for a directive
Article 26 – paragraph 1 – point b
(b) nicotine -containing products below the threshold set out in Article 18(1);
2013/05/28
Committee: ITRE