27 Amendments of Jan BŘEZINA 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 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 78 #
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 should 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 for non-essential elements of the Directive. 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 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 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 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 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 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 406 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. 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. New tobacco products that have been scientifically proven to be less harmful than conventional tobacco products may, by way of derogation from the provisions of Article 12(1)(b), be labelled with information on their reduced harmfulness.