69 Amendments of Oreste ROSSI related to 2012/0366(COD)
Amendment 73 #
Proposal for a directive
Recital 8
Recital 8
(8) In accordance with Article 114(3) of the Treaty ofn the Functioning of the European Union (hereinafter: “Treaty”), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. To that end, it is also essential to continue to provide education, information and prevention campaigns and programmes to help citizens who wish to give up smoking.
Amendment 109 #
Proposal for a directive
Recital 16
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 necessarywhich are essential for the manufacturinge 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 126 #
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, water- pipe 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. Or. it (See amendment to Article 6(10))
Amendment 136 #
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 haves 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, in order to be effective, 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 138 #
Proposal for a directive
Recital 22 a (new)
Recital 22 a (new)
Amendment 152 #
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 dimensionesign characteristics 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.
Amendment 176 #
Proposal for a directive
Recital 30
Recital 30
(30) Cross-border distance sales of tobacco, and practices such as the free distribution or swapping of tobacco products in public places for promotional purposes, facilitate access to tobacco products ofby young people and risk to undermineing compliance with the requirements provided for by tobacco control legislation and in particular by this Directive. Common rules on a notification system are necessary to ensure that this Directive achieves its full potential. The provision on notification of cross-border distance sales of tobacco in this Directive should apply notwithstanding the notification procedure set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, as of 13 June 2014. They should therefore be abolished. Or. it (See amendments to Article 16.)
Amendment 194 #
Proposal for a directive
Recital 33
Recital 33
(33) Non-tobacco nicotine-containing products are sold on the Union market. The different regulatory approaches taken by Member States to address health and safety concerns associated with these products have a negative impact on the functioning of the internal market, in particular considering that these products are subject to significant cross-border distance sales including via the internet.
Amendment 201 #
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 use provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine -containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine- containing products, whose nicotine content equals or exceeds the content of aExcluding non- tobacco nicotine -containing product previouslys authorised under Directive 2001/83/EC, to from the same legal frameworkcope of this Directive 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 fulfilled. Or. it (See amendments to Article 18.)
Amendment 208 #
Proposal for a directive
Recital 35
Recital 35
(35) Labelling provisProvisions on ingredients, labelling, and descriptions should be introduced for non-tobacco nicotine -containing products below the threshold set out incovered by this Directive in order to drawing the attention of consumers to potential health risks. Or. it (See amendments to Article 18.)
Amendment 214 #
Proposal for a directive
Recital 37
Recital 37
(37) In order to ensure uniform conditions for the implementation of this Directive, in particular concerning the format of ingredients reporting, and the determination of products with characterising flavours or with increased levels of toxicity and addictiveness and the methodology for determining whether a tobacco product has characterising flavour, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. Or. it (See amendment to Article 6(2), subparagraph 2.)
Amendment 226 #
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 methodology for determining whether a tobacco product has characterising flavour, 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, and 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 the Council. (See amendments to Article 3, Article 6(2), second subparagraph, and Article 18.)Or. it
Amendment 255 #
Proposal for a directive
Article 1 – paragraph 1 – point d
Article 1 – paragraph 1 – point d
(d) the prohibition of cross-border distance sales of tobacco products; Or. it See amendments to Article 16.
Amendment 267 #
Proposal for a directive
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
Amendment 293 #
Proposal for a directive
Article 2 – paragraph 1 – point 11 – introductory part
Article 2 – paragraph 1 – point 11 – introductory part
(11) ‘cross-border distance sales’ means a distance sales service where, at the time the consumer orders the product, the consumer is located in a Member State other than the Member State or the third country where the retail outlet is established; a retail outlet is deemed to be established in a Member State: Or. it See amendments to Article 16.
Amendment 294 #
Proposal for a directive
Article 2 – paragraph 1 – point 11 – point a
Article 2 – paragraph 1 – point 11 – point a
Amendment 295 #
Proposal for a directive
Article 2 – paragraph 1 – point 11 – point b
Article 2 – paragraph 1 – point 11 – point b
Amendment 307 #
Proposal for a directive
Article 2 – paragraph 1 – point 18
Article 2 – paragraph 1 – point 18
Amendment 310 #
Proposal for a directive
Article 2 – paragraph 1 – point 18 c (new)
Article 2 – paragraph 1 – point 18 c (new)
Amendment 317 #
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 321 #
Proposal for a directive
Article 2 – paragraph 1 – point 23
Article 2 – paragraph 1 – point 23
(23) ‘novel 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 Directive;
Amendment 326 #
Proposal for a directive
Article 2 – paragraph 1 – point 25
Article 2 – paragraph 1 – point 25
(25) ‘place on the market’ means to make products available to consumers located in the Union, with or without payment, including by means of distance sale; in case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located; ; Or. it See amendments to Article 16.
Amendment 343 #
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 10% in at least 10 Member States25% throughout the Union 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 Statesthroughout the Union 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 373 #
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the maximum yields laid down in paragraph 1, taking into account scientific development ando internationally agreed standards.
Amendment 389 #
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.(Text split between paragraph 3 and a new paragraph 3a for greater clarity.)
Amendment 394 #
Proposal for a directive
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
Amendment 413 #
Proposal for a directive
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Based on these methods, and taking into account scientific and technical developments as well as internationally agreed standards the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt and adapt methods of measurement.
Amendment 416 #
Proposal for a directive
Article 4 – paragraph 4 a (new)
Article 4 – paragraph 4 a (new)
Amendment 441 #
Proposal for a directive
Article 5 – paragraph 6 a (new)
Article 5 – paragraph 6 a (new)
Amendment 501 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
The Commission shall adopt by means of implementing actsbe empowered to adopt delegated acts, in accordance with Article 22, to lay down uniform rules on the procedures for determining whether a tobacco product falls within the scope of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.
Amendment 538 #
Proposal for a directive
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5a. Paragraph 5 shall not apply to technical measures intended to decrease specific harmful components of smoke or enhance the biodegradability of tobacco products.
Amendment 582 #
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco, water-pipe 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 611 #
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, in black Helvetica bold type on a white or coloured background. 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 634 #
Proposal for a directive
Article 8 – paragraph 4 – point b
Article 8 – paragraph 4 – point b
(b) to define the position, format, layout and design of the health warnings laid down in this Article, including their font typsize and background colour, with due regard for the linguistic constraints obtaining in each Member State.
Amendment 670 #
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 698 #
Proposal for a directive
Article 9 – paragraph 1 – point f
Article 9 – paragraph 1 – point f
(f) be reproduced in accordance with the format, layout, design and proportions specified by the Commission pursuant to paragraph 3; Or. it (See amendment to Article 9(3)(c).)
Amendment 712 #
Proposal for a directive
Article 9 – paragraph 1 – point g
Article 9 – paragraph 1 – point g
Amendment 746 #
Proposal for a directive
Article 9 – paragraph 3 – point c
Article 9 – paragraph 3 – point c
(c) define the position, format, layout, designlayout, design (including font type and size), rotation and proportions of the health warnings, with due regard for the linguistic constraints obtaining in each Member State;
Amendment 767 #
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The general 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. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with threemore than two official languages.
Amendment 772 #
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
3. The text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with threemore than two official languages.
Amendment 806 #
Proposal for a directive
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(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 threemore than two official languages.
Amendment 861 #
Proposal for a directive
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2a. The variety of tobacco used to manufacture the product and/or its country of origin may be indicated on the unit packet.
Amendment 910 #
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
Amendment 928 #
Proposal for a directive
Article 13 – paragraph 4
Article 13 – paragraph 4
Amendment 1014 #
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 1042 #
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 theprohibit 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 toon their territory from engageing in cross-border distance sales shall submit at least the following information to the competent authorities:.
Amendment 1047 #
Proposal for a directive
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1a. Member States shall prohibit on their territory the distribution of free or discounted tobacco products and the swapping of new, sealed packets of tobacco products for packets that have already been opened, irrespective of the channels used.
Amendment 1055 #
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 1063 #
Proposal for a directive
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 1071 #
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
Amendment 1080 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 1090 #
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
Amendment 1098 #
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 1107 #
Proposal for a directive
Article 16 – paragraph 5
Article 16 – paragraph 5
Amendment 1151 #
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 Directive 2001/83/EC:Articles 6(1) to (9), 10, 12(1) and (2) and 16 shall apply, mutatis mutandis, to nicotine-containing products other than tobacco products.
Amendment 1165 #
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. Nicotine-containing products other than tobacco products in respect of which marketing authorisations are granted under Directive 2011/83/EC shall not be covered by this Directive.
Amendment 1178 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 1191 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1205 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1216 #
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
Amendment 1224 #
Proposal for a directive
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 1237 #
Proposal for a directive
Article 18 – paragraph 4
Article 18 – paragraph 4
Amendment 1246 #
Proposal for a directive
Article 18 – paragraph 5
Article 18 – paragraph 5
Amendment 1261 #
Proposal for a directive
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than 30 % of the area of the corresponding surface of the unit packet and of any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with threemore than two official languages.
Amendment 1272 #
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(3a), 4(3), 4(4), and 4(4a), 6(2),6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(54(9) shall be conferred on the Commission for an indeterminate period of timefive years from [Office of Publications: please insert the date of the entry into force of this Directive]..
Amendment 1284 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The delegation of powers referred to in Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(54(9) 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 1294 #
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. A delegated act pursuant to Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(54(9) 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.
Amendment 1353 #
Proposal for a directive
Annex 1 – point 14 a (new)
Annex 1 – point 14 a (new)
Amendment 1356 #
Proposal for a directive
Annex 1 – heading 1 a (new)
Annex 1 – heading 1 a (new)