40 Amendments of Michèle RIVASI related to 2012/0366(COD)
Amendment 21 #
Proposal for a directive
Recital 4
Recital 4
(4) In other areas there are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This applies in particular to nicotine containing products, herbal products for smoking, ingredients and emissions, certain aspects of labelling and packaging and the, cross-border distance saland internet sales of tobacco products and point-of- sale displays as well as vending machines of tobacco products.
Amendment 25 #
Proposal for a directive
Recital 10 a (new)
Recital 10 a (new)
(10a) Polonium 210 has been shown to be a significant carcinogen in tobacco. Its presence in cigarettes could be eliminated almost completely by a combination of simple measures. It is thus appropriate to set a maximum yield for Polonium 210 that would result in a reduction of 95% of the current average content of Polonium 210 in cigarettes. An ISO standard to measure Polonium 210 in tobacco should be developed.
Amendment 30 #
Proposal for a directive
Recital 14
Recital 14
(14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additives integrated in the filter of cigarettes as well as additives colouring the tobacco smoke. Without harmonisation, the obstacles on the internal market are expected to increase in the coming years taking into account the implementation of the FCTC and its guidelines and considering experience gained in other jurisdictions outside the Union. It is thus appropriate to introduce a positive list of additives that may be used in tobacco products. The guidelines on Articles 9 and 10 FCTC call in particular for the removal of ingredients that increase palatability, create the impression that the tobacco products have health benefits, are associated with energy and vitality or have colouring properties.
Amendment 31 #
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14a) It is important not only to consider the properties of additives as such, but also of their combustion products. Additives as well as their combustion products should not meet the criteria for classification as hazardous in accordance with Regulation EC (No) 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Amendment 38 #
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, 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 39 #
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 necessary for manufacturing 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 makingflavour and are not linked to attractiveness. The application of this Directive should not discriminate between different tobacco varieties.
Amendment 58 #
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) Studies have shown that standardising the presentation of the name of the trade mark and of the pack colour (plain packaging) makes packaging less attractive and enhances the effectiveness of health warnings, thereby decreasing smoking uptake and tobacco consumption. The guidelines on Articles 11 and 13 FCTC call on Parties to consider adopting plain packaging requirements.
Amendment 65 #
Proposal for a directive
Recital 30
Recital 30
(30) Cross-border distanceInternet sales of tobacco facilitate access to tobacco products of young people and risk to undermine 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 services40 , and should therefore be prohibited, in line with the implementing guidelines of the Framework Convention on Tobacco Control. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and 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 the Council of 25 October 2011 on consumer rights, as of 13 June 2014.41
Amendment 72 #
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 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 aHowever, measuring nicotine delivery has proven to be difficult, as it depends on the products and how they are being used. Therefore, subjecting all nicotine -containing product previously authorised under Directive 2001/83/EC, to the same legal frameworks regardless of their nicotine content to Directive 2001/83/EC 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.
Amendment 73 #
Proposal for a directive
Recital 35
Recital 35
Amendment 76 #
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, 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 182/201143 .
Amendment 92 #
Proposal for a directive
Recital 41
Recital 41
(41) Member States should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this Directive, provided they are compatible with the Treaty and do not jeopardise the full application of this Directive. Accordingly, Member States could, for instance, maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the Treaty, with WTO obligations and do not affect the full application of this Directive. A prior notification is required for technical regulations pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on Information Society services44 . (If corresponding amendments introducing standardised packaging are not adopted, this amendment should fall.)
Amendment 109 #
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 to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 127 #
Proposal for a directive
Article 3 – paragraph 1 – point c a (new)
Article 3 – paragraph 1 – point c a (new)
(ca) 0.002 picocuries of Polonium 210
Amendment 153 #
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 2 a (new)
Article 4 – paragraph 1 – subparagraph 2 a (new)
The Commission shall ask ISO to develop a standard to measure Polonium 210 in tobacco.
Amendment 156 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Amendment 164 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Amendment 169 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 3
Article 6 – paragraph 1 – subparagraph 3
Amendment 170 #
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 179 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically imparts a characterising flavourflavour or increases palatability only when it exceeds a certain level of presence or concentration the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives or combination of additives that cause the characterising flavourby modifying Annex -I accordingly.
Amendment 181 #
Proposal for a directive
Article 6 – paragraph 4 – introductory part
Article 6 – paragraph 4 – introductory part
4. Member States shall prohibit the use ofAnnex -I shall not contain the following additives in tobacco products:
Amendment 185 #
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Member States shall prohibit tThe 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 shall be prohibited. Filters and capsules shall not contain tobacco.
Amendment 193 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
Amendment 195 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
Amendment 196 #
Proposal for a directive
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 201 #
Proposal for a directive
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In case scientific evidence and the experience gained in the application of paragraphs 7 and 8 shows that a certain additive or a certain quantity thereof amplify in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product only when it exceeds a certain level of presence or concentration, including standard safety margins, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives by modifying Annex -I accordingly.
Amendment 214 #
Proposal for a directive
Article 6 – paragraph 10 a (new)
Article 6 – paragraph 10 a (new)
10 a. In order to obtain the entry of an ingredient in Annex -I, manufacturers and importers shall make an application to the Commission. The application shall be accompanied by the following particulars: (a) Name or corporate name and permanent address of the applicant; (b) Chemical name of the ingredient; (c) Function of the ingredient and maximum quantity to be used per cigarette; (d) Clear evidence supported by scientific data that the ingredient does not fall under any of the exclusion criteria listed in this Article. The Commission may ask the relevant scientific committee whether the ingredient concerned falls under any of the exclusion criteria listed in this Article as such, or only as of a certain concentration. The Commission shall take a decision in accordance with the procedure laid down in paragraph 1 no later than one year after receiving the application.
Amendment 233 #
Proposal for a directive
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) cover 7580 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 346 #
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. All outer surfaces of the unit packet and any outside packaging of tobacco for smoking shall be standardised in the following way: (a) not contain any trade mark or any other mark, apart from the brand name and any variant name for the tobacco products; (b) be of a dark, unattractive colour set by the Commission; (c) the brand name, and any variant name shall: (i) not appear more than once on any one surface (ii) appear horizontally below, and in the same orientation as, the combined health warning, in the centre of the space remaining on the front and back surfaces of the unit packet and any outside packaging; (iii) comply with any more detailed rules set out in paragraph 3;
Amendment 380 #
Proposal for a directive
Title II – chapter IV – title
Title II – chapter IV – title
Amendment 382 #
Proposal for a directive
Article 16 – title
Article 16 – title
Amendment 383 #
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 the sale of tobacco products over the internet in their territory. (Should replace the whole article)
Amendment 393 #
Proposal for a directive
Article 16 a (new)
Article 16 a (new)
Article 16a Point-of-sale displays of tobacco 1. Member States shall prohibit point-of- sale displays and vending machines of tobacco in their territory. 2. Tobacco products shall be completely concealed from the customer except during the purchase or sale of tobacco products, or stocktaking, restocking, staff training or maintenance of the storage unit. 3. Display of tobacco products for those reasons listed in paragraph 2 may only last as long as is necessary to complete those tasks. 4. Prices of tobacco products shall be listed in a standardised format. No package deals or special discounts shall be displayed.
Amendment 415 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
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: (If adopted, paragraphs 2 to 5 of this Article should be deemed to be deleted.)
Amendment 418 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 419 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 425 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 478 #
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
Amendment 481 #
Proposal for a directive
Article 26 – paragraph 1 a (new)
Article 26 – paragraph 1 a (new)
Member States may allow nicotine containing products which are not in compliance with this Directive to be placed on the market until [Publications Office, please insert the exact date: entry into force + 48 months]:
Amendment 484 #
Proposal for a directive
Annex - I (new)
Annex - I (new)
Annex -I Additives approved for use in tobacco products Chemical name of the additive - function - maximum level permitted