Activities of Carl SCHLYTER related to 2012/0366(COD)
Plenary speeches (1)
Manufacture, presentation and sale of tobacco and related products (debate)
Shadow reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products PDF (1 MB) DOC (2 MB)
Amendments (40)
Amendment 80 #
Proposal for a directive
Recital 10 a (new)
Recital 10 a (new)
(10 a) 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 101 #
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 having a 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 avoided . Sweden should be allowed to regulate flavours in snus at a national level. If Sweden fails to do so within a certain period of time, the provisions of this Directive should apply.
Amendment 156 #
Proposal for a directive
Recital 24
Recital 24
(24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products, which are mainly consumed by older consumers, should be granted an exemption from certain labelling 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 labelling of these other tobacco products should follow specific ruleshould be subject to the same labelling requirements as cigarettes and roll-your-own tobacco products. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.
Amendment 168 #
Proposal for a directive
Recital 28
Recital 28
(28) In order to ensure independence and transparency, manufacturers of tobacco productMember States should conclude data storage contracts with independent third parties, under the auspices of an external auditor, who should be appointed by the Commission. The data related to the tracking and tracing system should be kept separate from other company related data and be under the control of and accessible at all times by the competent authorities from Member States and the Commission.
Amendment 179 #
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 services , 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.
Amendment 200 #
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 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 205 #
Proposal for a directive
Recital 35
Recital 35
Amendment 213 #
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 182/2011 .
Amendment 236 #
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 services . (If corresponding amendments introducing standardised packaging are not adopted, this amendment should fall.)
Amendment 355 #
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 397 #
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 451 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Amendment 479 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Amendment 483 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 3
Article 6 – paragraph 1 – subparagraph 3
Amendment 486 #
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 512 #
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 516 #
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 532 #
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 542 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
Amendment 548 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
Amendment 553 #
Proposal for a directive
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 559 #
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 570 #
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 productsFlavours used in tobacco for oral use (snus) shall be exempted from the prohibitvisions laid down in paragraphs 1 and 5. T 1. If Sweden does not take measures on flavours based on the FCTC and its guidelines within four years from the entry into force of this Directive, 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 583 #
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; and (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 621 #
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. 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. For tobacco for smoking other than cigarettes and roll- your-own tobacco, the general warning and the information message shall be printed on the lateral sides of the unit packets. Both the general warning and the information message shall cover 50% of the surface on which they are printed.
Amendment 677 #
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 757 #
Proposal for a directive
Article 10
Article 10
Amendment 897 #
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 988 #
Proposal for a directive
Article 14 – paragraph 6
Article 14 – paragraph 6
6. Member States shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party, which shall host the data storage facility for data relating to the manufacturers and importer concerneds of tobacco products under their jurisdiction. The data storage facility shall be physically located on the territory of the Union. The suitability of the third party, in particular its independence and technical capacities, as well as the contract, shall be approved and monitored by an external auditor, who is proposed and paid by the tobacco manufacturer and approvointed by the Commission. Member States shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the Member States, the Commission and the independent third party on a permanent basis. In duly justified cases Member States or the Commission can provide manufacturers or importers access to this information, provided commercially sensitive information remains adequately protected in conformity with the relevant national and Union legislations.
Amendment 1029 #
Proposal for a directive
Title 2 – chapter 4 – title
Title 2 – chapter 4 – title
Amendment 1031 #
Proposal for a directive
Article 16 – title
Article 16 – title
Amendment 1043 #
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
Amendment 1156 #
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 1(a) - (c), 2 to 5 of this Article should be deemed to be deleted.)
Amendment 1173 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 1185 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1199 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1309 #
Proposal for a directive
Article 23 – paragraph 3 a (new)
Article 23 – paragraph 3 a (new)
3 a. Member States shall report every two years to the Commission on the enforcement of the measures taken pursuant to Council Recommendation 2003/54/EC of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control , in particular with regard to age limits set in national legislation, as well as their plans to increase the age limit to achieve the goal of a "smoke-free generation".
Amendment 1330 #
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 1332 #
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
Amendment 1337 #
Proposal for a directive
Annex 1 a (new)
Annex 1 a (new)
Annex -I Additives approved for use in tobacco products Chemical name of the additive - function - maximum level permitted