42 Amendments of Christofer FJELLNER related to 2012/0366(COD)
Amendment 13 #
Proposal for a directive
Recital 13
Recital 13
(13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. In this light there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information should be ensured for the general public, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products and fulfils the Union’s international obligations contained in the WTO treaties.
Amendment 14 #
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 characterisingnon-tobacco dominant flavour other than tobacco, which may facilitate uptake ofr 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 avoidedraditional flavours such as menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns..
Amendment 25 #
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 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’, or ‘organic’, ‘without additives’, ‘without flavours’, ‘slim’, names, pictures, and figurative or other signs. Likewise, the size and appearance of individual ciga. In case the package cretates cana mislead consumers by creating theing impression that they cigarettes 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, health warnings must be adapted accordingly.
Amendment 40 #
Proposal for a directive
Recital 40
Recital 40
(40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States and consistent with WTO international obligations. Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved through this Directive.
Amendment 45 #
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 affectwith the WTO provisions, and do not jeopardise 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.
Amendment 144 #
Proposal for a directive
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
Amendment 170 #
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 use 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 prohibition . The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young peopleUpholds the ban on tobacco products for oral use, however, such a ban should not affect historically traditional tobacco products for oral use, which 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 172 #
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 use 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 prohibition . The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young people. As tobacco for oral use is prohibited to be placed on the internal market, oral tobacco products shall be exempted from the application of this Directive, except for Article 15. 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 190 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 199 #
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 which claim to have properties beneficial to human health. A significant number of nicotine-containing products werpresenting such claims have already been authorised under this regulatory regime. The authorisation Member Staktes into account the nicotine content of the product in question. Subjecting allare obliged to ensure 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 fulfilledich do not fall under Directive 2001/83/EC and which are placed on the common market comply with the appropriate legislation listed in [new] Annex IV.
Amendment 207 #
Proposal for a directive
Recital 35
Recital 35
(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directivefalling outside of the scope of Directive 2001/83/EC drawing the attention of consumers to potential health risks, and Member States should be obliged to ensure that national age restrictions for buying nicotine containing products are kept in line with those for the sale of tobacco products.
Amendment 230 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. However, a Member State may maintain more stringent national provisions, applicable to all products alike, in areas covered by the Directive, on grounds of overriding needs relating to the protection of public health. A Member State may also introduce more stringent provisions, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. Such national provisions shall be notified to the Commission together with the grounds for maintaining or introducing them. The Commission shall, within six months from the date of receiving the notification, approve or reject the provisions after having verified, taking into account the high level of health protection achieved through this Directive, whether or not they are justified, necessary and proportionate to their aim, compliant with the Treaty and the EU’s international obligations, including WTO obligations, and whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between the Member States. In the absence of a decision by the Commission within this period the national provisions shall be deemed to be approved.
Amendment 250 #
Proposal for a directive
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
Amendment 277 #
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 460 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products with a characterising flavour sweet and candy- like flavour.
Amendment 461 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products for smoking with a characterising flavour.
Amendment 476 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products for smoking, as long as the additives do not result in a product with a characterising flavour.
Amendment 569 #
Proposal for a directive
Article 6 – paragraph 10
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.
Amendment 799 #
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
This tobacco product can damage your health and is addictive, but presents substantially lower risks to your health than smoking
Amendment 1015 #
Proposal for a directive
Article 15
Article 15
Amendment 1018 #
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 should, however, not affect historically traditional tobacco products for oral use, which may be allowed by individual Member States.
Amendment 1020 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shallmay 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.
Amendment 1023 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Where necessary to achieve a high level of health protection, Member States shallmay 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.
Amendment 1024 #
Proposal for a directive
Article 15 – paragraph 1 a (new)
Article 15 – paragraph 1 a (new)
Maximum limits shall be set for toxic and carcinogenic substances present in smokeless tobacco products placed on the market. The substances and required limits are as detailed in [new] Annex III.
Amendment 1026 #
Proposal for a directive
Article 15 – paragraph 1 a (new)
Article 15 – paragraph 1 a (new)
Tobacco for oral use shall be exempted from the application of this Directive, except for Article 15.
Amendment 1027 #
Proposal for a directive
Article 15 – paragraph 1 b (new)
Article 15 – paragraph 1 b (new)
The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the substances and limit values laid down in paragraph 1a and Annex III, taking into account scientific developments and internationally agreed standards, taking account of the principles of proportionality, non-discrimination and the objective of developing the internal market with a high level of health protection.
Amendment 1150 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products that are presented as having properties for treating or preventing disease in human beings, other than through any message specified in paragraph 3, may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
Amendment 1162 #
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 1167 #
Proposal for a directive
Article 18 – paragraph 1 b (new)
Article 18 – paragraph 1 b (new)
Amendment 1168 #
Proposal for a directive
Article 18 – paragraph 1 c (new)
Article 18 – paragraph 1 c (new)
1c. Member States shall ensure that nicotine containing products comply with European Union consumer protection, safety and other relevant legislation in force.
Amendment 1169 #
Proposal for a directive
Article 18 – paragraph 1 d (new)
Article 18 – paragraph 1 d (new)
1d. No later than 12 months from entry into force of this Directive, each Member State shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in [new] Annex IV as it applies to nicotine containing products and the effectiveness of those measures.
Amendment 1170 #
Proposal for a directive
Article 18 – paragraph 1 e (new)
Article 18 – paragraph 1 e (new)
1e. Member States shall ensure that nicotine-containing products are not sold to persons below the national legal age for purchasing tobacco products.
Amendment 1171 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 1182 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1193 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
(b) products with a nicotine concentration exceeding 450 mg per ml or
Amendment 1196 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1218 #
Proposal for a directive
Article 18 – paragraph 2
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 grantey 1 April 2017, carry out a study on nicotine-containing products in consultation with relevant stakeholders and the Member States. This study will consider whether there is a need for specific legislation in regard to nicotine- containing products pursuant to Directive 2001/83/EC.
Amendment 1229 #
Proposal for a directive
Article 18 – paragraph 3 – introductory part
Article 18 – paragraph 3 – introductory part
Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1which do not fall under the scope of Directive 2001/83/EC shall carry the following health warning:
Amendment 1233 #
Proposal for a directive
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
This product contains nicotine which is addictive and canmay damage your health.
Amendment 1333 #
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);
Amendment 1359 #
Proposal for a directive
Annex 2 a (new)
Annex 2 a (new)
ANNEX III Maximum permissible content in smokeless tobacco, toxin per unit weight dry tobacco: NNN (N-nitrosonornicotine) plus NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1- butanone): 2.0 mg/kg B(a)P (Benzo[a]Pyrene): 5.0 µg/kg
Amendment 1360 #
Proposal for a directive
Annex 2 b (new)
Annex 2 b (new)