Activities of Niki TZAVELA related to 2012/0366(COD)
Shadow opinions (1)
OPINION 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
Amendments (12)
Amendment 71 #
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. Considering that a significant number of nicotine-containing products weare already authorised under this regulatory regime. The authorisation takes into account the ni, the Commission should as part of its upcotmine 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 relevant pharmaceutical legislation conduct a study and a full impact assessment, including stakeholder consultation, to determine the most appropriate regulation of electronic cigarettes on that basis.
Amendment 74 #
Proposal for a directive
Recital 35
Recital 35
Amendment 85 #
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. AThis directive fully harmonises certain aspects on the manufacture, presentation and sale of tobacco and related products and Member States should alsonot be allowed to maintroduce 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 nain or introduce in their national legislational provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved throughdiverging from the labelling and packaging requirements laid down in this Ddirective.
Amendment 91 #
Proposal for a directive
Recital 41
Recital 41
(41) Member States should remain free to maintain or introduce national legislations applybe able to adapt more stringent rules concerning to allbacco 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 compatiblewhich they deem necessary to protect public health, in-so- far as such rules fall outside the scope of the provisions of this Directive. In-so-far as tobacco or related products comply 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 procedurquirements of this Directive, Member States shall not prohibit or restrict the import, sale for the provision of information in the field of technical standards and regulations and on rules on Information Society services44 consumption of such products.
Amendment 125 #
Proposal for a directive
Article 2 – paragraph 1 – point 36 a (new)
Article 2 – paragraph 1 – point 36 a (new)
(36a) "Reconstituted tobacco" means the result of enhancement of different parts of the tobacco plant from threshing and the manufacture of tobacco products, whether used as a wrap for cigars and cigarillos either as sheets or individual strands as a component of the tobacco blend for cigarettes and other tobacco products.
Amendment 237 #
Proposal for a directive
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) cover 745 % of the external area of both the front and 60% of the external area of the back surface of the unit packet and any outside packaging;
Amendment 247 #
Proposal for a directive
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) be positioned at the bottopm edge of the unit packet and any outside packaging, and in the same direction as any other information appearing on the packaging;
Amendment 254 #
Proposal for a directive
Article 9 – paragraph 1 – point g
Article 9 – paragraph 1 – point g
Amendment 274 #
Proposal for a directive
Article 9 – paragraph 3 – point c
Article 9 – paragraph 3 – point c
(c) define the position, format, layout, design, rotation and proportions of the health warnings;
Amendment 279 #
Proposal for a directive
Article 9 – paragraph 3 – point d
Article 9 – paragraph 3 – point d
Amendment 470 #
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. AThis Directive shall not affect the right of 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 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 approveds to keep or introduce, in accordance with the Treaty, more stringent rules concerning the manufacture, import, sale and consumption of tobacco products which they deem necessary in order to protect public health, in-so-far as such rules fall outside the scope of the provisions of this Directive.
Amendment 471 #
Proposal for a directive
Article 24 – paragraph 3
Article 24 – paragraph 3