[ParlTrack]

Proposal for a directive
Recital 11

(11) In relation to the fixing of maximum yields, it might be necessary and appropriate at a later date to adapt the yields fixed or to fix maximum thresholds for emissions, taking into consideration scientific development and internationally agreed standards to assess their toxicity or addictiveness.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Recital 25

~~(25) Member States apply different rules on minimum number of cigarettes per packet. Those rules should be aligned in order to ensure free circulation of the concerned products.~~deleted

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Recital 30 a (new)

(30a) The Commission and Member States should increase their efforts to further control, prevent and suppress the illegal trade in tobacco goods manufactured in third countries.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Recital 35 a (new)

(35a) Member States should ensure that nicotine containing products are not sold to persons below the age required for purchasing tobacco products or related products.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
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.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
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, 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 Council.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
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.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 6 – paragraph 2 – subparagraph 2

The Commission shall adopt by means of implementing acts ~~uniform rules on the procedur~~criteria, procedures and methodologies 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 212.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 6 – paragraph 5

5. Member States shall prohibit the use of characterising flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity. Filters and capsules shall not contain tobacco.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 13 – paragraph 1

1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of roll-your- own tobacco shall have the form of a pouch, i.e. a rectangular pocket with a flap that covers the opening. The flap of the pouch shall cover at least 70% of the front of the packet. ~~A unit packet of cigarettes shall include at least 20 cigarettes. A unit packet of roll-your-own tobacco shall contain tobacco weighing at least 40 g.~~

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 14 – paragraph 1

1. For the purposes of effective tracking and tracing, Member States shall ensure that all unit packets of tobacco products including any external packaging, shall be marked with a unique, safe and indelible identifier. In order to ensure their integrity, unique identifiers shall be irremovably printed/affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or by the opening of the packet. In relation to products manufactured outside the Union the obligations laid down in this Article apply only to those destined to or placed on the Union market.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 18 – paragraph 1

1. The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC: (a) products with a nicotine level exceeding 2 mg per unit, or (b) products with a nicotine concentration exceeding 4 mg per ml or (c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.deleted

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
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 granted to nicotine- containing products pursuant to Directive 2001/83/EC.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 18 – paragraph 3

3. Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1 shall carry the following health warning: This product contains nicotine and can damage your health.deleted

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 18 – paragraph 4

4. The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10(4). In addition, it shall: a) be printed on the two largest surfaces of the unit packet and any outside packaging; 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 three official languages.deleted

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 18 – paragraph 5

~~5. The Commission shall be empowered to adopt~~ delegated acts in accordance with Article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position, format, layout, designand rotation of the health warnings.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 18 a (new)

Article 18a nicotine-containing products The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC or under the simplified procedure referred to in paragraphs 2 and 3: Simplified procedure 2. Under the simplified procedure, Member States shall require manufacturers and importers of nicotine- containing products to submit an application for a marketing authorisation, which shall contain the following: (a) evidence that the product is manufactured in accordance with the principles and guidelines of good manufacturing practice; (b) a detailed description of the product in question, including all ingredients and quantities thereof, as well as information on emissions; (c) a risk-management plan, including a system for monitoring and recording any adverse reactions. Member States may also require manufacturers or importers to carry out additional tests or submit additional information. Each Member State shall take due account of authorisations previously granted by another Member State. 3. For products authorised under the simplified procedure, Member States shall ensure that the following conditions are fulfilled: (a) the product is clearly labelled with the nicotine content, instructions for use, instructions for reporting adverse reactions, and details of the manufacturer; (b) each unit packet and any outside packaging shall carry the following health warning: This products is intended for use by existing smokers aged 18 or over as an alternative to tobacco cigarettes. It contains nicotine which is a highly addictive substance. Consult your doctor if you are pregnant, breast feeding, allergic to nicotine or propylene glycol, or have high blood pressure; (c) the use of characterising aromas shall not be authorised; (d) sale of the product shall be subject to the statutory age restrictions for the sale of tobacco products in the Member State in question; (e) advertising and promotion shall be appropriately regulated. 4. Member States shall ensure that nicotine-containing products are not sold to persons below the age required for purchasing tobacco products. 5. Member States shall monitor the development of the nicotine-containing products market, including any progress made in harm reduction, as well as any evidence of gateway use amongst young people. Based on the evidence, the Commission shall report back to the European Parliament and the Council five years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
Article 20 – paragraph 3

3. Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. The penalties provided for shall be effective, proportionate and dissuasive. All fines shall be greater than any financial rewards for infringement.

2013/06/13
Committee: JURI

Sergio Gaetano COFFERATI

Proposal for a directive
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 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.deleted

2013/06/13
Committee: JURI

Activities of Sergio Gaetano COFFERATI related to 2012/0366(COD)

Shadow opinions (1)

Amendments (19)

ParlTrack - 2011-2024