[ParlTrack]

Proposal for a directive
Recital 26

(26) Considerable volumes of illicit products, which do not comply with the requirements laid down in Directive 2001/37/EC, are placed on the market and indications are that these volumes might increase. Such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations. In addition, the FCTC obliges the Union to fight against illicit products, as part of a comprehensive tobacco control policy. Provision should thus be made for unit packets and any outside transport packaging of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the Union and their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security features that will facilitate the verification of whether or not products are authentic.

2013/05/14
Committee: ENVI

Linda McAVAN, Karl-Heinz FLORENZ

Proposal for a directive
Recital 33

(33) Nicotine-containing products are sold on the Union market. ~~The different regulatory approaches taken by Member States to address health and safety concerns associated with these products have a negative impact on th~~However, Member States have taken different regulatory approaches which are fun~~ctio~~dermining of the internal market, in particular considering that these products are subject to significant cross-border distance sales including via the internet. There is a need for harmonized rules, and given the potential of these products to aid with the harm reduction agenda, there should be an option for a light-touch regulatory regime to guarantee safety and quality, which is a middle-way between medicines and tobacco regulation.

2013/05/14
Committee: ENVI

Linda McAVAN

Proposal for a directive
Article 2 – paragraph 1 – point 24 a (new)

(24a) ‘outside transport packaging’ means any packaging, consisting of an aggregation of unit packets, in which tobacco products are transported from the manufacturer to the subsequent economic operators before being placed on the market, such as cartons, master cases and pallets;

2013/05/14
Committee: ENVI

Linda McAVAN

Proposal for a directive
Article 14 – paragraph 1

1. Member States shall ensure that all unit packets of tobacco products and any outside transport packaging shall be marked with a unique 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.

2013/05/21
Committee: ENVI

Linda McAVAN

Proposal for a directive
Article 14 – paragraph 1 a (new)

1a. Member States shall ensure that the unique identifiers of unit packets are linked to the unique identifier on the outside transport packaging. Any changes in links between unit packs and the outside transport packaging shall be recorded in the database mentioned in paragraph 6.

2013/05/21
Committee: ENVI

Linda McAVAN

Proposal for a directive
Article 18

Article 18 Nicotine-containing products 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. 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. 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. 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. 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, design and rotation of the health warnings.deleted

2013/05/14
Committee: ENVI

Linda McAVAN, Karl-Heinz FLORENZ

Proposal for a directive
Article 18 a (new)

Article 18 a Nicotine-containing products 1. Nicotine-containing products may only be placed on the market if they are authorised pursuant to: (a) Directive 2001/83/EC, or (b) The simplified procedure as set out in paragraph 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 shall be entitled to charge a fee for processing the application. They 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) flavourings shall not be allowed; (d) the sale of the product shall be restricted in line with the legal age for sale of tobacco products in the relevant Member State; (e) the products shall be available to be sold outside pharmacies; (f) advertising and promotion shall be appropriately regulated; 4. 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 5 years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary.

2013/05/14
Committee: ENVI

Linda McAVAN, Karl-Heinz FLORENZ

Proposal for a directive
Article 26 – paragraph 1 – introductory part

Member States may allow the following 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 + 2436 months]:

2013/05/14
Committee: ENVI

Linda McAVAN, Karl-Heinz FLORENZ

Proposal for a directive
Article 26 – paragraph 1 – point b

(b) nicotine containing products ~~below the threshold set out in Article 18(1)~~;

2013/05/14
Committee: ENVI

Activities of Linda McAVAN related to 2012/0366(COD)

Plenary speeches (3)

Reports (1)

Amendments (9)

ParlTrack - 2011-2024