BETA

42 Amendments of Nora BERRA related to 2012/0366(COD)

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 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.

2013/05/29
Committee: INTA

Proposal for a directive
Recital 30

(30) Cross-border distance 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. 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 2014Therefore, cross-border distance sales of tobacco should be prohibited.

2013/05/29
Committee: INTA

Proposal for a directive
Article 1 – paragraph 1 – point d

(d) the prohibition of cross-border distance sales of tobacco products;

2013/05/29
Committee: INTA

Proposal for a directive
Recital 18

(18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.deleted

2013/05/08
Committee: IMCO

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 outside 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.

2013/05/08
Committee: IMCO

Proposal for a directive
Recital 30

(30) Cross-border distance 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. 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 2014ross-border distance sales of tobacco should therefore be prohibited.

2013/05/08
Committee: IMCO

Proposal for a directive
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 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 a nicotine containing product previously authorised under Directive 2001/83/EC, to~~Applying 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 fulfilled.

2013/05/08
Committee: IMCO

Proposal for a directive
Recital 35

~~(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directive drawing the attention of consumers to potential health risks.~~deleted

2013/05/08
Committee: IMCO

Proposal for a directive
Article 1 – paragraph 1 – point d

(d) the prohibition of cross-border distance sales of tobacco products;

2013/05/08
Committee: IMCO

Proposal for a directive
Article 14 – paragraph 2 a (new)

2a. Member States shall ensure that the unique identifiers on the packets are linked to the unique identifiers on the outside packaging. Any change made to the link between unit packets and outside packaging must be entered into the database referred to in paragraph 6.

2013/05/29
Committee: INTA

Proposal for a directive
Article 14 – paragraph 3

3. Member States shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet, record the entry of all unit packets and outside packaging into their possession, as well as all intermediate movements and the final exit from their possession. This obligation can be fulfilled by recording in aggregated form, e.g. of outside packaging, provided that tracking and tracing of unit packets remains possible.

2013/05/29
Committee: INTA

Proposal for a directive
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 manufacturer and importer concerned. 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 pai~~shall be appointed by the Commission. The costs incurred as a result of the contract with the auditor and the database management services shall be covered by the tobacco manufacturers and ~~approved by the Commission~~importers. 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.

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 1 – introductory part

1. Member States shall ~~oblige retail outlets intending to engage in~~prohibit cross- border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potentialof tobacco to consumer is located~~. All retail outlets intend~~ ing t~~o engage in cross- border distance sales shall submit at least the following information to the competent authorities:~~he Union.

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 1 – point a

~~(a) name or corporate name and permanent address of the place of activity from where the tobacco products are supplied;~~deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 1 – point b

~~(b) the starting date of the activity of offering tobacco products for cross-border distance sales to the public by means of information society services;~~deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 6 – paragraph 10

10. Tobacco products other than cigarettes, 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.deleted

2013/05/08
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 1 – point c

~~(c) the address of the website/-s used for that purpose and all relevant information necessary to identify the website.~~deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 2

2. The competent authorities of the Member States shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in Directive 95/46/EC Retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant Member States.deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 3

3. If it is necessary in order to ensure compliance and facilitate enforcement, Member States of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this Directive in the Member State of destination.deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 4

4. Retail outlets engaged in distance sales shall be equipped with an age verification system, which verifies at the time of sale, that the purchasing consumer respects the minimum age foreseen under the national legislation of the Member State of destination. The retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system.deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 16 – paragraph 5

5. Personal data of the consumer shall only be processed in accordance with Directive 95/46/EC and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties. Personal data shall not be used or transferred beyond the purpose of this actual purchase. This also applies if the retail outlet forms part of a manufacturer of tobacco products.deleted

2013/05/29
Committee: INTA

Proposal for a directive
Article 14 – paragraph 2 a (new)

2a. Member States shall ensure that the unique identifiers of unit packets are linked to the unique identifier on the outside packaging. Any changes in the links between unit packets and the outside packaging shall be recorded in the database mentioned in paragraph 6.

2013/05/13
Committee: IMCO

Proposal for a directive
Article 14 – paragraph 3

3. Member States shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet, record the entry of all unit packets and outside packaging into their possession, as well as all intermediate movements and the final exit from their possession. This obligation can be fulfilled by recording in aggregated form, e.g. of outside packaging, provided that tracking and tracing of unit packets remains possible.

2013/05/13
Committee: IMCO

Proposal for a directive
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 manufacturer and importer concerned. 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 pai~~shall be appointed by the Commission. The costs incurred as a result of the contract with the auditor and the database management services shall be covered by the tobacco manufacturers and ~~approved by the Commission~~importers. 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.

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 1 – introductory part

1. Member States shall ~~oblige retail outlets intending to engage in~~prohibit cross- border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potentialof tobacco to consumer is located~~. All retail outlets intend~~ ing t~~o engage in cross- border distance sales shall submit at least the following information to the competent authorities:~~he Union.

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 1 – point a

~~(a) name or corporate name and permanent address of the place of activity from where the tobacco products are supplied;~~deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 1 – point b

~~(b) the starting date of the activity of offering tobacco products for cross-border distance sales to the public by means of information society services;~~deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 1 – point c

~~(c) the address of the website/-s used for that purpose and all relevant information necessary to identify the website.~~deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 2

2. The competent authorities of the Member States shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in Directive 95/46/EC Retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant Member States.deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 3

3. If it is necessary in order to ensure compliance and facilitate enforcement, Member States of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this Directive in the Member State of destination.deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 4

4. Retail outlets engaged in distance sales shall be equipped with an age verification system, which verifies at the time of sale, that the purchasing consumer respects the minimum age foreseen under the national legislation of the Member State of destination. The retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system.deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 16 – paragraph 5

5. Personal data of the consumer shall only be processed in accordance with Directive 95/46/EC and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties. Personal data shall not be used or transferred beyond the purpose of this actual purchase. This also applies if the retail outlet forms part of a manufacturer of tobacco products.deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 18 – paragraph 1 – introductory part

1. ~~The following n~~Nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:.

2013/05/13
Committee: IMCO

Proposal for a directive
Article 18 – paragraph 1 – point a

~~(a) products with a nicotine level exceeding 2 mg per unit, or~~deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 18 – paragraph 1 – point b

~~(b) products with a nicotine concentration exceeding 4 mg per ml or~~deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 18 – paragraph 1 – point c

~~(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.~~deleted

2013/05/13
Committee: IMCO

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.

2013/05/13
Committee: IMCO

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

2013/05/13
Committee: IMCO

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

2013/05/13
Committee: IMCO

Proposal for a directive
Article 18 – paragraph 4 – point a

~~(a) be printed on the two largest surfaces of the unit packet and any outside packaging;~~deleted

2013/05/13
Committee: IMCO

Proposal for a directive
Article 18 – paragraph 4 – point b

(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

2013/05/13
Committee: IMCO

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.

2013/05/13
Committee: IMCO