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27 March- The directive has been amended
Amendment 44
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Text proposed by the Commission Amendment
1. The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC: 1. Nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC.
Or. en
Justification
Analyses show that e-cigarettes contain chemicals and components which pose danger to consumers. For that reason, all NCP should be subject to control. Otherwise, products with levels of nicotine concentration just below the proposed thresholds, could reach the market without any authorisation. Not only a concentration of nicotine is relevant but a mixture of all substances is too. Consumers indicate as well, that they mainly use e-cigarettes to quit smoking, seeing it as a medicinal product, therefore they should be authorised in accordance with Directive 2001/83/EC.
Amendment 45
Proposal for a directive
Article 18 – paragraph 1a (new)
Text proposed by the Commission Amendment
1a. Member States shall ensure that nicotine-containing products are not sold to persons below the age required for purchasing tobacco products.
Or. en
Amendment 46
Proposal for a directive
Article 18 – paragraph 1 – point a
Text proposed by the Commission Amendment
(a) products with a nicotine level exceeding 2 mg per unit, deleted
Or. en
Amendment 47
Proposal for a directive
Article 18 – paragraph 1 – point b
Text proposed by the Commission Amendment
(b) products with a nicotine concentration exceeding 4 mg per ml deleted
Or. en
Amendment 48
Proposal for a directive
Article 18 – paragraph 1 – point c
Text proposed by the Commission Amendment
© products whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg of nicotine per ml. deleted
Or. en
Amendment 49
Proposal for a directive
Article 18 – paragraph 2
Text proposed by the Commission Amendment
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. deleted
Or. en
Amendment 50
Proposal for a directive
Article 18 – paragraph 3
Text proposed by the Commission Amendment
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: deleted
This product contains nicotine and can damage your health.
Or. en
Amendment 51
Proposal for a directive
Article 18 – paragraph 4
Text proposed by the Commission Amendment
4. The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10(4). In addition, it shall: deleted
(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.
Or. en
Amendment 52
Proposal for a directive
Article 18 – paragraph 5
Text proposed by the Commission Amendment
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
Or. en
Amendment 53
Proposal for a directive
Article 26 – paragraph 1 – introductory part
Text proposed by the Commission Amendment
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 + 24 months]: 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 + 36 months]:
Or. en
Justification
It is necessary to give Member States more time to adjust to the changes, as some Member States, and therefore companies, in particular small and medium-sized enterprises, and farmers will be affected by the Directive more than others.
Amendment 54
Proposal for a directive
Article 26 – paragraph 1 – point b
Text proposed by the Commission Amendment
(b) nicotine containing products below the threshold set out in Article 18(1); (b) nicotine containing products;
Or. en
Justification
In conformity with the amendment to Article 18 of the proposed Directive.
www.europarl.europa.eu/RegDat...)508048_EN.doc
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