BETA

38 Amendments of Sari ESSAYAH related to 2012/0366(COD)

Proposal for a directive
Recital 16 a (new)

(16a) In order to clarify where the borderline is being drawn, the Commission should draw up a list indicating precisely which ingredients are prohibited and which are permitted, particularly additives and - separately from them - aromas and flavourings. The list should also make it clear what total quantity of permitted additives, aromas and flavourings is permissible.

2013/05/29
Committee: ENVI

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

2013/05/29
Committee: ENVI

Proposal for a directive
Recital 20 a (new)

(20a) An effort should be made to eliminate obstacles effectively and by all available means to enable the use of plain packages to be introduced throughout EU territory as quickly as possible.

2013/05/29
Committee: ENVI

Proposal for a directive
Recital 24

(24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products, which are mainly consumed by older consumers, should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people. The labelling of these other tobacco products should follow specific rules. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.

2013/05/14
Committee: ENVI

Proposal for a directive
Recital 27

(27) An interoperable tracking and tracing system and a common security feature should be developed. For an initial period only cigarettes and roll-your-own tobacco should be subjected to the tracking and tracing system and the security features. This would allow producers of other tobacco products to benefit from the experiences gained in the meantime.

2013/05/14
Committee: ENVI

Proposal for a directive
Recital 29 b (new)

(29b) The sale and placing on the market of other types of tobacco for oral use should be prohibited throughout EU territory. The prohibition should particularly apply to tobacco intended for chewing such as snus and chewing tobacco; it should also apply to snuff intended to be sniffed through the nose.

2013/05/14
Committee: ENVI

Proposal for a directive
Recital 31

(31) All tobacco products have the potential to cause mortality, morbidity and disability and their consumption should be contained. It is therefore important to monitor developments as regards novel tobacco products. A notification obligation for novel tobacco products should be put on manufacturers and importers, without prejudice to the power of the Member StatesThe aim of the Directive is to reduce smoking and particularly to discourage young people and others from starting to smoke. Widening of the market by permitting new to ba~~n or to authorise them. The Commission should monitor the developments and submit a report 5 years after the date of transposition of this Directive, in order to assess whe~~cco products should therefore be prohibited as contrary to ther a~~mendments to~~im of thise Directive ~~are necessary~~.

2013/05/14
Committee: ENVI

Proposal for a directive
Recital 32

(32) I~~n order to ensure a level playing field,~~t is damaging and unnecessary for novel tobacco products, which are tobacco products in the sense of this Directive, ~~should respe~~to enter the market. It is therefore not justified to permit novel tobacco products t~~he requirements provided for in this Directive~~o enter the market and be approved. Permitting novel tobacco products is in conflict with the fundamental aim of the Directive to reduce the use of tobacco products.

2013/05/14
Committee: ENVI

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 the functioning of the internal market, in particular considering that these products are subject to significant cross-border distance sales including via the internet. E-cigarettes, in which nicotine is absorbed into the body together with air inhaled, should be treated equally with other nicotine sources absorbed into the body through air inhaled.

2013/05/14
Committee: ENVI

Proposal for a directive
Recital 34 a (new)

(34a) All products containing nicotine should be treated in the same way. They should be governed either by this directive or, in the case of large doses used for medicinal purposes, by the medicines legislation of the Member State. The medicines legislation of the Member State would define the limits of medicinal use of nicotine in accordance with the subsidiarity principle. In defining nicotine content, quantities of nicotine should be calculated as a daily dose and in the light of the largest dose.

2013/05/14
Committee: ENVI

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. Package labelling should correspond to pictorial warnings and package labelling required of tobacco products in this Directive.

2013/05/14
Committee: ENVI

Proposal for a directive
Recital 39 a (new)

(39a) The Directive should have the purpose of reducing smoking, and the aim should be ultimately to be able to put an end to smoking entirely, bearing in mind the huge and needless losses to public health and the economy.

2013/05/14
Committee: ENVI

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. Special attention should be devoted to implementation of the compulsory pictorial and textual warnings provided for in this Directive, and of other harmonisation rules, for example concerning cocoa. 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.

2013/05/14
Committee: ENVI

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

The aim of this Directive is toin the long term to put an end to the use of tobacco products and in the short term to reduce their use by approximateing the laws, regulations and administrative provisions of the Member States concerning:

2013/05/14
Committee: ENVI

Proposal for a directive
Article 5 – paragraph 4

4. Member States shall require manufacturers and importers to submit internal and external studies available to them on market research and preferences of various consumer groups, including young people, relating to ingredients and emissions. Member States shall also require manufacturers and importers to report the sales volume data per product, reported in sticks or kilograms, and per Member State on a yearly basis starting from the full calendar year following that of the entry into force of this Directive. Member States shall provide alternative or additional sales data, as appropriate, to ensure that information on sales volume requested under this paragraph is reliable and complete. Ingredients shall be defined in a uniform manner in all Member States, using a clear list common to the Member States.

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

Proposal for a directive
Article 10

~~[...]~~deleted

2013/05/21
Committee: ENVI

Proposal for a directive
Article 12 – paragraph 2

2. Prohibited elements and features may include but are not limited to texts, symbols, names, trade marks, figurative or other signs, misleading colours, inserts or other additional material such as adhesive labels, stickers, onserts, scratch-offs and sleeves or relate to the shape of the tobacco product itself. Cigarettes with a diameter of less than 7.5 mm shall ~~be deemed to be misleading.~~not be sold within the EU;

2013/05/21
Committee: ENVI

Proposal for a directive
Article 14 – paragraph 10

10. Tobacco products other than cigarettes and roll-your-own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5 years following the date referred to in paragraph 1 of Article 25.deleted

2013/05/14
Committee: ENVI

Proposal for a directive
Article 15 – paragraph 1

Member States shall prohibit the placing on the market of ~~tobacco for oral use~~smokeless tobacco products, such as tobacco for oral use, chewing tobacco and snuff, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.

2013/05/14
Committee: ENVI

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

1. Member States shall oblige retail outlets intending to engage in 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 outprohibit distance salets established outside the Union have to register with the competent authorities in the Member State where the actual or potential consumer is located. All retail outlets intending to engage in cross- border distance sales shall submit at least the following information to the competent authorities:of tobacco products.

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

Proposal for a directive
Article 17

Article 17 Notification of novel tobacco products 1. Member States shall require that manufacturers and importers of tobacco products notify the competent authorities of Member States of any novel tobacco product they intend to place on the markets of the Member States concerned. The notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with Article 5. The manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with: a) available scientific studies on toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions; (b) available studies and market research on preferences of various consumer groups, including young people and (c) other available and relevant information, including a risk/benefit analysis of the product, the expected effects on cessation of tobacco consumption, the expected effects on initiation of tobacco consumption and other predicted consumer perception. 2. Member States shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point (a) to (c) of paragraph 1. Member States shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information. Member States shall make available to the Commission all information received pursuant to this Article. Member States shall be entitled to introduce an authorisation system and charge a proportionate fee. 3. Novel tobacco products placed on the market shall respect the requirements set out in this Directive. The provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point (29) of Article 2 or tobacco for smoking in point (33) of Article 2.deleted

2013/05/14
Committee: ENVI

Proposal for a directive
Article 17 – paragraph 1 – introductory part

1. Member States shall require that manufacturers and importers of tobacco products notify the competent authorities of Member States of any novel tobacco product they intend to place on the markets of the Member States concerned. The notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with Article 5. The manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with:prohibit the placing on the market of any novel tobacco product.

2013/05/14
Committee: ENVI

Proposal for a directive
Article 17 – paragraph 2

2. Member States shall require that manufacturers and importers of tobacco products inform their competent authorities of any new or updated information referred to in point (a) to (c) of paragraph 1. Member States shall be entitled to require tobacco manufacturers or importers to carry out additional tests or submit additional information. Member States shall make available to the Commission all information received pursuant to this Article. Member States shall be entitled to introduce an authorisation system and charge a proportionate fee.deleted

2013/05/14
Committee: ENVI

Proposal for a directive
Article 17 – paragraph 3

3. Novel tobacco products placed on the market shall respect the requirements set out in this Directive. The provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point (29) of Article 2 or tobacco for smoking in point (33) of Article 2.deleted

2013/05/14
Committee: ENVI

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:

2013/05/14
Committee: ENVI

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

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

2013/05/14
Committee: ENVI

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

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

2013/05/14
Committee: ENVI

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

2013/05/14
Committee: ENVI

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.

2013/05/14
Committee: ENVI

Proposal for a directive
Article 18 – paragraph 3 – introductory part

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:

2013/05/14
Committee: ENVI

Proposal for a directive
Article 19 – paragraph 1 – introductory part

Each unit packet and any outside packaging of herbal products for smoking or nicotine-free products intended for vaporising or smoking shall carry the following health warning:

2013/05/14
Committee: ENVI