Next event: Follow-up document 2018/08/08 more...
- Follow-up document 2016/05/20
- Commission response to text adopted in plenary 2014/05/20
- Final act published in Official Journal 2014/04/29
- Draft final act 2014/04/03
- Final act signed 2014/04/03
- End of procedure in Parliament 2014/04/03
- Act adopted by Council after Parliament's 1st reading 2014/03/14
- Council Meeting 2014/03/14
- Decision by Parliament, 1st reading/single reading 2014/02/26
- Specific opinion 2014/01/24
- Contribution 2014/01/16
- REGNER Evelyn (S&D) appointed as rapporteur in JURI 2014/01/07
- Results of vote in Parliament 2013/10/08
- Debate in Parliament 2013/10/08
- Decision by Parliament, 1st reading/single reading 2013/10/08
- Committee report tabled for plenary, 1st reading/single reading 2013/07/24
Progress: Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | MCAVAN Linda ( S&D) | FLORENZ Karl-Heinz ( PPE), RIES Frédérique ( ALDE), SCHLYTER Carl ( Verts/ALE), CALLANAN Martin ( ECR), ANDERSON Martina ( GUE/NGL), SCOTTÀ Giancarlo ( EFD) |
Committee Opinion | AGRI | TABAJDI Csaba Sándor ( S&D) | |
Committee Opinion | ITRE | GOEBBELS Robert ( S&D) | Bendt BENDTSEN ( PPE) |
Committee Opinion | IMCO | HANDZLIK Małgorzata ( PPE) | Matteo SALVINI ( ENF), Catherine STIHLER ( S&D) |
Committee Opinion | INTA | KAZAK Metin ( ALDE) | Emma McCLARKIN ( ECR) |
Committee Opinion | JURI | LEHNE Klaus-Heiner ( PPE) | |
Committee Legal Basis Opinion | JURI | REGNER Evelyn ( S&D) | Sergio Gaetano COFFERATI ( S&D), Sajjad KARIM ( ECR) |
Lead committee dossier:
Legal Basis:
TFEU 114-p1
Legal Basis:
TFEU 114-p1Subjects
- 2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
- 3.10.06.09 Industrial plants, tobacco, hops
- 3.40.12 Luxury products industry, cosmetics
- 4.20 Public health
- 4.60.02 Consumer information, advertising, labelling
- 6.20.02 Export/import control, trade defence, trade barriers
Events
The Commission presents a report on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2014/40/EU on the approximation of the laws and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products (Tobacco Products Directive). Under the terms of the Directive, the Commission is required to draw up a report in respect of the delegation of power conferred on the Commission for a period of five years from 19 May 2014.
The Commission reports that it adopted two delegated acts based on Articles 10(3)(b) and 15(12) of the Tobacco Products Directive.
Delegated act adopted under Article 10(3)(b): this provision empowers the Commission to adopt delegated acts to establish and adapt a picture library . The pictures contained in that library are an integral part of the combined health warning which is required to appear on each unit packet and outside packaging of tobacco products for smoking placed on the EU market. Commission adopted Delegated Directive 2014/109/EU amending Annex II to Directive 2014/40/EU of the European Parliament and of the Council by establishing the library of picture warnings to be used on tobacco products.
Delegated act adopted under Article 15(12): the relevant provisions of Article 15 require Member States to ensure that:
all unit packets of tobacco products are marked with a unique identifier, in order to enable their movements to be recorded by all economic operators involved in the trade of tobacco products; manufacturers and importers of tobacco products conclude data storage contracts with an independent third party, for the purpose of hosting the data storage facility for all relevant traceability data recorded in this context
The Commission may adopt delegated acts to define the key elements of the data storage contracts , such as duration, renewability, expertise required or confidentiality, including the regular monitoring and evaluation of those contracts.
Accordingly, the Commission adopted Delegated Regulation (EU) 2018/573 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products, in order to ensure the effective functioning of the traceability system in general and the interoperability of the data storage system in particular.
Procedure : the two draft delegated acts were submitted to the Expert Group on Tobacco Policy prior to their adoption. The European Parliament has been systematically invited to the meetings of this Expert Group. The documents relevant to these consultations were transmitted simultaneously to the European Parliament and to the Council, as provided for in the Common Understanding between the European Parliament, the Council and the Commission on Delegated Acts . The European Parliament or the Council raised no objection to either of the delegated acts adopted by the Commission within the 2-month period provided for in the Directive.
As regards the other delegated powers conferred , the preconditions for their exercise have not yet been met.
The Directive states that the five-year duration of the delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. The Commission considers that the delegation of powers should be extended, since the rationale for the delegation has not changed and the powers granted are essential for achieving the objective of the Tobacco Products Directive.
The Commission presents a report on the potential risks to public health associated with the use of refillable electronic cigarettes in accordance with Directive 2014/40/EU.
The report identifies the particular risks that may be associated with refillable e-cigarettes and their refill containers . It does not consider the potential public health impact of e-cigarettes in general.
The document was prepared with input from the PRECISE study prepared by an external contractor, and analysed 277 cases of nicotine poisoning reported to poison centres in eight EU Member States (Austria, Hungary, Ireland, Lithuania, Netherlands, Portugal, Sweden and Slovenia) from January 2012 to March 2015.
The contractor performed chemical analysis on e-cigarette samples. It also conducted a survey amongst the e-cigarette industry to determine what they believed to be the main risks associated with refillable e-cigarettes
The Commission identified four main risks related to the use of refillable e-cigarettes, these being:
accidental ingestion of e-liquid (particularly with young children); dermal contact, where e-liquid contains nicotine and other products irritating to the skin (propylene glycol and flavours); mixing or customisation of liquids, where users blend their own e-liquid at home by purchasing ingredients separately; risks due to using untested combinations of e-liquid and device or hardware customisation.
Possible risks to health : the report concludes that the use of refillable electronic e-cigarettes, and the potential exposure to e-liquids containing nicotine in high concentrations, may pose risks to public health . Based on the limits set out in the Tobacco Products Directive, refillable e-cigarette devices can contain up to 40 mg nicotine and refill containers can hold up to 200 mg nicotine. There is, therefore, a particular risk for young children if they accidently ingest e-liquid especially from a refill container.
Measures to reduce risk : in the context of current scientific knowledge, the Commission considers that the measures relating to refillable e-cigarettes provided for in the Tobacco Products Directive and secondary legislation, combined with national regulation, provide an adequate and proportionate framework for the mitigation of such risks. This does not, however, preclude the need for further study of these products and their safety for consumers (in particular concerning poisoning from accidental ingestion of e-liquid and the hazard profile of flavours).
The rather high percentage of poisonings involving adults over the age of 18 (57%) also suggests the need to increase awareness amongst citizens on the toxicity of the e-liquids containing nicotine, perhaps through national educational campaigns.
Member States and the Commission should carefully monitor the market of refillable e-cigarettes, as well as the notifications received under Article 20(2) of the TPD.
Lastly, the report suggests that further research on certain aspects of e-cigarettes relevant to refillables, such as emissions testing and the safety of flavours or mixtures of flavours, should also be carried out. Additional research on these topics would benefit all users of e-cigarettes (whether they are disposable, rechargeable and refillable).
Corrigendum to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC ( Official Journal of the European Union L 127 of 29 April 2014 ) On page 19, point (f) of Article 10(1): for:
‘(f) be reproduced in accordance with the format, layout, design and proportions specified by the Commission pursuant to paragraph 3;’,
read:
‘(f) be reproduced in accordance with the format, layout, design and proportions specified by the Commission pursuant to paragraph 4;’.
The European Parliament adopted by 514 votes to 66, with 58 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products.
The issue had been referred back to the committee responsible during the session of 8 October.
Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise between Parliament and Council. The main amendments are the following:
Objectives of the Directive : the general objective should be to meet obligations under the WHO Framework Convention for Tobacco Control and to facilitate the functioning of the internal market in tobacco and related products, taking as a base a high level of health protection, especially for young people.
Maximum yields of tar, nicotine and carbon monoxide and other substances: the accuracy of the tar, nicotine and carbon monoxide indications shall be verified in accordance with ISO standard 8243. Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories that are not owned or controlled directly or indirectly by the tobacco industry.
Priority list of additives and enhanced reporting obligations : in addition to the reporting obligations laid down regarding the reporting of ingredients and emissions, enhanced reporting obligations shall apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list.
The Commission shall adopt implementing acts laying down and subsequently updating such a priority list of additives. A first list of additives shall be adopted containing at least 15 additives within 2 years of entry into force of the Directive.
Manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive that is included in the priority list must carry out comprehensive studies , which shall examine for each additive whether it contributes to the toxicity or addictiveness of the products concerned, or results in a characterising flavor, facilitates inhalation or nicotine uptake or leads to the formation of substances that have CMR properties.
Ingredients : the amended text prohibits the placing on the market of tobacco products containing a characterising flavour (a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla). Also prohibited are additives such as vitamins, caffeine or taurine, additives having colouring properties for emissions, additives that facilitate inhalation or nicotine uptake, and additives that have CMR properties in unburnt form.
The use of additives necessary for the manufacture of tobacco products, for example sugar, is allowed.
These provisions shall not apply to tobacco for oral use.
Labelling and packaging : the health warnings on a unit packet and any outside packaging are irremovably printed, indelible and fully visible . They shall remain intact when opening the unit packet other than packets with a flip-top lid. All unit packets of tobacco products, which are placed on the market, must carry a tamper proof security feature, composed of visible and invisible elements.
Members want the combined health warnings to cover 65 % of both, the external front and back surface of the unit packet and any outside packaging. The warnings must contain a corresponding colour photograph specified in the picture library in Annex II.
The labelling shall not include any element or feature that: (i) promotes a tobacco product or encourages its consumption; (ii) suggests that a particular tobacco product has properties or has other health or lifestyle benefits; (iii) resembles a food or a cosmetic product; (iv) suggests that a certain tobacco product has improved biodegradability or other environmental advantages.
Packets of less than 20 are forbidden.
Cross-border distance sales of tobacco products : the amended text states that Member States may prohibit cross-border distance sales of tobacco products to consumers. Member States shall cooperate to prevent such sales. Retail outlets engaging in cross-border distance sales of tobacco products may not supply such products to consumers in Member States where such sales have been prohibited.
Electronic cigarettes : in accordance with Parliament’s wishes, E-cigarettes should be regulated, either as medicinal products for stopping smoking or tobacco products . In the second case, the nicotine concentration must be no more than 20mg/ml . E-cigarettes should carry health warnings and should not be sold to children.
They would be subject to the same advertising restrictions as tobacco products.
Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market.
The Commission shall submit a report on the potential risks to public health associated with the use of refillable electronic cigarettes within 2 years after entry into force of the Directive and where appropriate thereafter.
The European Parliament adopted by 560 votes to 92, with 32 abstentions, amendments to the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products.
The issue has been referred back to the committee responsible . The vote has been postponed to a later date.
The main amendments adopted in plenary are the following:
Objectives of the Directive : the general objective should be to meet obligations under the WHO Framework Convention for Tobacco Control and to facilitate the functioning of the internal market in tobacco and related products, taking as a base a high level of health protection, especially for young people .
The Directive stipulated that Member States should prohibit cross border distance sales of tobacco products.
Maximum yields of tar, nicotine and carbon monoxide and other substances : the accuracy of the tar, nicotine and carbon monoxide indications shall be verified in accordance with ISO standard 8243. Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories monitored by the competent authorities of the Member States.
Members suggested setting a maximum yield of Polonium 210 which has been shown to be a significant carcinogen in tobacco. This would result in a reduction of 95% of the current average content of Polonium 210 in cigarettes.
Ingredients : an assessment should be carried out on the safety of additives for use in tobacco products. Additives should only be allowed in tobacco products if they are included in a Union list of authorised additives . That list should also indicate any conditions or restrictions on the use of allowed additives. Tobacco products containing additives not included in the Union list or used in a manner that does not comply with this Directive should not be placed on the Union market.
The following additives may not be approved : vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards; caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality; additives which, when used, may impart a characterising flavour ( fruit, spice, herb, alcohol, candy, menthol or vanilla). Additives essential to produce tobacco, such as sugar, would be authorised.
In order to obtain the approval of an additive, manufacturers and importers shall make an application to the Commission.
Labelling and packaging : Members requested that the health warnings should appear on all sides of the unit packet and any outside packaging and that they cover 65 % of the external area of both the front and back surface of the unit packet and any outside packaging.
The labelling of a unit packet and any outside packaging and the tobacco product itself and/or its brand name shall not include any element or feature that promotes a tobacco product and encourages its consumption by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions. Labels shall not include any information about nicotine, tar or carbon monoxide content.
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 20g.
Members rejected the banning of slim cigarettes.
Traceability and security : Member States should ensure that all unit packets and any outside transport packaging of tobacco products shall be marked with a unique identifier .
The unique identifier should determine the date and place of manufacturing, the manufacturing facility, the intended and actual shipment route from the place of manufacturing to the first retail outlet, including all warehouses used, the shipment date, shipment destination, consignee and point of departure.
Age limit : Member States should be encouraged, if they have not already done so, to formulate their national laws on the protection of young people in such a way that tobacco products may not be sold to, or consumed by, young people under the age of 18. Member States should also ensure that such prohibitions are respected.
Member States should report every two years to the Commission on the enforcement of the measures taken on the prevention of smoking and on initiatives to improve tobacco control, in particular with regard to age limits set in national legislation, as well as their plans to increase the age limit to achieve the goal of a ‘smoke-free generation’.
Imitation tobacco products : products aimed at underage consumers, such as food products and toys in the form of tobacco products that may be appealing to minors should be banned.
E-cigarettes : E-cigarettes should be regulated, but not be subject to the same rules as medicinal products unless they are presented as having curative or preventive properties. Those for which no such claims are made should contain no more than 30mg/ml of nicotine , should carry health warnings and should not be sold to anyone under 18 years old .
Manufacturers and importers would also have to supply the competent authorities with a list of all the ingredients that they contain. E-cigarettes would be subject to the same advertising restrictions as tobacco products.
Given the potential of nicotine-containing products to aid smoking cessation, Member States should ensure that they can be made available as widely as tobacco products. These products should be available to be sold outside pharmacies .
The Committee on the Environment, Public Health and Food Safety adopted the report by Linda McAVAN (S&D, UK) on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products.
The committee recommends that the European Parliament’s position at first reading following the ordinary legislative procedure should amend the Commission’s proposal as follows:
Aims of the Directive : according to Members, the Directive should also aim to prohibit cross-border distance sales of tobacco products.
The overall objective is to meet obligations under the WHO Framework Convention for Tobacco Control (FTCT) and in order to facilitate the functioning of the internal market in tobacco and related products, taking as a base a high level of health protection, especially for young people.
Maximum tar, nicotine, carbon monoxide and other yields : Members call for the accuracy of the indications for the other emissions of other combustible tobacco products to be verified in accordance with ISO standard 8243 .
Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories monitored by the competent authorities of the Member States.
The Commission shall be empowered to adopt delegated acts to reduce the maximum yields , where necessary, in order to take into account scientific development and internationally agreed standards. In addition, the Commission shall ask the International Organization for Standardization (ISO) to develop a standard to measure Polonium 210 in tobacco .
Ingredients : Members consider that an assessment should be carried out on the safety of additives for use in tobacco products. Additives should only be allowed in tobacco products if they are included in a Union list of authorised additives . Tobacco products containing additives not included in the Union list or used in a manner that does not comply with this Directive should not be placed on the Union market.
Additives associated with energy and vitality (e.g. caffeine and taurine), or creating the impression that products have health benefits (e.g. vitamins) are prohibited.
Additives which are essential for the manufacture of tobacco products may be approved (such as sugar).
In order to obtain the approval of an additive, manufacturers and importers shall make an application to the Commission.
Labelling and packaging : Members propose that Member States shall ensure that the health warnings on the fields of vision on all sides of the unit packet and any outside packaging are fully visible.
The labelling of a unit packet and any outside packaging and the tobacco product itself and / or its brand name shall not include any element or feature that suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health or lifestyle effects.
Labels shall not include any information about nicotine, tar or carbon monoxide content .
Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and water-pipe tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements.
Traceability and safety : an amendment states that Member States shall ensure that all unit packets and any outside transport packaging of tobacco products shall be marked with a unique identifier . The unique identifier shall determine the intended and actual shipment route from the place of manufacturing to the first retail outlet, including all warehouses used, the shipment date, shipment destination, consignee and point of departure.
Age limit : Member States should be encouraged, if they have not already done so, to formulate their national laws on the protection of young people in such a way that tobacco products may not be sold to, or consumed by, young people under the age of 18. They should also ensure that such prohibitions are respected.
Member States shall report every two years to the Commission, in particular with regard to age limits set in national legislation, as well as their plans to increase the age limit to achieve the goal of a "smoke-free generation".
Electronic cigarettes : the report stresses that Members States have taken different different regulatory approaches to address health and safety concerns associated with these products. There is a need for harmonised rules , and all nicotine-containing products should be regulated through a medicines regime which recognises the well-established use of nicotine. Given the potential of such products to aid with smoking cessation, Member States should ensure that they can be made available outside pharmacies.
PURPOSE: to revise Directive 2001/37/EC on tobacco products in order to improve the functioning of the internal market and ensure a high level of health protection.
PROPOSED ACT: Directive of the European Parliament and of the Council.
BACKGROUND: tobacco is the most significant cause of premature death in the EU, responsible for almost 700 000 deaths every year . More than ten years have passed since the adoption of the Directive 2001/37/EC on tobacco products. In line with market, scientific and international developments, it has become necessary to update and complement this Directive .
The overall objective of the revision is to improve the functioning of the internal market . In particular, the proposal aims to:
· update already harmonised areas, in order to overcome obstacles encountered by Member States in bringing their national legislation in line with new market, scientific and international developments;
· address product related measures not yet covered by the Directive;
· ensure that provisions of the Directive are not circumvented by the placing on the market of products not compliant with the Directive;
· ensure a harmonised implementation of international obligations following from the WHO Framework Convention on Tobacco Control (FCTC) , which is binding for the EU and all Member States.
With regard to health protection , the proposed revision:
· seeks to regulate tobacco products in a way that reflects their specific characteristics (nicotine has addictive properties) and the negative consequences of their consumption (mouth, throat and lung cancer, cardiovascular problems including heart attacks, strokes, clogged arteries, increased risk of blindness, impotence, lower fertility, impact on the unborn child etc);
· focuses on initiation of tobacco consumption, in particular by young people , taking into account that 70% of the smokers start before the age of 18 and 94% before the age of 25;
· create conditions which allow all citizens across the EU to take informed decisions about the products, based on accurate information on the health consequences of consuming tobacco products.
The Commission's proposal for a Regulation of the European Parliament and of the Council on establishing a Health for Growth Programme contains measures which have as their direct objective the protection of public health regarding tobacco products and advertisement required by or contributing to the objectives of EU legislation in this field.
IMPACT ASSESSMENT: the Commission undertook an impact assessment which accompanies the proposal. A high level of health protection has been taken as the basic criteria amongst the different strategic options that were considered during the review of the Directive.
LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU).
CONTENT : the revision of Directive 2001/37/CE focuses on the following areas:
1) Ingredients and emissions : the maximum yields of tar, nicotine and carbon monoxide as well as the measurement methods remain the same as in Directive 2001/37/EC.
The proposal:
· keeps in place the mandatory reporting system of ingredients and, in addition, provides that a common electronic format for the reporting and manufacturers are required to provide supporting data (e.g. marketing reports);
· provides that placing on the market of new or modified tobacco products must not take place before the submission of ingredients data . Reported data, excluding confidential information, must be published;
· prohibits tobacco products with characterising flavours , such as fruit flavours or chocolate, and prohibits flavourings in filters, papers or packages;
· forbids additives associated with energy and vitality (e.g. caffeine and taurine), or creating the impression that products have health benefits (e.g. vitamins);
· exempts tobacco products other than cigarettes, roll-your own tobacco and smokeless tobacco products, i.e. cigars, cigarillos and pipe tobacco from some provisions such as the prohibition of products with characterising flavours. The exemption shall be removed if there is a substantial change of circumstances (in terms of sales volume or prevalence level among young people).
2) Labelling and packaging : the proposal seeks to ensure that the appearance of the package reflects the characteristics of the product inside the package - a product that has negative health consequences, is addictive, and is not for the consumption of children and teenagers. In concrete terms, the proposal:
· provides that that combined warnings (picture plus text) of 75% should be displayed on both sides of the packages of tobacco products, presented in rotation;
· replaces tar, nicotine and carbon monoxide (TNCO) levels on the packages with an information message referring to harmful substances of tobacco;
· ensures that display of cessation information (e.g. quit-lines, websites) is added to the packages;
· states that neither packaging of tobacco products, nor the products themselves, shall include any elements that promote tobacco products or mislead consumers into believing that the product is less harmful than others, refers to flavours or tastes or resembles a food product;
· exempts tobacco products other than cigarettes and roll-your own tobacco from larger health warnings;
· provides that in order to increase the visibility of the health warnings on smokeless tobacco products , these will have to be put on both sides of the package according to the proposal, but their size will remain unchanged compared to Directive 2001/37.
3) Traceability and security features : the proposal:
· provides for an EU tracking and tracing system at packet level for tobacco products throughout the supply chain (excluding retail). Tobacco products other than cigarettes and roll-your-own-tobacco are granted a transitional period of five years;
· provides that technical standards to ensure compatibility between the tracking and tracing systems used as well as for the contracts with third parties shall be adopted by delegated acts. Technical standardisations for security features shall also be adopted through delegated acts.
4) Tobacco for oral use : the ban of placing on the market (including cross-border distance sale) of tobacco for oral use as set out in Directive 2001/37/EC is maintained (except for Sweden which has an exemption in its Accession Treaty).
5) Cross-border distance sales of tobacco products : cross-border distance sales of tobacco products fall outside the scope of Directive 2001/37/EC. The proposal:
· includes a notification obligation for retailers of tobacco products intending to engage in cross-border distance sales;
· allows Member States to require the retailer to appoint a natural person, who ensures compliance with the Directive of products delivered to customers in the Member States concerned;
· provides a mandatory age verification mechanism .
6) Novel tobacco products (do not fall within any of the established product categories): these products will have to respect requirements of the Directive (e.g. in terms of labelling and ingredients) to ensure a level playing field, and the applicable rules will depend on whether the product involves a combustion process or not.
The proposal also provides a notification obligation for novel tobacco products and the Commission will issue a report on market development in these products five years after the transposition deadline of the Directive.
7) Nicotine containing products (NCP): bearing in mind the novelty and the rapid growth of the market in NCP, the proposal removes current legislative divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products. The proposal provides that:
· NCP that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance;
· NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adapted health warning.
8) Herbal products for smoking : herbal products for smoking fall outside the scope of Directive 2001/37/EC and Member States regulate these products in different ways.
The proposal provides for adapted health warnings for herbal products for smoking to inform consumers about the adverse health effects of these products. In addition, no promotional or misleading elements are allowed on the packages.
BUDGETARY IMPLICATIONS: the estimated impact on expenditure (operational appropriations, human resources and other administrative expenditure) amounts to EUR 7,888 millions for the period 2014-2018.
DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU).
Documents
- Follow-up document: COM(2018)0579
- Follow-up document: EUR-Lex
- Follow-up document: COM(2016)0269
- Follow-up document: EUR-Lex
- Commission response to text adopted in plenary: SP(2014)446
- Final act published in Official Journal: Directive 2014/40
- Final act published in Official Journal: OJ L 127 29.04.2014, p. 0001
- Final act published in Official Journal: Corrigendum to final act 32014L0040R(01)
- Final act published in Official Journal: OJ L 150 17.06.2015, p. 0024
- Draft final act: 00143/2013/LEX
- Decision by Parliament, 1st reading/single reading: T7-0160/2014
- Specific opinion: PE527.873
- Contribution: COM(2012)0788
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T7-0398/2013
- Committee report tabled for plenary, 1st reading/single reading: A7-0276/2013
- Economic and Social Committee: opinion, report: CES0841/2013
- Specific opinion: PE516.597
- Committee opinion: PE508.180
- Committee opinion: PE507.956
- Debate in Council: 3247
- Committee opinion: PE508.048
- Committee opinion: PE510.591
- Committee opinion: PE510.734
- Amendments tabled in committee: PE513.101
- Amendments tabled in committee: PE510.711
- Amendments tabled in committee: PE510.717
- Amendments tabled in committee: PE510.718
- Amendments tabled in committee: PE510.712
- Amendments tabled in committee: PE510.713
- Amendments tabled in committee: PE510.714
- Amendments tabled in committee: PE510.715
- Amendments tabled in committee: PE510.716
- Amendments tabled in committee: PE510.719
- Amendments tabled in committee: PE510.720
- Amendments tabled in committee: PE510.721
- Amendments tabled in committee: PE510.722
- Committee draft report: PE508.085
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2012)0452
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2012)0453
- Legislative proposal published: COM(2012)0788
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SWD(2012)0452
- Document attached to the procedure: EUR-Lex SWD(2012)0453
- Committee draft report: PE508.085
- Amendments tabled in committee: PE510.712
- Amendments tabled in committee: PE510.713
- Amendments tabled in committee: PE510.714
- Amendments tabled in committee: PE510.715
- Amendments tabled in committee: PE510.716
- Amendments tabled in committee: PE510.719
- Amendments tabled in committee: PE510.720
- Amendments tabled in committee: PE510.721
- Amendments tabled in committee: PE510.722
- Amendments tabled in committee: PE510.717
- Amendments tabled in committee: PE510.718
- Amendments tabled in committee: PE510.711
- Amendments tabled in committee: PE513.101
- Committee opinion: PE510.734
- Committee opinion: PE508.048
- Committee opinion: PE510.591
- Committee opinion: PE507.956
- Committee opinion: PE508.180
- Specific opinion: PE516.597
- Economic and Social Committee: opinion, report: CES0841/2013
- Specific opinion: PE527.873
- Draft final act: 00143/2013/LEX
- Commission response to text adopted in plenary: SP(2014)446
- Follow-up document: COM(2016)0269 EUR-Lex
- Follow-up document: COM(2018)0579 EUR-Lex
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
- Contribution: COM(2012)0788
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- Luís Paulo ALVES
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- Franco BONANINI
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- Preslav BORISSOV
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- John BUFTON
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- Martin CALLANAN
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- María Auxiliadora CORREA ZAMORA
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- Spyros DANELLIS
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- Edite ESTRELA
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- Małgorzata HANDZLIK
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- Satu HASSI
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- Georgios KOUMOUTSAKOS
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- Linda McAVAN
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- Vladimír MAŇKA
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- Alajos MÉSZÁROS
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- Marek Henryk MIGALSKI
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- James NICHOLSON
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- Paul NUTTALL
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- Wojciech Michał OLEJNICZAK
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- Franz OBERMAYR
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- Dame Glenis WILLMOTT
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Amendments | Dossier |
2862 |
2012/0366(COD)
2013/05/07
AGRI
327 amendments...
Amendment 100 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 101 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 102 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19)
Amendment 103 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) 'maximum level' or 'maximum yield' means the maximum content or emission
Amendment 104 #
Proposal for a directive Article 2 – paragraph 1 – point 23 (23)
Amendment 105 #
Proposal for a directive Article 2 – paragraph 1 – point 25 (25) 'place on the market' means to make products available to consumers located in the Union, with or without payment
Amendment 106 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30)
Amendment 107 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) 'tobacco products' means products usable for consumption by consumers and consisting of, even partly, tobacco
Amendment 108 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) 'low-risk products' means any product containing tobacco which is placed on the market and significantly reduces the risk of diseases associated with the consumption of conventional tobacco products. A product designed to treat addiction to tobacco consumption, including cessation, is not a low-risk product if it has been approved as a medicinal product.
Amendment 109 #
Proposal for a directive Article 2 – paragraph 1 – point 36 b (new) (36 b) "standardised packaging" means the standardisation of pack colour and the removal of all branding from packaging, with the exception of the brand name which will appear in a standardised font and position on the package. Standardisation can also be extended to pack shape, size, method of opening and other forms of appearance. The relevant legal markings such as health warnings and tax stamps are retained on the package.
Amendment 110 #
Proposal for a directive Article 2 – paragraph 1 – point 36 c (new) (36c) ‘importer’ means any natural or legal person established within the Community who places a product from a third country on the Community market;
Amendment 111 #
Proposal for a directive Article 2 – paragraph 1 – point 36 d (new) (36d) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;
Amendment 112 #
Proposal for a directive Article 3 – paragraph 2 Amendment 113 #
Proposal for a directive Article 3 – paragraph 2 Amendment 114 #
Proposal for a directive Article 3 – paragraph 2 Amendment 115 #
Proposal for a directive Article 3 – paragraph 2 Amendment 116 #
Proposal for a directive Article 3 – paragraph 2 Amendment 117 #
Proposal for a directive Article 3 – paragraph 2 Amendment 118 #
Proposal for a directive Article 3 – paragraph 2 2. The Commission
Amendment 119 #
Proposal for a directive Article 3 – paragraph 2 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the maximum yields laid down in paragraph 1
Amendment 120 #
Proposal for a directive Article 3 – paragraph 3 Amendment 121 #
Proposal for a directive Article 3 – paragraph 3 Amendment 122 #
Proposal for a directive Article 3 – paragraph 3 Amendment 123 #
Proposal for a directive Article 3 – paragraph 3 Amendment 124 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 125 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes
Amendment 126 #
Proposal for a directive Article 3 – paragraph 3 a (new) Amendment 127 #
Proposal for a directive Article 4 – paragraph 3 Amendment 128 #
Proposal for a directive Article 4 – paragraph 3 3. The Commission
Amendment 129 #
Proposal for a directive Article 4 – paragraph 4 Amendment 130 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of
Amendment 131 #
Proposal for a directive Article 4 – paragraph 4 a (new) 4a. Member States shall notify the Commission of any methods of measurement that they use for emissions of tobacco products other than cigarettes. Based on these methods, and taking into account scientific and technical developments as well as internationally agreed standards the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt EU methods of measurement.
Amendment 132 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 1. Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions
Amendment 133 #
Proposal for a directive Article 5 – paragraph 6 a (new) 6a. This article shall not apply to tobacco products other than cigarettes until such time as the EU methods of measurement referred to in Article 4(4a) are adopted.
Amendment 134 #
Proposal for a directive Article 6 – paragraph 1 b (new) 1 b. The Commission shall adopt delegated acts in accordance with Article 2 establishing a negative list of additives which result in a product with a characterising flavour.
Amendment 135 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 136 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall
Amendment 137 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States
Amendment 138 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a
Amendment 139 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products
Amendment 140 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 With the exception of products referred to in Article 15, Member States shall prohibit the placing on the market of tobacco products with a characterising flavour.
Amendment 141 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of sugar and other additives which are essential for the manufacture of tobacco products
Amendment 142 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 143 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 144 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of sugar and additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product with a characterising flavour.
Amendment 145 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, particularly those which improve the quality of tobacco grown in unfavourable climatic conditions, as long as the additives do not result in a product with a characterising flavour.
Amendment 146 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product with a characterising or improved flavour.
Amendment 147 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 148 #
Proposal for a directive Article 6 – paragraph 2 Amendment 149 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 150 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 The Commission shall at the request of a Member State or may on its own initiative determine by means of
Amendment 151 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 The Commission shall at the request of a Member State or may on its own initiative determine by means of implementing acts whether a tobacco product falls within the scope of paragraph 1, on the basis of scientific evidence. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21. An independent panel shall be used to assist in the decision making.
Amendment 152 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 153 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 154 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 The Commission shall
Amendment 155 #
Proposal for a directive Article 6 – paragraph 3 Amendment 156 #
Proposal for a directive Article 6 – paragraph 3 Amendment 157 #
Proposal for a directive Article 6 – paragraph 3 Amendment 158 #
Proposal for a directive Article 6 – paragraph 3 Amendment 159 #
Proposal for a directive Article 6 – paragraph 3 3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration the Commission shall
Amendment 160 #
Proposal for a directive Article 6 – paragraph 4 – point a (a) vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards,
Amendment 161 #
Proposal for a directive Article 6 – paragraph 4 – point b (b) caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality,
Amendment 162 #
Proposal for a directive Article 6 – paragraph 4 – point c (c) additives having colouring properties for emissions
Amendment 163 #
Proposal for a directive Article 6 – paragraph 5 Amendment 164 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of
Amendment 165 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall
Amendment 166 #
Proposal for a directive Article 6 – paragraph 5 a (new) 5a. Paragraph 5 shall not apply to technical measures intended to decrease specific harmful components of smoke or enhance the biodegradability of tobacco products.
Amendment 167 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Amendment 168 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the toxic
Amendment 169 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, prohibit the placing on the market of tobacco products with additives (including paraffin, wax, fat, sugar, starch and cocoa) in quantities that increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product.
Amendment 170 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 a (new) However, Member States shall not, on that basis, prohibit the placing on the market of tobacco products containing menthol solely on the basis of their menthol content.
Amendment 171 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 2 Amendment 172 #
Proposal for a directive Article 6 – paragraph 9 Amendment 173 #
Proposal for a directive Article 6 – paragraph 9 Amendment 174 #
Proposal for a directive Article 6 – paragraph 9 Amendment 175 #
Proposal for a directive Article 6 – paragraph 10 Amendment 176 #
Proposal for a directive Article 6 – paragraph 10 Amendment 177 #
Proposal for a directive Article 6 – paragraph 10 Amendment 178 #
Proposal for a directive Article 7 – paragraph 1 1.
Amendment 179 #
Proposal for a directive Article 7 – paragraph 1 1. Each unit packet of tobacco products and any outside packaging shall carry health warnings in the official language or languages of the Member State where the product is placed on the market. In order to ensure consumers' right to have access to proper information, the different levels of harmfulness shall be indicated in the package of the tobacco product by distinguishing two categories: very harmful and extremely harmful. These categories shall be indicated by one to two black points, and text warnings taking into account the fact that all tobacco products are harmful.
Amendment 180 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably
Amendment 181 #
Proposal for a directive Article 7 – paragraph 7 a (new) 7 a. For the purpose of protecting public health, Member States may maintain or introduce national rules concerning the labelling and packaging of tobacco products which go beyond the rules laid down in this Directive, including the maintenance or introduction of provisions allowing standardised packaging of tobacco products.
Amendment 182 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 183 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 184 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 185 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 186 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width
Amendment 187 #
Proposal for a directive Article 8 – paragraph 4 Amendment 188 #
Proposal for a directive Article 8 – paragraph 4 Amendment 189 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 190 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 191 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 192 #
Proposal for a directive Article 8 – paragraph 4 – introductory part 4. The Commission shall be empowered to
Amendment 193 #
Proposal for a directive Article 8 – paragraph 4 – point b (b) to define the
Amendment 194 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning listed in Annex I and, optionally, a corresponding colour photograph specified in the picture library;
Amendment 195 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 196 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 197 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 198 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 199 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 200 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 201 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 202 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 203 #
Proposal for a directive Article 9 – paragraph 1 – point d (d) show the same text warning and, optionally, corresponding colour photograph on both sides of the unit packets and any outside packaging;
Amendment 204 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 205 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 206 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 207 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 208 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 209 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 210 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 211 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 212 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 213 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 214 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i)
Amendment 215 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii)
Amendment 216 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii) width: not less than
Amendment 217 #
Proposal for a directive Article 9 – paragraph 3 Amendment 218 #
Proposal for a directive Article 9 – paragraph 3 Amendment 219 #
Proposal for a directive Article 9 – paragraph 3 Amendment 220 #
Proposal for a directive Article 9 – paragraph 3 – introductory part 3. The Commission shall be empowered to
Amendment 221 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 222 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 223 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 224 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define
Amendment 225 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the
Amendment 226 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the position,
Amendment 227 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 228 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 229 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 23 #
Proposal for a directive Recital 4 (4) In other areas there are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This applies in particular to nicotine containing products, herbal products for smoking, ingredients and emissions, certain aspects of labelling and packaging
Amendment 230 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 232 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall cover
Amendment 233 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall 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
Amendment 234 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover
Amendment 235 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with
Amendment 236 #
Proposal for a directive Article 10 – paragraph 5 Amendment 237 #
Proposal for a directive Article 10 – paragraph 5 Amendment 238 #
Proposal for a directive Article 10 – paragraph 5 Amendment 239 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 – introductory part Amendment 24 #
Proposal for a directive Recital 6 (6) The size of the internal market in tobacco and related products, the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the Union in only a small number of production plants within the Member States and the resulting significant cross-border trade of tobacco and related products calls for stronger legislative action at
Amendment 240 #
Proposal for a directive Article 11 – paragraph 2 – point b (b) cover
Amendment 241 #
Proposal for a directive Article 11 – paragraph 2 – 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
Amendment 242 #
Proposal for a directive Article 11 – paragraph 3 Amendment 243 #
Proposal for a directive Article 11 – paragraph 3 Amendment 244 #
Proposal for a directive Article 11 – paragraph 3 Amendment 245 #
Proposal for a directive Article 12 – paragraph 1 – introductory part 1.
Amendment 246 #
Proposal for a directive Article 12 – paragraph 1 – point b b) suggests that a particular tobacco product
Amendment 247 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 248 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 249 #
Proposal for a directive Article 12 – paragraph 2 2.
Amendment 25 #
Proposal for a directive Recital 6 a (new) (6a) The European Union should pay particular attention to tobacco production in less-favoured areas, especially in the outermost regions where it is frequently associated with specific geographical and socio-economic characteristics, and the Union should allow the Member States concerned to implement specific measures to ensure continued production in these areas.
Amendment 250 #
Proposal for a directive Article 12 – paragraph 2 2. Prohibited elements and features may include but are not limited to texts, symbols, names,
Amendment 251 #
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
Amendment 252 #
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
Amendment 253 #
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.
Amendment 254 #
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.
Amendment 255 #
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.
Amendment 256 #
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.
Amendment 257 #
Proposal for a directive Article 12 – paragraph 2 a (new) 2a. The variety of tobacco used to manufacture the product and/or its country of origin may be indicated on the unit packet.
Amendment 258 #
Proposal for a directive Article 13 – paragraph 1 Amendment 259 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes
Amendment 26 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco,
Amendment 260 #
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 or without a flap that covers the opening. The flap, if any, 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.
Amendment 261 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened
Amendment 262 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than the flip-top lid. The flip-top lid, if any, of a cigarette packet shall be hinged only at the back of the packet.
Amendment 263 #
Proposal for a directive Article 13 – paragraph 2 a (new) Amendment 264 #
Proposal for a directive Article 13 – paragraph 3 Amendment 265 #
Proposal for a directive Article 13 – paragraph 3 Amendment 266 #
Proposal for a directive Article 13 – paragraph 3 Amendment 267 #
Proposal for a directive Article 13 – paragraph 3 Amendment 268 #
Proposal for a directive Article 13 – paragraph 3 Amendment 269 #
Proposal for a directive Article 13 – paragraph 3 Amendment 27 #
Proposal for a directive Recital 11 Amendment 270 #
Proposal for a directive Article 13 – paragraph 3 Amendment 271 #
Proposal for a directive Article 13 – paragraph 3 Amendment 272 #
Proposal for a directive Article 13 – paragraph 4 Amendment 273 #
Proposal for a directive Article 13 – paragraph 4 Amendment 274 #
Proposal for a directive Article 13 – paragraph 4 Amendment 275 #
Proposal for a directive Article 13 – paragraph 4 Amendment 276 #
Proposal for a directive Article 13 – paragraph 4 Amendment 277 #
Proposal for a directive Article 13 – paragraph 4 Amendment 278 #
Proposal for a directive Article 13 – paragraph 4 Amendment 279 #
Proposal for a directive Article 14 – paragraph 1 1. With the exception of products referred to in Article 15, Member States shall ensure that all unit packets of tobacco products 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.
Amendment 28 #
Proposal for a directive Recital 11 (11) In relation to the fixing of maximum yields, it might be necessary and
Amendment 280 #
Proposal for a directive Article 14 – paragraph 2 – point g Amendment 281 #
Proposal for a directive Article 14 – paragraph 2 – point h Amendment 282 #
Proposal for a directive Article 14 – paragraph 2 – point i Amendment 283 #
Proposal for a directive Article 14 – paragraph 2 – point j j) the identity of all purchasers from manufacturing to the first
Amendment 284 #
Proposal for a directive Article 14 – paragraph 2 – point k k) the invoice, order number and payment records
Amendment 285 #
Proposal for a directive Article 14 – paragraph 3 3. Member States shall ensure that
Amendment 286 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide
Amendment 287 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a
Amendment 288 #
Proposal for a directive Article 14 – paragraph 9 Amendment 289 #
Proposal for a directive Article 14 – paragraph 9 Amendment 29 #
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 progress and internationally agreed standards in order to evaluate their toxicity or addictiveness.
Amendment 290 #
Proposal for a directive Article 14 – paragraph 9 Amendment 291 #
Proposal for a directive Article 14 – paragraph 9 – point a Amendment 292 #
Proposal for a directive Article 14 – paragraph 9 – point b Amendment 293 #
Proposal for a directive Article 14 – paragraph 9 – point c Amendment 294 #
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
Amendment 295 #
Proposal for a directive Article 15 – paragraph 1 Member States shall
Amendment 296 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and
Amendment 298 #
Proposal for a directive Article 16 – title Amendment 299 #
Proposal for a directive Article 16 Amendment 30 #
Proposal for a directive Recital 11 (11) In relation to the fixing of maximum yields, it might be necessary and
Amendment 300 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 301 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1a. Member States shall prohibit on their territory the distribution of free or discounted tobacco products and the swapping of new, sealed packets of tobacco products for packets that have already been opened, irrespective of the channels used.
Amendment 302 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 303 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 304 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 305 #
Proposal for a directive Article 16 – paragraph 2 Amendment 306 #
Proposal for a directive Article 16 – paragraph 3 Amendment 307 #
Proposal for a directive Article 16 – paragraph 4 Amendment 308 #
Proposal for a directive Article 16 – paragraph 5 Amendment 309 #
Proposal for a directive Article 16 a (new) Article 16 a Point-of-sale displays of tobacco 1. Member States shall prohibit point-of- sale displays of tobacco in their territory. 2. Tobacco products shall be completely concealed from the customer except during the purchase or sale of tobacco products, or stocktaking, restocking, staff training or maintenance of the storage unit. 3. Display of tobacco products for those reasons listed in paragraph 2 may only last as long as is necessary to complete those tasks. 4. Prices of tobacco products shall be listed in a standardised format.
Amendment 31 #
Proposal for a directive Recital 15 Amendment 310 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and potentially lower-risk novel tobacco products
Amendment 311 #
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 which they intend to place on the markets of the Member States concerned and which, on the basis of substantial scientific evidence, they intend to make the subject of a claim that it is less harmful, or constitutes a lower risk, than conventional tobacco products. 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
Amendment 312 #
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 points (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. Member States shall be entitled to adopt specific labelling and packaging rules different from the requirements of this Directive for less harmful products. They shall notify such rules to the Commission.
Amendment 313 #
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. The provisions of Article 12(1)(b) shall not apply to new tobacco products that have been scientifically proven to be less harmful than conventional tobacco products.
Amendment 314 #
Proposal for a directive Article 17 – paragraph 3 a (new) 3a. Member States may authorise the sale and define rules on the placing on the market of new categories of tobacco products that have been scientifically proven to be less harmful than conventional tobacco products, provided that it has been demonstrated, pursuant to paragraph 1, that the use of such products can reduce the risks and illnesses associated with smoking, as well as the harm to public health, when compared with conventional tobacco products.
Amendment 315 #
Proposal for a directive Article 18 Amendment 316 #
Proposal for a directive Article 18 – paragraph 1 – point b b) products with a nicotine concentration exceeding 24 mg per ml or
Amendment 317 #
Proposal for a directive Article 18 – paragraph 2 Amendment 318 #
Proposal for a directive Article 18 – paragraph 5 Amendment 319 #
Proposal for a directive Article 18 – paragraph 5 Amendment 32 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour
Amendment 320 #
Proposal for a directive Article 18 – paragraph 5 Amendment 321 #
Proposal for a directive Article 18 a (new) Article 18 a Nicotine-containing products and products which are used in the same way as for tobacco-smoking may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC.
Amendment 322 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than
Amendment 323 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than 30 % of the area of the corresponding surface of the unit packet and of any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with
Amendment 324 #
Proposal for a directive Article 22 – paragraph 1 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. Delegated acts may only be adopted in those cases where provision is expressly made in this Directive for such a delegation of power.
Amendment 325 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts
Amendment 326 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 327 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 328 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 329 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 33 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco or menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 330 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2),6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3),
Amendment 331 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers
Amendment 332 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 333 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 334 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 335 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 336 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3),
Amendment 337 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act
Amendment 338 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 339 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 34 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco
Amendment 340 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 341 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 342 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3),
Amendment 343 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – introductory part In the report, the Commission shall indicate in particular the features which should be reviewed or developed in the light of developments in scientific and technical knowledge, including the development of internationally agreed rules and standards on products, and the socio- economic impact of the Directive’s application, and shall pay special heed to:
Amendment 344 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point b b) market developments in novel tobacco products considering, inter alia, notifications received under Article 17
Amendment 345 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c а (new) (cа) the impact on production and employment in the tobacco sector, paying particular attention to small and medium- sized farmers.
Amendment 346 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c a (new) (ca) the potential impact on European tobacco growing of the Directive.
Amendment 347 #
Proposal for a directive Article 24 – paragraph 1 1. Member States shall not prohibit or restrict the import, sale or consumption of tobacco or related products which comply with this Directive. At the same time, measures must be taken to restrict the import of tobacco products, including from third countries, which do not comply with this Directive.
Amendment 348 #
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
Amendment 349 #
Proposal for a directive Article 24 – paragraph 3 Amendment 35 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 350 #
Proposal for a directive Article 24 – paragraph 3 3. This Directive shall not affect the right of Member States to maintain or introduce, in accordance with the Treaty, national provisions concerning aspects not regulated by this Directive. These national provisions must be justified by overriding reasons of public interest and be necessary and proportionate to their aim. They must not be a means of arbitrary discrimination or a disguised restriction on trade between the Member States
Amendment 36 #
Proposal for a directive Recital 15 – footnote 36 Amendment 37 #
Proposal for a directive Recital 15 a (new) (15a) Reliable research shows that the level of tobacco growing in the EU is not linked to the number of EU citizens who smoke. At the same time, a majority of the tobacco grown in the EU comes from very small family farms, which find it very difficult to switch to a different production model. EU farmers should therefore have the opportunity to market the tobacco they produce for the needs of European consumers, while ensuring that the highest quality raw materials are used and complying with the standards on ingredients laid down in this Directive, without discriminating against tobacco varieties grown in unfavourable climatic conditions. In addition, Member States should take action to retrain tobacco farmers in order for them move into other agricultural sectors, particularly through the use of funds available under Regulation XXX (Rural Development).
Amendment 38 #
Proposal for a directive Recital 16 Amendment 39 #
Proposal for a directive Recital 16 (16)
Amendment 40 #
Proposal for a directive Recital 16 (16)
Amendment 41 #
Proposal for a directive Recital 16 (16) The prohibition of
Amendment 42 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives
Amendment 43 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products and used in particular to improve the quality of tobacco grown in the EU should be allowed, as long as they do not result in a characterising flavour. The Commission should ensure uniform conditions for the implementation of the provision on characterising flavour. Independent panels should be used by the Member States and by the Commission to assist in such decision making. The application of this Directive should not discriminate between different tobacco varieties or between the same tobacco varieties grown under different climatic conditions.
Amendment 44 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of sugar and additives necessary for manufacturing of tobacco products should be allowed, as long as they do not result in a characterising flavour.
Amendment 45 #
Proposal for a directive Recital 18 Amendment 46 #
Proposal for a directive Recital 18 Amendment 47 #
Proposal for a directive Recital 21 (21) Adaptation of the labelling provisions is also necessary to align the rules at Union level with international developments. For example the guidelines on Article 11 FCTC call for
Amendment 48 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For
Amendment 49 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’,
Amendment 50 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’,
Amendment 51 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’,
Amendment 52 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made
Amendment 53 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or
Amendment 54 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or other signs.
Amendment 55 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the d
Amendment 56 #
Proposal for a directive Recital 24 Amendment 57 #
Proposal for a directive Recital 24 (24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products
Amendment 58 #
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 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. The Commission and Member States should also ensure that any measures adopted in application of this Directive do not lead indirectly to an increase in the illicit trade in tobacco products.
Amendment 59 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13
Amendment 60 #
Proposal for a directive Recital 30 (30)
Amendment 61 #
Proposal for a directive Recital 30 (30) Cross-border distance sales of tobacco
Amendment 62 #
Proposal for a directive Recital 31 (31) All tobacco products have the potential to cause mortality, morbidity and disability and their manufacture, distribution and consumption should be
Amendment 63 #
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,
Amendment 64 #
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
Amendment 65 #
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
Amendment 66 #
Proposal for a directive Recital 37 Amendment 67 #
Proposal for a directive Recital 38 Amendment 68 #
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
Amendment 69 #
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
Amendment 70 #
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
Amendment 71 #
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
Amendment 72 #
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
Amendment 73 #
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
Amendment 74 #
Proposal for a directive Recital 40 (40)
Amendment 75 #
Proposal for a directive Recital 40 a (new) (40a) A Member State that deems it necessary to maintain and/or introduce national and/or regional provisions geared to preserving traditional tobacco plantations, for justified reasons relating to the socio-economic dependence of local communities, should be allowed to do so.
Amendment 76 #
Proposal for a directive Recital 41 (41)
Amendment 77 #
Proposal for a directive Recital 42 (42) Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data45. National data protection provisions must also be taken into account.
Amendment 78 #
Proposal for a directive Recital 43 a (new) (43a) This Directive should not lead to a deterioration in the living conditions of people whose livelihoods depend on tobacco growing in Europe and who often live in disadvantaged areas. Given that the aim of the Directive is solely to discourage consumption of tobacco products, any decisions concerning ingredients and additives should take due account of the possible socioeconomic repercussions for groups whose livelihoods depend on tobacco growing. The European tobacco growing sector should be protected because it accounts for only a very small proportion of consumption in the EU and, at the same time, contributes to the economic stability of certain European regions where the range of alternative crops is limited. A decrease in or an end to tobacco growing in the EU would have no impact on consumption levels, but would lead to an increase in imports from third countries and a reduction in quality standards.
Amendment 79 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property (Article 17).
Amendment 80 #
Proposal for a directive Article 1 – paragraph 1 – point d d) the prohibition of cross-border distance sales of tobacco products;
Amendment 81 #
Proposal for a directive Article 2 – paragraph 1 – point 2 (2)
Amendment 82 #
Proposal for a directive Article 2 – paragraph 1 – point 3 Amendment 83 #
Proposal for a directive Article 2 – paragraph 1 – point 4 Amendment 84 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distin
Amendment 85 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product; traditional tastes of tobacco products such as menthol are not considered to be ‘characterising flavours’;
Amendment 86 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 87 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 88 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 89 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 90 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – introductory part Amendment 91 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – point a Amendment 92 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – point b Amendment 93 #
Proposal for a directive Article 2 – paragraph 1 – point 13 Amendment 94 #
Proposal for a directive Article 2 – paragraph 1 – point 13 (13) ‘flavouring’ means an additive that imparts aroma and/or taste but is not essential to the process of manufacturing the tobacco product;
Amendment 95 #
Proposal for a directive Article 2 – paragraph 1 – point 18 Amendment 96 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18)
Amendment 97 #
Proposal for a directive Article 2 – paragraph 1 – point 18 a (new) ‘natural constituent’ means tobacco leaves and other natural, processed or unprocessed parts of tobacco plants, including expanded and reconstituted tobacco;
Amendment 98 #
Proposal for a directive Article 2 – paragraph 1 – point 18 a (new) (18a) ‘natural constituent’ means tobacco (leaves and other natural, processed or unprocessed parts of tobacco plants including expanded and reconstituted tobacco);
Amendment 99 #
Proposal for a directive Article 2 – paragraph 1 – point 19 source: PE-510.646
2013/05/08
IMCO
213 amendments...
Amendment 100 #
Proposal for a directive Recital 35 Amendment 101 #
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
Amendment 102 #
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
Amendment 103 #
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 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,
Amendment 104 #
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
Amendment 105 #
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,
Amendment 106 #
Proposal for a directive Recital 39 (39) The Commission should monitor the developments and submit a report
Amendment 107 #
Proposal for a directive Recital 40 (40)
Amendment 108 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent
Amendment 109 #
Proposal for a directive Recital 40 a (new) (40a) A Member State which considers it necessary to maintain and/or introduce national and/or regional measures for the upkeep of traditional tobacco plantations on the justified grounds that the local population is socioeconomically dependent on them and the production is of cultural value, should be authorised to do so.
Amendment 110 #
Proposal for a directive Recital 41 (41) Member States should
Amendment 111 #
Proposal for a directive Recital 41 (41) Member States should
Amendment 112 #
Proposal for a directive Recital 43 a (new) (43a) Member States should respect the right to clean air in the spirit of Articles 7 (b) and 12 of the International Covenant on Economic, Social and Cultural Rights providing for rights for safe and healthy working conditions and the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. This is within the aim of Article 37 of the Charter of Fundamental rights where a high level of environmental protection and the improvement of the quality of the environment must be integrated into the policies of the Union.
Amendment 113 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16),
Amendment 114 #
Proposal for a directive Article 1 – paragraph 1 – point c Amendment 115 #
Proposal for a directive Article 1 – paragraph 1 – point c Amendment 116 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 117 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 118 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 119 #
Proposal for a directive Article 2 – paragraph 1 – point 2 Amendment 120 #
Proposal for a directive Article 2 – paragraph 1 – point 2 (2) ‘additive’ means any substance
Amendment 121 #
Proposal for a directive Article 2 – paragraph 1 – point 3 Amendment 122 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product
Amendment 123 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 124 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 125 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 126 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – introductory part (11)
Amendment 127 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – point a Amendment 128 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – point b Amendment 129 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means an
Amendment 130 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means an additive,
Amendment 131 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means an
Amendment 132 #
Proposal for a directive Article 2 – paragraph 1 – point 18 a (new) Amendment 133 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) ‘maximum level’ or ‘maximum yield’ means the maximum content or emission
Amendment 134 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) ‘maximum level’
Amendment 135 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19)
Amendment 136 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) ‘maximum level’
Amendment 137 #
Proposal for a directive Article 2 – paragraph 1 – point 23 (23)
Amendment 138 #
Proposal for a directive Article 2 – paragraph 1 – point 24 a (new) (24a) 'plain packaging' means the standardised colour, font, size and position of brand names and brand variant on packages and the standardised colour of packages.
Amendment 139 #
Proposal for a directive Article 2 – paragraph 1 – point 25 (25)
Amendment 140 #
Proposal for a directive Article 2 – paragraph 1 – point 26 (26) ‘pipe tobacco’ means
Amendment 141 #
Proposal for a directive Article 2 – paragraph 1 – point 28 (28) ‘roll-your-own tobacco’ means
Amendment 142 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 143 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 144 #
Proposal for a directive Article 2 – paragraph 1 – point 33 (33) ‘tobacco for smoking’ means a tobacco product
Amendment 145 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) 'tobacco products' means products usable for consumption by consumers and consisting of, even partly, tobacco
Amendment 146 #
Proposal for a directive Article 2 – paragraph 1 – point 35 a (new) (35a) 'traditional tobacco flavour' means a tobacco flavour that has been continuously used in a Member State or part thereof for at least 30 years;
Amendment 147 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) ‘reduced risk product’ means any product containing tobacco which, when marketed, significantly reduces the risk of illnesses associated with the consumption of conventional tobacco products. A product used to treat addiction to tobacco consumption, including cessation, is not a reduced risk product if it has been approved as a medicinal product.
Amendment 148 #
Proposal for a directive Article 2 – paragraph 1 – point 36 b (new) (3 b) "standardised packaging" means the standardisation of pack colour and the removal of all branding from packaging, with the exception of the brand name which will appear in a standardised font and position on the package. Standardisation can also be extended to pack shape, size, method of opening and other forms of appearance. The relevant legal markings such as health warnings and tax stamps are retained on the package.
Amendment 149 #
Proposal for a directive Article 2 – paragraph 1 – point 36 c (new) (36c) ‘reduced-risk tobacco product' means any tobacco product which reduces the risk of diseases linked to the consumption of conventional tobacco products;
Amendment 150 #
Proposal for a directive Article 3 – paragraph 2 Amendment 151 #
Proposal for a directive Article 3 – paragraph 2 Amendment 152 #
Proposal for a directive Article 3 – paragraph 2 Amendment 153 #
Proposal for a directive Article 3 – paragraph 2 Amendment 154 #
Proposal for a directive Article 3 – paragraph 2 Amendment 155 #
Proposal for a directive Article 3 – paragraph 2 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the maximum yields laid down in paragraph 1
Amendment 156 #
Proposal for a directive Article 3 – paragraph 3 Amendment 157 #
Proposal for a directive Article 3 – paragraph 3 Amendment 158 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 159 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 160 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards, where available, and based on scientific evidence and on the yields notified by Member States, the Commission shall
Amendment 161 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 162 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 163 #
Proposal for a directive Article 3 – paragraph 3 a (new) 3a. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the maximum yields laid down in paragraph 3 (a) to internationally agreed standards, where available, or (b) where scientific evidence demonstrates that they increase the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar, nicotine and carbon monoxide fixed in paragraph 1.
Amendment 164 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 2 The accuracy of the tar
Amendment 165 #
Proposal for a directive Article 4 – paragraph 3 Amendment 166 #
Proposal for a directive Article 4 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the methods of measurement of the tar, nicotine and carbon monoxide yields, taking into account scientific and technical developments and using internationally agreed standards designed for a specific purpose and validated by the International Organisation for Standardisation.
Amendment 167 #
Proposal for a directive Article 4 – paragraph 4 Amendment 168 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Such measurement shall be based on scientific evidence. Based on these me
Amendment 169 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of
Amendment 170 #
Proposal for a directive Article 4 – paragraph 4 a (new) Amendment 171 #
Proposal for a directive Article 4 – paragraph 4 – b (new) 4b. The accuracy of the indications for the other emissions of other combustible tobacco products shall be verified in accordance with ISO standard 8243.
Amendment 172 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields, if available. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 173 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products, nicotine-containing products and herbal products for smoking to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields.
Amendment 174 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 2 Amendment 175 #
Proposal for a directive Article 5 – paragraph 6 a (new) Amendment 176 #
Proposal for a directive Article 5 – paragraph 6 b (new) 6b. Tobacco products other than cigarettes and roll-your-own cigarettes shall be exempted from the requirement to submit data on emissions and yields until measurement methodologies have been developed at Community level.
Amendment 177 #
Proposal for a directive Article 5 – paragraph 6 c (new) 6c. Tobacco products other than cigarettes and roll-your-own tobacco shall be excluded from information on emissions and values until measuring methods have been developed at Community level.
Amendment 178 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco
Amendment 179 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Amendment 180 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness.
Amendment 181 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour. Exemption shall be applicable for menthol as it is considered being traditional tobacco flavour and can not be classified with the other tobacco flavours.
Amendment 182 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco
Amendment 183 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 184 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall
Amendment 185 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not restrict or prohibit the use of
Amendment 186 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 The Commission shall
Amendment 187 #
Proposal for a directive Article 6 – paragraph 3 Amendment 188 #
Proposal for a directive Article 6 – paragraph 3 Amendment 189 #
Proposal for a directive Article 6 – paragraph 4 – point b (b) caffeine and taurine and other additives and stimulant compounds that
Amendment 190 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness. Filters and capsules shall not contain tobacco.
Amendment 191 #
Proposal for a directive Article 6 – paragraph 5 Amendment 192 #
Proposal for a directive Article 6 – paragraph 5 a (new) 5a. Paragraph 5 shall not apply to technical measures intended to decrease specific harmful components of smoke or enhance the biodegradability of tobacco products.
Amendment 193 #
Proposal for a directive Article 6 – paragraph 9 Amendment 194 #
Proposal for a directive Article 6 – paragraph 9 Amendment 195 #
Proposal for a directive Article 6 – paragraph 10 Amendment 196 #
Proposal for a directive Article 6 – paragraph 10 Amendment 197 #
Proposal for a directive Article 6 – paragraph 10 Amendment 198 #
Proposal for a directive Article 6 – paragraph 10 Amendment 199 #
Proposal for a directive Article 6 – paragraph 10 Amendment 200 #
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.
Amendment 201 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco and
Amendment 202 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco, water-pipe tobacco and smokeless tobacco products shall be exempted from
Amendment 203 #
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. Nasal tobacco products shall likewise be exempted. 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.
Amendment 204 #
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.
Amendment 205 #
Proposal for a directive Article 6 – paragraph 10 a (new) 10a. The provisions of Article 6(1), (2) and (3) shall not apply to tobacco for oral use (snus).
Amendment 206 #
Proposal for a directive Article 7 – paragraph 1 1. Each unit packet of tobacco products and any outside packaging shall carry health warnings in the official language or languages of the Member State where the product is placed on the market, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Amendment 207 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps which shall be placed at the opening of the tobacco product package, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 208 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by
Amendment 209 #
Proposal for a directive Article 7 – paragraph 3 3.
Amendment 210 #
Proposal for a directive Article 7 – paragraph 4 4. Member States shall ensure that the health warnings of the main surface of the
Amendment 211 #
Proposal for a directive Article 7 – paragraph 5 5. The health warnings shall in no way hide or interrupt the tax stamps, which shall be placed at the opening of the tobacco product package, price marks, tracking and tracing marks, or security features on unit packets.
Amendment 212 #
Proposal for a directive Article 7 – paragraph 7 7.
Amendment 213 #
Proposal for a directive Article 7 – paragraph 7 a (new) 7a. For the purpose of protecting public health, Member States may maintain or introduce national rules concerning the labelling and packaging of tobacco products which go beyond the rules laid down in this Directive, including the maintenance or introduction of provisions allowing standardised packaging of tobacco products.
Amendment 214 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 215 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 216 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 217 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 218 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message
Amendment 219 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 220 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 4
Amendment 221 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 222 #
Proposal for a directive Article 8 – paragraph 4 Amendment 223 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 224 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 225 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 226 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 227 #
Proposal for a directive Article 8 – paragraph 4 – point b (b) to define the
Amendment 228 #
Proposal for a directive Article 8 – paragraph 4 – point b (b) to define the position,
Amendment 229 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning listed in Annex I
Amendment 230 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 231 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover at least 75 % of the external area of both the front and back surface of the unit
Amendment 232 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 233 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 234 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 235 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 236 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 237 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 238 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 239 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 240 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 241 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 242 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 243 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 244 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 245 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 246 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 247 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 248 #
Proposal for a directive Article 9 – paragraph 1 – point f Amendment 249 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 250 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 251 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 252 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 253 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 254 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 255 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 256 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 257 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 258 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i Amendment 259 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not
Amendment 260 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than 6
Amendment 261 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii Amendment 262 #
Proposal for a directive Article 9 – paragraph 3 Amendment 263 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 264 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 265 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the position, format, layout, design
Amendment 266 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the
Amendment 267 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the
Amendment 55 #
Proposal for a directive Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 thereof,
Amendment 56 #
Proposal for a directive Recital 4 (4) In other areas there are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This applies in particular to nicotine containing products, herbal products for smoking, ingredients and emissions, certain aspects of labelling and packaging
Amendment 57 #
Proposal for a directive Recital 6 a (new) (6a) Tobacco production in disadvantaged areas such as the outermost regions, where it is frequently linked to special geographical and socioeconomic conditions and is of cultural value because of the craft-based production methods used, should receive special attention from the EU, which should allow the Member State the possibility of applying special measures to maintain production in these regions;
Amendment 58 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. To that end, it is also essential to continue to provide education, information and prevention campaigns and programmes to help citizens who wish to give up smoking.
Amendment 59 #
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.
Amendment 60 #
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, their toxicity or addictiveness.
Amendment 61 #
Proposal for a directive Recital 14 (14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additives integrated in the filter of cigarettes as well as additives colouring the tobacco smoke. Without harmonisation, the obstacles on the internal market are expected to increase in the coming years taking into account the implementation of the FCTC and its guidelines and considering experience gained in other jurisdictions outside the Union. The guidelines on Articles 9 and 10 FCTC call in particular for the removal of ingredients that increase palatability, create the impression that the tobacco products have health benefits, are associated with energy and vitality or have colouring properties. Ingredients that increase addictiveness and toxicity should also be removed.
Amendment 62 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco and menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 63 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 64 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation
Amendment 65 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 66 #
Proposal for a directive Recital 16 Amendment 67 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products sh
Amendment 68 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products should be allowed, as long as they do not result in a characterising flavour.. The Commission should ensure uniform conditions for the implementation of the provision on characterising flavour. Exemption should be made for menthol cigarettes as they are considered being traditional tobacco flavour products and should not be classified with the other flavoured tobacco products. Independent panels should be used by the Member States and by the Commission to assist in such decision making. The application of this Directive should not discriminate between different tobacco varieties.
Amendment 69 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives
Amendment 70 #
Proposal for a directive Recital 17 (17) Certain additives
Amendment 71 #
Proposal for a directive Recital 18 Amendment 72 #
Proposal for a directive Recital 18 Amendment 73 #
Proposal for a directive Recital 18 Amendment 74 #
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
Amendment 75 #
Proposal for a directive Recital 18 (18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco, water- pipe 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.
Amendment 76 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others.
Amendment 77 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined health warnings are more effective than text-only warnings. In this light combined health warnings should become mandatory throughout the Union and, to ensure they are effective, cover significant and visible parts of the packet surface.
Amendment 78 #
Proposal for a directive Recital 22 (22) The labelling provisions
Amendment 79 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined health warnings are more effective than text-only warnings. In this light combined health warnings should become mandatory throughout the Union and cover
Amendment 80 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features that appear on the packaging, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed by specifying which texts may be found on the package.
Amendment 81 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed through the appropriate packaging and labelling of such products and through informing consumers of the harm that they cause, so that the consumer is fully aware of the consequences of using a particular product.
Amendment 82 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’,
Amendment 83 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise
Amendment 84 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the d
Amendment 85 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’,
Amendment 86 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’,
Amendment 87 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise
Amendment 88 #
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
Amendment 89 #
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
Amendment 90 #
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 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. Coherent implementation of customs legislation will strengthen customs authorities in their fight against illicit trade, in particular through technical capacity building.
Amendment 91 #
Proposal for a directive Recital 28 (28) In order to ensure efficacy, independence and transparency, manufacturers of tobacco products should conclude data storage contracts with independent third parties, under the auspices of an external auditor. The data related to the tracking and tracing system should be kept separate from other company related data and be under the control of and accessible at all times by the competent authorities from Member States and the Commission.
Amendment 92 #
Proposal for a directive Recital 29 Amendment 93 #
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.
Amendment 94 #
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. C
Amendment 95 #
Proposal for a directive Recital 30 (30) Cross-border distance sales of tobacco, and practices such as the free distribution or swapping of tobacco products in public places for promotional purposes, 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.
Amendment 96 #
Proposal for a directive Recital 30 (30) Cross-border distance sales of tobacco
Amendment 97 #
Proposal for a directive Recital 31 (31) All tobacco products have the
Amendment 98 #
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 use 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
Amendment 99 #
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
source: PE-510.660
2013/05/13
IMCO
214 amendments...
Amendment 268 #
Proposal for a directive Article 9 – paragraph 3 – point c c) define the
Amendment 269 #
Proposal for a directive Article 9 – paragraph 3 – point c c) define the position, format, layout, design
Amendment 270 #
Proposal for a directive Article 9 – paragraph 3 – point c c) define the
Amendment 271 #
Proposal for a directive Article 9 – paragraph 3 – point c c) define the
Amendment 272 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 273 #
Proposal for a directive Article 9 – paragraph 3 – point d d
Amendment 274 #
Proposal for a directive Article 9 – paragraph 3 – point d d
Amendment 275 #
Proposal for a directive Article 10 Amendment 276 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general warning shall be printed or affixed by means of irremovable stickers on the most visible surface of the unit packet and any outside packaging. The text warnings listed in Annex I shall be rotated in such a way as to guarantee their regular appearance. These warnings shall
Amendment 277 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall 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
Amendment 278 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall cover
Amendment 279 #
Proposal for a directive Article 10 – paragraph 2 2. The text warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging, with the exception of the transparent plastic wrapping commonly used in the retail trade, provided that the warning on the packaging beneath this wrapping can be seen clearly through it. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.
Amendment 280 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with
Amendment 281 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover
Amendment 282 #
Proposal for a directive Article 10 – paragraph 3 a (new) 3a. In the case of unit packets the most visible surface of which exceeds 75 cm2, the warnings referred to in paragraphs 2 and 3 shall cover an area of at least 22.5 cm2 on each surface. That area shall be increased to 24 cm2 for Member States with two official languages and 26.25 cm2 for Member States with three official languages.
Amendment 283 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. The warnings may be affixed by means of stickers, provided that such stickers are irremovable. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;
Amendment 284 #
Proposal for a directive Article 10 – paragraph 4 – point a (a)
Amendment 285 #
Proposal for a directive Article 10 – paragraph 4 – point b (b) centred in the area in which they are required to
Amendment 286 #
Proposal for a directive Article 10 – paragraph 4 – point c (c) surrounded by a black border not less than
Amendment 287 #
Proposal for a directive Article 10 – paragraph 5 Amendment 288 #
Proposal for a directive Article 10 – paragraph 5 Amendment 289 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 This tobacco product can damage your health and is addictive, but presents substantially lower risks to your health than smoking
Amendment 290 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 This tobacco product
Amendment 291 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 This tobacco product
Amendment 292 #
Proposal for a directive Article 11 – paragraph 2 – 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
Amendment 293 #
Proposal for a directive Article 11 – paragraph 3 Amendment 294 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health
Amendment 295 #
Proposal for a directive Article 12 – paragraph 1 – point b b) suggests that a particular tobacco product
Amendment 296 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 297 #
Proposal for a directive Article 12 – paragraph 1 – point d d) in the case of tobacco for oral use, resembles a food product.
Amendment 298 #
Proposal for a directive Article 12 – paragraph 2 Amendment 299 #
Proposal for a directive Article 12 – paragraph 2 2.
Amendment 300 #
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.
Amendment 301 #
Proposal for a directive Article 12 – paragraph 2 – introductory part 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
Amendment 302 #
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.
Amendment 303 #
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, inserts, scratch-offs and sleeves or relate to the shape of the tobacco product itself.
Amendment 304 #
Proposal for a directive Article 12 – paragraph 2 2. Prohibited elements and features may include but are not limited to texts, symbols, names,
Amendment 305 #
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
Amendment 306 #
Proposal for a directive Article 12 – paragraph 2 2.
Amendment 307 #
Proposal for a directive Article 12 – paragraph 2 a (new) 2a. The variety of tobacco used to manufacture the product and/or its country of origin may be indicated on the unit packet.
Amendment 308 #
Proposal for a directive Article 12 – paragraph 2 b (new) 2b. A label with the statement "All cigarettes are equally harmful" shall be put on the unit packet.
Amendment 309 #
Proposal for a directive Article 13 Amendment 310 #
Proposal for a directive Article 13 – paragraph 1 Amendment 311 #
Proposal for a directive Article 13 – paragraph 1 Amendment 312 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a
Amendment 313 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape.
Amendment 314 #
Proposal for a directive Article 13 – paragraph 1 1.
Amendment 315 #
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.
Amendment 316 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a
Amendment 317 #
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.
Amendment 318 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of
Amendment 319 #
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
Amendment 320 #
Proposal for a directive Article 13 – paragraph 2 Amendment 321 #
Proposal for a directive Article 13 – paragraph 2 Amendment 322 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material, which are safe for the product and the user alike and environmentally-friendly and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than the flip-top lid. The flip-top lid of a cigarette packet shall be hinged only at the back of the packet.
Amendment 323 #
Proposal for a directive Article 13 – paragraph 2 a (new) Amendment 324 #
Proposal for a directive Article 13 – paragraph 2 b (new) 2b. No trade mark or any other mark may appear on the tobacco product itself
Amendment 325 #
Proposal for a directive Article 13 – paragraph 3 Amendment 326 #
Proposal for a directive Article 13 – paragraph 3 Amendment 327 #
Proposal for a directive Article 13 – paragraph 3 Amendment 328 #
Proposal for a directive Article 13 – paragraph 3 Amendment 329 #
Proposal for a directive Article 13 – paragraph 3 Amendment 330 #
Proposal for a directive Article 13 – paragraph 3 Amendment 331 #
Proposal for a directive Article 13 – paragraph 4 Amendment 332 #
Proposal for a directive Article 13 – paragraph 4 Amendment 333 #
Proposal for a directive Article 13 – paragraph 4 Amendment 334 #
Proposal for a directive Article 13 – paragraph 4 Amendment 335 #
Proposal for a directive Article 13 – paragraph 4 Amendment 336 #
Proposal for a directive Article 13 – paragraph 4 Amendment 337 #
Proposal for a directive Article 13 – paragraph 4 a (new) 4a. Unit packets of cigarettes and roll- your-own tobacco shall comply with plain packaging requirements laid down by the Commission following paragraph 4b of this Article.
Amendment 338 #
Proposal for a directive Article 13 – paragraph 4 b (new) 4b. The Commission shall adopt by means of implementing acts measures on plain packaging rules for unit packets of cigarettes and roll-your-own tobacco. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.
Amendment 339 #
Proposal for a directive Article 14 – paragraph 1 1.
Amendment 340 #
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 outside packaging, shall be marked with a unique, secure and irremovable 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.
Amendment 341 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets of tobacco products 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. In those Member States where tax stamps are applied on tobacco products the unique identifiers can be printed on the tax stamps.
Amendment 342 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets of tobacco products shall be marked with a unique identifier used together with a digital tax stamp in invisible ink. 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.
Amendment 343 #
Proposal for a directive Article 14 – paragraph 2 – introductory part 2. The unique identifier, which is secure and impossible to duplicate, shall allow determining:
Amendment 344 #
Proposal for a directive Article 14 – paragraph 2 – point e (e) the product
Amendment 345 #
Proposal for a directive Article 14 – paragraph 2 – point e (e) the product
Amendment 346 #
Proposal for a directive Article 14 – paragraph 2 – point g Amendment 347 #
Proposal for a directive Article 14 – paragraph 2 – point g (g) the intended shipment route, the shipment date, destination, place of departure and recipient;
Amendment 348 #
Proposal for a directive Article 14 – paragraph 2 – point g (g) the intended shipment route, the shipment date, shipment destination, point of departure and consignee;
Amendment 349 #
Proposal for a directive Article 14 – paragraph 2 – point h Amendment 350 #
Proposal for a directive Article 14 – paragraph 2 – point i (i) the
Amendment 351 #
Proposal for a directive Article 14 – paragraph 2 – point j (j) the identity of
Amendment 352 #
Proposal for a directive Article 14 – paragraph 2 – point k (k) the invoice, order number and payment records of
Amendment 353 #
Proposal for a directive Article 14 – paragraph 2 a (new) Amendment 354 #
Proposal for a directive Article 14 – paragraph 3 3. Member States shall ensure that all
Amendment 355 #
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
Amendment 356 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet, including importers, warehouses and transporting companies with the necessary equipment, determined by the Member States, allowing for the recording of the tobacco products purchased, sold, stored, transported or otherwise handled. The equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6.
Amendment 357 #
Proposal for a directive Article 14 – paragraph 5 5. Recorded data has to be transmitted to a database in a timely manner. The data cannot be modified or deleted by any economic operator involved in the trade of tobacco products, but the economic operator that introduced the data and other economic operators directly concerned by the transaction such as the supplier or the recipient can comment on previously introduced data. The economic operator concerned shall add the correct data and a reference to the previous entry which requires rectification in their view. In exceptional circumstances and upon submission of adequate evidence, the competent authority in the Member State in which the recording took place or if the recording took place outside the Union the competent authority in the Member State of importation, can authorise the modification or deletion of data previously registered. The recorded data has to be kept for the period of four years from manufacturing unless any Member State or the Commission request a longer period due to an on-going investigation.
Amendment 358 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall ensure that
Amendment 359 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 360 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 361 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique, secure and impossible-to-duplicate identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or other
Amendment 362 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form
Amendment 363 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a
Amendment 364 #
Proposal for a directive Article 14 – paragraph 9 Amendment 365 #
Proposal for a directive Article 14 – paragraph 9 Amendment 366 #
Proposal for a directive Article 14 – paragraph 9 – introductory part 9. The Commission shall be empowered, taking into account existing practices, technologies and commercial practicalities as well as global standards for tracking and tracing and authentication of fast moving consumer goods and relevant requirements under the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products to adopt delegated acts in accordance with Article 22:
Amendment 367 #
Proposal for a directive Article 14 – paragraph 10 10. Tobacco products other than cigarettes and fine-cut tobacco for the roll-your-own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of
Amendment 368 #
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
Amendment 369 #
Proposal for a directive Article 15 – paragraph 1 Amendment 370 #
Proposal for a directive Article 15 – paragraph 1 1. Member States
Amendment 371 #
Proposal for a directive Article 15 – paragraph 1 a (new) Member States shall set maximum limits for toxic or carcinogenic substances present in smokeless tobacco products placed on the market. The substances and required limits are as detailed in Annex IIa.
Amendment 372 #
Proposal for a directive Article 15 – paragraph 1 b (new) Amendment 373 #
Proposal for a directive Article 16 a (new) Article 16 a Point-of-Sale displays of tobacco products 1. Member States shall prohibit point-of- sale displays of tobacco products in their territory. 2. Tobacco products shall be completely concealed from the customer except during the purchase of sale of tobacco products, or stocktaking, restocking, staff training or maintenance of the storage unit. 3. Display of tobacco products for those reasons listed in paragraph 2 may only last as long as is necessary to complete those tasks. 4. Prices of tobacco products shall be listed in a standardised format.
Amendment 374 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 375 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 376 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 377 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 378 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 379 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 380 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 381 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 382 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 383 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 384 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 385 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 386 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 387 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 388 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 389 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 390 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 391 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1a. Member States shall prohibit on their territory the distribution of free or discounted tobacco products and the swapping of new, sealed packets of tobacco products for packets that have already been opened, irrespective of the channels used.
Amendment 392 #
Proposal for a directive Article 16 – paragraph 2 Amendment 393 #
Proposal for a directive Article 16 – paragraph 2 Amendment 394 #
Proposal for a directive Article 16 – paragraph 2 Amendment 395 #
Proposal for a directive Article 16 – paragraph 2 Amendment 396 #
Proposal for a directive Article 16 – paragraph 2 Amendment 397 #
Proposal for a directive Article 16 – paragraph 3 Amendment 398 #
Proposal for a directive Article 16 – paragraph 3 Amendment 399 #
Proposal for a directive Article 16 – paragraph 3 Amendment 400 #
Proposal for a directive Article 16 – paragraph 3 Amendment 401 #
Proposal for a directive Article 16 – paragraph 3 Amendment 402 #
Proposal for a directive Article 16 – paragraph 4 Amendment 403 #
Proposal for a directive Article 16 – paragraph 4 Amendment 404 #
Proposal for a directive Article 16 – paragraph 4 Amendment 405 #
Proposal for a directive Article 16 – paragraph 4 Amendment 406 #
Proposal for a directive Article 16 – paragraph 4 Amendment 407 #
Proposal for a directive Article 16 – paragraph 5 Amendment 408 #
Proposal for a directive Article 16 – paragraph 5 Amendment 409 #
Proposal for a directive Article 16 – paragraph 5 Amendment 410 #
Proposal for a directive Article 16 – paragraph 5 Amendment 411 #
Proposal for a directive Article 16 – paragraph 5 Amendment 412 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and novel potential reduced-risk tobacco products;
Amendment 413 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and granting of pre-marketing authorisation for reduced-risk tobacco products
Amendment 414 #
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
Amendment 415 #
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 and in respect of which they intend to make claims, based on solid scientific evidence, alleging reduced harmfulness or risk in comparison with conventional tobacco products. 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:
Amendment 416 #
Proposal for a directive Article 17 – paragraph 1 – point a a) available scientific studies on toxicity, impact on passive smoking, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions;
Amendment 417 #
Proposal for a directive Article 17 – paragraph 1 a (new) 1a. The Member States shall require manufacturers and importers of tobacco products to submit the information required under paragraph 1, points (a) to (c), to their competent agencies after the content and conclusions have been verified by independent scientific facilities.
Amendment 418 #
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. In connection with the placing on the market of reduced-risk tobacco products, Member States shall be entitled to introduce an authorisation system and charge a proportionate fee. Member States shall be entitled to lay down specific rules for reduced-risk products governing consumer information, packaging and labelling, ingredients and emissions and the methods used to measure tar, nicotine and carbon monoxide. Member States shall notify those rules to the Commission.
Amendment 419 #
Proposal for a directive Article 17 – paragraph 3 3. Novel and reduced-risk tobacco products placed on the market shall respect the requirements set out in this Directive. Reduced-risk tobacco products shall be covered by special provisions laid down by Member States under paragraph 2. 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.
Amendment 420 #
Proposal for a directive Article 17 – paragraph 3 a (new) Amendment 421 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 422 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 423 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 424 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 425 #
Proposal for a directive Article 18 – paragraph 1 b (new) 1b. For nicotine-containing products where paragraph 1 does not apply, the products may be placed on the market if they comply with this Directive
Amendment 426 #
Proposal for a directive Article 18 – paragraph 1 c (new) 1c. Member States shall ensure that nicotine containing products comply with Union consumer protection, safety and other relevant legislation in force.
Amendment 427 #
Proposal for a directive Article 18 – paragraph 1 d (new) 1d. No later than 12 months from entry into force of this Directive, each Member State shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in Annex IIb as it applies to nicotine containing products and the effectiveness of those measures.
Amendment 428 #
Proposal for a directive Article 18 – paragraph 1 e (new) 1e. For nicotine-containing products where paragraph 1 does not apply, the products may be placed on the market if they comply with this Directive.
Amendment 429 #
Proposal for a directive Article 18 – paragraph 1 f (new) 1f. Member States shall introduce a ban on the use of products containing nicotine in public places.
Amendment 430 #
Proposal for a directive Article 18 – paragraph 1 g (new) 1g. Member States shall introduce a minimum age to be able to access products containing nicotine.
Amendment 431 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 432 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 433 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 434 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 435 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 436 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 437 #
Proposal for a directive Article 18 – paragraph 2 Amendment 438 #
Proposal for a directive Article 18 – paragraph 2 Amendment 439 #
Proposal for a directive Article 18 – paragraph 2 2. The Commission shall, b
Amendment 440 #
Proposal for a directive Article 18 – paragraph 3 Amendment 441 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Amendment 442 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Amendment 443 #
Proposal for a directive Article 18 – paragraph 3 – subparagraph 1 This product contains nicotine and
Amendment 444 #
Proposal for a directive Article 18 – paragraph 3 – subparagraph 1 This product contains nicotine and
Amendment 445 #
Proposal for a directive Article 18 – paragraph 4 Amendment 446 #
Proposal for a directive Article 18 – paragraph 4 – point a Amendment 447 #
Proposal for a directive Article 18 – paragraph 4 – point b Amendment 448 #
Proposal for a directive Article 18 – paragraph 5 Amendment 449 #
Proposal for a directive Article 18 – paragraph 5 Amendment 450 #
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
Amendment 451 #
Proposal for a directive Article 19 – paragraph 1 – subparagraph 1 This product can damage your health and is addictive.
Amendment 452 #
Proposal for a directive Article 19 – paragraph 1 – subparagraph 1 This product can damage your health and is addictive.
Amendment 453 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than 30 % of the area of the corresponding surface of the unit packet and of any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with
Amendment 454 #
Proposal for a directive Article 22 – paragraph 2 Amendment 455 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 456 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 457 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3a), 4(3), 4(4),
Amendment 458 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 459 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4),
Amendment 460 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 461 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3),
Amendment 462 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 463 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4),
Amendment 464 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 465 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 466 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3),
Amendment 467 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 468 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4),
Amendment 469 #
Proposal for a directive Article 23 – paragraph 1 – subparagraph 2 With a view to drafting the report, the Commission shall be assisted by scientific and technical experts from the Member States in order to have all the necessary information available.
Amendment 470 #
Proposal for a directive Article 24 – paragraph 2 2.
Amendment 471 #
Proposal for a directive Article 24 – paragraph 3 Amendment 472 #
Proposal for a directive Article 25 – paragraph 1 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [Publications Office, please insert the exact date: entry into force +
Amendment 473 #
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 +
Amendment 474 #
Proposal for a directive Article 26 – paragraph 1 – point a (a)
Amendment 475 #
Proposal for a directive Article 26 – paragraph 1 – point a (a)
Amendment 476 #
Proposal for a directive Article 26 – paragraph 1 – point b (b) nicotine containing products
Amendment 477 #
Proposal for a directive Article 26 – paragraph 1 a (new) Member States may allow tobacco products other than cigarettes and roll- your-own cigarettes, 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 + 42 months).
Amendment 478 #
Proposal for a directive Article 26 – paragraph 1 b (new) Member States may permit the marketing of other tobacco products, which do not comply with this Directive, until (Publications Office, please insert exact date: entry into force + 36 months).
Amendment 479 #
Proposal for a directive Article 28 – paragraph 1 This Directive shall not enter into force
Amendment 480 #
Proposal for a directive Annex 2 a (new) ANNEX IIa Maximum permissible content in smokeless tobacco, toxin per unit weight dry tobacco: NNN (N-nitrosonornicotine) plus NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1- butanone): 2.0 mg/kg B(a)P (Benzo[a]Pyrene): 5.0 µg/kg
Amendment 481 #
Proposal for a directive Annex 2 b (new) ANNEX IIb EU legislation applicable to nicotine- containing products: General safety: General Product Safety Directive 2001/95/EC, in particular with regard to the RAPEX system - notification and alerts of dangerous products Packaging and labelling: Dangerous Substances Directive 67/548/EEC Dangerous Preparations Directive 99/45/EC Classification, Labelling and Packaging of Substances and Mixtures - the CLP Regulation 1272/2008 applies from 2015. Chemical safety: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) 1907/2006 Electrical safety: Low Voltage Directive 2006/95/EC Electro-Magnetic Compatibility Directive 2004/108/EC Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU (where appropriate) Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU Batteries Directive 2006/66/EC Weights and measures: Making-up by weight or by volume of certain pre-packaged products - Directive 76/211/EEC Nominal Quantities for Prepacked Products Directive 2007/45/EC Commercial practice: Distance Selling Directive 97/7/EC Directive on Electronic Commerce 2000/31/EC Misleading and Comparative Advertising Directive 2006/114/EC Unfair Commercial Practices Directive 2005/29/EC
source: PE-510.679
2013/05/14
ENVI
987 amendments...
Amendment 1000 #
Proposal for a directive Article 14 – paragraph 9 Amendment 1001 #
Proposal for a directive Article 14 – paragraph 9 Amendment 1002 #
Proposal for a directive Article 14 – paragraph 9 – introductory part 9.
Amendment 1003 #
Proposal for a directive Article 14 – paragraph 9 – point a Amendment 1004 #
Proposal for a directive Article 14 – paragraph 9 – point b Amendment 1005 #
Proposal for a directive Article 14 – paragraph 9 – point b (b) to define the international technical standards and introduce standardised requests for information to ensure that the systems used for
Amendment 1006 #
Proposal for a directive Article 14 – paragraph 9 – point b (b) to define the technical standards to ensure that the systems used for the unique identifiers and the related functions are fully compatible with each other across the Union and in line with international standards.
Amendment 1007 #
Proposal for a directive Article 14 – paragraph 9 – point c Amendment 1008 #
Proposal for a directive Article 14 – paragraph 9 – point c Amendment 1009 #
Proposal for a directive Article 14 – paragraph 9 – subparagraph 1 a (new) In drawing up the delegated acts foreseen in this paragraph, the Commission shall take into account existing practices, technologies and international standards for tracking and tracing and authentication of fast moving consumer goods, as well as relevant requirements of the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products.
Amendment 1010 #
Proposal for a directive Article 14 – paragraph 10 Amendment 1011 #
Proposal for a directive Article 14 – paragraph 10 Amendment 1012 #
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
Amendment 1013 #
Proposal for a directive Article 14 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 1014 #
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
Amendment 1015 #
Proposal for a directive Article 15 Amendment 1016 #
Proposal for a directive Article 15 – paragraph 1 Member States shall p
Amendment 1017 #
Proposal for a directive Article 15 – paragraph 1 Amendment 1018 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. This ban should, however, not affect historically traditional tobacco products for oral use, which may be allowed by individual Member States.
Amendment 1019 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. The labelling of tobacco for oral use shall be governed by the same rules as that of other smokeless tobacco products.
Amendment 1020 #
Proposal for a directive Article 15 – paragraph 1 Member States
Amendment 1021 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of
Amendment 1022 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. Member States and regions of Member States with a tradition of using oral tobacco shall have an opportunity to apply for a national or regional derogation from the prohibition on cultural or historical grounds.
Amendment 1023 #
Proposal for a directive Article 15 – paragraph 1 Where necessary to achieve a high level of health protection, Member States
Amendment 1024 #
Proposal for a directive Article 15 – paragraph 1 a (new) Maximum limits shall be set for toxic and carcinogenic substances present in smokeless tobacco products placed on the market. The substances and required limits are as detailed in [new] Annex III.
Amendment 1025 #
Proposal for a directive Article 15 – paragraph 1 a (new) The responsibility for regulating the content of snus shall lie with the Member State where the sale of snus is permitted in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden. Snus should therefore be exempt from the provisions of Article 6 of this Directive.
Amendment 1026 #
Proposal for a directive Article 15 – paragraph 1 a (new) Tobacco for oral use shall be exempted from the application of this Directive, except for Article 15.
Amendment 1027 #
Proposal for a directive Article 15 – paragraph 1 b (new) The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the substances and limit values laid down in paragraph 1a and Annex III, taking into account scientific developments and internationally agreed standards, taking account of the principles of proportionality, non-discrimination and the objective of developing the internal market with a high level of health protection.
Amendment 1028 #
Proposal for a directive Title 2 – chapter 4 – title Amendment 1029 #
Proposal for a directive Title 2 – chapter 4 – title Amendment 1030 #
Proposal for a directive Article 16 – title Amendment 1031 #
Proposal for a directive Article 16 – title Amendment 1032 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1033 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1034 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1035 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1036 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1037 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1038 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1.
Amendment 1039 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1040 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1041 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1042 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 1043 #
Proposal for a directive Article 16 – paragraph 1 – introductory part Amendment 1044 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1 a. Member States shall prohibit retail outlets established on their territory from distributing free or discounted tobacco products through cross-border distance channels or through any other channel.
Amendment 1045 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1a. A Member State may, for public health reasons, impose restrictions on imports of tobacco for personal use. A Member State must be able to apply such restrictions in particular when the price in the Member State where the product is purchased is significantly lower than the price in the Member State of origin or if the health warnings are not in its official language(s).
Amendment 1046 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1a. Sales of cigarettes and roll-your-own tobacco via the Internet shall be prohibited in the Union; Internet sales of other tobacco products and related nicotine-containing products shall be subject to more stringent monitoring in the Union;
Amendment 1047 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1a. Member States shall prohibit on their territory the distribution of free or discounted tobacco products and the swapping of new, sealed packets of tobacco products for packets that have already been opened, irrespective of the channels used.
Amendment 1048 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1049 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1050 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1051 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1052 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1053 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1054 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1055 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 1056 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1057 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1058 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1059 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1060 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1061 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1062 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1063 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 1064 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1065 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1066 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1067 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1068 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1069 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1070 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1071 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 1072 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1073 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1074 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1075 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1076 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1077 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1078 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1079 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1080 #
Proposal for a directive Article 16 – paragraph 2 Amendment 1081 #
Proposal for a directive Article 16 – paragraph 2 2.
Amendment 1082 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1083 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1084 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1085 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1086 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1087 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1088 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1089 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1090 #
Proposal for a directive Article 16 – paragraph 3 Amendment 1091 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1092 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1093 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1094 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1095 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1096 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1097 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1098 #
Proposal for a directive Article 16 – paragraph 4 Amendment 1099 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1100 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1101 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1102 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1103 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1104 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1105 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1106 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1107 #
Proposal for a directive Article 16 – paragraph 5 Amendment 1108 #
Proposal for a directive Article 16 a (new) Cross-border sales of tobacco products Article 16a Cross-border sales of tobacco products A ceiling on the import of products from another Member State shall be set for each of the tobacco products covered by this Directive. This ceiling shall be set by each Member States using the method of calculation which it regards as most appropriate (for example per person, per type of vehicle, an overall quantity covering several tobacco products).
Amendment 1109 #
Proposal for a directive Article 16 a (new) Article 16 a Point-of-sale displays of tobacco 1. Member States shall prohibit point-of- sale displays of tobacco in their territory. 2. Tobacco products shall be completely concealed from the customer except during the purchase or sale of tobacco products, or stocktaking, restocking, staff training or maintenance of the storage unit. 3. Display of tobacco products for those reasons listed in paragraph 2 may only last as long as is necessary to complete those tasks. 4. Prices of tobacco products shall be listed in a standardised format. No package deals or special discounts shall be displayed.
Amendment 1110 #
Proposal for a directive Article 16 a (new) Article 16a Member States which have implemented a national anti-smoking strategy may set quantitative limits on cross-border movements.
Amendment 1111 #
Proposal for a directive Title 2 – chapter 5 – title Amendment 1112 #
Proposal for a directive Article 17 Amendment 1113 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and potentially less harmful products
Amendment 1114 #
Proposal for a directive Article 17 – title Notification of
Amendment 1115 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and potentially reduced-risk novel tobacco products
Amendment 1116 #
Proposal for a directive Article 17 – title Notification of novel tobacco products
Amendment 1117 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and granting of pre-marketing authorisation for reduced-risk tobacco products
Amendment 1118 #
Proposal for a directive Article 17 – title Amendment 1119 #
Proposal for a directive Article 17 – paragraph 1 – introductory part 1. Member States shall
Amendment 1120 #
Proposal for a directive Article 17 – paragraph 1 – introductory part 1. The placing on the market of reduced-risk tobacco products must be authorised by the competent authorities of the Member State in which the producer or importer intends to place the product on the market. Member States shall require that manufacturers and importers of tobacco products
Amendment 1121 #
Proposal for a directive Article 17 – paragraph 1 – introductory part 1. Member States shall require that manufacturers and importers of reduced- risk tobacco products notify the competent authorities of Member States of any
Amendment 1122 #
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 and for which they intend, on the basis of solid scientific evidence, to make claims that they are less harmful or of lower risk than conventional tobacco products. 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:
Amendment 1123 #
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
Amendment 1124 #
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 as well as for products which they intend to claim potentially reduced harm or reduced risk compared to regular tobacco products based on scientific evidence. 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:
Amendment 1125 #
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, including reduced-risk products, 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, including reduced-risk products, shall also provide the competent authorities in question with:
Amendment 1126 #
Proposal for a directive Article 17 – paragraph 1 – point a a) available scientific studies on toxicity
Amendment 1127 #
Proposal for a directive Article 17 – paragraph 1 – point a (a) available scientific studies on
Amendment 1128 #
Proposal for a directive Article 17 – paragraph 1 – point b (b) available studies and market research on how consumers perceive and use the product, including its labelling, and on preferences of various consumer groups, including young people and
Amendment 1129 #
Proposal for a directive Article 17 – paragraph 1 – point b b) working summaries of the available studies and market research on preferences of various consumer groups, including young people and
Amendment 1130 #
Proposal for a directive Article 17 – paragraph 1 – point b b) available studies and market research on preferences of various consumer groups, including young people and chronic heavy smokers and
Amendment 1131 #
Proposal for a directive Article 17 – paragraph 1 – point c a (new) (c a) Member States shall be entitled to issue specific rules for products which they intend to claim potentially reduced harm or reduced risk that may deviate from the requirements of this Directive, and shall notify such rules to the Commission.
Amendment 1132 #
Proposal for a directive Article 17 – paragraph 2 Amendment 1133 #
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
Amendment 1134 #
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
Amendment 1135 #
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
Amendment 1136 #
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. In connection with the placing on the market of reduced-risk tobacco products, Member States shall be entitled to introduce an authorisation system and
Amendment 1137 #
Proposal for a directive Article 17 – paragraph 3 Amendment 1138 #
Proposal for a directive Article 17 – paragraph 3 3.
Amendment 1139 #
Proposal for a directive Article 17 – paragraph 3 3.
Amendment 1140 #
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. The provisions of Article 12(1)(b) shall not apply to new tobacco products that have been scientifically proven to be less harmful than conventional tobacco products.
Amendment 1141 #
Proposal for a directive Article 17 – paragraph 3 3. Novel and reduced-risk tobacco products placed on the market shall respect the requirements set out in this Directive. Reduced-risk tobacco products shall be covered by special provisions laid down by Member States under paragraph 2. 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.
Amendment 1142 #
Proposal for a directive Article 17 – paragraph 3 – point 1 (new) (1) The Commission shall submit a study on the health effects of passive inhalation of emissions from novel tobacco products, including reduced-risk products.
Amendment 1143 #
Proposal for a directive Article 17 – paragraph 3 a (new) 3a. Member States may authorise the sale and define rules on the marketing and labelling of new categories of tobacco products that have been scientifically proven to be less harmful than conventional tobacco products, provided that it has been demonstrated, pursuant to paragraph 1, that their use could reduce risks, smoking-related diseases and harm to public health when compared with conventional tobacco products.
Amendment 1144 #
Proposal for a directive Article 17 – paragraph 3 a (new) 3a. On the basis of independent, reliable and verifiable scientific and technical data, the Commission shall, within two years of the entry into force of this Directive, adopt delegated acts laying down rules governing evaluation, packaging, labelling, ingredients, placing on the market, presentation and sale of, and consumer information about, new tobacco products which are significantly less harmful than traditional tobacco products.
Amendment 1145 #
Proposal for a directive Article 17 – paragraph 3 a (new) 3a. Article 12(b) shall not apply to reduced-risk tobacco products.
Amendment 1146 #
Proposal for a directive Article 18 Amendment 1147 #
Proposal for a directive Article 18 Amendment 1148 #
Proposal for a directive Article 18 – paragraph 1 Amendment 1149 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1. Products which do not contain nicotine or which contain it in quantities smaller than those referred to in paragraph 1(a) may be placed on the market in accordance with the provisions of Directive 2001/95/EC on general product safety. 1a. Member States shall ensure that nicotine-containing products are not sold to persons below the age required for purchasing tobacco products or related products; The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
Amendment 1150 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1151 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1152 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1153 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1154 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1155 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1156 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1157 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1158 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1159 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 1160 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1. The following nicotine-containing products may only be placed on the market if they were authorised pursuant to the simplified registration procedure under Articles 14 and 15 of Directive 2001/83/EC:
Amendment 1161 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. Member States shall introduce a ban on the use of nicotine-containing products in public places.
Amendment 1162 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 1163 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. Where appropriate, Member States may impose marketing restrictions on nicotine-containing products similar to those which apply to the marketing of tobacco products.
Amendment 1164 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. Member States shall ensure that nicotine-containing products are not sold to persons below the age required for purchasing tobacco products.
Amendment 1165 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. Nicotine-containing products other than tobacco products in respect of which marketing authorisations are granted under Directive 2011/83/EC shall not be covered by this Directive.
Amendment 1166 #
Proposal for a directive Article 18 – paragraph 1 b (new) 1b. Member States shall introduce a minimum age for purchasing nicotine- containing products.
Amendment 1167 #
Proposal for a directive Article 18 – paragraph 1 b (new) Amendment 1168 #
Proposal for a directive Article 18 – paragraph 1 c (new) 1c. Member States shall ensure that nicotine containing products comply with European Union consumer protection, safety and other relevant legislation in force.
Amendment 1169 #
Proposal for a directive Article 18 – paragraph 1 d (new) 1d. No later than 12 months from entry into force of this Directive, each Member State shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in [new] Annex IV as it applies to nicotine containing products and the effectiveness of those measures.
Amendment 1170 #
Proposal for a directive Article 18 – paragraph 1 e (new) 1e. Member States shall ensure that nicotine-containing products are not sold to persons below the national legal age for purchasing tobacco products.
Amendment 1171 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1172 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1173 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1174 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1175 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1176 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1177 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1178 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1179 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 1180 #
Proposal for a directive Article 18 – paragraph 1 – point a a)
Amendment 1181 #
Proposal for a directive Article 18 – paragraph 1 – point a a) products for absorption with a nicotine level exceeding 2 mg per unit, or
Amendment 1182 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1183 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1184 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1185 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1186 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1187 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1188 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1189 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1190 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1191 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1192 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 1193 #
Proposal for a directive Article 18 – paragraph 1 – point b (b) products with a nicotine concentration exceeding
Amendment 1194 #
Proposal for a directive Article 18 – paragraph 1 – point b b) products for inhalation with a nicotine concentration exceeding 4 mg per ml or
Amendment 1195 #
Proposal for a directive Article 18 – paragraph 1 – point b b) products with a nicotine concentration exceeding 24 mg per ml or
Amendment 1196 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1197 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1198 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1199 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1200 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1201 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1202 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1203 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1204 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1205 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1206 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 1207 #
Proposal for a directive Article 18 – paragraph 1 – point c c) products whose intended use results in a mean maximum peak plasma concentration exceeding
Amendment 1208 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1209 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1210 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1211 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1212 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1213 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1214 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1215 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1216 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1217 #
Proposal for a directive Article 18 – paragraph 2 Amendment 1218 #
Proposal for a directive Article 18 – paragraph 2 2. The Commission shall, b
Amendment 1219 #
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
Amendment 1220 #
Proposal for a directive Article 18 – paragraph 2 a (new) 2a. Paragraphs 1 and 2 shall not apply to products whose entry onto the market is likely to lead to a significant improvement in the overall health of the population, taking into account both the degree to which they replace more harmful tobacco products, and the extent to which they are adopted by non-users of tobacco products. The decision shall be taken by Member States.
Amendment 1221 #
Proposal for a directive Article 18 – paragraph 3 Amendment 1222 #
Proposal for a directive Article 18 – paragraph 3 Amendment 1223 #
Proposal for a directive Article 18 – paragraph 3 Amendment 1224 #
Proposal for a directive Article 18 – paragraph 3 Amendment 1225 #
Proposal for a directive Article 18 – paragraph 3 – introductory part : Each unit packet and any outside packaging of nicotine-containing products
Amendment 1226 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Amendment 1227 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Each unit packet and any outside packaging of nicotine-containing products
Amendment 1228 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Amendment 1229 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Each unit packet and any outside packaging of nicotine-containing products
Amendment 1230 #
Proposal for a directive Article 18 – paragraph 3 – introductory part Each unit packet and any outside packaging of nicotine-containing products
Amendment 1231 #
Proposal for a directive Article 18 – paragraph 3 – subparagraph 1 This product contains nicotine and
Amendment 1232 #
Proposal for a directive Article 18 – paragraph 3 – subparagraph 1 This product contains nicotine, but not tobacco or tar, and can damage your health.
Amendment 1233 #
Proposal for a directive Article 18 – paragraph 3 – subparagraph 1 This product contains nicotine which is addictive and
Amendment 1234 #
Proposal for a directive Article 18 – paragraph 4 Amendment 1235 #
Proposal for a directive Article 18 – paragraph 4 Amendment 1236 #
Proposal for a directive Article 18 – paragraph 4 Amendment 1237 #
Proposal for a directive Article 18 – paragraph 4 Amendment 1238 #
Proposal for a directive Article 18 – paragraph 4 – point b (b) cover
Amendment 1239 #
Proposal for a directive Article 18 – paragraph 4 a (new) 4a. The Commission shall request an opinion from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) within 24 months of the entry into force of the Directive in order to obtain reliable scientific and toxicological information on whether or not the main ingredients of electronic cigarettes are harmful and on possible prudential measures to be taken in respect of this tobacco-related product;
Amendment 1240 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1241 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1242 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1243 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1244 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1245 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1246 #
Proposal for a directive Article 18 – paragraph 5 Amendment 1247 #
Proposal for a directive Article 18 – paragraph 5 5. The Commission shall
Amendment 1248 #
Proposal for a directive Article 18 – paragraph 5 5. The Commission shall, b
Amendment 1249 #
Proposal for a directive Article 18 – paragraph 5 a (new) 5a. No later than two years from the date specified in Article 25 paragraph 1, the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on whether to propose further legislation on the placing on the market of nicotine containing products not authorised pursuant to Directive 2001/83/EC. In the report, the Commission shall indicate in particular the features which should be considered in the light of developments in scientific and technical knowledge, including the development of internationally agreed rules and standards on products, paying special attention to: (a) standards for the manufacture and supply of nicotine containing products; (b) the appropriate minimum age of sale and purchase for nicotine containing products; (c) consumer information requirements; (d) advertising and communication in line with the harm reduction potential of the products, including the use of science based product claims; (e) the need to ensure availability of nicotine containing products to consumers of tobacco products. With a view to drafting the report the Commission, assisted by scientific and technical experts, shall analyse usage and consumption patterns of nicotine containing products.
Amendment 1250 #
Proposal for a directive Article 18 a (new) Amendment 1251 #
Proposal for a directive Article 19 – title Amendment 1252 #
Proposal for a directive Article 19 – paragraph 1 – introductory part Each unit packet and any outside packaging of
Amendment 1253 #
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:
Amendment 1254 #
Proposal for a directive Article 19 – paragraph 1 – subparagraph 1 This product
Amendment 1255 #
Proposal for a directive Article 19 – paragraph 1 – subparagraph 1 This natural product can damage your health
Amendment 1256 #
Proposal for a directive Article 19 – paragraph 1 – subparagraph 1 This product
Amendment 1257 #
Proposal for a directive Article 19 – paragraph 1 – subparagraph 1 This product
Amendment 1258 #
Proposal for a directive Article 19 – paragraph 2 2. The health warning shall be printed on the front
Amendment 1259 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than
Amendment 1260 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than
Amendment 1261 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than 30 % of the area of the corresponding surface of the unit packet and of any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with
Amendment 1262 #
Proposal for a directive Article 19 a (new) Article 19 a Imitation tobacco products The placing on the market of imitation tobacco products shall be prohibited.
Amendment 1263 #
Proposal for a directive Article 19 a (new) Amendment 1264 #
Proposal for a directive Article 20 – paragraph 3 a (new) 3 a. The negative economical and social consequences of the implementation of this Directive shall be counteracted by appropriate measures and financial support in the framework of the EU budget.
Amendment 1265 #
Proposal for a directive Article 22 Amendment 1266 #
Proposal for a directive Article 22 – paragraph 1 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. Delegated acts may only be adopted in cases in which this Directive expressly provides for such a delegation.
Amendment 1267 #
Proposal for a directive Article 22 – paragraph 1 a (new) 1 a. When preparing delegated acts the Commission shall ensure proper consultation at both Member State and Union level adhering to Article 4 paragraph 7, and Article 5 paragraph 3 of the WHO Framework Convention on Tobacco Control (FCTC).
Amendment 1268 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1269 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts
Amendment 1270 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1271 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(
Amendment 1272 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3a), 4(3), 4(4)
Amendment 1273 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall be conferred on the Commission for a
Amendment 1274 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1275 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1276 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1277 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1278 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 1279 #
Proposal for a directive Article 22 – paragraph 2 a (new) 2 a. Delegated acts issued on the basis of Article 8(4) and Article 9(3)(a)–(c) provide for a transition period of at least 24 months, during which smoking tobacco packaging featuring health warnings set out in this Directive, as well as in the delegated act announced on the basis of the authorisations contained in the above provisions, may be used in parallel.
Amendment 1280 #
Proposal for a directive Article 22 – paragraph 3 3.
Amendment 1281 #
Proposal for a directive Article 22 – paragraph 3 3.
Amendment 1282 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 1283 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(
Amendment 1284 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3)
Amendment 1285 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 1286 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 1287 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 1288 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 1289 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act
Amendment 1290 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1291 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1292 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1293 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4), 6(
Amendment 1294 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3a), 4(3), 4(4), 4(4a), 6(2), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3)
Amendment 1295 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1296 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1297 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1298 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 1299 #
Proposal for a directive Article 23 Amendment 1300 #
Proposal for a directive Article 23 – paragraph 1 a (new) 1 a. No later than 2 years from the date specified in Article 25 paragraph 1, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the economic and social consequences of the application of this Directive
Amendment 1301 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point b b) market developments in novel tobacco products considering, inter alia, notifications received under Article 17, with particular reference to evaluating the potential advantages of less harmful new categories of tobacco products and the decreased risk of smoking-associated diseases;
Amendment 1302 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c a (new) (ca) methodologies for more realistically assessing and regulating toxic exposure and harm;
Amendment 1303 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c a (new) (ca) The Directive’s potential impact on European tobacco cultivation.
Amendment 1304 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c b (new) (cb) evaluation of the addictive effects of those ingredients which encourage addiction;
Amendment 1305 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c c (new) (cc) evaluation of tobacco products which may have the potential to reduce harm;
Amendment 1306 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c d (new) (cd) development of standardised testing methods to measure the yields of constituents in cigarette smoke other than tar, nicotine and carbon monoxide;
Amendment 1307 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c e (new) (ce) toxicological data to be required from manufacturers on ingredients and the manner in which they should be tested in order to allow public health authorities to assess their use;
Amendment 1308 #
Proposal for a directive Article 23 – paragraph 2 – subparagraph 1 – point c f (new) (cf) development of standards concerning products other than cigarettes.
Amendment 1309 #
Proposal for a directive Article 23 – paragraph 3 a (new) 3 a. Member States shall report every two years to the Commission on the enforcement of the measures taken pursuant to Council Recommendation 2003/54/EC of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control , in particular with regard to age limits set in national legislation, as well as their plans to increase the age limit to achieve the goal of a "smoke-free generation".
Amendment 1310 #
Proposal for a directive Article 24 – paragraph 1 1. Subject to paragraphs 2 and 3, Member States shall not prohibit or restrict the import, sale or consumption of tobacco or related products which comply with this Directive.
Amendment 1311 #
Proposal for a directive Article 24 – paragraph 2 2.
Amendment 1312 #
Proposal for a directive Article 24 – paragraph 2 2.
Amendment 1313 #
Proposal for a directive Article 24 – paragraph 2 2. However,
Amendment 1314 #
Proposal for a directive Article 24 – paragraph 2 2. However, a Member State may maintain more stringent national provisions, applicable to
Amendment 1315 #
Proposal for a directive Article 24 – paragraph 2 2. However, a Member State
Amendment 1316 #
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. Provisions recommending retailers of tobacco products to not display them at the point of sale are considered suitable measures to safeguard 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.
Amendment 1317 #
Proposal for a directive Article 24 – paragraph 2 2. In the absence of a decision by the Commission within this period the national provisions shall be deemed to be approved. 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 to the requirements and principles of the single market 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.
Amendment 1318 #
Proposal for a directive Article 24 – paragraph 3 Amendment 1319 #
Proposal for a directive Article 24 – paragraph 3 3. This Directive shall not affect the right of Member States to maintain or introduce, in
Amendment 1320 #
Proposal for a directive Article 24 – paragraph 3 3. This Directive shall not affect the right of Member States to maintain or introduce, in accordance with the Treaty, national provisions concerning aspects not regulated by this Directive. These national provisions must be justified by overriding reasons of public interest and be necessary and proportionate to their aim. They must not be a means of arbitrary discrimination or a disguised restriction on trade between the Member States
Amendment 1321 #
Proposal for a directive Article 24 – paragraph 3 a (new) 3 a. This Directive shall under no circumstances affect the right of Member States to adopt more stringent rules, provided they are essential for the protection of public health and do not go excessively beyond the standards set in, or fall outside the scope of, this Directive.
Amendment 1322 #
Proposal for a directive Article 25 – paragraph 1 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [Publications Office, please insert the exact date: entry into force +
Amendment 1323 #
Proposal for a directive Article 25 – paragraph 1 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [Publications Office, please insert the exact date: entry into force + 18 months] and in the case of Article 6 by [Publications Office, please insert the exact date: entry into force + 36 months] at the latest. They shall forthwith communicate to the Commission the text of those provisions.
Amendment 1324 #
Proposal for a directive Article 26 Amendment 1325 #
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 +
Amendment 1326 #
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 +
Amendment 1327 #
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 [
Amendment 1328 #
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 +
Amendment 1329 #
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 +
Amendment 1330 #
Proposal for a directive Article 26 – paragraph 1 a (new) Member States may allow nicotine containing 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 + 48 months]:
Amendment 1331 #
Proposal for a directive Article 26 – paragraph 1 – point a a)
Amendment 1332 #
Proposal for a directive Article 26 – paragraph 1 – point b Amendment 1333 #
Proposal for a directive Article 26 – paragraph 1 – point b (b) nicotine containing products
Amendment 1334 #
Proposal for a directive Article 26 – paragraph 1 – point b (b) nicotine containing products
Amendment 1335 #
Proposal for a directive Article 26 – paragraph 1 – point b b) nicotine containing products
Amendment 1336 #
Proposal for a directive Article 26 – paragraph 1 – point c c) herbal products for smoking. Member States may allow tobacco products other than cigarettes and roll- you-own tobacco that do not comply with the provisions of this Directive until [Date of entry into force + 42 months].
Amendment 1337 #
Proposal for a directive Annex 1 a (new) Annex -I Additives approved for use in tobacco products Chemical name of the additive - function - maximum level permitted
Amendment 1338 #
Proposal for a directive Annex 1 – point 1 Amendment 1339 #
Proposal for a directive Annex 1 – point 2 Amendment 1340 #
Proposal for a directive Annex 1 – point 2 a (new) (2 a) Smoking causes bladder cancer
Amendment 1342 #
Proposal for a directive Annex 1 – point 5 Amendment 1343 #
Proposal for a directive Annex 1 – point 6 a (new) (6a) Smoking causes cancer of the bladder
Amendment 1344 #
Proposal for a directive Annex 1 – point 7 Amendment 1345 #
Proposal for a directive Annex 1 – point 8 Amendment 1346 #
Proposal for a directive Annex 1 – point 9 Amendment 1347 #
Proposal for a directive Annex 1 – point 10 10) Your smoke
Amendment 1348 #
Proposal for a directive Annex 1 – point 11 Amendment 1349 #
Proposal for a directive Annex 1 – point 12 Amendment 1351 #
Proposal for a directive Annex 1 – point 14 Amendment 1352 #
Proposal for a directive Annex 1 – point 14 a (new) (14 a) Smoking in presence of children can cause sudden infant death
Amendment 1353 #
Proposal for a directive Annex 1 – point 14 a (new) Amendment 1354 #
Proposal for a directive Annex 1 – point 14 b (new) (14 b) Smoking during pregnancy causes premature birth
Amendment 1355 #
Proposal for a directive Annex 1 – point 14 c (new) (14 c) Children that are forced to smoke passive are more vulnerable to asthma and meningitis
Amendment 1356 #
Proposal for a directive Annex 1 – heading 1 a (new) Amendment 1357 #
Proposal for a directive Annex 1 a (new) Amendment 1358 #
Proposal for a directive Annex 1 b (new) Table 1 - HPHCs in Table 2 - HPHCs in Table 3 - HPHCs in Roll- Cigarette Smoke Smokeless Tobacco your-own Tobacco Acetaldehyde Acetaldehyde Ammonia Acrolein Arsenic Arsenic Acrylonitrile Benzo[a]pyrene Cadmium 4-Aminobiphenyl Cadmium Nicotine 1-Aminonaphthalene Crotonaldehyde NNK* 2-Aminonaphthalene Formaldehyde NNN** Ammonia Nicotine Benzene NNK* Benzo[a]pyrene NNN** 1,3-Butadiene Carbon monoxide Crotonaldehyde Formaldehyde Isoprene Nicotine NNK* NNN** Toluene _____________ * 4-(methylnitrosamino)- 1-(3-pyridyl)-1-butanone ** N-nitrosonornicotine
Amendment 1359 #
Proposal for a directive Annex 2 a (new) ANNEX III Maximum permissible content in smokeless tobacco, toxin per unit weight dry tobacco: NNN (N-nitrosonornicotine) plus NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1- butanone): 2.0 mg/kg B(a)P (Benzo[a]Pyrene): 5.0 µg/kg
Amendment 1360 #
Proposal for a directive Annex 2 b (new) Amendment 155 #
Proposal for a directive Recital 24 (24)
Amendment 156 #
Proposal for a directive Recital 24 (24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products,
Amendment 157 #
Proposal for a directive Recital 24 (24) The labelling of tobacco products for smoking, other than cigarettes and roll- your-own tobacco
Amendment 158 #
Proposal for a directive Recital 24 (24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products,
Amendment 159 #
Proposal for a directive Recital 24 (24) Tobacco products for smoking, other than cigarettes
Amendment 160 #
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. It is absolutely essential that the common internal market should not be impeded by a multitude of specific national rules;
Amendment 161 #
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 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,
Amendment 162 #
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
Amendment 163 #
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
Amendment 164 #
Proposal for a directive Recital 27 Amendment 165 #
Proposal for a directive Recital 27 (27) An interoperable tracking and tracing system and a common security feature should be developed.
Amendment 166 #
Proposal for a directive Recital 28 Amendment 167 #
Proposal for a directive Recital 28 (28) In order to ensure independence and transparency,
Amendment 168 #
Proposal for a directive Recital 28 (28) In order to ensure independence and transparency,
Amendment 169 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition
Amendment 170 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition
Amendment 171 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition.
Amendment 172 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition . The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young people. As tobacco for oral use is prohibited to be placed on the internal market, oral tobacco products shall be exempted from the application of this Directive, except for Article 15. For other smokeless tobacco products that are not produced for the mass market, a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use.
Amendment 173 #
Proposal for a directive Recital 29 a (new) (29a) Given the general prohibition of the sale of oral tobacco (snus) in the EU, there is no cross-border interest in regulating the content of snus. The responsibility for regulating the content of snus thus lies with the Member State where the sale of snus is permitted in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden. Snus should therefore be exempt from the provisions of Article 6 of this Directive.
Amendment 174 #
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.
Amendment 175 #
Proposal for a directive Recital 30 (30) Cross-border distance sales
Amendment 176 #
Proposal for a directive Recital 30 (30) Cross-border distance sales of tobacco, and practices such as the free distribution or swapping of tobacco products in public places for promotional purposes, facilitate access to tobacco products
Amendment 177 #
Proposal for a directive Recital 30 (30) Cross-border distance sales of tobacco should be prohibited, as they facilitate access to tobacco products of young people and risk to undermine
Amendment 178 #
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.
Amendment 179 #
Proposal for a directive Recital 30 (30)
Amendment 180 #
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. By means of the revision of the Directive, the drafting of legislation will begin for a total ban on distance sales. 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
Amendment 181 #
Proposal for a directive Recital 30 a (new) (30a) Directive 2003/33/EC on advertising and sponsorship of tobacco products already prohibits the free distribution of these products in the context of the sponsorship of events. This Directive, which regulates aspects relating to the presentation and sale of tobacco and aims to achieve a high level of health protection and prevention of tobacco consumption among young people, extends the scope of the ban on free distribution to public places and specifically prohibits the distribution of printed material, discount coupons and similar special offers inside packages and wrappings.
Amendment 182 #
Proposal for a directive Recital 30 b (new) (30b) 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 and produced without the comprehensive controls required of European manufacturers. It is also time to move towards a harmonisation of tax on tobacco goods in all EU Member States, to prevent price differences between states, especially in cross-border areas, from acting as an incentive to tobacco consumption and to seal the commitment of all Member States to the aims of this Directive.
Amendment 183 #
Proposal for a directive Recital 30 c (new) (30 c) Member States apply different rules in allowing retailers and locally authorised sellers to advertise and display tobacco products within their premises: The provisions adopted in certain Members States which ban point of sale displays should be extended and considered as helpful in reducing tobacco consumption amongst young people.
Amendment 184 #
Proposal for a directive Recital 30 d (new) (30 d) Free distribution of tobacco products as promotional advertising, still used via online retail or tolerated in some public places in some Member States, should be prohibited.
Amendment 185 #
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.
Amendment 186 #
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.
Amendment 187 #
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 States to ban 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 whether amendments to this Directive are necessary to completely prevent novel tobacco products from entering the market.
Amendment 188 #
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 States to ban or to authorise them. The Commission should monitor the developments and submit a report 5 years after the date of transposition of this
Amendment 189 #
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 promote plans and campaigns to educate and create awareness of the serious health impact of smoking, and 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 States to ban or to authorise them. The Commission should monitor the development and submit a report 5 years after the transposition deadline of this Directive, in order to assess whether amendments to this Directive are necessary.
Amendment 190 #
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 States to ban or to authorise them. In so doing, Member States should take into account the possibility that new tobacco products may have a negative impact on the overall health of the population or the possibility that new tobacco products may limit the damage to the overall health of the population through the mass substitution of products used by smokers and the insignificant use of these products by non-smokers. The Commission should monitor the development, bearing in mind both possibilities, and submit a report
Amendment 191 #
Proposal for a directive Recital 32 (32) I
Amendment 192 #
Proposal for a directive Recital 33 (33) Nicotine-containing products are sold on the Union market.
Amendment 193 #
Proposal for a directive Recital 33 (33) Nicotine-containing products are being sold on the Union market in increasing quantities, Electronic cigarettes, which come in many different varieties with varying technical characteristics, are proving especially popular. This diversity makes them difficult to define in law, and means that several different European legal regimes apply to them depending on whether or not their purpose is to help people stop smoking and whether they contain addictive substances such as nicotine or toxic chemicals. The different regulatory approaches taken by Member States to address possible health and safety concerns associated with these new products
Amendment 194 #
Proposal for a directive Recital 33 (33) Non-tobacco 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.
Amendment 195 #
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.
Amendment 196 #
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. Member States collect a substantial amount of tax revenues from the production and sale of all tobacco products and therefore Member States should be strongly encouraged to spend those revenues directly on health care and information campaigns to inform young citizens about the major health risks of smoking.
Amendment 197 #
Proposal for a directive Recital 33 a (new) (33a) Before their products can be authorised for marketing, electronic cigarette producers and distributors must provide the supervisory authorities with an exact statement of their products’ essential ingredients (in terms of purity, impurities and stability), which must be visible on the packaging in accordance with Directive 2001/95/EC on general product safety; reliable scientific data concerning the non-toxicity of electronic cigarettes is also essential in the interests of both the consumer and the manufacturer or distributor; the Commission will, therefore, request an opinion from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) within 24 months of the entry into force of the Directive;
Amendment 198 #
Proposal for a directive Recital 34 Amendment 199 #
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 use provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products which claim to have properties beneficial to human health. A significant number of nicotine-containing products
Amendment 200 #
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 use 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
Amendment 201 #
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
Amendment 202 #
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 use provides a legal framework to assess the quality, safety and efficacy of medicinal products including certain nicotine containing products. A significant number
Amendment 203 #
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
Amendment 204 #
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.
Amendment 205 #
Proposal for a directive Recital 35 Amendment 206 #
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.
Amendment 207 #
Proposal for a directive Recital 35 (35) Labelling provisions should be introduced for nicotine containing products
Amendment 208 #
Proposal for a directive Recital 35 (35)
Amendment 209 #
Proposal for a directive Article 2 - point 36 a (new) (36a) ‘reduced risk product’ means any product containing tobacco which, when marketed, significantly reduces the risk of illnesses associated with the consumption of conventional tobacco products. A product used to treat addiction to tobacco consumption, including cessation, is not a reduced risk product if it has been approved as a medicinal product.
Amendment 210 #
Proposal for a directive Recital 37 Amendment 211 #
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
Amendment 212 #
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,
Amendment 213 #
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,
Amendment 214 #
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
Amendment 215 #
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
Amendment 216 #
Proposal for a directive Recital 38 Amendment 217 #
Proposal for a directive Recital 38 Amendment 218 #
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
Amendment 219 #
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
Amendment 220 #
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
Amendment 221 #
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
Amendment 222 #
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
Amendment 223 #
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
Amendment 224 #
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 use of health warnings, unique identifiers and security features in the labelling and packaging, defining key elements for contracts on data storage with
Amendment 225 #
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 m
Amendment 226 #
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
Amendment 227 #
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.
Amendment 228 #
Proposal for a directive Recital 40 (40) A Member State
Amendment 229 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling
Amendment 230 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute
Amendment 231 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved through this Directive. One example of a means of arbitrary discrimination is the rule that the surface covered by warnings be raised to over 60%. The aim of this Directive is to introduce uniform packaging and labelling requirements, so strict criteria must be applied regarding the leeway for Member States to adopt standards that diverge considerably from the rules established in this Directive.
Amendment 232 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Stricter national provisions require prior notification to
Amendment 233 #
Proposal for a directive Recital 40 A (new) (40a) Any Member State which considers it necessary to maintain and/or introduce national and/or regional measures to maintain traditional tobacco plantations, for justified reasons of socioeconomic dependence and land use, should be authorised to do so.
Amendment 234 #
Proposal for a directive Recital 41 Amendment 235 #
Proposal for a directive Recital 41 (41) Member States should
Amendment 236 #
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.
Amendment 237 #
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
Amendment 238 #
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
Amendment 239 #
Proposal for a directive Recital 41 a (new) (41a) If tobacco products or similar products comply with the requirements of this Directive, Member States may not prohibit or unreasonably restrict the import, sale or consumption of these products. Manufacturers must retain the safeguard of a certain minimum level of legal certainty.
Amendment 240 #
Proposal for a directive Recital 41 a (new) (41a) Member States shall supplement the legal provisions of this Directive with any measures to protect the health of European citizens. The gradual harmonisation of the taxation of tobacco products in the Union and information campaigns in the media and for young people in educational institutions are two essential tools in protecting young people against the dangers of smoking.
Amendment 241 #
Proposal for a directive Recital 42 (42) Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. National data protection provisions must also be taken into account.
Amendment 242 #
Proposal for a directive Recital 43 a (new) (43a) This Directive should not lead to any deterioration in the living conditions of people whose livelihoods depend on tobacco-growing in Europe and who often live in disadvantaged areas. Given that the aim of the Directive is solely to discourage consumption of tobacco products, any decisions concerning ingredients and additives should take due account of the possible socioeconomic repercussions for groups whose livelihoods depend on tobacco growing. The European tobacco- growing sector should be protected because it accounts for only a very small proportion of consumption in the EU and, at the same time, contributes to the economic stability of certain European regions where the range of alternative crops is limited. A decrease in or an end to tobacco growing in the EU would have no impact on consumption levels, but would lead to an increase in imports from third countries and a reduction in quality standards.
Amendment 243 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to
Amendment 244 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property (Article 17).
Amendment 245 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property (Article 17). The obligations imposed on manufacturers, importers and distributors of tobacco products are necessary to improve the functioning of the internal market while ensuring a high level of health and consumer protection as set out in Articles 35 and 38 of the Charter of Fundamental Rights of the European Union. The application of this Directive should respect the EU law and relevant international obligations.
Amendment 246 #
Proposal for a directive Recital 45 a (new) (45a) This Directive contributes significantly to protecting the health and wellbeing of European citizens, increasing the reliability of information received by consumers and seeking to provide better and more objective scientific evidence of the damage caused to human health by tobacco consumption. Its entry into force is therefore likely to reduce consumption and may have negative repercussions on tobacco growers and some traditional industries linked to this crop, which make an important contribution to the gross domestic product of Europe’s outermost regions and declining areas. With this prospect in mind, the European institutions should study measures to promote the development, conversion or introduction of new activities for people in this sector and to encourage and develop research into new, non-harmful uses for this crop.
Amendment 247 #
Proposal for a directive Article 1 – paragraph 1 – introductory part The aim of this Directive is
Amendment 248 #
Proposal for a directive Article 1 – paragraph 1 – point b (b) the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as
Amendment 249 #
Proposal for a directive Article 1 – paragraph 1 – point c Amendment 250 #
Proposal for a directive Article 1 – paragraph 1 – point c Amendment 251 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales and internet sales of tobacco products;
Amendment 252 #
Proposal for a directive Article 1 – paragraph 1 – point d (d)
Amendment 253 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 254 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) banning of cross-border distance sales of tobacco products;
Amendment 255 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 256 #
Proposal for a directive Article 1 – paragraph 1 – point f (f) the placing on the market and the labelling of certain products, which are related to tobacco products, namely nicotine-containing products such as e- cigarettes and herbal products for smoking;
Amendment 257 #
Proposal for a directive Article 1 – paragraph 1 – point f (f) the placing on the market and the labelling of certain products, which are related to tobacco products, namely tobacco-free nicotine-containing products and herbal products for smoking;
Amendment 258 #
Proposal for a directive Article 1 – paragraph 1 – subparagraph 2 in order to meet commitments under the WHO Framework Convention for Tobacco Control, taking into account future health research that will be developed under Horizon 2020 tackling the health consequence of tobacco consumption, and in order to facilitate the functioning of the internal market in tobacco and related products, taking as a bas
Amendment 259 #
Proposal for a directive Article 1 – paragraph 1 – subparagraph 2 in order to facilitate the functioning of the internal market in tobacco and related tobacco-free products, taking as a basis a high level of health protection, particularly for young people. This directive also seeks to keep the public informed about harmful effects on smokers without in effect rejecting the risk reduction policies that consist in encouraging smokers to turn to lower-risk products.
Amendment 260 #
Proposal for a directive Article 1 – paragraph 1 – subparagraph 2 Amendment 261 #
Proposal for a directive Article 2 – paragraph 1 – point 2 Amendment 262 #
Proposal for a directive Article 2 – paragraph 1 – point 2 Amendment 263 #
Proposal for a directive Article 2 – paragraph 1 – point 2 (2)
Amendment 264 #
Proposal for a directive Article 2 – paragraph 1 – point 2 (2)
Amendment 265 #
Proposal for a directive Article 2 – paragraph 1 – point 3 Amendment 266 #
Proposal for a directive Article 2 – paragraph 1 – point 3 Amendment 267 #
Proposal for a directive Article 2 – paragraph 1 – point 3 Amendment 268 #
Proposal for a directive Article 2 – paragraph 1 – point 4 Amendment 269 #
Proposal for a directive Article 2 – paragraph 1 – point 4 Amendment 270 #
Proposal for a directive Article 2 – paragraph 1 – point 4 Amendment 271 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4)
Amendment 272 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives,
Amendment 273 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘
Amendment 274 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than
Amendment 275 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means an aroma or taste distinguishable
Amendment 276 #
Proposal for a directive Article 2 – paragraph 1 – point 4 Amendment 277 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives,
Amendment 278 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol
Amendment 279 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 280 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 281 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 282 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco and menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy,
Amendment 283 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘
Amendment 284 #
Proposal for a directive Article 2 – paragraph 1 – point 4 4) 'characterising flavour' means a
Amendment 285 #
Proposal for a directive Article 2 – paragraph 1 – point 4 a (new) (4a) ‘menthol flavour’ means a characterising flavour based on mint and present in a large number of manufactured cigarettes which, at levels in excess of 0.3%, is tasted with each puff of smoke inhaled.
Amendment 286 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 287 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 288 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 289 #
Proposal for a directive Article 2 – paragraph 1 – point 8 (8)
Amendment 290 #
Proposal for a directive Article 2 – paragraph 1 – point 8 (8) ‘cigarillo’ means a
Amendment 291 #
Proposal for a directive Article 2 – paragraph 1 – point 8 a (new) Amendment 292 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – introductory part 11) 'cross-border distance sales' means a distance sales service where
Amendment 293 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – introductory part (11) ‘cross-border distance sales’ means a distance sales service where, at the time the consumer orders the product, the consumer is located in a Member State other than the
Amendment 294 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – point a Amendment 295 #
Proposal for a directive Article 2 – paragraph 1 – point 11 – point b Amendment 296 #
Proposal for a directive Article 2 – paragraph 1 – point 12 a (new) (12a) Comprehensive information should be provided by e-cigarette manufacturers concerning the different ingredients of their products, the effects of nicotine vaporization as well as any other impacts on human health due to the inhalation of potentially carcinogenic substances.
Amendment 297 #
Proposal for a directive Article 2 – paragraph 1 – point 13 Amendment 298 #
Proposal for a directive Article 2 – paragraph 1 – point 13 (13) 'flavouring' means an
Amendment 299 #
Proposal for a directive Article 2 – paragraph 1 – point 13 (13) ‘flavouring’ means an additive that imparts aroma and/or taste, with the exception of menthol;
Amendment 300 #
Proposal for a directive Article 2 – paragraph 1 – point 18 Amendment 301 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18)
Amendment 302 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18)
Amendment 303 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means an
Amendment 304 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means an additive,
Amendment 305 #
Proposal for a directive Article 2 – paragraph 1 – point 18 18) 'ingredient' means an additive,
Amendment 306 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means an additive, (except tobacco
Amendment 307 #
Proposal for a directive Article 2 – paragraph 1 – point 18 Amendment 308 #
Proposal for a directive Article 2 – paragraph 1 – point 18 a (new) (18a) ‘reconstituted tobacco’: result of the enhancement of different parts of the tobacco plant from threshing and the manufacture of tobacco products, used as sheets or individual strands as a component of the tobacco blend for cigarettes and other tobacco products;
Amendment 309 #
Proposal for a directive Article 2 – paragraph 1 – point 18 b (new) (18b) 'tobacco' means leaves and other processed or unprocessed parts of tobacco plants, including expanded and reconstituted tobacco;
Amendment 310 #
Proposal for a directive Article 2 – paragraph 1 – point 18 c (new) Amendment 311 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 312 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 313 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 314 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19)
Amendment 315 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) ‘maximum level’ or ‘maximum yield’ means the maximum content or emission
Amendment 316 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) ‘maximum level’
Amendment 317 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) ‘maximum level’ or ‘maximum yield’ means the maximum content or emission
Amendment 318 #
Proposal for a directive Article 2 – paragraph 1 – point 22 (22) 'nicotine-containing product' means a product usable for consumption by consumers via inhalation, ingestion or in other forms
Amendment 319 #
Proposal for a directive Article 2 – paragraph 1 – point 23 (23)
Amendment 320 #
Proposal for a directive Article 2 – paragraph 1 – point 23 (23) ‘
Amendment 321 #
Proposal for a directive Article 2 – paragraph 1 – point 23 (23) ‘novel tobacco product’ means a tobacco product other than a cigarette, roll- your-own tobacco, pipe tobacco, water-
Amendment 322 #
Proposal for a directive Article 2 – paragraph 1 – point 23 – point i (new) (i) ‘reduced-risk tobacco product’ means a novel tobacco product with a limited effect on health as attested by scientific evidence;
Amendment 323 #
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;
Amendment 324 #
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;
Amendment 325 #
Proposal for a directive Article 2 – paragraph 1 – point 25 (25) ‘place on the market’ means to make products available to consumers located in the Union, with or without payment
Amendment 326 #
Proposal for a directive Article 2 – paragraph 1 – point 25 (25) ‘place on the market’ means to make products available to consumers located in
Amendment 327 #
Proposal for a directive Article 2 – paragraph 1 – point 26 26) 'pipe tobacco' means tobacco consumed via a combustion or heating process and exclusively designed for the purpose of being used in a pipe;
Amendment 328 #
Proposal for a directive Article 2 – paragraph 1 – point 26 a (new) (26a)‘water pipe tobacco’ means tobacco intended solely for use in a water pipe such as a hookah (shisha), consisting of a moist mixture of tobacco, preservatives and flavours, often with a binding agent such as molasses or honey;
Amendment 329 #
Proposal for a directive Article 2 – paragraph 1 – point 28 (28) ‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers
Amendment 330 #
Proposal for a directive Article 2 – paragraph 1 – point 28 (28) ‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers
Amendment 331 #
Proposal for a directive Article 2 – paragraph 1 – point 28 (28) ‘roll-your-own tobacco’ means tobacco which can be used for
Amendment 332 #
Proposal for a directive Article 2 – paragraph 1 – point 28 a (new) (28a) ‘make-your-own’ tobacco means fine-cut loose tobacco which can be used for making cigarettes by consumers;
Amendment 333 #
Proposal for a directive Article 2 – paragraph 1 – point 30 Amendment 334 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10% in at least
Amendment 335 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) 'substantial change of circumstances' means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 336 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 337 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 338 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) 'substantial change of circumstances' means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 339 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) 'substantial change of circumstances' means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10% in at least 10 Member States based on sales data transmitted in accordance with Article 5(4);
Amendment 340 #
Proposal for a directive Article 2 – paragraph 1 – point 30 30) 'substantial change of circumstances' means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10% in at least 10 Member States
Amendment 341 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10% in at least the 10 Member States with the largest market volume, based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least the 10 Member States with the largest market volume, for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;
Amendment 342 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least 10 % in at least the 10 Member States with the highest per capita consumption, based on sales data transmitted in accordance with Article 5(4); or an increase of the prevalence level in the consumer group under 25 years of age by at least 5 percentage points in at least 10 Member States for the respective product category based on ____ [this date will be set at the moment of adoption of the Directive] Eurobarometer report or equivalent prevalence studies;
Amendment 343 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category
Amendment 344 #
Proposal for a directive Article 2 – paragraph 1 – point 33 a (new) (33a) ‘Tobacco for water pipes’ means tobacco designed exclusively for use in a water pipe;
Amendment 345 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) 'tobacco products' means products usable for consumption by consumers and consisting of, even partly, tobacco
Amendment 346 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) ‘tobacco products’ means products usable for consumption by consumers and consisting of, even partly, tobacco or some products containing nicotine, whether
Amendment 347 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) ‘tobacco products’ means products usable for consumption by consumers and consisting of, even partly, tobacco or derived from tobacco, whether genetically modified or not;
Amendment 348 #
Proposal for a directive Article 2 – paragraph 1 – point 34 (34) ‘tobacco products’ means products usable for consumption by consumers and consisting of, even partly, tobacco
Amendment 349 #
Proposal for a directive Article 2 – paragraph 1 – point 36 (36) ‘unit packet’ means the smallest individual packaging of a product that is placed on the market and is available to the final consumer.
Amendment 350 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) ‘imitation tobacco products’ means sweets, snacks, toys or any other products resembling tobacco products which may appeal to minors.
Amendment 351 #
Proposal for a directive Article 2 – paragraph 1 – point 36 b (new) (36b) ‘passive smoking’ means the involuntary inhalation of smoke from the combustion of cigarettes or cigars or from the exhalation of one or more smokers.
Amendment 352 #
Proposal for a directive Article 3 – paragraph 1 – point a (a) 1
Amendment 353 #
Proposal for a directive Article 3 – paragraph 1 – point b (b)
Amendment 354 #
Proposal for a directive Article 3 – paragraph 1 – point c (c)
Amendment 355 #
Proposal for a directive Article 3 – paragraph 1 – point c a (new) (ca) 0.002 picocuries of Polonium 210
Amendment 356 #
Proposal for a directive Article 3 – paragraph 2 Amendment 357 #
Proposal for a directive Article 3 – paragraph 2 Amendment 358 #
Proposal for a directive Article 3 – paragraph 2 Amendment 359 #
Proposal for a directive Article 3 – paragraph 2 Amendment 360 #
Proposal for a directive Article 3 – paragraph 2 Amendment 361 #
Proposal for a directive Article 3 – paragraph 2 Amendment 362 #
Proposal for a directive Article 3 – paragraph 2 Amendment 363 #
Proposal for a directive Article 3 – paragraph 2 Amendment 364 #
Proposal for a directive Article 3 – paragraph 2 Amendment 365 #
Proposal for a directive Article 3 – paragraph 2 Amendment 366 #
Proposal for a directive Article 3 – paragraph 2 Amendment 367 #
Proposal for a directive Article 3 – paragraph 2 Amendment 368 #
Proposal for a directive Article 3 – paragraph 2 Amendment 369 #
Proposal for a directive Article 3 – paragraph 2 Amendment 370 #
Proposal for a directive Article 3 – paragraph 2 Amendment 371 #
Proposal for a directive Article 3 – paragraph 2 2. The Commission
Amendment 372 #
Proposal for a directive Article 3 – paragraph 2 2.
Amendment 373 #
Proposal for a directive Article 3 – paragraph 2 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the maximum yields laid down in paragraph 1
Amendment 374 #
Proposal for a directive Article 3 – paragraph 2 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to
Amendment 375 #
Proposal for a directive Article 3 – paragraph 3 Amendment 376 #
Proposal for a directive Article 3 – paragraph 3 Amendment 377 #
Proposal for a directive Article 3 – paragraph 3 Amendment 378 #
Proposal for a directive Article 3 – paragraph 3 Amendment 379 #
Proposal for a directive Article 3 – paragraph 3 Amendment 380 #
Proposal for a directive Article 3 – paragraph 3 Amendment 381 #
Proposal for a directive Article 3 – paragraph 3 Amendment 382 #
Proposal for a directive Article 3 – paragraph 3 Amendment 383 #
Proposal for a directive Article 3 – paragraph 3 Amendment 384 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes
Amendment 385 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 386 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 387 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 388 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 389 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 390 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards, where available, and based on scientific evidence and on the yields notified by Member States, the
Amendment 391 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards,
Amendment 392 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Taking into account internationally agreed standards, where available, and based on scientific evidence and on the yields notified by Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt and adapt maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that increase in an appreciable manner the toxic or addictive effect of tobacco products beyond the threshold of toxicity and addictiveness stemming from the yields of tar, nicotine and carbon monoxide fixed in paragraph 1, with the source of the objective data supporting these decisions always being provided.
Amendment 393 #
Proposal for a directive Article 3 – paragraph 3 a (new) 3a. The Commission shall set maximum yields for other emissions of cigarettes and for emissions of tobacco products other than cigarettes that have a harmful or addictive effect, taking into account internationally agreed standards, where available, and based on scientific evidence. The Commission shall also ensure the development of recording methods in respect of compliance with these yields. Member States may set maximum yields other than those established by the Commission if these offer further protection to consumer health.
Amendment 394 #
Proposal for a directive Article 3 – paragraph 3 a (new) Amendment 395 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 1 Amendment 396 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 2 a (new) Tests verifying the validity of the result supplied by the tobacco companies shall be done on a regular basis by independent testing laboratories monitored by the competent authorities of the Member States.
Amendment 397 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 2 a (new) The Commission shall ask ISO to develop a standard to measure Polonium 210 in tobacco.
Amendment 398 #
Proposal for a directive Article 4 – paragraph 2 – subparagraph 1 The measurement referred to in paragraph 1 shall be carried out or verified by independent testing laboratories which are approved and monitored by the competent authorities of
Amendment 399 #
Proposal for a directive Article 4 – paragraph 2 – subparagraph 2 Amendment 400 #
Proposal for a directive Article 4 – paragraph 2 – subparagraph 2 Member States shall send the Commission a list of approved laboratories, specifying the criteria used for approval, any economic ties the laboratories may have and the methods of monitoring applied, and update it whenever any change is made. Member States shall document the independence of the laboratories. Additional checks may be carried out on laboratories, if the Commission so wishes, and the Commission can decide to exclude a laboratory. The Commission shall make the list of approved laboratories as indicated by Member States publicly available.
Amendment 401 #
Proposal for a directive Article 4 – paragraph 3 Amendment 402 #
Proposal for a directive Article 4 – paragraph 3 Amendment 403 #
Proposal for a directive Article 4 – paragraph 3 Amendment 404 #
Proposal for a directive Article 4 – paragraph 3 Amendment 405 #
Proposal for a directive Article 4 – paragraph 3 3. The Commission
Amendment 406 #
Proposal for a directive Article 4 – paragraph 3 3. The
Amendment 407 #
Proposal for a directive Article 4 – paragraph 4 Amendment 408 #
Proposal for a directive Article 4 – paragraph 4 Amendment 409 #
Proposal for a directive Article 4 – paragraph 4 Amendment 410 #
Proposal for a directive Article 4 – paragraph 4 Amendment 411 #
Proposal for a directive Article 4 – paragraph 4 Amendment 412 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes. Based on these methods, and taking into account scientific and technical developments as well as internationally agreed standards, the
Amendment 413 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of
Amendment 414 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes as well as vapours inhaled from e-cigarettes. Based on these methods, and taking into account scientific and technical developments as well as internationally agreed standards the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adopt and adapt methods of measurement.
Amendment 415 #
Proposal for a directive Article 4 – paragraph 4 a (new) 4a. The Commission shall ensure the development of new standard methods of measurement with respect to the existing methods for the measurement of nicotine, tar and carbon monoxide in cigarettes, methods for measuring emissions other than nicotine, tar and carbon monoxide and methods for measuring emissions from other tobacco products. These measurement methods should genuinely be able to measure harmfulness in relation to smoking-related diseases. Member States shall at least make use of the standard measurement methods produced by the Commission.
Amendment 416 #
Proposal for a directive Article 4 – paragraph 4 a (new) Amendment 417 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Amendment 418 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products to submit annually to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields.
Amendment 419 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields. Manufacturers or importers shall test and report to the competent authorities of the Member States quantities of Harmful and Potentially Harmful Constituents (HPHCs) based on the list established in Annex Ia. However, within the timeframes described in Article 25 for transposition, manufacturers or importers shall test and report for each of the constituents present in the abbreviated list set out in Annex Ib. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 420 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products to submit, on an annual basis, to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 421 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products, nicotine-containing products and herbal products for smoking to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 422 #
Proposal for a directive Article 5 – paragraph 1 a (new) 1a. First and foremost, Member States shall examine tobacco product ingredients so as to assess the need to take measures under Regulations (EC) No 1907/2006 (REACH) and (EC) No 1272/2008 (CLP). On the basis of those examinations, and taking account of the precautionary principle, Member States shall submit scientific dossiers to the European Chemicals Agency, in particular pursuant to Articles 59(3) and 69(4) of Regulation (EC) No 1907/2006 and Article 37(1) of Regulation (EC) No 1272/2008. Member States shall report regularly to the Commission on the measures under examination in connection with tobacco product ingredients and on the steps which they have taken, where appropriate, on that basis. Every three years, the Commission shall publish a report on the progress made by Member States in this connection.
Amendment 423 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 2 Amendment 424 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 2 The list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products.
Amendment 425 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 2 The list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products. The list shall indicate their status, including whether the ingredients have been registered under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as well as their classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
Amendment 426 #
Proposal for a directive Article 5 – paragraph 2 2. Member States shall ensure the dissemination of information submitted in accordance with paragraph 1 on a
Amendment 427 #
Proposal for a directive Article 5 – paragraph 2 2. Member States shall ensure the dissemination of information submitted in accordance with paragraph 1 on a
Amendment 428 #
Proposal for a directive Article 5 – paragraph 3 Amendment 429 #
Proposal for a directive Article 5 – paragraph 3 Amendment 430 #
Proposal for a directive Article 5 – paragraph 4 Amendment 431 #
Proposal for a directive Article 5 – paragraph 4 Amendment 432 #
Proposal for a directive Article 5 – paragraph 4 4. Member States shall require manufacturers and importers to
Amendment 433 #
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.
Amendment 434 #
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 and chronic heavy smokers, 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
Amendment 435 #
Proposal for a directive Article 5 – paragraph 5 Amendment 436 #
Proposal for a directive Article 5 – paragraph 5 Amendment 437 #
Proposal for a directive Article 5 – paragraph 5 5. All data and information to be provided to and by Member States under this Article shall be provided in electronic form. Member States shall store the information electronically
Amendment 438 #
Proposal for a directive Article 5 – paragraph 6 – subparagraph 1 (new) In respect of other tobacco products, it shall not be mandatory to establish emission data, since there are currently no appropriate measuring procedures.
Amendment 439 #
Proposal for a directive Article 5 – paragraph 6 a (new) 6a. Manufacturers of tobacco products other than cigarettes and roll-your-own tobacco shall be exempt from the requirement to provide information on emissions and yields until such time as an appropriate measuring method has been developed at Union level.
Amendment 440 #
Proposal for a directive Article 5 – paragraph 6 a (new) 6 a. Proportionate fees may be charged by Member States for personalised medicines that will be needed for patients that suffer from diseases such as cancer, respiratory, cardiovascular and rare diseases submitted to them under this Article.
Amendment 441 #
Proposal for a directive Article 5 – paragraph 6 a (new) Amendment 443 #
Proposal for a directive Article 6 – paragraph 1 Amendment 444 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the p
Amendment 445 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 446 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 447 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 448 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 449 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 450 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 451 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 452 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the
Amendment 453 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of
Amendment 454 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products
Amendment 455 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products
Amendment 456 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour as well as additives that are intended to be added to the tobacco product after its manufacture, for instance by the consumer.
Amendment 457 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing
Amendment 458 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness.
Amendment 459 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the EU market of tobacco products with a characterising flavour.
Amendment 460 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour sweet and candy- like flavour.
Amendment 461 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products for smoking with a characterising flavour.
Amendment 462 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Amendment 463 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 464 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 465 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States
Amendment 466 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives
Amendment 467 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of sugar or other additives which are essential for the manufacture of tobacco products
Amendment 468 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not restrict or prohibit the use of
Amendment 469 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives, such as sugar, which are essential for the manufacture of tobacco products
Amendment 470 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 471 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products,
Amendment 472 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of
Amendment 473 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product with a characterising flavour. On the other hand, Member States shall undertake to reduce as far as possible the presence of flavours said to be essential, such as certain sugars with adverse effects on health such as fructose and glucose.
Amendment 474 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product
Amendment 475 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 With the exception of products referred to in Article 15, Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the additives do not result in a product with a characterising flavour.
Amendment 476 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products for smoking, as long as the additives do not result in a product with a characterising flavour.
Amendment 477 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of
Amendment 478 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not
Amendment 479 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Amendment 480 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 481 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 482 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 483 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 484 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 486 #
Proposal for a directive Article 6 – paragraph 2 Amendment 487 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 488 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 489 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 490 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 491 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 492 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 493 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 Amendment 494 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 The Commission shall at the request of a Member State or may on its own initiative
Amendment 495 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 The Commission shall at the request of a Member State or may on its own initiative determine by means of implementing acts whether a tobacco product falls within the scope of paragraph 1, on the basis of scientific evidence. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21. An independent panel shall be used to assist in the decision making.
Amendment 496 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 497 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 498 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 499 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 500 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 501 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 The Commission shall
Amendment 502 #
Proposal for a directive Article 6 – paragraph 3 Amendment 503 #
Proposal for a directive Article 6 – paragraph 3 Amendment 504 #
Proposal for a directive Article 6 – paragraph 3 Amendment 505 #
Proposal for a directive Article 6 – paragraph 3 Amendment 506 #
Proposal for a directive Article 6 – paragraph 3 Amendment 507 #
Proposal for a directive Article 6 – paragraph 3 Amendment 508 #
Proposal for a directive Article 6 – paragraph 3 Amendment 509 #
Proposal for a directive Article 6 – paragraph 3 Amendment 510 #
Proposal for a directive Article 6 – paragraph 3 Amendment 511 #
Proposal for a directive Article 6 – paragraph 3 3. In case the
Amendment 512 #
Proposal for a directive Article 6 – paragraph 3 3. In case
Amendment 513 #
Proposal for a directive Article 6 – paragraph 4 Amendment 514 #
Proposal for a directive Article 6 – paragraph 4 Amendment 515 #
Proposal for a directive Article 6 – paragraph 4 – introductory part 4.
Amendment 516 #
Proposal for a directive Article 6 – paragraph 4 – introductory part 4.
Amendment 517 #
Proposal for a directive Article 6 – paragraph 4 – point a Amendment 518 #
Proposal for a directive Article 6 – paragraph 4 – point a (a) vitamins
Amendment 519 #
Proposal for a directive Article 6 – paragraph 4 – point a a) vitamins
Amendment 520 #
Proposal for a directive Article 6 – paragraph 4 – point a a (new) (a a) sugar or similar additives which mitigate or alter the original tobacco flavour or taste in order to improve its palatability or attractiveness, or
Amendment 521 #
Proposal for a directive Article 6 – paragraph 4 – point b Amendment 522 #
Proposal for a directive Article 6 – paragraph 4 – point b (b) caffeine and taurine
Amendment 523 #
Proposal for a directive Article 6 – paragraph 4 – point b b) caffeine and taurine
Amendment 524 #
Proposal for a directive Article 6 – paragraph 4 – point c Amendment 525 #
Proposal for a directive Article 6 – paragraph 4 – point c a (new) ca) Member States shall prohibit the use of 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.
Amendment 526 #
Proposal for a directive Article 6 – paragraph 4 – point c a (new) (ca) Commercial references to any form of additive which could lead consumers to conclude that a tobacco product has health benefits, reduces the risks of tobacco consumption or provides energy, vitality or any other similar benefit shall be strictly prohibited in all cases.
Amendment 527 #
Proposal for a directive Article 6 – paragraph 5 Amendment 528 #
Proposal for a directive Article 6 – paragraph 5 Amendment 529 #
Proposal for a directive Article 6 – paragraph 5 Amendment 530 #
Proposal for a directive Article 6 – paragraph 5 Amendment 531 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of
Amendment 532 #
Proposal for a directive Article 6 – paragraph 5 5.
Amendment 533 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages
Amendment 534 #
Proposal for a directive Article 6 – paragraph 5 5.
Amendment 535 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness. Filters and capsules shall not contain tobacco.
Amendment 536 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings and/or additives in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour, taste, smell or smoke intensity. Filters and capsules shall not contain tobacco
Amendment 537 #
Proposal for a directive Article 6 – paragraph 5 a (new) 5 a. Technical features aiming to reduce some harmful components of smoke are not affected.
Amendment 538 #
Proposal for a directive Article 6 – paragraph 5 a (new) 5a. Paragraph 5 shall not apply to technical measures intended to decrease specific harmful components of smoke or enhance the biodegradability of tobacco products.
Amendment 539 #
Proposal for a directive Article 6 – paragraph 6 Amendment 540 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Amendment 541 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, prohibit the placing on the market of tobacco products with additives
Amendment 542 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Amendment 543 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on public scientific evidence originating from impeccably qualified scientific sources and published in annex to any administrative decision, prohibit the placing on the market of tobacco products with additives in quantities that increase in an
Amendment 544 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the to
Amendment 545 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, prohibit the placing on the market of tobacco products with additives in quantities that increase in a
Amendment 546 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, prohibit the placing on the market of tobacco products with additives in quantities that increase
Amendment 547 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 2 Amendment 548 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 2 Amendment 549 #
Proposal for a directive Article 6 – paragraph 8 Amendment 550 #
Proposal for a directive Article 6 – paragraph 8 Amendment 551 #
Proposal for a directive Article 6 – paragraph 8 Amendment 552 #
Proposal for a directive Article 6 – paragraph 8 Amendment 553 #
Proposal for a directive Article 6 – paragraph 8 Amendment 554 #
Proposal for a directive Article 6 – paragraph 9 Amendment 555 #
Proposal for a directive Article 6 – paragraph 9 Amendment 556 #
Proposal for a directive Article 6 – paragraph 9 Amendment 557 #
Proposal for a directive Article 6 – paragraph 9 Amendment 558 #
Proposal for a directive Article 6 – paragraph 9 Amendment 559 #
Proposal for a directive Article 6 – paragraph 9 9. In case scientific evidence
Amendment 560 #
Proposal for a directive Article 6 – paragraph 9 9. In case scientific evidence and the experience gained in the application of paragraphs 7 and 8 shows that a certain additive or a certain quantity thereof amplif
Amendment 561 #
Proposal for a directive Article 6 – paragraph 9 9. In case scientific evidence and the experience gained in the application of paragraphs 7 and 8 shows that a certain additive or a certain quantity thereof amplify
Amendment 562 #
Proposal for a directive Article 6 – paragraph 10 Amendment 563 #
Proposal for a directive Article 6 – paragraph 10 Amendment 564 #
Proposal for a directive Article 6 – paragraph 10 Amendment 565 #
Proposal for a directive Article 6 – paragraph 10 Amendment 566 #
Proposal for a directive Article 6 – paragraph 10 Amendment 567 #
Proposal for a directive Article 6 – paragraph 10 Amendment 568 #
Proposal for a directive Article 6 – paragraph 10 Amendment 569 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 570 #
Proposal for a directive Article 6 – paragraph 10 10.
Amendment 571 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 572 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco and
Amendment 573 #
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
Amendment 574 #
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.
Amendment 575 #
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.
Amendment 576 #
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.
Amendment 577 #
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.
Amendment 578 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco, water-pipe tobacco and smokeless tobacco products shall be exempted from
Amendment 579 #
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. Nasal tobacco products shall likewise be exempted. 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.
Amendment 580 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco, tobacco for water pipes 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.
Amendment 581 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products shall not 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.
Amendment 582 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco, water-pipe 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.
Amendment 583 #
Proposal for a directive Article 6 – paragraph 10 a (new) 10 a. In order to obtain the entry of an ingredient in Annex -I, manufacturers and importers shall make an application to the Commission. The application shall be accompanied by the following particulars: (a) name or corporate name and permanent address of the applicant; (b) chemical name of the ingredient; (c) function of the ingredient and maximum quantity to be used per cigarette; and (d) clear evidence supported by scientific data that the ingredient does not fall under any of the exclusion criteria listed in this Article. The Commission may ask the relevant scientific committee whether the ingredient concerned falls under any of the exclusion criteria listed in this Article as such, or only as of a certain concentration. The Commission shall take a decision in accordance with the procedure laid down in paragraph 1 no later than one year after receiving the application.
Amendment 584 #
Proposal for a directive Article 6 – paragraph 10 a (new) 10a. Oral tobacco (snus) shall be exempt from the provisions of Article 6 of this Directive.
Amendment 585 #
Proposal for a directive Article 6 a (new) Article 6 a A support fund for tobacco growers shall be established in regions where tobacco is produced to compensate for losses incurred by growers as a result of implementing the Directive. Money from this fund shall be allocated to growers affected by the fall in demand for raw tobacco, as well as to growers who wish to cease cultivating tobacco and change their production profile.
Amendment 586 #
Proposal for a directive Article 7 – paragraph 1 1.
Amendment 587 #
Proposal for a directive Article 7 – paragraph 1 1. Each unit packet of tobacco products and any outside packaging, with the exception of the transparent cellophane used in retail sales, shall carry health warnings in the official language or languages of the Member State where the product is placed on the market.
Amendment 588 #
Proposal for a directive Article 7 – paragraph 2 2. Health warnings shall occupy the entire surface reserved for them
Amendment 589 #
Proposal for a directive Article 7 – paragraph 3 Amendment 590 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably p
Amendment 591 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 592 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps,
Amendment 593 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet. The same safety considerations justify the retention of the provision in Directive 2001/37/EC permitting warnings to be affixed to cigar boxes by means of removable stickers.
Amendment 594 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of non-transparent wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 595 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet. In the case of tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products health warnings may be affixed by means of stickers, provided that these cannot be removed.
Amendment 596 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet. In the case of products manufactured in small quantities, the above-mentioned health warnings may be attached in the form of adhesive labels, provided that this is done at the point of origin and they cannot be removed without destroying the packaging.
Amendment 597 #
Proposal for a directive Article 7 – paragraph 3 a (new) 3a. To ensure clearness and visibility, particularly of the graphic warnings, adhesive labels may be used, provided they cannot be removed from the packaging and solely in the case of packaging materials on which it is difficult or impossible to print the combined warning.
Amendment 598 #
Proposal for a directive Article 7 – paragraph 4 4. Member States shall ensure that the health warnings o
Amendment 599 #
Proposal for a directive Article 7 – paragraph 4 4. Member States shall ensure that the health warnings and health costs of the main surface of the unit packet and any outside packaging are fully visible,
Amendment 600 #
Proposal for a directive Article 7 – paragraph 5 5. The health warnings shall in no way hide or interrupt the tax stamps, which shall be placed at the opening of the packaging of tobacco products, price marks, tracking and tracing marks, or security features on unit packets.
Amendment 601 #
Proposal for a directive Article 7 – paragraph 6 6. Member States
Amendment 602 #
Proposal for a directive Article 7 – paragraph 7 Amendment 603 #
Proposal for a directive Article 7 – paragraph 7 a (new) 7a. The unit packet and its surrounding packaging shall not include printed vouchers offering discounts, free distribution, two-for-one or other similar offers involving any type of tobacco product covered by this Directive...
Amendment 604 #
Proposal for a directive Article 8 Amendment 605 #
Proposal for a directive Article 8 – paragraph 2 – subparagraph 1 – introductory part Amendment 606 #
Proposal for a directive Article 8 – paragraph 2 – subparagraph 1 – subparagraph 1 Amendment 607 #
Proposal for a directive Article 8 – paragraph 2 – subparagraph 1 – subparagraph 1 Tobacco smoke contains over 70 substances
Amendment 608 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 609 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 610 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 611 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 612 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 613 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 614 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall
Amendment 615 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 616 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 617 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 618 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 619 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 620 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not
Amendment 621 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message shall cover 50% of the surface on which they are printed. For tobacco for smoking other than cigarettes and roll- your-own tobacco, the general warning and the information message shall be printed on the lateral sides of the unit packets. Both the general warning and the information message shall cover 50% of the surface on which they are printed.
Amendment 622 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm for cuboids and for shoulder packets. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message shall cover 50% of the surface on which they are printed.
Amendment 623 #
Proposal for a directive Article 8 – paragraph 4 Amendment 624 #
Proposal for a directive Article 8 – paragraph 4 Amendment 625 #
Proposal for a directive Article 8 – paragraph 4 Amendment 626 #
Proposal for a directive Article 8 – paragraph 4 Amendment 627 #
Proposal for a directive Article 8 – paragraph 4 – point a Amendment 628 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 629 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 630 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 631 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 632 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 633 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 634 #
Proposal for a directive Article 8 – paragraph 4 – point b (b) to define the
Amendment 635 #
Proposal for a directive Article 9 – title Amendment 636 #
Proposal for a directive Article 9 – title Combined health warnings for tobacco for smoking and prevention campaigns
Amendment 637 #
Proposal for a directive Article 9 – paragraph 1 – introductory part 1. Each unit packet and any outside packaging of tobacco for smoking shall carry
Amendment 638 #
Proposal for a directive Article 9 – paragraph 1 – introductory part 1. Each unit packet and any outside packaging of tobacco for smoking shall carry
Amendment 639 #
Proposal for a directive Article 9 – paragraph 1 – introductory part 1. Each unit packet and any outside packaging of tobacco for smoking shall carry
Amendment 640 #
Proposal for a directive Article 9 – paragraph 1 – introductory part 1. Each unit packet and any outside packaging of tobacco for smoking shall carry
Amendment 641 #
Proposal for a directive Article 9 – paragraph 1 – introductory part 1. Each unit packet and any outside packaging of tobacco for smoking shall carry combined picture and text health warnings. The combined health warnings shall:
Amendment 642 #
Proposal for a directive Article 9 – paragraph 1 – point a Amendment 643 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning
Amendment 644 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning listed in Annex I
Amendment 645 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning listed in Annex I
Amendment 646 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning listed in Annex I
Amendment 647 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised of a text warning listed in Annex I and, optionally, a corresponding colour photograph specified in the picture library;
Amendment 648 #
Proposal for a directive Article 9 – paragraph 1 – point a (a) be comprised either of a text warning listed in Annex I or of a text warning and a corresponding colour photograph specified in the picture library;
Amendment 649 #
Proposal for a directive Article 9 – paragraph 1 – point a a (new) (aa) Member States may require combined health warnings in the form of the text warning and a colour photograph specified in the picture library.
Amendment 650 #
Proposal for a directive Article 9 – paragraph 1 – point a b (new) (ab) Member States may request authorisation to use health warnings comprised of a text warning listed in Annex I and a corresponding colour photograph specified in the picture library.
Amendment 651 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 652 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 653 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) continue to cover
Amendment 654 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 655 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 656 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 657 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 658 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 659 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 660 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 661 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 662 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 663 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 664 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 665 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 666 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 667 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 668 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 669 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 670 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 671 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 672 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 673 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 674 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 675 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 676 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) in conjunction with the bar codes, tax stamps, track and trace and other essential markings, cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 677 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 678 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 679 #
Proposal for a directive Article 9 – paragraph 1 – point d Amendment 680 #
Proposal for a directive Article 9 – paragraph 1 – point d Amendment 681 #
Proposal for a directive Article 9 – paragraph 1 – point d (d) show the same text warning
Amendment 682 #
Proposal for a directive Article 9 – paragraph 1 – point d (d) show the same text warning and, optionally, corresponding colour photograph on both sides of the unit packets and any outside packaging;
Amendment 683 #
Proposal for a directive Article 9 – paragraph 1 – point e Amendment 684 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the
Amendment 685 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 686 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 687 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the
Amendment 688 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 689 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 690 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 691 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the
Amendment 692 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the
Amendment 693 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 694 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 695 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 696 #
Proposal for a directive Article 9 – paragraph 1 – point e a (new) (ea) be positioned on each unit packet and on any external packaging, and in the same direction as any other information appearing on the packaging;
Amendment 697 #
Proposal for a directive Article 9 – paragraph 1 – point f Amendment 698 #
Proposal for a directive Article 9 – paragraph 1 – point f (f) be reproduced in accordance with the
Amendment 699 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 700 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 701 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 702 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 703 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 704 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 705 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 706 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 707 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 708 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 709 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 710 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 711 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 712 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 713 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 714 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 715 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not
Amendment 716 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than
Amendment 717 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than
Amendment 718 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than
Amendment 719 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than 6
Amendment 720 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height:
Amendment 721 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii) width: not less than
Amendment 722 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii) width: not
Amendment 723 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii) width:
Amendment 942 #
Proposal for a directive Article 14 – paragraph 2 – introductory part 2. The unique identifier, which is secure and impossible to duplicate, shall allow determining
Amendment 943 #
Proposal for a directive Article 14 – paragraph 2 – point e (e) the product
Amendment 944 #
Proposal for a directive Article 14 – paragraph 2 – point f Amendment 945 #
Proposal for a directive Article 14 – paragraph 2 – point g Amendment 946 #
Proposal for a directive Article 14 – paragraph 2 – point g Amendment 947 #
Proposal for a directive Article 14 – paragraph 2 – point g Amendment 948 #
Proposal for a directive Article 14 – paragraph 2 – point g 2012/0366(COD) Article 14(2)(g) (g) the intended shipment route
Amendment 949 #
Proposal for a directive Article 14 – paragraph 2 – point g (g) the intended shipment route, the shipment date, destination, place of departure and recipient;
Amendment 950 #
Proposal for a directive Article 14 – paragraph 2 – point g (g) the intended shipment route from the manufacturer to the first customer and the warehouses used;
Amendment 951 #
Proposal for a directive Article 14 – paragraph 2 – point h Amendment 952 #
Proposal for a directive Article 14 – paragraph 2 – point h Amendment 953 #
Proposal for a directive Article 14 – paragraph 2 – point h Amendment 954 #
Proposal for a directive Article 14 – paragraph 2 – point i Amendment 955 #
Proposal for a directive Article 14 – paragraph 2 – point i (i) the
Amendment 956 #
Proposal for a directive Article 14 – paragraph 2 – point i (i) the actual shipment route from manufacturing to the first
Amendment 957 #
Proposal for a directive Article 14 – paragraph 2 – point i (i) the actual shipment route from manufacturing to the first
Amendment 958 #
Proposal for a directive Article 14 – paragraph 2 – point i i) the
Amendment 959 #
Proposal for a directive Article 14 – paragraph 2 – point j Amendment 960 #
Proposal for a directive Article 14 – paragraph 2 – point j Amendment 961 #
Proposal for a directive Article 14 – paragraph 2 – point j (j) the identity of all purchasers from manufacturing to the first
Amendment 962 #
Proposal for a directive Article 14 – paragraph 2 – point j j) the identity of all purchasers from manufacturing to the first
Amendment 963 #
Proposal for a directive Article 14 – paragraph 2 – point j (j) the identity of all purchasers from manufacturing to the first
Amendment 964 #
Proposal for a directive Article 14 – paragraph 2 – point j (j) the identity of all purchasers from manufacturing to the first
Amendment 965 #
Proposal for a directive Article 14 – paragraph 2 – point k Amendment 966 #
Proposal for a directive Article 14 – paragraph 2 – point k Amendment 967 #
Proposal for a directive Article 14 – paragraph 2 – point k (k) the invoice, order number and payment records of all purchasers from manufacturing to the first
Amendment 968 #
Proposal for a directive Article 14 – paragraph 2 – point k k) the invoice, order number and payment records of all purchasers from manufacturing to the first
Amendment 969 #
Proposal for a directive Article 14 – paragraph 2 – point k (k) the invoice, order number and payment records of all purchasers from manufacturing to the first
Amendment 970 #
Proposal for a directive Article 14 – paragraph 2 a (new) 2a. Member States shall ensure that the unique identifiers of unit packs are linked to the unique identifier on the outside packaging. Any changes in links between unit packs and the outside packaging should be recorded in the database mentioned in paragraph 6.
Amendment 971 #
Proposal for a directive Article 14 – paragraph 2 a (new) 2a. Member States shall also ensure that cigarette products, destined to or placed on the Union market, are manufactured in such a complex way to safeguard the final product against counterfeiting. Security features in this sense are: (a) cigarette paper; (b) tipping paper; (c) watermarks; (c) perforation; (d) rotogravure printing (e) multicolour printing.
Amendment 972 #
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
Amendment 973 #
Proposal for a directive Article 14 – paragraph 3 3. Member States shall ensure that
Amendment 974 #
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 transport 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.
Amendment 975 #
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
Amendment 976 #
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
Amendment 977 #
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
Amendment 978 #
Proposal for a directive Article 14 – paragraph 3 a (new) 3a. The technology used for tracking and tracing should belong to and be operated by economic entities without any legal or commercial link to the tobacco industry.
Amendment 979 #
Proposal for a directive Article 14 – paragraph 4 Amendment 980 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide
Amendment 981 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet, including importers, warehouses and transporting companies with the necessary equipment, determined by the Member States, allowing for the recording of the tobacco products purchased, sold, stored, transported or otherwise handled. The equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6.
Amendment 982 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the
Amendment 983 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first
Amendment 984 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the
Amendment 985 #
Proposal for a directive Article 14 – paragraph 5 Amendment 986 #
Proposal for a directive Article 14 – paragraph 6 Amendment 987 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 988 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 989 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 990 #
Proposal for a directive Article 14 – paragraph 7 Amendment 991 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible and invisible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or other elements mandated by legislation.
Amendment 992 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a
Amendment 993 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, which is secure and impossible to duplicate, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or other elements mandated by legislation.
Amendment 994 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature
Amendment 995 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form
Amendment 996 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature
Amendment 997 #
Proposal for a directive Article 14 – paragraph 9 Amendment 998 #
Proposal for a directive Article 14 – paragraph 9 Amendment 999 #
Proposal for a directive Article 14 – paragraph 9 source: PE-510.712
2013/05/21
ENVI
218 amendments...
Amendment 724 #
Proposal for a directive Article 9 – paragraph 2 Amendment 725 #
Proposal for a directive Article 9 – paragraph 2 2. The combined health warnings shall be divided into three sets rotating on an annual basis.
Amendment 726 #
Proposal for a directive Article 9 – paragraph 2 2.
Amendment 727 #
Proposal for a directive Article 9 – paragraph 2 2. The
Amendment 728 #
Proposal for a directive Article 9 – paragraph 2 2. The
Amendment 729 #
Proposal for a directive Article 9 – paragraph 2 2. The combined health warnings shall be divided into three sets rotating on an annual basis, except for the warnings referred to in paragraph 1(b). Member States shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand.
Amendment 730 #
Proposal for a directive Article 9 – paragraph 2 2. The combined health warnings and information on tobacco related diseases shall be
Amendment 731 #
Proposal for a directive Article 9 – paragraph 2 2. The combined health warnings shall be divided into three sets rotating on an annual basis. Member States shall ensure that each combined health warning is displayed as nearly as possible on equal numbers of each brand. As part of a specific anti-smoking campaign, Member States may, for domestically produced tobacco products intended for domestic consumption, adapt the use of the verbal warnings listed in Annex 1, as well as the use of images and photographs, to the purposes of the campaign in question.
Amendment 732 #
Proposal for a directive Article 9 – paragraph 2 – point 1 (new) (1) Smoking prevention campaigns and information programmes on the health risks associated with smoking are the most effective ways of attaining the aims of this Directive. Information and prevention campaigns and programmes to be carried out above all in primary schools shall be managed by the competent authorities of the Member States and financed partly by means of the proceeds from penalties established by those same States for breaches of the national provisions implementing this Directive.
Amendment 733 #
Proposal for a directive Article 9 – paragraph 3 Amendment 734 #
Proposal for a directive Article 9 – paragraph 3 Amendment 735 #
Proposal for a directive Article 9 – paragraph 3 Amendment 736 #
Proposal for a directive Article 9 – paragraph 3 Amendment 737 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 738 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 739 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 740 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 741 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 742 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 743 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 744 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 745 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 746 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the
Amendment 747 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the
Amendment 748 #
Proposal for a directive Article 9 – paragraph 3 – point c c) define the position, format, layout, design
Amendment 749 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 750 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 751 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 752 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 753 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 754 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 758 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes
Amendment 759 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes
Amendment 760 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes and roll-your-own tobacco shall be exempted from the obligations to carry the information message laid down in Article 8(2) and the
Amendment 761 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco products for smoking other than cigarettes and roll-your-own tobacco shall
Amendment 762 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes and roll-your-own tobacco shall not be exempted from the obligations to carry the information message laid down in Article 8(2) and the combined health warnings in Article 9. In addition to the general warning specified in Article 8(1), each unit packet and any outside packaging
Amendment 763 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general warning shall be printed on
Amendment 764 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general warning shall be printed on the most visible surface of the unit packet and any outside packaging. The text warnings listed in Annex I shall be rotated in such a way as to guarantee their regular appearance. These warnings shall be printed on the other most visible surface of the unit packet and any outside packaging, except where this duplication affects the legibility of the message, as in the case of transparent wrapping covering the rigid or paper packaging used in retail sales.
Amendment 765 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall cover
Amendment 766 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall cover
Amendment 767 #
Proposal for a directive Article 10 – paragraph 2 2. The general warning referred to in paragraph 1 shall 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
Amendment 768 #
Proposal for a directive Article 10 – paragraph 2 2. The text warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging, except in the case of the transparent wrapping covering the rigid or paper packaging used in retail sales. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.
Amendment 769 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover
Amendment 770 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging.
Amendment 771 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover
Amendment 772 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with
Amendment 773 #
Proposal for a directive Article 10 – paragraph 3 3. The text warning referred to in paragraph 1 shall cover 40 % of the external area of the corresponding surface of the unit packet and any outside packaging and may also be displayed by means of undetachable stickers on goods with small production runs. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with three official languages.
Amendment 774 #
Proposal for a directive Article 10 – paragraph 3 a (new) 3a. In the case of packets whose most visible surface has an area exceeding 75 cm², the warnings referred to in paragraphs 2 and 3 must cover an area of at least 22.5 cm² on each surface. That area shall be increased to 24 cm² for Member States with two official languages and 26.25 cm² for Member States with three official languages.
Amendment 775 #
Proposal for a directive Article 10 – paragraph 3 a (new) 3a. In the case of packets whose most visible side has an area exceeding 75 cm², the warnings referred to in paragraphs 2 and 3 must, however, cover an area of at least 22.5 cm² on each side. That area shall be increased to 24 cm² for Member States with two official languages and 26.25 cm² for Member States with three official languages.
Amendment 776 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. The warnings may also be affixed in the form of irremovable labels. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;
Amendment 777 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. The warnings may be affixed by means of stickers, provided that such stickers are irremovable. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of
Amendment 778 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black
Amendment 779 #
Proposal for a directive Article 10 – paragraph 4 – point b (b) centred in the area in which they are required to be printed,
Amendment 780 #
Proposal for a directive Article 10 – paragraph 4 – point c (c) surrounded by a black border
Amendment 781 #
Proposal for a directive Article 10 – paragraph 4 – point c (c) surrounded by a black border
Amendment 782 #
Proposal for a directive Article 10 – paragraph 4 – point c (c) surrounded by a black border not
Amendment 783 #
Proposal for a directive Article 10 – paragraph 5 Amendment 784 #
Proposal for a directive Article 10 – paragraph 5 Amendment 785 #
Proposal for a directive Article 10 – paragraph 5 Amendment 786 #
Proposal for a directive Article 10 – paragraph 5 Amendment 787 #
Proposal for a directive Article 10 – paragraph 5 Amendment 788 #
Proposal for a directive Article 10 – paragraph 5 Amendment 789 #
Proposal for a directive Article 10 – paragraph 5 Amendment 790 #
Proposal for a directive Article 10 – paragraph 5 Amendment 791 #
Proposal for a directive Article 10 – paragraph 5 Amendment 792 #
Proposal for a directive Article 10 – paragraph 5 Amendment 793 #
Proposal for a directive Article 10 – paragraph 5 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22, to withdraw the exemption laid down in paragraph 1 if there is a substantial change of circumstances
Amendment 794 #
Proposal for a directive Article 10 – paragraph 5 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22
Amendment 795 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 – introductory part Amendment 796 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 – introductory part Each unit packet and any outside packaging of smokeless tobacco products, other than electronic inhalers that vaporise a liquid solution simulating the act of smoking, shall carry the following health warning:
Amendment 797 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 1 – introductory part Except in the case of snuff, each unit packet and any outside packaging of smokeless tobacco products shall carry the following health warning:
Amendment 798 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 2 This tobacco product
Amendment 799 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 2 This tobacco product can damage your health and is addictive, but presents substantially lower risks to your health than smoking
Amendment 800 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 2 This tobacco product
Amendment 801 #
Proposal for a directive Article 11 – paragraph 1 – subparagraph 2 This tobacco product
Amendment 802 #
Proposal for a directive Article 11 – paragraph 1 a (new) 1a. Each unit packet and any outside packaging of electronic inhalers that vaporise a liquid solution simulating the act of smoking shall carry the following health warning: This product contains nicotine and can be addictive.
Amendment 803 #
Proposal for a directive Article 11 – paragraph 2 – point b (b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging.
Amendment 804 #
Proposal for a directive Article 11 – paragraph 2 – point b (b) cover
Amendment 805 #
Proposal for a directive Article 11 – paragraph 2 – point b (b) cover
Amendment 806 #
Proposal for a directive Article 11 – paragraph 2 – 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
Amendment 807 #
Proposal for a directive Article 11 – paragraph 2 – subparagraph 1 (new) In the case of micro-packagings, whose largest surface has an area of less than 25 cm2, the general warning must occupy at least 20% of this area.
Amendment 808 #
Proposal for a directive Article 11 – paragraph 3 Amendment 809 #
Proposal for a directive Article 11 – paragraph 3 Amendment 810 #
Proposal for a directive Article 11 – paragraph 3 Amendment 811 #
Proposal for a directive Article 11 – paragraph 3 Amendment 812 #
Proposal for a directive Article 12 – paragraph 1 Amendment 813 #
Proposal for a directive Article 12 – paragraph 1 Amendment 814 #
Proposal for a directive Article 12 – paragraph 1 – introductory part 1.
Amendment 815 #
Proposal for a directive Article 12 – paragraph 1 – introductory part 1. The labelling of a unit packet and any outside packaging and the tobacco product itself and/or its brand name shall not include any element or feature that:
Amendment 816 #
Proposal for a directive Article 12 – paragraph 1 – introductory part 1. The labelling of a unit packet and any outside packaging and the tobacco product itself shall not include a brand name or any element or feature that:
Amendment 817 #
Proposal for a directive Article 12 – paragraph 1 – introductory part 1. The labelling of a unit packet and any outside packaging and the tobacco product itself shall not include any information about nicotine, tar or carbon monoxide content or any element or feature that:
Amendment 818 #
Proposal for a directive Article 12 – paragraph 1 – point a (a) promotes a tobacco product and encourages its consumption by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions;
Amendment 819 #
Proposal for a directive Article 12 – paragraph 1 – point a a (new) (aa) suggests that a particular tobacco product is less harmful than others, except in cases in which it can be scientifically demonstrated that the harmful effect is significantly less than that of tobacco products already available for purchase;
Amendment 820 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) uses texts, names, marks or figurative or other symbols suggest
Amendment 821 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product
Amendment 822 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product
Amendment 823 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health
Amendment 824 #
Proposal for a directive Article 12 – paragraph 1 – point b b) directly or comparatively suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health or social effects;
Amendment 825 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product is less harmful than others or has vitalising, energetic, healing, rejuvenating
Amendment 826 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 827 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 828 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 829 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 830 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 831 #
Proposal for a directive Article 12 – paragraph 1 – point d Amendment 832 #
Proposal for a directive Article 12 – paragraph 1 – point d d) resembles a food, cosmetic or everyday product
Amendment 833 #
Proposal for a directive Article 12 – paragraph 1 – point d (d) in the case of tobacco for oral use, resembles a food product.
Amendment 834 #
Proposal for a directive Article 12 – paragraph 2 Amendment 835 #
Proposal for a directive Article 12 – paragraph 2 Amendment 836 #
Proposal for a directive Article 12 – paragraph 2 2. Prohibited elements and features
Amendment 837 #
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
Amendment 838 #
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
Amendment 839 #
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,
Amendment 840 #
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,
Amendment 841 #
Proposal for a directive Article 12 – paragraph 2 2. Prohibited elements and features may include but are not limited to texts, symbols, names,
Amendment 842 #
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,
Amendment 843 #
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
Amendment 844 #
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.
Amendment 845 #
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.
Amendment 846 #
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.
Amendment 847 #
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.
Amendment 848 #
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
Amendment 849 #
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.
Amendment 850 #
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.
Amendment 851 #
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.
Amendment 852 #
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
Amendment 853 #
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
Amendment 854 #
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.
Amendment 855 #
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.
Amendment 856 #
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.
Amendment 857 #
Proposal for a directive Article 12 – paragraph 2 – point 1 (new) (1) Scientifically established communications that a particular product is less harmful than others should be excluded from the provisions of paragraph 1 (b) and paragraph 2. Manufacturers shall submit information to the competent authorities of the Member States indicating that the product is less harmful.
Amendment 858 #
Proposal for a directive Article 12 – paragraph 2 – subparagraph 1 (new) In the case of filter cigarettes, the tipping paper must afford sufficient protection against product counterfeiting by means of its complexity. To this end it must, at the minimum, possess the following characteristics: (a) several visible print colours and production using gravure printing; (b) all white areas must be coated; (c) complex printing with partially thin structures; (d) printing on white base paper; (e) pre-perforation situated sufficiently far from the end of the cigarette.
Amendment 859 #
Proposal for a directive Article 12 – paragraph 2 – point 1 (new) (1) The cigarette paper must include watermarks.
Amendment 860 #
Proposal for a directive Article 12 – paragraph 2 a (new) 2a. Prohibited elements and features may include misleading texts and graphics.
Amendment 861 #
Proposal for a directive Article 12 – paragraph 2 a (new) 2a. The variety of tobacco used to manufacture the product and/or its country of origin may be indicated on the unit packet.
Amendment 862 #
Proposal for a directive Article 13 Amendment 863 #
Proposal for a directive Article 13 Amendment 864 #
Proposal for a directive Article 13 Amendment 865 #
Proposal for a directive Article 13 – paragraph 1 Amendment 866 #
Proposal for a directive Article 13 – paragraph 1 Amendment 867 #
Proposal for a directive Article 13 – paragraph 1 Amendment 868 #
Proposal for a directive Article 13 – paragraph 1 Amendment 869 #
Proposal for a directive Article 13 – paragraph 1 Amendment 870 #
Proposal for a directive Article 13 – paragraph 1 Amendment 871 #
Proposal for a directive Article 13 – paragraph 1 Amendment 872 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of
Amendment 873 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of
Amendment 874 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape
Amendment 875 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape.
Amendment 876 #
Proposal for a directive Article 13 – paragraph 1 1.
Amendment 877 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall
Amendment 878 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes
Amendment 879 #
Proposal for a directive Article 13 – paragraph 1 1.
Amendment 880 #
Proposal for a directive Article 13 – paragraph 1 1.
Amendment 881 #
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
Amendment 882 #
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
Amendment 883 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have an approximately cuboid shape. A unit packet of roll-your-
Amendment 884 #
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
Amendment 885 #
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
Amendment 886 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid or a shoulder shape. A unit packet of roll-your-
Amendment 887 #
Proposal for a directive Article 13 – paragraph 2 Amendment 888 #
Proposal for a directive Article 13 – paragraph 2 Amendment 889 #
Proposal for a directive Article 13 – paragraph 2 Amendment 890 #
Proposal for a directive Article 13 – paragraph 2 Amendment 891 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and
Amendment 892 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall
Amendment 893 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall
Amendment 894 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened
Amendment 895 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than the flip-top lid. The flip-top lid of a cigarette packet shall be hinged only at the back of the packet. The areas of the packet which are not covered with health warnings shall be designed in a sufficiently complicated and multicoloured style. At least one of the printed colours must create structures perceptible to the sense of touch.
Amendment 896 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed
Amendment 897 #
Proposal for a directive Article 13 – paragraph 2 a (new) 2a. All outer surfaces of the unit packet and any outside packaging of tobacco for smoking shall be standardised in the following way: (a) not contain any trade mark or any other mark, apart from the brand name and any variant name for the tobacco products; (b) be of a dark, unattractive colour set by the Commission; (c) the brand name, and any variant name shall: (i) not appear more than once on any one surface; (ii) appear horizontally below, and in the same orientation as, the combined health warning, in the centre of the space remaining on the front and back surfaces of the unit packet and any outside packaging; (iii) comply with any more detailed rules set out in paragraph 3.
Amendment 898 #
Proposal for a directive Article 13 – paragraph 3 Amendment 899 #
Proposal for a directive Article 13 – paragraph 3 Amendment 900 #
Proposal for a directive Article 13 – paragraph 3 Amendment 901 #
Proposal for a directive Article 13 – paragraph 3 Amendment 902 #
Proposal for a directive Article 13 – paragraph 3 Amendment 903 #
Proposal for a directive Article 13 – paragraph 3 Amendment 904 #
Proposal for a directive Article 13 – paragraph 3 Amendment 905 #
Proposal for a directive Article 13 – paragraph 3 Amendment 906 #
Proposal for a directive Article 13 – paragraph 3 Amendment 907 #
Proposal for a directive Article 13 – paragraph 3 Amendment 908 #
Proposal for a directive Article 13 – paragraph 3 Amendment 909 #
Proposal for a directive Article 13 – paragraph 3 Amendment 910 #
Proposal for a directive Article 13 – paragraph 3 Amendment 911 #
Proposal for a directive Article 13 – paragraph 3 3. The
Amendment 912 #
Proposal for a directive Article 13 – paragraph 3 3. The
Amendment 913 #
Proposal for a directive Article 13 – paragraph 3 3.
Amendment 914 #
Proposal for a directive Article 13 – paragraph 3 3. The Commission
Amendment 915 #
Proposal for a directive Article 13 – paragraph 4 Amendment 916 #
Proposal for a directive Article 13 – paragraph 4 Amendment 917 #
Proposal for a directive Article 13 – paragraph 4 Amendment 918 #
Proposal for a directive Article 13 – paragraph 4 Amendment 919 #
Proposal for a directive Article 13 – paragraph 4 Amendment 920 #
Proposal for a directive Article 13 – paragraph 4 Amendment 921 #
Proposal for a directive Article 13 – paragraph 4 Amendment 922 #
Proposal for a directive Article 13 – paragraph 4 Amendment 923 #
Proposal for a directive Article 13 – paragraph 4 Amendment 924 #
Proposal for a directive Article 13 – paragraph 4 Amendment 925 #
Proposal for a directive Article 13 – paragraph 4 Amendment 926 #
Proposal for a directive Article 13 – paragraph 4 Amendment 927 #
Proposal for a directive Article 13 – paragraph 4 Amendment 928 #
Proposal for a directive Article 13 – paragraph 4 Amendment 929 #
Proposal for a directive Article 13 – paragraph 4 Amendment 930 #
Proposal for a directive Article 13 – paragraph 4 4. The
Amendment 933 #
Proposal for a directive Article 14 – paragraph 1 Amendment 934 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets and any outside packaging of tobacco products 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.
Amendment 935 #
Proposal for a directive Article 14 – paragraph 1 1. With the exception of products referred to in Article 15, Member States shall ensure that all unit packets of tobacco products 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.
Amendment 936 #
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 outside packaging, shall be marked with a unique, secure and irremovable 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.
Amendment 937 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets of tobacco products marketed in the EU 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
Amendment 938 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets of tobacco products shall be marked with a unique identifier. In order to ensure their integrity, unique and secure 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.
Amendment 939 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets of tobacco products shall be marked with a unique identifier. In order to ensure their integrity, unique identifiers
Amendment 940 #
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.
Amendment 941 #
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.
source: PE-510.717
2013/05/28
ITRE
464 amendments...
Amendment 100 #
Proposal for a directive Article 2 – paragraph 1 – point 4 4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or the traditional flavour of menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 101 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives,
Amendment 102 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4)
Amendment 103 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4)
Amendment 104 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 105 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco and menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 106 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 107 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) (4) 'characterising flavour' means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 108 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 109 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘
Amendment 110 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 111 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 112 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 113 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 114 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 115 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18)
Amendment 116 #
Proposal for a directive Article 2 – paragraph 1 – point 18 a (new) (18a) ‘reconstituted tobacco’ means the result of the enhancement of different parts of the tobacco plant from threshing and the manufacture of tobacco products, used as sheets or individual strands as a component of the tobacco blend for cigarettes and other tobacco products
Amendment 117 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 118 #
Proposal for a directive Article 2 – paragraph 1 – point 19 (19) 'maximum level'
Amendment 119 #
Proposal for a directive Article 2 – paragraph 1 – point 23 a (new) (23a) "Tobacco products with lower risk" means a tobacco product that is designed and marketed to reduce the risks of smoking compared to conventional tobacco products, especially cigarettes, which is placed on the market after the entry into force of this Directive.
Amendment 120 #
Proposal for a directive Article 2 – paragraph 1 – point 30 Amendment 121 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 122 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30)
Amendment 123 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30)
Amendment 124 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) ‘reduced risk product’ means any product containing tobacco which, when marketed, significantly reduces the risk of illnesses associated with the consumption of conventional tobacco products. A product designed to treat addiction to tobacco consumption, including smoking cessation, is not a low-risk product if it has been approved as a medicinal product.
Amendment 125 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) "Reconstituted tobacco" means the result of enhancement of different parts of the tobacco plant from threshing and the manufacture of tobacco products, whether used as a wrap for cigars and cigarillos either as sheets or individual strands as a component of the tobacco blend for cigarettes and other tobacco products.
Amendment 126 #
Proposal for a directive Article 3 – paragraph 1 – introductory part 1. The yield of cigarettes placed on the market
Amendment 127 #
Proposal for a directive Article 3 – paragraph 1 – point c a (new) (ca) 0.002 picocuries of Polonium 210
Amendment 128 #
Proposal for a directive Article 3 – paragraph 2 Amendment 129 #
Proposal for a directive Article 3 – paragraph 2 Amendment 130 #
Proposal for a directive Article 3 – paragraph 2 Amendment 131 #
Proposal for a directive Article 3 – paragraph 2 Amendment 132 #
Proposal for a directive Article 3 – paragraph 2 Amendment 133 #
Proposal for a directive Article 3 – paragraph 2 Amendment 134 #
Proposal for a directive Article 3 – paragraph 2 Amendment 135 #
Proposal for a directive Article 3 – paragraph 2 Amendment 136 #
Proposal for a directive Article 3 – paragraph 2 Amendment 137 #
Proposal for a directive Article 3 – paragraph 2 Amendment 138 #
Proposal for a directive Article 3 – paragraph 2 Amendment 139 #
Proposal for a directive Article 3 – paragraph 2 Amendment 140 #
Proposal for a directive Article 3 – paragraph 3 Amendment 141 #
Proposal for a directive Article 3 – paragraph 3 Amendment 142 #
Proposal for a directive Article 3 – paragraph 3 Amendment 143 #
Proposal for a directive Article 3 – paragraph 3 Amendment 144 #
Proposal for a directive Article 3 – paragraph 3 Amendment 145 #
Proposal for a directive Article 3 – paragraph 3 Amendment 146 #
Proposal for a directive Article 3 – paragraph 3 Amendment 147 #
Proposal for a directive Article 3 – paragraph 3 Amendment 148 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 149 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 150 #
Proposal for a directive Article 4 – paragraph 3 Amendment 151 #
Proposal for a directive Article 4 – paragraph 4 Amendment 152 #
Proposal for a directive Article 5 – paragraph 1 – subparagraph 1 Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products by brand name and type, as well as their emissions and yields resulting from intended use. Manufacturers or importers shall also inform the competent authorities of the concerned Member States if the composition of a product is modified affecting the information provided under this Article. Information required under this Article shall be submitted prior to the placing of the market of a new or modified tobacco product.
Amendment 153 #
Proposal for a directive Article 4 – paragraph 1 – subparagraph 2 a (new) The Commission shall ask ISO to develop a standard to measure Polonium 210 in tobacco.
Amendment 154 #
Proposal for a directive Article 5 – paragraph 2 2. Member States shall ensure the dissemination of information submitted in accordance with paragraph 1 on a
Amendment 155 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 156 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Amendment 157 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour other than the traditional flavour of menthol, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness.
Amendment 158 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour where this increases in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product.
Amendment 159 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit
Amendment 160 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour. This shall not apply in respect of the placing on the market of snus in Sweden, in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden.
Amendment 161 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a
Amendment 162 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall
Amendment 163 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States
Amendment 164 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Amendment 165 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not restrict or prohibit the use of additives which are essential for the manufacture of tobacco products, as long as the use of those additives does not result in a product with a characterising flavour.
Amendment 166 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 167 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 168 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products
Amendment 169 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 3 Amendment 170 #
Proposal for a directive Article 6 – paragraph 2 Amendment 171 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 1 The Commission shall at the request of a Member State or may on its own initiative determine by means of implementing acts whether a tobacco product falls within the scope of paragraph 1, based on scientific evidence. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.
Amendment 172 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 Amendment 173 #
Proposal for a directive Article 6 – paragraph 3 Amendment 174 #
Proposal for a directive Article 6 – paragraph 3 Amendment 175 #
Proposal for a directive Article 6 – paragraph 3 Amendment 176 #
Proposal for a directive Article 6 – paragraph 3 Amendment 177 #
Proposal for a directive Article 6 – paragraph 3 3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration the Commission shall
Amendment 178 #
Proposal for a directive Article 6 – paragraph 3 3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration
Amendment 179 #
Proposal for a directive Article 6 – paragraph 3 3. In case
Amendment 180 #
Proposal for a directive Article 6 – paragraph 4 – introductory part 4. Member States shall
Amendment 181 #
Proposal for a directive Article 6 – paragraph 4 – introductory part 4.
Amendment 182 #
Proposal for a directive Article 6 – paragraph 4 – point a a) vitamins
Amendment 183 #
Proposal for a directive Article 6 – paragraph 4 – point b b) caffeine and taurine
Amendment 184 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of
Amendment 185 #
Proposal for a directive Article 6 – paragraph 5 5.
Amendment 186 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of characterising flavour
Amendment 187 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall
Amendment 188 #
Proposal for a directive Article 6 – paragraph 5 5.
Amendment 189 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity where these increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product.. Filters and capsules shall not contain tobacco.
Amendment 190 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity, provided that there is unequivocal scientific proof that the particular additive increases the product’s toxicity or addictiveness. Filters and capsules shall not contain tobacco.
Amendment 191 #
Proposal for a directive Article 6 – paragraph 5 a (new) 5a. This shall not apply to technical measures intended to decrease specific harmful components of smoke or enhance the biodegradability of tobacco.
Amendment 192 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, restrict or, if adequately justified, prohibit the placing on the market of tobacco products with additives in quantities that increase in a
Amendment 193 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Amendment 194 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 1 Member States shall, based on scientific evidence, restrict or, if appropriately justified, prohibit the placing on the market of tobacco products with additives in quantities that increase in a
Amendment 195 #
Proposal for a directive Article 6 – paragraph 7 – subparagraph 2 Amendment 196 #
Proposal for a directive Article 6 – paragraph 8 Amendment 197 #
Proposal for a directive Article 6 – paragraph 9 Amendment 198 #
Proposal for a directive Article 6 – paragraph 9 Amendment 199 #
Proposal for a directive Article 6 – paragraph 9 Amendment 200 #
Proposal for a directive Article 6 – paragraph 9 Amendment 201 #
Proposal for a directive Article 6 – paragraph 9 9. In case scientific evidence
Amendment 202 #
Proposal for a directive Article 6 – paragraph 10 Amendment 203 #
Proposal for a directive Article 6 – paragraph 10 Amendment 204 #
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
Amendment 205 #
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
Amendment 206 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco and
Amendment 207 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 208 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 209 #
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.
Amendment 21 #
Proposal for a directive Recital 4 (4) In other areas there are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This applies in particular to nicotine containing products, herbal products for smoking, ingredients and emissions, certain aspects of labelling and packaging
Amendment 210 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products shall not be exempted from the prohibitions laid down in paragraphs 1 and 5.
Amendment 211 #
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.
Amendment 212 #
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.
Amendment 213 #
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.
Amendment 214 #
Proposal for a directive Article 6 – paragraph 10 a (new) 10 a. In order to obtain the entry of an ingredient in Annex -I, manufacturers and importers shall make an application to the Commission. The application shall be accompanied by the following particulars: (a) Name or corporate name and permanent address of the applicant; (b) Chemical name of the ingredient; (c) Function of the ingredient and maximum quantity to be used per cigarette; (d) Clear evidence supported by scientific data that the ingredient does not fall under any of the exclusion criteria listed in this Article. The Commission may ask the relevant scientific committee whether the ingredient concerned falls under any of the exclusion criteria listed in this Article as such, or only as of a certain concentration. The Commission shall take a decision in accordance with the procedure laid down in paragraph 1 no later than one year after receiving the application.
Amendment 215 #
Proposal for a directive Article 6 – paragraph 10 a (new) 10a. Oral tobacco (snus) shall be exempt from the provisions of Article 6 of this Directive.
Amendment 216 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, and without prejudice to the labelling provisions in Article 10 and 11, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 217 #
Proposal for a directive Article 7 – paragraph 3 3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed or irremovably affixed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet.
Amendment 218 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit
Amendment 219 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 22 #
Proposal for a directive Recital 6 (6) The size of the internal market in
Amendment 220 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general
Amendment 221 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 222 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 223 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets.
Amendment 224 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message shall cover
Amendment 225 #
Proposal for a directive Article 8 – paragraph 4 Amendment 226 #
Proposal for a directive Article 8 – paragraph 4 Amendment 227 #
Proposal for a directive Article 8 – paragraph 4 Amendment 228 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 229 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 23 #
Proposal for a directive Recital 6 a (new) (6a) The European Union should pay particular attention to tobacco production in less-favoured areas, especially in the outermost regions where it is frequently associated with specific environmental, geographical and socio-economic characteristics, using artisanal, eco- friendly methods, and the Union should allow the Member States to implement specific measures to ensure continued production in these areas, thereby safeguarding the corresponding jobs.
Amendment 230 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 231 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 232 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 233 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 234 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 235 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 236 #
Proposal for a directive Article 9 – paragraph 1 – point c c) cover
Amendment 237 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 238 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 239 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 24 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. Smoking is a current and global problem with devastating consequences, and adolescence is when most smokers start consuming tobacco.
Amendment 240 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 241 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 242 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 243 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 244 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 245 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 246 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 247 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 248 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 249 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the
Amendment 25 #
Proposal for a directive Recital 10 a (new) (10a) Polonium 210 has been shown to be a significant carcinogen in tobacco. Its presence in cigarettes could be eliminated almost completely by a combination of simple measures. It is thus appropriate to set a maximum yield for Polonium 210 that would result in a reduction of 95% of the current average content of Polonium 210 in cigarettes. An ISO standard to measure Polonium 210 in tobacco should be developed.
Amendment 250 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 251 #
Proposal for a directive Article 9 – paragraph 1 – point e e) be positioned
Amendment 252 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 253 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 254 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 255 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 256 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 257 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 258 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 259 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 26 #
Proposal for a directive Recital 11 Amendment 260 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 261 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 262 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 263 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than
Amendment 264 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than
Amendment 265 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii) width: not less than
Amendment 266 #
Proposal for a directive Article 9 – paragraph 1 – point g a (new) (ga) For the packaging of roll-your-own tobacco and for tobacco packagings with a surface larger than 75 cm2 in area the health warnings must occupy at least 22.5 cm2 of the surface. That area shall be increased to 24 cm2 for Member States with two official languages and 26.25 cm2 for Member States with three official languages.
Amendment 267 #
Proposal for a directive Article 9 – paragraph 3 Amendment 268 #
Proposal for a directive Article 9 – paragraph 3 Amendment 269 #
Proposal for a directive Article 9 – paragraph 3 Amendment 27 #
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, namely by taking into consideration scientific developments and internationally agreed standards for assessing their toxicity or addictiveness.
Amendment 270 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 271 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 272 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 273 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 274 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the position,
Amendment 275 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the
Amendment 276 #
Proposal for a directive Article 9 – paragraph 3 – point c (c) define the position,
Amendment 277 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 278 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 279 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 28 #
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 their toxicity or addictiveness, with their toxicity or addictiveness being assessed using the latest scientific findings and internationally agreed standards.
Amendment 280 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 281 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes and roll-your-own tobacco shall be exempted from the obligations
Amendment 282 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 1 Tobacco for smoking other than cigarettes and roll-your-own tobacco shall not be exempted from the obligations to carry the information message laid down in Article 8(2) and the combined health warnings in Article 9. In addition to the general warning specified in Article 8(1), each unit packet and any outside packaging of these products shall carry a text warning listed in Annex I. The general warning specified in Article 8(1) shall include a reference to the cessation services in accordance with Article 9(1)(b).The general warning specified in Article 8(1) shall include a reference to the cessation services in accordance with Article 9(1)(b).
Amendment 283 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general text warning shall be printed on the most visible surface of the unit packet and any outside packaging with the exception of transparent packaging used in retail sales. The text warnings listed in Annex I shall be rotated in such a way as to guarantee their regular appearance. These warnings shall be printed on the other most visible surface of the unit packet and any outside packaging with the exception of transparent packaging used in retail sales.
Amendment 284 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging. The text warnings listed in Annex I shall be rotated in such a
Amendment 285 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general warning shall be printed or irremovably affixed on the most visible surface of the unit packet and any outside packaging. The text warnings listed in Annex I shall be rotated in such a way as to guarantee their regular appearance. These warnings shall be printed or affixed on the other most visible surface of the unit packet and any outside packaging.
Amendment 286 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 a (new) Amendment 287 #
Proposal for a directive Article 10 – paragraph 2 2. The text warning referred to in paragraph 1 shall cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging, with the exception of transparent packaging used in retail sales. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.
Amendment 288 #
Proposal for a directive Article 10 – paragraph 3 – subparagraph 1 a (new) In the case of unit packets whose most visible surface exceeds 75 cm2, the warnings referred to in paragraphs 2 and 3 shall cover an area of at least 22.5 cm2 on each surface. That area shall be increased to 24 cm2 for Member States with two official languages and to 26.25 cm2 for Member States with three official languages.
Amendment 289 #
Proposal for a directive Article 10 – paragraph 3 a (new) 3a. However, in the case of unit packets intended for products other than cigarettes, the most visible surface of which exceeds 75 cm2, the warnings referred to in paragraph 2 shall cover an area of at least 22,5 cm2 on each surface. That area shall being creased to 24 cm2 for Member States with two official languages and 26,25 cm2 for Member States with three official languages.
Amendment 29 #
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.
Amendment 290 #
Proposal for a directive Article 10 – paragraph 4 – introductory part 4. The general text warning and the text warning referred to in paragraph 1 shall be:
Amendment 291 #
Proposal for a directive Article 10 – paragraph 4 a (new) 4a. For packaging with front and back surfaces larger than 75 cm2 in area the health warnings on both surfaces must occupy at least 22.5 cm2 of each surface. That area shall be increased to 24 cm2 for Member States with two official languages and 26.25 cm2 for Member States with three official languages.
Amendment 292 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. The warnings may be displayed by means of stickers, provided that such stickers cannot be removed. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible p
Amendment 293 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black
Amendment 294 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. Warnings may be affixed by means of stickers, provided that such stickers are not removable. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;
Amendment 295 #
Proposal for a directive Article 10 – paragraph 4 – point b (b) centred in the area in which they are required to be printed or affixed, parallel to the top edge of the unit packet and any outside packaging;
Amendment 296 #
Proposal for a directive Article 10 – paragraph 4 – point b (b) centred in the area in which they are required to be printed or irremovably affixed, parallel to the top edge of the unit packet and any outside packaging;
Amendment 297 #
Proposal for a directive Article 10 – paragraph 4 – point c (c) surrounded by a black border
Amendment 298 #
Proposal for a directive Article 10 – paragraph 5 Amendment 299 #
Proposal for a directive Article 10 – paragraph 5 Amendment 30 #
Proposal for a directive Recital 14 (14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additives integrated in the filter of cigarettes as well as additives colouring the tobacco smoke. Without harmonisation, the obstacles on the internal market are expected to increase in the coming years taking into account the implementation of the FCTC and its guidelines and considering experience gained in other jurisdictions outside the Union. It is thus appropriate to introduce a positive list of additives that may be used in tobacco products. The guidelines on Articles 9 and 10 FCTC call in particular for the removal of ingredients that increase palatability, create the impression that the tobacco products have health benefits, are associated with energy and vitality or have colouring properties.
Amendment 300 #
Proposal for a directive Article 10 – paragraph 5 Amendment 301 #
Proposal for a directive Article 10 – paragraph 5 Amendment 302 #
Proposal for a directive Article 10 – paragraph 5 Amendment 303 #
Proposal for a directive Article 10 – paragraph 5 Amendment 304 #
Proposal for a directive Article 10 – paragraph 5 Amendment 305 #
Proposal for a directive Article 10 – paragraph 5 Amendment 306 #
Proposal for a directive Article 11 – paragraph 2 – point a (a) be printed on the
Amendment 307 #
Proposal for a directive Article 11 – paragraph 2 – point a (a) be printed or affixed on the two largest surfaces of the unit packet and any outside packaging;
Amendment 308 #
Proposal for a directive Article 11 – paragraph 2 – point b (b) cover
Amendment 309 #
Proposal for a directive Article 11 – paragraph 3 Amendment 31 #
Proposal for a directive Recital 14 a (new) (14a) It is important not only to consider the properties of additives as such, but also of their combustion products. Additives as well as their combustion products should not meet the criteria for classification as hazardous in accordance with Regulation EC (No) 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Amendment 310 #
Proposal for a directive Article 11 – paragraph 3 Amendment 311 #
Proposal for a directive Article 11 – paragraph 3 Amendment 312 #
Proposal for a directive Article 11 – paragraph 3 Amendment 313 #
Proposal for a directive Article 11 – paragraph 3 Amendment 314 #
Proposal for a directive Article 12 – paragraph 1 Amendment 315 #
Proposal for a directive Article 12 – paragraph 1 – point a a (new) (aa) suggests that a particular tobacco product is less harmful than others, except in cases in which it can be scientifically demonstrated that the harmful effect is significantly less than that of tobacco products already available for purchase;
Amendment 316 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product
Amendment 317 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 318 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 319 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 32 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products,
Amendment 320 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 321 #
Proposal for a directive Article 12 – paragraph 1 a (new) 1a. The provision in paragraph 1 c will not apply to cigars and pipe tobacco;
Amendment 322 #
Proposal for a directive Article 12 – paragraph 2 Amendment 323 #
Proposal for a directive Article 12 – paragraph 2 2. Prohibited elements and features
Amendment 324 #
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
Amendment 325 #
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,
Amendment 326 #
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.
Amendment 327 #
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.
Amendment 328 #
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.
Amendment 329 #
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.
Amendment 33 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 330 #
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.
Amendment 331 #
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.
Amendment 332 #
Proposal for a directive Article 12 – paragraph 2 2.
Amendment 333 #
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.
Amendment 334 #
Proposal for a directive Article 12 – paragraph 2 a (new) 2a. Paragraph 2 shall not apply to trademarks that existed as at 19 December 2012.
Amendment 335 #
Proposal for a directive Article 13 Amendment 336 #
Proposal for a directive Article 13 Amendment 337 #
Proposal for a directive Article 13 – paragraph 1 Amendment 338 #
Proposal for a directive Article 13 – paragraph 1 Amendment 339 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape.
Amendment 34 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco or menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 340 #
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 or without a flap that covers the opening. The flap, if any, 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.
Amendment 341 #
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 cuboid or cylindrical shape, or 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
Amendment 342 #
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
Amendment 343 #
Proposal for a directive Article 13 – paragraph 2 Amendment 344 #
Proposal for a directive Article 13 – paragraph 2 Amendment 345 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than the flip-top lid. The flip-top lid, if any, of a cigarette packet shall be hinged only at the back of the packet.
Amendment 346 #
Proposal for a directive Article 13 – paragraph 2 a (new) 2a. All outer surfaces of the unit packet and any outside packaging of tobacco for smoking shall be standardised in the following way: (a) not contain any trade mark or any other mark, apart from the brand name and any variant name for the tobacco products; (b) be of a dark, unattractive colour set by the Commission; (c) the brand name, and any variant name shall: (i) not appear more than once on any one surface (ii) appear horizontally below, and in the same orientation as, the combined health warning, in the centre of the space remaining on the front and back surfaces of the unit packet and any outside packaging; (iii) comply with any more detailed rules set out in paragraph 3;
Amendment 347 #
Proposal for a directive Article 13 – paragraph 3 Amendment 348 #
Proposal for a directive Article 13 – paragraph 3 Amendment 349 #
Proposal for a directive Article 13 – paragraph 3 Amendment 35 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco or the traditional flavour of menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 350 #
Proposal for a directive Article 13 – paragraph 3 Amendment 351 #
Proposal for a directive Article 13 – paragraph 3 Amendment 352 #
Proposal for a directive Article 13 – paragraph 3 Amendment 353 #
Proposal for a directive Article 13 – paragraph 3 Amendment 354 #
Proposal for a directive Article 13 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to define more detailed rules for the
Amendment 355 #
Proposal for a directive Article 13 – paragraph 4 Amendment 356 #
Proposal for a directive Article 13 – paragraph 4 Amendment 357 #
Proposal for a directive Article 13 – paragraph 4 Amendment 358 #
Proposal for a directive Article 13 – paragraph 4 Amendment 359 #
Proposal for a directive Article 13 – paragraph 4 Amendment 36 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having
Amendment 360 #
Proposal for a directive Article 13 – paragraph 4 Amendment 361 #
Proposal for a directive Article 13 – paragraph 4 Amendment 362 #
Proposal for a directive Article 13 – paragraph 4 Amendment 363 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall ensure that all unit packets of tobacco products shall be marked with a unique, safe and impossible to duplicate 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.
Amendment 364 #
Proposal for a directive Article 14 – paragraph 2 – introductory part 2. The
Amendment 365 #
Proposal for a directive Article 14 – paragraph 2 – point j (j) the identity of all purchasers from manufacturing to the first
Amendment 366 #
Proposal for a directive Article 14 – paragraph 2 – point k (k) the invoice, order number and payment records of all purchasers from manufacturing to the first
Amendment 367 #
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
Amendment 368 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first
Amendment 369 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the
Amendment 37 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 370 #
Proposal for a directive Article 14 – paragraph 9 Amendment 371 #
Proposal for a directive Article 14 – paragraph 9 Amendment 372 #
Proposal for a directive Article 14 – paragraph 9 Amendment 373 #
Proposal for a directive Article 14 – paragraph 10 Amendment 374 #
Proposal for a directive Article 14 – paragraph 10 10. T
Amendment 375 #
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
Amendment 376 #
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
Amendment 377 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. This ban shall, however, not affect traditional tobacco products for oral use, which may be allowed by individual Member States.
Amendment 378 #
Proposal for a directive Article 15 – paragraph 1 Member States shall
Amendment 379 #
Proposal for a directive Article 15 – paragraph 1 a (new) The responsibility for regulating the content of snus shall lie with the Member State where the sale of snus is permitted in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden. Snus should therefore be exempt from the provisions of Article 6 of this Directive.
Amendment 38 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a
Amendment 380 #
Proposal for a directive Title II – chapter IV – title Amendment 382 #
Proposal for a directive Article 16 – title Amendment 383 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 384 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 385 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 386 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 387 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 388 #
Proposal for a directive Article 16 – paragraph 2 Amendment 389 #
Proposal for a directive Article 16 – paragraph 3 Amendment 39 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with
Amendment 390 #
Proposal for a directive Article 16 – paragraph 4 Amendment 391 #
Proposal for a directive Article 16 – paragraph 5 Amendment 392 #
Proposal for a directive Article 16 a (new) Article 16a Cross-border sales of tobacco products The maximum quantity of products imported from another Member State may be set for all tobacco products covered under this Directive. This ceiling shall be set by each Member States using the method of calculation which it regards as most appropriate (for example per person, per type of vehicle, an overall quantity covering several tobacco products).
Amendment 393 #
Proposal for a directive Article 16 a (new) Article 16a Point-of-sale displays of tobacco 1. Member States shall prohibit point-of- sale displays and vending machines of tobacco in their territory. 2. Tobacco products shall be completely concealed from the customer except during the purchase or sale of tobacco products, or stocktaking, restocking, staff training or maintenance of the storage unit. 3. Display of tobacco products for those reasons listed in paragraph 2 may only last as long as is necessary to complete those tasks. 4. Prices of tobacco products shall be listed in a standardised format. No package deals or special discounts shall be displayed.
Amendment 394 #
Proposal for a directive Article 16 a (new) Article 16a Cross-border distance sales of tobacco products Member States shall prohibit the cross- border distance sales of tobacco products.
Amendment 395 #
Proposal for a directive Article 17 – title Amendment 396 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and potentially lower-risk novel tobacco products
Amendment 397 #
Proposal for a directive Article 17 – paragraph 1 – introductory part 1. Member States shall conduct a market approval system for tobacco products with a lower risk which shall be carried out for a reasonable fee. Member States shall require that manufacturers and importers of tobacco products notify the competent authorities of Member States of any novel tobacco products and for all tobacco products with a lower risk they intend to place on the markets of the Member States concerned
Amendment 398 #
Proposal for a directive Article 17 – paragraph 1 – introductory part 1. Member States shall require that
Amendment 399 #
Proposal for a directive Article 17 – paragraph 1 – point a (a)
Amendment 40 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products sh
Amendment 400 #
Proposal for a directive Article 17 – paragraph 1 – point b (b) available studies and market research on the perception and use of the product including labelling by consumers as well as to the preferences of various consumer groups,
Amendment 401 #
Proposal for a directive Article 17 – paragraph 1 – point c Amendment 402 #
Proposal for a directive Article 17 – paragraph 2 2. Member States shall
Amendment 403 #
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. The new market authorisation procedure in the Member States shall stipulate the following: 1. scientific risk assessment, 2. empirical standards regarding evidence of health risks, 3. reduction of harmful substances in smoke, 4. compliance with the provisions of subparagraphs (a) to (c) of paragraph 1, 5. Post-marketing surveillance. Requirements in respect of labelling, text health warnings, product description, packaging, measuring, including methods for measuring tar, nicotine and carbon monoxide, as well as the additional ingredients used in reduced-risk tobacco products, shall also be included among the conditions for market authorisation in the Member States. 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
Amendment 404 #
Proposal for a directive Article 17 – paragraph 2 2. Member States shall require that manufacturers and importers of tobacco products inform their competent authorities
Amendment 405 #
Proposal for a directive Article 17 – paragraph 3 3.
Amendment 406 #
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. New tobacco products that have been scientifically proven to be less harmful than conventional tobacco products may, by way of derogation from the provisions of Article 12(1)(b), be labelled with information on their reduced harmfulness.
Amendment 407 #
Proposal for a directive Article 17 – paragraph 3 3.
Amendment 409 #
Proposal for a directive Article 18 Amendment 41 #
Proposal for a directive Recital 18 Amendment 410 #
Proposal for a directive Article 18 Amendment 411 #
Proposal for a directive Article 18 Amendment 413 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 414 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 415 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 416 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 417 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 418 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 419 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 42 #
Proposal for a directive Recital 18 (18)
Amendment 420 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 421 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 422 #
Proposal for a directive Article 18 – paragraph 1 – point b (b) products with a nicotine concentration exceeding 24 mg per ml or
Amendment 423 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 424 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 425 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 426 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. Member States shall introduce a ban on the use of nicotine-containing products in public places.
Amendment 427 #
Proposal for a directive Article 18 – paragraph 1 b (new) 1b. Member States shall introduce a minimum age for purchasing nicotine-containing products.
Amendment 428 #
Proposal for a directive Article 18 – paragraph 2 Amendment 429 #
Proposal for a directive Article 18 – paragraph 2 Amendment 43 #
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
Amendment 430 #
Proposal for a directive Article 18 – paragraph 2 Amendment 431 #
Proposal for a directive Article 18 – paragraph 2 Amendment 432 #
Proposal for a directive Article 18 – paragraph 3 – subparagraph 1 Amendment 433 #
Proposal for a directive Article 18 – paragraph 4 Amendment 434 #
Proposal for a directive Article 18 – paragraph 5 Amendment 435 #
Proposal for a directive Article 18 – paragraph 5 Amendment 436 #
Proposal for a directive Article 18 – paragraph 5 Amendment 437 #
Proposal for a directive Article 18 – paragraph 5 Amendment 438 #
Proposal for a directive Article 18 – paragraph 5 5. The Commission shall, b
Amendment 439 #
Proposal for a directive Article 18 a (new) Article 18a Nicotine-containing products Nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC.
Amendment 44 #
Proposal for a directive Recital 18 (18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco
Amendment 440 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than
Amendment 441 #
Proposal for a directive Article 22 – paragraph 1 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. Delegated acts may only be adopted in those cases where provision is expressly made in this Directive for such a delegation of power.
Amendment 442 #
Proposal for a directive Article 22 – paragraph 2 Amendment 443 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts
Amendment 444 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4),
Amendment 445 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 446 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 447 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts
Amendment 448 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4)
Amendment 449 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 45 #
Proposal for a directive Recital 19 (19) Disparities still exist between national provisions regarding the labelling of tobacco products, in particular with regard to the
Amendment 450 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 451 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall be conferred on the Commission for a
Amendment 452 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers
Amendment 453 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4),
Amendment 454 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 455 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 456 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 457 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 458 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of power
Amendment 459 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 46 #
Proposal for a directive Recital 20 (20) Such disparities are liable to constitute a barrier to trade and to impede the operation of the internal market in tobacco products, and should therefore be eliminated. Also, consumers in some Member States may be better informed about the health risks of tobacco products than in others. Without further harmonising action at Union level, the existing disparities are likely to increase in the coming years.
Amendment 460 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act
Amendment 461 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4),
Amendment 462 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 463 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 464 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 465 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 466 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 467 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4)
Amendment 468 #
Proposal for a directive Article 23 – paragraph 1 – subparagraph 1 No later than
Amendment 469 #
Proposal for a directive Article 24 – paragraph 2 Amendment 47 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others.
Amendment 470 #
Proposal for a directive Article 24 – paragraph 2 2.
Amendment 471 #
Proposal for a directive Article 24 – paragraph 3 Amendment 472 #
Proposal for a directive Article 24 – paragraph 3 3. This Directive shall not affect the right of Member States to maintain or introduce, in accordance with the Treaty, national provisions concerning aspects not regulated by this Directive. These national provisions must be justified by overriding reasons of public interest and be necessary and proportionate to their aim. They must not be a means of arbitrary discrimination or a disguised restriction on trade between the Member States
Amendment 473 #
Proposal for a directive Article 24 – paragraph 3 a (new) Amendment 474 #
Proposal for a directive Article 24 a (new) Article 24a Cooperation and support for the Member States This Directive shall be supplemented by EU support for the national health systems of the Member States, guaranteeing the public, universal and free nature of those systems, and they shall guarantee access to smoking cessation consultations and the corresponding treatments as part of their programmes.
Amendment 475 #
Proposal for a directive Article 26 – paragraph 1 – point a (a)
Amendment 476 #
Proposal for a directive Article 26 – paragraph 1 – point a (a)
Amendment 477 #
Proposal for a directive Article 26 – paragraph 1 – point b Amendment 478 #
Proposal for a directive Article 26 – paragraph 1 – point b Amendment 479 #
Proposal for a directive Article 26 – paragraph 1 – point b Amendment 48 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products
Amendment 480 #
Proposal for a directive Article 26 – paragraph 1 – point b (b) nicotine
Amendment 481 #
Proposal for a directive Article 26 – paragraph 1 a (new) Member States may allow nicotine containing 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 + 48 months]:
Amendment 482 #
Proposal for a directive Article 26 – paragraph 1 a (new) Member States may allow tobacco products other than cigarettes and roll- your-own tobacco, 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 + 42 months]:
Amendment 483 #
Proposal for a directive Article 28 – paragraph 1 This Directive shall not enter into force
Amendment 484 #
Proposal for a directive Annex - I (new) Annex -I Additives approved for use in tobacco products Chemical name of the additive - function - maximum level permitted
Amendment 49 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’,
Amendment 50 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package,
Amendment 51 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’,
Amendment 52 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’,
Amendment 53 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or other signs.
Amendment 54 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as
Amendment 55 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise
Amendment 56 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise
Amendment 57 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful.
Amendment 58 #
Proposal for a directive Recital 23 a (new) (23a) Studies have shown that standardising the presentation of the name of the trade mark and of the pack colour (plain packaging) makes packaging less attractive and enhances the effectiveness of health warnings, thereby decreasing smoking uptake and tobacco consumption. The guidelines on Articles 11 and 13 FCTC call on Parties to consider adopting plain packaging requirements.
Amendment 59 #
Proposal for a directive Recital 24 (24)
Amendment 60 #
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
Amendment 61 #
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 easy cost comparisons for the consumer and the free circulation of the concerned products.
Amendment 62 #
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
Amendment 63 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use38 prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition39 .
Amendment 64 #
Proposal for a directive Recital 29 a (new) (29a) Given the general prohibition of the sale of oral tobacco (snus) in the EU, there is no cross-border interest in regulating the content of snus. The responsibility for regulating the content of snus thus lies with the Member State where the sale of snus is permitted in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden. Snus should therefore be exempt from the provisions of Article 6 of this Directive.
Amendment 65 #
Proposal for a directive Recital 30 (30)
Amendment 66 #
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
Amendment 67 #
Proposal for a directive Recital 31 (31) All tobacco products have the potential to cause mortality, morbidity and disability and their manufacture, distribution and consumption should be
Amendment 68 #
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 States to ban or to authorise them. The Commission should monitor the development and submit a report
Amendment 69 #
Proposal for a directive Recital 34 Amendment 70 #
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 use
Amendment 71 #
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
Amendment 72 #
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.
Amendment 73 #
Proposal for a directive Recital 35 Amendment 74 #
Proposal for a directive Recital 35 Amendment 75 #
Proposal for a directive Recital 35 (35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directive, explicitly drawing the attention of consumers to potential health risks.
Amendment 76 #
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,
Amendment 77 #
Proposal for a directive Recital 38 Amendment 78 #
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
Amendment 79 #
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
Amendment 80 #
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
Amendment 81 #
Proposal for a directive Recital 38 (38)
Amendment 82 #
Proposal for a directive Recital 39 (39) The Commission should monitor the developments and submit a report
Amendment 83 #
Proposal for a directive Recital 39 a (new) (39a) Emphasis is placed on the importance and responsibility of the Member States in protecting public health and taking preventive action, providing public guarantees, monitoring and advice for young people, and carrying out preventive public anti-smoking campaigns, particularly in schools; universal free access to smoking cessation consultations and the corresponding treatments is considered vital.
Amendment 84 #
Proposal for a directive Recital 40 (40)
Amendment 85 #
Proposal for a directive Recital 40 (40)
Amendment 86 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all
Amendment 87 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More
Amendment 88 #
Proposal for a directive Recital 40 a (new) (40a) This Directive takes a very comprehensive approach to creating uniform rules for the manufacture, presentation and sale of tobacco products and similar products. Many of the rules in the Directive enter the area of fundamental rights. In order to allay concerns regarding legal certainty, Member States should not be allowed to adopt any provisions that diverge from the labelling and packaging requirements standardised in this Directive.
Amendment 89 #
Proposal for a directive Recital 40 a (new) (40a) A Member State that deems it necessary to maintain and/or introduce national and/or regional provisions geared to preserving traditional tobacco plantations, for justified reasons relating to the socio-economic dependence of local communities, should be allowed to do so.
Amendment 90 #
Proposal for a directive Recital 41 (41) Member States should remain free to
Amendment 91 #
Proposal for a directive Recital 41 (41) Member States should
Amendment 92 #
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.
Amendment 93 #
Proposal for a directive Recital 41 a (new) (41a) Member States should supplement the legislative provisions of this Directive with any measures that are useful to help protect the health of European citizens. The gradual harmonisation of the taxation of tobacco products in the Union and information campaigns in the media and for young people in educational institutions are two essential tools in combating the dangers of smoking among young people.
Amendment 94 #
Proposal for a directive Recital 41 a (new) (41a) If tobacco products or similar products comply with the requirements of this Directive, Member States may not prohibit or unreasonably restrict the import, sale or consumption of these products. Manufacturers must retain the safeguard of a certain minimum level of legal certainty.
Amendment 95 #
Proposal for a directive Recital 41 b (new) (41b) The Member States should cover the health costs related to tobacco consumption by a tax levied directly on tobacco products;
Amendment 96 #
Proposal for a directive Recital 42 (42) Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data45. National data protection provisions must also be taken into account.
Amendment 97 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the Charter of Fundamental Rights of the European Union, notably the protection of personal data (Article 8), the freedom of expression and information (Article 11), freedom of economic operators to conduct business (Article 16), and the right to property (Article 17).
Amendment 98 #
Proposal for a directive Article 1 – paragraph 1 – subparagraph 1 a (new) This Directive shall not apply to snus in Sweden, in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden.
Amendment 99 #
Proposal for a directive Article 2 – paragraph 1 – point 2 (2)
source: PE-510.829
2013/05/29
INTA
330 amendments...
Amendment 10 #
Proposal for a directive Recital 12 a (new) (12a) Child labour is still a persisting feature of tobacco production. The increasing awareness of consumers about health and human rights problems related to production and processing methods equally require an improved tracking, tracing and reporting system with a view to identify the origin and the conditions under which tobacco was harvested and to give consumers the choice to choose tobacco produced without child labour and children exposed to toxic dangers;
Amendment 100 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products other than nasal tobacco shall be exempted from the prohibitions laid down in paragraphs 1 and 5.
Amendment 100 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 101 #
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.
Amendment 101 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products
Amendment 102 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
Amendment 102 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising
Amendment 103 #
Proposal for a directive Article 7 – paragraph 7 a (new) 7a. Unit packages should also carry traceable information on the place of harvest of the tobacco used, with a view to identify whether it was produced on the basis of child labour.
Amendment 103 #
Proposal for a directive Recital 15 – footnote 36 Amendment 104 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets
Amendment 104 #
Proposal for a directive Recital 16 Amendment 105 #
Proposal for a directive Article 8 – paragraph 3 3. For cigarette packets the general warning and the information message shall
Amendment 105 #
Proposal for a directive Recital 16 (16) The
Amendment 106 #
Proposal for a directive Article 8 – paragraph 4 Amendment 106 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with
Amendment 107 #
Proposal for a directive Article 8 – paragraph 4 Amendment 107 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual
Amendment 108 #
Proposal for a directive Article 9 – paragraph 1 – introductory part 1. Each unit packet and any outside packaging of tobacco for smoking shall carry combined health warnings
Amendment 108 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products sh
Amendment 109 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 109 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives
Amendment 11 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received.
Amendment 110 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 110 #
Proposal for a directive Recital 16 a (new) Amendment 111 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 111 #
Proposal for a directive Recital 16 b (new) (16 b) One of the aims of this Directive is to reduce the consumption of tobacco products, especially among young and vulnerable consumers, which will result in the decrease of the production of the tobacco in the Union and can lead to loss of jobs, moving the industry outside the Union and need to restructure the farms traditionally basing its production on tobacco. Therefore appropriate measures and financial support must be envisaged in the framework of the Union budget in order to counteract the economic and social consequences of this Directive.
Amendment 112 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 112 #
Proposal for a directive Recital 16 c (new) (16 c) The implementation of the Directive’s provisions could lead to a reduction in demand for raw tobacco originating in EU Member States. A support fund for tobacco growers should therefore be established in regions where tobacco is grown in order to compensate growers for the losses that they incur as a consequence of the Directive’s implementation.
Amendment 113 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 113 #
Proposal for a directive Recital 17 Amendment 114 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging; Member States are, however, encouraged to proceed with plain packaging;
Amendment 114 #
Proposal for a directive Recital 17 (17) Certain additives are used to create the impression that tobacco products have health benefits, present reduced health hazards or increase mental alertness and physical performance.
Amendment 115 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned at the botto
Amendment 115 #
Proposal for a directive Recital 17 (17) Certain additives are used to create the impression that tobacco products have health benefits, present reduced health hazards or increase mental alertness and physical performance. Other additives such as sugar are used to mitigate or to improve the flavour and taste of tobacco products in order to enable easier consumption. These additives should be prohibited in order to ensure uniform rules and a high level of health protection.
Amendment 116 #
Proposal for a directive Article 9 – paragraph 1 – point e (e) be positioned
Amendment 116 #
Proposal for a directive Recital 17 a (new) (17 a) An increasing number of people, most of them being children, suffer from asthma and various allergies. Not all causes of asthma are understood, as indicated by WHO, but risk factors including allergens, tobacco and chemical irritants need to be prevented to enable people to enjoy a good quality of life.
Amendment 117 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 117 #
Proposal for a directive Recital 17 b (new) (17 b) The Commission should carefully monitor the addition of sugar substances which constitutes more than 10% of the total amount of additives in cigarettes. The Commission should, in particular, ask the industry to reformulate tobacco products in order to manufacture new products free of inverted sugar (fructose and glucose) which have hazardous effects on health.
Amendment 118 #
Proposal for a directive Article 9 – paragraph 1 – point g Amendment 118 #
Proposal for a directive Recital 18 Amendment 119 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i Amendment 119 #
Proposal for a directive Recital 18 Amendment 12 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to
Amendment 120 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height: not less than
Amendment 120 #
Proposal for a directive Recital 18 Amendment 121 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii Amendment 121 #
Proposal for a directive Recital 18 Amendment 122 #
Proposal for a directive Article 9 – paragraph 3 Amendment 122 #
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
Amendment 123 #
Proposal for a directive Article 9 – paragraph 3 Amendment 123 #
Proposal for a directive Recital 18 (18) Considering that the Directive
Amendment 124 #
Proposal for a directive Article 9 – paragraph 3 Amendment 124 #
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. The Commission should carefully monitor the use of water-pipe tobacco by young people as there is increasing evidence of their use beyond the traditional, older market. In this regard, articles 6 and 10 should apply to those products and health warnings be placed on packets of chicha tobacco which often do not comply with the European legislation.
Amendment 125 #
Proposal for a directive Article 9 – paragraph 3 – point d Amendment 125 #
Proposal for a directive Recital 18 (18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco, water- pipe 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.
Amendment 126 #
Proposal for a directive Article 10 – paragraph 1 – subparagraph 2 The general warning shall be printed or affixed by means of non-removable stickers on the most visible surface of the unit packet and any outside packaging. The text warnings listed in Annex I shall be rotated in such a way as to guarantee their regular appearance. These warnings shall
Amendment 126 #
Proposal for a directive Recital 18 (18) Considering the Directive’s focus on young people, tobacco products other than cigarettes, roll-your-own tobacco, water- pipe 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.
Amendment 127 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black
Amendment 127 #
Proposal for a directive Recital 18 (18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco, tobacco for water pipes 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.
Amendment 128 #
Proposal for a directive Article 10 – paragraph 4 – point a (a)
Amendment 128 #
Proposal for a directive Recital 18 a (new) (18a) Member States should be encouraged, if they have not already done so, to formulate their national laws on the protection of young people in such a way that tobacco products may not be sold to, and consumed by, young people under the age of 18; Member States should also ensure that these prohibitions are respected;
Amendment 129 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. The general warning could be shown using self-adhesive paper provided that they cannot be removed. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;
Amendment 129 #
Proposal for a directive Recital 18 b (new) (18 b) The FCTC in article 16 points to the responsibility of Parties to the Convention to address products aimed at underage consumers, such as food products and toys in the form of tobacco products that may be appealing to minors. In recent years, several products, such as shisha vaping sticks, have been placed on the market that do not contain nicotine but have the form of cigarettes and try to imitate the smoking process through vaporising substances, the harmless nature of which is not yet scientifically proven, and through an electric light imitating the burning process of a cigarette. Such products are clearly produced to be appealing to young and underage consumers, and are increasingly popular by minors in several Member States. Increasing concern is expressed at the habits created by young consumers and minors by the use of such imitation cigarettes. Therefore, these products should be prohibited through this directive.
Amendment 13 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. In this light there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information should be ensured for the general public, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products and fulfils the Union’s international obligations contained in the WTO treaties.
Amendment 130 #
Proposal for a directive Article 10 – paragraph 4 – point a (a) printed in black Helvetica bold type on a white background. The warnings may be attached in adhesive form, provided that they cannot be removed. In order to accommodate language requirements, Member States may determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required;
Amendment 130 #
Proposal for a directive Recital 19 (19) Disparities still exist between national provisions regarding the labelling of tobacco products, in particular with regard to the use of combined health warnings consisting of a picture and a text, which only 10 Member States had brought in by 2013, information on cessation services and promotional elements in and on packets.
Amendment 131 #
Proposal for a directive Article 10 – paragraph 4 – point b (b) centred in the area in which they are required to
Amendment 131 #
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.
Amendment 132 #
Proposal for a directive Article 10 – paragraph 5 Amendment 132 #
Proposal for a directive Recital 21 (21) Adaptation of the labelling provisions is also necessary to align the rules at Union level with international developments.
Amendment 133 #
Proposal for a directive Article 10 – paragraph 5 Amendment 133 #
Proposal for a directive Recital 21 (21) Adaptation of the labelling provisions is also necessary to align the rules at Union level with international developments. For example the guidelines on Article 11 FCTC call for
Amendment 134 #
Proposal for a directive Article 10 – paragraph 5 Amendment 134 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar,
Amendment 135 #
Proposal for a directive Article 10 – paragraph 5 Amendment 135 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others.
Amendment 136 #
Proposal for a directive Article 10 – paragraph 5 Amendment 136 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets ha
Amendment 137 #
Proposal for a directive Article 11 – paragraph 1 This tobacco product
Amendment 137 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined health warnings with both clear pictorial and text warnings are more effective than text-only warnings. In this light combined health warnings should become mandatory throughout the Union and cover significant and visible parts of the packet surface. A minimum size should be set for all health warnings to ensure their visibility and effectiveness.
Amendment 138 #
Proposal for a directive Article 11 – paragraph 2 – point b (b) cover
Amendment 138 #
Proposal for a directive Recital 22 a (new) Amendment 139 #
Proposal for a directive Article 11 – paragraph 3 Amendment 139 #
Proposal for a directive Recital 23 Amendment 14 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a
Amendment 140 #
Proposal for a directive Article 11 – paragraph 3 Amendment 140 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The
Amendment 141 #
Proposal for a directive Article 12 – paragraph 1 Amendment 141 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products
Amendment 142 #
Proposal for a directive Article 12 – paragraph 1 – point a a (new) (aa) suggests that a particular tobacco product is less harmful than others, except in cases in which it can be scientifically demonstrated that the harmful effect is significantly less than that of tobacco products already available for purchase;
Amendment 142 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’,
Amendment 143 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product
Amendment 143 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as
Amendment 144 #
Proposal for a directive Article 12 – paragraph 1 – point c Amendment 144 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package
Amendment 145 #
Proposal for a directive Article 12 – paragraph 1 – point d a (new) (da) refers to technical features aiming to reduce some harmful components of smoke or increase the biodegradability of tobacco products.
Amendment 145 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the
Amendment 146 #
Proposal for a directive Article 12 – paragraph 2 Amendment 146 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The
Amendment 147 #
Proposal for a directive Article 12 – paragraph 2 Amendment 147 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful.
Amendment 148 #
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,
Amendment 148 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’,
Amendment 149 #
Proposal for a directive Article 12 – paragraph 2 2. Prohibited elements and features
Amendment 149 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed through the appropriate packaging and labelling of such products and through informing consumers of their harmfulness, so that the consumer is fully aware of the consequences of using a given product.
Amendment 15 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco and menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 150 #
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.
Amendment 150 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features that appear on packaging, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without flavours’, 'slim', names, pictures, and figurative or other signs.
Amendment 151 #
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.
Amendment 151 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package
Amendment 152 #
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.
Amendment 152 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the d
Amendment 153 #
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, inserts, scratch-offs and sleeves or relate to the shape of the tobacco product itself.
Amendment 153 #
Proposal for a directive Recital 23 a (new) (23a) Tobacco products have been shown to contain and emit many noxious substances and known carcinogens hazardous to human health when burnt. Scientific studies have clearly proven that passive smoking is a cause of death, illness and disability and that passive smoking is dangerous in particular to unborn children and infants. It can cause or aggravate respiratory problems in persons inhaling smoke. The health warnings should therefore also draw attention to the dangers to health of passive smoking.
Amendment 154 #
Proposal for a directive Article 13 Amendment 154 #
Proposal for a directive Recital 23 b (new) (23 b) Studies have shown that standardising the presentation of the name of the trade mark and of the pack colour (plain packaging) makes packaging less attractive and enhances the effectiveness of health warnings, thereby decreasing smoking uptake and tobacco consumption. The guidelines on Articles 11 and 13 FCTC call on Parties to consider adopting plain packaging requirements.
Amendment 155 #
Proposal for a directive Article 13 Amendment 156 #
Proposal for a directive Article 13 – paragraph 1 Amendment 157 #
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 or without a flap that covers the opening. The flap, if any, 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.
Amendment 158 #
Proposal for a directive Article 13 – paragraph 2 Amendment 159 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall not contain an opening that can be re-closed or re-sealed after the opening is first opened, other than the flip-top lid. The flip-top lid, if any, of a cigarette packet shall be hinged only at the back of the packet.
Amendment 16 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 160 #
Proposal for a directive Article 13 – paragraph 3 Amendment 161 #
Proposal for a directive Article 13 – paragraph 3 Amendment 162 #
Proposal for a directive Article 13 – paragraph 3 Amendment 163 #
Proposal for a directive Article 13 – paragraph 3 Amendment 164 #
Proposal for a directive Article 13 – paragraph 3 Amendment 165 #
Proposal for a directive Article 13 – paragraph 4 Amendment 166 #
Proposal for a directive Article 13 – paragraph 4 Amendment 167 #
Proposal for a directive Article 13 – paragraph 4 Amendment 168 #
Proposal for a directive Article 13 – paragraph 4 Amendment 169 #
Proposal for a directive Article 13 – paragraph 4 Amendment 17 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 170 #
Proposal for a directive Article 14 – paragraph 1 1. Member States shall
Amendment 171 #
Proposal for a directive Article 14 – paragraph 1 1. In order to enable effective monitoring and identification, Member States shall ensure that all unit packets of tobacco products, including all outside packaging, shall be marked with a unique identifi
Amendment 172 #
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.
Amendment 173 #
Proposal for a directive Article 14 – paragraph 2 – point a (new) (a) the place of origin of the tobacco used; as well as health and human rights conditions under which it was harvested (in particular child labour rate);
Amendment 174 #
Proposal for a directive Article 14 – paragraph 2 – point e (e) the product name and description;
Amendment 175 #
Proposal for a directive Article 14 – paragraph 2 – point g (g) the intended shipment route, the shipment date, shipment destination, point of departure and consignee;
Amendment 176 #
Proposal for a directive Article 14 – paragraph 2 – point g (g) the intended shipment route
Amendment 177 #
Proposal for a directive Article 14 – paragraph 3 3. Member States shall
Amendment 178 #
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.
Amendment 179 #
Proposal for a directive Article 14 – paragraph 3 a (new) 3a. Member States shall ensure, in accordance with the Seoul Protocol to Eliminate Illicit Trade in Tobacco Products, that the technology used for tracking and tracing should belong to economic entities without any legal or commercial link to the tobacco industry in the supply chain.
Amendment 18 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 180 #
Proposal for a directive Article 14 – paragraph 4 Amendment 181 #
Proposal for a directive Article 14 – paragraph 5 5. Recorded data cannot be modified or deleted by any economic operator involved in the trade of tobacco products, but the economic operator that introduced the data and other economic operators directly concerned by the transaction such as the supplier or the recipient can comment on previously introduced data. The economic operator concerned shall add the correct data and a reference to the previous entry
Amendment 182 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 183 #
Proposal for a directive Article 14 – paragraph 6 6. Member States shall
Amendment 184 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form, including through tax stamps and price marks, or other elements mandated by legislation. Member States may combine their national fiscal marking with the tamper-proof security feature, provided that it complies with the technical specifications mentioned into this paragraph.
Amendment 185 #
Proposal for a directive Article 14 – paragraph 9 Amendment 186 #
Proposal for a directive Article 14 – paragraph 9 Amendment 187 #
Proposal for a directive Article 14 – paragraph 9 – introductory part 9. The Commission shall be empowered, taking into account existing practices, technologies and commercial practicalities as well as global standards for tracking and tracing and authentication of fast-moving consumer goods and relevant requirements under the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, to adopt delegated acts in accordance with Article 22:
Amendment 188 #
Proposal for a directive Title 2 – chapter 3 – title Amendment 189 #
Proposal for a directive Article 15 a (new) Article 15 a Member States shall set maximum limits for toxic or carcinogenic substances present in smokeless tobacco products placed on the market.
Amendment 19 #
Proposal for a directive Recital 16 a (new) Amendment 190 #
Proposal for a directive Article 15 – paragraph 1 Amendment 191 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 192 #
Proposal for a directive Article 16 – paragraph 1 – introductory part 1. Member States shall
Amendment 193 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 194 #
Proposal for a directive Article 16 – paragraph 1 – point a Amendment 195 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 196 #
Proposal for a directive Article 16 – paragraph 1 – point b Amendment 197 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 198 #
Proposal for a directive Article 16 – paragraph 1 – point c Amendment 199 #
Proposal for a directive Article 16 – paragraph 1 a (new) 1a. Cross-border sales of cigarettes and roll-your-own tobacco, including via the Internet, shall be prohibited in the Union; Internet sales of other tobacco products and related nicotine-containing products shall be subject to more stringent monitoring by the Union and the Member States.
Amendment 20 #
Proposal for a directive Recital 18 Amendment 200 #
Proposal for a directive Article 16 – paragraph 1 b (new) 1b. It shall continue to be possible for Member States, on grounds of overriding needs relating to the protection of public health, to impose restrictions on imports of tobacco for personal use. Such restrictions shall be possible, in particular, where there is a significant difference of price between products of different geographic origins or if the health warnings are not in the official language(s) of the country where the product is purchased.
Amendment 201 #
Proposal for a directive Article 16 – paragraph 1 c (new) 1c. Member States shall prohibit retail outlets established on their territory from distributing free or discounted tobacco products through cross-border distance channels or through any other channel.
Amendment 202 #
Proposal for a directive Article 16 – paragraph 2 Amendment 203 #
Proposal for a directive Article 16 – paragraph 2 Amendment 204 #
Proposal for a directive Article 16 – paragraph 3 Amendment 205 #
Proposal for a directive Article 16 – paragraph 3 Amendment 206 #
Proposal for a directive Article 16 – paragraph 4 Amendment 207 #
Proposal for a directive Article 16 – paragraph 4 Amendment 208 #
Proposal for a directive Article 16 – paragraph 5 Amendment 209 #
Proposal for a directive Article 16 – paragraph 5 Amendment 21 #
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 other than nasal 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.
Amendment 210 #
Proposal for a directive Article 17 – title Notification of novel tobacco products and potentially lower-risk novel tobacco products
Amendment 211 #
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 which they intend to place on the markets of the Member States concerned and which, on the basis of substantial scientific evidence, they intend to make the subject of a claim that it is less harmful, or constitutes a lower risk, than conventional tobacco products. 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:
Amendment 212 #
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
Amendment 213 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 214 #
Proposal for a directive Article 18 – paragraph 1 – point a Amendment 215 #
Proposal for a directive Article 18 – paragraph 1 – point b Amendment 216 #
Proposal for a directive Article 18 – paragraph 1 – point b (b) products with a nicotine concentration exceeding 24 mg per ml or
Amendment 217 #
Proposal for a directive Article 18 – paragraph 1 – point c Amendment 218 #
Proposal for a directive Article 18 – paragraph 2 Amendment 219 #
Proposal for a directive Article 18 – paragraph 5 Amendment 22 #
Proposal for a directive Recital 22 (22) The labelling provisions also need to be adapted to new scientific evidence. For example the indication of the yields for tar, nicotine and carbon monoxide on cigarette packets have proven to be misleading as it makes consumers believe that certain cigarettes are less harmful than others.
Amendment 220 #
Proposal for a directive Article 18 – paragraph 5 Amendment 221 #
Proposal for a directive Article 18 – paragraph 5 5. The Commission shall, b
Amendment 222 #
Proposal for a directive Article 19 – paragraph 3 3. The health warning shall comply with the requirements laid down in Article 10(4). It shall cover not less than
Amendment 223 #
Proposal for a directive Article 22 Amendment 224 #
Proposal for a directive Article 22 – paragraph 1 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. Delegated acts may be adopted only in those cases where provision is expressly made in this Directive for such a delegation of power.
Amendment 225 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts
Amendment 226 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers
Amendment 227 #
Proposal for a directive Article 22 – paragraph 5 5. . A delegated act
Amendment 228 #
Proposal for a directive Article 24 – paragraph 2 Amendment 229 #
Proposal for a directive Article 24 – paragraph 2 2. However, a Member State
Amendment 23 #
Proposal for a directive Recital 23 Amendment 230 #
Proposal for a directive Article 24 – paragraph 2 2. However, a Member State may maintain
Amendment 231 #
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
Amendment 232 #
Proposal for a directive Article 24 – paragraph 3 3. This Directive shall not affect the right of Member States to maintain or introduce, in accordance with the Treaty, national provisions concerning aspects not regulated by this Directive. These national provisions must be justified by overriding reasons of public interest and be necessary and proportionate to their aim. They must
Amendment 233 #
Proposal for a directive Article 24 – paragraph 3 a (new) 3a. This Directive shall under no circumstances affect the right of Member States to adopt more stringent rules, provided they are essential for the protection of public health and do not go disproportionately further than the standards laid down in, or fall outside the scope of, this Directive.
Amendment 234 #
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 +
Amendment 235 #
Proposal for a directive Article 26 – paragraph 1 – point a (a)
Amendment 24 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products
Amendment 25 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’
Amendment 26 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’, ‘slim’, names, pictures, and figurative or other signs.
Amendment 27 #
Proposal for a directive Recital 23 (23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package,
Amendment 28 #
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
Amendment 29 #
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 the illegal trafficking of tobacco and tobacco products can be combated, particularly along the external borders of the Union but also from non-EU countries; and so that their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security
Amendment 30 #
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
Amendment 31 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use38 prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition39. Upholds the ban on tobacco products for oral use, however, such a ban should not affect historically traditional smokeless tobacco products, which may be allowed by individual Member States. The prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive, has adverse health effects and is attractive to young people. For other smokeless tobacco products that are not produced for the mass market, a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use.
Amendment 32 #
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.
Amendment 33 #
Proposal for a directive Recital 30 (30) Cross-border distance sales of tobacco products as well as free promotional or discounted distribution of tobacco products 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.
Amendment 34 #
Proposal for a directive Recital 30 (30)
Amendment 35 #
Proposal for a directive Recital 30 a (new) (30a) The Commission and the Member States must increase their efforts to improve, under their agreements with non-EU countries, the checking, prevention and suppression of illegal employment in the tobacco sector.
Amendment 36 #
Proposal for a directive Recital 31 (31) All tobacco products have the potential to cause mortality, morbidity and disability and their sale and consumption should be contained, in particular by means of education and prevention from taking up the habit of smoking. It is therefore important to monitor developments as regards n
Amendment 37 #
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
Amendment 38 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for
Amendment 39 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved
Amendment 4 #
Proposal for a directive Recital 4 (4) In other areas there are still substantial differences between the Member States’ laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This applies in particular to nicotine containing products, herbal products for smoking, ingredients and emissions, certain aspects of labelling and packaging and the cross-border
Amendment 40 #
Proposal for a directive Recital 40 (40) A Member State that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this Directive should be allowed to do so, for all products alike, on grounds of overriding needs relating to the protection of public health. A Member State should also be allowed to introduce more stringent provisions, applying to all products alike, on grounds relating to the specific situation of this Member State and provided the provisions are justified by the need to protect public health. More stringent national provisions should be necessary and proportionate, not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States and consistent with WTO international obligations. Stricter national provisions require prior notification to, and approval from, the Commission taking into account the high level of health protection achieved through this Directive.
Amendment 41 #
Proposal for a directive Recital 40 a (new) (40a) This Directive lays down very comprehensive uniform rules governing the manufacture, design and marketing of tobacco products and similar products. Many of its provisions encroach on fundamental rights. In the interests of legal certainty, Member States should not be allowed to adopt provisions which depart from any of the labelling and packaging requirements laid down in this Directive.
Amendment 42 #
Proposal for a directive Recital 40 a (new) (40a) A Member State that deems it necessary to maintain and/or introduce national and/or regional provisions geared to preserving traditional tobacco plantations, for justified reasons relating to the socio-economic dependence of local communities, should be allowed to do so.
Amendment 43 #
Proposal for a directive Recital 41 (41) Member States should remain free to maintain or introduce national legislations applying to
Amendment 44 #
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
Amendment 45 #
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
Amendment 46 #
Proposal for a directive Recital 41 a (new) (41a) Accordingly, Member States shall supplement the legal provisions of this Directive with any measures to protect the health of European citizens. Member States which benefit substantially from taxes and duties on the production and sale of tobacco might, for example, be urged to use this revenue to finance prevention and information campaigns in the media and targeting young people and schools.
Amendment 47 #
Proposal for a directive Recital 41 a (new) (41a) The provisions mentioned in the Directive are justified and consistent with intellectual property rights as enshrined in TRIPS, as the TRIPS aim, which is to guarantee distinction between brands and protect against undue use of trademarks, is maintained.
Amendment 48 #
Proposal for a directive Recital 41 a (new) (41a) If tobacco products or similar products comply with the requirements of this Directive, Member States may not prohibit or unreasonably restrict the import, sale or consumption of these products. Manufacturers must continue to enjoy the safeguard of a minimum level of legal certainty.
Amendment 49 #
Proposal for a directive Recital 42 (42) Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. National data protection provisions must also be taken into account.
Amendment 5 #
Proposal for a directive Recital 4 (4) In other areas there are still substantial differences between the Member States’ laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are
Amendment 50 #
Proposal for a directive Recital 43 a (new) (43a) This Directive should not lead to deterioration in the living conditions of people whose livelihoods depend on tobacco growing in Europe and who often live in disadvantaged areas. Given that the aim of the Directive is solely to discourage consumption of tobacco products, any decisions concerning ingredients and additives should take due account of the possible socioeconomic repercussions for groups whose livelihoods depend on tobacco growing. The European tobacco growing sector should be protected because it accounts for only a very small proportion of consumption in the EU and, at the same time, contributes to the economic stability of certain European regions where the range of alternative crops is limited. A decrease in or an end to tobacco growing in the EU would have no impact on consumption levels, but would lead to an increase in imports from third countries and a reduction in quality standards.
Amendment 51 #
Proposal for a directive Recital 45 (45) The proposal affects several fundamental rights as laid down in the
Amendment 52 #
Proposal for a directive Article 1 – paragraph 1 – point b (b) the labelling and packaging of tobacco products including
Amendment 53 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 54 #
Proposal for a directive Article 1 – paragraph 1 – point d (d) the prohibition of cross-border distance sales of tobacco products;
Amendment 55 #
Proposal for a directive Article 1 – paragraph 1 – point d (d)
Amendment 56 #
Proposal for a directive Article 1 – paragraph 1 – point f a (new) (fa) the requirement to implement a system, outside the control of the tobacco industry, for the tracking and tracing of tobacco products, in order to secure the supply chain and assist in the detection, prevention and punishment of illicit trade;
Amendment 57 #
Proposal for a directive Article 2 – paragraph 1 – point 2 a (new) (2a) ‘essential additive’ means an ingredient which is indispensable for the manufacturing of a tobacco products;
Amendment 57 #
The European Parliament rejects the Commission proposal.
Amendment 58 #
Proposal for a directive Article 2 – paragraph 1 – point 3 Amendment 58 #
Proposal for a directive Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof and Article 168 thereof in relation to Article 16 of this Directive,
Amendment 59 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 59 #
Proposal for a directive Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168 thereof,
Amendment 6 #
Proposal for a directive Recital 6 (6) The size of the internal market in tobacco and related products, the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the Union in only a small number of production plants within the Member States and the resulting significant cross-border trade of tobacco and related products calls for stronger legislative action at Union
Amendment 60 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco and traditional flavours such as menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 60 #
Proposal for a directive Recital 1 (1) Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products lays down rules at Union level concerning tobacco products. Due to scientific, market and international developments, including the improved availability on the market of e-cigarettes, substantial changes are to be made to that Directive. For the sake of clarity it is appropriate to repeal Directive 2001/37/EC and to replace it by a new Directive.
Amendment 61 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 61 #
Proposal for a directive Recital 2 (2) In its reports of 2005 and 2007 on the application of Directive 2001/37/EC, submitted in accordance with Article 11 of that Directive, the Commission identified areas in which further action was considered useful. In 2008 and 2010 the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) provided scientific advice to the Commission on smokeless tobacco products and tobacco
Amendment 62 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘
Amendment 62 #
Proposal for a directive Recital 3 a (new) (3a) Health warning serves as a part of an organised, effective and long term anti- smoking strategy, with well defined scope and objectives.
Amendment 63 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distinguishable aroma or taste other than tobacco or menthol, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, candy
Amendment 63 #
Proposal for a directive Recital 4 (4) In other areas there are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco and related products which impede the functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This applies in particular to nicotine containing products, herbal products for smoking, ingredients and emissions, certain aspects of labelling and packaging
Amendment 64 #
Proposal for a directive Article 2 – paragraph 1 – point 4 (4) ‘characterising flavour’ means a distin
Amendment 64 #
Proposal for a directive Recital 6 (6) The size of the internal market in tobacco and related products, the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the Union in only a small number of production plants within the Member States and the resulting significant cross-border trade, including internet sales, of tobacco and related products calls for legislative action at Union rather than national level to achieve the smooth operation of the internal market
Amendment 65 #
Proposal for a directive Article 2 – paragraph 1 – point 6 (6) ‘cigar’ or ‘cigarillo’ means a roll of tobacco consumed via a combustion process including a small type of cigar with a diameter of up to 8 mm and further defined in Article 4(1) of Council Directive 2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to manufactured tobacco46 ;
Amendment 65 #
Proposal for a directive Recital 6 a (new) (6a) Tobacco production in disadvantaged areas, especially the outermost regions, which is often associated with specific environmental, geographical and cultural conditions and craft-based, environmentally-friendly methods, should receive special attention from the EU, which should allow the Member State the possibility of applying specific measures to maintain production in these regions.
Amendment 66 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 66 #
Proposal for a directive Recital 6 b (new) (6b) At the same time, it is essential that the principles or guidelines of the ‘Small Business Act’ are also taken into account in this Directive;
Amendment 67 #
Proposal for a directive Article 2 – paragraph 1 – point 8 Amendment 67 #
Proposal for a directive Recital 7 a (new) (7a) When taking legislative action, however, it is also necessary to take into account the results of recent studies showing the loss of around EUR 12 billion in tax revenue in the EU as a result of illicit trade in tobacco products, and that legal trade in cigarettes is declining while illicit trade currently accounts for around 10% of the EU-wide tobacco market, and 30% in some Member States, and is steadily increasing. The introduction of further restrictions could well lead to a further increase in these figures.
Amendment 68 #
Proposal for a directive Article 2 – paragraph 1 – point 13 (13) ‘flavouring’ means an additive that imparts aroma and/or taste
Amendment 68 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. In accordance with the principle of producer responsibility, manufacturers of tobacco products should therefore be made responsible for all health costs arising as a consequence of tobacco consumption.
Amendment 69 #
Proposal for a directive Article 2 – paragraph 1 – point 18 (18) ‘ingredient’ means any additive
Amendment 69 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: ‘Treaty’), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people
Amendment 7 #
Proposal for a directive Recital 6 a (new) (6a) Tobacco production in disadvantaged areas, especially the outermost regions, which is often associated with specific environmental, geographical and cultural conditions and craft-based, environmentally-friendly methods, should receive special attention from the EU, which should allow the Member State the possibility of applying specific measures to maintain production in these regions, thereby safeguarding the jobs provided by this sector
Amendment 70 #
Proposal for a directive Article 2 – paragraph 1 – point 18 a (new) (18a) ‘reconstituted tobacco’ is a product which results from the enhancement of different parts of the tobacco plant from threshing and the manufacture of tobacco products, whether used as a wrap for cigars and cigarillos either as sheets or individual strands as a component of the tobacco blend for cigarettes and other tobacco products.
Amendment 70 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty o
Amendment 71 #
Proposal for a directive Article 2 – paragraph 1 – point 25 (25) ‘place on the market’ means
Amendment 71 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people
Amendment 72 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 72 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. Public education and awareness campaigns should be promoted through periodic counselling in primary and secondary schools.
Amendment 73 #
Proposal for a directive Article 2 – paragraph 1 – point 30 (30) ‘substantial change of circumstances’ means an increase of the sales volumes by product category, such as pipe tobacco, cigar, cigarillo, by at least
Amendment 73 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty o
Amendment 74 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) ‘unique identification markings’ means a security feature which is both material-based and digitally-based
Amendment 74 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty o
Amendment 75 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) ‘reduced risk product’ means any product containing tobacco which, when marketed, significantly reduces the risk of illnesses associated with the consumption of conventional tobacco products. A product used to treat addiction to tobacco consumption, including cessation, is not a reduced risk product if it has been approved as a medicinal product.
Amendment 75 #
Proposal for a directive Recital 8 a (new) (8a) Tobacco products contain carcinogens. It is vital that the tobacco industry commit itself to work diligently on reducing the level of carcinogens in all kinds of tobacco.
Amendment 76 #
Proposal for a directive Article 3 – paragraph 1 – introductory part 1. The yield of cigarettes placed on the market
Amendment 76 #
Proposal for a directive Recital 8 a (new) (8a) Whereas with a view to safeguarding the health of workers who may be exposed to passive smoking the consumption of tobacco should be forbidden at all points of sale.
Amendment 77 #
Proposal for a directive Article 3 – paragraph 2 Amendment 77 #
Proposal for a directive Recital 8 b (new) (8b) Whereas with a view to preventing smoking among young people, people under the age of 18 should be forbidden access to points of sale.
Amendment 78 #
Proposal for a directive Article 3 – paragraph 2 Amendment 78 #
Proposal for a directive Recital 9 a (new) (9 a) Given that in many Member States large percentages of smokers are unlikely to stop smoking entirely, legislation should take into account their right to know objectively the impact the possible use of tobacco has on their health - information which they also receive through the packaging of the product they are likely to use.
Amendment 79 #
Proposal for a directive Article 3 – paragraph 2 Amendment 79 #
Proposal for a directive Recital 10 (10) For measuring the tar, nicotine and carbon monoxide yields of cigarettes, reference should be made to ISO standards 4387, 10315 and 8454, which are internationally recognised standards. For other emissions there are no internationally agreed standards or tests for quantifying the yields,
Amendment 8 #
Proposal for a directive Recital 8 (8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: ‘Treaty’), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people, especially adolescents and women. Calls, in order to promote education and prevention schemes, for the establishment of a European Smoking Prevention Fund which would also finance schemes to help people give up smoking, would prevent them from taking up smoking and would provide information about the harmful effects of smoking on health.
Amendment 80 #
Proposal for a directive Article 3 – paragraph 2 Amendment 80 #
Proposal for a directive Recital 10 a (new) (10 a) Polonium 210 has been shown to be a significant carcinogen in tobacco. Its presence in cigarettes could be eliminated almost completely by a combination of simple measures. It is thus appropriate to set a maximum yield for Polonium 210 that would result in a reduction of 95% of the current average content of Polonium 210 in cigarettes. An ISO standard to measure Polonium 210 in tobacco should be developed.
Amendment 81 #
Proposal for a directive Article 3 – paragraph 2 Amendment 81 #
Proposal for a directive Recital 11 (11) In relation to the fixing of maximum yields, it might be necessary and appropriate
Amendment 82 #
Proposal for a directive Article 3 – paragraph 3 Amendment 82 #
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.
Amendment 83 #
Proposal for a directive Article 3 – paragraph 3 3. Member States shall notify the Commission of the maximum yields that they set for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 83 #
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.
Amendment 84 #
Proposal for a directive Article 4 – paragraph 3 Amendment 84 #
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 developments and internationally agreed standards to assess their toxicity or addictiveness.
Amendment 85 #
Proposal for a directive Article 4 – paragraph 4 4. Member States shall notify the Commission of the methods of measurement that they use for other emissions of cigarettes and for emissions of tobacco products other than cigarettes.
Amendment 85 #
Proposal for a directive Recital 12 (12) In order to exercise their regulatory function, Member States and the Commission require comprehensive information on ingredients and emissions to assess the
Amendment 86 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a
Amendment 86 #
Proposal for a directive Recital 12 (12) In order to exercise their regulatory function, Member States and the Commission require comprehensive information on ingredients and emissions to assess the attractiveness, addictiveness and toxicity of tobacco products and the risks to health associated with the consumption of such products. To this end,
Amendment 87 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a
Amendment 87 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received.
Amendment 88 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products,
Amendment 88 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. In this light there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information should be ensured for the general public, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products and that World Trade Organisation (WTO) agreements are complied with.
Amendment 89 #
Proposal for a directive Article 6 – paragraph 2 Amendment 89 #
Proposal for a directive Recital 13 (13) The current use of different reporting formats makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. In this light there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information, allowing enough space for this information on the unit packets, should be ensured for the general public, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products.
Amendment 9 #
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 developments and internationally agreed standards against which their toxicity or addictiveness is assessed.
Amendment 90 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 The Commission shall
Amendment 90 #
Proposal for a directive Recital 13 a (new) (13a) Whereas a mandatory list of ingredients must be compiled as a matter of urgency, since, according to the 2010 report of the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)1, an increasing proportion of the ingredients in cigarettes – an average of 10% of their weight – are additives whose sole purpose is to make smoke more palatable by changing properties such as colour, acridity, odour and taste. __________________ 1 Almost 600 different additives were identified.
Amendment 91 #
Proposal for a directive Article 6 – paragraph 3 Amendment 91 #
Proposal for a directive Recital 14 (14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU and impedes an effective harmonised investigation at EU level on the health effects and attractiveness of tobacco products. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients or their combination. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches
Amendment 92 #
Proposal for a directive Article 6 – paragraph 3 Amendment 92 #
Proposal for a directive Recital 14 (14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result,
Amendment 93 #
Proposal for a directive Article 6 – paragraph 3 3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive, which is not essential for manufacture, or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives or combination of additives that cause the characterising flavour.
Amendment 93 #
Proposal for a directive Recital 14 (14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or
Amendment 94 #
Proposal for a directive Article 6 – paragraph 3 3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically impart a characterising flavour when it exceeds a certain level of presence or concentration the Commission shall
Amendment 94 #
Proposal for a directive Recital 14 a (new) (14a) In order to protect human health, the safety of additives for use in tobacco products should be assessed (risk assessment) and they should receive authorisation from the Commission prior to being marketed in the Community. Additives should only then be permitted for use in tobacco products if they are included in an EU list of authorised additives.
Amendment 95 #
Proposal for a directive Article 6 – paragraph 5 Amendment 95 #
Proposal for a directive Recital 14 b (new) (14 b) It is important not only to consider the properties of additives as such, but also of their combustion products. Additives as well as their combustion products should not meet the criteria for classification as hazardous in accordance with Regulation EC (No) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures1. _____________ 1 OJ L 353, 31.12.2008, p. 1.
Amendment 96 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of characterising flavour
Amendment 96 #
Proposal for a directive Recital 15 Amendment 97 #
Proposal for a directive Article 6 – paragraph 5 5. Member States shall prohibit the use of flavourings, except menthol, 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. Technical features aimed at reducing some harmful components of smoke or increasing the biodegradability of tobacco products are not affected.
Amendment 97 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products,
Amendment 98 #
Proposal for a directive Article 6 – paragraph 9 Amendment 98 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns.
Amendment 99 #
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.
Amendment 99 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco and menthol, which may facilitate uptake of tobacco consumption or affect consumption patterns.
source: PE-513.031
2013/06/13
JURI
109 amendments...
Amendment 100 #
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
Amendment 101 #
Proposal for a directive Article 7 – paragraph 1 1. Each unit packet of tobacco products and any outside packaging shall carry health warnings in the official language or languages of the Member State where the product is placed on the market, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Amendment 102 #
Proposal for a directive Article 8 – paragraph 4 – point b Amendment 103 #
Proposal for a directive Article 9 – paragraph 1 – point b (new) (b) include smoking cessation information such as phone numbers, e-mail addresses and/or Internet sites designed to inform consumers about the programmes available to support those who want to stop smoking; those platforms designed to inform consumers about the programmes available to support those who want to stop smoking should play active role in promoting knowledge on the severe effects of smoking among children and youth as those most at risk of becoming dependent on tobacco;
Amendment 104 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover
Amendment 105 #
Proposal for a directive Article 9 – paragraph 1 – point c (c) cover at least 75 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 106 #
Proposal for a directive Article 9 – paragraph 1 – point g – introductory part (g) for unit packets of cigarettes, respect the following dimensions as a minimum:
Amendment 107 #
Proposal for a directive Article 9 – paragraph 1 – point g – point i (i) height:
Amendment 108 #
Proposal for a directive Article 9 – paragraph 1 – point g – point ii (ii) width:
Amendment 109 #
Proposal for a directive Article 9 – paragraph 3 – point c Amendment 110 #
Proposal for a directive Article 10 – paragraph 5 Amendment 111 #
Proposal for a directive Article 12 – paragraph 1 – point a (a) promotes a tobacco product by means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions
Amendment 112 #
Proposal for a directive Article 12 – paragraph 1 – point b Amendment 113 #
Proposal for a directive Article 12 – paragraph 1 – point b (b) suggests that a particular tobacco product is less harmful than others
Amendment 114 #
Proposal for a directive Article 12 – paragraph 1 – point b a (new) (ba) suggests that a particular tobacco product has vitalising, energetic, healing, rejuvenating, natural, organic or otherwise positive health or social effects;
Amendment 115 #
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
Amendment 116 #
Proposal for a directive Article 12 – paragraph 1 a (new) (1a) A Member State may exempt a product from the provisions under paragraph 1(b) if a manufacturer demonstrates that such product as it is actually used by the consumer will significantly reduce the risk of tobacco related disease to the tobacco user. Manufacturers shall submit to the competent authorities in the Member States scientific evidence substantiating the reduced risk benefit of the product. Member States shall be entitled to determine the criteria of such authorization taking as a basis a high level of protection of consumers and public health;
Amendment 117 #
Proposal for a directive Article 13 – paragraph 1 1. A unit packet of cigarettes shall have a cuboid shape
Amendment 118 #
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.
Amendment 119 #
Proposal for a directive Article 13 – paragraph 2 2. A cigarette packet can be of carton or soft material and shall
Amendment 120 #
Proposal for a directive Article 13 – paragraph 2 a (new) Amendment 121 #
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.
Amendment 122 #
Proposal for a directive Article 14 – paragraph 2 – introductory part 2. The unique, safe and impossible to duplicate identifier shall allow determining:
Amendment 123 #
Proposal for a directive Article 14 – paragraph 2 – point g Amendment 124 #
Proposal for a directive Article 14 – paragraph 2 – point h Amendment 125 #
Proposal for a directive Article 14 – paragraph 2 – point i (i) the actual shipment route from manufacturing to the first
Amendment 126 #
Proposal for a directive Article 14 – paragraph 2 – point j (j) the identity of all purchasers from manufacturing to the first
Amendment 127 #
Proposal for a directive Article 14 – paragraph 2 – point k (k) the invoice, order number and payment records of all purchasers from manufacturing to the first
Amendment 128 #
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
Amendment 129 #
Proposal for a directive Article 14 – paragraph 4 4. Member States shall ensure that
Amendment 130 #
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 and accessible 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
Amendment 131 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique, safe and impossible to duplicate identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a visible, tamper proof security feature of at least 1 cm², which shall be irremovably printed or affixed, indelible and in no way hidden or interrupted in any form, including through
Amendment 132 #
Proposal for a directive Article 14 – paragraph 8 8. In addition to the unique identifier, Member States shall require that all unit packets of tobacco products which are placed on the market carry a
Amendment 133 #
Proposal for a directive Article 14 – paragraph 9 – point c (c) to define the technical standards for the security feature and their possible rotation and to adapt them to scientific, market and technical development. Delegated acts shall be based on current practices, technologies and commercial uses and shall consider international accepted standards for tracking, tracing and authentication of fast moving consumer goods, including provision of the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products.
Amendment 134 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. This ban should, however, not affect historically traditional tobacco products for oral use, which may be allowed by individual Member States;
Amendment 135 #
Proposal for a directive Article 15 – paragraph 1 Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. Member States and regions of Member States with a tradition of using oral tobacco shall have an opportunity to apply for a national or regional derogation from the prohibition on cultural or historical grounds.
Amendment 136 #
Proposal for a directive Article 16 – title Amendment 137 #
Article 16 a Point-of-sale displays of tobacco 1. Member States shall prohibit point-of- sale displays of tobacco in their territory. 2. Tobacco products shall be completely concealed from the customer except during the purchase or sale of tobacco products, or stocktaking, restocking, staff training or maintenance of the storage unit. 3. Display of tobacco products for those reasons listed in paragraph 2 may only last as long as is necessary to complete those tasks. 4. Prices of tobacco products shall be listed in a standardised format. No package deals or special discounts shall be displayed.
Amendment 138 #
Proposal for a directive Article 16 – paragraph 4 4. Retail outlets engaged in distance sales
Amendment 139 #
Proposal for a directive Article 16 – paragraph 5 a (new) 5a. Advertising of tobacco product via internet as well as using for that purpose profiling of personal data's shall not be permitted.
Amendment 140 #
Proposal for a directive Article 17 – paragraph 2 a (new) 2a. In connection with the marketing of reduced-harm tobacco products, Member States shall introduce an authorisation system and charge a proportionate fee. They shall also specify rules applicable to the scientific assessment of risk and the type of evidence to be presented, including, but not only, clinical and non- clinical information and other available studies examining how consumers use and perceive the product. Member States may diverge from the requirements laid down by this Directive in relation to authorised reduced-harm products in order to illustrate their less harmful nature.
Amendment 141 #
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. Nonetheless, novel tobacco products which, based on the information provided in accordance with this Article, are less harmful than cigarettes are exempted from the provision of the Article 12 paragraph 1 letter (b).
Amendment 142 #
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, unless otherwise authorised as provided for in paragraph 2 of this Article. 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.
Amendment 143 #
Proposal for a directive Article 18 – paragraph 1 Amendment 144 #
Proposal for a directive Article 18 – paragraph 1 – introductory part 1.
Amendment 145 #
Amendment 146 #
Amendment 147 #
Amendment 148 #
Proposal for a directive Article 18 – paragraph 1 a (new) 1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 149 #
Proposal for a directive Article 18 – paragraph 1 b (new) 1b. For nicotine-containing products where paragraph 1 does not apply, the products may be placed on the market if they comply with this Directive
Amendment 150 #
Proposal for a directive Article 18 – paragraph 1 c (new) 1c. Member States shall ensure that nicotine containing products comply with European Union consumer protection, safety and other relevant legislation in force.
Amendment 151 #
Proposal for a directive Article 18 – paragraph 1 d (new) 1d. No later than 12 months from entry into force of this Directive, each Member State shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in [new] Annex IV as it applies to nicotine containing products and the effectiveness of those measures.
Amendment 152 #
Proposal for a directive Article 18 – paragraph 1 e (new) 1e. Member States shall ensure that nicotine-containing products are not sold to persons below the national legal age for purchasing tobacco products.
Amendment 153 #
Proposal for a directive Article 18 – paragraph 1 f (new) 1f. Where appropriate, Member States may impose marketing restrictions on nicotine-containing products similar to those which apply to the marketing of tobacco products.
Amendment 154 #
Proposal for a directive Article 18 – paragraph 2 Amendment 155 #
Proposal for a directive Article 18 – paragraph 2 2. The Commission shall, b
Amendment 156 #
Proposal for a directive Article 18 – paragraph 3 Amendment 157 #
Proposal for a directive Article 18 – paragraph 3 3. Each unit packet and any outside packaging of nicotine-containing products
Amendment 158 #
Proposal for a directive Article 18 – paragraph 4 Amendment 159 #
Proposal for a directive Article 18 – paragraph 5 Amendment 160 #
Proposal for a directive Article 18 a (new) Amendment 161 #
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.
Amendment 162 #
Proposal for a directive Article 20 – paragraph 3 a (new) 3a. The negative economical and social consequences of the implementation of this Directive shall be counteracted by appropriate measures and financial support in the framework of the EU budget.
Amendment 163 #
Proposal for a directive Article 22 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 164 #
Proposal for a directive Article 22 – paragraph 3 3. The delegation of powers referred to in Articles
Amendment 165 #
Proposal for a directive Article 22 – paragraph 5 5. A delegated act pursuant to Articles
Amendment 166 #
Proposal for a directive Article 23 – paragraph 1 a (new) 1a. No later than 2 years from the date specified in Article 25 paragraph 1, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the economic and social consequences of the application of this Directive
Amendment 167 #
Proposal for a directive Article 24 – paragraph 2 Amendment 168 #
Proposal for a directive Article 25 – paragraph 1 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [Publications Office, please insert the exact date: entry into force +
Amendment 169 #
Proposal for a directive Article 26 – paragraph 1 – point b (b) nicotine containing products
Amendment 170 #
Proposal for a directive Annex I a (new) Amendment 62 #
Proposal for a directive Recital 6 Amendment 63 #
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 standards generally agreed to assess their toxicity or addictiveness.
Amendment 64 #
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.
Amendment 65 #
Proposal for a directive Recital 14 (14) The lack of a harmonised approach on ingredients regulation affects the functioning of the internal market and impacts on the free movement of goods across the EU. Some Member States have adopted legislation or entered into binding agreements with the industry allowing or prohibiting certain ingredients. As a result, some ingredients are regulated in some Member States, but not in others. Member States are also taking different approaches as regards additives integrated in the filter of cigarettes as well as additives colouring the tobacco smoke.
Amendment 66 #
Proposal for a directive Recital 15 Amendment 67 #
Proposal for a directive Recital 15 (15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising flavour other than tobacco, which may make tobacco products more palatable, and therefore facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people. Measures introducing unjustified differences of treatment between flavoured cigarettes (e.g. menthol and clove cigarettes) should be avoided.
Amendment 68 #
Proposal for a directive Recital 16 (16) The prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether, but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour. The use of additives necessary for manufacturing of tobacco products
Amendment 69 #
Proposal for a directive Recital 16 a (new) (16a) One of the aims of the Directive is to reduce the consumption of tobacco products, especially among young and vulnerable consumers, which will result in the decrease of the production of the tobacco in the European Union and can lead to loss of jobs, moving the industry outside the European Union and need to restructure the farms traditionally basing its production on tobacco. Therefore appropriate measures and financial support must be envisaged in the framework of the EU budget in order to counteract the economic and social consequences of the Directive.
Amendment 70 #
Proposal for a directive Recital 25 Amendment 71 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition.
Amendment 72 #
Proposal for a directive Recital 29 (29) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC confirmed this prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden derogation from this prohibition.
Amendment 73 #
Proposal for a directive Recital 30 a (new) (30a) The Commission and the Member States should commit themselves to the effective implementation of the FCTC's protocol to eliminate illicit trade in tobacco products. Efforts should be made to prevent and improve the control of illegal trafficking of tobacco products manufactured in third countries.
Amendment 74 #
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.
Amendment 75 #
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 use provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products which claim to have properties beneficial to human health. A significant number of nicotine-containing products
Amendment 76 #
Proposal for a directive Recital 35 (35) Labelling provisions should be introduced for nicotine containing products
Amendment 77 #
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.
Amendment 78 #
Proposal for a directive Recital 36 (36) The regulation of herbal products for smoking differs between Member States and these products are often perceived as harmless or less harmful despite the health risk caused by their combustion.
Amendment 79 #
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
Amendment 80 #
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
Amendment 81 #
Proposal for a directive Recital 38 Amendment 82 #
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
Amendment 83 #
Proposal for a directive Article 2 – paragraph 1 – point 3 (3) 'age verification system' means a computing system that unambigouisly confirms the consumer's age in electronic form according to national requirements; it can also mean a physical verification system in form accordant to national requirements, that unambiguously confirms the consumer age in situations other than direct purchase for example by the usage of vending machines;
Amendment 84 #
Proposal for a directive Article 2 – paragraph 1 – point 19 Amendment 85 #
Proposal for a directive Article 2 – paragraph 1 – point 25 (25) ‘place on the market’ means to make products available to consumers located in the Union, with or without payment, including by means of distance sale or by use of vending machines; in case of cross- border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located;
Amendment 86 #
Proposal for a directive Article 2 – paragraph 1 – point 36 a (new) (36a) ‘reduced-harm tobacco product’ means a tobacco product which has been shown, on the basis of scientific evidence, to demonstrably reduce the harmful effects of smoking, regardless of whether the product in question qualifies as a novel tobacco product under the terms of Article 2(23).
Amendment 87 #
Proposal for a directive Article 3 – paragraph 2 Amendment 88 #
Proposal for a directive Article 3 – paragraph 3 Amendment 89 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour, where it was unequivocally proved by scientific studies that the additive increases toxicity of the products or facilitate addiction.
Amendment 90 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 1 Member States shall prohibit the placing on the market of tobacco products with a characterising flavour, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Amendment 91 #
Proposal for a directive Article 6 – paragraph 1 – subparagraph 2 Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products,
Amendment 92 #
Proposal for a directive Article 6 – paragraph 2 – subparagraph 2 The Commission shall adopt by means of implementing acts
Amendment 93 #
Proposal for a directive Article 6 – paragraph 3 Amendment 94 #
5. Member States shall prohibit the use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity, where it was unequivocally proved by scientific studies that the additive increases toxicity of the products or facilitate addiction. Filters and capsules shall not contain tobacco.
Amendment 95 #
Amendment 96 #
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.
Amendment 97 #
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.
Amendment 98 #
Proposal for a directive Article 6 – paragraph 9 Amendment 99 #
Proposal for a directive Article 6 – paragraph 10 10. Tobacco products other than cigarettes
source: PE-513.109
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PURPOSE: to improve the functioning of the internal market for tobacco and related products, taking as a base a high level of protection of human health, especially for young people. LEGISLATIVE ACT: Directive 2014/40/EU of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC. CONTENT: this Directive replaces Directive 2001/37/EC and aims to approximate the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, that is, electronic cigarettes and refill containers, and herbal products for smoking. Maximum emission levels for tar, nicotine, carbon monoxide and other substances: by virtue of the new Directive, the emission levels from cigarettes placed on the market or manufactured in the Member States shall not be greater than: a) 10mg of tar per cigarette; b) 1mg of nicotine per cigarette; c) 10mg of carbon monoxide per cigarette. The accuracy of the measurements shall be determined in accordance with ISO standard 8243. The measurements shall be verified by laboratories which are approved and monitored by the competent authorities of the Member States. Those laboratories shall not be owned or controlled directly or indirectly by the tobacco industry. Reporting of ingredients and emissions: the Directive shall require manufacturers and importers of tobacco products to declare the ingredients contained in all tobacco products, as well as the tar, nicotine and carbon monoxide emissions of cigarettes. Additional enhanced reporting obligations should be provided for in respect of additives contained in cigarettes and roll-your-own tobacco included on a priority list. A first list of additives, containing at least 15 additives, shall be adopted no later than two years after the entry into force of the Directive. Ingredients: the Directive prohibits the placing on the market of tobacco products containing characterising flavour (perfume of fruit, spices, aromatic plants, alcohol, sweets, menthol or vanilla). Furthermore, additives such as vitamins, taurine or caffeine, as well as additives having colouring properties for emissions, as well as additives that facilitate inhalation or nicotine uptake, and that have CMR properties in unburnt form. Additives which are essential for the manufacture of tobacco products, for example, sugar, shall, however, be authorised. In the case of tobacco products with a characterising flavour, whose Union-wide sales volumes represent 3% or more in a particular product category, the provisions of this Directive shall apply from 20 May 2020. The prohibition on tobacco products with a characterising flavour shall not apply to other tobacco products such as cigars, cigarillos and smokeless tobacco products. In addition, this Regulation shall not apply to tobacco for oral use (snus). Labelling and packaging: cigarette packets shall carry combined health warnings containing a colour photograph and a text warning covering 65% of both the external front and back surface of the unit packet and any outside packaging. Health warnings will also cover 50% of the lateral surfaces of packets (such as Smoking kills quit now or Tobacco smoke contains over 70 substances known to cause cancer.) Unit packets of cigarettes shall have a cuboid shape and shall include at least 20 cigarettes. A unit packet of roll-your-own tobacco shall contain tobacco weighing not less than 30g. The health warnings should be irremovably printed, indelible and fully visible in the official language or languages of the Member State where the product is placed on the market. Member States may exempt tobacco products for smoking other than cigarettes, roll-your-own tobacco and waterpipe tobacco from the obligations to carry the information message and the combined health warnings In that event, they will be required to ensure that a general warning with reference to smoking cessation services and one of the text warnings appears on the products. Each unit packet of smokeless tobacco products shall carry the following health warning: This tobacco product damages your health and is addictive. In addition, each unit packet of herbal products for smoking shall carry the following health warning: Smoking this product damages your health. The labelling of unit packets shall not include any element or feature that: i) promotes a tobacco product or encourages its consumption; ii) suggests that a particular tobacco product has other health or lifestyle benefits; iii) resembles a food or a cosmetic product; iv) suggests that a certain tobacco product has improved biodegradability. Traceability: Member States shall ensure that all unit packets of tobacco products are marked with a unique identifier. This identifier shall allow the following to be determined, among others, the date and place of manufacturing, the manufacturing facility, the product description, the intended market of retail sale, and the intended shipment route. All unit packets of tobacco products, which are placed on the market, should carry a tamper proof security feature. Tobacco for oral use and cross-border distance sales: the Directive provides that the Member States prohibit the sale of tobacco for oral use, without prejudice to the Act of Accession of Austria, Finland and Sweden. Member States should, therefore, be allowed to prohibit cross-border distance sales. Member States should cooperate with each other in order to prevent such sales. Notification: the Directive requires the manufacturers and importers of novel tobacco products to submit a notification to the competent authorities of Member States of any such product they intend to place on the national market concerned. Electronic cigarettes: electronic cigarettes should be regulated like medicinal products if they permit smoking cessation or as tobacco products. In the second case, their nicotine concentration should not exceed 20mg/ml. Manufacturers and importers of electronic cigarettes and refill containers should be required to submit a notification of the relevant products before they are placed on the market. Electronic cigarettes should be banned for children and carry health warnings. They shall be subject to the same restrictions as tobacco products as regards advertising. The Commission shall submit a report on the potential risks to public health associated with the use of refillable electronic cigarettes by 20 May 2016 and whenever appropriate thereafter. Where the placing on the market of specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered to extend such a prohibition to all Member States. ENTRY INTO FORCE: 9.05.2014. TRANSPOSITION: no later than 20.05.2016. The measures shall apply from this date. DELEGATED ACTS: the Commission may adopt delegated acts in order to adapt the Directive to technical, scientific and international developments in tobacco manufacture, consumption and regulation. The power to adopt such acts shall be conferred on the Commission for a period of five years from 19 May 2014. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification (this period can be extended for two months). If the European Parliament or the Council make objections, the delegated act will not enter into force. New
Corrigendum to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (Official Journal of the European Union L 127 of 29 April 2014)
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PURPOSE: to revise Directive 2001/37/EC on tobacco products in order to improve the functioning of the internal market and ensure a high level of health protection. PROPOSED ACT: Directive of the European Parliament and of the Council. BACKGROUND: tobacco is the most significant cause of premature death in the EU, responsible for almost 700 000 deaths every year. More than ten years have passed since the adoption of the Directive 2001/37/EC on tobacco products. In line with market, scientific and international developments, it has become necessary to update and complement this Directive. The overall objective of the revision is to improve the functioning of the internal market. In particular, the proposal aims to: · update already harmonised areas, in order to overcome obstacles encountered by Member States in bringing their national legislation in line with new market, scientific and international developments; · address product related measures not yet covered by the Directive; · ensure that provisions of the Directive are not circumvented by the placing on the market of products not compliant with the Directive; · ensure a harmonised implementation of international obligations following from the WHO Framework Convention on Tobacco Control (FCTC), which is binding for the EU and all Member States. With regard to health protection, the proposed revision: · seeks to regulate tobacco products in a way that reflects their specific characteristics (nicotine has addictive properties) and the negative consequences of their consumption (mouth, throat and lung cancer, cardiovascular problems including heart attacks, strokes, clogged arteries, increased risk of blindness, impotence, lower fertility, impact on the unborn child etc); · focuses on initiation of tobacco consumption, in particular by young people, taking into account that 70% of the smokers start before the age of 18 and 94% before the age of 25; · create conditions which allow all citizens across the EU to take informed decisions about the products, based on accurate information on the health consequences of consuming tobacco products. The Commission's proposal for a Regulation of the European Parliament and of the Council on establishing a Health for Growth Programme contains measures which have as their direct objective the protection of public health regarding tobacco products and advertisement required by or contributing to the objectives of EU legislation in this field. IMPACT ASSESSMENT: the Commission undertook an impact assessment which accompanies the proposal. A high level of health protection has been taken as the basic criteria amongst the different strategic options that were considered during the review of the Directive. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). CONTENT : the revision of Directive 2001/37/CE focuses on the following areas: 1) Ingredients and emissions: the maximum yields of tar, nicotine and carbon monoxide as well as the measurement methods remain the same as in Directive 2001/37/EC. The proposal: · keeps in place the mandatory reporting system of ingredients and, in addition, provides that a common electronic format for the reporting and manufacturers are required to provide supporting data (e.g. marketing reports); · provides that placing on the market of new or modified tobacco products must not take place before the submission of ingredients data. Reported data, excluding confidential information, must be published; · prohibits tobacco products with characterising flavours, such as fruit flavours or chocolate, and prohibits flavourings in filters, papers or packages; · forbids additives associated with energy and vitality (e.g. caffeine and taurine), or creating the impression that products have health benefits (e.g. vitamins); · exempts tobacco products other than cigarettes, roll-your own tobacco and smokeless tobacco products, i.e. cigars, cigarillos and pipe tobacco from some provisions such as the prohibition of products with characterising flavours. The exemption shall be removed if there is a substantial change of circumstances (in terms of sales volume or prevalence level among young people). 2) Labelling and packaging: the proposal seeks to ensure that the appearance of the package reflects the characteristics of the product inside the package - a product that has negative health consequences, is addictive, and is not for the consumption of children and teenagers. In concrete terms, the proposal: · provides that that combined warnings (picture plus text) of 75% should be displayed on both sides of the packages of tobacco products, presented in rotation; · replaces tar, nicotine and carbon monoxide (TNCO) levels on the packages with an information message referring to harmful substances of tobacco; · ensures that display of cessation information (e.g. quit-lines, websites) is added to the packages; · states that neither packaging of tobacco products, nor the products themselves, shall include any elements that promote tobacco products or mislead consumers into believing that the product is less harmful than others, refers to flavours or tastes or resembles a food product; · exempts tobacco products other than cigarettes and roll-your own tobacco from larger health warnings; · provides that in order to increase the visibility of the health warnings on smokeless tobacco products, these will have to be put on both sides of the package according to the proposal, but their size will remain unchanged compared to Directive 2001/37. 3) Traceability and security features: the proposal: · provides for an EU tracking and tracing system at packet level for tobacco products throughout the supply chain (excluding retail). Tobacco products other than cigarettes and roll-your-own-tobacco are granted a transitional period of five years; · provides that technical standards to ensure compatibility between the tracking and tracing systems used as well as for the contracts with third parties shall be adopted by delegated acts. Technical standardisations for security features shall also be adopted through delegated acts. 4) Tobacco for oral use: the ban of placing on the market (including cross-border distance sale) of tobacco for oral use as set out in Directive 2001/37/EC is maintained (except for Sweden which has an exemption in its Accession Treaty). 5) Cross-border distance sales of tobacco products: cross-border distance sales of tobacco products fall outside the scope of Directive 2001/37/EC. The proposal: · includes a notification obligation for retailers of tobacco products intending to engage in cross-border distance sales; · allows Member States to require the retailer to appoint a natural person, who ensures compliance with the Directive of products delivered to customers in the Member States concerned; · provides a mandatory age verification mechanism. 6) Novel tobacco products (do not fall within any of the established product categories): these products will have to respect requirements of the Directive (e.g. in terms of labelling and ingredients) to ensure a level playing field, and the applicable rules will depend on whether the product involves a combustion process or not. The proposal also provides a notification obligation for novel tobacco products and the Commission will issue a report on market development in these products five years after the transposition deadline of the Directive. 7) Nicotine containing products (NCP): bearing in mind the novelty and the rapid growth of the market in NCP, the proposal removes current legislative divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products. The proposal provides that: · NCP that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance; · NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adapted health warning. 8) Herbal products for smoking: herbal products for smoking fall outside the scope of Directive 2001/37/EC and Member States regulate these products in different ways. The proposal provides for adapted health warnings for herbal products for smoking to inform consumers about the adverse health effects of these products. In addition, no promotional or misleading elements are allowed on the packages. BUDGETARY IMPLICATIONS: the estimated impact on expenditure (operational appropriations, human resources and other administrative expenditure) amounts to EUR 7,888 millions for the period 2014-2018. DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU). New
PURPOSE: to revise Directive 2001/37/EC on tobacco products in order to improve the functioning of the internal market and ensure a high level of health protection. PROPOSED ACT: Directive of the European Parliament and of the Council. BACKGROUND: tobacco is the most significant cause of premature death in the EU, responsible for almost 700 000 deaths every year. More than ten years have passed since the adoption of the Directive 2001/37/EC on tobacco products. In line with market, scientific and international developments, it has become necessary to update and complement this Directive. The overall objective of the revision is to improve the functioning of the internal market. In particular, the proposal aims to: · update already harmonised areas, in order to overcome obstacles encountered by Member States in bringing their national legislation in line with new market, scientific and international developments; · address product related measures not yet covered by the Directive; · ensure that provisions of the Directive are not circumvented by the placing on the market of products not compliant with the Directive; · ensure a harmonised implementation of international obligations following from the WHO Framework Convention on Tobacco Control (FCTC), which is binding for the EU and all Member States. With regard to health protection, the proposed revision: · seeks to regulate tobacco products in a way that reflects their specific characteristics (nicotine has addictive properties) and the negative consequences of their consumption (mouth, throat and lung cancer, cardiovascular problems including heart attacks, strokes, clogged arteries, increased risk of blindness, impotence, lower fertility, impact on the unborn child etc); · focuses on initiation of tobacco consumption, in particular by young people, taking into account that 70% of the smokers start before the age of 18 and 94% before the age of 25; · create conditions which allow all citizens across the EU to take informed decisions about the products, based on accurate information on the health consequences of consuming tobacco products. The Commission's proposal for a Regulation of the European Parliament and of the Council on establishing a Health for Growth Programme contains measures which have as their direct objective the protection of public health regarding tobacco products and advertisement required by or contributing to the objectives of EU legislation in this field. IMPACT ASSESSMENT: the Commission undertook an impact assessment which accompanies the proposal. A high level of health protection has been taken as the basic criteria amongst the different strategic options that were considered during the review of the Directive. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). CONTENT : the revision of Directive 2001/37/CE focuses on the following areas: 1) Ingredients and emissions: the maximum yields of tar, nicotine and carbon monoxide as well as the measurement methods remain the same as in Directive 2001/37/EC. The proposal: · keeps in place the mandatory reporting system of ingredients and, in addition, provides that a common electronic format for the reporting and manufacturers are required to provide supporting data (e.g. marketing reports); · provides that placing on the market of new or modified tobacco products must not take place before the submission of ingredients data. Reported data, excluding confidential information, must be published; · prohibits tobacco products with characterising flavours, such as fruit flavours or chocolate, and prohibits flavourings in filters, papers or packages; · forbids additives associated with energy and vitality (e.g. caffeine and taurine), or creating the impression that products have health benefits (e.g. vitamins); · exempts tobacco products other than cigarettes, roll-your own tobacco and smokeless tobacco products, i.e. cigars, cigarillos and pipe tobacco from some provisions such as the prohibition of products with characterising flavours. The exemption shall be removed if there is a substantial change of circumstances (in terms of sales volume or prevalence level among young people). 2) Labelling and packaging: the proposal seeks to ensure that the appearance of the package reflects the characteristics of the product inside the package - a product that has negative health consequences, is addictive, and is not for the consumption of children and teenagers. In concrete terms, the proposal: · provides that that combined warnings (picture plus text) of 75% should be displayed on both sides of the packages of tobacco products, presented in rotation; · replaces tar, nicotine and carbon monoxide (TNCO) levels on the packages with an information message referring to harmful substances of tobacco; · ensures that display of cessation information (e.g. quit-lines, websites) is added to the packages; · states that neither packaging of tobacco products, nor the products themselves, shall include any elements that promote tobacco products or mislead consumers into believing that the product is less harmful than others, refers to flavours or tastes or resembles a food product; · exempts tobacco products other than cigarettes and roll-your own tobacco from larger health warnings; · provides that in order to increase the visibility of the health warnings on smokeless tobacco products, these will have to be put on both sides of the package according to the proposal, but their size will remain unchanged compared to Directive 2001/37. 3) Traceability and security features: the proposal: · provides for an EU tracking and tracing system at packet level for tobacco products throughout the supply chain (excluding retail). Tobacco products other than cigarettes and roll-your-own-tobacco are granted a transitional period of five years; · provides that technical standards to ensure compatibility between the tracking and tracing systems used as well as for the contracts with third parties shall be adopted by delegated acts. Technical standardisations for security features shall also be adopted through delegated acts. 4) Tobacco for oral use: the ban of placing on the market (including cross-border distance sale) of tobacco for oral use as set out in Directive 2001/37/EC is maintained (except for Sweden which has an exemption in its Accession Treaty). 5) Cross-border distance sales of tobacco products: cross-border distance sales of tobacco products fall outside the scope of Directive 2001/37/EC. The proposal: · includes a notification obligation for retailers of tobacco products intending to engage in cross-border distance sales; · allows Member States to require the retailer to appoint a natural person, who ensures compliance with the Directive of products delivered to customers in the Member States concerned; · provides a mandatory age verification mechanism. 6) Novel tobacco products (do not fall within any of the established product categories): these products will have to respect requirements of the Directive (e.g. in terms of labelling and ingredients) to ensure a level playing field, and the applicable rules will depend on whether the product involves a combustion process or not. The proposal also provides a notification obligation for novel tobacco products and the Commission will issue a report on market development in these products five years after the transposition deadline of the Directive. 7) Nicotine containing products (NCP): bearing in mind the novelty and the rapid growth of the market in NCP, the proposal removes current legislative divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products. The proposal provides that: · NCP that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance; · NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adapted health warning. 8) Herbal products for smoking: herbal products for smoking fall outside the scope of Directive 2001/37/EC and Member States regulate these products in different ways. The proposal provides for adapted health warnings for herbal products for smoking to inform consumers about the adverse health effects of these products. In addition, no promotional or misleading elements are allowed on the packages. BUDGETARY IMPLICATIONS: the estimated impact on expenditure (operational appropriations, human resources and other administrative expenditure) amounts to EUR 7,888 millions for the period 2014-2018. DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU). |
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