45 Amendments of Frédérique RIES related to 2012/0366(COD)
Amendment 58 #
Proposal for a directive
Citation 1
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 71 #
Proposal for a directive
Recital 8
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. by paying particular attention to the 80 million young Europeans who have never smoked;
Amendment 87 #
Proposal for a directive
Recital 13
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. A mandatory list of ingredients must be compiled with a view to ensuring the greatest possible transparency for the general public in respect of the contents of tobacco products, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the manufacturers of tobacco products. The list must include a statement of the most dangerous ingredients along similar lines to that required by the US Family Smoking Prevention and Tobacco Control Act, which obliges manufacturers to disclose the presence of any substances in cigarette smoke identified by the US Food and Drug Administration as ‘hazardous or potentially hazardous’ for human health. Annexes I(a) and (b) have been provided for the purposes of setting out such a list.
Amendment 90 #
Proposal for a directive
Recital 13 a (new)
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 114 #
Proposal for a directive
Recital 17
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. These additiveFor example the action of menthol is problematical. Because of its local anaesthetic property, menthol allows a deeper inhalation of the irritating tobacco smoke. As such, more smoke can be inhaled and deeper puffs can be attained, resulting in a higher nicotine dose. These additives that increase the attractiveness of tobacco products should be prohibited in order to ensure uniform rules and a high level of health protection.
Amendment 117 #
Proposal for a directive
Recital 17 b (new)
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 124 #
Proposal for a directive
Recital 18
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
Recital 18
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 130 #
Proposal for a directive
Recital 19
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 193 #
Proposal for a directive
Recital 33
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 have a negative, which have been on the EU market for less than 10 years, have an 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 197 #
Proposal for a directive
Recital 33 a (new)
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 202 #
Proposal for a directive
Recital 34
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 of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. SIn the event that similar use is made of them, subjecting all nicotine- containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.
Amendment 245 #
Proposal for a directive
Recital 45
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. 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 252 #
Proposal for a directive
Article 1 – paragraph 1 – point d
Article 1 – paragraph 1 – point d
(d) cross-borderthe prohibition of distance sales of tobacco products;
Amendment 257 #
Proposal for a directive
Article 1 – paragraph 1 – point f
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 259 #
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 2
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 275 #
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘characterising flavour’ means an aroma or taste distinguishable aroma or tastby everyone other than tobacco, resulting from an additive or combination of additives, including but not limited to fruit, spice, herb, alcohol, or candy, menthol or vanilla observable before or upon intended use of the tobacco product;
Amendment 285 #
Proposal for a directive
Article 2 – paragraph 1 – point 4 a (new)
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 328 #
Proposal for a directive
Article 2 – paragraph 1 – point 26 a (new)
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
Article 2 – paragraph 1 – point 28
(28) ‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers or retail outlets;
Amendment 334 #
Proposal for a directive
Article 2 – paragraph 1 – point 30
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 10five Member States based on sales data transmitted representing 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 rept least 5% of the population of the EU based on sales data transmitted in accordance with Article 5(4), ort orn equivalent prevalence studies;
Amendment 346 #
Proposal for a directive
Article 2 – paragraph 1 – point 34
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 genetically modified or not;
Amendment 351 #
Proposal for a directive
Article 2 – paragraph 1 – point 36 b (new)
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 419 #
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 1
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 473 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
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 578 #
Proposal for a directive
Article 6 – paragraph 10
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 on the basis of data supplied by competent authorities in Member States.
Amendment 593 #
Proposal for a directive
Article 7 – paragraph 3
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 725 #
Proposal for a directive
Article 9 – paragraph 2
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 branThe combined health warnings shall be printed in such a way as to ensure that each brand can be readily recognised.
Amendment 759 #
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
Tobacco for smoking other than cigarettes and, roll-your-own tobacco and water-pipe tobacco shall 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).
Amendment 1028 #
Proposal for a directive
Title 2 – chapter 4 – title
Title 2 – chapter 4 – title
Amendment 1030 #
Proposal for a directive
Article 16 – title
Article 16 – title
Amendment 1038 #
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Member StatesInternet shall oblige retail outlets intending to engage in cross- border distancees of cigarettes and roll-your-own tobacco shales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State wl be prohibited in the Union. Internet sales of othere the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potential consumer is located. All retail outlets intending to engage in cross- border distance sales shall submit at least the following information to the competent authorities:obacco products and related nicotine-containing products shall be subject to more stringent monitoring in the Union.
Amendment 1081 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The competent authorities of the Member States shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in Directive 95/46/EC. Retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant Member StateMember States which have implemented a national anti-smoking strategy may set quantitative limits on cross-border movements.
Amendment 1149 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
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 1180 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
a) pProducts with a nicotine level exceeding 2 mg per unit, orhich are presented as having properties beneficial to human health, or as having therapeutic qualities in terms of being a smoking cessation; b) the amount of nicotine in the cartridge is greater than 10 mg, or if the charging solution "e-liquid" has a higher concentration of nicotine than or equal to 20 mg / ml.
Amendment 1190 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1204 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1232 #
Proposal for a directive
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
This product contains nicotine, but not tobacco or tar, and can damage your health.
Amendment 1239 #
Proposal for a directive
Article 18 – paragraph 4 a (new)
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 1255 #
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
This natural product can damage your health
Amendment 1315 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. However, a Member State mayshall have the right to 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 alsshall also have the right to 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 1340 #
Proposal for a directive
Annex 1 – point 2 a (new)
Annex 1 – point 2 a (new)
(2 a) Smoking causes bladder cancer
Amendment 1343 #
Proposal for a directive
Annex 1 – point 6 a (new)
Annex 1 – point 6 a (new)
(6a) Smoking causes cancer of the bladder
Amendment 1357 #
Proposal for a directive
Annex 1 a (new)
Annex 1 a (new)
Amendment 1358 #
Proposal for a directive
Annex 1 b (new)
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