BETA

Activities of Karl-Heinz FLORENZ related to 2012/0366(COD)

Plenary speeches (1)

Manufacture, presentation and sale of tobacco and related products (debate)
2016/11/22
Dossiers: 2012/0366(COD)

Shadow reports (1)

REPORT 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 PDF (1 MB) DOC (2 MB)
2016/11/22
Committee: ENVI
Dossiers: 2012/0366(COD)
Documents: PDF(1 MB) DOC(2 MB)

Amendments (55)

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.
2013/05/29
Committee: ENVI
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.
2013/05/29
Committee: ENVI
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 smokeless tobaccotobacco for oral use 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.
2013/05/29
Committee: ENVI
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, 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.
2013/05/29
Committee: ENVI
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.
2013/05/29
Committee: ENVI
Amendment 192 #
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 thHowever, Member States have taken different regulatory approaches which are functiodermining of the internal market, in particular considering that these products are subject to significant cross-border distance sales including via the internet. There is a need for harmonized rules, and given the potential of these products to aid with the harm reduction agenda, there should be an option for a light-touch regulatory regime to guarantee safety and quality, which is a middle-way between medicines and tobacco regulation.
2013/05/14
Committee: ENVI
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. 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.
2013/05/14
Committee: ENVI
Amendment 260 #
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 2
in order to facilitate the functioning of the internal market in tobacco and related products, taking as a basis a high level of health protection. Does not affect English version. Or. de Justification
2013/05/14
Committee: ENVI
Amendment 263 #
Proposal for a directive
Article 2 – paragraph 1 – point 2
(2) 'additive' means a substance contained in a tobacco product, its unitwhich is used in the manufacture of a tobacco product, including its components such as paper, filter, inks, capsules, adhesives, packet or anyd outside packaging, and is still present, including in modified form, in the finished product with the exception of tobacco leaves and other natural or unprocessed parts of tobacco plants;
2013/05/14
Committee: ENVI
Amendment 276 #
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; Does not affect English version. Or. de Justification
2013/05/14
Committee: ENVI
Amendment 301 #
Proposal for a directive
Article 2 – paragraph 1 – point 18
(18) 'ingredient' means an additive, tobacco (leaves and other natural, processed or unprocessed parts of tobacco plants including expanded and reconstituted tobacco), as well as any substance present in a finished tobacco product including paper, filter, inks, capsules and adhesives and tobacco;
2013/05/14
Committee: ENVI
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;
2013/05/14
Committee: ENVI
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.
2013/05/14
Committee: ENVI
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 and packaging of substances and mixtures. The list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients in burnt or unburnt form as appropriate, referring in particular to their effects on health of consumers and taking into account, inter alia, any addictive effects. The list shall be established in descending order of the weight of each ingredient included in the product. Within one year following the entry into force of this Directive, manufacturers and importers of tobacco products shall submit the list of ingredients and all the accompanying information referred to above. Member States shall penalise manufacturers and importers of tobacco products who fail to submit that list and the accompanying information by the time limit. Other than for tar, nicotine and carbon monoxide and for emissions referred to in Article 4 paragraph 4, the manufacturers and importers shall indicate the measurement methods used. Member States may also require manufacturers or importers to carry out other tests as may be laid down by the competent national authorities in order to assess the effects of substances on health, taking into account, inter alia, their addictiveness and toxicity.
2013/05/14
Committee: ENVI
Amendment 445 #
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. (1) Tobacco products may contain only additives listed in Annex Ia. (2) The following additives shall not be included in Annex Ia: (a) additives which increase addictiveness or toxicity; (b) vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards; (c) caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality; (d) additives having colouring properties for emissions. (3) Additives which, when used, may produce a characterising flavour in tobacco products shall not be used in: (a) cigarettes, (b) roll-your-own tobacco, (c) smokeless tobacco, excluding nasal tobacco, (d) components such as filters, papers, packages, capsules or adhesives, for example, of tobacco products not coming under (a), (b) or (c). The use of other technical features which make it possible to change the flavour or smoke intensity shall not be allowed. (4) The Commission shall be empowered to adopt delegated acts in accordance with Article 22 concerning the amendment of Annex Ia. For all or specific categories of tobacco products, the Commission may lay down conditions or restrictions such as area of use, maximum quantities, concentration limits or purity requirements. It shall base its action on opinions by the European Food Safety Authority and take account of Regulation (EC) No 1907/2006. (5) Member States shall prohibit the placing on the market of tobacco products which contain additives not listed in Annex Ia.
2013/05/14
Committee: ENVI
Amendment 462 #
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.deleted
2013/05/14
Committee: ENVI
Amendment 482 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 3
Member States shall notify to the Commission measures taken pursuant to this paragraph.deleted
2013/05/14
Committee: ENVI
Amendment 492 #
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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.deleted
2013/05/14
Committee: ENVI
Amendment 500 #
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 2
The Commission shall adopt by means of implemeting acts uniform rules on the procedures for determining whether a tobacco product falls within the scope of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.deleted
2013/05/14
Committee: ENVI
Amendment 508 #
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 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.deleted
2013/05/14
Committee: ENVI
Amendment 514 #
Proposal for a directive
Article 6 – paragraph 4
4. Member States shall prohibit the use of the following additives in tobacco products: a) vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards, or b) caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality, or c) additives having colouring properties for emissions.deleted
2013/05/14
Committee: ENVI
Amendment 517 #
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, ordeleted
2013/05/14
Committee: ENVI
Amendment 521 #
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, ordeleted
2013/05/14
Committee: ENVI
Amendment 524 #
Proposal for a directive
Article 6 – paragraph 4 – point c
c) additives having colouring properties for emissions.deleted
2013/05/14
Committee: ENVI
Amendment 530 #
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. Filters and capsules shall not contain tobacco.deleted
2013/05/14
Committee: ENVI
Amendment 539 #
Proposal for a directive
Article 6 – paragraph 6
6. Member States shall ensure that provisions or conditions set out under Regulation (EC) No 1907/2006 are applied to tobacco products as appropriate.deleted
2013/05/14
Committee: ENVI
Amendment 540 #
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 or addictive effect of a tobacco product.deleted
2013/05/14
Committee: ENVI
Amendment 547 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Member States shall notify to the Commission measures taken pursuant to this paragraph.deleted
2013/05/14
Committee: ENVI
Amendment 551 #
Proposal for a directive
Article 6 – paragraph 8
8. The Commission shall at the request of a Member State or may on its own initiative determine by means of an implementing act whether a tobacco product falls within the scope of paragraph 7. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21 and shall be based on the latest scientific evidence.deleted
2013/05/14
Committee: ENVI
Amendment 556 #
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 in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives.deleted
2013/05/14
Committee: ENVI
Amendment 567 #
Proposal for a directive
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.deleted
2013/05/14
Committee: ENVI
Amendment 572 #
Proposal for a directive
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco productstobacco for oral use 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.
2013/05/14
Committee: ENVI
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.
2013/05/14
Committee: ENVI
Amendment 675 #
Proposal for a directive
Article 9 – paragraph 1 – point c
(c) cover 765 % of the external area of both the front and back surface of the unit packet and any outside packaging;
2013/05/14
Committee: ENVI
Amendment 718 #
Proposal for a directive
Article 9 – paragraph 1 – point g – point i
(i) height: not less than 6455 mm;
2013/05/14
Committee: ENVI
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.
2013/05/21
Committee: ENVI
Amendment 801 #
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 2
This tobacco product canis damageing to your health and is addictive
2013/05/21
Committee: ENVI
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:
2013/05/21
Committee: ENVI
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.
2013/05/21
Committee: ENVI
Amendment 859 #
Proposal for a directive
Article 12 – paragraph 2 – point 1 (new)
(1) The cigarette paper must include watermarks.
2013/05/21
Committee: ENVI
Amendment 877 #
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 40 g.
2013/05/21
Committee: ENVI
Amendment 890 #
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.deleted
2013/05/21
Committee: ENVI
Amendment 925 #
Proposal for a directive
Article 13 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to make either cuboid or cylindric shape mandatory for unit packets of tobacco products other than cigarettes and roll-your-own tobacco if there is a substantial change of circumstances as established in a Commission report.
2013/05/21
Committee: ENVI
Amendment 1250 #
Proposal for a directive
Article 18 a (new)
Article 18 a Nicotine-containing products 1. Nicotine-containing products may only be placed on the market if they are authorised pursuant to: (a) Directive 2001/83/EC, or (b) The simplified procedure as set out in paragraph 2 and 3. Simplified procedure 2. Under the simplified procedure, Member States shall require manufacturers and importers of nicotine- containing products to submit an application for a marketing authorisation, which shall contain the following: (a) Evidence that the product is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice; (b) A detailed description of the product in question, including all ingredients and quantities thereof, as well as information on emissions; (c) A Risk-Management Plan, including a system for monitoring and recording any adverse reactions; Member States shall be entitled to charge a fee for processing the application. They may also require manufacturers or importers to carry out additional tests or submit additional information. Each Member State shall take due account of authorisations previously granted by another Member State. 3. For products authorised under the simplified procedure, Member States shall ensure that the following conditions are fulfilled: (a) the product is clearly labelled with the nicotine content, instructions for use, instructions for reporting adverse reactions, and details of the manufacturer; (b) each unit packet and any outside packaging shall carry the following health warning: This products is intended for use by existing smokers aged 18 or over as an alternative to tobacco cigarettes. It contains nicotine which is a highly addictive substance. Consult your doctor if you are pregnant, breast feeding, allergic to nicotine or propylene glycol, or have high blood pressure (c) flavourings shall not be allowed; (d) the sale of the product shall be restricted in line with the legal age for sale of tobacco products in the relevant Member State; (e) the products shall be available to be sold outside pharmacies; (f) advertising and promotion shall be appropriately regulated; 4. Member States shall monitor the development of the nicotine-containing products market, including any progress made in harm reduction, as well as any evidence of gateway use amongst young people. Based on the evidence, the Commission shall report back to the European Parliament and the Council 5 years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary.
2013/05/14
Committee: ENVI
Amendment 1257 #
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 1
This product can damages your health.
2013/05/14
Committee: ENVI
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(3), 6(9), 6(104), 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 an indeterminate period of time from [Office of Publications: please insert the date of the entry into force of this Directive].
2013/05/14
Committee: ENVI
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(3), 6(9), 6(104), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
2013/05/14
Committee: ENVI
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(3), 6(9), 6(104), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
2013/05/14
Committee: ENVI
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.
2013/05/14
Committee: ENVI
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 + 2436 months]:
2013/05/14
Committee: ENVI
Amendment 1334 #
Proposal for a directive
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);
2013/05/14
Committee: ENVI
Amendment 1343 #
Proposal for a directive
Annex 1 – point 6 a (new)
(6a) Smoking causes cancer of the bladder
2013/05/14
Committee: ENVI
Amendment 1352 #
2013/05/14
Committee: ENVI
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
2013/05/14
Committee: ENVI