BETA

Activities of Catherine STIHLER related to 2012/0366(COD)

Shadow opinions (1)

OPINION 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
2016/11/22
Committee: IMCO
Dossiers: 2012/0366(COD)
Documents: PDF(437 KB) DOC(706 KB)

Amendments (48)

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 and the, cross-border distance saleand internet sales of tobacco products and point-of-sale displays of tobacco products.
2013/05/08
Committee: IMCO
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.
2013/05/08
Committee: IMCO
Amendment 66 #
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. 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.deleted
2013/05/08
Committee: IMCO
Amendment 73 #
Proposal for a directive
Recital 18
(18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.deleted
2013/05/08
Committee: IMCO
Amendment 87 #
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 by defining which text may be placed on the package and with the use of plain packaging. Studies have shown that plain packages are less attractive and enhance the effectiveness of health warnings, thereby decreasing smoking uptake and tobacco consumption.
2013/05/08
Committee: IMCO
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 granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young peoplesubject to the same labelling requirements as cigarettes and roll-your-own tobacco products. The labelling of these other tobacco products should follow specific rules. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.
2013/05/08
Committee: IMCO
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.
2013/05/08
Committee: IMCO
Amendment 156 #
Proposal for a directive
Recital 24
(24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products, which are mainly consumed by older consumers, should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people. The labelling of these other tobacco products should follow specific ruleshould be subject to the same labelling requirements as cigarettes and roll-your-own tobacco products. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.
2013/05/14
Committee: ENVI
Amendment 179 #
Proposal for a directive
Recital 30
(30) Cross-border distanceInternet 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. 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 , and should therefore be prohibited, in line with the implementing guidelines of the Framework Convention on Tobacco Control. 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 contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer rights, as of 13 June 2014.
2013/05/14
Committee: ENVI
Amendment 184 #
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.
2013/05/08
Committee: IMCO
Amendment 198 #
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
2013/05/08
Committee: IMCO
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 already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine- containing products, whose nicotine content equals or exceeds the content of aHowever, measuring nicotine delivery has proven to be difficult, as it depends on the products and how they are being used. Therefore, subjecting all nicotine -containing product previously authorised under Directive 2001/83/EC, to the same legal frameworks regardless of their nicotine content to Directive 2001/83/EC 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.
2013/05/14
Committee: ENVI
Amendment 205 #
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.deleted
2013/05/14
Committee: ENVI
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 435 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. Tobacco for smoking other than cigarettes and roll- you-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.
2013/05/08
Committee: IMCO
Amendment 230 #
Proposal for a directive
Article 9 – paragraph 1 – point c
(c) cover 785 % of the external area of both the front and back surface of the unit packet and any outside packaging;
2013/05/08
Committee: IMCO
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. Accordingly, Member States could, for instance, maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the Treaty, with WTO obligations and do not affect the full application of this Directive. A prior notification is required for technical regulations pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on Information Society services . (If corresponding amendments introducing standardised packaging are not adopted, this amendment should fall.)
2013/05/14
Committee: ENVI
Amendment 260 #
Proposal for a directive
Article 9 – paragraph 1 – point g – point i
(i) height: not less than 648 mm;
2013/05/08
Committee: IMCO
Amendment 275 #
Proposal for a directive
Article 10
Labelling of tobacco for smoking other than cigarettes and roll-your-own tobacco 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 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 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. 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 three official languages. 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 three official languages. 4. The general warning and the text warning referred to in paragraph 1 shall be: (a) printed in black Helvetica bold type on a white background. 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; (b) centred in the area in which they are required to be printed, parallel to the top edge of the unit packet and any outside packaging; (c) surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning. 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 as established in a Commission report.Article 10 deleted
2013/05/13
Committee: IMCO
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.
2013/05/13
Committee: IMCO
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.
2013/05/13
Committee: IMCO
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.
2013/05/13
Committee: IMCO
Amendment 451 #
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. The use of additives in tobacco products other than those listed in Annex -I, or listed in that Annex but not used in accordance with the conditions laid down in that Annex, shall be prohibited. Annex -I shall only contain substances that do not meet the criteria for classification as hazardous in accordance with Regulation EC (No) 1272/2008, and that do not result in such substances upon combustion. Annex -I shall not contain flavours or substances that increase palatability. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to establish and modify Annex -I..
2013/05/14
Committee: ENVI
Amendment 479 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Member States shall not prohibit the use of aAdditives which are essential for the manufacture of tobacco products may be included in Annex -I, as long as the additives do not result in a product with a characterising flavourflavour and are not linked to attractiveness of tobacco products.
2013/05/14
Committee: ENVI
Amendment 483 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 3
Member States shall notify the Commission of measures taken pursuant to this paragraph.deleted
2013/05/14
Committee: ENVI
Amendment 486 #
Proposal for a directive
Article 6 – paragraph 2
2. 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. The Commission shall adopt by means of implementing 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 512 #
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 imparts a characterising flavourflavour or increases palatability only 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 flavourby modifying Annex -I accordingly.
2013/05/14
Committee: ENVI
Amendment 516 #
Proposal for a directive
Article 6 – paragraph 4 – introductory part
4. Member States shall prohibit the use ofAnnex -I shall not contain the following additives in tobacco products:
2013/05/14
Committee: ENVI
Amendment 532 #
Proposal for a directive
Article 6 – paragraph 5
5. Member States shall prohibit tThe 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 shall be prohibited. Filters and capsules shall not contain tobacco.
2013/05/14
Committee: ENVI
Amendment 542 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Member States shallAnnex -I shall not contain, 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.
2013/05/14
Committee: ENVI
Amendment 548 #
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 553 #
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 559 #
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 only when it exceeds a certain level of presence or concentration, including standard safety margins, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives by modifying Annex -I accordingly.
2013/05/14
Committee: ENVI
Amendment 568 #
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 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.
2013/05/14
Committee: ENVI
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.
2013/05/14
Committee: ENVI
Amendment 677 #
Proposal for a directive
Article 9 – paragraph 1 – point c
(c) cover 7580 % 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 757 #
Proposal for a directive
Article 10
[...]deleted
2013/05/21
Committee: ENVI
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.
2013/05/21
Committee: ENVI
Amendment 1029 #
Proposal for a directive
Title 2 – chapter 4 – title
Cross-border distance sSales of tobacco products
2013/05/14
Committee: ENVI
Amendment 1031 #
Proposal for a directive
Article 16 – title
Cross-border distanceInternet sales of tobacco products
2013/05/14
Committee: ENVI
Amendment 1043 #
Proposal for a directive
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail 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:prohibit the sale of tobacco products over the internet in their territory. (Should replace the whole article)
2013/05/14
Committee: ENVI
Amendment 1156 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC: . (If adopted, paragraphs 1(a) - (c), 2 to 5 of this Article should be deemed to be deleted.)
2013/05/14
Committee: ENVI
Amendment 1173 #
Proposal for a directive
Article 18 – paragraph 1 – point a
(a) products with a nicotine level exceeding 2 mg per unit, ordeleted
2013/05/14
Committee: ENVI
Amendment 1185 #
Proposal for a directive
Article 18 – paragraph 1 – point b
(b) products with a nicotine concentration exceeding 4 mg per ml ordeleted
2013/05/14
Committee: ENVI
Amendment 1199 #
Proposal for a directive
Article 18 – paragraph 1 – point c
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.deleted
2013/05/14
Committee: ENVI
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]:
2013/05/14
Committee: ENVI
Amendment 1332 #
Proposal for a directive
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);deleted
2013/05/14
Committee: ENVI
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
2013/05/14
Committee: ENVI