Activities of Christian ENGSTRÖM 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
Amendments (43)
Amendment 114 #
Proposal for a directive
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
Amendment 178 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco productsfor smoking with a characterising flavour.
Amendment 182 #
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 productsfor smoking, as long as the additives do not result in a product with a characterising flavour.
Amendment 199 #
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 nicotine containing products which claim to have properties beneficial to human health. A significant number of nicotine-containing products werpresenting such claims have already been authorised under this regulatory regime. The authorisation Member Staktes into account the nicotine content of the product in question. Subjecting allare obliged to ensure 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 fulfilledich do not fall under Directive 2001/83/EC and which are placed on the common market comply with the appropriate legislation listed in [new] Annex IV.
Amendment 207 #
Proposal for a directive
Recital 35
Recital 35
(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directivefalling outside of the scope of Directive 2001/83/EC drawing the attention of consumers to potential health risks, and Member States should be obliged to ensure that national age restrictions for buying nicotine containing products are kept in line with those for the sale of tobacco products.
Amendment 250 #
Proposal for a directive
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
Amendment 289 #
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 1
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 370 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Member States shallmay 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.
Amendment 371 #
Proposal for a directive
Article 15 – paragraph 1 a (new)
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)
Article 15 – paragraph 1 b (new)
Amendment 421 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products that are presented as having properties for treating or preventing disease in human beings, other than through any message specified in paragraph 3, may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:.
Amendment 424 #
Proposal for a directive
Article 18 – paragraph 1 a (new)
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)
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)
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)
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 431 #
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 433 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 435 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 439 #
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The Commission shall, be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations grantey 1 April 2017, carry out a study on nicotine-containing products in consultation with relevant stakeholders and the Member States. This study will consider whether there is a need for specific legislation with regard to nicotine- containing products pursuant to Directive 2001/83/EC.
Amendment 461 #
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
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 476 #
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 for smoking, as long as the additives do not result in a product with a characterising flavour.
Amendment 476 #
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);
Amendment 480 #
Proposal for a directive
Annex 2 a (new)
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 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
Amendment 799 #
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 2
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 1020 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shallmay 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.
Amendment 1024 #
Proposal for a directive
Article 15 – paragraph 1 a (new)
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 1027 #
Proposal for a directive
Article 15 – paragraph 1 b (new)
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 1150 #
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products that are presented as having properties for treating or preventing disease in human beings, other than through any message specified in paragraph 3, may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
Amendment 1162 #
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC.
Amendment 1167 #
Proposal for a directive
Article 18 – paragraph 1 b (new)
Article 18 – paragraph 1 b (new)
Amendment 1168 #
Proposal for a directive
Article 18 – paragraph 1 c (new)
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)
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)
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
Article 18 – paragraph 1 – point a
Amendment 1182 #
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 1196 #
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 1218 #
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The Commission shall, be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations grantey 1 April 2017, carry out a study on nicotine-containing products in consultation with relevant stakeholders and the Member States. This study will consider whether there is a need for specific legislation in regard to nicotine- containing products pursuant to Directive 2001/83/EC.
Amendment 1229 #
Proposal for a directive
Article 18 – paragraph 3 – introductory part
Article 18 – paragraph 3 – introductory part
Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1which do not fall under the scope of Directive 2001/83/EC shall carry the following health warning:
Amendment 1233 #
Proposal for a directive
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
This product contains nicotine which is addictive and canmay damage your health.
Amendment 1333 #
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);
Amendment 1359 #
Proposal for a directive
Annex 2 a (new)
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)
Annex 2 b (new)