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Document 02014L0040-20150106
Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (Text with EEA relevance)
Consolidated text: Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (Text with EEA relevance)
Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (Text with EEA relevance)
02014L0040 — EN — 06.01.2015 — 001.002
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DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127 29.4.2014, p. 1) |
Amended by:
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COMMISSION DELEGATED DIRECTIVE 2014/109/EU Text with EEA relevance of 10 October 2014 |
L 360 |
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17.12.2014 |
Corrected by:
DIRECTIVE 2014/40/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 3 April 2014
on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC
(Text with EEA relevance)
TITLE I
COMMON PROVISIONS
Article 1
Subject matter
The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning:
the ingredients and emissions of tobacco products and related reporting obligations, including the maximum emission levels for tar, nicotine and carbon monoxide for cigarettes;
certain aspects of the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as traceability and security features that are applied to tobacco products to ensure their compliance with this Directive;
the prohibition on the placing on the market of tobacco for oral use;
cross-border distance sales of tobacco products;
the obligation to submit a notification of novel tobacco products;
the placing on the market and the labelling of certain products, which are related to tobacco products, namely electronic cigarettes and refill containers, and herbal products for smoking;
in order to facilitate the smooth functioning of the internal market for tobacco and related products, taking as a base a high level of protection of human health, especially for young people, and to meet the obligations of the Union under the WHO Framework Convention for Tobacco Control (‘FCTC’).
Article 2
Definitions
For the purposes of this Directive, the following definitions shall apply:
‘tobacco’ means leaves and other natural processed or unprocessed parts of tobacco plants, including expanded and reconstituted tobacco;
‘pipe tobacco’ means tobacco that can be consumed via a combustion process and exclusively intended for use in a pipe;
‘roll-your-own tobacco’ means tobacco which can be used for making cigarettes by consumers or retail outlets;
‘tobacco products’ means products that can be consumed and consist, even partly, of tobacco, whether genetically modified or not;
‘smokeless tobacco product’ means a tobacco product not involving a combustion process, including chewing tobacco, nasal tobacco and tobacco for oral use;
‘chewing tobacco’ means a smokeless tobacco product exclusively intended for the purpose of chewing;
‘nasal tobacco’ means a smokeless tobacco product that can be consumed via the nose;
‘tobacco for oral use’ means all tobacco products for oral use, except those intended to be inhaled or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets;
‘tobacco products for smoking’ means tobacco products other than a smokeless tobacco product;
‘cigarette’ means a roll of tobacco that can be consumed via a combustion process and is further defined in Article 3(1) of Council Directive 2011/64/EU ( 14 );
‘cigar’ means a roll of tobacco that can be consumed via a combustion process and is further defined in Article 4(1) of Directive 2011/64/EU;
‘cigarillo’ means a small type of cigar and is further defined in Article 8(1) of Council Directive 2007/74/EC ( 15 );
‘waterpipe tobacco’ means a tobacco product that can be consumed via a waterpipe. For the purpose of this Directive, waterpipe tobacco is deemed to be a tobacco product for smoking. If a product can be used both via waterpipes and as roll-your-own tobacco, it shall be deemed to be roll-your-own tobacco;
‘novel tobacco product’ means a tobacco product which:
does not fall into any of the following categories: cigarettes, roll-your-own tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or tobacco for oral use; and
is placed on the market after 19 May 2014;
‘herbal product for smoking’ means a product based on plants, herbs or fruits which contains no tobacco and that can be consumed via a combustion process;
‘electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges;
‘refill container’ means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette;
‘ingredient’ means tobacco, an additive, as well as any substance or element present in a finished tobacco product or related products, including paper, filter, ink, capsules and adhesives;
‘nicotine’ means nicotinic alkaloids;
‘tar’ means the raw anhydrous nicotine-free condensate of smoke;
‘emissions’ means substances that are released when a tobacco or related product is consumed as intended, such as substances found in smoke, or substances released during the process of using smokeless tobacco products;
‘maximum level’ or ‘maximum emission level’ means the maximum content or emission, including zero, of a substance in a tobacco product measured in milligrams;
‘additive’ means a substance, other than tobacco, that is added to a tobacco product, a unit packet or to any outside packaging;
‘flavouring’ means an additive that imparts smell and/or taste;
‘characterising flavour’ means a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla, which is noticeable before or during the consumption of the tobacco product;
‘addictiveness’ means the pharmacological potential of a substance to cause addiction, a state which affects an individual's ability to control his or her behaviour, typically by instilling a reward or a relief from withdrawal symptoms, or both;
‘toxicity’ means the degree to which a substance can cause harmful effects in the human organism, including effects occurring over time, usually through repeated or continuous consumption or exposure;
‘substantial change of circumstances’ means an increase of the sales volumes by product category by at least 10 % in at least five Member States based on sales data transmitted in accordance with Article 5(6) or an increase of the level of prevalence of use in the under 25 years of age consumer group by at least five percentage points in at least five Member States for the respective product category based on the Special Eurobarometer 385 report of May 2012 or equivalent prevalence studies; in any case, a substantial change of circumstances is deemed not to have occurred if the sales volume of the product category at retail level does not exceed 2,5 % of total sales of tobacco products at Union level;
‘outside packaging’ means any packaging in which tobacco or related products are placed on the market and which includes a unit packet or an aggregation of unit packets; transparent wrappers are not regarded as outside packaging;
‘unit packet’ means the smallest individual packaging of a tobacco or related product that is placed on the market;
‘pouch’ means a unit packet of roll-your own tobacco, either in the form of a rectangular pocket with a flap that covers the opening or in the form of a standing pouch;
‘health warning’ means a warning concerning the adverse effects on human health of a product or other undesired consequences of its consumption, including text warnings, combined health warnings, general warnings and information messages, as provided for in this Directive;
‘combined health warning’ means a health warning consisting of a combination of a text warning and a corresponding photograph or illustration, as provided for in this Directive;
‘cross-border distance sales’ means distance sales to consumers where, at the time the consumer orders the product from a retail outlet, the consumer is located in a Member State other than the Member State or the third country where that retail outlet is established; a retail outlet is deemed to be established in a Member State:
in the case of a natural person: if he or she has his or her place of business in that Member State;
in other cases: if the retail outlet has its statutory seat, central administration or place of business, including a branch, agency or any other establishment, in that Member State;
‘consumer’ means a natural person who is acting for purposes which are outside his or her trade, business, craft or profession;
‘age verification system’ means a computing system that unambiguously confirms the consumer's age electronically in accordance with national requirements;
‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark;
‘import of tobacco or related products’ means the entry into the territory of the Union of such products unless the products are placed under a customs suspensive procedure or arrangement upon their entry into the Union, as well as their release from a customs suspensive procedure or arrangement;
‘importer of tobacco or related products’ means the owner of, or a person having the right of disposal over, tobacco or related products that have been brought into the territory of the Union;
‘placing on the market’ means to make products, irrespective of their place of manufacture, available to consumers located in the Union, with or without payment, including by means of distance sale; in the case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located;
‘retail outlet’ means any outlet where tobacco products are placed on the market including by a natural person.
TITLE II
TOBACCO PRODUCTS
CHAPTER I
Ingredients and emissions
Article 3
Maximum emission levels for tar, nicotine, carbon monoxide and other substances
The emission levels from cigarettes placed on the market or manufactured in the Member States (‘maximum emission levels’) shall not be greater than:
10 mg of tar per cigarette;
1 mg of nicotine per cigarette;
10 mg of carbon monoxide per cigarette.
Article 4
Measurement methods
The accuracy of the tar, nicotine and carbon monoxide measurements shall be determined in accordance with ISO standard 8243.
Those laboratories shall not be owned or controlled directly or indirectly by the tobacco industry.
Member States shall communicate to the Commission a list of approved laboratories, specifying the criteria used for approval and the methods of monitoring applied, and shall update that list whenever any change is made. The Commission shall make those lists of approved laboratories publicly available.
Article 5
Reporting of ingredients and emissions
Member States shall require manufacturers and importers of tobacco products to submit to their competent authorities the following information by brand name and type:
a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products, in descending order of the weight of each ingredient included in the tobacco products;
the emission levels referred to in Article 3(1) and (4);
where available, information on other emissions and their levels.
For products already placed on the market that information shall be provided by 20 November 2016.
Manufacturers or importers shall also inform the competent authorities of the Member States concerned, if the composition of a product is modified in a way that affects the information provided under this Article.
For a new or modified tobacco product the information required under this Article shall be submitted prior to the placing on the market of those products.
Furthermore, for cigarettes and roll-your-own tobacco, a technical document setting out a general description of the additives used and their properties, shall be submitted by the manufacturer or importer.
Other than for tar, nicotine and carbon monoxide and for emissions referred to in Article 4(4), manufacturers and importers shall indicate the methods of measurement of emissions used. Member States may also require manufacturers or importers to carry out studies as may be prescribed by the competent authorities in order to assess the effects of ingredients on health, taking into account, inter alia, their addictiveness and toxicity.
Article 6
Priority list of additives and enhanced reporting obligations
In addition to the reporting obligations laid down in Article 5, enhanced reporting obligations shall apply to certain additives contained in cigarettes and roll-your-own tobacco that are included in a priority list. The Commission shall adopt implementing acts laying down and subsequently updating such a priority list of additives. This list shall contain additives:
for which initial indications, research, or regulation in other jurisdictions exist suggesting that they have one of the properties set out in points (a) to (d) of paragraph 2 of this Article; and
which are amongst the most commonly used additives by weight or number according to the reporting of ingredients pursuant to paragraphs 1 and 3 of Article 5.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2). A first list of additives shall be adopted by 20 May 2016 and shall contain at least 15 additives.
Member States shall require manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive that is included in the priority list provided for in paragraph 1, to carry out comprehensive studies, which shall examine for each additive whether it:
contributes to the toxicity or addictiveness of the products concerned, and whether this has the effect of increasing the toxicity or addictiveness of any of the products concerned to a significant or measurable degree;
results in a characterising flavour;
facilitates inhalation or nicotine uptake; or
leads to the formation of substances that have CMR properties, the quantities thereof, and whether this has the effect of increasing the CMR properties in any of the products concerned to a significant or measurable degree.
Manufacturers or importers shall submit these reports to the Commission and a copy thereof to the competent authorities of those Member States where a tobacco product containing this additive is placed on the market at the latest 18 months after the additive concerned has been included in the priority list pursuant to paragraph 1. The Commission and the Member States concerned may also request supplementary information from manufacturers or importers regarding the additive concerned. This supplementary information shall form part of the report.
The Commission and the Member States concerned may require these reports to be peer reviewed by an independent scientific body, in particular as regards their comprehensiveness, methodology and conclusions. The information received shall assist the Commission and Member States in taking the decisions pursuant to Article 7. The Member States and the Commission may charge manufacturers and importers of tobacco products proportionate fees for those peer reviews.
Article 7
Regulation of ingredients
Member States shall not prohibit the use of additives which are essential for the manufacture of tobacco products, for example sugar to replace sugar that is lost during the curing process, provided those additives do not result in a product with a characterising flavour and do not increase to a significant or measureable degree the addictiveness, toxicity or the CMR properties of the tobacco product.
Member States shall notify the Commission of the measures taken pursuant to this paragraph.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
Member States shall prohibit the placing on the market of tobacco products containing the following additives:
vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;
caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;
additives having colouring properties for emissions;
for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake; and
additives that have CMR properties in unburnt form.
Member States shall notify to the Commission the measures they have taken pursuant to this paragraph.
CHAPTER II
Labelling and packaging
Article 8
General provisions
Article 9
General warnings and information messages on tobacco products for smoking
Each unit packet and any outside packaging of tobacco products for smoking shall carry one of the following general warnings:
‘Smoking kills – quit now’
or
‘Smoking kills’
Member States shall determine which of the general warnings referred to in the first subparagraph is to be used.
Each unit packet and any outside packaging of tobacco products for smoking shall carry the following information message:
‘Tobacco smoke contains over 70 substances known to cause cancer.’
For packets in the form of a shoulder box with a hinged lid that result in the lateral surfaces being split into two when the packet is open, the general warning and the information message shall appear in their entirety on the larger parts of those split surfaces. The general warning shall also appear on the inside of the top surface that is visible when the packet is open.
The lateral surfaces of this type of packet shall have a height of not less than 16 mm.
For roll-your-own tobacco marketed in pouches the general warning and the information message shall appear on the surfaces that ensure the full visibility of those health warnings. For roll-your-own tobacco in cylindrical packets the general warning shall appear on the outside surface of the lid and the information message on the inside surface of the lid.
Both the general warning and the information message shall cover 50 % of the surfaces on which they are printed.
The general warning and information message referred to in paragraphs 1 and 2 shall be:
printed in black Helvetica bold type on a white background. In order to accommodate language requirements, Member States may determine the font size, provided that the font size specified in national law ensures that the relevant text occupies the greatest possible proportion of the surface reserved for these health warnings; and
at the centre of the surface reserved for them, and on cuboid packets and any outside packaging they shall be parallel to the lateral edge of the unit packet or of the outside packaging.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
Article 10
Combined health warnings for tobacco products for smoking
Each unit packet and any outside packaging of tobacco products for smoking shall carry combined health warnings. The combined health warnings shall:
contain one of the text warnings listed in Annex I and a corresponding colour photograph specified in the picture library in Annex II;
include smoking cessation information such as telephone numbers, e-mail addresses or Internet sites intending to inform consumers about the programmes that are available to support persons who want to stop smoking;
cover 65 % of both the external front and back surface of the unit packet and any outside packaging. Cylindrical packets shall display two combined health warnings, equidistant from each other, each covering 65 % of their respective half of the curved surface;
show the same text warning and corresponding colour photograph on both sides of the unit packets and any outside packaging;
appear at the top edge of a unit packet and any outside packaging, and be positioned in the same direction as any other information appearing on that surface of the packaging. Transitional exemptions from that obligation on the position of the combined health warning may apply in Member States where tax stamps or national identification marks used for fiscal purposes remain mandatory, as follows:
in those cases, where the tax stamp or national identification mark used for fiscal purposes is affixed at the top edge of a unit packet made of carton material, the combined health warning that is to appear on the back surface may be positioned directly below the tax stamp or national identification mark;
where a unit packet is made of soft material, Member States may allow for a rectangular area to be reserved for the tax stamp or national identification mark used for fiscal purposes of a height not exceeding 13 mm between the top edge of the packet and the top end of the combined health warnings.
The exemptions referred to in points (i) and (ii) shall apply for a period of three years from 20 May 2016. Brand names or logos shall not be positioned above the health warnings;
be reproduced in accordance with the format, layout, design and proportions specified by the Commission pursuant to paragraph 4;
in the case of unit packets of cigarettes, respect the following dimensions:
height: not less than 44 mm;
width: not less than 52 mm.
The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to:
adapt the text warnings listed in Annex I taking into account scientific and market developments;
establish and adapt the picture library referred to in point (a) of paragraph 1 of this Article taking into account scientific and market developments.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
Article 11
Labelling of tobacco products for smoking other than cigarettes, roll-your-own tobacco and waterpipe tobacco
The general warning shall appear on the most visible surface of the unit packet and any outside packaging.
Member States shall ensure that each text warning is displayed to the extent possible in equal numbers on each brand of these products. The text warnings shall appear on the next most visible surface of the unit packet and any outside packaging.
For unit packets with a hinged lid, the next most visible surface is the one that becomes visible when the packet is open.
The health warnings shall be surrounded by a black border of a width of not less than 3 mm and not more than 4 mm. This border shall appear outside the surface reserved for the health warnings.
Article 12
Labelling of smokeless tobacco products
Each unit packet and any outside packaging of smokeless tobacco products shall carry the following health warning:
‘This tobacco product damages your health and is addictive.’
In addition, it shall:
appear on the two largest surfaces of the unit packet and any outside packaging;
cover 30 % of the surfaces 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 more than two official languages.
Article 13
Product presentation
The labelling of unit packets and any outside packaging and the tobacco product itself shall not include any element or feature that:
promotes a tobacco product or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions; labels shall not include any information about the nicotine, tar or carbon monoxide content of the tobacco product;
suggests that a particular tobacco product is less harmful than others or aims to reduce the effect of some harmful components of smoke or has vitalising, energetic, healing, rejuvenating, natural, organic properties or has other health or lifestyle benefits;
refers to taste, smell, any flavourings or other additives or the absence thereof;
resembles a food or a cosmetic product;
suggests that a certain tobacco product has improved biodegradability or other environmental advantages.
Article 14
Appearance and content of unit packets
Article 15
Traceability
The unique identifier shall allow the following to be determined:
the date and place of manufacturing;
the manufacturing facility;
the machine used to manufacture the tobacco products;
the production shift or time of manufacture;
the product description;
the intended market of retail sale;
the intended shipment route;
where applicable, the importer into the Union;
the actual shipment route from manufacturing to the first retail outlet, including all warehouses used as well as the shipment date, shipment destination, point of departure and consignee;
the identity of all purchasers from manufacturing to the first retail outlet; and
the invoice, order number and payment records of all purchasers from manufacturing to the first retail outlet.
The third party's activities shall be monitored by an external auditor, who is proposed and paid by the tobacco manufacturer and approved by the Commission. The external auditor shall submit an annual report to the competent authorities and to the Commission, assessing in particular any irregularities in relation to access.
Member States shall ensure that the Commission, the competent authorities of the Member States, and the external auditor have full access to the data storage facilities. In duly justified cases the Commission or the Member States may grant manufacturers or importers access to the stored data, provided that commercially sensitive information remains adequately protected in conformity with the relevant Union and national law.
The Commission shall, by means of implementing acts:
determine the technical standards for the establishment and the operation of the tracking and tracing system as provided for in this Article, including the marking with a unique identifier, the recording, transmitting, processing and storing of data and access to stored data;
determine the technical standards for ensuring that the systems used for the unique identifier and the related functions are fully compatible with each other across the Union.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
Article 16
Security feature
Member States requiring tax stamps or national identification marks used for fiscal purposes may allow that they are used for the security feature provided that the tax stamps or national identification marks fulfil all of the technical standards and functions required under this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
CHAPTER III
Tobacco for oral use, cross-border distance sales of tobacco products and novel tobacco products
Article 17
Tobacco for oral use
Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Article 18
Cross-border distance sales of tobacco products
Member States may prohibit cross-border distance sales of tobacco products to consumers. Member States shall cooperate to prevent such sales. Retail outlets engaging in cross-border distance sales of tobacco products may not supply such products to consumers in Member States where such sales have been prohibited. Member States which do not prohibit such sales shall require 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 consumers are located. Retail outlets established outside the Union shall be required to register with the competent authorities in the Member State where the actual or potential consumers are located. All retail outlets intending to engage in cross-border distance sales shall submit at least the following information to the competent authorities when registering:
name or corporate name and permanent address of the place of activity from where the tobacco products will be supplied;
the starting date of the activity of offering tobacco products for cross-border distance sales to consumers by means of Information Society services, as defined in point 2 of Article 1 of Directive 98/34/EC;
the address of the website or websites used for that purpose and all relevant information necessary to identify the website.
Article 19
Notification of novel tobacco products
Member Stes shall require manufacturers and importers of novel tobacco products to submit a notification to the competent authorities of Member States of any such product they intend to place on the national market concerned. The notification shall be submitted in electronic form six months before the intended placing on the market. It shall be accompanied by a detailed description of the novel tobacco product concerned as well as instructions for its use and information on ingredients and emissions in accordance with Article 5. The manufacturers and importers submitting a notification of a novel tobacco product shall also provide the competent authorities with:
available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions;
available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers;
other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.
TITLE III
ELECTRONIC CIGARETTES AND HERBAL PRODUCTS FOR SMOKING
Article 20
Electronic cigarettes
This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.
The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:
the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;
a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;
information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article;
a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.
Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned.
Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them.
Member States shall ensure that:
nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;
the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;
the nicotine-containing liquid does not contain additives listed in Article 7(6);
only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in point (b) of the second subparagraph of paragraph 2 of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture;
except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;
electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use;
electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.
Member States shall ensure that:
unit packets of electronic cigarettes and refill containers include a leaflet with information on:
instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;
contra-indications;
warnings for specific risk groups;
possible adverse effects;
addictiveness and toxicity; and
contact details of the manufacturer or importer and a legal or natural contact person within the Union;
unit packets and any outside packaging of electronic cigarettes and refill containers:
include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;
without prejudice to point (i) of this point, do not include elements or features referred to in Article 13, with the exception of Article 13(1)(a) and (c) concerning information on the nicotine content and on flavourings; and
carry one of the following health warnings:
‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers’.
or
‘This product contains nicotine which is a highly addictive substance.’
Member States shall determine which of these health warnings is to be used;
health warnings comply with the requirements specified in Article 12(2).
Member States shall ensure that:
commercial communications in Information Society services, in the press and other printed publications, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited, except for publications that are intended exclusively for professionals in the trade of electronic cigarettes or refill containers and for publications which are printed and published in third countries, where those publications are not principally intended for the Union market;
commercial communications on the radio, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers, are prohibited;
any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;
any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited;
audiovisual commercial communications to which Directive 2010/13/EU of the European Parliament and of the Council ( 19 ) applies, are prohibited for electronic cigarettes and refill containers.
Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit, annually, to the competent authorities:
comprehensive data on sales volumes, by brand name and type of the product;
information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users;
the mode of sale of the products; and
executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.
Member States shall monitor the market developments concerning electronic cigarettes and refill containers, including any evidence that their use is a gateway to nicotine addiction and ultimately traditional tobacco consumption among young people and non-smokers.
Member States shall, upon request, make all information received pursuant to this Article available to the Commission and other Member States. The Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.
Should any of these economic operators consider or have reason to believe that electronic cigarettes or refill containers, which are in their possession and are intended to be placed on the market or are placed on the market, are not safe or are not of good quality or are otherwise not in conformity with this Directive, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with this Directive, to withdraw or to recall it, as appropriate. In such cases the economic operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available or is intended to be made available, giving details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action.
Member States may also request additional information from the economic operators, for example on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.
Where, in application of the first subparagraph of this paragraph, the placing on the market of specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 27 to extend such a prohibition to all Member States, if such an extension is justified and proportionate.
These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).
Article 21
Herbal products for smoking
Each unit packet and any outside packaging of herbal products for smoking shall carry the following health warning:
‘Smoking this product damages your health.’
Article 22
Reporting of ingredients of herbal products for smoking
TITLE IV
FINAL PROVISIONS
Article 23
Cooperation and enforcement
Article 24
Free movement
Article 25
Committee procedure
Article 26
Competent authorities
Member States shall designate the competent authorities that shall be responsible for the implementation and enforcement of the obligations provided for in this Directive within three months of 20 May 2016. Member States shall inform the Commission about the identity of the designated authorities without delay. The Commission shall publish that information in the Official Journal of the European Union.
Article 27
Exercise of the delegation
Article 28
Report
When drafting the report, the Commission shall be assisted by scientific and technical experts in order to have all the necessary information at its disposal.
In the report, the Commission shall indicate, in particular, the elements of the Directive which should be reviewed or adapted in the light of scientific and technical developments, including the development of internationally agreed rules and standards on tobacco and related products. The Commission shall pay special attention to:
the experience gained with respect to the design of package surfaces not governed by this Directive taking into account national, international, legal, economic and scientific developments;
market developments concerning novel tobacco products considering, inter alia, notifications received under Article 19;
market developments which constitute a substantial change of circumstances;
the feasibility, benefits and possible impact of a European system for the regulation of the ingredients used in tobacco products, including the establishment, at Union level, of a list of ingredients that may be used or present in, or added to tobacco products, taking into account, inter alia, the information collected in accordance with Articles 5 and 6;
market developments concerning cigarettes with a diameter of less than 7,5 mm, and consumer perception of their harmfulness as well as the misleading character of such cigarettes;
the feasibility, benefits and possible impact of a Union database containing information on ingredients and emissions from tobacco products collected in accordance with Articles 5 and 6;
market developments concerning electronic cigarettes and refill containers considering, amongst others, information collected in accordance with Article 20, including on the initiation of consumption such products by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavours;
market developments and consumer preferences as regards waterpipe tobacco, with a particular focus on its flavours.
The Member States shall assist the Commission and provide all available information for carrying out the assessment and preparing the report.
Article 29
Transposition
The Member States shall apply those measures from 20 May 2016, without prejudice to Articles 7(14), 10(1)(e), 15(13) and 16(3).
Article 30
Transitional provision
Member States may allow the following products, which are not in compliance with this Directive, to be placed on the market until 20 May 2017:
tobacco products manufactured or released for free circulation and labelled in accordance with Directive 2001/37/EC before 20 May 2016;
electronic cigarettes or refill containers manufactured or released for free circulation before 20 November 2016;
herbal products for smoking manufactured or released for free circulation before 20 May 2016.
Article 31
Repeal
Directive 2001/37/EC is repealed with effect from 20 May 2016, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law of that Directive.
References to the repealed Directive shall be construed as references to this Directive and read in accordance with the correlation table in Annex III to this Directive.
Article 32
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 33
Addressees
This Directive is addressed to the Member States.
ANNEX I
LIST OF TEXT WARNINGS
(referred to in Article 10 and Article 11(1))
Smoking causes 9 out of 10 lung cancers
Smoking causes mouth and throat cancer
Smoking damages your lungs
Smoking causes heart attacks
Smoking causes strokes and disability
Smoking clogs your arteries
Smoking increases the risk of blindness
Smoking damages your teeth and gums
Smoking can kill your unborn child
Your smoke harms your children, family and friends
Smokers' children are more likely to start smoking
Quit smoking – stay alive for those close to you
Smoking reduces fertility
Smoking increases the risk of impotence
ANNEX II
Picture Library (of combined health warnings)
(referred to in Article 10(1))
Set 1
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