Explanatory Memorandum to COM(2012)788 - Approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products - Main contents
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| dossier | COM(2012)788 - Approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, ... |
|---|---|
| source | COM(2012)788  |
| date | 19-12-2012 |
Directive 2001/37/EC 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 products (Tobacco Products Directive, hereafter TPD), was adopted on 5 June 2001.
More than ten years have passed since the adoption of the TPD. In line with market, scientific and international developments it has become necessary to update and complete the TPD. A revision is explicitly foreseen in Article 11 of the current TPD and has been repeatedly called for by Council and Parliament. The initiative to revise the TPD is included in the Commission's Work Plan 2012.
The overall objective of the revision is to improve the functioning of the internal market. In particular, the proposal aims to:
Ÿ Update already harmonised areas to overcome Member States' obstacles to bring their national legislations in line with new market, scientific and international developments.
Ÿ Address product related measures not yet covered by the TPD insofar as heterogeneous development in Member States has led to, or is likely to lead to, fragmentation of the internal market.
Ÿ Ensure that provisions of the Directive are not circumvented by placing on the market of products not compliant with the TPD.
It is also important to ensure a harmonised implementation of international obligations following from the WHO Framework Convention on Tobacco Control (FCTC), which is binding for the EU and all Member States, and a consistent approach to non-binding FCTC commitments, if there is a risk of diverging national transposition.
In line with Article 114 TFEU a high level of health protection has been taken as a basis when choosing between different policy options identified in the review of the TPD. In this context, the proposal seeks to regulate tobacco products in a way that reflects their specific characteristics (nicotine has addictive properties) and the negative consequences of their consumption (mouth, throat and lung cancer, cardiovascular problems including heart attacks, strokes, clogged arteries, increased risk of blindness, impotence, lower fertility, impact on the unborn child etc).
Tobacco is the most significant cause of premature death in the EU, responsible for almost 700,000 deaths every year. The proposal focuses on initiation of tobacco consumption, in particular by young people, taking into account that 70% of the smokers start before the age of 18 and 94% before the age of 25 years i. This is also reflected in the selection and focus of the proposed policy areas and the products primarily targeted (cigarettes, roll-your-own and smokeless tobacco products). In addition, the revision should create conditions which allow all citizens across the EU to take informed decisions about the products, based on accurate information on the health consequences of consuming tobacco products. Finally, all smokers should benefit from measures contained in the TPD (e.g. health warnings and ingredients regulation).
From a broader perspective, the revision will contribute to the overall aim of the EU to promote the well-being of its people (TEU Art.
3) and the Europe 2020 strategy, as keeping people healthy and active longer, and helping people to prevent avoidable diseases and premature death, will have a positive impact on productivity and competitiveness. An unintended, but welcome side effect of the measures against trade of products non-complying with the requirements of the Directive may be that the tax revenues of Member States are better protected, as these products often also circumvent national tax legislation.
The revision of the TPD focuses on five policy areas: Smokeless tobacco products and extension of the product scope (i.e. nicotine containing products and herbal products for smoking), packaging & labelling, ingredients/additives, cross-border distance sales and traceability and security features.
While a number of elements can be maintained from the existing Directive (e.g. tar, nicotine and carbon monoxide yields, ingredients reporting and the ban of placing on the market of oral tobacco), in many areas very substantial changes are proposed and some areas are added to the Directive.
In preparation for this proposal, a public consultation was held between 24 September and 17 December 2010. The Commission received more than 85,000 contributions from a wide range of stakeholders. Citizen contributions accounted for 96% of the survey response, 57% of which are “duplicate”/repeated responses i which appear to be the result of several citizen mobilisation campaigns that took place in some Member States. The actions and efforts of these campaigns have affected the overall quantitative data of the public consultation, which indicate that most of the citizens responding to the consultation were against changes to the TPD. This outcome deviates significantly from the latest Eurobarometer survey, published in May 2012. The Eurobarometer survey indicates that EU citizens, including smokers, are largely in favour of tobacco control measures, including the ones hereby proposed such as putting pictorial warnings on all tobacco packages and introducing security features.[10] Unlike public consultations it is important to note that respondents in Eurobarometer surveys are selected randomly. Member States representatives and - even more so - health NGOs favour the introduction of strict tobacco control measures, while tobacco industry and retailers are against some of the stricter measures. A report presenting the outcome of the consultation was published on 27 July 2011, and contributions have been published online i.
Targeted discussions with stakeholders took place throughout the revision process. A first exchange of views with health NGOs, tobacco- and pharmaceutical industries took place on 3 and 4 December 2009 and on 19 and 20 October 2010 and targeted discussions with NGOs, growers, cigarette producers, other tobacco producers, distributors of tobacco products and upstream suppliers of tobacco products have continued throughout 2011 and 2012 i. A number of written contributions were also received, which have been carefully considered in assessing the impacts of different policy options. The Commissioner for Health and Consumer Policy met with Health NGOs and economic stakeholders in February-March 2012 i. The revision of TPD has also been discussed regularly in the TPD Regulatory Committee from 2009 to 2012 i.
The policy area 'traceability and security features' was added to the revision in response to concerns put forward by some stakeholders that the selling of contraband or counterfeit products non-complying with the requirements of the Directive is already today a significant problem[15].
3. LEGAL ELEMENTS OF THE PROPOSAL[16]
The maximum yields of tar, nicotine and carbon monoxide as well as the measurement methods remain the same as in Directive 2001/37/EC.
Directive 2001/37/EC stipulates that Member States require manufacturers and importers of tobacco products to report on the ingredients used in such products. This proposal keeps in place this mandatory reporting system of ingredients and, in addition, foresees a common electronic format for the reporting and manufacturers are required to provide supporting data (e.g. marketing reports). Fees charged by Member States for handling the information submitted to them shall not exceed the cost attributable to those activities. In addition, the proposal foresees that placing on the market of new or modified tobacco products must not take place before the submission of ingredients data. Reported data, excluding confidential information, is published.
The harmonised reporting format and mandatory reporting will create a level playing field and facilitate collection, analysis and monitoring of data. It will also reduce the administrative burden of the industry, Member States and the Commission and provide a more robust system to handle sensitive data.
The current Directive 2001/37/EC does not harmonise Member States regulation on additives. Some Member States have therefore adopted legislation or concluded agreements with industry allowing or prohibiting certain ingredients. As a result, some ingredients are forbidden in some Member States, but not in others. The proposal foresees that tobacco products with characterising flavours, such as fruit flavours or chocolate, are prohibited. Test panels will assist in the decision making process. Additives associated with energy and vitality (e.g. caffeine and taurine), or creating the impression that products have health benefits (e.g. vitamins) are prohibited. No flavourings are allowed in filters, papers or packages. Tobacco products with increased toxicity or addictiveness shall not be placed on the market. Member States shall ensure that provisions or conditions set out under REACH[17] are applied to tobacco products as appropriate.
The proposal exempts tobacco products other than cigarettes, roll-your own tobacco and smokeless tobacco products, i.e. cigars, cigarillos and pipe tobacco from some provisions such as the prohibition of products with characterising flavours. This exemption is justified considering that these products are mainly consumed by older consumers, while the focus of this proposal is to regulate tobacco products in such a way as they do not encourage young people to start using tobacco. The exemption shall be removed if there is a substantial change of circumstances (in terms of sales volume or prevalence level among young people). The proposal addresses the heterogeneous development in Member States in relation to ingredients regulation and takes into account international developments, such as provisions of FCTC on regulation of the contents of tobacco products and guidelines therein. It allows industry to adapt the production lines in one go whilst allowing industry some margin to differentiate between products. It focuses on products particularly attractive to young people and is estimated to reduce smoking initiation. It addresses recent market developments, including the new technology of inserting additives (e.g. menthol) in the filters of the cigarettes, and allows for further guidance and developments through delegated acts.
The proposal foresees that combined warnings (picture plus text) of 75% should be displayed on both sides of the packages of tobacco products, presented in rotation. Directive 2001/37/EC already makes text health warnings mandatory and picture warnings optional. Eight Member States have already taken the initiative to make pictorial warnings obligatory in their territories (two will follow in 2013). Tar, nicotine and carbon monoxide (TNCO) levels on the packages, as stipulated under Directive 2001/37/EC, are replaced with an information message referring to harmful substances of tobacco. Display of cessation information (e.g. quit-lines, websites) is added to the packages. Packaging of tobacco products, or the products themselves, shall not include any elements that promote tobacco products or mislead consumers to believe that the product is less harmful than others, refers to flavours or tastes or resembles a food product. The proposal also includes requirements for packages, e.g. cuboid shape for cigarette packages and minimum number of cigarettes per package.
Under the proposal, Member States would retain their power to regulate the area of the package not regulated by this Directive or other Union legislation, including implementing provisions providing full standardisation of packaging of tobacco products (including colours and font), as far as these provisions are compatible with the Treaty. The Commission will report on experiences gained with respect to surfaces not governed by the Directive five years after its transposition deadline.
The proposal exempts tobacco products other than cigarettes and roll-your own tobacco from larger health warnings. In order to increase the visibility of the health warnings on smokeless tobacco products, these will have to be put on both sides of the package according to the proposal, but their size will remain unchanged compared to Directive 2001/37. Other tobacco products (e.g. cigars and pipe tobacco) will be subject to rules corresponding to the provisions set out in Directive 2001/37 EC, i.e. text warnings of not less than 30% (front) plus 40% (back) of the packages[18]. The exemption shall be removed if there is a substantial change of circumstances (in terms of sales volume or prevalence level among young people).
The proposal seeks to ensure that the appearance of the package reflects the characteristics of the product inside the package - a product that has negative health consequences, is addictive, and is not for the consumption of children and teenagers. The proposal provides for an update of current provisions on packaging and labelling in relation to scientific and international development and addresses the current fragmented development in Member States, in particular as regards pictorial warnings. The proposal will both ensure effective display of the health warnings and leave a certain space on the package for display of trademarks. The limitation of the product scope to cigarettes and roll-your-own tobacco in a first stage is justified because other tobacco products (e.g. cigars and pipe tobacco) are primarily used by older consumers. The proposal is based on new evidence showing that bigger and pictorial warnings are more effective[19] and current indications of tar, nicotine and carbon monoxide levels are misleading. The exact size of the warning (75%) has been suggested after thorough analysis of scientific evidence and international experience[20] as well as international developments (Article 11 FCTC and its guidelines call for large double sided picture warnings, and strict rules on misleading information) as well as considerations of the impact on economic stakeholders.
Directive 2001/37/EC grants a power to the Commission to adopt technical measures related to traceability and identification, but this power has not been used. As the concept of traceability has developed over the past years, it is necessary to adapt and complete the legislation in terms of traceability and security features. The proposal foresees an EU tracking and tracing system at packet level for tobacco products throughout the supply chain (excluding retail). Member States shall ensure that manufacturers of tobacco products conclude data storage contracts with independent third parties in order to ensure independence of the system and full transparency and accessibility by Member States and the Commission at all times. Processing of personal data should respect relevant data protection provisions, including rules and safeguards laid down in Directive 95/46/EC[21]. In addition to tracking and tracing, visible security features shall be put on all tobacco products placed on the EU market in order to facilitate the identification of authentic products.
Technical standards to ensure compatibility between the tracking and tracing systems used as well as for the contracts with third parties shall be adopted by delegated acts. Technical standardisations for security features shall also be adopted by the use of delegated acts.
Tobacco products other than cigarettes and roll-your-own-tobacco are granted a transitional period of five years.
The proposal ensures compliance with the requirements of the Directive, creates a level playing field between different operators (currently only the biggest four tobacco manufacturers are required to develop and use tracking and tracing systems), facilitates market surveillance and empowers consumers in verifying the authenticity of tobacco products. The proposal does not aim at an integration of the tracking and tracing system with existing excise and customs system (in particular the systems responsible for bulk movement control, such as Excise Movement and Control System (EMCS).
The ban of placing on the market (including cross-border distance sale) of tobacco for oral use (snus) as set out in Directive 2001/37/EC is maintained (except for Sweden which has an exemption in its Accession Treaty[22]).
It is not considered justified to lift the current ban which was introduced already in 1992 and which was justified from an internal market point of view since three Member States had already banned or announced a ban of oral tobacco due to the harmful and addictive effects of the product. At that point in time oral tobacco had also started to be distributed on the market of certain Member States in such a way as to attract young people. The harmful effect of oral tobacco has been confirmed by the Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and other studies. Given the continuous development of oral tobacco, in particular oral tobacco flavoured in a significant manner and presented in attractive packages in the Swedish market, there is a risk of uptake (also of other tobacco products) in new users, including young people. The industry confirmed that oral tobacco has huge market potential if the ban on oral tobacco were lifted.
The current ban was seen as proportionate by the Court of Justice of the European Union in 2004 due to the harmful effects, the uncertainty of oral tobacco as a substitute for cigarettes, the addictive and toxic properties of nicotine, oral tobacco's risk potential for young people and the novelty of the product[23]. This reasoning is still valid today.
Cross-border distance sales of tobacco products fall outside the scope of Directive 2001/37/EC. The proposal includes a notification obligation for retailers of tobacco products intending to engage in cross-border distance sales. The proposal allows Member States to require the retailer to appoint a natural person, who ensures compliance with the Directive of products delivered to customers in Member States concerned. Mandatory age verification mechanism is also foreseen.
The proposal facilitates legal activity without removing any sales channels, while allowing consumers legitimate access to tobacco products not available on their domestic market. It reinforces the effect on the internal market by preventing purchasing of products not complying with the provisions of the Directive, including health warnings in the right language and ingredients regulation. It also aims at addressing underage purchasing. An unintended side-effect is that the proposal will reduce the availability of cheaper products not respecting national price policies.
Novel tobacco products are products containing tobacco which do not fall within any of the established product categories (e.g. cigarette, roll-your-own tobacco, pipe tobacco, water-pipe tobacco, cigar, cigarillo, chewing tobacco, nasal tobacco or tobacco for oral use) and which are placed on the market after the entry into force of the Directive. These products will have to respect requirements of the Directive (e.g. in terms of labelling and ingredients) to ensure a level playing field, and the applicable rules will depend on whether the product involves a combustion process or not.
The proposal also foresees a notification obligation for novel tobacco products and a report on the market development in these products will be issued by the Commission five years after the transposition deadline of the Directive.
The introduction of a notification system for novel tobacco products would contribute to increasing the knowledge base as regards these products for purpose of possible future amendments to the Directive.
NCP fall outside the scope of Directive 2001/37/EC and Member States have so far taken different regulatory approaches to address these products, including regulating them as medicinal products, applying certain provisions that are used for tobacco products or having no specific legislation.
The proposal stipulates that NCP that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance[24]. NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adapted health warning. The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received a market authorisation under the medicinal products' legislation.
The proposal removes current legislative divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products, increases legal certainty and consolidates the on-going development in Member States. It also encourages research and innovation in smoking cessation with the aim of maximising health gains. Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people – unaware of the content and effects of these products – inadvertently develop a nicotine addiction.
The labelling requirement set out in this proposal for NCP containing nicotine below the identified threshold will better inform consumers about the health risks associated with the products.
Herbal products for smoking fall outside the scope of Directive 2001/37/EC and Member States regulate these products in different ways.
The proposal foresees adapted health warnings for herbal products for smoking to inform consumers about the adverse health effects of these products. In addition, no promotional or misleading elements are allowed on the packages.
The proposal ensures a more homogenous development in the EU and creates a safety net for consumers. The proposal also provides consumers and potential consumers with more appropriate information about the adverse health effects of herbal products for smoking and thus allows them to make informed choices.
Directive 2001/37/EC was adopted on the basis of Article 95 of the Treaty establishing the European Community, TEC (now Article 114 Treaty on the Functioning of the European Union, TFEU)[25]. The choice of the legal base has been confirmed by the Court of Justice of the European Union[26]. The same legal basis is appropriate for this proposal, aiming at revising Directive 2001/37EC. Article 114 TFEU empowers the European Parliament and the Council to adopt measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market. According to Article 114 TFEU, the Commission should aim at ensuring a high level of health protection in its proposal envisaged in paragraph 1 of Article 114.
First, this legal basis is appropriate to update, in light of scientific and international developments, the existing level of harmonisation as regards display of tar, nicotine and carbon monoxide levels, the size of the warnings and certain aspects in the area of traceability features[27]. Second, approximation of national legislations on tobacco products under Article 114 is justified when it is necessary to remove obstacles to the free movement of goods[28]. This is particularly relevant as regards measures related to product scope, labelling and ingredients. Third, harmonisation is justified to ensure that certain provisions concerning the internal market are not circumvented[29]. This is particularly relevant for the areas on cross-border distance sales and traceability and security features. Measures foreseen in these areas will facilitate licit activity and thus prevent sale of tobacco products not complying with the TPD, including health warnings in the right language and ingredients regulation.
The objectives of the proposed action cannot be sufficiently achieved by the Member States, neither at central nor at regional or local level, but can rather be best achieved at Union level (Article 5 TEU).
Some of the areas included in this proposal are already harmonised, but need to be updated in accordance with market, scientific and international developments. Due to the harmonisation which already exists under Directive 2001/37/EC, Member States are prevented from acting unilaterally, for example to increase the size of the health warnings or to remove the display of tar, nicotine and carbon monoxide.
Other areas relevant for this proposal are subject to different legal approaches in Member States which have led to obstacles to the functioning of the internal market. For example, for labelling and ingredients, the heterogeneous situations in Member States have resulted in a situation where the industry has to produce different product lines for different markets. Only a harmonised approach at EU-level in such areas can remove obstacles to cross-border trade and avoid fragmentation, while ensuring a comparable high level of health protection.
Finally, it is very difficult for a Member State to act unilaterally in some areas due to the difficulties to enforce such an action when other Member States have different rules. For example, it appears almost impossible for a Member State to regulate tobacco internet sales, e.g. regarding the minimum legal age to purchase tobacco, if such sales are unregulated in other Member States. A legally binding and EU wide measure therefore produces clear benefits. The same holds true for the EU tracking and tracing system, when tobacco products regularly move across borders.
This proposal also contributes to greater consistency, both between and within Member States, and a higher level of legal certainty, for example in the area of nicotine containing products where the legal current situation is complex and unclear, which undermines the level playing field.
Under the principle of proportionality, the content and form of the Union action shall not exceed what is necessary to achieve the objectives of the Treaty (Article 5 TEU). This proposal provides an appropriate level of margin for implementation by the Member States. It fully respects responsibilities of the Member States to organise, finance and deliver health services and medical care. It is a balanced proposal, which is ambitious while respecting legitimate interests of stakeholders.
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 proposal takes the form of a Directive which will replace as a whole Directive 2001/37/EC.
Even though the proposed changes do not affect all provisions of Directive 2001/37/EC, the text would have to undergo numerous modifications which would change its current presentation. Against this background, it is proposed to repeal Directive 2001/37/EC and, for reasons of clarity, to replace it with a new act modelled on the Directive in force but enriched with new elements and adjustments.
Contents
- Budgetary implications
- 2. Results of CONSULTATIONS with interested parties AND IMPACT ASSESSMENT
- 3.1. Ingredients and emissions
- 3.2. Labelling and packaging
- 3.3. Traceability and security features
- 3.4. Tobacco for oral use
- 3.5. Cross-border distance sales of tobacco products
- 3.6. Novel tobacco products
- 3.7. Nicotine containing products (NCP)
- 3.8. Herbal products for smoking
- 3.9. Union competence
- 3.9.1. Legal base
- 3.9.2. Subsidiarity
- 3.9.3. Proportionality
- 3.9.4. Fundamental Rights
- 3.9.5. Legal form
The budgetary implications of the proposal are as follows:
Ÿ Commission staff to continue to manage and further develop the EU regulatory framework on tobacco products’ regulation (functioning of this Directive and drafting of delegated/implementing acts), including Commission bodies or staff to provide scientific opinion and technical support.
Ÿ Commission staff to continue to support Member States in ensuring its effective and efficient implementation, including the development of an implementation plan and a network of Member States to discuss implementation.
Ÿ Costs for continue organising meetings of the Committee set up under this Directive, including reimbursement of the members appointed by the Member States.
Ÿ Costs for further development of a new EU wide electronic format for ingredients reporting.
Ÿ Costs for coordination of new test panels approved and monitored by Member States.
Ÿ Costs for continuing to keep the health warnings up to date, including testing of new warnings.
Ÿ Costs for continuing participation in international cooperation.
Details of the costs are set out in the legislative financial statement. The proposal allows Member States to charge a fee for handling the ingredients reporting.
The budgetary impact is consistent with the MFF 2014-2020 as proposed by the Commission.