(1)

Directive 2001/37/EC of the European Parliament and of the Council (4) lays down rules at Union level concerning tobacco products. In order to reflect scientific, market and international developments, substantial changes to that Directive would be needed and it should therefore be repealed and replaced by a new Directive.

(2)

In its reports of 2005 and 2007 on the application of Directive 2001/37/EC the Commission identified areas in which further action was considered useful for the smooth functioning of the internal market. In 2008 and 2010 the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) provided scientific advice to the Commission on smokeless tobacco products and tobacco additives. In 2010 a broad stakeholder consultation took place, which was followed by targeted stakeholder consultations and accompanied by studies by external consultants. Member States were consulted throughout the process. The European Parliament and the Council repeatedly called on the Commission to review and update Directive 2001/37/EC.

(3)

In certain areas covered by Directive 2001/37/EC, Member States are legally or in practice prevented from effectively adapting their legislation to new developments. This is in particular relevant for the labelling rules, where Member States have not been permitted to increase the size of the health warnings, change their location on an individual packet (‘unit packet’) or replace misleading warnings on the tar, nicotine and carbon monoxide (TNCO) emission levels.

(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 present obstacles to the smooth functioning of the internal market. In the light of scientific, market and international developments these discrepancies are expected to increase. This also applies to electronic cigarettes and refill containers for electronic cigarettes (‘refill containers’), herbal products for smoking, ingredients and emissions from tobacco products, certain aspects of labelling and packaging and to cross-border distance sales of tobacco products.

(5)

Those obstacles should be eliminated and, to this end, the rules on the manufacture, presentation and sale of tobacco and related products should be further approximated.

(6)

The size of the internal market in tobacco and related products, the increasing tendency of manufacturers of tobacco products to concentrate production for the entire Union in only a small number of production plants within the Union and the resulting significant cross-border trade of tobacco and related products calls for stronger legislative action at Union rather than national level to achieve the smooth functioning of the internal market.

(7)

Legislative action at Union level is also necessary in order to implement the WHO Framework Convention on Tobacco Control (‘FCTC’) of May 2003, the provisions of which are binding on the Union and its Member States. The FCTC provisions on the regulation of the contents of tobacco products, the regulation of tobacco product disclosures, the packaging and labelling of tobacco products, advertising and illicit trade in tobacco products are particularly relevant. The Parties to the FCTC, including the Union and its Member States, adopted a set of guidelines for the implementation of FCTC provisions by consensus during various Conferences.

(8)

In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (TFEU), a high level of health protection should be taken as a base for legislative proposals and, in particular, any new developments based on scientific facts should be taken into account. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco on human health, health protection should be given high importance, in particular, to reduce smoking prevalence among young people.

(9)

It is necessary to establish a number of new definitions in order to ensure that this Directive is uniformly applied by Member States. Where different obligations imposed by this Directive apply to different product categories and the relevant product falls into more than one of those categories (e.g. pipe, roll your-own tobacco), the stricter obligations should apply.

(10)

Directive 2001/37/EC established maximum limits for tar, nicotine and carbon monoxide yields of cigarettes that should also be applicable to cigarettes which are exported from the Union. Those maximum limits and that approach remain valid.

(11)

For measuring the tar, nicotine and carbon monoxide yields of cigarettes (hereinafter referred to as ‘emission levels’), reference should be made to the relevant, internationally recognised ISO standards. The verification process should be protected from tobacco industry influence by using independent laboratories, including State laboratories. Member States should be able to use laboratories situated in other Member States of the Union. For other emissions from tobacco products, there are no internationally agreed standards or tests for quantifying maximum levels. The ongoing efforts at international level to develop such standards or tests should be encouraged.

(12)

As regards establishing maximum emission levels, it could be necessary and appropriate at a later date to reduce the emission levels for tar, nicotine and carbon monoxide or to establish maximum levels for other emissions from tobacco products, taking into consideration their toxicity or addictiveness.

(13)

In order to carry out their regulatory tasks, Member States and the Commission require comprehensive information on the ingredients and emissions from tobacco products to assess the attractiveness, addictiveness and toxicity of tobacco products and the health risks associated with the consumption of such products. To this end, the existing reporting obligations for ingredients and emissions should be strengthened. Additional enhanced reporting obligations should be provided for in respect of additives included in a priority list in order to assess, inter alia their toxicity, addictiveness and carcinogenic, mutagenic or reprotoxic properties (‘CMR properties’), including in combusted form. The burden of such enhanced reporting obligations for SMEs should be limited to the extent possible. Such reporting obligations are consistent with the obligation placed on the Union to ensure a high level of protection for human health.

(14)

The use of differing reporting formats, as is currently the case, makes it difficult for manufacturers and importers to fulfil their reporting obligations and burdensome for the Member States and the Commission to compare, analyse and draw conclusions from the information received. Therefore, there should be a common mandatory format for the reporting of ingredients and emissions. The greatest possible transparency of product information should be ensured for the general public, whilst ensuring that appropriate account is taken of the trade secrets of the manufacturers of tobacco products. Existing systems for the reporting of ingredients should be taken into account.

(15)

The lack of a harmonised approach to regulating the ingredients of tobacco products affects the smooth functioning of the internal market and has a negative impact on the free movement of goods across the Union. 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 certain Member States, but not in others. Member States also take differing approaches as regards additives in the filters of cigarettes as well as additives colouring the tobacco smoke. Without harmonisation, the obstacles to the smooth functioning of the internal market are expected to increase in the coming years, taking into account the implementation of the FCTC and the relevant FCTC guidelines throughout the Union and in the light of experience gained in other jurisdictions outside the Union. The FCTC guidelines in relation to the regulation of the contents of tobacco products and regulation of tobacco product disclosures call in particular for the removal of ingredients that increase palatability, create the impression that tobacco products have health benefits, are associated with energy and vitality or have colouring properties.

(16)

The likelihood of diverging regulation is further increased by concerns over tobacco products having a characterising flavour other than one of tobacco, which could facilitate initiation of tobacco consumption or affect consumption patterns. Measures introducing unjustified differences of treatment between different types of flavoured cigarettes should be avoided. However, products with characterising flavour with a higher sales volume should be phased out over an extended time period to allow consumers adequate time to switch to other products.

(17)

The prohibition of tobacco products with characterising flavours does not preclude the use of individual additives outright, but it does oblige manufacturers 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 the manufacture of tobacco products, for example sugar to replace sugar that is lost during the curing process, should be allowed, as long as they do not result in a characterising flavour or increase the addictiveness, toxicity or CMR properties of the product. An independent European advisory panel should assist in such decision making. The application of this Directive should not lead to discrimination between different tobacco varieties, nor should it prevent product differentiation.

(18)

Certain additives are used to create the impression that tobacco products have health benefits, present reduced health risks or increase mental alertness and physical performance. These additives, as well as additives that have CMR properties in unburnt form, should be prohibited in order to ensure uniform rules throughout the Union and a high level of protection of human health. Additives that increase addictiveness and toxicity should also be prohibited.

(19)

Considering this Directive's focus on young people, tobacco products other than cigarettes and roll-your-own tobacco, should be granted an exemption from certain requirements relating to ingredients as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns of young people.

(20)

Given the general prohibition of the sale of tobacco for oral use in the Union, the responsibility for regulating the ingredients of tobacco for oral use, which requires in-depth knowledge of the specific characteristics of this product and of its patterns of consumption, should, in accordance with the principle of subsidiarity, remain with Sweden, where the sale of this product is permitted pursuant to Article 151 of the Act of Accession of Austria, Finland and Sweden.

(21)

In line with the purposes of this Directive, namely to facilitate the smooth functioning of the internal market for tobacco and related products, taking as a base a high level of health protection, especially for young people, and in line with Council Recommendation 2003/54/EC (5), Member States should be encouraged to prevent sales of such products to children and adolescents, by adopting appropriate measures that lay down and enforce age limits.

(22)

Disparities still exist between national provisions regarding the labelling of tobacco products, in particular with regard to the use of combined health warnings consisting of a picture and a text, information on cessation services and promotional elements in and on unit packets.

(23)

Such disparities are liable to constitute a barrier to trade and to impede the smooth functioning of the internal market in tobacco products, and should, therefore, be eliminated. Also, it is possible that consumers in some Member States are better informed about the health risks of tobacco products than consumers in other Member States. Without further action at Union level, the existing disparities are likely to increase in the coming years.

(24)

Adaptation of the provisions on labelling is also necessary to align the rules that apply at Union level to international developments. For example, the FCTC guidelines on the packaging and labelling of tobacco products call for large picture warnings on both principal display areas, mandatory cessation information and strict rules on misleading information. The provisions on misleading information will complement the general ban on misleading business to consumer commercial practices laid down in Directive 2005/29/EC of the European Parliament and of the Council (6).

Member States that use tax stamps or national identification marks for fiscal purposes on the packaging of tobacco products may, in some cases, have to provide for these stamps and marks to be repositioned in order to allow for the combined health warnings to be at the top of the principal display areas, in line with this Directive and the FCTC guidelines. Transitional arrangements should be put in place to allow Member States to maintain tax stamps or national identification marks used for fiscal purposes at the top of unit packets for a certain period after transposition of this Directive.

(25)

The labelling provisions should also be adapted to new scientific evidence. For example, the indication of the emission levels for tar, nicotine and carbon monoxide on unit packets of cigarettes has proven to be misleading as it leads consumers to believe that certain cigarettes are less harmful than others. Evidence also suggests that large combined health warnings comprised of a text warning and a corresponding colour photograph are more effective than warnings consisting only of text. As a consequence, combined health warnings should become mandatory throughout the Union and cover significant and visible parts of the surface of unit packets. Minimum dimensions should be set for all health warnings to ensure their visibility and effectiveness.

(26)

For tobacco products for smoking, other than cigarettes and roll-your-own tobacco products, which are mainly consumed by older consumers and small groups of the population, it should be possible to continue to grant an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns of young people. The labelling of these other tobacco products should follow rules that are specific to them. The visibility of health warnings on smokeless tobacco products should be ensured. Health warnings should, therefore, be placed on the two main surfaces of the packaging of smokeless tobacco products. As regards waterpipe tobacco, which is often perceived as less harmful than traditional tobacco products for smoking, the full labelling regime should apply in order to avoid consumers being misled.

(27)

Tobacco products or their packaging could mislead consumers, in particular young people, where they suggest that these products are less harmful. This is, for example, the case if certain words or features are used, such as the words ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’ or ‘slim’, or certain names, pictures, and figurative or other signs. Other misleading elements might include, but are not limited to, inserts or other additional material such as adhesive labels, stickers, onserts, scratch-offs and sleeves or relate to the shape of the tobacco product itself. Certain packaging and tobacco products could also mislead consumers by suggesting benefits in terms of weight loss, sex appeal, social status, social life or qualities such as femininity, masculinity or elegance. Likewise, the size and appearance of individual cigarettes could mislead consumers by creating the impression that they are less harmful. Neither the unit packets of tobacco products nor their outside packaging should include printed vouchers, discount offers, reference to free distribution, two-for-one or other similar offers that could suggest economic advantages to consumers thereby inciting them to buy those tobacco products.

(28)

In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimensions of the health warnings as well as regarding certain aspects of the appearance of the unit packets of tobacco products, including the shape and opening mechanism. When prescribing a cuboid shape for a unit packet, rounded or bevelled edges should be considered acceptable, provided the health warning covers a surface area that is equivalent to that on a unit packet without such edges. Member States apply different rules on the minimum number of cigarettes per unit packet. Those rules should be aligned in order to ensure free circulation of the products concerned.

(29)

Considerable volumes of illicit products, which do not fulfil the requirements laid down in Directive 2001/37/EC, are placed on the market and there are indications that these volumes might increase. Such illicit products undermine the free circulation of compliant products and the protection provided for by tobacco control legislation. In addition, the FCTC requires the Union to combat illicit tobacco products, including those illegally imported into the Union, as part of a comprehensive Union policy on tobacco control. Provision should, therefore, be made for unit packets of tobacco products to be marked with a unique identifier and security features and for their movements to be recorded so that such products can be tracked and traced throughout the Union and their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security features that will facilitate the verification of whether or not tobacco products are authentic.

(30)

An interoperable tracking and tracing system and security features should be developed at Union level. For an initial period only cigarettes and roll-your-own tobacco should be subjected to the tracking and tracing system and the security features. This would allow manufacturers of other tobacco products to benefit from the experience gained prior to the tracking and tracing system and security features becoming applicable to those other products.

(31)

In order to ensure independence and transparency of the tracking and tracing system, manufacturers of tobacco products should conclude data storage contracts with independent third parties. The Commission should approve the suitability of those independent third parties and an independent external auditor should monitor their activities. The data related to the tracking and tracing system should be kept separate from other company related data and should be under the control of, and accessible at all times by, the competent authorities from Member States and the Commission.

(32)

Council Directive 89/622/EEC (7) prohibited the sale in the Member States of certain types of tobacco for oral use. Directive 2001/37/EC reaffirmed that prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden grants Sweden a derogation from the prohibition. The prohibition of the sale of tobacco for oral use should be maintained in order to prevent the introduction in the Union (apart from Sweden) of a product that is addictive and has adverse health effects. For other smokeless tobacco products that are not produced for the mass market, strict provisions on labelling and certain provisions relating to their ingredients are considered sufficient to contain their expansion in the market beyond their traditional use.

(33)

Cross-border distance sales of tobacco products could facilitate access to tobacco products that do not comply with this Directive. There is also an increased risk that young people would get access to tobacco products. Consequently, there is a risk that tobacco control legislation would be undermined. Member States should, therefore, be allowed to prohibit cross-border distance sales. Where cross-border distance sales are not prohibited, common rules on the registration of retail outlets engaging in such sales are appropriate to ensure the effectiveness of this Directive. Member States should, in accordance with Article 4(3) of the Treaty on European Union (TEU) cooperate with each other in order to facilitate the implementation of this Directive, in particular with respect to measures taken as regards cross-border distance sales of tobacco products.

(34)

All tobacco products have the potential to cause mortality, morbidity and disability. Accordingly, their manufacture, distribution and consumption should be regulated. It is, therefore, important to monitor developments as regards novel tobacco products. Manufacturers and importers should be obliged to submit a notification of novel tobacco products, without prejudice to the power of the Member States to ban or to authorise such novel products.

(35)

In order to ensure a level playing field, novel tobacco products, that are tobacco products as defined in this Directive, should comply with the requirements of this Directive.

(36)

Electronic cigarettes and refill containers should be regulated by this Directive, unless they are - due to their presentation or function - subject to Directive 2001/83/EC of the European Parliament and of the Council (8) or to Council Directive 93/42/EEC (9). Diverging legislation and practices as regards these products, including on safety requirements, exist between Member States, hence, action at Union level is required to improve the smooth functioning of the internal market. A high level of public health protection should be taken into account when regulating these products. In order to enable Member States to carry out their surveillance and control tasks, manufacturers and importers of electronic cigarettes and refill containers should be required to submit a notification of the relevant products before they are placed on the market.

(37)

Member States should ensure that electronic cigarettes and refill containers comply with the requirements of this Directive. Where the manufacturer of the relevant product is not established in the Union, the importer of that product should bear the responsibilities relating to the compliance of those products with this Directive.

(38)

Nicotine-containing liquid should only be allowed to be placed on the market under this Directive, where the nicotine concentration does not exceed 20 mg/ml. This concentration allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette. In order to limit the risks associated with nicotine, maximum sizes for refill containers, tanks and cartridges should be set.

(39)

Only electronic cigarettes that deliver nicotine doses at consistent levels should be allowed to be placed on the market under this Directive. Delivery of nicotine doses at consistent levels under normal conditions of use is necessary for health protection, safety and quality purposes, including to avoid the risk of accidental consumption of high doses.

(40)

Electronic cigarettes and refill containers could create a health risk when in the hands of children. Therefore, it is necessary to ensure that such products are child- and tamperproof, including by means of child-proof labelling, fastenings and opening mechanisms.

(41)

In view of the fact that nicotine is a toxic substance and considering the potential health and safety risks, including to persons for whom the product is not intended, nicotine-containing liquid should only be placed on the market in electronic cigarettes or in refill containers that meet certain safety and quality requirements. It is important to ensure that electronic cigarettes do not break or leak during use and refill.

(42)

The labelling and packaging of these products should display sufficient and appropriate information on their safe use, in order to protect human health and safety, should carry appropriate health warnings and should not include any misleading elements or features.

(43)

Disparities between national laws and practices on advertising and sponsorship concerning electronic cigarettes present an obstacle to the free movement of goods and the freedom to provide services and create an appreciable risk of distortion of competition. Without further action at Union level, those disparities are likely to increase over the coming years, also taking into account the growing market for electronic cigarettes and refill containers. Therefore, it is necessary to approximate the national provisions on advertising and sponsorship of those products having cross-border effects, taking as a base a high level of protection of human health. Electronic cigarettes can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalize the action of smoking. For this reason, it is appropriate to adopt a restrictive approach to advertising electronic cigarettes and refill containers.

(44)

In order to perform their regulatory tasks, the Commission and Member States need comprehensive information on market developments as regards electronic cigarettes and refill containers. To this end manufacturers and importers of these products should be subject to reporting obligations on sales volumes, preference of various consumer groups and mode of sales. It should be ensured that this information is made available to the general public, taking the need to protect trade secrets duly into account.

(45)

In order to ensure appropriate market surveillance by Member States, it is necessary that manufacturers, importers and distributors operate an appropriate system for monitoring and recording suspected adverse effects and inform the competent authorities about such effects so that appropriate action can be taken. It is warranted to provide for a safeguard clause that would allow Member States to take action to address serious risks to public health.

(46)

In the context of an emerging market for electronic cigarettes, it is possible that, although complying with this Directive, specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, placed on the market could pose an unforeseen risk to human health. It is therefore advisable to provide for a procedure to address this risk, which should include the possibility for a Member State to adopt provisional appropriate measures. Such provisional appropriate measures could involve the prohibition of the placing on the market of specific electronic cigarettes or refill containers, or of a type of electronic cigarette or refill container. In this context, the Commission should be empowered to adopt delegated acts in order to prohibit the placing on the market of specific electronic cigarettes or refill containers, or of a type of electronic cigarette or refill container. The Commission should be empowered to do so, when at least three Member States have prohibited the products concerned on duly justified grounds and it is necessary to extend this prohibition to all Member States in order to ensure the smooth functioning of the internal market for products complying with this Directive but not presenting the same health risks. The Commission should report on the potential risks associated with refillable electronic cigarettes by 20 May 2016.

(47)

This Directive does not harmonise all aspects of electronic cigarettes or refill containers. For example, the responsibility for adopting rules on flavours remains with the Member States. It could be useful for Member States to consider allowing the placing on the market of flavoured products. In doing so, they should be mindful of the potential attractiveness of such products for young people and non smokers. Any prohibition of such flavoured products would need to be justified and notification thereof submitted in accordance with Directive 98/34/EC of the European Parliament and of the Council (10).

(48)

Moreover, this Directive does not harmonise the rules on smoke-free environments, or on domestic sales arrangements or domestic advertising, or brand stretching, nor does it introduce an age limit for electronic cigarettes or refill containers. In any case, the presentation and advertising of those products should not lead to the promotion of tobacco consumption or give rise to confusion with tobacco products. Member States are free to regulate such matters within the remit of their own jurisdiction and are encouraged to do so.

(49)

The regulation of herbal products for smoking differs between Member States and these products are often perceived as harmless or less harmful despite the health risk caused by their combustion. In many cases consumers do not know the content of these products. In order to ensure the smooth functioning of the internal market and improve information to consumers, common labelling rules and ingredients reporting for these products should be introduced at Union level.

(50)

In order to ensure uniform conditions for the implementation of this Directive implementing powers should be conferred on the Commission concerning the laying down and updating of a priority list of additives for enhanced reporting, the laying down and updating of the format for the reporting of ingredients and for the dissemination of that information, determining whether a tobacco product has a characterising flavour or has increased levels of toxicity, addictiveness or CMR properties, the methodology for determining whether a tobacco product has a characterising flavour, the procedures for the establishment and operation of an independent advisory panel for determining tobacco products with characterising flavours, the precise position of health warnings on pouches of roll-your-own tobacco, the technical specifications for the layout, design, and shape of combined health warnings, the technical standards for the establishment and operation of the tracking and tracing system, for ensuring the compatibility of the systems for the unique identifiers and for the security features, as well as establishing a common format for notification of electronic cigarettes and refill containers and the technical standards for the refill mechanisms for such products. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11).

(51)

In order to ensure that this Directive is fully operational and to adapt it to technical, scientific and international developments in tobacco manufacture, consumption and regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adopting and adapting maximum emission levels and methods for measuring those emissions, setting maximum levels for additives that result in a characterising flavour or that increase toxicity or addictiveness, withdrawing certain exemptions granted to tobacco products other than cigarettes and roll-your-own tobacco, adapting the health warnings, establishing and adapting the picture library, defining the key elements of the data storage contracts to be concluded for the purposes of the tracking and tracing system, and extending measures adopted by Member States to the entire Union concerning specific electronic cigarettes or refill containers or a type of electronic cigarette or refill container. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(52)

The Commission should monitor the developments as regards the implementation and impact of this Directive and submit a report by 21 May 2021, and when necessary thereafter, in order to assess whether amendments to this Directive are necessary. The report should include information on the surfaces of unit packets of tobacco products that are not governed by this Directive, market developments concerning novel tobacco products, market developments that amount to a substantial change of circumstances, market developments concerning, and the consumer perception of, slim cigarettes, of waterpipe tobacco and of electronic cigarettes and refill containers.

The Commission should prepare a report regarding the feasibility, benefits and impact of a European system for the regulation of ingredients in tobacco products, including the feasibility and benefits of establishing a list of ingredients at Union level that can be used, or present in or added to tobacco products (so-called ‘positive list’). In preparing that report, the Commission should evaluate, inter alia, the available scientific evidence on the toxic and addictive effects of ingredients.

(53)

Tobacco and related products which comply with this Directive should benefit from the free movement of goods. However, in light of the different degrees of harmonisation achieved by this Directive, the Member States should, under certain conditions, retain the power to impose further requirements in certain respects in order to protect public health. This is the case in relation to the presentation and the packaging, including colours, of tobacco products other than health warnings, for which this Directive provides a first set of basic common rules. Accordingly, Member States could, for example, introduce provisions providing for further standardisation of the packaging of tobacco products, provided that those provisions are compatible with the TFEU, with WTO obligations and do not affect the full application of this Directive.

(54)

Moreover, in order to take into account possible future market developments, Member States should also be allowed to prohibit a certain category of tobacco or related products, on grounds relating to the specific situation in the Member State concerned and provided the provisions are justified by the need to protect public health, taking into account the high level of protection achieved through this Directive. Member States should notify such stricter national provisions to the Commission.

(55)

A Member State should remain free to maintain or introduce national laws applying to all products placed on its national market for aspects not regulated by this Directive, provided they are compatible with the TFEU and do not jeopardise the full application of this Directive. Accordingly and under those conditions, a Member State could, inter alia, regulate or ban paraphernalia used for tobacco products (including waterpipes) and for herbal products for smoking as well as regulate or ban products resembling in appearance a type of tobacco or related product. Prior notification is required for national technical regulations pursuant to Directive 98/34/EC.

(56)

Member States should ensure that personal data are only processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council (12).

(57)

This Directive is without prejudice to Union laws governing the use and labelling of genetically modified organisms.

(58)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (13), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

(59)

The obligation to respect the fundamental rights and legal principles enshrined in the Charter of Fundamental Rights of the European Union is not changed by this Directive. Several fundamental rights are affected by this Directive. It is therefore necessary to ensure that the obligations imposed on manufacturers, importers and distributors of tobacco and related products not only guarantee a high level of health and consumer protection, but also protect all other fundamental rights and are proportionate with respect to the smooth functioning of the internal market. The application of this Directive should respect Union law and relevant international obligations.

(60)

Since the objectives of this Directive, namely to approximate the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, cannot be sufficiently achieved by the Member States, but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

(1)

The main motive for cross-border organised crime, including mafia-type criminal organisation, is financial gain. As a consequence, competent authorities should be given the means to trace, freeze, manage and confiscate the proceeds of crime. However, the effective prevention of and fight against organised crime should be achieved by neutralising the proceeds of crime and should be extended, in certain cases, to any property deriving from activities of a criminal nature.

(2)

Organised criminal groups operate without borders and increasingly acquire assets in Member States other than those in which they are based and in third countries. There is an increasing need for effective international cooperation on asset recovery and mutual legal assistance.

(3)

Among the most effective means of combating organised crime is providing for severe legal consequences for committing such crime, as well as effective detection and the freezing and confiscation of the instrumentalities and proceeds of crime.

(4)

Although existing statistics are limited, the amounts recovered from proceeds of crime in the Union seem insufficient compared to the estimated proceeds. Studies have shown that, although regulated by Union and national law, confiscation procedures remain underused.

(5)

The adoption of minimum rules will approximate the Member States’ freezing and confiscation regimes, thus facilitating mutual trust and effective cross-border cooperation.

(6)

The Stockholm Programme and the Justice and Home Affairs Council Conclusions on confiscation and asset recovery adopted in June 2010 emphasise the importance of a more effective identification, confiscation and re-use of criminal assets.

(7)

The current Union legal framework on freezing, seizure and confiscation of assets consists of Joint Action 98/699/JHA (4), Council Framework Decision 2001/500/JHA (5), Council Framework Decision 2003/577/JHA (6), Council Framework Decision 2005/212/JHA (7) and Council Framework Decision 2006/783/JHA (8).

(8)

The Commission implementation reports on Framework Decisions 2003/577/JHA, 2005/212/JHA and 2006/783/JHA show that existing regimes for extended confiscation and for the mutual recognition of freezing and confiscation orders are not fully effective. Confiscation is hindered by differences between Member States’ law.

(9)

This Directive aims to amend and expand the provisions of Framework Decisions 2001/500/JHA and 2005/212/JHA. Those Framework Decisions should be partially replaced for the Member States bound by this Directive.

(10)

Member States are free to bring confiscation proceedings which are linked to a criminal case before any competent court.

(11)

There is a need to clarify the existing concept of proceeds of crime to include the direct proceeds from criminal activity and all indirect benefits, including subsequent reinvestment or transformation of direct proceeds. Thus proceeds can include any property including that which has been transformed or converted, fully or in part, into other property, and that which has been intermingled with property acquired from legitimate sources, up to the assessed value of the intermingled proceeds. It can also include the income or other benefits derived from proceeds of crime, or from property into or with which such proceeds have been transformed, converted or intermingled.

(12)

This Directive provides for a broad definition of property that can be subject to freezing and confiscation. That definition includes legal documents or instruments evidencing title or interest in such property. Such documents or instruments could include, for example, financial instruments, or documents that may give rise to creditor claims and are normally found in the possession of the person affected by the relevant procedures. This Directive is without prejudice to the existing national procedures for keeping legal documents or instruments evidencing title or interest in property, as they are applied by the competent national authorities or public bodies in accordance with national law.

(13)

Freezing and confiscation under this Directive are autonomous concepts, which should not prevent Member States from implementing this Directive using instruments which, in accordance with national law, would be considered as sanctions or other types of measures.

(14)

In the confiscation of instrumentalities and proceeds of crime following a final decision of a court and of property of equivalent value to those instrumentalities and proceeds, the broad concept of criminal offences covered by this Directive should apply. Framework Decision 2001/500/JHA requires Member States to enable the confiscation of instrumentalities and proceeds of crime following a final conviction and to enable the confiscation of property the value of which corresponds to such instrumentalities and proceeds. Such obligations should be maintained for the criminal offences not covered by this Directive, and the concept of proceeds as defined in this Directive should be interpreted in the similar way as regards criminal offences not covered by this Directive. Member States are free to define the confiscation of property of equivalent value as subsidiary or alternative to direct confiscation, as appropriate in accordance with national law.

(15)

Subject to a final conviction for a criminal offence, it should be possible to confiscate instrumentalities and proceeds of crime, or property the value of which corresponds to such instrumentalities or proceeds. Such final conviction can also result from proceedings in absentia. When confiscation on the basis of a final conviction is not possible, it should nevertheless under certain circumstances still be possible to confiscate instrumentalities and proceeds, at least in the cases of illness or absconding of the suspected or accused person. However, in such cases of illness and absconding, the existence of proceedings in absentia in Member States would be sufficient to comply with this obligation. When the suspected or accused person has absconded, Member States should take all reasonable steps and may require that the person concerned be summoned to or made aware of the confiscation proceedings.

(16)

For the purposes of this Directive, illness should be understood to mean the inability of the suspected or accused person to attend the criminal proceedings for an extended period, as a result of which the proceedings cannot continue under normal conditions. Suspected or accused persons may be requested to prove illness, for example by a medical certificate, which the court should be able to disregard if it finds it unsatisfactory. The right of that person to be represented in the proceedings by a lawyer should not be affected.

(17)

When implementing this Directive in respect of confiscation of property the value of which corresponds to instrumentalities, the relevant provisions could be applicable where, in view of the particular circumstances of the case at hand, such a measure is proportionate, having regard in particular to the value of the instrumentalities concerned. Member States may also take into account whether and to what extent the convicted person is responsible for making the confiscation of the instrumentalities impossible.

(18)

When implementing this Directive, Member States may provide that, in exceptional circumstances, confiscation should not be ordered, insofar as it would, in accordance with national law, represent undue hardship for the affected person, on the basis of the circumstances of the respective individual case which should be decisive. Member States should make a very restricted use of this possibility, and should only be allowed to provide that confiscation is not to be ordered in cases where it would put the person concerned in a situation in which it would be very difficult for him to survive.

(19)

Criminal groups engage in a wide range of criminal activities. In order to effectively tackle organised criminal activities there may be situations where it is appropriate that a criminal conviction be followed by the confiscation not only of property associated with a specific crime, but also of additional property which the court determines constitutes the proceeds of other crimes. This approach is referred to as extended confiscation. Framework Decision 2005/212/JHA provides for three different sets of minimum requirements that Member States can choose from in order to apply extended confiscation. As a result, in the process of transposition of that Framework Decision, Member States have chosen different options which resulted in divergent concepts of extended confiscation in national jurisdictions. That divergence hampers cross-border cooperation in relation to confiscation cases. It is therefore necessary to further harmonise the provisions on extended confiscation by setting a single minimum standard.

(20)

When determining whether a criminal offence is liable to give rise to economic benefit, Member States may take into account the modus operandi, for example if a condition of the offence is that it was committed in the context of organised crime or with the intention of generating regular profits from criminal offences. However, this should not, in general, prejudice the possibility to resort to extended confiscation.

(21)

Extended confiscation should be possible where a court is satisfied that the property in question is derived from criminal conduct. This does not mean that it must be established that the property in question is derived from criminal conduct. Member States may provide that it could, for example, be sufficient for the court to consider on the balance of probabilities, or to reasonably presume that it is substantially more probable, that the property in question has been obtained from criminal conduct than from other activities. In this context, the court has to consider the specific circumstances of the case, including the facts and available evidence based on which a decision on extended confiscation could be issued. The fact that the property of the person is disproportionate to his lawful income could be among those facts giving rise to a conclusion of the court that the property derives from criminal conduct. Member States could also determine a requirement for a certain period of time during which the property could be deemed to have originated from criminal conduct.

(22)

This Directive lays down minimum rules. It does not prevent Member States from providing more extensive powers in their national law, including, for example, in relation to their rules on evidence.

(23)

This Directive applies to criminal offences which fall within the scope of the instruments listed herein. Within the scope of those instruments, Member States should apply extended confiscation at least to certain criminal offences as defined in this Directive.

(24)

The practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread. The current Union legal framework does not contain binding rules on the confiscation of property transferred to third parties. It is therefore becoming increasingly necessary to allow for the confiscation of property transferred to or acquired by third parties. Acquisition by a third party refers to situations where, for example, property has been acquired, directly or indirectly, for example through an intermediary, by the third party from a suspected or accused person, including when the criminal offence has been committed on their behalf or for their benefit, and when an accused person does not have property that can be confiscated. Such confiscation should be possible at least in cases where third parties knew or ought to have known that the purpose of the transfer or acquisition was to avoid confiscation, on the basis of concrete facts and circumstances, including that the transfer was carried out free of charge or in exchange for an amount significantly lower than the market value. The rules on third party confiscation should extend to both natural and legal persons. In any event the rights of bona fide third parties should not be prejudiced.

(25)

Member States are free to define third party confiscation as subsidiary or alternative to direct confiscation, as appropriate in accordance with national law.

(26)

Confiscation leads to the final deprivation of property. However, preservation of property can be a prerequisite to confiscation and can be of importance for the enforcement of a confiscation order. Property is preserved by means of freezing. In order to prevent the dissipation of property before a freezing order can be issued, the competent authorities in the Member States should be empowered to take immediate action in order to secure such property.

(27)

Since property is often preserved for the purposes of confiscation, freezing and confiscation are closely linked. In some legal systems freezing for the purposes of confiscation is regarded as a separate procedural measure of a provisional nature, which may be followed by a confiscation order. Without prejudice to different national legal systems and to Framework Decision 2003/577/JHA, this Directive should approximate some aspects of the national systems of freezing for the purposes of confiscation.

(28)

Freezing measures are without prejudice to the possibility for a specific property to be considered evidence throughout the proceedings, provided that it would ultimately be made available for effective execution of the confiscation order.

(29)

In the context of criminal proceedings, property may also be frozen with a view to its possible subsequent restitution or in order to safeguard compensation for the damage caused by a criminal offence.

(30)

Suspected or accused persons often hide property throughout the entire duration of criminal proceedings. As a result confiscation orders cannot be executed, leaving those subject to confiscation orders to benefit from their property once they have served their sentences. It is therefore necessary to enable the determination of the precise extent of the property to be confiscated even after a final conviction for a criminal offence, in order to permit the full execution of confiscation orders when no property or insufficient property was initially identified and the confiscation order remains unexecuted.

(31)

Given the limitation of the right to property by freezing orders, such provisional measures should not be maintained longer than necessary to preserve the availability of the property with a view to possible subsequent confiscation. This may require a review by the court in order to ensure that the purpose of preventing the dissipation of property remains valid.

(32)

Property frozen with a view to possible subsequent confiscation should be managed adequately in order not to lose its economic value. Member States should take the necessary measures, including the possibility of selling or transferring the property to minimise such losses. Member States should take relevant measures, for example the establishment of national centralised Asset Management Offices, a set of specialised offices or equivalent mechanisms, in order to effectively manage the assets frozen before confiscation and preserve their value, pending judicial determination.

(33)

This Directive substantially affects the rights of persons, not only of suspected or accused persons, but also of third parties who are not being prosecuted. It is therefore necessary to provide for specific safeguards and judicial remedies in order to guarantee the preservation of their fundamental rights in the implementation of this Directive. This includes the right to be heard for third parties who claim that they are the owner of the property concerned, or who claim that they have other property rights (‘real rights’, ‘ius in re’), such as the right of usufruct. The freezing order should be communicated to the affected person as soon as possible after its execution. Nevertheless, the competent authorities may postpone communicating such orders to the affected person due to the needs of the investigation.

(34)

The purpose of communicating the freezing order is, inter alia, to allow the affected person to challenge the order. Therefore, such communication should indicate, at least briefly, the reason or reasons for the order concerned, it being understood that such indication can be very succinct.

(35)

Member States should consider taking measures allowing confiscated property to be used for public interest or social purposes. Such measures could, inter alia, comprise earmarking property for law enforcement and crime prevention projects, as well as for other projects of public interest and social utility. That obligation to consider taking measures entails a procedural obligation for Member States, such as conducting a legal analysis or discussing the advantages and disadvantages of introducing measures. When managing frozen property and when taking measures concerning the use of confiscated property, Member States should take appropriate action to prevent criminal or illegal infiltration.

(36)

Reliable data sources on the freezing and confiscation of the proceeds of crime are scarce. In order to allow for the evaluation of this Directive, it is necessary to collect a comparable minimum set of appropriate statistical data on freezing and confiscation of property, asset tracing, judicial and asset disposal activities.

(37)

Member States should endeavour to collect data for certain statistics at a central level, with a view to sending them to the Commission. This means that the Member States should make reasonable efforts to collect the data concerned. It does not mean, however, that the Member States are under an obligation to achieve the result of collecting the data where there is a disproportionate administrative burden or when there are high costs for the Member State concerned.

(38)

This Directive respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union (‘the Charter’) and the European Convention for the Protection of Human Rights and Fundamental Freedoms (‘the ECHR’), as interpreted in the case-law of the European Court of Human Rights. This Directive should be implemented in accordance with those rights and principles. This Directive should be without prejudice to national law in relation to legal aid and does not create any obligations for Member States’ legal aid systems, which should apply in accordance with the Charter and the ECHR.

(39)

Specific safeguards should be put in place, so as to ensure that as a general rule reasons are given for confiscation orders, unless when, in simplified criminal proceedings in minor cases, the affected person has waived his or her right to be given reasons.

(40)

This Directive should be implemented taking account of the provisions of Directive 2010/64/EU of the European Parliament and of the Council (9), Directive 2012/13/EU of the European Parliament and of the Council (10) and Directive 2013/48/EU of the European Parliament and of the Council (11) which concern procedural rights in criminal proceedings.

(41)

Since the objective of this Directive, namely facilitating confiscation of property in criminal matters, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(42)

In accordance with Articles 3 and 4a(1) of Protocol (No 21) on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU), Ireland has notified its wish to take part in the adoption and application of this Directive. In accordance with that Protocol, Ireland is to be bound by this Directive only in respect of the offences covered by the instruments by which it is bound.

(43)

In accordance with Articles 1, 2 and 4a(1) of Protocol (No 21) on the position of the United Kingdom and Ireland in respect of the Area of Freedom, Security and Justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Directive and is not bound by it or subject to its application. Subject to its participation in accordance with Article 4 of that Protocol, the United Kingdom is to be bound by this Directive only in respect of the offences covered by the instruments by which it is bound.

(44)

In accordance with Articles 1 and 2 of Protocol (No 22) on the position of Denmark annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application,

(1)

‘proceeds’ means any economic advantage derived directly or indirectly from a criminal offence; it may consist of any form of property and includes any subsequent reinvestment or transformation of direct proceeds and any valuable benefits;

(2)

‘property’ means property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents or instruments evidencing title or interest in such property;

(3)

‘instrumentalities’ means any property used or intended to be used, in any manner, wholly or in part, to commit a criminal offence or criminal offences;

(4)

‘confiscation’ means a final deprivation of property ordered by a court in relation to a criminal offence;

(5)

‘freezing’ means the temporary prohibition of the transfer, destruction, conversion, disposal or movement of property or temporarily assuming custody or control of property;

(6)

‘criminal offence’ means an offence covered by any of the instruments listed in Article 3.

(a)

Convention drawn up on the basis of Article K.3(2)(c) of the Treaty on European Union on the fight against corruption involving officials of the European Communities or officials of the Member States of the European Union (12) (‘Convention on the fight against corruption involving officials’);

(b)

Council Framework Decision 2000/383/JHA of 29 May 2000 on increasing protection by criminal penalties and other sanctions against counterfeiting in connection with the introduction of the euro (13);

(c)

Council Framework Decision 2001/413/JHA of 28 May 2001 on combating fraud and counterfeiting on non-cash means of payment (14);

(d)

Council Framework Decision 2001/500/JHA of 26 June 2001 on money laundering, the identification, tracing, freezing, seizing and confiscation of instrumentalities and the proceeds of crime (15);

(e)

Council Framework Decision 2002/475/JHA of 13 June 2002 on combating terrorism (16);

(f)

Council Framework Decision 2003/568/JHA of 22 July 2003 on combating corruption in the private sector (17);

(g)

Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (18);

(h)

Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (19);

(i)

Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (20);

(j)

Directive 2011/93/EU of the European Parliament and of the Council of 13 December 2011 on combating the sexual abuse and sexual exploitation of children and child pornography, and replacing Council Framework Decision 2004/68/JHA (21);

(k)

Directive 2013/40/EU of the European Parliament and of the Council of 12 August 2013 on attacks against information systems and replacing Council Framework Decision 2005/222/JHA (22),

(1)

In its White Paper of 28 March 2011 entitled ‘Roadmap to a Single European Transport Area – Towards a competitive and resource efficient transport system’, the Commission set out a ‘zero-vision’ objective whereby the Union should move close to zero fatalities in road transport by 2050. With a view to attaining that objective, vehicle technology is expected to contribute greatly to improvement of the safety record of road transport.

(2)

In its Communication entitled ‘Towards a European road safety area: policy orientations on road safety 2011-2020’, the Commission proposed a further halving of the overall number of road fatalities in the Union by 2020, starting from 2010. With a view to attaining that goal, the Commission set out seven strategic objectives, and identified actions for safer vehicles, a strategy to reduce the number of injuries and measures to improve the safety of vulnerable road users, in particular motorcyclists.

(3)

Roadworthiness testing is a part of a wider regime designed to ensure that vehicles are kept in a safe and environmentally acceptable condition during their use. That regime should cover periodic roadworthiness testing of vehicles and technical roadside inspection of vehicles used for commercial road transport activities, as well as providing for a vehicle registration procedure allowing for the suspension of a vehicle’s authorisation to be used in road traffic where the vehicle constitutes an immediate risk to road safety. Periodic testing should be the main tool to ensure roadworthiness. Technical roadside inspections of commercial vehicles should merely be complementary to periodic testing.

(4)

Member States should be allowed to set higher test standards than those required by this Directive.

(5)

Enforcement of roadworthiness measures may include awareness campaigns focusing on vehicle owners and aimed at developing good practices and habits resulting from basic checks on their vehicles.

(6)

Vehicles with malfunctioning technical systems have an impact on road safety and may contribute to road crashes involving injuries or fatalities. That impact could be reduced if adequate improvements to the roadworthiness testing system were put in place. Early disclosure of a deficiency in the roadworthiness of a vehicle would help to remedy that deficiency and hence prevent accidents.

(7)

Vehicles with malfunctioning emission control systems have a greater impact on the environment than properly maintained vehicles. Therefore, a periodic regime of roadworthiness tests would contribute to improving the environment by reducing average vehicle emissions.

(8)

Member States should consider appropriate measures to prevent adverse manipulation of, or tampering with, vehicle parts and components that could have a negative bearing on required safety and environmental characteristics of the vehicle, in particular through the periodic roadworthiness test, including effective, proportionate, dissuasive and non-discriminatory penalties.

(9)

During the last two decades, requirements in respect of vehicle emissions for type-approval have been continuously strengthened. However, air quality has not improved as much as predicted with the tightening of emission standards for vehicles, especially in respect of nitrogen oxides (NOx) and fine particulate matter. Possibilities for improving test cycles to match on-road conditions should be closely examined in order to develop future solutions, including the establishment of test methods for the measurement of NOx levels and of limit values for NOx emissions.

(10)

For vehicles complying with emission classes Euro 6 and Euro VI, on-board diagnostics systems (OBD) are becoming more effective in assessing emissions, justifying their use as an equivalent to standard emission testing for the purpose of roadworthiness tests. With a view to providing for the use of OBD in roadworthiness tests for vehicles up to emission classes Euro 5 and Euro V, Member States should be able to allow this testing method in accordance with the manufacturer’s recommendations and other requirements for such vehicles where the equivalence, taking into account any relevant type-approval legislation, where appropriate, has been independently verified.

(11)

A number of technical standards and requirements in respect of vehicle safety have been adopted in the Union. It is necessary to ensure, through a regime of periodic roadworthiness tests, that vehicles continue to meet safety standards. That regime should apply to certain categories of vehicles as defined in Directives 2002/24/EC (3), 2003/37/EC (4) and 2007/46/EC of the European Parliament and of the Council (5).

(12)

Wheeled tractors with a maximum design speed exceeding 40 km/h are increasingly used to replace trucks in local transport activities and for commercial road haulage purposes. Their risk potential is comparable to that of trucks, and vehicles in that category, which are used mainly on public roads, should therefore be subject to roadworthiness testing.

(13)

Vehicles of historical interest are supposed to conserve the heritage of the period during which they were constructed, and are considered to be hardly used on public roads. It should be left to Member States to determine the periodicity of roadworthiness testing for such vehicles. It should also be for Member States to regulate roadworthiness testing for other types of specialised vehicles.

(14)

Vehicles used exclusively on remote territories of Member States, in particular on small islands with fewer than 5 000 inhabitants or in sparsely populated areas with a population density below five persons per square kilometre, are used under conditions that may require a specific roadworthiness testing regime. Member States should therefore be empowered to exempt such vehicles from the application of this Directive.

(15)

Roadworthiness testing is a sovereign activity and should therefore be carried out by the Member States or by public or private bodies entrusted to carry out such testing under their supervision. Member States should invariably remain responsible for roadworthiness testing, even where the national system allows for private bodies, including those which also perform vehicle repairs, to carry out roadworthiness testing.

(16)

Member States should be empowered to designate testing centres located outside their territory to carry out roadworthiness tests for vehicles registered in their territory, if those testing centres have already been authorised to carry out tests on vehicles by the Member State in which they are located.

(17)

For the inspection of vehicles, and especially for their electronic safety components, it is crucial to have access to the technical specifications of each individual vehicle. Consequently, vehicle manufacturers should provide the data needed for verification of the functionality of safety and environment-related components. The provisions concerning access to repair and maintenance information should likewise be applied for that purpose, allowing inspection centres to have access to all information necessary for roadworthiness testing. The data should include the details that allow the functionality of the vehicle safety systems to be monitored in a way that allows such systems to be tested in a periodic technical inspection environment. This is of crucial importance, especially in the field of electronically controlled systems, and should cover all elements that have been installed by the manufacturer.

(18)

Vehicles used on public roads are required to be roadworthy when they are used. The holder of the registration certificate and, where applicable, the operator of the vehicle should be responsible for keeping the vehicle in a roadworthy condition.

(19)

It is important for road safety and for its impact on society that vehicles used on roads should be in a proper technical condition. Therefore, Member States should not be prevented from allowing, on a voluntary basis, additional roadworthiness tests.

(20)

To allow for a degree of flexibility for holders of a registration certificate and operators, Member States should be able to specify a period of several weeks in which the periodic roadworthiness test is to be performed.

(21)

Testing during the life cycle of a vehicle should be relatively simple, quick and inexpensive, while at the same time effective in achieving the objectives of this Directive.

(22)

Roadworthiness tests should cover all items relevant to the specific design, construction and equipment of the tested vehicle. Compatibility between parts and components, such as between wheels and wheel hubs, should be treated as a critical safety item and should be checked during roadworthiness testing. In the context of those items, and considering the current state of vehicle technology, modern electronic systems should be included in the list of items to be tested. With a view to harmonising roadworthiness testing, recommended testing methods should be established for each of the test items. Those items should be updated to take account of evolving research and technical progress in the field of vehicle safety.

(23)

In order to facilitate harmonisation and to ensure consistency of standards, a non-exhaustive list of the main reasons for failure should be provided in respect of all test items. To achieve consistency in the judgement of the condition of the tested vehicle, detected failures should be assessed to a common standard.

(24)

With a view to better applying the principle of freedom of movement within the Union, for the purpose of re-registration of a vehicle, Member States should recognise roadworthiness certificates issued by other Member States. This should not affect the right of a Member State to verify the roadworthiness certificate and the vehicle identification during re-registration and to require a new roadworthiness test to be carried out under the conditions laid down in this Directive.

(25)

Odometer fraud should be regarded as an offence liable to a penalty, because manipulation of an odometer may lead to an incorrect evaluation of the roadworthiness of a vehicle. The recording of mileage in the roadworthiness certificate and access for inspectors to that information should facilitate the detection of odometer tampering or manipulation. The exchange of information on odometer readings between the competent authorities of Member States should be examined by the Commission.

(26)

A roadworthiness certificate should be issued after each test. This should include, inter alia, information concerning the identity of the vehicle and the results of the test. The test results should be made available electronically. With a view to ensuring a proper follow-up of roadworthiness tests, Member States should collect and retain such information in a database, in particular for the purposes of analysis of the results of the periodic roadworthiness tests.

(27)

The holder of the registration certificate and, where applicable, the operator of a vehicle subject to a roadworthiness test during which deficiencies are found, in particular those which represent a risk to road safety, should rectify such deficiencies without delay. In the case of dangerous deficiencies, it may be necessary to restrict the use of the vehicle until those deficiencies are fully rectified.

(28)

Where a tested vehicle belongs to a vehicle category which is not subject to registration in the Member State where it has been put into service, that Member State should be allowed to require that the proof of test be displayed in a visible manner on the vehicle.

(29)

In order to achieve a high quality of testing throughout the Union, test equipment to be used during testing, its maintenance and its calibration should be verified with reference to specifications provided by the Member States or by manufacturers.

(30)

It should be possible for alternative equipment reflecting technological progress and innovation to be used, provided that an equivalent high-quality level of testing is ensured.

(31)

When authorising testing centres on their territory, Member States should take into account the fact that Directive 2006/123/EC of the European Parliament and of the Council (6) excludes from its scope services of general interest in the field of transport.

(32)

Testing centres should ensure the objectivity and the high quality of the vehicle testing. Therefore, in order to meet minimum requirements in terms of quality management, testing centres should comply with the requirements laid down by the authorising Member State.

(33)

High standards of roadworthiness testing require that testing personnel have a high level of skills and competences. A training system including initial training and periodic refreshers or an appropriate examination should be introduced. Provision should be made for a transitional period to allow for a smooth transition of existing testing personnel into the periodic training or examination regime. In order to ensure high standards of training, competence and testing, Member States should be allowed to lay down additional competence and corresponding training requirements.

(34)

Inspectors, when carrying out roadworthiness tests, should act independently and their judgement should not be affected by conflicts of interest, including those of an economic or personal nature. There should therefore be no direct correlation between the reward of inspectors and the results of roadworthiness tests. It should be possible for Member States to prescribe requirements regarding the separation of activities or to authorise a private body to carry out both roadworthiness tests and vehicle repairs, even on the same vehicle in cases where the supervising body has established to its satisfaction that a high level of objectivity is maintained.

(35)

The results of a roadworthiness test should not be altered for commercial purposes. Only if the findings of a roadworthiness test performed by an inspector are manifestly incorrect should the supervising body be able to modify the results of that test.

(36)

With a view to ensuring that a high quality of testing is maintained over time, Member States should set up a quality assurance system that covers the processes of authorisation, supervision, withdrawal, suspension or cancellation of authorisation to carry out roadworthiness tests.

(37)

Accreditation of testing centres under Regulation (EC) No 765/2008 of the European Parliament and of the Council (7) should not constitute an obligation for the Member States.

(38)

In several Member States, a high number of private authorised testing centres carry out roadworthiness tests. In order to ensure the efficient exchange of information between Member States in this regard, national contact points should be designated.

(39)

Roadworthiness testing forms part of a wider regulatory scheme, governing vehicles throughout their lifetime from approval via registrations and inspections until scrapping. Sharing of the information contained in national and manufacturers’ electronic vehicle databases should in principle help to improve the efficiency of the entire chain of vehicle administration and should help to reduce costs and administrative burdens. The Commission should examine the feasibility, costs and benefits of establishing an electronic vehicle information platform by taking advantage of existing and already implemented IT solutions with regard to international data exchange, so as to minimise costs and avoid duplication. In carrying out its examination of this issue, the Commission should consider the most appropriate way to link the existing national systems with a view to exchanges of information on data relating to roadworthiness testing and odometer readings between the competent authorities of Member States responsible for testing, registration and vehicle approval, testing centres, test equipment manufacturers and vehicle manufacturers. The Commission should also examine the feasibility, costs and benefits of collection and storage of available information concerning the main safety-related components of vehicles which have been involved in serious accidents as well as the possibility of making information on accident history and odometer readings available in anonymised form to vehicle inspectors, holders of registration certificates and accident researchers.

(40)

In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8).

(41)

The Commission should not adopt implementing acts relating to the information to be made accessible by vehicle manufacturers for roadworthiness testing where the committee established pursuant to this Directive delivers no opinion on the draft implementing act presented by the Commission.

(42)

In order to update the vehicle category designations in Article 2(1) and Article 5(1) and (2), to update point 3 of Annex I in respect of methods, and to adapt point 3 of Annex I, in respect of the list of test items, methods and assessment of deficiencies, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(43)

Roadworthiness has a direct impact on road safety and should therefore be reviewed periodically. The Commission should report on the effectiveness of the provisions of this Directive, including those relating to its scope, the frequency of testing, further enhancement of the roadworthiness system through electronic information exchange and the potential in the future for mutual recognition of roadworthiness certificates.

(44)

Testing facilities and equipment used in testing centres should fulfil the requirements set out for carrying out roadworthiness tests. Since this necessitates substantial investment and adaptations which it may not be possible to carry out immediately, a period of five years should be granted to comply with those requirements. A period of five years should likewise be granted to enable supervisory bodies to fulfil all the criteria and requirements concerning the authorisation and supervision of testing centres.

(45)

Since the objective of this Directive, namely to improve road safety by laying down minimum common requirements and harmonised rules concerning roadworthiness tests of vehicles within the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(46)

This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union as referred to in Article 6 of the Treaty on European Union.

(47)

This Directive integrates and updates the rules contained in Commission Recommendation 2010/378/EU (9) with a view to better regulating roadworthiness testing outcomes.

(48)

This Directive updates the technical requirements laid down in Directive 2009/40/EC of the European Parliament and of the Council (10) and enlarges its scope in order to include, in particular, provisions concerning the setting-up of testing centres and of their supervisory bodies as well as the designation of inspectors entrusted to carry out roadworthiness tests. Therefore, that Directive should be repealed,