Tag Archives: RA

Rare diseases: Europe’s challenges

Rare diseases: Europe’s challenges

Outline of the Community (European Union) legislation about Rare diseases: Europe’s challenges


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Rare diseases: Europe’s challenges

The Commission proposes a strategic approach to improving the recognition of rare diseases and patient access to suitable treatment. It supports cooperation between the European Union (EU) Member States and the development of a network of experts made up of health professionals.

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 11 November 2008 on Rare Diseases – Europe’s challenges [COM(2008) 679 final – Not published in the Official Journal].


Rare diseases, 80% being genetic in origin, are defined as those diseases which affect not more than 5 per 10 000 persons in Europe. The limited number of patients accounts for the current low level of medical knowledge and expertise, even though these diseases can lead to the death or disability of the people affected.

This communication presents a comprehensive Community strategy aimed at supporting the recognition, prevention, management and treatment of rare diseases. The Commission encourages Member States to share their knowledge and resources in this field. The Commission will be assisted by the European Union Advisory Committee on Rare Diseases (EUACRD).

Identification and visibility

The Commission is contributing to the development of the International Classification of Diseases (ICD) developed by the World Health Organisation (WHO) and to the classification and codification of rare diseases in the new version of this classification. The Commission also supports the development of an evolving European database aimed at professionals and patients.

Information networks and European Reference Networks for rare diseases are essential means for exchanging best practice and epidemiological expertise.

Screening, diagnosis and prevention

Member States should be able to use comparable data with regard to the screening and primary prevention of rare diseases. Early diagnosis of diseases can be made using biological tests. The design and validation of these tests can be facilitated through the establishment of European reference networks of expert diagnostic laboratories.

Access to care

Member States are undertaking concrete measures to ensure the quality of and universal access to care, in particular by establishing centres of expertise at national and regional levels. Their activity could be extended to providing social services in order to improve the quality of life of patients.

Access to medication

National authorities should proceed with a joint scientific assessment of orphan medicinal products. Member States should adapt their pricing and reimbursement systems on the basis of this assessment.

The Commission requests that the European Medicines Agency (EMA) encourage a common approach to improving access to compassionate use programmes. These programmes allow the provision of new medicines before they have been approved and/or reimbursed.

Regulations applicable to medical devices should be adapted to the market for orphan medicinal products. The Commission should also provide for incentive measures to encourage pharmaceutical companies to develop new treatments.


Information and Communication Technologies (ICTs) contribute to facilitating the exchange of scientific data. The telemedicine systems and services can enable professionals to share their expertise and to gain specialist knowledge.

Scientific research is supported by the 7th Framework Programme, which funds the development of computer assisted modelling, in particular, with the aim of increasing knowledge of the physiological and pathological processes of rare diseases.


Proposal for a Council recommendation of 11 November 2008 on a European action in the field of rare diseases[COM(2008) 726 final – Not published in the Official Journal].

This Proposal is based on the conclusions of the communication of 11 November 2008 which promotes a European strategic approach to rare diseases. In this context, the Council invites Member States to:

  • establish strategies and national plans before 2013 in order to ensure universal access to and the high quality of care;
  • adopt a European definition of rare diseases so that they can be referenced and coded more easily in care and reimbursement systems;
  • identify research priorities and ongoing projects, with particular regard to basic, clinical and translational research and enable patients to benefit from new therapeutic advances;
  • encourage the development of national and regional centres of expertise, cross-border care and expert networks;
  • adopt common methods in terms of screening, treatment and monitoring therapeutic techniques;
  • support the activities of parent associations;
  • ensure the viability of research infrastructures at national and European levels.

The Commission is invited to inform the Council on the progress of actions undertaken by Member States as part of the comprehensive strategy on rare diseases.

Rare diseases

Rare diseases

Outline of the Community (European Union) legislation about Rare diseases


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Rare diseases

Document or Iniciative

Council Recommendation 2009/C 151/02 of 8 June 2009 on an action in the field of rare diseases.


This Recommendation aims at introducing measures at European level to increase level of knowledge on rare diseases, as well as improve the quality of life and care of patients.

Plans and strategies

The European Commission recommends that Member States introduce plans or strategies to combat rare diseases. The aim is provide patients suffering from these diseases with high quality care, diagnosis, treatment and effective orphan drugs.

In this regard, Member States are encouraged to adopt a plan or strategy under their respective social and health schemes by 2013. These plans or strategies should integrate all current and future initiatives at local, regional and national levels in the field of rare diseases.

These national initiatives should form part of the framework of the European Project for Rare Diseases National Plans Development (EUROPLAN), which itself belongs to the Community action programme in the field of public health for 2008-2013.

Definitions, codification and inventorying

At present, a rare disease is defined as such if it does not affect more than 5 in 10 000 persons. The Commission considers this definition needs expanding and encourages Member States to work together on a definition which takes into account the parameters of incidence.

The Commission action aims to facilitate the coding and traceability of rare diseases in all health information systems, and particularly in the future version of the International Classification of Diseases (ICD). An inventory could be established on the basis of the Orphanet network or other networks.

Member States are called upon to support specific information networks, registers and databases relating to diseases.


Current knowledge in research on rare diseases should be updated.

Needs and priorities should be determined in the field of basic, clinical, translational and social research before encouraging national researchers to participate in this kind of programme.

The European Commission is responsible for establishing cooperation with third countries and fostering the exchange of information and the sharing of expertise.

Centres of expertise and European Reference Networks

The Commission invites Member States to identify qualified centres of expertise by the end of 2013 and ensure that these centres benefit from support measures. These centres are to be encouraged to participate in European Reference Networks and to develop a multidisciplinary approach.

Healthcare pathways for patients suffering from a rare disease should be created through cooperation between experts and professionals in this field. Experts should be mobile in order to facilitate the treatment of patients in their own environment.

Information and communication technologies (ICTs) such as telemedicine should be integrated, ensuring distant access to specific healthcare.

Gathering expertise at European level

The Commission considers it crucial to gather different national experts in the field of rare diseases together in order to support:

  • the exchange of best practice in terms of diagnostic tools and medical care as well as education and social care;
  • teaching and training for healthcare professionals;
  • medical training in the diagnosis of diseases and aspects related to genetics, immunology, neurology, oncology or paediatrics;
  • guidelines on population screening;
  • exchange of information between Member States.

Empowerment of patient organisations

The creation and development of associations for patients suffering from rare diseases are encouraged insofar as this facilitates access for patients to up-to-date information.


A first Community action programme on rare diseases covering the period 1999 to 2003 defined a rare disease as a disease affecting less than 5 in 10 000 persons. Its aim was to improve knowledge in this field. This Recommendation forms part of this perspective and aims to enhance cooperation and knowledge in order to improve cover and treatment for rare diseases.

Related Act

Commission Decision No (EC) 2009/872 of 30 November 2009 establishing a European Union Committee of Experts on Rare Diseases

This Decision establishes an EU committee of experts on rare diseases. The committee is tasked with:

  • implementing Community action programmes;
  • preparing Commission reports;
  • providing opinions and recommendations;
  • assisting the Commission in disseminating the measures taken at Community level, as well drawing up guidelines.

The Committee comprises 51 members and their alternates. The Committee shall be convened by the Commission and shall meet on its premises three times a year.

Radiological protection for persons undergoing medical examination or treatment

Radiological protection for persons undergoing medical examination or treatment

Outline of the Community (European Union) legislation about Radiological protection for persons undergoing medical examination or treatment


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Radiological protection for persons undergoing medical examination or treatment

Document or Iniciative

Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, and repealing Directive 84/466/Euratom.


This Directive repeals Directive 84/466 Euratom laying down basic measures for the radiation protection of persons undergoing medical examination or treatment. It also supplements Directive 96/29/Euratom.

Objective and scope

Medical exposure continues to constitute the major source of EU citizens’ exposure to artificial sources of ionising radiation. However, the use of ionising radiation has allowed great progress in many areas of medicine. It is therefore essential that practices involving medical exposure are carried out in optimised radiation protection conditions. This is also the objective of this Directive.

The Directive applies to the following types of exposure:

  • exposure of patients as part of their own medical diagnosis or treatment,
  • exposure of individuals as part of occupational health surveillance,
  • exposure of individuals as part of health screening programmes,
  • exposure of individuals voluntarily participating in medical research programmes,
  • exposure of individuals as part of medico-legal procedures.


Medical exposure must show a sufficient net benefit compared with the individual detriment that the exposure might cause, taking into account the benefits and risks of available alternative techniques.

All individual medical exposures must be justified in advance, taking into account the specific objectives of the exposure and the characteristics of the individual involved. Cases of medical exposure for biomedical and medical research must be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities.
Special attention must be given to the justification of medical exposures for medico-legal purposes.

In general, exposure which cannot be justified should be prohibited.


All doses due to medical exposure must be kept as low as reasonably achievable consistent with obtaining the required diagnostic information.

Member States must promote the establishing and use of diagnostic reference levels for radiodiagnostic examinations, having regard to European diagnostic reference levels.

For each medical research project, Member States must ensure that:

  • the individuals concerned are participating voluntarily,
  • those individuals are informed about the risks of this exposure,
  • a dose constraint is established for individuals for whom no direct medical benefit is expected from this exposure,
  • in the case of patients who voluntarily agree to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner and/or prescriber.

Member States must ensure that dose constraints are established for exposure of individuals in contact with exposed patients. Instructions must be handed out before the patient leaves the medical institution.

Clinical responsibility

Member States must ensure that any medical exposure is effected under the clinical responsibility of a practitioner.


Written protocols for every type of standard radiological practice must be established for each piece of equipment. In addition, recommendations concerning referral criteria for medical exposure must be made available to the prescribers of medical exposure.

Radiotherapeutic practices must be carried out with the assistance of a medical physics expert. For radiological practices, such an expert may be consulted on an advisory basis.

Clinical audits must be carried out in accordance with national procedures, and corrective measures must be taken where diagnostic reference levels are consistently exceeded.


Member States must ensure that practitioners receive theoretical and practical training. Continuing training must be provided after qualification. Member States must also encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools.


Member States must take steps to avoid the unnecessary proliferation of radiological equipment. They must ensure that all radiological equipment in use is kept under strict surveillance regarding radiation protection, that an up-to-date inventory is available to the competent authorities, and that appropriate quality assurance programmes are implemented by the holder of the installation. Acceptance testing must be carried out before the first use of all equipment, and thereafter performance testing on a regular basis, and after any major maintenance procedure.

The competent authorities must ensure that the holders of radiological installations take the necessary steps to improve inadequate or defective features of the equipment.

In the case of fluoroscopy, examinations without an image intensification or equivalent techniques are prohibited. Moreover, fluoroscopic examinations without devices to control the dose rate shall be limited to justified circumstances.

Special practices and protection

Appropriate radiological equipment, practical techniques and ancillary equipment must used for medical exposure:

  • of children,
  • as part of a health screening programme,
  • involving high doses to the patient.

Special attention must be given to the protection of women during pregnancy and while breast-feeding.

Accident prevention

Member States must ensure that all reasonable steps are taken to reduce the probability and magnitude of accidental or unintended doses to patients.

Estimates of population doses

Member States must ensure that the distribution of individual dose estimates from medical exposure is determined for the population and, where necessary, for relevant reference groups.


Member States must ensure that the provisions introduced in compliance with this Directive are enforced by means of an inspection system.



Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 97/43/Euratom



OJ L 180 of 09.07.1997

Related Acts

Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency [Official Journal L 357 of 7.12.1989]

Rail transport statistics

Rail transport statistics

Outline of the Community (European Union) legislation about Rail transport statistics


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Transport > Rail transport

Rail transport statistics

Document or Iniciative

Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics [See amending acts].


The Commission requires statistics on freight transport and rail transport passengers in order to ensure the monitoring and development of the common transport policy and the preparation of measures in the field of transport safety.

The scope of this regulation covers all railway undertakings in the European Union (EU). Each EU country must report statistics which relate to rail transport on its national territory. EU countries may exclude from the scope of this regulation:

  • railway undertakings which operate entirely or mainly within industrial and similar installations;
  • railway undertakings which provide local tourist services.

The statistics to be collected are set out in Annexes A to H to this regulation. The main tables setting out the annual statistics on goods and passenger transport are shown in Annexes A to D, and the quarterly statistics are shown in Annex E. Annexes F and G show the regional statistics and statistics on traffic flows on the rail network and Annex H shows statistics on accidents.

For each type of data, the corresponding annex specifies:

  • the list of variables and the corresponding units of measurement;
  • the reference periods and frequency;
  • the list of tables with the breakdown for each table;
  • the deadlines for transmission of data;
  • the first reference period for which data are to be transmitted;
  • where necessary, additional comments.

EU countries must also provide a list of the railway undertakings for which statistics are provided, as specified in Annex I. Goods must be classified in accordance with Annex J and dangerous goods must additionally be classified in accordance with Annex K. The contents of the annexes may be adapted by the Commission.

Although the national authorities (national statistical institutes) are responsible for the coordination and quality control of the statistics transmitted to Eurostat, EU countries may designate any public or private organisation to participate in collecting the data. Different sources (surveys, administrative data, etc.) may be used in any combination to obtain the required statistics. The statistics are transmitted to Eurostat by the EU countries.

The regulation provides for the dissemination of all data specified in Annexes A to H, so long as the data is already available to the EU public or approval has been explicitly given in advance for such disclosure by the undertakings concerned. Information reported under Annex I may not be disseminated.

Eurostat will develop and publish methodological recommendations (taking account of the best practices in the rail sector) to assist EU countries in maintaining the quality of statistics in this domain. The quality of the statistical data will be evaluated by Eurostat.

After data have been collected over three years, the Commission will send a report to the European Parliament and to the Council on the quality and costs of the statistics, the benefits of their availability and the burden on undertakings.

The Commission will be assisted by the Statistical Programme Committee.

EU countries must provide results for the year 2002 in accordance with Directive 80/1177/EEC. Directive 80/1177/EEC is repealed with effect from 1 January 2003.


Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 91/2003


OJ L 14 of 21.1.2003

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1192/2003


OJ L 167 of 4.7.2003

Regulation (EC) No 219/2009


OJ L 87 of 31.3.2009

Successive amendments and corrections to Regulation (EC) No 91/2003 have been incorporated in the basic text. This consolidated versionis for reference purposes only.

Related Acts

Report from the Commission to the European Parliament and the Council on experience acquired in the application of Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics [COM(2007)832 final – Not published in the Official Journal].

Commission Regulation (EC) No 332/2007 of 27 March 2007 on the technical arrangements for the transmission of railway transport statistics [Official Journal L 88 of 29.3.2007].

Rail infrastructure: multi-annual contracts

Rail infrastructure: multi-annual contracts

Outline of the Community (European Union) legislation about Rail infrastructure: multi-annual contracts


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Transport > Rail transport

Rail infrastructure: multi-annual contracts

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 6 February 2008 entitled “Multi-annual contracts for rail infrastructure quality” [COM (2008) 54 final – not published in the Official Journal].


The Commission recommends extending the system of multi-annual contracts between the State and the rail infrastructure management to improve the quality and maintenance of infrastructures in this sector.

Legal framework and legal requirements regarding the rail infrastructure

Current EU legislation requires defining measures to reduce the costs of infrastructure provision and of charges for their use, taking account of safety and maintaining the quality of the infrastructure service. Nevertheless, there are no obligations at European level for monitoring infrastructure service.

Member States may choose to meet this obligation by way of regulatory measures and/or contractual agreements known as multi-annual contracts, concluded for a minimum period of three years. The situation regarding multi-annual contracts varies widely between the Member States. In fact half of all Member States do not use them, nor are they considering using them.

Apart from these rules, EU rail directives set out other provisions which may be helpful in terms of implementation, namely:

  • Member States must take the necessary measures to develop their national infrastructure;
  • Infrastructure managers’ expenditure and revenue must balance over a reasonable period of time.

Other particular provisions apply regarding validity and transparency of financial transfers from the State, taking account of the requirement for management independence on the part of the infrastructure manager and the economic nature of its activities.

The role of multi-annual contracts

The availability and the quality of the infrastructure have a strong impact on the competitiveness of the rail sector. However, maintenance of infrastructure does not always gain the finance that railway operators expect to enable them to compete with other modes of transport. Almost one third of managers state that the finance available to them is not sufficient to maintain their network.

If properly negotiated and prepared, a multi-annual contract can bring many advantages. More particularly, its role is to:

  • Provide a long-term financing framework for maintenance forcing both parties to take a long-term view and develop maintenance programmes on the basis of future service demand. In fact, it is important that the rail infrastructure corresponds with future transport demand structures in order to boost traffic and revenues. These contracts also permit trade-offs between taxpayers’ and users’ interests, between maintenance and quality of the network, and between short-term maintenance and renewal;
  • Complementing the charging system by transfers made within the framework of these contracts so as to ensure financial stability. A multi-annual contract has to be consistent with the charging framework, which has to comply with the existing charging rules;
  • Enable effective cost control by long-term planning of rail maintenance to reduce unit costs. This procedure enables the volume of work to be adapted without changing plans at the last minute. With a multi-annual allocation, the manager can actually make use of funds in a more flexible manner which is thus better suited to business needs, rather than according to the rigid rules of public spending;
  • Enable benchmarking and regulatory supervision by setting performance targets more effectively. In fact, setting more precise performance targets makes it easier to gauge the relative positions of infrastructure managers and to define cost effectiveness in terms of a national infrastructure manager’s cost elements and their performance in comparison with other managers;
  • Improve performance based on performance-related payments and not on compensating the infrastructure manager for a particular expenditure as well as reinforcing quality control. Quality criteria can be divided into two categories: Indicators based on the quality of the train service (speed, safety) and indicators based on infrastructure provision (maintenance costs per km of track, percentage of lines under temporary speed restrictions);
  • Secure the effectiveness of contractual agreements providing for, for example, sanctions applicable in cases of non-compliance. The monitoring process should be undertaken by an independent body rather than by the two contracting parties. Sanctions may consist of penalties (fines), reduced financial input or even a replacement of infrastructure managers and need to be progressive and in proportion with the infringement.

Member States and their infrastructure managers should conclude multi-annual contracts which comply with the national strategic transport plan and with the infrastructure managers’ business plans. The State should consult stakeholders on any proposal for multi-annual contracts before entering into a new contract or renegotiating existing provisions.

Infrastructure managers should check track condition at least once a year on all their lines and more frequently on main lines, and should indicate cases where infrastructure quality is considered to be substandard.


Some years after the adoption of the rail infrastructure package, consultations conducted by the Commission revealed concerns in the areas of sustainable financing of the existing infrastructure, the quality of infrastructure service and how to improve the performance of infrastructure managers.

Radio spectrum policy programme

Radio spectrum policy programme

Outline of the Community (European Union) legislation about Radio spectrum policy programme


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Information society > Radiofrequencies

Radio spectrum policy programme (Proposal)

8a of Directive 2002/21/EC invites the European Commission to implement a five-year radio spectrum policy programme in order to manage it better.


Proposal for a Decision of the European Parliament and of the Council of 20 September 2010 establishing the first radio spectrum policy programme [COM(2010) 471 final – Not published in the Official Journal].


This Proposal aims to put in place a five-year radio spectrum policy programme. This Proposal forms part of a package of measures presented by the European Commission in September 2010 which includes a Communication on broadband and a Recommendation on Next Generation Access networks. This programme sets the parameters of the spectrum required for the functioning of the internal market, both in electronic communications and in other fields such as transport, research and energy.

Programme policy objectives

The objectives of the radio spectrum policy programme are to:

  • make sufficient spectrum available to satisfy growing needs;
  • maximise flexibility in the use of spectrum;
  • enhance the efficient use of spectrum;
  • promote competition between electronic communications services in particular;
  • harmonise the internal market and develop transnational services;
  • avoid interference and disturbances;
  • protect human health.

Enhancing the efficient and flexible use of spectrum

Member States are required to:

  • adopt by 1 January 2013 authorisation and allocation measures appropriate for the development of broadband services, such as allowing, for example, relevant operators direct or indirect access to contiguous blocks of spectrum of at least 10 MHz;
  • foster the collective use of spectrum as well as shared use of spectrum;
  • cooperate to develop harmonised standards for radio equipment and terminals;
  • adopt selection conditions and procedures which promote investment and efficient use of spectrum.

The European Commission shall develop guidelines on authorisation conditions and procedures for spectrum bands concerning infrastructure sharing and coverage conditions in order to avoid over-fragmentation of the internal market.

Promoting competition

In order to ensure fair competition in the market, Member States may adopt the following measures:

  • limiting the amount of spectrum for which rights of use are granted to any economic operator;
  • limiting the granting of new rights of use in certain bands in order to prevent certain economic operators from accumulating too many spectrum frequencies and harming competition;
  • prohibiting transfers of spectrum usage rights;
  • amending the existing rights of certain operators in cases of excessive accumulation, in accordance with Article 14 of Directive 2002/20/EC.

Defining spectrum for wireless broadband communications

Member States shall allocate a sufficient portion of spectrum for all European citizens to have access to broadband by 2020.

Member States shall authorise the use of harmonised bands by 2012 in order to allow consumers easy access to wireless broadband services.

Member States shall make the 800 MHz band (the digital dividend) available for electronic communications services by 2013, allowing for exceptions.

The Commission is invited to adopt measures to ensure that Member States allow trading within the EU of spectrum usage rights in the harmonised bands.

The Commission may ensure the availability of additional spectrum bands for the provision of harmonised satellite services for broadband access.

Responding to specific spectrum needs

In addition to communications, spectrum must be available for the following specific needs:

  • monitoring the Earth’s atmosphere and surface;
  • developing and exploiting space applications;
  • improving transport systems, for example through GALILEO;
  • services related to civil protection;
  • the results of research and development projects.

In order to save energy in spectrum use, the Commission shall conduct studies on creating a low-carbon policy and developing energy-saving technologies.

Creating an inventory of existing uses of and emerging needs for spectrum

The Commission, along with Member States, shall create an inventory of existing spectrum use and of future needs for spectrum with regard to the bands between 300 MHz to 3 GHz. This inventory should provide more transparency and highlight the advantages and disadvantages of spectrum use.

Participating in international negotiations and cooperating with different bodies

The Union shall participate in international negotiations relating to spectrum matters, in accordance with the rules of the Treaty, to defend its interests. In international negotiations, Member States shall ensure that the spectrum required for the development of EU policies is available.

Member States are required to ensure that the international agreements they sign up to are in accordance with EU legislation.

If required, the EU may provide political and technical support to Member States during bilateral negotiations with third countries.

The Commission and Member States must work closely with the European Conference of Postal and Telecommunications Administrations (ECPT), standardisation bodies and the Joint Research Centre (JRC) on technical issues in order to ensure the best use of spectrum outside the EU.


Proposal Official Journal Procedure

COM(2010) 471


Rail safety: transport of dangerous goods by rail

Rail safety: transport of dangerous goods by rail

Outline of the Community (European Union) legislation about Rail safety: transport of dangerous goods by rail


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Transport > Rail transport

Rail safety: transport of dangerous goods by rail

Document or Iniciative

Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail [See amending acts].


The purpose of this Directive is to establish national safety standards at the level of the international standards set in the Convention Convention concerning International Carriage by Rail (COTIF). It also aims to create a single market in the transport of dangerous goods by rail.

International standards

All the Member States are Contracting Parties to the COTIF that defines the rules concerning the contract for international carriage of goods by rail (CIM *). The COTIF does not cover the national carriage of dangerous goods by rail. The CIM constitutes the regulations concerning the international carriage of dangerous goods by rail (RID *).

Scope and derogations

Member States may exempt the transport of dangerous goods conducted by means of transport equipment belonging to the armed forces from the scope of this Directive.

Member States retain the right to lay down safety requirements for national or international transport, in so far as this Directive does not cover that area. This applies, for example, to the running of trains or the marshalling of freight wagons.

Each Member State also retains the right to regulate or prohibit, strictly for reasons other than safety, the internal transport of certain dangerous goods by rail.

Directive 96/49/EC is repealed by Directive 2008/68/EC as from 30 June 2009.

Key terms used in the act

  • RID: the regulations concerning the international carriage of dangerous goods by rail, appearing as Annex I to Appendix B to the Convention concerning international carriage by rail (COTIF);
  • CIM: the uniform rules concerning the contract for international carriage of goods by rail, appearing as Appendix B to the Convention concerning international carriage by rail (COTIF).


Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 96/49/EC [Procedure SYN/1994/0284] 17.9.1996 1.1.1997 OJ L 235 of 17.9.1996
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2000/62/EC 1.11.2000 1.5.2001 OJ L 279 of 1.11.2000
Directive 2001/6/EC 21.2.2001 31.12.2001/31.12.2002 OJ L 30 of 1.2.2001
Decision 2002/885/EC 1.7.2001 1.7.2001/1.7.2003 OJ L 308 of 9.11.2002
Directive 2003/29/EC 9.4.2003 1.7.2003 OJ L 90 of 8.4.2003
Directive 2004/89/EC 6.10.2004 1.10.2004 OJ L 293 of 16.9.2004
Directive 2004/110/EC 30.12.2004 1.7.2005 OJ L 365 of 10.12.2004
Directive 2006/90/EC 24.11.2006 1.7.2007 OJ L 305 of 4.11.2006

Related Acts

CommissionDecision of 13October 2005 amending Decision 2005/180/EC on authorising Member States to adopt certain derogations pursuant to Council Directive 96/49/EC with regard to the transport of dangerous goods by rail [Official Journal L 293 of 09.11.2005].

Commission Decision of 4 March 2005 authorising Member States to adopt certain derogations pursuant to Council Directive 96/49/EC with regard to the transport of dangerous goods by rail [Official Journal L 61 of 08.03.2005].

Annexes A and B to Council Directive 96/49/EC as announced in CommissionDirective (repealed) adapting for the third time to technical progress Council Directive 96/49/EC on theapproximation of the laws of the Member States with regard to the transport of dangerous goods by rail [Official Journal L 121 of 26.04.2004].
The transport of dangerous goods by rail is authorised subject to compliance with the conditions imposed in the annexes. The annexes to the directive cover:

  • dangerous goods which are barred from carriage;
  • dangerous goods which are authorised for carriage and the conditions attaching to them.

CouncilDirective of 3June 1996 on the appointment and vocational qualification of safety advisers for the transport of dangerous goods by road, rail and inland waterway [Official Journal L 145 of 19.06.1996].

Railway safety

Railway safety

Outline of the Community (European Union) legislation about Railway safety


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Transport > Rail transport

Railway safety

Document or Iniciative

Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification [See amending act(s)].


The Directive applies to the railway system of the Member States and covers safety requirements for the system as a whole, including infrastructure and traffic management, and the interaction between railway undertakings and infrastructure managers.

In this connection, the Directive focuses on four major aspects:

  • the setting up, in each Member State, of an authority responsible for supervising safety;
  • the mutual recognition of safety certificates delivered in the Member States;
  • the establishment of common safety indicators (CSIs) in order to assess that the system complies with the common safety targets (CSTs) and facilitate the monitoring of railway safety performance;
  • the definition of common rules for safety investigations.

Development and management of safety

Safety rules and standards, such as operating rules, signalling rules, requirements on staff and technical requirements applicable to rolling stock have been devised mainly nationally.

These national safety rules, should gradually be replaced by rules based on common standards, established by technical specifications for interoperability (TSIs). The Commission has the power to suspend the implementation of a national safety rule for a maximum of six months.

In this connection, the Member States will ensure that:

  • railway safety is generally maintained and continuously improved, taking into consideration the development of European legislation;
  • safety rules are laid down, applied and enforced in an open and non-discriminatory manner;
  • responsibility for the safe operation of the railway system and the control of risks associated with it is borne by the infrastructure managers and railway undertakings;
  • information is collected on common safety indicators through annual reports in order to assess the achievement of the CSTs and monitor the general development of railway safety.

In order to coordinate the different rules, a distinction must be drawn between two sets of actors:

  • infrastructure managers, which are bodies or companies responsible, in particular for establishing, building and maintaining infrastructure or a part of it, and safety. In some Member States, however, safety may be delegated to railway undertakings.
  • Railway undertakings, which are public or private undertakings engaged in the supply of goods and/or passenger transport services by rail.

Safety certification

In order to be granted access to the railway infrastructure, a railway undertaking must hold a safety certificate. This safety certificate may cover the whole railway network of a Member State or only a defined part thereof.

For international transport services it should be enough to approve the safety management system in one Member State and give the approval European validity.

Adherence to national laws on the other hands should be subject to additional certification in each Member State.

The safety certificate must be renewed upon application by the railway undertaking at intervals not exceeding five years. It must be wholly or partly updated whenever the type or extent of the operation is substantially altered.

A railway undertaking applying for authorisation to place rolling stock in service in another Member State will submit a technical file concerning the rolling stock or type of rolling stock to the relevant safety authority, indicating its intended use on the network.

In addition to the safety requirements laid down in the certificate, licensed railway undertakings must comply with national requirements, compatible with European law and applied in a non-discriminatory manner, relating to health, safety and social conditions, including legal provisions relating to driving time, and the rights of workers and consumers.

An essential aspect of safety is the training and certification of staff, particularly of train drivers. The training covers operating rules, the signalling system, the knowledge of routes and emergency procedures.

Maintenance of vehicles

Before it is placed in service or used on the network, each vehicle is assigned a maintenance entity (which may be, in particular, a railway undertaking or an infrastructure manager). The entity ensures the working order of vehicles by introducing a system of maintenance in accordance with the vehicle’s maintenance book and the applicable safety requirements.

National safety authority

Each Member State must establish a safety authority which is independent from railway undertakings, infrastructure managers, applicants for certificates and procurement entities. It will respond promptly to requests and applications, communicate its requests for information without delay and adopt all its decisions within four months after all requested information has been provided.

The safety authority will carry out all inspections and investigations that are needed for the accomplishment of its tasks and be granted access to all relevant documents and to premises, installations and equipment of infrastructure managers and railway undertakings.

Accident and incident investigations

Serious train accidents, such as derailments and collisions with fatal consequences, occur rarely, but when they do they attract public interest and the interest of safety professionals all over Europe.

Criteria governing the independence of the investigating body are strictly defined so that this body has no link with the various actors of the sector. This body decides whether or not an investigation of such an accident or incident should be undertaken, and determines the extent of investigations and the procedure to be followed.

Each Member State must ensure that investigations of accidents and incidents are conducted by a permanent body, which comprises at least one investigator able to perform the function of investigator–in–charge in the event of an accident or incident.


Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2004/49/EC



OJ L 164 of 30.4.2004

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2008/110/EC



OJ L 345 of 23.12.2008

The successive amendments and corrigenda to Directive 2004/49/CE been incorporated into the original text. This consolidated versionis of mere documentary value.


Directive 2008/57/EC of 17 June 2008 of the European Parliament and of the Council on the interoperability of the rail system within the Community (Text with EEA relevance).
This Directive lays down the provisions relating to authorisations for placing in service of railway vehicles. This text recasts Directive 2001/16/EC on the interoperability of the trans-European conventional rail system and Directive 96/48/EC on the interoperability of the trans-European high speed rail system.
The procedures for authorisations for placing in service were previously regulated by Directive 96/48/EC (for the new or renewed parts of the rail system) and by Directive 2004/49/EC (concerning vehicles already in service).

Commission Regulation (EC) 653/2007 of 13 June 2007 on the use of a common European format for safety certificates and application documents in accordance with Article 10 of Directive 2004/49/EC of the European Parliament and of the Council and on the validity of safety certificates delivered under Directive 2001/14/EC (Text with EEA relevance).

Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (Text with EEA relevance).



Outline of the Community (European Union) legislation about Radiofrequencies


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Information society > Radiofrequencies


Radio frequencies allow images, sound and information to be transmitted over large distances by radio waves. They are the basis of mobile communications. European companies are among the largest global players in this sector. This success is largely explained by the development of a European GSM technical standard. Around two billion people now use mobile phones complying with the European GSM standard.

In order to support the internal market for wireless services and to promote innovation in electronic communications, the European Union plans to regulate and coordinate the use of the radio spectrum.

Mobile communications

  • Use of mobile phones on aircraft
  • Legal framework for mobile TV
  • Strengthening the internal market for mobile TV
  • Roaming on public mobile telephone networks
  • Mobile broadband services
  • Third-generation mobile communications
  • Radio frequencies: digital European cordless telecommunications – DECT – UMTS
  • Mobile communications GSM – UMTS

Radio spectrum

  • Radio spectrum policy programme (Proposal)
  • Towards optimal use of the digital dividend
  • Radio local area networks (Wi-Fi networks)
  • Radio Spectrum Policy Group
  • Regulatory framework for radio spectrum policy
  • Next steps in radio spectrum policy
  • World Radiocommunication Conference 2003
  • World Radiocommunications Conference 2000 (WRC-2000)
  • Radio Frequency Identification (RFID) in Europe: steps towards a policy framework
  • Radio frequencies: European Radio Communications Committee

Radio Frequency Identification in Europe: steps towards a policy framework

Radio Frequency Identification in Europe: steps towards a policy framework

Outline of the Community (European Union) legislation about Radio Frequency Identification in Europe: steps towards a policy framework


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Information society > Radiofrequencies

Radio Frequency Identification (RFID) in Europe: steps towards a policy framework

Document or Iniciative

Communication from the Commission to the Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 15 March 2007 – “Radio Frequency Identification (RFID) in Europe: steps towards a policy framework” [COM(2007) 96 – Not published in the Official Journal].


RFID is a method for exchanging information between a marker (radio tag) *, which can be incorporated into any object, and a reader, a wireless device that identifies the information using radiofrequencies. The technology is more powerful when the reader is linked to communication networks such as the internet, which makes the information available over the world-wide web.

The widespread deployment of RFID technology is an important stage in the development of many sectors, including transport, health and retail trade. Its applications range from the traceability of food, to automated payments, and the mobility and observation of patients suffering from Alzheimer’s disease. It can therefore have a significant contribution to improving the lives of citizens.

However, the technology also raises concerns about the protection of privacy, health and the environment.

From a technical and commercial point of view, RFID is ready for mass deployment. However, there are some outstanding issues relating to the legal and policy framework for the technology.

Confidentiality and Security

RFID technology raises confidentiality issues and security concerns as it can be used to gather and distribute personal data. As a result, it is difficult to achieve wide public acceptance of the technology, as the public wants to see measures taken to protect its rights. For this reason, the social, political, ethical and legal implications of the deployment of RFID should be taken into account.

Under the current legislation, the national public authorities are responsible for ensuring the application of national legislation as regards data processing procedures, including for RFID applications. As regards the security of the RFID system, the Member States, the Commission and businesses should take concerted action concerning technical and organisational aspects and business procedures. To this end, the Commission encourages the consolidation of good practice and the drawing up of design criteria for RFID technology so risks are restricted from the start.

Reducing the threat to security and privacy requires permanent scrutiny of all implications of RFID. To that end, an approach that focuses on each individual RFID application may prove more effective than a more general approach, because each application has its own risks and advantages.

Awareness and information campaigns can play a key role here. The Commission’s public consultation indicated that the general public is often poorly informed about the possibilities and challenges of RFID technology.

The European Union has put in place a vast array of legal instruments to protect personal data. The importance of protecting personal data is recognised in the EC Treaty (Article 16) and in the Charter of Fundamental Rights (Article 8). Moreover, the European legislative framework in this field is defined by the general Data Protection Directive and the ePrivacy Directive. These Directives guarantee the protection of personal data, while taking account of innovations in data processing procedures.

Database management

Data storage and access also constitute problems for the drawing up of policy on the deployment of RFID. Given this new phase in the development of the internet, account should be taken of possible breakdowns in or accidental damage to the technology, as well as of individuals who might seek to exploit the technology for their own ends. The World Summit on the Information Society provides a framework for the emerging policy debate on this subject.

Radio spectrum*

The availability of radio frequencies and the harmonisation of conditions for their use are key issues in the functioning of RFID applications in Europe. The Commission’s streamlining of the use of the radio spectrum within the EU has since 2002 provided a new basis for the deployment of RFID technology.


The standards governing RFID must facilitate the harmonious distribution of services, while taking account of the rapid development of the technology. Participants in the consultation have expressed the view that the Commission should play a more active role in promoting interoperability and the streamlining of international standards.

Environmental and health issues

Environmental concerns relate to the processing of waste and the use of dangerous substances. These issues are dealt with in the Community legislation on electrical and electronic equipment. As regards health concerns, even though the effects of exposing the population and workers to the electromagnetic fields (EMFs) * of RFIDs are thought to be low, they continue to cause a range of concerns. Moreover, the Community legal framework limits exposure to EMFs.


The deployment of RFID solutions goes hand in hand with enhancing the role of information and communications technology (ICT) in developing the European economy. ICT must become one of the leading sectors of our economy.

Key terms used in the act
  • Electronic chip (or integrated circuit): electronic component whose size can now be reduced to that of a dot. Silicon is the basic raw material used to manufacture it.
  • ag (or marker): small object composed of a chip attached to an antenna. These two components are enclosed in a container that can be incorporated into some objects. The device sends information via radio waves that can be captured by an appropriate reader and potentially placed on the Internet.
  • Radio spectrum: the entirety of radio frequencies available for the transmission of information.
  • magnetic fields: area in which electromagnetic forces are exerted. The intensity of the field varies, as the forces intensify as they approach the antenna. Prolonged exposure to electromagnetic fields may have negative effects on human health. However, according to the World Health Organisation, the level of exposure to the radio frequencies from base stations and wireless networks is so low that there is no reason to be concerned about its effect on human health.