4th Railway Package - Technical Pillar


Since 1991, the European railway sector has constantly been reformed by the European Union. The 4th Railway Package, which was adopted in 2016 is by far the largest and most complex legal initiative introduced so far. The 4th Railway Package consists of a political and a technical pillar which introduce substantial reforms for all stakeholders concerned. 

This Guide illustrates in four different chapters the reforms in the field of vehicle authorisation, safety certification and ERTMS trackside approval as well as the new role of the European Union Agency for Railways as ‘frequently asked questions’. Given the fact that the implementation of the 4th Railway Package is an ongoing process, the Guide will be updated on a regular basis, in line with the progress of the reforms being made on EU level.

Christian Rausch
Chairman of the Group of Representative Bodies (GRB)

What is the Safety Directive?


This Directive lays down provisions to ensure the development and improvement of the safety of the Union rail system and improved access to the market for rail transport services by:

  1. harmonising the regulatory structure in the Member States;
  2. defining responsibilities between the actors in the Union rail system;
  3. developing common safety targets (‘CSTs’) and common safety methods (‘CSMs’) with a view to gradually removing the need for national rules;
  4. setting out the principles for issuing, renewing, amending and restricting or revoking safety certificates and authorisations;
  5. requiring the establishment, for each Member State, of a national safety authority and an accident and incident investigating body; and
  6. defining common principles for the management, regulation and supervision of railway safety.

How did EU safety legislation evolve?


In 2004, the Railway Safety Directive 2004/49/EC was adopted to create a common European regulatory framework for safety, i.e. the tasks and responsibilities related to a safety management system (SMS).

The Directive introduced common safety methods (CSMs), developed by ERA to provide a common approach to assess the level of safety and performance of all actors (RUs, IMs, wagon keepers, etc.) at EU level and in Member States. It introduced a certification scheme for entities in charge of maintenance (ECM) of freight wagons and required Member States to develop a system of national safety rules.

Directive 2004/49/EC was complemented by Directive 2008/57/EC (interoperability) and 2008/68/EC (inland transport of dangerous goods).

The EC adopted Regulation 445/2011/EU introducing a system of certification of entities in charge of maintenance for freight wagons.

⇒ With each Directive, the EU extended the scope of safety and strengthened the role of the EU vs the Member States. However, the powers and the status of the ERA as such remained unchanged.

What is 2016/798 about?


Directive 2016/798 extends the scope of safety whilst centralising supervision on EU level. This is achieved by making ERA the single body for granting single safety certificates and by creating new bodies, tools and processes with the ERA to allow it to exercise its new mandate.

What is the scope of 2016/798?


The Directive applies to:

  • the entire Union rail system.;
  • as well as to ‘tram-trains’ as so far as they operate on national rail infrastructure.

The Directive does NOT apply to (unless Member States decide otherwise):

  • local public transport systems (metros, trams and other light rail systems);
  • Member States may exclude privately owned railway infrastructure (incl sidings), local, historical or touristic infrastructure and vehicles, light rail infrastructure occasionally used, vehicles primarily used on light rail infrastructure.

What are the main changes?


The main changes in 2016/798 are summarised below:


  • the Agency will issue the single safety certificate;
  • introduction of a European common occurrence reporting (COR) instrument;
  • clarification of the role and responsibilities of the railway actors;
  • the supervision role is maintained by the national safety authorities;
  • More details can be found in the chapter on the ERA Regulation.


  • Directive 2016/798 states clearly that “each actor is responsible for its own part in the railway system”, but the need for corporation between RUs and IMs increases due to the number of interfaces that need to be addressed to ensure a safe railway;.

Common Occurrence Reporting (COR):

  • The discussions on the common occurrence reporting comprising SAIT (Safety Alerts IT Tool) and SMD (Safety Management Data) are ongoing. A SAIT system was launched by ERA in September 2016 and is available for use, this system will also be developed further. For the SMD system, consultation has taken place over the past year and the options of a tool are currently being defined by ERA. A final solution has not yet been found for the interface between European and national occurrence reporting.

How will the future processes look like?

  • The implementing act on practical arrangements for single safety certificates was adopted on 7th of July 2017 by the Member States and will have to be implemented in practice with the beginning of the transition period;
  • The Implementing Act on Practical Arrangement foresees that all applications for national and international safety certifications will have to be submitted to the ERA via its IT portal (One-Stop Shop -OSS) ;
  • The ERA will be responsible for multi-country safety certifications (the single safety certificate) and could be responsible for single country safety certificates if the applicant choses so;
  • The ERA can outsource the processing of the applications to individual experts via a pool of external experts (incl those of NSAs);
  • The recommendation of NSAs involved in the application procedure will have to be taken into consideration by the ERA with all approvals;
  • The ERA will charge fees & charges for the processing of the applications for safety certification following a pre-defined calculation method;
  • In the case of a positive opinion, the ERA will grant the safety certification to the applicant and allocates a so-called EIN (European Identification Number).

Which role will NSAs have in the future?

  • The NSAs will issue safety certifications for single country applications (single Member State only) if selected by the applicant;
  • The concrete role of the NSAs in the safety certification procedure consists in checking the application as regards their respective national part; For this system to work, the ERA must have concluded a cooperation contract with each NSA; 
  • NSAs will keep the supervision role, which consists in overseeing the continued compliance with all legal obligations by Rus and IMs to use a SMS (safety management system), line with the CSM developed by the ERA;
  • NSAs will have to exchange information and coordinate their supervision activities for international RU operations with the Agency;
  • NSAs will also have to exchange information with the ERA as regards their supervision activities
  • NSAs will also have to report to the ERA within the scope of the new mandate of the ERA to monitor and audit them (as well as other bodies, such as ECMs, NoBos, etc.). The final audit conditions to be applied by ERA to NSAs are still under discussion.

⇒ The future cooperation between NSAs and the ERA will require the cooperation agreements, audit tools to be approved and NSAs to agree with the usage conditions of ERA’s application tool (OSS), the appeal processes and the fees & charges related to certifications.

Will there be a transition period?

  • With the new EU safety certification procedure to start on 16th of June 2019, the ERA proposes a 1-year shadow-running phase, starting on 16th of June 2018;
  • With regards to the transposition, Member States may consider postponing the transposition of the directive by up to 1 year, by 16th of June 2020; 
  • In addition, ERA has to sign a cooperation agreement with each national safety authority (NSA).

How much will the new procedure cost?

  • The Safety Directive foresees that the ERA will charge for its services, like for vehicle authorisations and approvals for ERTMS track-side equipment. These so-called “fees and charges” are currently under discussion between the EC DG MOVE, EC DG Budget, the ERA as well as the Member States (NSAs). It is worth noting that the ERA intends to become partially self-funding;
  • A first assessment conducted by an external consultant for the EC in 2016 into the fees and charges of NSAs for safety certifications revealed substantial varieties which prevented a benchmark to be established.

⇒ Applicants will have to get prepared for a new procedure with so far undefined costs (time, experts, ERA, etc.).

What is the role of the Appeal Body?

  • The Safety Directive stipulates that the ERA and the NSAs take full responsibility for the certifications they issue;
  • In the case of litigations related to a safety certification, the applicant shall refer its case to a so-called ‘Board of Appeal’ of the ERA;
  • This body will be composed of experts which are appointed by the Management Board of the ERA (Member States/NSAs, EC, ERA);
  • In the case of diverging views between the ERA, the NSAs and / or the applicant, the Board of Appeal shall provide an opinion;
  • The ERA will charge fees & charges for the opinion of the Board of Appeal to the plaintiff.

⇒ The ERA Board of Appeal can overrule the opinion of a NSA and thus overrule national interests.

⇒ The Executive Director of the ERA can overrule the Appeal Body.

⇒ Disclaimer: The final text will be adopted early 2018

What are the open issues?


There are several open issues:

  • The EU has reduced the budget allocation for all EU agencies by 10%. This has an impact on ERA in terms of available resources, the quality and quantity of safety certificates to be processed but also the future fees and charges to be applied by the ERA to the sector;
  • The EU is empowered to adopt implementing and delegated acts to change TSIs, CSMs or safety certification processes. This ‘secondary acts’ follows a shorter timescale and a ‘limited’ consultation procedure. This means that changes may be more frequent, making the legal and technical framework less predictable;
  • Member States must have agreed on the date for the transition period;
  • Member States must have transposed Directive 2016/798 into national law to allow the sector to submit applications for safety certification with the ERA;
  • National safety rules (NSRs) which have not been included in the revision of TSI OPE or notified to the EC until 16th of June 2016 or which do not comply with the new legislation and EU criteria will have to be deleted from the relevant register. Furthermore, national rules should not only be reduced but replaced by a harmonised European solution. The Single Rule Database tool which is due to contain all national rules after the cleaning up process is still to be created. This may create an unclear framework which rules apply and are in line with EU legislation;
  • The ERA is developing a common occurrence reporting system for the railway sector to exchange data on incidents which may have an impact on safety. Development and use are currently being discussed by all stakeholders;
  • Current agreements of non-EU Member States (e.g. Switzerland, Norway, others) with EU Member States regulating safety certification will become void and require these non-EU Member States to conclude an agreement directly with the ERA by June 2019.

What are the next steps?

  • 16/06/2018: ERA IT portal (OSS) to be completed to allow ERA to process safety certifications in the transition phase;
  • 16/06/2018: Potential date for the start of the shadow running for safety certifications;
  • 16/06/2019: ERA to issue safety certificates in those MSs not having asked the EC and the ERA for an extension of the right to issue safety certifications by 1 year and which have transposed the Safety Directive into national law on that date;
  • 16/06/2020: ERA to issue safety certificates in all MSs which have transposed 2016/797 into national law by that date.