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 ERA Regulation?

  1. This Regulation establishes a European Union Agency for Railways (‘the Agency’).
  2. This Regulation provides for: (a) the establishment and tasks of the Agency; (b) the tasks of the Member States in the context of this Regulation.
  3. This Regulation supports the establishment of the single European railway area, and in particular the objectives relating to: (a) interoperability within the Union rail system provided for in Directive (EU) 2016/797; (b) safety of the Union rail system provided for in Directive (EU) 2016/798; (c) the certification of train drivers provided for in Directive 2007/59/EC of the European Parliament and of the Council

How did the EU legislation for the ERA evolve?


The European Railway Agency (ERA) was set up by means of Regulation (EC) no 881/2004 in April 2004 with the aim to improve interoperability and safety of the European rail network. Its main tasks have been to harmonise, register and monitor TSIs across the entire European rail network and to set common safety targets for the European railways.

At that time, ERA had no decision-making powers. Its only role consisted in supporting the EC with technical assistance in the fields of interoperability and safety.

In 2006, the EC adopted a decision concerning mandates to ERA for developing TSIs under Directive 2001/16/EC and common safety methods and common harmonised requirements for safety certification under Directive 2004/49/EC.

In 2007, the EC adopted a decision concerning a framework mandate to ERA for the performance or certain activities under Directives 96/48/EC and 2001/16/EC.

Regulation (EC) no 1335/2008 assigned new tasks to the Agency in response to the changes made to the Railway Safety Directive 2004/49/EC and to the Directive on the interoperability of the rail system 2008/57/EC.

In 2010, the EC adopted a decision concerning a mandate to ERA to develop and review TSIs with a view to extending their scope to the whole rail system in the EU.

⇒ With each legal act, 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 remained unchanged.

What is 2016/796 about?

  • Regulation 2016/796 extends the mandate and tasks of the ERA in line with the scope of Directive 2016/797 (Interoperability Directive) and Directive 2016/798 (Safety Directive). De jure the Agency becomes an authority responsible for issuing authorisations for the placing on the market of railway vehicles and vehicle types, for issuing single safety certificates for railway undertakings in the European Union and for granting ERTMS trackside approval. With this new Regulation the Agency has become the ERTMS system authority;
  • The Agency was also given the mandate to reduce the number of the national rules;

What are the main changes?


The main changes in 2016/796 are summarised below: ERA:

  • the ERA is a legal body on its own;
  • the ERA is the only body to issue EU-wide vehicle authorisations, approvals of ERTMS track-side equipment tenders and safety certificates;
  • the ERA invoices fees & charges for its authorisations, approvals and certificates as well as for the support tools (IT tools, etc.);
  • the ERA has become the system authority for all registers and databases related to 2016/797, 2016/798 and 2007/59/EC ) and for ERTMS.;
  • the ERA can issue opinions, recommendations, technical documents, reports and guidelines;
  • the ERA has the mandate to supervise and audit National Safety Authorities (NSAs); ECMs (entities in charge of maintenance), NoBos (notified bodies), as well as to monitor RU’s and IM’s SMS;
  • the role and powers of the ERA to issue and apply EU rules as well as to reject national rules have been strengthened;
  • the ERA can conclude agreements with non-EU countries (cooperation agreements, etc.);
  • The ERA will be involved in R&D.

Member States:

  • the powers of the Member States to issue and apply national technical and safety rules are reduced whilst those of the ERA have been strengthened.


  • the role of the infrastructure register (‘RINF’) has been strengthened and will be used for pre-operational route compatibility checks;
  • the ERA will set up a new register for changes and change requests related to the telematic TSIs (TAF and TAP);
  • the European vehicle register (EVR) must include information relevant for people with reduced mobility (PRM) and will incorporate all national vehicle registers;
  • the ERA will have to develop a single rules database (SRD) which will replace several existing registers. (Reference Document Database (RDD) and Notification IT (NOTIF-IT)).

Other IT tools:

  • the Agency developed the One-Stop Shop tool as electronic portal to submit applications for safety certification, vehicle authorisation and ERTMS trackside approval;
  • the ERA developed a new ‘instrument’ for the exchange of safety-related information between the different actors and bodies (COR SAIT and COR SMD).

How will the future processes look like?


The relevant processes related to vehicle authorisations, approvals of ERTMS track-side equipment tenders and safety certificates are described in the previous chapters.

Will there be a transition period?


No, as a Regulation applies from the date of its entering into force.

How much will the new procedure cost?

  • The ERA will apply fees and charges for vehicle authorisations, approvals of ERTMS track-side equipment tenders and safety certificates issued by its services;
  • Furthermore, the ERA is expected to apply indirect costs related to applications, such as the usage and maintenance costs of the IT tool (OSS).

⇒ The ERA fees & charges are a new financial instrument of the ERA which will determine the costs for all applicants for vehicle authorisations, approvals of ERTMS tracks-side equipment tenders and safety certificates.

Which role will NSAs have in the future?

  • The ERA needs to conclude cooperation agreements with the respective NSAs in the EU and non-EU countries;
  • These cooperation agreements also require the NSAs to accept the future ERA audit and monitoring tools;
  • NSAs will have to adapt their respective systems and processes, especially about the processing of national applications which will have to be processed through the ERA IT portal.

What is the role of the Appeal Body?

  • In the case of litigations related to a safety certification, vehicle authorisation or ERTMS trackside approval, 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 which have been outlined in the previous chapter already. The main concerns / issues are:

  • insufficient budget allocation for ERA which may have an impact on the quality and quantity of all authorisations, approvals and certificates to be used by the ERA;
  • impact of the budget allocation on the future ERA fees and charges related to the above;
  • the cooperation of the ERA with the NSAs in these processes (time, double work, competence, redundancies, re-assessments, etc.);
  • the timely and smooth delivery of various generic processes and IT tools by the ERA;
  • the new tools developed by the ERA (i.e. common occurrence reporting tool, etc.);
  • the impact of the ERA on national rules;
  • the cooperation agreements of the ERA with non-EU Member States.

What are the next steps?

  • 16/06/2018: Potential date for the start of the shadow running for vehicle authorisation, approvals of ERTMS track-side component tenders and safety certifications;
  • 18/01/2019: ERA IT portal (OSS) – Version 1.00
  • 16/06/2019: ERA to issue vehicle authorisations, approvals of ERTMS track-side component tenders and safety certificates in those MSs which have transposed the Interoperability and the Safety Directive into national law on that date;
  • 16/06/2020: ERA to issue vehicle authorisations, approvals of ERTMS track-side component tenders and safety certificates in all MSs which have asked for 1 additional transitional year and have transposed 2016/797 and 2016/798 into national law on that date;
  • 16/06/2021: European Vehicle Register (EVR) expected to be operational.
  • 2021: Register of the Infrastructure (RINF) expected to be ready and fully update according to the 4RP process for the VA.