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 Interoperability Directive?


1.This Directive establishes the conditions to be met to achieve interoperability within the Union rail system in a manner compatible with Directive (EU) 2016/798 in order to define an optimal level of technical harmonisation, to make it possible to facilitate, improve and develop rail transport services within the Union and with third countries and to contribute to the completion of the single European railway area and the progressive achievement of the internal market. Those conditions concern the design, construction, placing on the market, placing in service, upgrading, renewal, operation and maintenance of the parts of that system as well as the professional qualifications of, and health and safety conditions applying to, the staff who contribute to its operation and maintenance.

2.This Directive lays down the provisions relating to, for each subsystem, the interoperability constituents, the interfaces and procedures, and

How did EU interoperability legislation evolve?


Technical interoperability is at the core of virtually any reform of the EU railway sector. To create the single European railway area with smooth cross-border train operations, the EU decided to impose harmonisation of technical interfaces and subsystems in the form of technical specifications for Interoperability: Technical Specifications for Interoperability.

The first such Directive was adopted in 1996 with 1996/48/EC, which was amended 5 years later by 2001/16/EC, and again 3 years later by 2004/50/EC. These were amended 4 years later by recast directive 2008/57/EC, which received further amendments in 2009 by 2009/131/EC and 2011 by 2011/18/EU.

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

What is 2016/797 about?


Directive 2016/797 extends the scope of interoperability whilst introducing a new process for European vehicle authorisation and for ERTMS trackside approval. For that purpose, ERA has been given an enhanced role and is developing several new tools and processes, such as:

  • a One-Stop-Shop (OSS) which will serve as IT-portal for all stakeholders to submit their applications for vehicle authorisation;
  • a Board of Appeal (BoA) which will serve as body deciding on litigation cases;
  • databases (i.e. Register of infrastructure (RINF), Single Rules Database (SRD), among others.

What is the scope of 2016/797?


The Directive applies to:

  • the entire Union rail system;
  • ‘tram-trains’ as when they operate on national rail infrastructure;

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

  • Local public transport systems (metros, trams and other light rail systems);
  • 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 2016/797 are summarised below:


  • the Agency will issue vehicle authorisation and approve ERTMS trackside tenders;
  • more details can be found in the chapter on the ERA Regulation.


  • the cases for possible non-application of TSIs is reduced;
  • the EC published delegated acts defining the Agency’s mandate and objectives for the forthcoming TSI revisions starting in September 2017.


  • the role of RUs and IMs in the technical route compatibility processes via the register of infrastructure (‘RINF’) is re-defined.

How will the new processes look like?


Directive 2016/797 defines the procedure for vehicle authorisation and ERTMS track-side approval:

  • the final procedure for vehicle authorisation and ERTMS track-side approval is still under discussion[1];
  • Directive 2016/797 foresees that all applications for national and international vehicle authorisations as well as for the approval of ERTMS track-side equipment tenders will have to be submitted to the ERA via its IT portal (One-Stop-Shop, OSS)[2];
  • the applicant can still choose the relevant NSA as authorising entity if the area of use is limited to one Member State;
  • 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 following a pre-defined calculation method;
  • in the case of a positive opinion, the ERA will grant the vehicle authorisation or the approval of the ERTMS track-side component tender to the applicant;
  • following the positive decision of the ERA, the NSA will then continue processing the ERTMS track-side equipment tendering.


[1]     For both procedures to work in practice, a so-called ‘pre-engagement phase’ (a sort of commitment on the date for submissions) has been designed but which can only be applied once the practical arrangements themselves have been agreed upon.

[2]     Directive 2016/797 stipulates that all applications, whether they are national or international, will have to be submitted and processed via the ERA IT tool. This will then also involve cases which are handled by national actors only (i.e. the NSA and the national applicant) for national vehicle authorisations. This will imply that NSAs review their processes.


Will there be a transition period?


Vehicle authorisations are amongst the lengthiest and costly processes in the railway sector with up to 2 years or more duration. With the new EU vehicle authorisation procedure to start on 16th of June 2019, the ERA proposes a 1-year shadow-running phase, starting on 16th of June 2018.

Furthermore, the practical details of the transition are still being discussed. These are of particularly importance for all pending applications with NSAs and their further processing by the ERA from 16th of June 2019 onwards. The ERA and the NSAs are currently discussing the practicalities for transferring applications and the acceptance and processing by ERA of those parts already assessed by the NSAs.

With regard to the transposition, Member States may consider extending the transposition of the directive by up to 1 year, by 16th June 2020.

In addition, ERA has to sign a cooperation agreement with each national safety authority (NSA).

Which role will NSAs have in the future?

  • The NSA will issue vehicle authorisations for single country applications (single Member State only) when selected by the applicant.;
  • For all other cases, the NSA role will be limited to the assessments for the defined area of use based on national rules (if any);
  • The same system of cooperation between the Agency and the NSA also exists for ERTMS track-side approvals.;
  • For this dual system to work, the ERA must have concluded a cooperation agreement with each NSA.

The future cooperation between NSAs and the ERA will require the cooperation agreements to be signed, 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 authorisations and approvals.

How much will the new procedure costs?


The Interoperability Directive foresees that the ERA will charge for its services. 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.

It is worth noting that the vehicle authorisation procedure already exists in the EU and for which fees & charges are levied by NSAs. However, the approval of ERTMS track-side equipment tenders is a new procedure. Therefore, IMs will have to prepare for a new procedure and costs as regards to ERTMS track-side equipment. So far 5 IMs have agreed to participate in so-called ‘learning cases’ launched by ERA in order to better define ERTMS track-side approval processes and thereby limiting their costs. However, the outcome of these cases will be too late for the intended legislative act on ERTMS track-side component approval which is to be adopted by May 2018.

What is the role of the Appeal Body?

  • The Interoperability Directive stipulates that the ERA and the NSAs take full responsibility for the authorisations they issue;
  • In the case of litigations related to a vehicle authorisation, 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 Appeal Body 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 available resources, the quality and quantity of vehicle authorisations 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 or vehicle authorisation processes. These ‘secondary acts’ follow a shorter timescale and a ‘limited’ consultation procedure. This means that changes could be more frequent, making the legal and technical framework less predictable;
  • the final details of the vehicle authorisation procedure must be adopted in November 2017 (implementation regulation on practical arrangements for vehicle authorisation) to allow for the preparation of the shadow running phase in mid-2018; 
  • Member States must have transposed Directive 2016/797 into national law to allow the sector to submit applications with the ERA. By December 2018, Member States must have communicated their date for the transition period;
  • the role of RINF in the route compatibility checks between RUs and IMs is considered by the GRB to be insufficient. The sector (CER, EIM, UNIFE, EPTTOLA, UIRR, FEDECRAIL) published a ‘RINF Vision Paper’ which has yet to be assessed by the EC and by ERA ;
  • national technical rules (NTRs) which have not been notified to the EC until 16th of June 2016 or 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;
  • current agreements of non-EU Member States (e.g. Switzerland, Norway and others) with EU Member States regulating vehicle authorisation and cross-acceptance procedures 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: Adoption of an implementing act regarding the technical and functional specifications for the European vehicle register (EVR);
  • 16/06/2018: ERA’s IT portal (OSS) to be completed to allow ERA to process authorisations and certifications in the shadow running phase;
  • 16/06/2018: Potential date for the start of the shadow running phase for vehicle authorisations;
  • 16/06/2019: ERA to issue vehicle authorisations in those Member States not having asked for an extension and which have transposed the Interoperability Directive into national law on that date;
  • 16/06/2020: ERA to issue vehicle authorisations in all MSs which have transposed 2016/797 into national law by that date.;