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)

Major Legal Acts

What are the Major Legal Acts?

4.3 

 

Document

Where to find the document

Available language(s)

Cluster: IOD & RSD Directives

New Safety Directive

Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (recast)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.138.01.0102.01.ENG

All languages

“Old” Safety Directive

Directive 2004/49/EC on safety on the Community’s railways (Railway Safety Directive)

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1405504560784&uri=CELEX:02004L0049-20091218 v

All languages

New Interoperability Directive

Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.138.01.0044.01.ENG

All languages

“Old” Interoperability Directive

Directive 2008/57/EC on the interoperability of the rail system within the Community (repealing Directives 96/48/EC and 2001/16/EC from 19 July 2010);

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2008.191.01.0001.01.ENG

All languages

Cluster: ERA Regulation

Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.138.01.0001.01.ENG

All languages

Cluster: TSIs

TSIs in force

(+ Application Guides)

www.era.europa.eu/activities/technical-specifications-interoperability_en

All languages

Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474 (TSI WAG)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562247130979&uri=CELEX:02013R0321-20190616

All languages

Commission Implementing Regulation (EU) 2019/774 of 16 May 2019 amending Regulation (EU) No 1304/2014 as regards application of the technical specification for interoperability relating to the subsystemrolling stock — noise’ to the existing freight wagons (TSI NOI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562064131843&uri=CELEX:02014R1304-20190616

All languages

Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474 (TSI Package + ERATV) 

(consolidated version, July 2019)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2019.139.01.0108.01.ENG&toc=OJ:L:2019:139I:TOC

 

All languages

 

Commission Implementing Regulation (EU) 2019/773 of 16 May 2019 on the technical specification for interoperability relating to the operation and traffic management subsystem of the rail system within the European Union and repealing Decision 2012/757/EU (OPE TSI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562064131843&uri=CELEX:32019R0773

All languages

 

Commission Implementing Regulation (EU) 2019/777 of 16 May 2019 on the common specifications for the register of railway infrastructure and repealing Implementing Decision 2014/880/EU (RINF)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2019.139.01.0312.01.ENG&toc=OJ:L:2019:139I:FULL

All languages

 

 Commission Implementing Regulation (EU) 2019/775 of 16 May 2019 amending Regulation (EU) No 454/2011 as regards Change Control Management (TAP TSI CCM)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2019.139.01.0103.01.ENG&toc=OJ:L:2019:139I:FULL

All languages

 

Commission Implementing Regulation (EU) 2019/778 of 16 May 2019 amending Regulation (EU) No 1305/2014 as regards Change Control Management (TAF TSI CCM)

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2019.139.01.0356.01.ENG&toc=OJ:L:2019:139I:FULL

All languages

 

Commisson Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility (Revision PRM TSI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562064131843&uri=CELEX:02014R1300-20190616

All languages

Commission Regulation (EU)
No 1299/2014 of 18 November
2014 on the technical
specifications for interoperability
relating to the ‘infrastructure’
subsystem of the rail system in the European Union (INF TSI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562139850395&uri=CELEX:02014R1299-20190616

All languages

Commission Regulation (EU)
No 1302/2014 of 18 November
2014 concerning a technical
specification for interoperability
relating to the ‘rolling stock —
locomotives and passenger
rolling stock’ subsystem of the
rail system in the European Union
(Loc & Pas TSI) 

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562064131843&uri=CELEX:02014R1302-20190616

All languages

Commission Regulation (EU) No
1301/2014 of 18 November 2014
on the technical specifications for
interoperability relating to the
'energy' subsystem of the rail
system‘ in the Union (ENE TSI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562064131843&uri=CELEX:02014R1301-20190616

All languages

Commission Regulation (EU)
No 1303/2014 of 18 November
2014 concerning the technical
specification for interoperability
relating to safety in railway
tunnels of the rail system of the
European Union (SRT TSI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562139920081&uri=CELEX:02014R1303-20190616

All languages

Commission Regulation
(EU) 2016/919 of 27 May 2016 on the technical specification for
interoperability relating to the
control‐command and signalling subsystems of the rail system in the European Union (CCS TSI)

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562246940409&uri=CELEX:02016R0919-20190616

All languages

Mandate for the TSI revision

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017D1474

All languages

Cluster: Vehicle Authorisation

Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1523609449005&uri=CELEX:32018R0545

All languages

Guidelines for the practical arrangements for the vehicle authorisation process (new)

https://www.era.europa.eu/sites/default/files/applicants/docs/guidelines_practical_arrangement_for_va_en.pdf 

 English 

Commission Implementing Regulation (EU) 2019/250 of 12 February 2019 on the templates for ‘EC’ declarations and certificates for railway interoperability constituents and subsystems, on the model of declaration of conformity to an authorised railway vehicle type and on the ‘EC’ verification procedures for subsystems

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1550676343251&uri=CELEX:32019R0250

All languages

Cluster: Safety Certification

COMMISSION IMPLEMENTING REGULATION (EU) establishing practical arrangements for issuing single safety certificates to railway undertakings 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0763 

All languages

Application Guide

www.era.europa.eu/sites/default/files/activities/docs/guide_ssc_application_for_applicants_en.pdf

English

Cluster Safety Authorisation

Commission Recommendation on practical arrangements for issuing safety authorisations to infrastructure managers

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2019.139.01.0390.01.ENG&toc=OJ:L:2019:139I:FULL

English

Commission Delegated Regulation (EU) …/... establishing common safety methods on safety management system requirements

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=PI_COM:C(2018)1392

All languages

Application Guide

https://www.trafi.fi/filebank/a/1531114202/9b0ae9a1c2425d1af398305d87b40f5c/31297-SMS_Requirements_Guide_-_v_1_0.pdf

English

Cluster: ERTMS

Draft Commission Recommendation of 18 July 2018 on guidance for the harmonised implementation of the European Rail Traffic Management System in the Union

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018H0719(01)

All languages

Cluster: Board(s) of Appeal

Commission Implementing Regulation laying down the rules of procedure of the Board(s) of Appeal of the European Union Agency for Railways

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R0867 

All languages

Cluster: Fees and Charges

Commission Implementing Regulation on the fees and charges payable to the European Union Agency for railways and their conditions of payment

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32018R0764 

All languages

Cluster: EVR

COMMISSION IMPLEMENTING ACT on the specification for the European Vehicle Register referred to in Article 47 of Directive (EU) 2016/797 and repealing Decision 2007/756/EC

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.268.01.0053.01.ENG&toc=OJ:L:2018:268:TOC 

All languages

Cluster: Revision of ECM Regulation

Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles and repealing Commission Regulation (EU) No 445/2011

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2019.139.01.0360.01.ENG&toc=OJ:L:2019:139I:TOC

All languages

Cluster: ERATV

Commission Implementing
Decision of 4 October 2011 on the European register of authorised types of railway vehicles (notified under document C(2011) 6974) 

(consolidated version, July 2019)

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562142518145&uri=CELEX:02011D0665-20190616

All languages

 

EU Legal Acts - Overviewegal Act

Legal Act

Description

Regulation

A "regulation" is a binding legislative act. It must be applied in its entirety across the EU. No transposition

Directive

A "directive" is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Transposition necessary

Decisions

A "decision" is binding on those to whom it is addressed (e.g. an EU country or an individual company) and is directly applicable. 

Recommendations

A "recommendation" is not binding but allows the institutions to make their views known and to suggest a line of action without imposing any legal obligation on those to whom it is addressed.

Implementing  Act

Before the Commission can adopt an implementing act, it must usually consult a committee in which every EU country is represented. The committee enables EU countries to oversee the Commission's work as it adopts an implementing act – a procedure referred to in EU jargon as ‘comitology’.

Delegated Act

The Commission prepares and adopts delegated acts after consulting expert groups, composed of representatives from each EU country, which meet on a regular or occasional basis.

 

The 4th Railway Package - Technical Pillar

What does it contain?

5.0 

The 4th Railway Package is a set of 6 legislative texts designed to complete the single market for Rail services (Single European Railway Area). Its overarching goal is to revitalise the rail sector and make it more competitive vis-à-vis other modes of transport. It comprises two 'pillars' which have been negotiated largely in parallel:

The technical pillar addresses interoperability, safety authorisation, ERTMS track-side certification but also the reduction of national rules and the increased role of the EU Agency for Railways (ERA) to deliver authorisations and certifications.

The 'technical pillar' was adopted by the European Parliament and the Council in April 2016 and comprises:

The political pillar addresses market opening, tendering of public service contracts and access to national rail passenger markets.

The 'market pillar' was adopted in December 2016 and comprises:

Why was it proposed?

4.0 

The 4th Railway Package (RP) is meant to achieve the following objectives:

  • Boost the competitiveness of the railway sector by significantly reducing costs and administrative burden;
  • save businesses from having to file costly multiple applications for vehicle authorisations and safety certificates in the case of operations beyond one single member state;
  • create a ‘one-stop shop’ IT tool which will act as a single-entry point for all such applications, using easy, transparent and consistent procedures;
  • Harmonise the implementation of ERTMS;
  • Reduce the large number of national rules and make them more transparent.

 

What are the milestones?

5.0 

The overview of the milestones of the 4th RP is shown below:

4th Railway Package Entry into force* Transposition**
Political Pillar
DIR (EU) 2016/2370 ‘Governance‘  24/12/2016  25/12/2018 
REG (EU) 2016/2338 ‘PSO’  24/12/2017  -
Technical pillar 
DIR 2016/797 ‘Interoperability’  15/06/2016  16/06/2019 
DIR 2016/798 ‘Safety’ 15/06/2016  16/06/2019
REG (EU) 2016/796 ‘ERA’   15/06/2016  -

 

*Entry into force: Legal texts need to be published. After the 20th day following its publication in the Official Journal of the European Union, a text enters into force.;

**Transposition: Member States are given a certain period to transpose EU legislation into national law. The timeframe depends on the type of the legal initiative. In the case of a Directive, Member States normally have 2 years from the date of the entry into force. For the case of Directives 2016/797 and 2016/798 the transposition period ends after three years on the 16th June 2019. However, some Member States took the option to postpone the transposition by 1 year.

Note on Switzerland: VA and SSC delivered by the Agency will be recognized from 16th of June 2019 but the full transposition of the directives will take place later on.

In the case of a Regulation, there is no transposition period as this type of legislation applies immediately to EU countries' national law when they entered into force (see point 1 above).

In the case of very complex legislation, such as the 4th Railway Package, the EU foresees various initiatives to help the Member States preparing the transposition. During this so-called “implementation phase”, the EU launches e.g. shadow running processes, pilot schemes, etc. This Guide addresses exactly this phase.

Why is it important ?

4.0 

The technical pillar of the 4th RP brings substantial reforms:

  • such as a new harmonised approach to safety certification and vehicle authorisation
  • an enhanced role for the Agency
  • a harmonised implementation of ERTMS and reduced national rules

For more information have a look on the ERA website.

⇒ Each of these individual reforms has a far-reaching impact on the rail sector (financial, operational, legal, procedural, etc.).

The Interoperability Directive (EU) 2016/797

What is the Interoperability Directive?

1.0 
  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 the conditions of overall compatibility of the Union rail system required in order to achieve its interoperability
  3. This Directive defines the subsystems, either structural or functional, forming part of the railway system of the European Union. For each of those subsystems, the essential requirements need to be specified and the technical specifications determined, particularly in respect of constituents and interfaces, in order to meet those essential requirements. The essential requirements as defined in Annex 3 of the directive are safety, reliability and availability, health, environmental protection, technical compatibility and accessibility.

How did EU interoperability legislation evolve?

1.0 

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.

The first such Directive was adopted in 1996 with 1996/48/EC on the interoperability of the trans-European high-speed rail system. This was accompanied 5 years later by Directive 2001/16/EC on the interoperability of the trans-European conventional rail system, both of which were then amended 3 years later by 2004/50/EC. As new amendments were introduced, in 2008 it is deemed appropriate to recast the Directives for the sake of clarity and to merge their provisions together into a single instrument with a view to simplification. This resulted in Directive 2008/57/EC on the interoperability of the rail system within the Community.  Further minor amendments to 2008/57/EC were made 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 interlinking and technical harmonisation of the national rail networks with the aim of establishing an area without internal frontiers and therefore improved access and competition.

What is 2016/797 about?

 

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

  • a One-Stop Shop (OSS) IT tool which serves as the IT-portal for all stakeholders to submit their applications for vehicle authorisation as well as single safety certification and ERTMS Trackside approvals;
  • a Board of Appeal (BoA) which will serve as body deciding on litigation cases;
  • enhanced databases (i.e. Register of infrastructure (RINF), a new European Vehicle Register (EVR) replacing ECVVR and a new Single Rules Database (SRD) replacing RDD in the future, 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?

5.0 

The main changes in 2016/797 are summarised below:

ERA:

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

TSIs:

  • the cases for possible non-application of TSIs is reduced;
  • TSIs should indicate when the upgrade and renewal of infrastructure and vehicles requires a new authorisation;
  • the EC published a delegated act defining the Agency’s mandate and objectives for the forthcoming TSI revisions starting in September 2017.

RUs/IMs:

  • 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 procedure for vehicle authorisation is defined in the VA implementing Regulation (EU) 2018/545 and the corresponding guidance;
  • 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 have to be submitted to the ERA via the One-Stop-Shop(OSS)[1];
  • 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.

More information:


[1]     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?

5.0 

Article 55 of (EU) 2018/545 sets out the transitional provisions for the new regime. These are of particularly importance for all pending applications with NSAs and their further processing by the ERA from 16th of June 2019 onwards, in particular the practicalities for transferring applications and the acceptance and processing by ERA of those parts already assessed by the NSAs.

Some Member States have decided to extend the transposition of the directive until 16th June 2020. With regard to the transposition dates in the respective Member State please refer to the table above.

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;
  • The NSAs remain responsible for the supervision of the railway actors at national level;
  • 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 prior to their national implementation.

The future cooperation between NSAs and the ERA will require 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 ERA Regulation foresees that the Agency will charge for the services provided under the Interoperability Directive. The rules for fees and charges are laid down in Commission Implementing Regulation (EU) 2018/764.

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.

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 Appeal Body’s Rules of Procedure are laid down in Commission Implementing Regulation 2018/867

More information: https://www.era.europa.eu/agency/board-appeal_en  

What are the next steps?

 
  • 16/02/2019: The OSS becomes operational allowing the submission of applications for vehicle authorisation;
  • 16/06/2019: ERA starts full operation and issue vehicle authorisations for those Member States having transposed the Interoperability Directive;
  • 16/06/2020: ERA issues vehicle authorisations for all MSs which have transposed 2016/797.

The Safety Directive (EU) 2016/798

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.

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?

5.0 

The main changes in 2016/798 are summarised below:

ERA:

  • 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.

RUs/IMs:

  • 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. The work on common safety methods for common occurrence reporting (CSM COR) will start, based on the RISC mandate, in 2020.

How will the future processes look like?

 
  • It is foreseen 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 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.

How much will the new procedure cost?

 

The ERA Regulation foresees that the Agency will charge for the services provided under the Safety Directive. The rules for fees and charges are laid down in Commission Implementing Regulation (EU) 2018/764. It is worth noting that procedures for the assessment of SMS already exists in the EU and for which fees & charges are levied by NSAs.

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.

When does the new safety certification regime apply?

 

The new safety certification regime applies as of 16 June 2019 with transitional provisions.

Transitional provisions apply in the case where a National Safety Authority (NSA) recognises that it will not be able to take its decision over the issue of a safety certificate in accordance with Directive 2004/49/EC before either 16 June 2019 or, 16 June 2020 in respect of those Member States that have notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798.

In such a case, the NSA has to promptly inform the applicant and the Agency. The applicant is requested to submit, from 16 June 2019 or 16 June 2020 as appropriate, a revised application through the One-Stop Shop and the single safety certificate will be issued by the selected safety certification body (i.e. the Agency or the relevant NSA).

The Agency, when acting as safety certification body, will take into account the results of the assessment carried out by the NSA relating to the Part A safety certificate in order to avoid any duplication of assessment and so, minimise the inconvenience for the applicant. In that respect, the Agency will assist the applicant to supplement the application file with additional evidence necessary to comply with the additional requirements introduced by the new legal framework. The Agency and the NSA will also cooperate and coordinate for assessing the application file.

The decisions issued by the Agency between 16 June 2019 and 16 June 2020 should exclude the network(s) of any Member States having not yet transposed Directive (EU) 2016/798. However, a single safety certificate issued by the Agency should be recognised as equivalent to a Part A safety certificate issued under Directive 2004/49/EC whilst the NSA should continue to issue its Part B safety certificate with a validity period not exceeding the one of the corresponding single safety certificate issued by the Agency.

More information under https://www.era.europa.eu/applicants/applications-single-safety-certificates_en

The ERA Regulation (EU) 2016/796

What is the ERA Regulation?

5.0 

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:

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

What are the main changes?

 

The main changes in 2016/796 are summarised below:

ERA:

  • 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 becomes the system authority for telematic applications and ERTMS;
  • the ERA manages all registers and databases related to 2016/797, 2016/798 and 2007/59/EC;
  • 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 and spare parts coordination.

Role of ERA with regards to registers:

  • 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)).

New IT tools under ERA management:

  • 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.

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.

What are the next steps?

 
  • 16/06/2019: ERA starts full operation and issue vehicle authorisations, approvals of ERTMS track-side component tenders and safety certificates for those Member States having transposed the Interoperability and the Safety Directive;
  • 16/06/2020: ERA issues vehicle authorizations, approvals of ERTMS track-side component tenders and safety certificates for all MS.