Guidance

Railway interoperability: stakeholder guidance

Published 19 January 2022

Applies to England, Scotland and Wales

This guidance is intended as an aid for stakeholders to explain the process of seeking an authorisation for structural subsystems in Great Britain and covers the stages from the design and construction of a structural subsystem through to its use on the rail system.

Although the Railways (Interoperability) Regulations 2011 (RIR 2011) is UK-wide in its application, different rules and processes may need to be applied in Northern Ireland, due to the application of the Northern Ireland Protocol.

Stakeholders should email railsafety@infrastructure-ni.gov.uk at the Department for Infrastructure (DfI) in NI if they have a query about the interoperability regime in NI.

The Department for Transport (DfT) is also working with France to implement aspects of the recast Interoperability and Safety Directives for the Channel Tunnel to help ensure procedures and processes are as consistent as possible throughout the Fixed Link.

Detailed guidance on the regime covering the Channel Tunnel will be published in due course. Stakeholders should contact the Office of Rail and Road (ORR) if they have any queries.

Stakeholders are advised to refer to the Railways (Interoperability) Regulations 2011 as amended by the Exit Regulations as the primary source of information, as these notes are for guidance purposes only.

Background

Interoperability supports rail safety and technical compatibility between trains and infrastructure, and it also enables the railway to compete more effectively with other forms of transport. It establishes common standards and assessment processes for new, upgraded or renewed rail vehicles, infrastructure and components.

The interoperability regime is established by the RIR 2011. These regulations have recently been amended to ensure that the railway interoperability regime remains operable and there is a clear and accessible technical standards framework as a result of the UK’s withdrawal from the EU.

In total, there have been 4 sets of regulations that implement changes to the UK’s interoperability framework as a result of EU withdrawal, which are as follows:

1. The Railways (Interoperability) (Amendment) (EU Exit) Regulations 2019 (2019/345), which corrected deficiencies that arose as a result of EU Exit and ensured that a clear and accessible domestic legal framework was established for interoperability. This included the creation of a framework for the Secretary of State for Transport to publish national technical specification notices (NTSNs) under a new Regulation 3A.

2. The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (2019/1310), which corrected minor drafting errors in SI 2019/345.

3. The Railways (Interoperability) (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2020 (2020/318) which made further amendments to both RIR 2011 and SI 2019/345 and corrected a body of retained EU law necessary for the regulatory framework to function correctly after the Transition Period (IP) Completion Day.

4. The Railways (Miscellaneous Amendments and Revocations and Transitional Provisions) (EU Exit) 2020 (2020/786), which made changes to SI 2019/345 to reflect the change across the statute book from 1 January 2021 to replace ‘exit day’ with ‘IP Completion Day’ as a result of the ratification of the Withdrawal Agreement.

A separate guidance document has also been prepared to demonstrate what the amendments to the text of RIR 2011 look like since all the Exit Regulations came into force on 1 January 2021.

The Railways interoperability EU Exit Regulations Keeling is available.

Life cycle of a project

RIR 2011 includes a number of requirements from the design stage of a project until the eventual use of the project subsystem.

This can be summarised as follows:

• design and construction stage
  • appointing an approved body and/or a designated body
  • making relevant declarations
• application for an authorisation
  • compiling a technical file in preparation for an authorisation
  • authorisation of a subsystem
• operation of a structural subsystem
• retention of documentation
• changes to the subsystem requiring a new authorisation

The project entity

The project entity is the lead entity responsible for seeing a subsystem through the authorisation process.

The project entity is responsible for engaging a conformity assessment body to certify the subsystem’s conformity with national technical specification notices (NTSNs) and national technical rules (NTRs). The entity makes a UK declaration of verification (if the project is a structural subsystem) for submission to the safety authority with the subsystem’s technical file.

RIR 2011 distinguishes between the project entity, the owner and the operator and places specific responsibilities on each during the development and operational phases of the subsystem.

The project entity may be a contracting entity that hires another organisation to design, construct, renew or upgrade a subsystem.

The project entity may also be a manufacturer, or an authorised representative of a contracting entity or manufacturer.

The project entity could also be the owner, operator or another body, and the role may be handed from one to another during the life of the project.

In the case of infrastructure projects, the project entity may be a body such as Network Rail as the manager of the infrastructure, or a third party (for example, a local authority).

In some cases, more than one body could simultaneously be the project entity. It is essential that the relevant parties recognise which role or roles they are carrying out at any given point in the life of the subsystem and establish among themselves as early as possible who will be carrying out this role under RIR 2011.

The project

Structural subsystems must be designed, constructed and installed to meet the essential requirements when placed into service.

They must also be technically compatible with the rail system in which they are intended to be operated.

To meet the essential requirements, the structural subsystem must be built in compliance with relevant standards: NTSNs and NTRs.

Under RIR, certain parts of the railway fall outside the scope of the regulations. These are either described in the regulations as blanket exemptions, such as narrow-gauge railways less than 350mm, or are captured in a published exclusion list, such as trams, metros and light railways.

DfT maintains a list of those parts of the rail system that fall outside of scope of RIR 2011. Projects can apply to DfT to be added to this list.

Standards

In Great Britain, the relevant rail technical standards are:

• National technical specification notices (NTSNs)
• National technical rules (NTRs)

They are published by the Secretary of State for Transport respectively in accordance with Regulations 3B and 3C of RIR 2011.

There are also track-change versions available on the Rail Safety and Standards Board (RSSB) website that highlight how the NTSNs differ from the corresponding EU technical specification for interoperability (TSI). Please note that versions hosted on the RSSB website are for guidance purposes only and projects should ensure they comply with the versions listed on GOV.UK.

NTRs are Railway Group Standards (RGSs) and are managed by RSSB.

Appointment of an approved body and designated body

The project entity must engage either an approved body to carry out the UK verification assessment procedure to ensure compliance with the relevant NTSNs or an EU notified body to carry out the EC verification assessment procedure to ensure compliance with the relevant TSIs.

If there are applicable UK-specific rules, the project entity must also engage a designated body to carry out the UK verification assessment procedure in relation to any relevant NTRs and specific cases within NTRs or NTSNs.

All approved bodies currently appointed for rail interoperability in the UK are also designated bodies.

The project entity must engage an approved body, or an EU notified body before either the completion of the design stage of the project subsystem; or before commencement of the manufacturing stage of the project subsystem, whichever is the earlier.

Approved bodies accredited and appointed to carry out conformity assessment work for rail interoperability are listed on the UK Market Conformity Assessment Body Database (UKMCAB).

Designated bodies are listed at Rail interoperability: approved bodies and designated bodies.

Interoperability constituents

RIR 2011 defines an interoperability constituent as any elementary component, group of components, sub-assembly or complete assembly of equipment that is incorporated or intended to be incorporated into a subsystem upon which the interoperability of the rail system depends directly or indirectly; and the concept of a ‘constituent’ covers both tangible objects and intangible objects such as software.

The lists of interoperability constituents are set out in chapter 5 of the relevant NTSN or TSI. Some typical examples of interoperability constituents include brakes, wheels, horns and headlamps.

The relevant requirements for each interoperability constituent are set out in the relevant NTSN and TSI. 

Products that are deemed to be interoperability constituents should be assessed against the relevant requirements so that the manufacturer obtains the relevant certificates, independently of the subsystem into which they are integrated (or they may self-certify if the NTSN or TSI enables this process). 

The assessment is a necessary step before placing the constituent on the UK market.

The relevant NTSN for the subsystem (with reference to the modules NTSN) will state the relevant procedures for the assessment of conformity and suitability for use of an interoperability constituent, including whether it can be self-certified or if certification must be conducted by the approved body.

Interoperability constituents with EC certification

The UK will treat interoperability constituents placed anywhere on the EU market before 31 December 2020 as interoperability constituents placed on the UK market under RIR 2011.

The Exit Regulations do not require an additional process to place such interoperability constituents on the market again in the UK. This is covered in Part 3 of the regulations and the transitional arrangements in Regulation 47A.

If a person wishes to place an interoperability constituent with an EC declaration of conformity or suitability for use on the GB market from 1 January 2021, where the UK and EU technical standards remain aligned (with no applicable UK-specific cases), it will be possible for a person to do so on the basis of that EC declaration. This will be made subject to a 1 January 2023 deadline through further regulatory changes.

The NTSNs will identify if there is a UK-specific case that is relevant to an interoperability constituent.

If there is an applicable UK-specific case, it will be necessary for anyone seeking to place that constituent on the GB market from 1 January 2021 (based upon an EC declaration drawn up before, on or after that date) to engage a UK-designated body to assess that the constituent meets the requirements of the UK-specific case and draw up a UK declaration of conformity or suitability for use. That is unless the pre-exit specific case provision applies under Regulation 23 (2) (b), which makes provision for ICs with EC declarations previously assessed against the same specific case but not placed on the market prior to 31 December 2020.

This must be done in accordance with the procedure set out in the NTSN concerning the further assessment of interoperability constituents that hold an EC declaration of conformity or suitability for use.

If no EC declaration was drawn up, then the engagement of a designated body to undertake the assessment still applies.

An interoperability constituent, to which a UK-specific case applies and in respect of which an EC declaration of conformity or suitability for use was drawn up before 1 January 2021, can, however, be placed on the GB market on the basis of that EC declaration. This is subject to the 1 January 2023 deadline if:

• there is no material difference between the technical specifications of the applicable UK specific case and a pre-exit specific case against which the interoperability constituent was previously assessed
• there are no other applicable UK-specific cases

RIR 2011 provides that material difference in this context does not include a TSI or notified national technical rule (NNTR) requirement that was reproduced in the NTSN or NTR.

Non-compliance (Regulation 14)

When a project is seeking an authorisation but is unable to comply with the whole or part of a relevant NTSN, they must apply in writing to DfT for an exemption. The circumstances in which an exemption can be granted for a new subsystem, or the renewal or upgrade of an existing one, are when:

• a project was already at an advanced stage when the new NTSN was published^{[footnote 1]}
• following an accident or natural disaster, it would not be economically or technically possible for a project to comply with all or part of the NTSN to allow for the rapid restoration of the subsystem
• a project is employing an innovative solution that does not comply with the existing NTSNs or the assessment methods in the NTSNs cannot be applied for this innovative solution

Additionally, 2 further exemptions are available only for projects that are upgrading or renewing an existing subsystem. They are:

• when applying the NTSN would compromise the economic viability of the project or the compatibility of the project with the rail system in the United Kingdom^{[footnote 2]}
• when the loading gauge, track gauge, space between tracks or electrification voltage in the applicable NTSN is not compatible with those of the existing infrastructure

Which exemptions might be available to different projects

Type of exemption	Upgrade	Renewal	New subsystem
Project at an advanced stage	Y	Y	Y
Loading gauge, track gauge, space between tracks or electrification voltage in NTSN not compatible with existing infrastructure	Y	Y	N
Economic viability or incompatibility with existing rail system in UK	Y	Y	N
After an accident or natural disaster, applying the NTSN partly or in full is not economically or technically possible to allow for rapid restoration	Y	Y	Y
Innovative solutions	Y	Y	Y

Y = yes, this exemption is possible for this kind of project
N = no, this exemption is not possible

When developing an application, projects should refer to Regulation 14A of RIR 2011, which contains a checklist of items to include in a Regulation 14 exemption request.

If you require further guidance, email DfT at interoperability@dft.gov.uk to discuss the individual case. DfT will then discuss it with ORR and other relevant parties and provide guidance to the project before a formal submission for disapplication is made in writing.

Deviations from national technical rules

If a project cannot comply with a national technical rule requirement (contained in an RGS) you may consider seeking the views of the relevant RSSB standards committee about a possible deviation.

Further guidance on how to apply for a deviation is available on RSSB’s website.

Authorisation to place into service

Before first using a structural subsystem, an authorisation to place into service must be obtained from ORR. This requirement also applies to vehicles with an authorisation to place into service or an authorisation to place on the market issued in an EU member state or by the European Union Agency for Railways.^{[footnote 3]}

The purpose of the authorisation issued by the ORR is to confirm that the structural subsystem meets the essential requirements and complies with the relevant NTSNs and NTRs.

A project entity seeking authorisation must apply in writing to ORR and include the technical file and the UK declaration of verification.

The safety authority can only issue an authorisation for the placing in service of a structural subsystem if it is satisfied that the:

• UK declaration of verification has been drawn up in accordance with schedule 54 of RIR 2011
• structural subsystem is technically compatible with the rail system into which it is being integrated
• structural subsystem has been so designed, constructed and installed as to meet the essential requirements relating to that subsystem when placed in service

The application for authorisation must also comply with Regulations 4 (requirement for authorisation), 15 (essential requirements for project subsystems) and 16 (role of project entity) of the RIR 2011.

There is no mandatory time limit for ORR to determine an application for an authorisation. However, applicants are advised to allocate at least 4 weeks into their project timescales and engage with ORR early in the planning stages of the project to ensure all relevant information is supplied for them to make a timely decision.

Operation of a structural subsystem

The operator of a structural subsystem has a responsibility under RIR 2011 to maintain it in accordance with the standards which were applicable when the infrastructure or vehicle was first authorised, or subsequent updates to those standards (Regulation 20 of RIR 2011). This is necessary for the safe operation of the railway.

Retention of documents

Regulation 19 of RIR 2011 requires that from the time an applicant for a project subsystem receives an authorisation to be placed in service until such time as it is permanently withdrawn from service, they must keep the technical file, including relevant declaration of verification. This requirement passes to the new owner if the applicant for authorisation subsequently transfers ownership of the subsystem.

The owner must also provide a copy of the technical file to ORR if requested, as well as any other safety authority in a country where the subsystem is used.

In addition to retaining the documentation, the owner must also document any alterations to the project subsystem and add these to the technical file. This includes maintenance manuals and any relevant safety assessment reports.

If the project subsystem is subsequently transferred to a new owner, this must include the transfer of the technical file. The new owner is then responsible for retaining the relevant documentation in accordance with Regulation 19.

Upgrade and renewal

Regulation 13 of RIR 2011 enables a project to make an application to DfT, as the competent authority, when it considers itself to meet the definition of an upgrade or renewal project.

The purpose of the application is to seek a decision whether an authorisation to place into service is required for the work and the extent to which the NTSNs should apply to the project.

This is not a mandatory application process, so in most circumstances, the upgrade or renewal project should simply proceed to comply with the NTSNs and seek authorisation if there are not any problems achieving compliance.

It is not possible to seek a decision from DfT about whether the work is upgrade or renewal as there are not any provisions for such a decision under RIR 2011. The project must determine this for itself.

There is a mechanism under Regulation 12 for a list to be published by DfT describing the types of project deemed to be upgrade or renewal, but this provision has not been used.

The definitions of upgrade or renewal under RIR 2011 are as follows:

• ‘upgrading’ means any major modification work on a subsystem or part of a subsystem that improves the overall performance of the subsystem; and cognate words shall be construed accordingly

• ‘renewal’ means any major substitution work on a subsystem or part subsystem which does not change the overall performance of the subsystem; and cognate words shall be construed accordingly

Projects are advised to refer to these definitions and seek authorisation accordingly.

If they apply under Regulation 13, DfT will consult with ORR before issuing a decision that an authorisation is not required.

The types of factors DfT might take into consideration under Regulation 13 applications include the scale of the project, safety risks, whether it is novel, its complexity and interface with other subsystems.

Regulation 13 lists the information to be provided in an application:

(a) a file setting out details of the project

(b) the project entity’s assessment of whether there are any new or changed safety risks resulting from the works envisaged and how any such risks will be managed

(c) identification of any NTSN, or part of an NTSN, for which exemptions may, or will, be sought pursuant to Regulation 14

(d) an indication of any NTSN, or part of an NTSN, which it is proposed should not apply if the competent authority determines that the subsystem requires authorisation.

1. Exemptions of this kind may also be available for projects which concern the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of the rail system, as well as the professional qualifications and health and safety conditions of the staff who contribute to its operation and maintenance. ↩

2. Exemptions of this kind may also be available for extensions of existing subsystems. ↩

3. Note: there is an exemption from the need to obtain an authorisation in cases where a vehicle has been authorised in another COTIF contracting state and is compliant with Article 3(a) of Appendix G to COTIF. In those cases, the vehicle is deemed to be authorised in the United Kingdom. Nevertheless, the operator of the vehicle should contact the ORR to inform them that they intend to operate the vehicle in the UK and provide sufficient evidence that the vehicle has received an authorisation and meets the criteria set out in Article 3(a) of Appendix G to COTIF. In most cases, this will only apply to go anywhere (GE) wagons. ↩