Commission Regulation (EU) No 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock — freight wagons’ of the rail system in the European Union and repealing Decision 2006/861/EC Text with EEA relevance

The applicant or any entity authorised by the applicant (e.g. a keeper) shall provide this documentation to the entity in charge of maintenance as soon as it is assigned for the maintenance of the unit.

On the basis of these three documents, the entity in charge of maintenance shall define a maintenance plan and appropriate maintenance requirements at maintenance operational level under its sole responsibility (not in the scope of the assessment against this TSI).

The documentation includes a list of safety critical components. Safety critical components are components for which a single failure has a credible potential to lead directly to a serious accident as defined in Article 3(12) of Directive (EU) 2016/798.

The safety critical components and their specific servicing, maintenance and maintenance traceability requirements are identified by the designers/manufacturers at design phase and through a collaboration between designers/manufacturers and the concerned entities in charge of maintenance after vehicles have entered into operation.

4.5.1.   General documentation

The general documentation comprises:

• — Drawings and description of the unit and its components.

• — Any legal requirement concerning the maintenance of the unit.

• — Drawing of systems (electrical, pneumatic, hydraulic and control-circuit diagrams).

• — Additional on-board systems (description of the systems including description of functionality, specification of interfaces and data processing and protocols).

• — Configuration files for each vehicle (parts list and bill of material) to enable (in particular but not only) traceability during maintenance activities.

4.5.2.   Maintenance design justification file

The maintenance design justification file explains how maintenance activities are defined and designed in order to ensure that the rolling stock characteristics will be kept within permissible limits of use during its lifetime. The file shall give input data in order to determine the criteria for inspection and the periodicity of maintenance activities.  The maintenance design justification file comprises:

• — Precedents, principles and methods used to design the maintenance of the unit.

• — Precedents, principles and methods used to identify the safety critical components and their specific operational, servicing, maintenance and traceability requirements.

• — Limits of the normal use of the unit (e.g. km/month, climatic limits, foreseen types of loads, etc.).

• — Relevant data used to design the maintenance and origin of these data (return of experience).

• — Tests, investigations and calculations carried out to design the maintenance.

4.5.3.   Maintenance description file

The maintenance description file describes how maintenance activities can be conducted. Maintenance activities include, among others, inspections, monitoring, tests, measurements, replacements, adjustments and repairs.

Maintenance activities are split into:

• — preventive maintenance (scheduled and controlled), and

• — corrective maintenance.

The maintenance description file includes the following:

• — Component hierarchy and functional description which sets up the boundaries of the rolling stock by listing all the items belonging to the product structure of that rolling stock and using an appropriate number of discrete levels. The lowest item of the hierarchy shall be a replaceable component.

• — Parts list which shall contain the technical and functional descriptions of the spare parts (replaceable units). The list shall include all parts specified for changing based on condition, which may require a replacement following electrical or mechanical malfunction or which will foreseeable require a replacement after an accidental damage. Interoperability constituents shall be indicated and referenced to their corresponding declaration of conformity.

• — Safety critical components list: The safety critical components list shall contain the specific servicing, maintenance and servicing/maintenance traceability requirements.

• — Limit values for components which are not to be exceeded in service. It is permitted to specify operational restrictions in degraded mode (limit value reached).

• — List of reference to the European legal obligations to which components or subsystems are subject.

• — Maintenance plan ([^E0008]) i.e. the structured set of tasks to perform the maintenance including the activities, procedures and means. The description of this set of tasks includes: (a) Disassembly/assembly instructions drawings necessary for correct assembly/disassembly of replaceable parts. (b) Maintenance criteria. (c) Checks and tests in particular of safety relevant parts; these include visual inspection and non-destructive tests (where appropriate e.g. to detect deficiencies that may impair safety). (d) Tools and materials required to undertake the task. (e) Consumables required to undertake the task. (f) Personal protective safety provision and equipment.

• — Necessary tests and procedures to be undertaken after each maintenance operation before re-entry into service of rolling stock.

4.6.   Professional competencies

The professional competencies of staff required for the operation and maintenance of units are not covered by this TSI.

4.7.   Health and safety conditions

The provisions for health and safety of staff required for the operation and maintenance of units are covered by essential requirements 1.1.5, 1.3.1, 1.3.2, 2.5.1 and 2.6.1 set out in Annex III to  Directive (EU) 2016/797.

In particular, the following points of Section 4.2 specify provisions for health and safety of staff:

point 4.2.2.1.1: End coupling,

point 4.2.6.1: Fire safety,

point 4.2.6.2: Protection against electrical hazards.

If the unit is fitted with a manual coupling system, a free space for shunters during coupling and uncoupling shall be provided.

All protruding parts deemed a hazard to operational staff shall be clearly indicated and/or fitted with protective devices.

The unit shall be equipped with footsteps and handrails except in those cases it is not intended to be operated with staff on-board, e.g. for shunting.

4.8.   Parameters to be recorded in the technical file and European register of authorised types of vehicles

The technical file shall contain at least the following parameters:

• — Type, position and resiliency of the end coupling

• — Load due to dynamic traction forces and compressive forces

• — Gauge reference profiles to which the unit complies

• — Conformity, if any, to target gauge reference profile(s) G1, GA, GB and GC

• — Compliance, if any, to gauge lower reference profile(s)  GI1 and GI2

• — Mass per axle (tare and fully laden)

• — Position of the axles along the unit and number of axles

• — Length of the unit

• — Maximum design speed

• — Track gauges(s) the unit can be operated on

• — Compatibility with train detection systems (track circuits/axle counters/loop equipment)

• — Compatibility with hot axle box detection systems

• — In-service temperature range of the axle bearings

• — Nature of the signal which controls the brake (example: pneumatic main brake pipe, electric brake type XXX, etc.)

• — Characteristics of the control line and of its coupling with other units (main brake pipe diameter, section of the electric cable etc.)

• — Individual nominal performance of the brake unit, depending on the brake mode, if any (response time, brake force, level of adhesion required, etc.)

• — Braking distance or brake weight depending on the brake mode, if any.

• — Thermal load of the brake components expressed in terms of speed, axle load, gradient and brake distance

• — Temperature range and severity level of snow/ice/hail conditions

• — Ability/inability to be hump shunted

• — Presence of footsteps and/or handrails

• — Minimum brake force and, where relevant, maximum brake force and breakover loading mass for the parking brake (if applicable)

• — Number of axles where the parking brake is applied

• — Presence of one or more of the following functions: DDF, DPF, DDAF

• — Description of the signal informing of a derailment or a precursor to a derailment and its transmission for units fitted with DDF or DPF.

• — The compliance with wagon equipment requirement WE as set out in 7.1.2.2 of RID

• — The compliance with 7.1.2.1.1 to 7.1.2.1.6 of RID.

The rolling stock data that must be recorded in the ‘European register of authorised types of vehicles (ERATV)’ are set out in the Commission Implementing Decision 2011/665/EU of 4 October 2011 on the European register of authorised types of railway vehicles ([^E0009]).

4.9.   Route compatibility checks before the use of authorised vehicles

The parameters of the subsystem ‘rolling stock — freight wagons’ to be used by the railway undertaking, for the purpose of route compatibility check, are described in Appendix D1 of Commission Implementing Regulation (EU) 2019/773 ([^E0010])

5. INTEROPERABILITY CONSTITUENTS

5.1.   General

Interoperability constituents (ICs), as defined in Article 2(f) of  Directive (EU) 2016/797, are listed in Section 5.3 together with:

• — their area of use covering parameters of the subsystem, and

• — the reference to corresponding requirements defined in Section 4.2.

When a requirement is identified in Section 5.3 as being assessed at IC level, an assessment for the same requirement at subsystem level is not required.

5.2.   Innovative solutions

As stated in Article 10a, innovative solutions may require new specifications and/or new assessment methods. Such specifications and assessment methods shall be developed using the process described in point 6.1.3 whenever an innovative solution is envisaged for an interoperability constituent.

5.3.   Interoperability constituent specifications

5.3.1.   Running gear

The running gear shall be designed for all application ranges, the areas of use, as defined by the following parameters:

• — Track gauge

• — Maximum speed

• — Maximum cant deficiency

• — Minimum tare of the unit

• — Maximum axle load

• — Range of distances between bogie pivots or range of wheelbase of ‘two-axle units’

• — Maximum height of centre of gravity of empty unit

• — Coefficient of height of centre of gravity of loaded unit

• — Minimum torsional stiffness coefficient of car body

• — Maximum mass distribution coefficient for empty units with: Image omitted; see official source Where: Izz = moment of inertia of the car body relative to the vertical axis through the centre of gravity of the car body m = mass of the car body 2a* = wheelbase

• — Minimum nominal wheel diameter

• — Rail inclination.

The parameters speed and axle load may be considered in combination in order to define the appropriate area of use (e.g. maximum speed and tare weight).

The running gear shall comply with the requirements expressed in points 4.2.3.5.2 and 4.2.3.6.1. These requirements shall be assessed at IC level.

5.3.2.   Wheelset

For the purpose of this TSI, wheelsets include the main parts ensuring the mechanical interface with the track (wheels and connecting elements: e.g. transverse axle, independent wheel axle). Accessories parts (axle bearings, axle boxes and brake discs) are assessed at subsystem level.

The wheelset shall be assessed and designed for the area of use as defined by:

• — track gauge,

• — nominal wheel tread diameter, and

• — maximum vertical static force.

A wheelset shall comply with the requirements on geometrical and mechanical parameters defined in point 4.2.3.6.2. These requirements shall be assessed at IC level.

5.3.3.   Wheel

A wheel shall be designed and assessed for an area of use defined by:

• — nominal tread diameter,

• — maximum vertical static force,

• — maximum speed,

• — in-service limits, and

• — maximum braking energy.

A wheel shall comply with the requirements on geometrical, mechanical and thermo mechanical parameters defined in point 4.2.3.6.3. These requirements shall be assessed at IC level.

5.3.4.   Axle

An axle shall be designed and assessed for an area of use defined by:

• — maximum vertical static force.

An axle shall comply with the requirements on mechanical parameters defined in point 4.2.3.6.4. These requirements shall be assessed at IC level.

5.3.4a.   Friction element for wheel tread brakes

The friction element for wheel tread brakes shall be designed and assessed for an area of use defined by:

• — dynamic friction coefficients and their tolerance bands,

• — minimum static friction coefficient,

• — maximum permitted brake forces applied on the element,

• — suitability for train detection by systems based on track circuits,

• — suitability for severe environmental conditions.

A friction element for wheel tread brakes shall comply with the requirements defined in point 4.2.4.3.5. These requirements shall be assessed at IC level.

5.3.4b.   Automatic variable gauge system

An IC ‘automatic variable gauge system’ shall be designed and assessed for an area of use defined by:

• — the track gauges the system is designed for,

• — the range of maximum static axle loads,

• — the range of nominal wheel tread diameters,

• — the maximum design speed of the unit, and

• — the types of track gauge changeover facility(ies) the system is designed for, including the nominal speed through the track changeover facility(ies) and the maximum axial forces during the automatic gauge changeover process.

An automatic variable gauge system shall comply with the requirements set out in point 4.2.3.6.6; these requirements shall be assessed at IC level as set out in point 6.1.2.6.

5.3.5.   Rear-end signal

The rear-end signal, as described in Appendix E, is an independent IC. There are no requirements in Section 4.2 dealing with the rear-end signal. Its assessment by the notified body is not part of the EC verification of the subsystem.

5.3.6.   Devices to secure semi-trailers

Devices to secure semi-trailers shall be designed and assessed for an area of use defined by:

• — semi-trailers to which the device to secure semi-trailers is compatible,

• — the unit to which the device to secure semi-trailers can be safely mounted.

Devices to secure semi-trailers shall comply with the requirements set out in points 4.2.2.4.1, 4.2.2.4.2 and 4.2.2.4.3. The conformity of devices to secure semi-trailers with those requirements shall be assessed at interoperability constituent level in accordance with point 6.1.2.7.

6. CONFORMITY ASSESSMENT AND EC VERIFICATION

6.1.   Interoperability constituent

6.1.1.   Modules

The conformity assessment of an interoperability constituent shall be performed in accordance with the module(s) described in Table 8.

Table 8

Modules for conformity assessment of interoperability constituents

Module CA1	Internal production control plus product verification by individual examination
Module CA2	Internal production control plus product verification at random intervals
Module CB	EC-Type examination
Module CD	Conformity to type based on quality management system of the production process
Module CF	Conformity to type based on product verification
Module CH	Conformity based on full quality management system
Module CH1	Conformity based on full quality management system plus design examination
Module CV	Type validation by in-service experience (suitability for use)

These modules are specified in detail in Decision 2010/713/EU.

6.1.2.   Conformity assessment procedures

The manufacturer or his authorised representative established within the Union shall choose one of the modules or module combinations indicated in Table 9 in accordance with the required constituent.

Table 9

Modules to be applied for interoperability constituents

Point	Constituent	Modules	Modules	Modules	Modules	Modules	Modules
Point	Constituent	CA1 or CA2	CB + CD	CB + CF	CH	CH1	CV
Point	Constituent
4.2.2.4.1, 4.2.2.4.2 and 4.2.2.4.3	Devices to secure semi-trailers – strength, locking force and indications	X [^E0013]	X	X	X [^E0013]	X
4.2.3.6.1	Running gear		X	X		X
4.2.3.6.1	Running gear — established	X			X
4.2.3.6.2	Wheelset	X [^E0011]	X	X	X [^E0011]	X
4.2.3.6.3	Wheel	X [^E0011]	X	X	X [^E0011]	X
4.2.3.6.4	Axle	X [^E0011]	X	X	X [^E0011]	X
4.2.3.6.6	Automatic variable gauge system	X [^E0011]	X	X	X [^E0011]	X	X [^E0012]
4.2.4.3.5	Friction element for wheel tread brakes	X [^E0011]	X	X	X [^E0011]	X	X [^E0012]
5.3.5	Rear-end signal	X			X

Modules CA1, CA2 or CH may be used only in the case of products placed on the market, and therefore developed, before the entry into force of this TSI, provided that the manufacturer demonstrates to the NoBo that design review and type examination were performed for previous applications under comparable conditions, and are in conformity with the requirements of this TSI; this demonstration shall be documented, and is considered as providing the same level of proof as module CB or design examination according to module CH1.

Module CV shall be used in case the manufacturer of friction element for wheel tread brakes has no sufficient return of experience (according to its own judgment) for the proposed design.

Modules CA1, CA2 or CH may be used only in the case of products placed on the market, and therefore developed, before 4 November 2025, provided that the manufacturer demonstrates to the NoBo that design review and type examination were performed for previous applications under comparable conditions, and are in conformity with the requirements of this TSI; this demonstration shall be documented, and is considered as providing the same level of proof as module CB or design examination according to module CH1.

Within the application of the chosen module or module combination the interoperability constituent shall be assessed against the requirements mentioned in Section 4.2. If necessary, additional requirements concerning the assessment of particular interoperability constituents are given in the following clauses.

In case of a specific case applicable to a component defined as interoperability constituent in section 5.3 of this TSI, the corresponding requirement can be part of the verification at interoperability constituent level only in the case where the component remains compliant to the chapters 4 and 5 of this TSI and where the specific case does not refer to a national rule (i.e. additional requirement compatible with the core TSI and fully specified in the TSI).

In other cases, the verification shall be made at subsystem level; when a national rule applies to a component, the concerned Member State may define relevant applicable conformity assessment procedures.

6.1.2.1   Running gear

The demonstration of conformity for running dynamic behaviour is set out in the specification referenced in Appendix D Index [8].

Units equipped with an established running gear as described in that specification are presumed to be in conformity with the relevant requirement provided that the running gears are operated within their established area of use.

The minimum axle load and maximum axle load during operation of a wagon equipped with an established running gear shall be compliant with the loading conditions between tare and loaded specified for the established running gear, as in the specification referenced in Appendix D Index [8].

In case the minimum axle load is not achieved by the mass of the vehicle in tare condition, conditions for use can be applied to the wagon requiring to operate it always with a minimum payload or a ballast (for example with an empty loading device), to be compliant with the parameters of the specification referenced in Appendix D Index [8].

In such case, the parameter ‘Mass of wagon in tare conditions’ used for dispensation of on track tests can be substituted by ‘Minimum axle load’. This shall be reported in the Technical File as a condition for use.

The assessment of the bogie frame strength shall be based on the specification referenced in Appendix D Index [9].

6.1.2.2.   Wheelset

The demonstration of conformity for the mechanical behaviour of the wheelset assembly shall be carried out in accordance with the specification referenced in Appendix D Index [10], which defines limit values for the axial assembly force and the associated verification test.

6.1.2.3.   Wheel

• (a)Forged and rolled wheels: The mechanical characteristics shall be proven following the procedure described in the specification referenced in Appendix D Index [11].

• If the wheel is intended to be used with brake blocks acting on the wheel running surface, the wheel shall be thermo mechanically proven by taking into account the maximum braking energy foreseen. A type test, as described in the specification referenced in Appendix D Index [11], shall be performed in order to check that the lateral displacement of the rim during braking and the residual stress are within the specified tolerance limits.

• The decision criteria of residual stresses for forged and rolled wheels are set out in the same specification.

• Alternative demonstration of conformity is allowed in accordance with point 6.1.2.4a.

• (b)Other types of wheels: Other types of wheels are permitted for units in national use. In that case the decision criteria and the fatigue stress criteria shall be specified in national rules. Those national rules shall be notified by Member States in accordance with Article 17(3) of  Directive (EU) 2016/797.

A verification procedure shall exist to ensure at the production phase that no defects may adversely affect safety due to any change in the mechanical characteristics of the wheels. The tensile strength of the material in the wheel, the hardness of the rim, the fracture toughness (only for tread-braked wheels), the resistance to impact, the material characteristics and the material cleanliness shall be verified. The verification procedure shall specify the batch sampling used for each characteristic to be verified.

6.1.2.4.   Axle

In addition to the requirement for the assembly above, the demonstration of conformity of the mechanical resistance and fatigue characteristics of the axle shall be based on the specification referenced in Appendix D, Index [12].

That specification includes the decision criteria for the permissible stress. A verification procedure shall exist to ensure at the production phase that no defects may adversely affect safety due to any change in the mechanical characteristics of the axles. The tensile strength of the material in the axle, the resistance to impact, the surface integrity, the material characteristics and the material cleanliness shall be verified. The verification procedure shall specify the batch sampling used for each characteristic to be verified.

Alternative demonstration of conformity is allowed in accordance with point 6.1.2.4a.

6.1.2.4a

Where the EN standards referred to in points 6.1.2.2, 6.1.2.3 and 6.1.2.4 do not cover the proposed technical solution, it is permitted to use other standards to demonstrate conformity of the mechanical behaviour of the wheelset assembly, the mechanical characteristics of the wheels and the mechanical resistance and fatigue characteristics of the axle respectively; in that case the notified body shall verify that the alternative standards form part of a technically consistent set of standards applicable to the design, construction and testing of the wheelsets, containing specific requirements for wheelset, wheels and axles covering:

• — wheelset assembly,

• — mechanical resistance,

• — fatigue characteristics,

• — permissible stress limits,

• — thermomechanical characteristics.

Only standards that are publicly available can be referred to in the demonstration required above. The verification carried out by the notified body shall ensure the consistency between the methodology of the alternative standards, the assumptions taken by the applicant, the intended technical solution and the intended area of use.

6.1.2.5.   Friction elements for wheel tread brakes

The demonstration of conformity of friction elements for wheel tread brakes shall be carried out by determining the following friction element properties in accordance with the European Railway Agency (ERA) technical document  ERA/TD/2013-02/INT version 3.0 of 27.11.2015 published on the ERA website (http://www.era.europa.eu):

• — dynamic friction performance (chapter 4);

• — static friction coefficient (chapter 5);

• — mechanical characteristics including properties in respect to shear strength test and flexural strength test (chapter 6).

Demonstration of the following suitabilities shall be carried out in accordance with chapters 7 and/or 8 of the ERA technical document  ERA/TD/2013-02/INT version 3.0 of 27.11.2015 published on the ERA website (http://www.era.europa.eu), if the friction element is intended to be suitable for:

• — train detection by systems based on track circuits; and/or

• — severe environmental conditions.

If a manufacturer does not have sufficient return of experience (according with its own judgement) for the proposed design, the type validation by in-service experience procedure (module CV) shall be part of the assessment procedure for suitability for use. Before commencing in-service tests, a suitable module (CB or CH1) shall be used to certify the design of the interoperability constituent.

The in-service tests shall be organised on request from the manufacturer, who must obtain agreement from a railway undertaking that will contribute to such an assessment.

The suitability for train detection by systems based on track circuits for friction elements intended to be used in subsystems beyond the scope set out in chapter 7 of the ERA technical document  ERA/TD/2013-02/INT version 3.0 of 27.11.2015 published on the ERA website (http://www.era.europa.eu) may be demonstrated using the procedure for innovative solutions described in point 6.1.3.

The suitability for severe environmental conditions by a dynamometer test for friction elements intended to be used in subsystems beyond the scope set out in clause 8.2.1 of the ERA technical document  ERA/TD/2013-02/INT version 3.0 of 27.11.2015 published on the ERA website (http://www.era.europa.eu) may be demonstrated using the procedure for innovative solutions described in point 6.1.3.

6.1.2.6.   Automatic variable gauge system

The assessment procedure shall be based on a validation plan covering all aspects mentioned in points 4.2.3.6.6 and 5.3.4b.

The validation plan shall be consistent with the safety analysis required in clause 4.2.3.6.6 and shall define the assessment needed in all the following different phases:

• — Design review

• — Static tests (bench tests and integration-in-the-wheelset/unit tests)

• — Test on track gauge changeover facility(ies), representative of in-service conditions

• — On-track tests, representative of in-service conditions.

Regarding the demonstration of compliance to the safety level required in point 4.2.3.6.6, the assumptions considered for the safety analysis related to the unit the system is intended to be integrated in, and related to the mission profile of that unit, shall be clearly documented.

The automatic variable gauge system may be subject to an assessment of suitability for use (module CV). Before commencing in-service tests, a suitable module (CB or CH1) shall be used to certify the design of the interoperability constituent. The in-service tests shall be organised on request from the manufacturer, who must obtain an agreement from a railway undertaking for its contribution to such assessment.

The certificate delivered by the notified body in charge of the conformity assessment shall include both the conditions for use as per clause 5.3.4b and the type(s) and operating conditions of the track gauge changeover facility(ies) the automatic variable gauge system has been assessed for.

6.1.2.7.   Device to secure semi-trailers

The conformity of devices to secure semi-trailers with the requirements of points 4.2.2.4.1, 4.2.2.4.2 and 5.3.6 of this Annex shall be assessed in accordance with the procedures in Sections 2.1 and 2.2 of the ERA Technical Document referenced in Appendix D.2, Index [D].

The conformity of devices to secure semi-trailers with the requirements of points 4.2.2.4.3 and 5.3.6 shall be assessed in accordance with the prescriptions in Section 2.3 of the ERA Technical Document referenced in Appendix D.2, Index [D].

6.1.3.   Innovative solutions

If an innovative solution referred to in Article 10a is proposed for an interoperability constituent, the manufacturer or his authorised representative established within the Union shall apply the procedure set out in Article 10a.

6.2.   Subsystem

6.2.1.   Modules

The EC verification of the subsystem ‘Rolling stock — freight wagons’ shall be performed in accordance with the module(s) described in Table 10.

Table 10

Modules for EC verification of subsystems

SB	EC-Type Examination
SD	EC verification based on quality management system of the production process
SF	EC verification based on product verification
SH1	EC verification based on full quality management system plus design examination

These modules are specified in detail in Decision 2010/713/EU.

6.2.2.   EC verification procedures

The applicant shall choose one of the following combinations of modules or module for the EC verification of the subsystem:

• — (SB+SD), or

• — (SB+SF), or

• — (SH1).

Within the application of the chosen module or module combination the subsystem shall be assessed against the requirements mentioned in Section 4.2. If necessary, additional requirements concerning the assessment of particular constituents are given in the following clauses.

6.2.2.1.   Strength of unit

The demonstration of conformity shall be in accordance with one of the specifications referenced in Appendix D, either Index [3] or Index [1].

Regarding joints, a recognised verification procedure shall exist to ensure at the production phase that no defect may decrease the intended mechanical characteristics of the structure.

6.2.2.2.   Safety against derailment running on twisted track

The demonstration of conformity shall be carried out in accordance with the specification referenced in Appendix D Index [7].

6.2.2.3.   Running dynamic behaviour

On-track tests

The demonstration of conformity shall be carried out in accordance with the specification referenced in Appendix D Index [7].

For units operated on the 1 668 mm track gauge network, the evaluation of the estimated value for the guiding force normalized to the radius Rm = 350 m in accordance with that specification, shall be calculated in accordance with the following formula:

Ya,nf,qst = Ya,f,qst – (11 550 m/Rm – 33) kN.

The limit value of the quasi-static guiding force Yj,a,qst shall be 66 kN.

Values of cant deficiency can be adapted to 1 668 mm track gauge by multiplying the corresponding 1 435 mm parameter values by the following conversion factor: 1 733/1 500.

The combination of the highest equivalent conicity and speed for which the unit meets the stability criterion in the specification referenced in Appendix D Index [7] shall be recorded in the report.

6.2.2.4.   Axle box/bearings

The demonstration of conformity for mechanical resistance and fatigue characteristics of the rolling bearing shall be in accordance with the specification referenced in Appendix D Index [13].

It is permitted to use other standards for the above demonstration of conformity where the EN standards do not cover the proposed technical solution; in that case the notified body shall verify that the alternative standards form part of a technically consistent set of standards applicable to the design, construction and testing of the bearings.

Only standards that are publicly available can be referred to in the demonstration required above.

In the case of bearings manufactured according to a design developed and already used to place products on the market before the entry into force of relevant TSIs applicable to those products, the applicant is allowed to deviate from the demonstration of conformity above and refer to design review and type examination performed for previous applications under comparable conditions instead; this demonstration shall be documented and is considered as providing the same level of proof as type examination according to module SB or design examination according to module SH1.

6.2.2.4a.   Automatic variable gauge systems

The safety analysis required in point 4.2.3.6.6, and performed at IC level, shall be consolidated at the level of the unit; in particular, the assumptions made in accordance with point 6.1.2.6 may need to be reviewed to take into account the unit and its mission profile.

6.2.2.5.   Running gear for manual change of wheelsets

Changeover between 1 435 mm and 1 668 mm track gauges

The technical solutions described in the specification referenced in Appendix D Index [14] for axle units and for bogie units are deemed to be compliant with the requirements in point 4.2.3.6.7.

Changeover between 1 435 mm and 1 524 mm track gauges

The technical solution described in the specification referenced in Appendix D Index [15] is deemed to be compliant with the requirements in point 4.2.3.6.7.

6.2.2.6.   Thermal capacity

Calculations, simulations or tests shall demonstrate that the temperature of the brake block, brake pad or brake disc does not exceed their thermal capacity. The following shall be taken into account:

• (a) concerning the emergency brake application: the critical combination of speed and payload considering straight and level track, minimum wind and dry rails;

• (b) concerning the continuous brake application:
• — the range up to the maximum braking power,
• — the range up to the maximum speed, and
• — the corresponding brake application time.

6.2.2.7.   Environmental conditions

Steel materials are deemed to comply with all the ranges indicated in point 4.2.5 if the material properties are determined down to – 20 °C.

6.2.2.8.   Fire safety

6.2.2.8.1.   Barriers and spark arresters

Barriers and spark arresters shall be tested in accordance with the specification referenced in Appendix D Index [19]. Steel sheets of at least 2 mm thickness and aluminium sheets of at least 5 mm thickness are deemed to comply with the integrity requirements without testing.

6.2.2.8.2.   Materials

6.2.2.8.2.1.   Test

Testing of the materials ignitability and flame spread properties shall be performed in accordance with the specification referenced in Appendix D Index [20] for which the limit value shall be CFE ≥ 18 kW/m².

For rubber parts of bogies, the testing shall be performed in accordance with the specification referenced in Appendix D Index [23] for which the limit value shall be MARHE ≤ 90 kW/m² under the test conditions set out in the specification referenced in Appendix D Index [22].

6.2.2.8.2.2.   Components exempted from testing

Wheelsets, coated or uncoated, are deemed to comply with the required ignitability and flame spread properties without testing.

6.2.2.8.2.3.   Materials exempted from testing

The following materials are deemed to comply with the required ignitability and flame spread properties without testing:

• — metals and alloys with inorganic coatings (such as, but not limited to: galvanised coating, anodic coating, chromate film, phosphate conversion coating),

• — metals and alloys with an organic coating with a nominal thickness less than 0,3 mm (such as, but not limited to paints, plastic coating, asphaltic coating),

• — metals and alloys with a combined inorganic and organic coating of which the nominal thickness of the organic layer is less than 0,3 mm,

• — glass, stoneware, ceramic and natural stone products,

• — materials that meet the requirements of category C-s3, d2 or higher in accordance with the specification referenced in Appendix D Index [21].

6.2.2.8.3   Cables

The electrical cables shall be selected and installed in accordance with the specification referenced in Appendix D Indexes [24] and [25].

6.2.2.8.4   Flammable liquids

The measures taken shall be in accordance with the specification referenced in Appendix D Index [26].

6.2.3.   Innovative solutions

If an innovative solution referred to in Article 10a is proposed for the ‘rolling stock — freight wagons’ subsystem, the applicant shall apply the procedure set out in Article 10a.

6.3.   Subsystem containing components corresponding to interoperability constituents not holding an EC declaration

A Notified Body is permitted to issue an EC certificate of verification of a subsystem, even if one or more of the components corresponding to interoperability constituents incorporated within the subsystem are not covered by a relevant EC declaration of conformity in accordance with this TSI (non-certified ICs), if the constituent was manufactured before the entry into force of this TSI and the type of constituent has been:

• — used in a subsystem already approved, and

• — placed in service in at least one Member State before the entry in force of this TSI.

The EC verification of the subsystem shall be carried out by the notified body against the requirements of Chapter 4 by using the corresponding requirements concerning assessment in Chapter 6 together with Chapter 7 except for specific cases. For this EC verification the modules of the subsystem, set out in point 6.2.2, apply.

EC declarations of conformity or suitability for use shall not be drawn up for the components assessed in this manner.

6.4.   Project phases where assessment is required

The assessment shall cover the following two phases as identified by ‘X’ in the Table F.1 of Appendix F in this TSI. In particular, where a type test is identified the conditions and requirements of Section 4.2 shall be considered.

• (a) Design and development phase:
• — Design review and/or design examination
• — Type test: test to verify the design, if and as defined in the Section 4.2.

• (b) Production phase:
• — Routine test to verify the conformity of production. The entity in charge of the assessment of the routine tests is determined according to the assessment module chosen.

Appendix F is structured according to Section 4.2. Where relevant, a reference to the points of Sections 6.1 and 6.2 is given.

6.5.   Constituents holding an EC declaration of conformity

Where a constituent has been identified as an IC and held an EC declaration of conformity before the entry into force of this TSI, its treatment under this TSI is set out as follows:

• (a) In the case this constituent is not recognised as an IC in this TSI, neither the certificate nor the declaration are valid for the EC verification procedure related to this TSI.

• (b) The EC certificates of conformity, EC-type examination certificates and EC-design examination certificates of the following ICs shall remain valid under this TSI until their expiry:
• — Wheelset;
• — Wheel;
• — Axle.

7. IMPLEMENTATION

7.1.   Authorisation for placing on the market

• (1)This TSI is applicable to the subsystem ‘rolling stock — freight wagons’ within the scope set out in its points 1.1, 1.2 and 2.1, which are placed on the market after the date of application of this TSI, except where point 7.1.1 ‘Application to ongoing projects’ applies.

• (2)This TSI is also applicable on a voluntary basis to:

• — units referred to in point 2.1(a) in running mode, in case they correspond to a ‘unit’ as defined in this TSI, and

• — units as defined in point 2.1(c), in case they are in empty configuration.

• In case the applicant chooses to apply this TSI, the corresponding EC declaration of verification shall be recognised as such by Member States.

• (3)Compliance with this Annex in its version applicable before 28 September 2023 is deemed equivalent to compliance with this TSI, except for changes listed in Appendix A.

7.1.1.   Application to ongoing projects

• (1)The application of this TSI applicable from 28 September 2023 is not mandatory for projects that, on that date, are in phase A or phase B as defined in points 7.2.3.1.1 and 7.2.3.1.2 of the ‘previous TSI’ (i.e. this Regulation, as amended by Commission Implementing Regulation (EU) 2020/387 ([^E0014])).

• (2)Without prejudice to Appendix A, Table A.2, the application of the requirements of Chapters 4, 5, 6 to projects referred in point (1) is possible on a voluntary basis.

• (3)If the applicant chooses not to apply this TSI version to an ongoing project, the version of this TSI applicable at the beginning of phase A as referred to in point (1) remains applicable.

7.1.2.   Mutual recognition of the first authorisation of placing on the market

In accordance with Article 21(3)(b) of Directive (EU) 2016/797 the authorisation for placing of the market of a vehicle (as defined in this TSI) is granted on the basis of:

• — in accordance with point (a) of Article 21(3): the ‘EC’ declaration of verification as provided for in Article 15 of the same directive, and

• — in accordance with (d) of Article 21(3): evidence of the technical compatibility of the unit with the network in the area of use covering the EU network.

Points (b) and (c) of Article 21(3) of Directive (EU) 2016/797 do not represent any additional requirement. The technical compatibility of the vehicle with the network being covered by rules (TSIs or national rules), this aspect is also considered at the level of the ‘EC’ verification.

Therefore, the conditions for having an area of use not limited to particular national networks are specified below as additional requirements to be covered in the EC verification of the subsystem rolling stock. These conditions shall be seen as complementary to the requirements in Section 4.2 and must be fulfilled in their entirety:

• (a) The unit must be equipped with forged and rolled wheels assessed according to point 6.1.2.3(a).

• (b) The compliance/non-compliance with the requirements regarding the axle bearing condition monitoring by line side equipment as set out in point 7.3.2.2.(a) must be recorded in the technical file.

• (c) The reference profile established for the unit as per point 4.2.3.1 must be allocated to one of the target reference profile(s) G1, GA, GB and GC including those used for the lower part GI1 and GI2.

• (d) The unit must be compatible with the train detection systems based on track circuits, on axle counters and on loop equipment as specified in clauses 4.2.3.3(a), 4.2.3.3(b) and 4.2.3.3(c).

• (d1) If the unit has electronic equipment on board emitting interference current via the rail, the ‘influencing unit’ (as defined in the technical document referenced in Appendix D.2 Index [A]) of which the unit is planned to be part shall be compliant with specific cases for track circuits notified under Article 13 of CCS TSI by applying the harmonised vehicle test methods and vehicle impedance referred in the technical document referenced in Appendix D.2 Index [A].  Compliance of the unit shall be demonstrated based on the technical document referred in Article 13 of CCS TSI and is checked by the notified body as part of EC verification.

• (d2) If the unit has electrical or electronic equipment on board emitting interference electromagnetic fields:
• — close to the wheel sensor of an axle counter, or
• — induced by the return current via the rail if applicable. The ‘influencing unit’ (as defined in the technical document referenced in Appendix D.2 Index [A]) of which the unit is planned to be part shall be compliant with specific cases for axle counters notified under Article 13 of CCS TSI. Compliance of the unit shall be demonstrated by applying the harmonised vehicle test methods referred in the technical document referenced in appendix D.2 index [A] or alternatively based on the technical document referred in Article 13 of CCS TSI. It is checked by the Notified Body as part of EC verification.

• (e) The unit must be equipped with the manual coupling system in accordance with the prescriptions set out in Appendix C, Section 1, including the fulfilment of Section 8 or with any semi-automatic or automatic coupling system.

• (f) The brake system must be in accordance with the conditions of Appendix C, Sections 9, 14 and 15 when applying the reference case set out in point 4.2.4.2.

• (g) The unit must be marked with all applicable markings in accordance with the specification referenced in Appendix D Index [2]. The compliance of the unit with the Wagon Equipment requirements (WE) as set out in Appendix I shall be marked on both sides of the unit as depicted in Figure 3, even if the unit is not intended for the transport of dangerous goods: Figure 3 Marking of the unit with wagon equipment Image omitted; see official source In this example, the wagon is fitted with wagon equipment 1, 3, 2, 4 and 6. The letters shall be of the same font type as the GE marking. The size of the letters shall be at least 100 mm high. The outer measures of the frame shall be at least 275 mm wide and 140 mm high, the frame shall be 7 mm thick. The marking shall be located on the right-hand side of the area containing the European Vehicle Number and the TEN marking.

• (h) The minimum and, where relevant maximum parking brake force, the number of wheelsets (N) and the number of wheelsets on which the parking brake is applied (n) shall be marked as set out in  Figure 4: Figure 4 Marking of the parking brake force Image omitted; see official source Image omitted; see official source

7.2.   General rules for implementation

7.2.1.   Substitution of constituents

This section deals with substitutions of constituents as referred to in Article 2 of Directive (EU) 2016/797.

The following categories have to be considered:

Certified ICs: Components which correspond to an IC in Chapter 5 and which are holding a certificate of conformity.

Other components: Any component, which is not corresponding to an IC in Chapter 5.

Non-certified ICs: Components which correspond to an IC in Chapter 5 but are not holding a certificate of conformity and which are produced before the expiry of the transitional period referred to in Article 8.

Table 11 shows the possible permutations.

Table 11

Substitution permutation table

	... substituted by ...	... substituted by ...	... substituted by ...
	... certified ICs	... other components	... non-certified ICs
Certified ICs …	Check	not possible	check
Other components …	not possible	check	not possible
Non-certified ICs …	Check	not possible	check

The word ‘check’ in Table 11 means that the entity in charge of maintenance (ECM) may under its responsibility substitute a component by another one utilising the same function and at least the same performance in accordance with the relevant TSI requirements considering that these components are:

• — suitable, i.e. conform to the relevant TSI(s),

• — used within its area of use,

• — enabling interoperability,

• — meeting the essential requirements, and

• — in line with restrictions stated in the technical file.

7.2.2.   Changes to a unit in operation or to an existing unit type

7.2.2.1.   Introduction

This point 7.2.2 defines the principles to be applied by the entities managing the change and authorising entities in line with the EC verification procedure described in Article 15(9), Article 21(12) and Annex IV of Directive (EU) 2016/797. This procedure is further developed in Article 13, 15 and 16 of Commission Implementing Regulation (EU) 2018/545 ([^E0015]) and in Commission Decision 2010/713/EC ([^E0016]).

This point 7.2.2 applies in case of any change(s) to a unit in operation or to an existing unit type, including renewal or upgrade. It does not apply in case of changes:

• — that do not introduce a deviation from the technical files accompanying the EC declarations for verification for the subsystems, if any, and

• — that do not have an impact on basic parameters not covered by the EC declaration, if any.

The holder of the vehicle type authorisation shall provide, under reasonable conditions, the information necessary for assessing the changes to the entity managing the change.

7.2.2.2.   Rules to manage changes in both a unit or a unit type

Parts and basic parameters of the unit that are not affected by the change(s) are exempt from conformity assessment against the provisions in this TSI.

Without prejudice to point 7.2.2.3, compliance with the requirements of this TSI or Commission Regulation (EU) No 1304/2014 ([^E0017]) (‘TSI NOI’) (see point 7.2 of TSI NOI) shall only be needed for the basic parameters in this TSI which may be affected by the change(s).

In accordance with Articles 15 and 16 of Commission Implementing Regulation (EU) 2018/545 and Decision 2010/713/EU and by application of modules SB, SD/SF or SH1 for the EC verification, and if relevant in accordance with Article 15(5) of Directive (EU) 2016/797, the entity managing the change shall inform a notified body of all changes affecting the conformity of the subsystem with requirements of the relevant TSI(s) requiring new checks by a notified body. This information shall be provided by the entity managing the change with corresponding references to the technical documentation relating to the existing EC type or design examination certificate.

Without prejudice of the general safety judgement mandated in article 21(12)(b) of Directive (EU) 2016/797, in case of changes requiring reassessment of the safety requirements set out in clauses 4.2.4.2 for the brake system, a new authorization for placing on the market will be required unless one of the following conditions are met:

• — The brake system fulfils the conditions of C.9 and C.14 of Appendix C after change or,

• — Both the original and changed brake systems fulfil the safety requirements set out in clause 4.2.4.2.

National migration strategies related to the implementation of other TSIs (e.g. TSIs covering fixed installations) shall be taken into account when defining to what extent the TSIs covering rolling stock needs to be applied.

The basic design characteristics of the rolling stock are defined in Table 11a. Based on these tables and on the safety judgement mandated in Article 21(12)(b) of Directive (EU) 2016/797, the changes shall be categorised as follows:

• — 15(1)(c) of Commission Implementing Regulation (EU) 2018/545 if they are above the thresholds set out in column 3 and below thresholds set out in column 4 unless the safety judgement mandated in Article 21(12)(b) of Directive (EU) 2016/797 requires to categorise them as 15(1)(d), or

• — 15(1)(d) of Commission Implementing Regulation (EU) 2018/545 if they are above the thresholds set out in column 4 or if the safety judgement mandated in Article 21(12)(b) of Directive (EU) 2016/797 requires to categorise them as 15(1)(d).

The determination whether the changes are beyond or above the thresholds mentioned above shall be done in reference to the values of the parameters at the time of the last authorisation of the rolling stock or rolling stock type.

Changes not referred to in the paragraph above are deemed not to have any impact on the basic design characteristics and will be categorised as 15(1)(a) or 15(1)(b) of Commission Implementing Regulation (EU) 2018/545, unless the safety judgement mandated in Article 21(12)(b) of Directive (EU) 2016/797 requires to categorise them as 15(1)(d).

The safety judgement mandated in Article 21(12)(b) of Directive (EU) 2016/797 shall cover all changes concerning basic parameters of table 1, related to all the essential requirements, in particular the requirements ‘Safety’ and ‘Technical compatibility’.

Without prejudice to clause 7.2.2.3, all changes shall remain compliant with the applicable TSIs regardless their classification.

The replacement of a whole element within a rake of permanently connected elements after a severe damage does not require a conformity assessment against this TSI, as long as the element is identical to the one it replaces. Such element must be traceable and certified in accordance with any national or international rule, or any code of practice widely acknowledged in the railway domain.

Table 11a

Basic design characteristics related to basic parameters set out in the WAG TSI

1. TSI clause	2. Related basic design characteristic(s)	3. Changes impacting the basic design characteristic and not classified as 21(12)(a) of Directive (EU) 2016/797	4. Changes impacting the basic design characteristic and classified as 21(12)(a) of Directive (EU) 2016/797
4.2.2.1.1  End coupling	Type of end coupling	Change of end coupler type	N/A
4.2.3.1  Gauging	Reference profile	N/A	Change of reference profile the vehicle is conform to
	Minimum vertical convex curve radius capability	Change in minimum vertical convex curve radius capability the unit is compatible with of more than 10 %	N/A
	Minimum vertical concave curve radius capability	Change in minimum vertical concave curve radius capability the unit is compatible with of more than 10 %	N/A
4.2.3.2.  Compatibility with load carrying capacity of lines	Permissible payload for different line categories	Change [^E0018] of any of the vertical loading characteristics resulting in a change of the line category(ies) the wagon is compatible with	N/A
4.2.3.3  Compatibility with train detection systems	Compatibility with train detection systems	N/A	Change of declared compatibility with one or more of the three train detection systems: Track circuits Axle counters Loop equipment
4.2.3.4  Axle bearing condition monitoring	On-board detection system	N/A	Fitting/Removal of on-board detection system
4.2.3.5  Running safety	Combination of maximum speed and maximum cant deficiency for which the unit was assessed	N/A	Increase in maximum speed of more than 15 km/h or change of more than ± 10 % in maximum admissible cant deficiency
4.2.3.5.3  Derailment detection and prevention function	Presence and type of derailment detection and prevention function(s)	Fitting/removing of prevention/detection function	N/A
	Rail inclination	N/A	Change of rail inclination the vehicle is conform to [^E0019]
4.2.3.6.2  Characteristics of wheelsets	Wheelset gauge	N/A	Change of track gauge the wheelset is compatible with
4.2.3.6.3  Characteristics of wheels	Minimum required in-service wheel diameter	Change of minimum required in-service diameter of more than 10 mm	N/A
4.2.3.6.6  Automatic variable gauge systems	Wheelset gauge changeover facility	Change in the unit leading to a change in the changeover facility(ies) the wheelset is compatible with	Change of track gauge(s) the wheelset is compatible with
4.2.4.3.2.1  Service brake	Stopping distance	Change of stopping distance of more than ± 10 % Note: Brake weight percentage (also called ‘lambda’ or ‘braked mass percentage’) or braked mass may also be used, and can be derived (directly or via stopping distance) from deceleration profiles by a calculation. The allowed change is the same (± 10 %)	N/A
4.2.4.3.2.1  Service brake	Maximum deceleration for the load condition ‘design mass under normal payload’ at the maximum design speed	Change of more than ± 10 % on the maximum average brake deceleration	N/A
4.2.4.3.2.1  Service brake
4.2.4.3.2.2  Parking brake	Parking brake	Parking brake function installed/removed	N/A
4.2.4.3.3  Thermal capacity	Thermal capacity expressed in terms of Speed Gradient Brake distance	N/A	New reference case declared
4.2.4.3.4  Wheel slide protection (WSP)	Wheel slide protection	N/A	Fitting/removal of WSP function
4.2.5  Environmental conditions	Temperature range	Change of temperature range (T1, T2, T3)	N/A
	Snow, ice and hail conditions	Change of the selected range ‘snow, ice and hail’ (nominal or severe)	N/A

Change of the loading characteristics is not to be re-assessed in operation (loading/unloading of the wagon)

The rolling stock fulfilling one of the following conditions are deemed to be compatible with all rail inclinations: — Rolling stock assessed according to EN 14363:2016 — Rolling stock assessed according to EN 14363:2005 (amended or not amended by ERA/TD/2012-17/INT) or UIC 518:2009 with the result, that there is no restriction to one rail inclination — vehicles assessed according to EN 14363:2005 (amended or not amended by ERA/TD/2012-17/INT) or UIC 518:2009 with the result, that there is a restriction to one rail inclination and a new assessment of the wheel-rail-contact test conditions based on real wheel- and rail profiles and measured track gauge show compliance with the requirements on wheel-rail-contact conditions of EN 14363:2016

In order to establish the EC type or design examination certificate, the notified body selected by the entity managing the change may refer to:

• — the original EC type or design examination certificate for parts of the design that are unchanged or those that are changed but do not affect the conformity of the subsystem, as far as it is still valid,

• — additional EC type or design examination certificate (amending the original certificate) for modified parts of the design that affect the conformity of the subsystem with the TSIs referred to in the certification framework defined in point 7.2.3.1.1.

In case the validity period of the EC type or design examination certificate for the original type is limited to 10 years (due to the application of the former Phase A/B concept), the validity period of the EC type or design examination certificate for the modified type, type variant or type version shall be limited to 14 years after the date of appointment of a notified body by the applicant for the initial rolling stock type (beginning of phase A of the original EC type or design examination certificate).

7.2.2.3.   Particular rules for units in operation not covered by an EC declaration of verification with a first authorisation for placing in service before 1 January 2015

The following rules apply, in addition to point 7.2.2.2, to units in operation with a first authorisation for placing in service before 1 January 2015, where the scope of the change has an impact on basic parameters not covered by the EC declaration.

The compliance with technical requirements of this TSI is deemed established when a basic parameter is improved in the direction of the TSI defined performance and the entity managing the change demonstrates that the corresponding essential requirements are met and the safety level is maintained and, where reasonably practicable, improved. The entity managing the change shall in this case justify the reasons for which the TSI defined performance was not met, taking into account migration strategies of other TSIs as stated in section 7.2.2.2. This justification shall be in the technical file, if any, or in the original technical documentation of the unit.

The particular rule set out in the above paragraph is not applicable in changes impacting the basic parameters and classified as 21(12)a set out in table 11b. For those changes, compliance with the TSI requirements is mandatory.

Table 11b

Changes to basic parameters for which compliance with TSI requirements is mandatory for rolling stock not holding an EC type or design examination certificate

TSI clause	Related basic design characteristic(s)	Changes impacting the basic design characteristic and classified as 21(12)(a) of Directive (EU) 2016/797
4.2.3.1  Gauging	Reference profile	Change of reference profile the unit is conform to
4.2.3.3  Compatibility with train detection systems	Compatibility with train detection systems	Change of declared compatibility with one or more of the three train detection systems: Track circuits Axle counters Loop equipment
4.2.3.4  Axle bearing condition monitoring	On-board detection system	Fitting/Removal of on-board detection system
4.2.3.6.2  Characteristics of wheelsets	Wheelset gauge	Change of track gauge the wheelset is compatible with
4.2.3.6.6  Automatic variable gauge systems	Wheelset gauge changeover facility	Change of track gauge(s) the wheelset is compatible with

7.2.2.4.   Rules for the extension of the area of use for units in operation having an authorisation in accordance with Directive 2008/57/EC or in operation before 19 July 2010

• (1) In the absence of full conformity with this TSI, point 2 applies to units that fulfil the following conditions when requesting an extension of their area of use in accordance with Article 21(13) of Directive (EU) 2016/797:
• 1. they have been authorised in accordance with Directive 2008/57/EC or put in operation before 19 July 2010;
• 1. they are registered with ‘Valid’ registration code ‘00’, in the National Vehicle Register in accordance with Commission Decision 2007/756/EC ([^E0020]) or in the European Vehicle Register in accordance with Commission Implementing Decision (EU) 2018/1614 ([^E0021]) and maintained in a safe state of running in accordance with Commission Implementing Regulation (EU) 2019/779 ([^E0022]).

The following provisions for extension of area of use apply also in combination with a new authorisation as defined in point (a) of Article 14(3) of Regulation (EU) 2018/545.

• (2) Authorisation for an extended area of use of the units referred to in point 1 shall be based on the existing authorisation, if any, the technical compatibility between the unit and the network in accordance with point (d) of Article 21(3) of Directive (EU) 2016/797 and compliance with the Basic Design Characteristics of Table 11a of this TSI, taking into account any restrictions or limitations.

The applicant shall provide an ‘EC declaration of verification’ accompanied by technical files giving evidence of compliance with the requirements set out in this TSI, or with provisions having equivalent effect, for each basic parameter referred to in column 1 of Table 11a of this TSI, through one or a combination of the following:

• (a) compliance with requirements of this TSI as referred above;

• (b) compliance with corresponding requirements set out in a previous TSI as referred above;

• (c) compliance with alternative specifications deemed to have equivalent effect to the relevant requirements set out in this TSI as referred above;

• (d) evidence that the requirements for technical compatibility with the network of the extended area of use are equivalent to the requirements for technical compatibility with the network for which the unit is already authorised or in operation. Such evidence shall be provided by the applicant and may be based on the information in the register of railway infrastructure (RINF).
• (3) The equivalent effect of alternative specifications to the requirements of this TSI (point 2(c)) and the equivalence of requirements for technical compatibility with the network (point 2(d)) shall be justified and documented by the Applicant by applying the risk management process set out in Annex I of Regulation (EU) No 402/2013. The applicant shall provide a positive assessment by an assessment body (CSM RA).
• (4) In addition to the requirements referred to in point 2 and where applicable, the applicant shall provide an ‘EC declaration of verification’ accompanied by technical files giving evidence of compliance with the following:
• (a) specific cases relating to any part of the extended area of use, listed in this TSI, TSI NOI and CCS TSI;
• (b) the national rules referred to in points (a), (c) and (d) of Article 13(2) of Directive (EU) 2016/797 as notified in accordance with Article 14 of that Directive.
• (5) The authorising entity shall make publicly available through the Agency website details of the alternative specifications referred to in point 2(c) and of the requirements for technical compatibility with the network referred to in point 2(d) on the basis of which it granted authorisations for the extended area of use.
• (6) Where an authorised vehicle benefited from non-application of TSIs or part of them pursuant to Article 9 of Directive 2008/57/EC, the applicant shall seek derogation(s) in the Member States of the extended area of use in accordance to Article 7 of Directive (EU) 2016/797.
• (7) In accordance with Article 54(2) of Directive (EU) 2016/797, wagons used under Regolamento Internazionale Veicoli (RIV) shall be deemed authorised in accordance with the conditions under which they were used, including the area of use where they are operated. Following a change which requires a new authorisation for placing on the market in accordance with Article 21(12) of Directive (EU) 2016/797, wagons accepted under the latest RIV agreement shall conserve the area of use in which they were operating without further checks on the unchanged parts.

7.2.2.5.   Rules for units in operation that are equipped with devices to secure semi-trailers

Units in operation that are equipped with devices to secure semi-trailers shall be made to comply with the requirements in point 4.2.2.4.2 within a transitional period as set out in Table A.2 in Appendix A.

The conformity of devices to secure semi-trailers with the requirements in point 4.2.2.4.2 shall be assessed in accordance with the procedure in Section 2.2 of the ERA Technical Document referenced in Appendix D.2, Index [D].

The conformity shall be assessed:

• (a) by keepers in respect of their vehicle fleets, once per combination of unit type and type of the device to secure semi-trailers. The keeper may delegate the assessment to the manufacturer of the devices to secure semi-trailers, or the entity in charge of maintenance assigned to its vehicles; or

• (b) by manufacturers in respect of vehicles produced by them, once per combination of unit type and type of the device to secure semi-trailers. The evidence of conformity may then be provided to any keeper.

Each individual unit which corresponds to the positively assessed combination shall have an entry in its technical documentation which refers to the tests done and confirms that it complies with the requirements in point 4.2.2.4.2. The conformity with the requirements in point 4.2.2.4.2 shall also be included in the markings on the unit, in accordance with point 4.2.2.4.4.

An assessment by a notified body shall not be required.

Units in operation that are equipped with devices to secure semi-trailers shall be made to comply with the requirements in points 4.2.2.4.4 within a transitional period as set out in Table A.2.

The conformity of the marking of each individual unit shall be assessed in accordance with the prescriptions in Section 2.4 of the ERA Technical Document referenced in Appendix D.2, Index [D]. The conformity shall be assessed by the keeper. The keeper may delegate the assessment to the entity in charge of maintenance assigned to its units.

Each individual unit which has been positively assessed shall have an entry in its technical documentation which confirms that it complies with the requirements in point 4.2.2.4.4.

An assessment by a notified body shall not be required.

7.2.3.   Rules related to the EC type or design examination certificates

7.2.3.1.   Rolling stock subsystem

This point concerns a rolling stock type (unit type in the context of this TSI), as defined in Article 2(26) of Directive (EU) 2016/797, which is subject to an EC type or design verification procedure in accordance with section 6.2 of this TSI. It also applies to the EC type or design verification procedure in accordance with the TSI NOI, which refers to this TSI for its scope of application to freight units.

The TSI assessment basis for an EC type or design examination is defined in columns ‘Design review’ and ‘Type test’ of Appendix F of this TSI and of Appendix C of the TSI NOI.

7.2.3.1.1.   Definitions

(1) Initial assessment framework

The initial assessment framework is the set of TSIs (this TSI and the TSI NOI) applicable at the beginning of the design phase when the notified body is contracted by the applicant.

(2) Certification framework

The certification framework is the set of TSIs (this TSI and the TSI NOI) applicable at the time of issuing the EC type or design examination certificate. It is the initial assessment framework amended with the revisions of TSIs that came into force during the design phase.

(3) Design phase