(51)

section 7.2 is replaced as follows: ‘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 Section 6.3. Table 11 shows the possible permutations. Table 11 Substitution permutation table ... 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 an existing unit 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 (*3) and in Commission Decision 2010/713/EC (*4). This point 7.2.2 applies in case of any change(s) to an existing unit or 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 clause 7.2.2.3, compliance with the requirements of this TSI or the TSI Noise (Commission Regulation (EU) No 1304/2014 (*5), see clause 7.2 of that TSI) 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 (1) 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 Rail inclination N/A Change of rail inclination the vehicle is conform to (2) 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 Maximum deceleration for the load condition 'maximum speed under normal payload at the maximum design speed Change of more than ± 10 % on the maximum average brake deceleration N/A 4.2.4.3.2.2 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 In order to establish the EC type or design examination certificate, the notified body selected by the entity managing the change is permitted to 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 (during 10 years phase B period). 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 latest revision of this TSI in force at that time. In any case, the entity managing the change shall ensure that the technical documentation which is relating to the EC type or design examination certificate is updated accordingly. The updated technical documentation, related to the EC type or design examination certificate is referred to in the technical file accompanying the EC declaration of verification issued by the entity managing the change for rolling stock declared as conformant to the modified type. 7.2.2.3 Particular rules for existing units 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 clause 7.1.2.2, to existing units 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 design characteristics 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 7.2.3 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 Noise, 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 Noise. 7.2.3.1.1 Phase A Phase A starts once a notified body, which is responsible for EC verification, is appointed by the applicant and ends when the EC type or design examination certificate is issued. The TSI assessment basis for a type is defined for a phase A period, with a duration of maximum four years. During the phase A period the assessment basis for EC verification to be used by the notified body will not change. When a revision of this TSI or of the TSI Noise comes into force during the phase A period, it is permissible (but not mandatory) to use the revised version(s), either totally or for particular sections, unless explicitly otherwise specified in the revision of these TSIs. In case of application limited to particular sections, the applicant has to justify and document that applicable requirements remain consistent, and this has to be approved by the notified body. 7.2.3.1.2 Phase B The phase B period defines the period of validity of the EC type or design examination certificate once it is issued by the notified body. During this time, units may be EC certified on the basis of conformity to type. The EC type or design examination certificate of EC verification for the subsystem is valid for a ten-year phase B period after its issue date, even if a revision of this TSI or of the TSI Noise come into force, unless explicitly otherwise specified in the revision of these TSIs. During this period of validity, new rolling stock of the same type is permitted to be placed on the market on the basis of an EC declaration of verification referring to the type certificate of verification. The updated technical documentation related to the EC type or design examination certificate is referred to in the technical file accompanying the EC declaration of verification issued by the applicant for rolling stock declared as conformant to the modified type. 7.2.3.2 Interoperability constituents This point concerns interoperability constituents which are subject to EC type examination (module CB), design examination (module CH1) or to suitability for use (module CV) in accordance with section 6.1 of this TSI. The EC type or design examination or suitability for use certificate is valid for a ten-year period. During this time, new constituents of the same type are permitted to be placed on the market without a new type assessment, unless explicitly otherwise specified in the revision of this TSI. Before the end of the ten-year period, the constituent shall be assessed according to the latest revision of this TSI in force at that time, for those requirements that have changed or are new in comparison to the certification basis. (*3) Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (OJ L 90, 6.4.2018, p. 66)." (*4) Commission Decision 2010/713/EU of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (OJ L 319, 4.12.2010, p. 1)." (*5) Commission Regulation (EU) No 1304/2014 of 26 November 2014 on the technical specification for interoperability relating to the subsystem ‘rolling stock — noise’ amending Decision 2008/232/EC and repealing Decision 2011/229/EU (OJ L 356, 12.12.2014, p. 421).’;"