séminaire uip sur le 4ème paquet...

Séminaire UIPsur le 4ème Paquet Ferroviaire

Hugues DELSOIR

Paris, 29.11.2018

Legal framework

The technical pillar of the 4th Railway Package (4RWP)Background

Slide 3

2004• 2nd railway package: Interoperability Directive amended (covering TEN network), Safety

Directive 2004/49/CE and Regulation 881/2004 (European Railway Agency created)

2007• 3rd railway package: passenger rights better guaranteed, opening of the market for

international railway services (from January 2010), European license for train drivers

2008• Interoperability Directive 2008/57/EC covering all the railway network

• Directive 2008/110/EC amending the Safety Directive (ECMs introduced)

2016

• 4th railway package (technical pillar): major revision of ERA regulation, Interoperability and Safety directives: new roles and responsibilities for ERA, single safety certificate and improved vehicle authorisation process

Vehicle authorisation processLegislative framework (4RWP)

Slide 4

• Regulation (EU) 2016/796 The Agency regulation

• Directive (EU) 2016/797 Interoperability

• Directive (EU) 2016/798 Safety

Directives & Regulations

• (EU) 2018/545 Practical arrangements for the vehicle authorisation process

• (EU) 402/2013 CSM for risk evaluation and assessment

• EC declaration of verification (voted RISC Nov 2018)

• Cross-acceptance (draft; target : 2nd half 2019)

Commission Implementing

Regulations

• ERA-PRG-005/02_361 Guidelines for the practical arrangements for the vehicle authorisation process

• ERA-PRG-005/02_374 Catalogue of examplesGuidance

• Cooperation agreements between the Agency and the NSAsAgreements

Vehicle authorisation processLegislative framework (4RWP)

Slide 5

www.era.europa.eu

What’s new ?

Vehicle authorisation processWhat is new?

Slide 7

ONE SINGLE AUTHORISATION

FIRST AUTHORISATION

MS1

ADDITIONAL AUTHORISATION

MS2

ADDITIONAL AUTHORISATION

MS3

3rd RWP 4th RWP

Authorisation for placing in service

Authorisation for placing on the market

Vehicle type

Vehicles

+Variant & Version

Authorising entity

Vehicle authorisation processOverview - Context

Slide 8

PLACING ON THE MARKET OF

MOBILE SUBSYSTEMS

1

VEHICLE AUTHORISATION FOR PLACING ON

THE MARKET/ VEHICLE TYPE

AUTHORISATION

2

CHECK BEFORE THE USE OF

AUTHORISED VEHICLE

3

The Agency (in collaboration with concerned NSAs)

• Essential Requirements• No need for authorisation of

the mobile subsystem• EC Declaration of Verification

• Technical compatibility of the subsystems within the vehicle

• Safe integration of the subsystems within the vehicle

• Technical compatibility of the vehicle with the network in the area of use

Route compatibilityon the basis of the Register of Infrastructure (RINF) and national rules

SUPERVISION

4 In case of non-compliance to essential requirements noticed during operation by Railway undertakings or ultimately by NSA and inducing safety risks (e.g. during supervision activities) authorisation can be suspended, revoked or amended.

>1 MS Only 1 MS

The Agency or NSA(Applicant's

choice)

Railway Undertaking

One-Stop Shop

NSA(s)

Applicant

Vehicle authorisation processAuthorising entity

Slide 9

Area of use covering more than one Member State:

The Agency is the authorising entity and issues the vehicle type authorisation for placing on the market and/or the vehicle type

authorisation.

In collaboration with the concerned NSAs for the area of use (cooperation agreements the Agency/ NSAs)

Area of use limited to one Member State:

Applicant has the choice to address the application to either the concerned NSA or the Agency

Every application is to be submitted through the One-Stop Shop (OSS)

Vehicle authorisation processNew/amended roles and responsibilities

Slide 10

Further clarification

Holder of vehicle type

authorisation

Applicant

The Agency

KeeperNSA

Authorising entity

Infrastructure manager

One VA process

Vehicle authorisation processThe process

Slide 12

Stage 1 Preparation of the application

Stage 2 Pre-engagement

Stage 3 Conformity assessment

Stage 4 Submitting the application

Stage 5 Processing the application

Stage 6 Final documentation

Suspension, revocation or amendment of an issued authorisation

EU H

AR

MO

NISED

PR

OC

ESS

5 (+ 2) vehicle authorisation cases

Slide 13

FIRST AUTHORISATION - For a new vehicle type (including its variants and versions), and where applicable the first vehicle(s)

NEW AUTHORISATION - After a change (requiring an authorisation) of an already authorised vehicle type (including its variants and versions) and/or vehicle(s)

EXTENDED AREA OF USE - For an already authorised vehicle type (including its variants and versions) and/or vehicle(s) in order to extend the area of use without a change of the design

RENEWED VEHICLE TYPE AUTHORISATION - For an already authorised type (including its variants and versions) in the event of a change to any relevant provisions in TSIs or national rules requiring the renewal of its authorisation

CONFORMITY TO TYPE - For vehicles or series of vehicles conform to an already authorised and valid vehicle type (including its variants and versions)

May be combined:• FIRST + CONFORMITY• NEW + EXTENSION

Vehicle authorisation processSome key new/amended features of the process

Slide 14

EU HARMONISED PROCESS

Changes to authorised vehicles/ vehicle types

Categorisation of changes

Vehicles authorised under a different regime

Notification of changes to vehicles

Requirements capture

Use of CSM RA

Temporary authorisations

Pre-engagement

Content of application

Assessment of the application

Issues log

Board of appeal

Arbitration

Pre-engagement baseline

Type, variant & version

Vehicle TypeDefines the basic design characteristics of vehicle(s) [as covered by a type or design examination certificate described in the

relevant verification module]

Vehicle Type VariantOption for the configuration of a vehicle

type that requires an authorisation

Vehicle Type VersionOption for the configuration of a vehicle

type or vehicle type variant that does not require an authorisation

VehicleRailway vehicle suitable for circulation on wheels on railway lines, with or without traction; a vehicle is composed of one or more structural or functional subsystems

Vehicle authorisation processType, variant & version

Vehicle authorisation processType, variant & version

Slide 17

1. Vehicle type = The design (”the concept”) of the vehicle

2. Vehicle type version = an option for the configuration of a typefollowing changes in the basic design characteristics that do notrequire a new authorisation

3. Vehicle type variant = option for a configuration of a typeestablished during first authorisation or changes of an existingtype that require a new authorisation

4. Vehicle type version/variant was introduced at the request of theindustry to facilitate the authorisation of platform concepts

5. Vehicle type authorisation should facilitate the authorisation ofvehicles in conformity to an authorised type (“series”)

Vehicle Type Holder

Vehicle authorisation processHolder of the vehicle type authorisation

Slide 19

1. Vehicles and vehicle types are composed of one or moresubsystems

2. A mobile subsystem is placed on the market by the applicant forthe subsystem without authorisation

3. The applicant for the mobile subsystem = contracting entity,manufacturer or its authorised representatives.

4. The applicant for the mobile subsystem issues an EC Declarationof Verification, EC DofV, that is accompanied by the technical file

5. The applicant for the mobile subsystem takes the responsibility:

– for meeting the relevant requirements (Union law and national rules) (Article 15(2) of Directive (EU) 2016/797); and

– to decide when a new EC DofV is required in the event of renewal or upgrading of the subsystem (Article 15(5) of Directive (EU) 2016/797).


Slide 20

1. The applicant for the vehicle type takes the responsibility for thevehicle type as a whole– There is no ’technical file’ for the vehicle type

2. ‘Holder of the vehicle type authorisation’ means the natural orlegal person that has applied for and received the vehicle typeauthorisation

3. For a vehicle type, there can only be one holder (clear allocation ofresponsibilities).

4. The holder is responsible for the configuration management of thevehicle type. This to ensure that vehicles type keeps meetingessential requirements after authorisation

5. The role of the holder cannot be transferred / sold, unless if acompany ceases to exist (to be treated as another asset)


Slide 21

1. In case of a change of an authorised vehicle type where the newapplicant becomes the holder:

– The new holder is primarily responsible for the new design and the newvehicle type as a whole

– Initial (previous) holder remains liable for the unchanged parts

– New holder is responsible for the changes and the interfaces with theunchanged parts

2. In case of existing vehicles, the holder will be established:

– According to ERATV registration (holder is already registered)

– Only in case of changes, following article 15

Changes to vehicle (type)

Vehicle authorisation processChanges

Slide 23

1. When a new authorisation is required in case of a change to anauthorised vehicle/vehicle type?

Article 21(12) of Directive (EU) 2016/797

2. At least one of the following criteria shall be triggered:

– Art 21(12)(a): changes beyond the thresholds defined in the TSIs (basicdesign characteristics)

– Art 21(12)(b): change has the potential to impact safety adversely (even if inthe real implementation it does not)

– Art 21(1)(c): it is required by the relevant TSIs (specific changes alwaysrequire a new authorisation)

3. A change that does not require authorisation on the grounds ofrules compliance, namely 21(12)(a) or (c), may still affect adverselysafety, and may require a new authorisation.


Slide 24

1. The Regulation (EU) 2018/545 defines 4 categories of changes:

– Art 15(1)(a): the change does not introduce a deviation in the technical filesaccompanying the EC declaration(s) of verification

no changes in the design

– Art 15(1)(b): change that introduces a deviation in the technical files but doesnot impact basic design characteristics nor triggers article 21(12) of Directive(EU) 2016/797:

change in the design that does not require a new authorisation

– Art 15(1)(c): change that impacts basic design characteristics but does nottrigger article 21(12) of Directive (EU) 2016/797 and does not require a newauthorisation

change in the design that needs to be reflected in ERATV without the need to apply for a new authorisation

– Art 15(1)(d): change that triggers article 21(12) and requires a newauthorisation

change in the design that requires a new authorisation


Slide 25

1. The entity managing the change does not have to be the holder ofthe vehicle type authorisation:

2. If the entity managing the change is the holder of the vehicle typeauthorisation:

– Change according to 15(1)(a) or (b) -> no new authorisation

– Change according to 15(1)(c) -> no new authorisation (version)

– Change according to 15(1)(d) -> new authorisation (variant or type)

3. If the entity managing the change it is not the holder of the vehicletype authorisation :

– Changes according to 15(1)(b),(c) or (d) -> new authorisation (type)

4. Only the elements of the design that are changed and theirinterfaces with the unmodified parts need to be assessed

Vehicle authorisation processERATV

Slide 27

1. ERATV remains the repository of authorised vehicle types

2. Applications for authorisation shall contain the data to fill-in ERATV

3. Responsibilities regarding ERATV:

– Authorising Entity for checking the consistency of the data, for completingERATV and for the publication of the register

– Applicant for the integrity (accuracy and technical relevance) of the dataprovided in the application

– Holder of the vehicle type authorisation for providing the data to create aversion and for integrity of the data

4. ERATV type authorisation must be valid in order to authorisevehicles in conformity with that type

5. Holder of the vehicle type authorisation shall inform theAuthorising Entity in case a type authorisation is not anymore valid

Basic Design Charateristics

Vehicle authorisation processBasic design characteristics (BDCs) and basic parameters

Slide 29

Vehicle design

Basic Parameters

Basic design characteristics

NRs referred to in TSIs (Specific

cases, Open points)

TSI

Other directives, manufacturer’s procedures

Other (non-basic) design characteristics(e.g. related to Confort)

Vehicle authorisation processBasic design characteristics (BDCs): where?

Slide 30

1. Article 48 (c) of Regulation 2018/545:

– Type and/or design examination certificates -> chapters 7 of TSIs LOC&PAS,WAG & CCS (+changes that trigger 21(12)(a) of Directive 2016/797)

– Area of use of the vehicle

– Conditions for use and other restrictions (issues authorisation)

– Reference to declaration by the proposer referred to in article 3(11) ofRegulation (EU) 402/2013

2. Annex II of (revised) ERATV decision

Area of Use

Vehicle authorisation processExtension of the area of use

Slide 32

1. Authorisation case defined in Article 14(1)(c) of Regulation (EU)2016/797

2. Change of the area of use of an authorised type without changes inthe design (without modifications)

3. The checks to be performed shall be limited to the technicalcompatibility between the vehicle and the extended network

4. Checks already carried out af the first authorisation shall not berepeated

5. If the extension of the area of use covers networks in another MS,the Agency shall be the authorising entity.

6. Extension of the area of use also applies within 1 MS. The applicantcan choose the NSA or the Agency as Authorising Entity

Vehicle authorisation processExtension of the area of use

Slide 33

1. The case of authorisation including stations in neighbouring MSs isnot considered an extension of the area of use nor a case with anarea of use covering more than 1 MS

2. In most cases, there is a need to change the design beforeextending the area of use

– Combination of 2 authorisation cases in article 14(1) of Regulation (EU)2018/545:

New authorisation + extended area of use

– Vehicles and/or vehicle types need to be authorised after the change in theMSs of the original area of use

– Then the changed vehicles and/or vehicle types authorisation is extendedto new network(s)

– 1 single application combining both cases through OSS

– 1 common 1+4 month timeframe for to both cases

Transitional provisions

Scenarios for the transitional period

Slide 35

Possible transposition dates:

16/06/2019

16/06/2020

Some explanation :• Vehicle Authorisations: F°(Area of use)

• Different transposition dates in MS

• Some Applicant for Vehicle Authorisation need to follow two different regimes in parallel

• Situation will be more clear at the end of the year (notifications of transposition dates by 16/12/18)

✓ Very late✓ Makes planning difficult✓ That’s why better to start now

Scenarios for the transitional period

Slide 36

Scenarios for applicants where Authorisation expected from the second half of 2019until 16/06/2020

MS 106/2019

MS 206/2019

MS 1 06/2020

MS 206/2020

MS 1 06/2019

MS 2 06/2020

ERA issues VA (2016/797 & 2018/545)

ERA issues VA (2016/797 & 2018/545)MS 2 issues Additional Authorisation (2008/57)

MS 1 (or 2) issues First Authorisation (2008/57)MS 2 (or 1) issues Additional Authorisation

(2008/57)

(1)

(2)

(3)

Vehicle authorisation processEntry into force

Slide 37

1. OSS will be accessible for applicants on 16th February 2019

2. Applicants will be able to build applications (pre-engagement andauthorisation) from that moment onwards

3. Submission of applications will be possible on 16th June 2019

4. Assessment of applications under the 4THRP can only start on16th June 2019

5. Where the date for authorisation falls shortly after the relevantdate, the applicant should contact the Agency sufficiently inadvance of the entry into force of the Regulation (EU) 2018/545

– Engage with the Agency in the Learning Cases activity (informal pre-engagement)

One Stop Shop

OSS

Slide 39

The one-stop-shop (OSS) will be the IT system, managed by the Agency, through which all applications for single safety certificates, vehicle authorisations and vehicle type authorisations shall be submitted either to the relevant National Safety Authority or to the Agency.

The one-stop-shop shall be used by the applicants irrespective of the intended area of operation or area of use (one Member State or a number of Member States).

All issues identified by the respective authority during the assessment, the replies of the applicant and the final decision shall be communicated with the use of the one-stop-shop.

OSS

Slide 40

All users representing the Agency and the NSAs shall be registered in advance in the one-stop-shop by their own organizations.

An applicant, before submitting its application, shall go through the self—registration process.

The one-stop-shop will be delivered in a number of releases with different sets of functionalities available. The first limited release will be available June 2018 for the shadow running and testing purposes. The release fully supporting all basic processes will be available February 2019. Additional functionalities may be developed after that date.

Fees and Charges

Fees and Charges

Slide 42

Commission Implementing Regulation (EU) 2018/764 on the fees and charges payable to the European Union Agency for Railways and their conditions of payment.

The fees and charges should be equal or lower than the current average;For applications submitted to the NSAs their national charging principles apply;For applications submitted to the Agency, principles set by the regulation on fees and charges payable to the EU Agency for Railways apply;the fee should consist of the fee for the assessment made by the Agency and the fee for the assessment made by the relevant NSAs;

Commission Implementing Regulation (EU) 2018/764 on the fees and charges payable to the European Union Agency for Railways and their conditions of payment.

The fees and charges should be equal or lower than the current average;For applications submitted to the NSAs their national charging principles apply;For applications submitted to the Agency, principles set by the regulation on fees and charges payable to the EU Agency for Railways apply;the fee should consist of the fee for the assessment made by the Agency and the fee for the assessment made by the relevant NSAs;

Fees and Charges 2

Slide 43

The Agency together with relevant NSAs shall monitor their costs and inform the applicant when the cost risks exceeding the estimate by more than 15%;Payment of fees and charges shall be denominated in Euro;the invoice shall be issued through the one-stop-shop.

The part of the fee for the Agency assessment shall be based on hourly rate and the one for the NSA assessment shall be based on national principles;

Upon request of the applicant the Agency together with relevant NSA shall issue a non-binding estimate of the amount of fees and charges to be paid;

The Agency together with relevant NSAs shall monitor their costs and inform the applicant when the cost risks exceeding the estimate by more than 15%;Payment of fees and charges shall be denominated in Euro;the invoice shall be issued through the one-stop-shop.

Board of Appeal

Board of Appeal

Slide 45

Commission Implementing Regulation (EU) 2018/867 laying down the rules of procedure of the Board(s) of Appeal of the European Union Agency for Railways.

The Board of Appeal is the arena of last resort;Appeals against decisions made by the Agency should be rare.This is because they will only be used where the Agency declines to issue or restricts a Single Safety Certificate giving its reasons for doing so and the applicant wishes to appeal this decision;

In practice use of the Board of Appeal would mean that all other attempts to resolve the matter through the assessment process have failed to reach a satisfactory resolution.

Cooperation Agreements

Slide 46

NSA Sub group has reached agreement on draft Cooperation AgreementsKyriakos Doulis from the Agency will begin bilaterals with NSAs depending on transposition dates during 2018 to develop details.

Co-operation is needed over the results from Supervision and Assessment.

séminaire uip sur le 4ème paquet...

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