02019R0250 — EN — 16.06.2020 — 001.001

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►B COMMISSION IMPLEMENTING REGULATION (EU) 2019/250 of 12 February 2019 on the templates for ‘EC’ declarations and certificates for railway interoperability constituents and subsystems, on the model of declaration of conformity to an authorised railway vehicle type and on the ‘EC’ verification procedures for subsystems in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 201/2011 (Text with EEA relevance) (OJ L 042 13.2.2019, p. 9)

Amended by:









▼B

COMMISSION IMPLEMENTING REGULATION (EU) 2019/250

of 12 February 2019

on the templates for ‘EC’ declarations and certificates for railway interoperability constituents and subsystems, on the model of declaration of conformity to an authorised railway vehicle type and on the ‘EC’ verification procedures for subsystems in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 201/2011

(Text with EEA relevance)







Article 1

Subject matter

This Regulation lays down:

(a) the template for the ‘EC’ declaration of conformity or suitability for use of an interoperability constituent as referred to in Article 9(2) of Directive (EU) 2016/797;

(b) the details of the ‘EC’ verification procedures of subsystems and the template for the ‘EC’ declaration of verification as referred to in Article 15(9) of Directive (EU) 2016/797;

(c) the template for the Intermediate Statement of Verification of the subsystem as referred to in Article 15(9) of Directive (EU) 2016/797;

(d) the template for the certificates of conformity or suitability for use of an interoperability constituent as referred to in Article 9(2) and the template for the certificates of verification of a subsystem as referred to in Article 15(9) of Directive (EU) 2016/797;

(e) the model of declaration of conformity to an authorised vehicle type as referred to in Article 24(4) of Directive (EU) 2016/797.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a) ‘“EC” declaration of conformity’ means the declaration established for an interoperability constituent by the manufacturer or its authorised representative in which the manufacturer or its authorised representative declares on its sole responsibility that the interoperability constituent concerned, which has been subject to the relevant verification procedures, complies with the relevant Union law;

(b) ‘“EC” declaration of suitability for use’ means the supplementary declaration to the ‘EC’ declaration of conformity of the interoperability constituent established for an interoperability constituent by the manufacturer or its authorised representative in which the manufacturer or its authorised representative declares on its sole responsibility that the interoperability constituent concerned, which has been subject to the relevant verification procedures, satisfies the requirements for suitability for use specified in the relevant TSI;

(c) ‘“EC” declaration of verification’ means the declaration established for a subsystem by the applicant in which the applicant declares on its sole responsibility that the subsystem concerned, which has been subject to the relevant verification procedures, satisfies the requirements of the relevant Union law and any relevant national rules;

(d) ‘Subsystem placed in service without an “EC” declaration of verification’ means a subsystem, fixed or mobile, that has been placed in service before ‘EC’ verification procedure was applicable to it in accordance with Council Directive 96/48/EC ( 1 ), Directive 2001/16/EC of the European Parliament and of the Council ( 2 ) or Directive 2008/57/EC, and thus without an ‘EC’ declaration of verification.

(e) ‘Intermediate Statement of Verification’ means the document established either by the notified body selected by the applicant, in the case of TSI requirements, or by a designated body, in the case of requirements stemming from national rules, which registers the results of a stage of the verification procedure;

(f) ‘“EC” certificate of conformity’ means the certificate delivered for an interoperability constituent by the notified body of the conformity of an interoperability constituent, considered in isolation, with the Union technical specifications to be met;

(g) ‘“EC” certificate of suitability for use’ means the certificate delivered for an interoperability constituent by the notified body of the suitability for use of an interoperability constituent considered within its railway environment;

(h) ‘certificate of verification’ means the certificate delivered for a subsystem either by the notified body or by the designated body regarding the verification of conformity respectively with relevant TSIs or with relevant national rules from the design stage to the acceptance stage before the subsystem is placed on the market or in service and which covers verification of the interfaces of the subsystem in question with the system into which it is incorporated;

(i) ‘“EC” certificate of verification’ means the certificate delivered for a subsystem by the notified body regarding solely the verification of conformity with relevant TSIs;

(j) ‘declaration of conformity to an authorised vehicle type’ means the declaration established for a vehicle by the applicant in which the applicant declares on its sole responsibility that the vehicle concerned, which has been subject to the relevant verification procedures, conforms to an authorised vehicle type and satisfies the requirements of the relevant Union law and relevant national rules.

(k) ‘ERADIS ID’ means the alphanumeric code used to identify an ‘EC’ declaration of conformity or suitability for use of interoperability constituent or an ‘EC’ declaration of verification of subsystem and which is established in accordance with Annex VII.

Article 3

‘EC’ declaration of conformity or ‘EC’ declaration of suitability for use

1. The manufacturer or its authorised representative shall establish ‘EC’ declaration of conformity of interoperability constituent or ‘EC’ declaration of suitability for use of interoperability constituent in accordance with the template set out in Annex I.

2. An ‘EC’ declaration of conformity or ‘EC’ declaration of suitability for use shall be written in one of the official languages of the Union and it shall be in the same language as its accompanying documents.

Article 4

Accompanying documents for ‘EC’ declaration of conformity or ‘EC’ declaration of suitability for use

An ‘EC’ declaration of conformity or suitability for use of interoperability constituents shall be accompanied by the following documents:

(a) ‘EC’ certificate of conformity and, where appropriate, ‘EC’ certificate of suitability for use;

(b) technical documentation in accordance with Commission Decision 2010/713/EU ( 3 ).

Article 5

‘EC’ declaration of verification

1. An ‘EC’ declaration of verification shall be based on the information resulting from the verification procedures for subsystems set out in Article 15 of Directive (EU) 2016/797 and Annex IV to that Directive. One ‘EC’ declaration of verification shall comprise the verification in respect with Union law and, where appropriate, national rules.

2. The applicant shall establish ‘EC’ declaration of verification in accordance with the template set out in Annex II, and in accordance with the template set out in Annex III when it relates to a subsystem initially placed in service without an ‘EC’ declaration of verification.

3. An ‘EC’ declaration of verification shall be written in one of the official languages of the Union and it shall be in the same language as its accompanying documents.

Article 6

Verification procedure in case of a change to a subsystem

1. In the event of a change to a subsystem, the applicant shall analyse the change and assess the impact on the ‘EC’ declaration of verification.

2. Where the validity of an element of the relevant ‘EC’ declaration of verification is impacted by that change, the applicant shall update the ‘EC’ declaration of verification or shall establish a new ‘EC’ declaration of verification. A new ‘EC’ declaration of verification shall be established whenever a new authorisation according to criteria set out in Articles 18(6) and 21(12) of Directive (EU) 2016/797 is required.

3. Where a change affects a basic parameter, the applicant shall assess the need for, and where required carry out the ‘EC’ verification procedure set out in Article 15 of Directive (EU) 2016/797 and Annex IV to that Directive for the changed subsystem.

Article 7

Verification procedure in case of a change to a subsystem placed in service without an ‘EC’ declaration of verification

1. In the event of a change to a subsystem placed in service without an ‘EC’ declaration of verification, the applicant shall analyse the change and assess the impact on the existing design and maintenance documentation.

2. Where a change is made to a subsystem that affects a basic parameter, the applicant shall assess the need for, and where required carry out the ‘EC’ verification procedure in accordance with Article 15 of Directive (EU) 2016/797.

3. The conformity assessment body shall only assess the parts of the subsystem that are changed, and assess the interfaces to the unchanged parts of the subsystem.

4. An ‘EC’ declaration of verification shall be established by the applicant for the whole subsystem by declaring under its sole responsibility that:

(a) the changed part and the interfaces to the unchanged parts of the subsystem have been subject to the relevant verification procedures and comply with the relevant Union law and any relevant national rules.

(b) the unchanged part has been brought into use in the railway system and has been maintained in its design operating state since the date of bringing into use in the railway system until the date of the establishment of EC declaration of verification.

Article 8

Intermediate Statement of Verification

1. An intermediate Statement of Verification shall be based on the same relevant conformity assessment modules as those used for the issuing of a certificate of verification for a subsystem.

2. The notified body or the designated body shall establish the Intermediate Statement of Verification in accordance with the template set out in Annex IV.

3. The Intermediate Statement of Verification shall be written in one of the official languages of the Union and it shall be in the same language as its accompanying documents.

Article 9

Certificate of conformity or suitability for use and of verification

Certificate of verification of subsystem, ‘EC’ certificate of verification and ‘EC’ certificate of conformity or suitability for use of interoperability constituents shall be established in accordance with the template set out in Annex V.

Article 10

Declaration of conformity to an authorised vehicle type

1. An applicant shall establish a declaration of conformity to an authorised vehicle type in accordance with the model structure set out in Annex VI.

2. A declaration of conformity to an authorised vehicle type shall be written in one of the official languages of the Union and it shall be in the same language as its accompanying documents.

Article 11

Repeal

Regulation (EU) No 201/2011 is repealed with effect from 16 June 2019.

▼M1

The Annex to Regulation (EU) No 201/2011 shall continue to apply to declaration of conformity to type referred to in Article 26(4) of Directive 2008/57/EC until 15 June 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 and that have not notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

The Annex to Regulation (EU) No 201/2011 shall continue to apply to declaration of conformity to type referred to in Article 26(4) of Directive 2008/57/EC until 30 October 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

▼B

Article 12

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 16 June 2019 in the Member States that have not notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797.

Article 11 shall apply from 16 June 2019 in the Member States that have notified the Agency and the Commission of an intention to extend the transposition period of Directive (EU) 2016/797 in accordance with Article 57(2) thereof.

▼M1

This Regulation shall apply from 16 June 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 and that have not notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

It shall apply in all Member States from 31 October 2020.

▼B

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

TEMPLATE FOR ‘EC’ DECLARATION OF CONFORMITY OR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS

‘EC’ declaration of conformity or suitability for use of interoperability constituent

‘EC’ declaration identification number [ERADIS ID] ( 4 )

We, Manufacturer or Authorised representative

[Business name]

[Complete postal address]

Declare under our sole responsibility that the following interoperability constituent ( 5 ):

[Name/short description of interoperability constituent, unique identification of the interoperability constituent]

to which this declaration refers complies with the relevant Union law:

[Title(s) of the Directive(s); Title(s) of the TSI(s); Title(s) of European Specifications]

has been assessed by the following Notified Body:

[Business name]

[Registration number]

[Full address]

In accordance with the following approval(s) and/or certificate(s):

[Approval(s), date of issue][Certificate number(s), date of issue]

The following conditions of use and other restrictions apply ( 6 ):

[List or reference to the list of conditions of use and other restrictions]

The following procedures have been followed in order to declare conformity:

[The modules chosen by manufacturer for the assessment of the interoperability constituent]

List of Annexes

[Titles of the Annexes (Technical documentation or technical file accompanying the ‘EC’ declaration of conformity or suitability for use)] ( 7 )

Done on:

[Date DD/MM/YYYY]

Signature of Manufacturer/Authorised representative

[First Name, Surname]









ANNEX II

TEMPLATE FOR ‘EC’ DECLARATION OF VERIFICATION OF SUBSYSTEM

‘EC’ declaration of verification of subsystem

‘EC’ declaration identification number [ERADIS ID] ( 8 )

We, Applicant:

[Business name]

[Complete postal address]

Declare under our sole responsibility that the following subsystem ( 9 ):

[Name/short description of the subsystem, unique identification of the subsystem]

to which this declaration refers has been subject to the relevant verification procedures and complies with the relevant Union law and any relevant national rules:

[Reference to: the Directive(s); TSI(s); Relevant national rules;]

has been assessed by the following conformity assessment bodies:







Notified Body: Business name Registration number Full address Designated Body: Business name Identification number Full address Assessment body [Risk assessment]: Business name Identification number Full address

In accordance with the following certificate(s) and or report(s):

[Certificate(s) number(s), report(s) number(s), date(s) of issue]

The following conditions of use and other restrictions apply ( 10 ):

[List or reference to the list of conditions of use and other restrictions]

The following procedures have been followed in order to declare conformity:

[The modules chosen by applicant for the verification of the subsystem]

Identification of the technical file accompanying this declaration

[Reference to the technical file accompanying the ‘EC’ declaration of verification of subsystem in accordance with Article 15(4) of Directive (EU) 2016/797]

Reference to former ‘EC’ declaration of verification (where applicable)

[Yes/No]

Done on:

[date DD/MM/YYYY]

Signature of Applicant

First Name, Surname









ANNEX III

TEMPLATE FOR ‘EC’ DECLARATION OF VERIFICATION FOR SUBSYSTEM INITIALLY PLACED IN SERVICE WITHOUT AN ‘EC’ DECLARATION

‘EC’ declaration of verification of subsystem

‘EC’ declaration identification number [ERADIS ID] ( 11 )

We, Applicant:

[Business name]

[Complete postal address]

Declare under our sole responsibility that for the subsystem to which this declaration refers ( 12 ):

[Name/short description of the subsystem, unique identification of the subsystem]

The changed part of the subsystem:

[Name/short description of the parts of the subsystem]

has been subject to the relevant verification procedures and complies with the relevant Union law and any relevant national rules:

[Reference to: the Directive(s); TSI(s); Relevant national rules;]

has been assessed by the following conformity assessment bodies:







Notified Body: Business name Registration number Full address Designated Body: Business name Identification number Full address Assessment body [Risk assessment]: Business name Identification number Full address

In accordance with the following certificate(s) and or report(s):

[Certificate(s) number(s), report(s) number(s), date(s) of issue]

The unchanged part of the subsystem to which this declaration refers has been brought into use in the railway system and has been maintained in its design operating state since the date of bringing into use in the railway system until the date of the establishing the ‘EC’ declaration of verification.

The following conditions of use and other restrictions apply ( 13 ):

[List or reference to the list of conditions of use and other restrictions]

The following procedures have been followed in order to declare conformity:

[The modules chosen by applicant for the verification of the subsystem]

Identification of the technical file accompanying this declaration

[Reference to the technical file accompanying the ‘EC’ declaration of verification of subsystem in accordance with Article 15(4) of Directive (EU) 2016/797]

Reference to former ‘EC’ declaration of verification (where applicable)

[Yes/No]

Done on:

[date DD/MM/YYYY]

Signature of Applicant

First Name, Surname









ANNEX IV

TEMPLATE FOR INTERMEDIATE STATEMENT OF VERIFICATION

Intermediate Statement of Verification

Number [unique ISV identification number ensuring traceability of the document] ( 14 )

Object of Assessment ( 15 ):

[Unique Identification of the subsystem or of the part of the subsystem: identification of whole or of the part of the subsystem, and stages of verification in accordance with point 2.2.3 of Annex IV to Directive (EU) 2016/797]

Applicant, where applicable also Manufacturer and Manufacturing locations:

[Name(s), Address(es)]

Assessment Requirements:

[Reference to: the Directive(s), the TSI(s), the non-application of TSI(s), the relevant National Rules, European specifications, other Acceptable Means of Compliance]

Module(s) applied:

[The modules as chosen by the applicant for the assessment of the subsystem or of a part of the subsystem, and stages of verification]

Assessment/Audit result:

[Including reference to the assessment/audit report]

The following conditions and limits of use apply ( 16 ):

[List or reference to the list of conditions and limits of use]

Annex of ISV ( 17 ) (where applicable)

[Yes/No]

Documentation accompanying this ISV:

[reference to accompanying documents; list or file of documents used for the assessment]

Validity:

[Time and conditions of validity of ISV]

Done on:

[date DD/MM/YYYY]







Notified Body Signature First Name, Surname [OR] Designated Body Signature First Name, Surname Business name Business name Registration number Identification number Complete postal address Complete postal address

Page 1[/nn]

Annex to Intermediate Statement of Verification [where applicable]

Number [unique ISV identification number]

Object of Assessment:

[Unique Identification of the subsystem or of the part of the subsystem: identification of whole or of the part of the subsystem, and stages of verification in accordance with point 2.2.3 of Annex IV to Directive (EU) 2016/797]

Done on:

[date DD/MM/YYYY]







Notified Body Signature First Name, Surname [OR] Designated Body Signature First Name, Surname Business name Business name Registration number Identification number Complete postal address Complete postal address

Page n/nn









ANNEX V

TEMPLATE FOR CERTIFICATE

[‘EC’] ( 18 )Certificate of [conformity/suitability for use/verification]

Number [unique certificate identification number] ( 19 )

Object of Assessment ( 20 ):

[Unique Identification of the Interoperability Constituent or of the Subsystem]

Applicant, where applicable also Manufacturer and manufacturing locations:

[Name(s), Address(es)]

Assessment Requirements:

[Reference to: the Directive(s), the TSI(s), the relevant National Rules, European specifications, other Acceptable Means of Compliance]

Module(s) applied:

[The module(s) as chosen by the applicant for the assessment of the Interoperability Constituent or of the Subsystem]

Assessment/Audit result:

[Including reference to the assessment/audit report]

The following conditions and limits of use apply ( 21 ):

[List or reference to the list of conditions and limits of use]

Annex ( 22 ) (where applicable):

[Yes/No]

Documentation accompanying this [‘EC’] (23) Certificate:

[reference to accompanying documents; list or file of documents used for the assessment]

Validity:

[Time and conditions of validity of certificate]

Done on:

[date DD/MM/YYYY]







Notified Body Signature First Name, Surname [OR] Designated Body Signature First Name, Surname Business name Business name Registration number Identification number Complete postal address Complete postal address

page 1[/nn]

Annex to the [‘EC’] ( 23 )certificate [where applicable ( 24 )]

Number [unique certificate identification number]

Object of Assessment:

[Unique Identification of the Interoperability Constituent or of the Subsystem]

Done on:

[date DD/MM/YYYY]







Notified Body Signature First Name, Surname [OR] Designated Body Signature First Name, Surname Business name Business name Registration number Identification number Complete postal address Complete postal address

page n/nn









ANNEX VI

MODEL OF DECLARATION OF CONFORMITY TO AN AUTHORISED VEHICLE TYPE

Declaration of conformity to an authorised vehicle type

We,

Applicant

[Business name] ( 25 )

[Full address]

Declare under our sole responsibility that vehicle [European Vehicle Number/pre-reserved Vehicle Number/agreed means of identification] ( 26 ) to which this declaration refers

— conforms to authorised vehicle type [ERATV identification of the type/version/variant of vehicle]

— complies with the relevant Union law and relevant national rules, as indicated in the annexes to this declaration,

— has undergone all verification procedures necessary for establishing this declaration.

List of annexes ( 27 )

[Titles of the annexes]

Signed for and on behalf of [name of the applicant]

Done at [place], [date DD/MM/YYYY]

[name, function] [signature]









ANNEX VII

STRUCTURE AND CONTENT OF THE ‘EC’ DECLARATION IDENTIFICATION NUMBER

Each ‘EC’ declaration of conformity or suitability for use of interoperability constituent and ‘EC’ declaration of verification of subsystem shall receive an alphanumeric code consisting of 2 letters and 24 digits with the following structure:







CC RRRRRRRRRRRRRR YYYY NNNNNN Country code (two letters) National registration number of the applicant (fourteen digits) Year (four digits) Counter (six digits) Field 1 Field 2 Field 3 Field 4

FIELD 1 — Country code (two letters)

The country code shall be assigned based on standard ISO 3166.

FIELD 2 — National registration number of the applicant (fourteen digits number)

The national registration number of the applicant shall be the legal registration/identification number, given either by Tax Office or by Commercial Register or some other authority that registers companies in the Member State.

If number is shorter than fourteen digits, the first digits should be left blank-00, like in case of counter.

FIELD 3 — Year (four digits)

This field shall indicate the year in which the document was issued.

FIELD 4 — Counter (six digits)

The counter shall a progressive number incremented by one unit each time a declaration is issued.

Every year the counter restarts from zero.

The counter shall be related to the issuing body.