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Document 02019R0250-20200616
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02019R0250 — EN — 16.06.2020 — 001.001
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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 (OJ L 042 13.2.2019, p. 9) |
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/779 of 12 June 2020 |
L 188 |
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15.6.2020 |
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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:
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;
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;
the template for the Intermediate Statement of Verification of the subsystem as referred to in Article 15(9) of Directive (EU) 2016/797;
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;
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:
‘“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;
‘“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;
‘“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;
‘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.
‘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;
‘“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;
‘“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;
‘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;
‘“EC” certificate of verification’ means the certificate delivered for a subsystem by the notified body regarding solely the verification of conformity with relevant TSIs;
‘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.
‘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
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:
‘EC’ certificate of conformity and, where appropriate, ‘EC’ certificate of suitability for use;
technical documentation in accordance with Commission Decision 2010/713/EU ( 3 ).
Article 5
‘EC’ declaration of verification
Article 6
Verification procedure in case of a change to a subsystem
Article 7
Verification procedure in case of a change to a subsystem placed in service without an ‘EC’ declaration of verification
An ‘EC’ declaration of verification shall be established by the applicant for the whole subsystem by declaring under its sole responsibility that:
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.
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
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
Article 11
Repeal
Regulation (EU) No 201/2011 is repealed with effect from 16 June 2019.
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.
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.
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.
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:
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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:
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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]
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Notified Body Signature First Name, Surname |
[OR] |
Designated Body Signature First Name, Surname |
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Business name |
Business name |
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Registration number |
Identification number |
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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]
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Notified Body Signature First Name, Surname |
[OR] |
Designated Body Signature First Name, Surname |
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Business name |
Business name |
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Registration number |
Identification number |
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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]
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Notified Body Signature First Name, Surname |
[OR] |
Designated Body Signature First Name, Surname |
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Business name |
Business name |
|
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Registration number |
Identification number |
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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]
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Notified Body Signature First Name, Surname |
[OR] |
Designated Body Signature First Name, Surname |
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Business name |
Business name |
|
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Registration number |
Identification number |
|
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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
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:
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CC |
RRRRRRRRRRRRRR |
YYYY |
NNNNNN |
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Country code (two letters) |
National registration number of the applicant (fourteen digits) |
Year (four digits) |
Counter (six digits) |
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|
|
|
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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.
( 1 ) Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system (OJ L 235, 17.9.1996, p. 6).
( 2 ) Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the trans-European conventional rail system (OJ L 110, 20.4.2001, p. 1).
( 3 ) 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).
( 4 ) The information in square brackets [ ] is provided to support the user in correctly and exhaustively compiling the template.
( 5 ) The description of the interoperability constituent shall enable unique identification and allow for traceability.
( 6 ) When a reference to a list of conditions of use and other restrictions is made, such list shall be accessible to the authorising entity.
( 7 ) Technical documentation in accordance with Decision 2010/713/EU.
( 8 ) The information in square brackets [ ] is provided to support the user in correctly and exhaustively compiling the template.
( 9 ) The description of the subsystem shall enable unique identification and allow for traceability.
( 10 ) When a reference to a list of conditions of use and other restrictions is made, such list shall be accessible to the authorising entity.
( 11 ) The information in square brackets [ ] is provided to support the user in correctly and exhaustively compiling the template.
( 12 ) The description of the subsystem shall enable unique identification and allow for traceability.
( 13 ) When a reference to a list of conditions of use and other restrictions is made, such list shall be accessible to the authorising entity.
( 14 ) The information in square brackets [ ] is provided to support the user in compiling the template.
( 15 ) The description of the subsystem or part of the subsystem shall enable unique identification and allow for traceability.
( 16 ) When a reference to a list of conditions of use and other restrictions is made, such list shall be accessible to the authorising entity.
( 17 ) It is good practice to issue ISV as a single page document; if the relevant information for the ISV does not fit all on one page, the Annex provides sufficient space for any other relevant information to be considered.
( 18 ) ‘EC’ applies only to certificates issued by a Notified Body including certificates covering both Notified Body and Designated Body tasks when it is the same entity. ‘EC’ is to be omitted on certificates issued by a Designated Body.
( 19 ) The information in square brackets [ ] is just provided to support the user in correctly and exhaustively compiling the template.
( 20 ) The description of the interoperability constituent or the subsystem shall enable unique identification and allow for traceability.
( 21 ) When a reference to a list of conditions of use and other restrictions is made, such list shall be accessible to the authorising entity
( 22 ) It is good practice to issue certificates as a single page document; if the relevant information for the certificate does not fit all on one page, the Annex provides sufficient space for any other relevant information to be considered.
( 23 ) ‘EC’ applies only to certificates issued by a Notified Body including certificates covering both Notified Body and Designated Body tasks when it is the same entity. ‘EC’ is to be omitted on certificates issued by a Designated Body.
( 24 ) It is good practice to issue certificates as a single page document; if the relevant information for the certificate does not fit all on one page, the Annex provides sufficient space for any other relevant information to be considered.
( 25 ) The information in square brackets [ ] is to support the user in correctly and exhaustively compiling the template.
( 26 ) For an existing vehicle, the existing European Vehicle Number (EVN) at the time of establishing this declaration shall be used to identify the vehicle.
For a new vehicle, if at the moment of establishing this declaration the vehicle has not yet been assigned a pre-reserved Vehicle Number in accordance with Commission Implementing Decision (EU) 2018/1614 (OJ L 268, 26.10.2018, p. 53), the vehicle shall be identified by another identification system agreed by the applicant and the authorising entity.
In accordance with point 3 of Section 3.2.1 of Annex II to that Decision, the reserved Vehicle Number shall become the EVN at the time of the registration.
( 27 ) Annexes shall include copies of EC declaration(s) of verification of subsystem(s).