title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on detailed obligations of European Electronic Toll Service providers, minimum content of the European Electronic Toll Service domain statement, electronic interfaces, requirements for interoperability constituents and repealing Decision 2009/750/EC

text:
                              EUROPEAN
                              COMMISSION
                                                    Brussels, 28.11.2019
                                                    C(2019) 9080 final
                COMMISSION IMPLEMENTING REGULATION (EU) …/...
                                        of 28.11.2019
   on detailed obligations of European Electronic Toll Service providers, minimum content
       of the European Electronic Toll Service domain statement, electronic interfaces,
     requirements for interoperability constituents and repealing Decision 2009/750/EC
EN                                                                                EN
 ---pagebreak---                    COMMISSION IMPLEMENTING REGULATION (EU) …/...
                                                   of 28.11.2019
   on detailed obligations of European Electronic Toll Service providers, minimum content
        of the European Electronic Toll Service domain statement, electronic interfaces,
       requirements for interoperability constituents and repealing Decision 2009/750/EC
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive (EU)2019/520 of the European Parliament and of the Council of
   19 March 2019 on the interoperability of electronic road toll systems and facilitating cross-
   border exchange of information on the failure to pay road fees in the Union 1, and in particular
   Articles 5(11), 6(9), 14(3), 15(6) and 15(7) thereof,
   After consulting the Electronic Toll Committee,
   Whereas:
   (1)     In order to complete the legislative framework for ensuring the interoperability of
           electronic road toll systems, it is necessary to lay down detailed requirements in
           respect of obligations of European Electronic Toll Service (EETS) providers, the
           content of the EETS domain statement, electronic interfaces and requirements for
           interoperability constituents.
   (2)     In order to avoid performance problems of the EETS system, EETS providers, should
           be required to monitor their service and collaborate with the toll charger when
           performing toll system tests.
   (3)     EETS providers should provide specific data to the toll charger so that the verification
           of the calculation of the toll applied can take place.
   (4)     To ensure smooth functioning of the EETS system, EETS providers should provide
           technical support for the identification of the on-board-equipment.
   (5)     Where the measures provided for in this Regulation entail the processing of personal
           data, they should be carried out in accordance with Union law on the protection of
           personal data and privacy, in particular Regulation (EU) 2016/679 of the European
           Parliament and of the Council2, and, where applicable, Directive 2002/58/EC of the
           European Parliament and of the Council3. To this end, EETS providers should not be
           required to provide more client data to the toll chargers than is necessary to ensure the
           correct functioning of the EETS.
   1
           OJ L 91, 29.3.2019 , p.45.
   2
           Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the
           protection of natural persons with regard to the processing of personal data and on the free movement of
           such data, and repealing Directive 95/46/EC, OJ L 119, 4.5.2016, p. 1.
   3
           Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the
           processing of personal data and the protection of privacy in the electronic communications sector, OJ L
           201, 31.7.2002, p. 37.
EN                                                         1                                                        EN
 ---pagebreak---    (6)     In order to provide appropriate information to the users, invoicing should reflect the
           various service and toll price components in a transparent manner.
   (7)     The minimum content of an EETS domain statement should be specified to give EETS
           providers sufficient clarity regarding the conditions for providing EETS in the
           corresponding toll domain.
   (8)     Seamless functioning of the EETS requires a minimum level of harmonisation of the
           electronic interfaces, and of the functioning of the interfaces between parties, in
           particular, between the toll chargers and the EETS providers.
   (9)     Specific infrastructure requirements should be laid down to allow for the correct
           communication and functioning of the equipment of the parties involved and to
           achieve a smooth and secure functioning of the EETS interoperability and
           enforcement.
   (10)    To make the process of accrediting EETS providers more effective, some
           harmonisation of the procedure for assessment of conformity to specifications and
           suitability for use of interoperability constituents across the different EETS domains is
           needed. Therefore, it is necessary to lay down such a procedure, including the content
           and format of the EC declarations.
   (11)    In order to ensure the coherence of the legal framework and the proper functioning of
           the EETS system, Commission Decision 2009/750/EC4 should be repealed from the
           date by which Directive (EU) 2019/520 must be transposed in all Member States,
           which is the date on which this Regulation and the delegated acts referred to in that
           Directive will start to apply.
   (12)    The measures provided for in this Regulation are in accordance with the opinion of the
           Electronic Toll Committee, referred to in Article 31(1) of Directive (EU) 2019/520.
   HAS ADOPTED THIS REGULATION:
                                                      Article 1
                                                        Scope
   This Regulation lays down detailed obligations for EETS providers, information on the
   minimum content of the EETS domain statement, specifications for the electronic interfaces
   between the interoperability constituents, requirements for these constituents, and the
   procedure to be applied by Member States to assess conformity to specifications and
   suitability for use of interoperability constituents.
                                                      Article 2
                                    Detailed obligations of EETS providers
   1.        For monitoring the performance of their services, EETS providers shall put in place
             audited operational processes that provide for appropriate measures when
             performance problems or integrity breaches are detected.
   4
           Commission Decision 2009/750/EC of 6 October 2009 on the definition of the European Electronic
           Toll Service and its technical elements, OJ L 268, 13.10.2009, p. 11.
EN                                                        2                                               EN
 ---pagebreak---    2. In Global Navigation Satellite System based systems, EETS providers shall monitor
      the availability of navigation and positioning satellite localisation data. They shall
      inform toll chargers of any difficulties they may have in establishing toll declaration
      data that relate to the reception of satellite signals.
   3. A toll charger may require the cooperation of an EETS provider to perform
      unannounced and detailed toll system tests involving vehicles circulating or having
      recently circulated on the toll charger’s EETS domain(s). The number of vehicles
      submitted to such tests over a year for a particular EETS provider shall be
      commensurate with the average annual traffic or traffic projections of that EETS
      provider on the toll charger’s EETS domain(s).
   4. Unless otherwise agreed, the EETS provider shall provide the toll charger with the
      following information, which is needed to apply the toll to EETS users’ vehicles, or
      to allow the toll charger to verify the calculation of the toll applied to EETS users’
      vehicles by the EETS providers:
      (a)    the licence plate number of the EETS user’s vehicle, including the international
             licence plate country code;
      (b)    an identifier of the EETS user's account;
      (c)    an identifier of the OBE, if used in an EETS domain;
      (d)    the vehicle classification parameters necessary to establish the applicable tariff.
      The data exchange shall be compliant with the provisions of Annex I of this
      Implementing Regulation.
   5. EETS providers shall provide appropriate service and technical support to ensure
      correct setting-up of the on-board equipment. EETS providers shall be responsible
      for fixed vehicle classification parameters stored in on-board equipment or in their
      back office. Variable vehicle classification parameters, which can vary from trip to
      trip or within a trip, and are intended to be introduced by in-vehicle intervention shall
      be configurable through an appropriate human-machine interface.
   6. Where applicable, invoicing of individual EETS users by EETS providers shall
      clearly separate the service charges of the EETS provider from the tolls incurred, and
      shall at a minimum specify - unless the user decides otherwise - the time and the
      location of the tolls incurred, and the user-relevant composition of specific tolls.
   7. EETS providers shall inform EETS users immediately of any non-declaration of tolls
      in relation to their account, offering, the opportunity to regularise the account before
      any enforcement action is taken, where this is possible under national legislation.
                                           Article 3
                                   EETS domain statement
      The EETS domain statement referred to in Article 6(2) of Directive (EU) 2019/520
      shall as a minimum contain the elements listed in Annex II of this Implementing
      Regulation, and shall comply with the requirements provided for in that Annex.
EN                                             3                                                 EN
 ---pagebreak---                                               Article 4
                               EETS stakeholder roles and interfaces
   1.      Toll chargers and EETS providers shall put in place common interfaces and
           implement communication protocols in conformity with the requirements of Annex I
           of this Implementing Regulation. Through interoperable communication channels,
           EETS providers shall provide toll chargers with secure information relative to tolling
           operations and control/enforcement in conformity with applicable technical
           specifications.
   2.      EETS providers shall ensure that toll chargers are able to easily and unambiguously
           detect whether a vehicle circulating on their EETS domain requiring the use of an
           OBE and allegedly using EETS is actually equipped with a validated and properly
           functioning EETS OBE that provides correct information.
   3.      EETS OBE shall provide a human-machine interface, that indicates to the user that
           the OBE is functioning properly, and an interface for declaring variable toll
           parameters and for indicating the settings of those parameters.
                                              Article 5
                         Conformity to specifications and suitability for use
           Conformity to specification and suitability for use of interoperability constituents
           shall be assessed in compliance with Annex III of this Implementing Regulation.
                                              Article 6
                                               Repeal
          Decision 2009/750/EC is repealed with effect from 19 October 2021.
                                              Article 7
          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 19
          October 2021.
          This Regulation shall be binding in its entirety and directly applicable in all Member
          States.
   Done at Brussels, 28.11.2019
                                               For the Commission
                                               The President
                                               Ursula VON DER LEYEN
EN                                                4                                               EN
 ---documentbreak---                               EUROPEAN
                              COMMISSION
                                                    Brussels, 28.11.2019
                                                    C(2019) 9080 final
                                                    ANNEXES 1 to 3
                                         ANNEXES
                                            to the
            COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX
   on detailed obligations of European Electronic Toll Service providers, minimum content
       of the European Electronic Toll Service domain statement, electronic interfaces,
     requirements for interoperability constituents and repealing Decision 2009/750/EC
EN                                                                                EN
 ---pagebreak---                                                       ANNEX I
                   EUROPEAN ELECTRONIC TOLL SERVICE INTERFACES
   European Electronic Toll Service (EETS) providers and toll chargers shall use the following
   electronic interfaces:
   1.        Electronic radio interfaces at the roadside between the EETS provider’s on-board
             equipment (OBE) and the toll charger’s fixed or mobile equipment. As a minimum,
             standardised roadside interfaces between OBE and toll chargers’ fixed and mobile
             roadside equipment shall support:
             (a)    Dedicated Short-Range Communication (DSRC) charging transactions,
                    complying with the following requirements:
                    (i) EETS providers’ OBE shall support EN 15509:20141 as well as those
                    clauses of ETSI ES 200674-1 V2.4.12 that relate to interoperability;
                    (ii) toll chargers’ fixed and mobile roadside equipment shall support EN
                    15509:2014. Within Italy, toll chargers’ fixed and mobile roadside equipment
                    may support instead those clauses of ETSI ES 200674-1 V2.4.1 that relate to
                    interoperability;
             (b)    real-time compliance checking transactions compliant to EN ISO 12813:20153;
             (c)    localisation augmentation (where applicable)                     compliant to EN ISO
                    13141:20154.
             EETS OBEs shall comply with points 1(a), 1(b) and 1(c). EETS OBEs provided for
             users of light-duty vehicles must comply with the provisions referred to in point 1(a)
             as referred to in Article 3(6) of Directive (EU) 2019/520.
             Toll chargers may implement any of the provisions referred to in points 1(a), 1(b)
             1(c) and 2 in their fixed or mobile roadside equipment according to their
             requirements.
             Where the toll charger implements a new version of a standard for an interface
             between the roadside equipment and the OBE, the interface shall continue to support
             the previous version of the standard for a limited period to allow for the continued
             compatibility of its electronic toll collection system with the OBEs in operation. The
             duration of this period shall be published by the toll charger in its EETS domain
             statement and may not be shorter than two years.
   2.        Electro-optical imaging systems at the toll charger’s fixed or mobile equipment at the
             roadside, providing means for automatic number plate recognition (ANPR), in toll
             systems where the installation and use of an OBE is not required.
   3.        Electronic interfaces between the respective back office systems.
             Toll chargers shall only implement those aspects of the interface that are linked to
             the technology used on the EETS domain under their responsibility (GNSS, DSRC
             and/or ANPR).
   1
           Electronic fee collection - Interoperability application profile for DSRC
   2
           Intelligent Transport Systems (ITS); Road Transport and Traffic Telematics (RTTT); Dedicated Short
           Range Communications (DSRC); Part 1: Technical characteristics and test methods for High Data Rate
           (HDR) data transmission equipment operating in the 5,8 GHz Industrial, Scientific and Medical (ISM)
           band.
   3
           Electronic fee collection – Compliance check communication for autonomous systems
   4
           Electronic fee collection — Localisation augmentation communication for autonomous systems
EN                                                          1                                                  EN
 ---pagebreak---       3.1. The following back office interfaces shall be implemented by both EETS
      providers and toll chargers independently of the technology used in the EETS toll
      domain:
             (a)    exchange of information to support exception handling from toll chargers
                    to EETS providers.
             (b)    exchange of EETS user-related lists from EETS providers and toll
                    chargers.
             (c)    exchange of trust objects.
             (d)    exchange of toll context data.
             (e)    optionally, exchange of payment claims according to the adopted
                    business model.
      3.2. The following back office interfaces shall be additionally implemented by both
      EETS providers and toll chargers for EETS domains, which implement the GNSS
      technology:
             (a)    submission and validation of global navigation satellite system (GNSS)
                    toll declarations.
             (b)    optionally, exchange of payment announcements according to the
                    adopted business model.
             (c)    optionally, exchange of billing details according to the adopted business
                    model.
      3.3. The following back office interfaces shall be additionally implemented by both
      EETS providers and toll chargers for EETS domains that implement the DSRC
      technology:
             (a)    exchange of billing details.
             (b)    optionally, exchange of payment claims based on dedicated short-range
                    communication (DSRC) charging transactions.
      3.4. The following back office interfaces shall be additionally implemented by both
      EETS providers and toll chargers for EETS domains that implement the ANPR
      technology:
             (a)    optionally, exchange of billing details.
             (b)    optionally, exchange of payment claims based on ANPR charging
                    transactions.
      The electronic interfaces for DSRC- and GNSS-based schemes between the
      respective back office systems of the toll charger and those of the EETS provider
      shall comply with CEN/TS 16986:20165, as corrected by CEN/TS
      16986:2016/AC:2017, at the latest five years from date of applicability of this
      Implementing Regulation. Where the toll charger or EETS provider implements a
      new version of a standard, it shall continue to support, for a limited period, lasting
      not less than two years, data exchange compatible with the previous version of the
      standard to ensure the continuous compatibility of the back offices.
   5
     Electronic Fee Collection - Interoperable application profiles for information exchange between Service
     Provision and Toll Charging
EN                                                  2                                                        EN
 ---pagebreak---                                                ANNEX II
        MINIMUM CONTENTS OF A EUROPEAN ELECTRONIC TOLL SERVICE
                                      DOMAIN STATEMENT
   A European Electronic Tolling Service (EETS) domain statement shall contain the following
   information:
   1.      A section on procedural conditions, which shall be non-discriminatory and shall
           include at least:
           (a)   the toll transaction policy (including authorisation parameters, toll context data,
                 black lists);
           (b)   the procedures and Service Level Agreement, including the format for
                 communicating toll declaration data or billing data, times and frequency for the
                 transfer of toll declaration data, accepted percentage of missed/erroneous tolls,
                 accuracy of toll declaration data, operational availability performance;
           (c)   the invoicing policy;
           (d)   the payment policy;
           (e)   a reference to the relevant conciliation body and its competences related to
                 disputes concerning the remuneration of EETS-providers and of the main
                 service provider;
           (f)   the commercial conditions.
   1.1.    The section on the commercial conditions shall include at least the following
           elements applicable to the EETS providers:
           (a)   any applicable fixed charge based on the costs incurred by the toll charger, for
                 providing, operating and maintaining an EETS compliant system. The toll
                 charger may not impose on EETS providers the fixed charge based on these
                 costs if the costs of providing, operating and maintaining an EETS compliant
                 system are included in the toll;
           (b)   any applicable fixed charge to be paid by EETS providers based on the cost of
                 the accreditation procedure, as referred to in Article 2(20) of Directive (EU)
                 2019/520, including the cost of the assessment of conformity to specifications
                 or suitability for use of interoperability constituents;
           (c)   any applicable requirements for a bank guarantee or equivalent financial
                 instrument, which may not exceed the average monthly toll transaction amount
                 paid by the EETS provider for this toll domain. This amount shall be
                 determined based on the total toll transaction amount paid by the EETS
                 provider for this toll domain in the previous year. For new EETS providers and
                 for new toll domains, the amount shall be based on the expected average toll
                 transactions payable by the EETS provider for this toll domain within the
                 invoicing period based on the number of contracts and average toll per contract
                 estimated in the EETS provider's business plan for the specific toll domain.
   1.2.    The commercial conditions shall also include, as a minimum, a description of the
           elements used to define the fixed and/or variable remuneration paid by the toll
           charger to the EETS provider. The remuneration may vary according to the following
           elements:
EN                                                 3                                                 EN
 ---pagebreak---         (a)   the amount of the toll collected by the EETS provider on behalf of the toll
              charger;
        (b)   the number of active pieces of on-board-equipment (OBE) provided by the
              EETS provider, which are in use in the EETS domain of the toll charger
              concerned;
        (c)   where applicable, the number of toll transactions, or another indication of the
              cost of mobile communications between the OBE and the back office of the
              EETS provider;
        (d)   the invoices issued by the EETS provider to EETS users for tolls due for the
              use of the EETS domain concerned;
        (e)   the nature of other services outsourced by the toll charger to the EETS
              provider.
   1.3. The domain statement shall also include a description of the specific requirements
        and obligations of the main service provider, which differ from the ones of the EETS
        providers and, which justify any differences in the remuneration of the main service
        provider compared to that of the EETS providers.
   2.   A section defining ex ante the steps of the accreditation of an EETS provider to the
        EETS domain and an indicative duration of the accreditation procedure. This section
        shall set out the complete procedure for the assessment of the conformity to
        specifications and the suitability for use of interoperability constituents. It shall
        include a list of required certificates, laboratory and field tests and their indicative
        costs, and measurable criteria or parameters indicating conformity to specifications.
        The section shall contain references to all applicable international or European
        standards related to electronic tolling and exceptions to their application in the EETS
        domain. It shall also specify all technical requirements that are specific to the EETS
        domain and not covered by the international or European standards.
        The same acceptance procedure shall apply to all EETS providers.
   3.   A section on the toll context data.
EN                                              4                                                EN
 ---pagebreak---                                                   ANNEX III
          CONFORMITY TO SPECIFICATIONS AND SUITABILITY FOR USE OF
                                INTEROPERABILITY CONSTITUENTS
   CONFORMITY TO SPECIFICATIONS
   Compliance of interoperability constituents (including road side equipment and interfaces)
   with the requirements referred to in Article 15(4) and 15(5) of Directive 2019/520/EU and
   with all relevant technical specifications and standards shall, prior to their placing on the
   market, be demonstrated by means of either of the following conformity assessment
   procedures, adapted to the specificity of the sector based on the modules provided by
   Decision No 768/2008/EC6:
   (a)        internal production control as set out in section I (module A);
   (b)        EU type examination as set out in section II (Module B) which is followed by
              Conformity to type based on internal production control set out in section III
              (Module C).
   I.         Module A - Internal production control
   Internal production control is the conformity assessment procedure whereby the manufacturer
   fulfils the obligations laid down in points (a), (b) and (c) , and ensures and declares on his sole
   responsibility that the interoperability constituents concerned satisfy the requirements referred
   to in Article 15(4) and 15(5) of Directive (EU) 2019/520.
   (a)        Technical documentation
              The manufacturer shall prepare the technical documentation. The documentation
              shall make it possible to assess the interoperability constituent's conformity to the
              relevant requirements, and shall include an adequate analysis and assessment of the
              risk(s). The technical documentation shall specify the applicable requirements and
              cover, as far as relevant for the assessment, the design, manufacture and operation of
              the interoperability constituent. The technical documentation shall, wherever
              applicable, contain at least the following elements:
                    (i) a general description of the interoperability constituent,
                    (ii) conceptual design and manufacturing drawings and schemes of
                    components, sub-assemblies, circuits, etc.
                    (iii) descriptions and explanations necessary for the understanding of those
                    drawings and schemes and the operation of the interoperability constituent,
                    (iv) reference to the category of interfaces as set out in Annex I,
                    (v) a list of the standards and/or other relevant technical specifications, applied
                    in full or in part, and descriptions of the solutions adopted to meet the
                    requirements referred to in Section I,
                    (vi) results of design calculations made, examinations carried out, etc., and
                    (vii) test reports.
   (b)        Manufacturing
   6
            Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
            framework for the marketing of products and repealing Council Decision 93/465/EEC (Text with EEA
            relevance)
EN                                                      5                                                    EN
 ---pagebreak---             The manufacturer shall take all measures necessary so that the manufacturing process
            and its monitoring ensure compliance of the manufactured interoperability
            constituents with the technical documentation referred to in point (a) and with the
            requirements of the legislative instruments that apply to them.
   (c)      ’EC’ declaration of conformity
            The manufacturer shall draw up a written ‘EC’ declaration of conformity for an
            interoperability constituent model and keep it together with the technical
            documentation at the disposal of the national authorities for 10 years after the
            interoperability constituent has been placed on the market. The ‘EC’ declaration of
            conformity shall identify the interoperability constituent for which it has been drawn
            up.
            A copy of the ‘EC’ declaration of conformity shall be made available to the relevant
            authorities upon request.
   (d)      Authorised representative
   The manufacturer's obligations set out in point (b) may be fulfilled by his authorised
   representative, on his behalf and under his responsibility, provided that they are specified in
   the mandate.
   II.      Module B - EU-type examination
   1.       EU-type examination is the part of a conformity assessment procedure in which a
            notified body examines the technical design of an interoperability constituent and
            verifies and attests that the technical design of the interoperability constituent meets
            the requirements of the legislative instrument that apply to it.
   2.       EU-type examination may be carried out in one of the following ways:
                  –      examination of a specimen, representative of the production envisaged,
                         of the complete interoperability constituent (production type),
                  –      assessment of the adequacy of the technical design of the interoperability
                         constituent through examination of the technical documentation and
                         supporting evidence referred to in point 3, plus examination of
                         specimens, representative of the production envisaged, of one or more
                         critical parts of the interoperability constituent (combination of
                         production type and design type),
                  –      assessment of the adequacy of the technical design of the interoperability
                         constituent through examination of the technical documentation and
                         supporting evidence referred to in point 3, without examination of a
                         specimen (design type).
   3.       The manufacturer shall lodge an application for EU-type examination with a single
            notified body of his choice.
            The application shall include:
            (a)   the name and address of the manufacturer and, if the application is lodged by
                  the authorised representative, his name and address as well,
            (b)   a written declaration that the same application has not been lodged with any
                  other notified body,
            (c)   the technical documentation, which shall make it possible to assess the
                  interoperability constituent's conformity with the applicable requirements of
EN                                                  6                                                EN
 ---pagebreak---             the legislative instrument and shall include an adequate analysis and
            assessment of the risk(s). The technical documentation shall specify the
            applicable requirements and cover, as far as relevant for the assessment, the
            design, manufacture and operation of the interoperability constituent. The
            technical documentation shall contain, wherever applicable, at least the
            following elements:
            (i) a general description of the interoperability constituent,
            (ii) conceptual design and manufacturing drawings and schemes of
            components, sub-assemblies, circuits, etc.,
            (iii) descriptions and explanations necessary for the understanding of those
            drawings and schemes and the operation of the interoperability constituent,
            (iv) a list of the harmonised standards and/or other relevant technical
            specifications the references of which have been published in the Official
            Journal of the European Union, applied in full or in part, and descriptions of
            the solutions adopted to meet the essential requirements of the legislative
            instrument where those harmonised standards have not been applied. In the
            event of partly applied harmonised standards, the technical documentation shall
            specify the parts which have been applied,
            (v) results of design calculations made, examinations carried out, etc., and
            (vi) test reports,
      (d)   the specimens representative of the production envisaged. The notified body
            may request further specimens if needed for carrying out the test programme,
      (e)   the supporting evidence for the adequacy of the technical design solution. This
            supporting evidence shall mention any documents that have been used, in
            particular where the relevant harmonised standards and/or technical
            specifications have not been applied in full. The supporting evidence shall
            include, where necessary, the results of tests carried out by the appropriate
            laboratory of the manufacturer, or by another testing laboratory on his behalf
            and under his responsibility.
   4. The notified body shall:
      With regard to the interoperability constituent:
      4.1. examine the technical documentation and supporting evidence to assess the
      adequacy of the technical design of the interoperability constituent;
      With regard to the specimen(s):
      4.2. verify that the specimen(s) have been manufactured in conformity with the
      technical documentation, and identify the elements which have been designed in
      accordance with the applicable provisions of the relevant harmonised standards
      and/or technical specifications, as well as the elements which have been designed
      without applying the relevant provisions of those standards;
      4.3. carry out appropriate examinations and tests, or have them carried out, to
      check whether, where the manufacturer has chosen to apply the solutions in the
      relevant harmonised standards and/or technical specifications, these have been
      applied correctly;
EN                                            7                                             EN
 ---pagebreak---           4.4 carry out appropriate examinations and tests, or have them carried out, to
          check whether, where the solutions in the relevant harmonised standards and/or
          technical specifications have not been applied, the solutions adopted by the
          manufacturer meet the corresponding essential requirements of the legislative
          instrument;
          4.5. agree with the manufacturer on a location where the examinations and tests
          will be carried out.
   5.     The notified body shall draw up an evaluation report that records the activities
          undertaken in accordance with point 4 and their outcomes. Without prejudice to its
          obligations vis-à vis the notifying authorities, the notified body shall release the
          content of that report, in full or in part, only with the agreement of the manufacturer.
   6.     Where the type meets the requirements of the specific legislative instrument that
          apply to the interoperability constituent concerned, the notified body shall issue an
          EU-type examination certificate to the manufacturer. The certificate shall contain the
          name and address of the manufacturer, the conclusions of the examination, the
          conditions (if any) for its validity and the necessary data for identification of the
          approved type. The certificate may have one or more annexes attached.
          The certificate and its annexes shall contain all relevant information to allow the
          conformity of manufactured interoperability constituents with the examined type to
          be evaluated and to allow for in-service control.
          Where the type does not satisfy the applicable requirements of the legislative
          instrument, the notified body shall refuse to issue an EU-type examination certificate
          and shall inform the applicant accordingly, giving detailed reasons for its refusal.
   7.     The notified body shall keep itself apprised of any changes in the generally
          acknowledged state of the art which indicate that the approved type may no longer
          comply with the applicable requirements of the legislative instrument, and shall
          determine whether such changes require further investigation. If so, the notified body
          shall inform the manufacturer accordingly.
          The manufacturer shall inform the notified body that holds the technical
          documentation relating to the EU-type examination certificate of all modifications to
          the approved type that may affect the conformity of the interoperability constituent
          with the essential requirements of the legislative instrument or the conditions for
          validity of the certificate. Such modifications shall require additional approval in the
          form of an addition to the original EU-type examination certificate.
   8.     Each notified body shall inform its notifying authorities concerning the EU-type
          examination certificates and/or any additions thereto which it has issued or
          withdrawn, and shall, periodically or upon request, make available to its notifying
          authorities the list of certificates and/or any additions thereto refused, suspended or
          otherwise restricted.
          Each notified body shall inform the other notified bodies concerning the EU-type
          examination certificates and/or any additions thereto, which it has refused,
          withdrawn, suspended or otherwise restricted, and, upon request, concerning the
          certificates and/or additions thereto which it has issued.
   The Commission, the Member States and the other notified bodies may, on request, obtain a
          copy of the EU-type examination certificates and/or additions thereto. On request,
          the Commission and the Member States may obtain a copy of the technical
EN                                                  8                                              EN
 ---pagebreak---            documentation and the results of the examinations carried out by the notified body.
           The notified body shall keep a copy of the EU-type examination certificate, its
           annexes and additions, as well as the technical file including the documentation
           submitted by the manufacturer, until the expiry of the validity of the certificate.
   9.      The manufacturer shall keep a copy of the EU-type examination certificate, its
           annexes and additions together with the technical documentation at the disposal of
           the national authorities for 10 years after the interoperability constituent has been
           placed on the market.
   10.     The manufacturer's authorised representative may lodge the application referred to in
           point 3 and fulfil the obligations set out in points 7 and 9, provided that they are
           specified in the mandate.
   III.    Module C - Conformity to type based on internal production control
   1.      Conformity to type based on internal production control is the part of a conformity
           assessment procedure whereby the manufacturer fulfils the obligations laid down in
           points 2 and 3, and ensures and declares that the interoperability constituents
           concerned are in conformity with the type described in the EU-type examination
           certificate and satisfy the requirements of the legislative instrument that apply to
           them.
   2.      Manufacturing
           The manufacturer shall take all measures necessary so that the manufacturing process
           and its monitoring ensure conformity of the manufactured interoperability
           constituents with the approved type described in the EU-type examination certificate
           and with the requirements of the legislative instrument that apply to them.
   3.      Conformity marking and declaration of conformity
           3.1. The manufacturer shall affix the required conformity marking set out in the
           legislative instrument to each individual interoperability constituent that is in
           conformity with the type described in the EC-type examination certificate and
           satisfies the applicable requirements of the legislative instrument.
           3.2. The manufacturer shall draw up a written declaration of conformity for a
           interoperability constituent model and keep it at the disposal of the national
           authorities for 10 years after the interoperability constituent has been placed on the
           market. The declaration of conformity shall identify the interoperability constituent
           model for which it has been drawn up.
           A copy of the declaration of conformity shall be made available to the relevant
           authorities upon request.
   4.      Authorised representative
           The manufacturer's obligations set out in point 3 may be fulfilled by his authorised
           representative, on his behalf and under his responsibility, provided that they are
           specified in the mandate.
   IV.     Tests specifications
   The conformity evaluation of implementation to the requirements referred under point 1 of
   Annex I of this Implementing Regulation and in Article 5(4) of Directive 2019/520 may be
   evaluated by applying the following tests specifications:
EN                                                9                                               EN
 ---pagebreak---              –      Annex I 1(a) of this Implementing Regulation related to the DSRC charging
                    transactions: EN 15876-1:20167, ETSI TS 102 708-1-1:20108, ETSI TS 102
                    708-1-2:20109, ETSI TS 102 708-2-1:201310 and ETSI TS 102 708-2-2:201811,
                    respectively;
             –      Annex I 1(b) of this Implementing Regulation related to the real-time
                    compliance checking transactions: EN ISO 13143-1:201612;
             –      Annex I 1(c) of this Implementing Regulation related to the localisation
                    augmentation: EN ISO 13140-1:201613.
   V.        Suitability for use (interoperability of service)
             The suitability for use of interoperability constituents is assessed by operation or use
             of the constituents in service, integrated representatively into the EETS toll system
             (including test environments) of the toll charger(s) on whose domain the on-board
             equipment must circulate over a specified operation time. The assessment of
             suitability for use may include tests predefined in the EETS domain statement or
             pilots with real users. The toll charger or its authorised representative as well as the
             EETS provider, the manufacturer or an authorised representative and the notified
             body to which the EETS provider applied to, shall comply with each step of the
             suitability-for-use assessment based on measurable criteria or parameters defined in
             the EETS domain statement in accordance with Annex II.
   To carry out such an assessment by means of in-service experience for demonstrating the in-
   service interoperability of the constituents, the manufacturer, EETS provider or an authorised
   representative shall either collaborate directly with the toll charger(s) or apply to a notified
   body, subject to requirements in points (a) and (b). The relevant toll charger may require that
   tests and/or pilots are carried out by means of the infrastructure provided for by the toll
   charger, regardless of whether the EETS provider choses to directly collaborate with the toll
   charger or applies to a notified body.
             (a)    Where the EETS provider collaborates directly with the toll charger(s) on
                    whose domain the on-board equipment shall circulate:
             The manufacturer, EETS provider or an authorised representative shall:
                    (1)    provide for tests or place in service one or more specimens representative
                           of the interoperability constituent(s), as required by the toll charger(s);
   7
           Electronic fee collection - Evaluation of on-board and roadside equipment for conformity to EN 15509
   8
           Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data
           transmission equipment operating in the 5,8 GHz ISM band; Part 1: Data Link Layer; Sub-Part 1:
           Protocol Implementation Conformance Statement (PICS) proforma specification
   9
           Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data
           transmission equipment operating in the 5,8 GHz ISM band; Part 1: Data Link Layer; Sub-Part 2: Test
           Suite Structure and Test Purposes (TSS&TP)
   10
           Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data
           transmission equipment operating in the 5,8 GHz ISM band; Part 2: Application Layer; Sub-part 1:
           Protocol Implementation Conformance Statement (PICS) proforma specification
   11
           Intelligent Transport Systems (ITS); RTTT; Test specifications for High Data Rate (HDR) data
           transmission equipment operating in the 5,8 GHz ISM band; Part 2: Application Layer; Sub-Part 2: Test
           Suite Structure and Test Purposes (TSS & TP)
   12
           Electronic fee collection — Evaluation of on-board and roadside equipment for conformity to ISO
           12813 - Part 1: Test suite structure and test purposes
   13
           Electronic fee collection — Evaluation of on-board and roadside equipment for conformity to ISO
           13141 - Part 1: Test suite structure and test purposes
EN                                                         10                                                    EN
 ---pagebreak---          (2)   monitor the in-service behaviour of the interoperability constituent(s) by
               a procedure agreed and surveyed by the toll charger(s);
         (3)   give evidence to the toll charger(s) that the interoperability constituents
               meet all the interoperability requirements of this (these) Toll Charger(s);
         (4)   draw up a declaration of suitability for use, conditional to obtaining a
               suitability for use attestation delivered by the toll charger(s). The
               declaration of suitability for use covers the assessment by the toll
               charger(s) of the suitability for use of the EETS interoperability
               constituents within the EETS environment of this (these) Toll Charger(s);
   The toll charger shall:
         (1)   clearly define the programme for validation by in-service experience
         (2)   approve the monitoring procedure of the in-service behaviour in its toll
               domains and carry out specific verifications;
         (3)   assess the in-service interoperability with its system;
         (4)   attest the suitability for use on its toll domains in cases where the
               behaviour of the interoperability constituents is successful .
   (b)   Where the EETS provider applies to a notified body, the manufacturer, EETS
         provider or an authorised representative shall:
         (1)   provide for tests or place in service one or more specimens representative
               of the interoperability constituent(s), as required and specified by the toll
               charger(s);
         (2)   monitor the in-service behaviour of the interoperability constituents using
               a procedure approved and surveyed by the notified body.
         (3)   provide evidence to the notified body that the interoperability
               constituent(s) meet(s) all the interoperability requirements of the toll
               charger(s), including the results of in-service experience;
         (4)   draw up the ‘EC’ declaration of suitability-for-use, conditional to
               obtaining a suitability-for-use certificate delivered by the notified body.
               The ‘EC’ declaration of suitability for use covers the
               assessment/judgement by the notified body of the suitability for use of
               the EETS interoperability constituents, considered within the EETS
               domain and environment of the selected toll charger(s) and, particularly
               in cases where interfaces are involved, in relation to the technical
               specifications, particularly those of a functional nature, which are to be
               checked;
   The notified body shall:
         (1)   take into consideration the ‘EC’ declaration of conformity to
               specifications as well as the requirements laid down in the EETS domain
               statement of the toll charger(s).
         (2)   organise collaboration with the relevant toll charger(s);
         (3)   verify the technical documentation and the programme for validation by
               in-service experience;
EN                                        11                                                 EN
 ---pagebreak---                   (4)    approve the monitoring procedure of the in-service behaviour and carry
                         out specific surveillance;
                  (5)    assess in-service interoperability with toll charger systems and
                         operational processes;
                  (6)    issue a suitability-for-use certificate in cases where the behaviour of the
                         interoperability constituents is successful;
                  (7)    issue an explanatory report in case where the behaviour of the
                         interoperability constituent(s)is unsuccessful. The report shall also
                         consider problems that may arise because of non-compliance of a toll
                         charger’s systems and processes with relevant standards and technical
                         specifications. If appropriate, the report shall make recommendations
                         with a view to resolving the problems.
   VI.      Content and format of the declarations of conformity to specifications and
            declarations of suitability for use
   1.       Content of the ‘EC’ Declaration of conformity
            The EC declaration of conformity shall state that the fulfilment of requirements set
            out in Article 15(4), (5) an (6) of Directive (EU) 2019/520 has been demonstrated.
            The EC declaration of conformity shall have the model structure set out in point 2 of
            this Section. It shall contain the elements specified in the relevant modules set out in
            this Annex and shall be continuously updated. It shall be translated into the language
            or languages required by the Member State in which market the interoperability
            constituent is placed or made available.
            By drawing up the EC declaration of conformity, the manufacturer shall assume
            responsibility for the compliance of the interoperability constituent.
   2.       Model the EC Declaration of conformity
            (1)   No … (unique identification of the interoperability constituent):
            (2)   Name and address of the manufacturer or his authorised representative:
            (3)   This declaration of conformity is issued under the sole responsibility of the
                  manufacturer (or installer):
            (4)   Object of the declaration (identification of interoperability constituent allowing
                  traceability. It may include a photograph, where appropriate):
            (5)   The object of the declaration described above is in conformity with the relevant
                  Union harmonisation legislation: …
            (6)   References to the relevant harmonised standards used or references to the
                  specifications in relation to which conformity is declared:
            (7)   Where applicable, the notified body ... (name, number) … performed …
                  (description of intervention) … and issued the certificate: …
            (8)   Additional information:
   Signed for and on behalf of: …………………………………
   (place and date of issue):
   (name, function) (signature):
EN                                                  12                                               EN
 ---pagebreak---    ‘EC’ declarations of suitability for use and the accompanying documents must be dated and
   signed.
   The declarations shall be written in the same language as the instructions and must contain the
   following:
   (a)     references to the relevant legislation;
   (b)     the name and address of the manufacturer, EETS provider or authorised
           representative established within the Union (provide the trade name and full address
           of the authorised representative and the trade name of the manufacturer);
   (c)     description of interoperability constituent(s) (make, type, version, etc.);
   (d)     description of the procedure followed in order to declare conformity to specifications
           or suitability for use;
   (e)     all the relevant requirements met by the interoperability constituents and, in
           particular, their conditions of use;
   (f)     where applicable, name and address of the toll charger(s)/notified body(ies) involved
           in the procedure followed for the assessment of conformity to specifications or
           suitability for use;
   (g)     where appropriate, reference to the technical specifications;
   (h)     identification of the signatory empowered to enter into commitments on behalf of the
           manufacturer or of the manufacturer’s authorised representative established within
           the Union.
EN                                                 13                                              EN