COMMISSION IMPLEMENTING REGULATION (EU) …/...
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establishing practical arrangements for issuing single safety certificates to railway undertakings pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council, and repealing Commission Regulation (EC) No 653/2007
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety, and in particular Article 10(10) thereof,
Whereas:
(1)The method for assessing conformity with the requirements for obtaining a railway single safety certificate is established in Commission Delegated Regulation (EU) No ../.. [the Regulation on conformity assessment]. However, additional provisions harmonising the approach to safety certification at Union level and fostering collaboration among all the parties involved in the safety assessment process are necessary, in order to reduce the complexity, length and cost of the certification procedure.
(2)Taking into account the experience gained in the preparation of the cooperation agreements referred to in Article 11(1) of Directive (EU) 2016/798, early contact with the applicant in the form of coordination ("pre-engagement") is recognised as good practice to facilitate the development of the relationship between the parties involved in the safety assessment process. Such pre-engagement should be offered before an application for a single safety certificate is submitted, with the aim of enabling the certification body to become familiar with the applicant’s safety management system, clarifying how the safety assessment process will be conducted and how decisions will be made and verifying that the applicant has received sufficient information to know what is expected of it. Clarifications given in the context of pre-engagement should not affect the outcome of the assessment.
(3)The Agency should monitor the expiry dates of all valid single safety certificates with an area of operation in more than one Member State and should share that information with the relevant national safety authorities in order to facilitate the planning of their respective safety assessment activities.
(4)The Agency should publish and keep up to date an application guide, free of charge, describing and where necessary explaining the requirements set out in this Regulation and Delegated Regulation (EU) …/… [on conformity assessment]. With the aim of harmonising the approach to the exchange and recording of information through the one-stop shop, the application guide should also include model templates developed by the Agency in cooperation with the national safety authorities.
(5)The Agency and the national safety authorities should implement internal procedures or arrangements to ensure the requirements of the safety assessment are fulfilled.
(6)To avoid any duplication of assessment and to reduce the administrative burden and cost for the applicant, the Agency and the national safety authorities should take into account the cooperation agreements and multilateral agreements concluded pursuant to Article 11 of Directive (EU) 2016/798, where relevant.
(7)Where the intended area of operation is limited to one Member State, and the applicant intends to operate to one or more stations close to the border in neighbouring Member States with similar network characteristics and similar operating rules, it should be able to do so without an extension of its area of operation to those neighbouring Member States. When submitting its application for a single safety certificate, the applicant should select the safety certification body in accordance with Article 10(5) and (8) of Directive (EU) 2016/798Where the Agency acts as the safety certification body it should consult the relevant national safety authorities and should take into account the relevant cross-border agreements.
(8)Where the Agency acts as the safety certification body, the applicant should have the right to submit its application file to the Agency in any official language of the Union, without any obligation to translate it. This principle applies without prejudice to the possibility for the national safety authority to define a language policy concerning the part of the application referred to in Article 10(3)(b) of Directive (EU) 2016/798. During the course of the assessment, the national safety authority should have the right to address documents pertaining to the assessment to the Agency in a language of its Member State, without any obligation to translate them.
(9)The Agency and the national safety authorities should register the details and the outcome of the assessment in the one-stop shop, to support and justify the decisions at each stage of the safety assessment process. If the Agency and the national safety authorities have their own information management systems for the purposes of safety assessment, they should ensure that all relevant information is transferred to the one-stop shop for the same reasons.
(10)The Agency and the national safety authorities should develop internal arrangements or procedures for managing the issuing of single safety certificates with a view to reducing administrative burdens and costs for the applicant. In that respect, the applicant should have the possibility to submit copies of documents in the application file. The original documents should be available for verification by the Agency and national authorities following the issuing of the single safety certificate.
(11)It is necessary to harmonise the categorisation of issues in the assessment process to ensure that the applicant understands the severity of any issues raised by the Agency or by a national safety authority. That categorisation is particularly important when several national safety authorities are involved in the process.
(12)According to Article 31(3) of Directive (EU) 2016/798, the new safety certification regime will start from 16 June 2019. However, Member States have the possibility to notify the Agency and the Commission pursuant to Article 33(2) of that Directive that they have extended the transposition period and may in consequence continue to issue certificates in accordance with Directive 2004/49/EC of the European Parliament and of the Council until 16 June 2020. It is therefore necessary to clarify how the new regime should apply in addition to the old one where the intended area of operation includes one or more of those Member States. More specifically, a single safety certificate issued by the Agency should be recognised as equivalent to the part of the safety certificate referred to in point (a) of Article 10(2) of Directive 2004/49/EC. That certification is valid throughout the Union for equivalent rail transport operations. Therefore, Member States which have notified the Agency and the Commission pursuant to Article 33(2) of Directive (EU) 2016/798 should accept a single safety certificate issued by the Agency as equivalent to the part issued in accordance with point (a) of Article 10(2) of Directive 2004/49/EC.
(13)The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 21 of Council Directive 96/48/EC,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
This Regulation sets out the practical arrangements to be applied by railway undertakings when submitting applications for single safety certificates or for the renewal or update of such certificates through the one-stop shop facility referred to in Article 12 of Regulation (EU) 2016/796 of the European Parliament and of the Council ("one-stop shop").
It also sets out the practical arrangements to be applied by safety certification bodies when assessing applications for single safety certificates, or for the renewal or update of such certificates as well as for coordinating with the national safety authorities concerned by the intended area of operation.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1)‘safety certification body’ means the body responsible for issuing a single safety certificate, either the Agency or a national safety authority;
(2)‘date of receipt of the application’ means:
(a)where the Agency acts as the safety certification body, the first working day common to the Agency and to the national safety authorities concerned by the intended area of operation following the acknowledgement of receipt of the application file;
(b)where a national safety authority acts as the safety certification body, the first working day in the Member State concerned following the acknowledgement of receipt of the application file;
(3)‘pre-engagement’ means a procedural stage preceding the submission of an application, in the course of which the applicant may request additional information on the following stages of the safety assessment process from the safety certification body and the national safety authorities concerned by the intended area of operation.
Article 3
Responsibilities of the Agency and the national safety authorities
1.In addition to the issuing of single safety certificates, the safety certification body shall be responsible for the following tasks:
(a)the planning, implementation and monitoring of the assessment work it carries out;
(b)the assignment of tasks to and the setting up of coordination arrangements between the relevant parties.
2.The safety certification body and the national safety authorities concerned by the intended area of operation shall accept pre-engagement at the request of the applicant and shall provide any clarifications requested by the applicant in the context of the pre-engagement.
3.For the purposes of issuing single safety certificates, the safety certification body and the national safety authorities concerned by the intended area of operation shall, each for their own part, compile the following information:
(a)the details of the assessment, including the reasons for the decisions taken during the assessment and the identification of any limitation or condition of use to be included in the single safety certificate;
(b)the outcome of the assessment, including summary conclusions and where appropriate, an opinion concerning the issuing of the single safety certificate.
4.Where the Agency acts as the safety certification body, it shall compile the information referred to in point (b) of paragraph 3 in the final outcome of the assessment.
5.The Agency shall monitor the expiry dates of all valid single safety certificates with an area of operation in more than one Member State and share that information with the relevant national safety authorities.
6.National safety authorities shall share with the Agency and other national safety authorities concerned by the intended area of operation all relevant information that may have an impact on the safety assessment process.
7.The Agency shall publish and keep up to date an application guide, free of charge, describing and where necessary explaining the requirements set out in this Regulation and Delegated Regulation (EU) …/… [on conformity assessment]. The application guide shall also include model templates developed by the Agency in cooperation with the national safety authorities.
8.The national safety authorities shall publish and keep up to date an application guide, free of charge, describing and where necessary explaining the national rules that apply in respect of the intended area of operation and the applicable national procedural rules.
9.The Agency and the national safety authority shall establish internal arrangements or procedures for managing the safety assessment process Those arrangements or procedures shall take into account the agreements referred to in Article 11 of Directive (EU) 2016/798.
10.Each single safety certificate shall be given a unique European Identification Number (EIN). The Agency shall define the structure and content of EINs and make them available on its website.
11.Where the Agency acts as the safety certification body and the applicant intends to operate to stations in Member States with similar network characteristics and similar operating rules, when those stations are close to the border of the intended area of operation, the single safety certificate shall also be valid until such stations without requesting an extension of the area of operation, following consultation of the competent national safety authorities and taking into consideration the relevant cross-border agreements.
Article 4
Responsibilities of applicants
1.Without prejudice to the timeframe allowed for the assessment set out in Article 6, the applicant shall submit the application for a single safety certificate, or for the update or renewal of such a certificate, through the one-stop shop before the following dates, as appropriate:
(a)the planned start date of any new rail transport operation;
(b)the planned start date of a rail transport operation under conditions other than those laid down in the current single safety certificate, following a substantial change made to the type, extent or area of operation;
(c)the expiry date of the current single safety certificate.
2.When submitting an application for a new single safety certificate, the applicant shall provide all the information listed in the Annex.
3.When submitting an application for the update or renewal of a single safety certificate, the applicant shall provide the information listed in the Annex and describe changes made since the current certificate was issued.
4.The selection of the safety certification body made by the applicant shall be binding until the safety assessment process is completed or terminated.
5.When the applicant requests pre-engagement, it shall submit the information listed in points 1 to 6 of the Annex through the one-stop shop.
6.Where the submitted file contains copies of documents issued by entities other than the safety certification body, the applicant shall keep the originals for at least 5 years after the end of the period of validity of the single safety certificate. In the case of renewal or update, the applicant shall keep the originals of all documents in the file for at least 5 years after the end of the period of validity of the renewed or updated single safety certificate. The applicant shall produce those original documents at the request of the Agency or the national safety authorities.
Article 5
Language
1.Where the Agency acts as the safety certification body, the language to be used for the application shall be as follows:
(a)for the part of the application file referred to in point (a) of Article 10(3) of Directive (EU) 2016/798, one of the official languages of the Union;
(b)for the parts of the application file referred to in point (b) of Article 10(3) of Directive (EU) 2016/798, as well as for the parts of the application file referred to in point 8.1 of the Annex to this Regulation, the language determined in accordance with the application guide referred to in Article 3(8) of this Regulation.
2.Any decision concerning the issuing of the single safety certificate taken by the Agency, including the reasons for the decision in the final outcome of the assessment and where applicable, the single safety certificate, shall be in the language referred to in point (a) of paragraph 1.
Article 6
Procedural stages and timeframes
1.The stages of the safety assessment process shall be as set out in Annex I to Delegated Regulation [on conformity assessment].
2.The safety certification body and the national safety authorities concerned by the intended area of operation shall evaluate, each for their own part, whether the application file contains the required documentary evidence listed in the Annex. The safety certification body shall inform the applicant, without undue delay, and in any case no later than one month following the date of receipt of the application, whether the application is complete.
3.If the applicant is informed that its file is complete, the decision on the issuing of the single safety certificate shall be taken no later than four months following the date on which the applicant is informed that the application is complete.
4.If the applicant is informed that its file is not complete, the safety certification body, in coordination with the national safety authorities concerned by the intended area of operation, shall request the necessary supplementary information promptly, including justifications and details of the timeframe for the applicant’s response.
The timeframe for providing supplementary information shall be reasonable, proportionate to the difficulty of providing the information requested and agreed with the applicant as soon as it is informed that its file is not complete. If the applicant does not provide the required information within the agreed timeframe, the safety certification body may decide to extend the timeframe for the applicant’s response or to reject the application after notice.
The decision on the issuing of the single safety certificate shall be taken no later than four months following the date on which the requested supplementary information is submitted by the applicant.
5.Even if the application file is complete, the Agency or any national safety authority concerned by the intended area of operation may request further information at any time prior to taking its decision and shall set a reasonable deadline for the provision thereof. Such a request shall extend the time limit laid down in paragraph 3 of this Article under the conditions laid down in Annex I to Delegated Regulation … [on conformity assessment].
6.The timeframe referred in paragraph 3 of this Article may be extended by the Agency for the following periods referred to in Article 10(7) of Directive (EU) 2016/798:
(a)the period of cooperation with a view to agreeing on a mutually acceptable assessment;
(b)the period when the matter is referred to the Board of Appeal for arbitration.
Article 7
Communication
1.The safety certification body, the national safety authorities concerned by the intended area of operation and the applicant shall communicate through the one-stop shop as regards any issue referred to in Article 12.
2.The status of all stages of the safety assessment process, the outcome of the assessment and the decision on the application shall be communicated to the applicant through the one-stop shop.
3.Without prejudice to paragraph 1, the application guides of the Agency and of the national safety authorities shall establish the rules for communicating between themselves and with the applicant.
4.The one-stop shop shall acknowledge receipt of the application for a single safety certificate.
Article 8
Period of validity of single safety certificates
Single safety certificates shall be valid for a period of five years.
However, if a shorter period is necessary to ensure the effective control of risks affecting the safety of railway operations, the safety certification body may decide, in coordination with the national safety authorities concerned by the intended area of operation, to grant the single safety certificate for a period of less than five years. In this case, the safety certification body shall include the reasons for its decision in the outcome of the assessment registered in accordance with Article 9.
Article 9
Information management
The safety certification body and the national safety authorities concerned by the intended area of operation shall register the details and outcome of the assessment referred to in Article 3(3) in the one-stop shop. The Agency shall also register the final outcome of the assessment referred to in Article 3(4) in the one-stop shop.
Where the national safety authorities use an information management system for processing the applications addressed to them, they shall transfer all relevant information to the one-stop shop.
Article 10
Visits and inspections on the sites of railway undertakings and audits
1.When undertaking visits and inspections on the sites of applicants, and audits, the Agency and national safety authorities shall be authorised to collect additional evidence that is not in the application file and, in the case of renewal or update, to get assurance that areas of concern not previously covered or resolved by supervision, have been adequately addressed by the applicant. The objectives and scope of visits, inspections and audits shall be agreed between the Agency and the national safety authorities concerned by the intended area of operation, as well as the role assigned to each authority in those tasks.
2.When arranging a visit or inspection on the sites of the applicant, or an audit, the applicant shall provide details of who will represent it and the site safety rules and procedures that need to be respected by the body responsible for carrying out the visit or inspection. The timeframe for visits, inspections and audits, including the provision of the information referred above, shall be agreed among the Agency, the national safety authorities concerned by the intended area of operation and the applicant.
3.The body responsible for carrying out the visit or inspection or the audit shall produce a report, identifying issues identified in the course of the assessment that can be closed by evidence provided during the visit, inspection or audit. That report may also include additional issues referred to Article 12 to be resolved by the applicant within an agreed timeframe.
Article 11
Coordination between the Agency and national safety authorities
1.When acting as the certification body, the Agency shall coordinate with the national safety authorities concerned by the intended area of operation at the different stages of the safety assessment process. The Agency and the national safety authorities shall discuss any issues relating to the safety assessment process, including any deficiency, and any requests for supplementary information which have an impact on the timeframe of the assessment or have the potential to affect the work of the other national safety authorities concerned by the area of operation.
2.Without prejudice to paragraph 1, each body involved in the safety assessment process may take direct contact with the applicant with regard to issues related to its own part of the assessment.
3.Before deciding on the issuing of a single safety certificate, the Agency and the national safety authorities concerned by the intended area of operation shall take the following steps:
(a)discuss the outcome of their respective assessments;
(b)agree on any residual concerns to be deferred for consideration during later supervision;
(c)agree on any limitations or conditions of use to be included in the single safety certificate.
4.When the applicant establishes an action plan to address the residual concerns referred to in point (b) of paragraph 4, the national safety authorities shall agree which of them shall follow up its completion. To that end, the national safety authorities shall coordinate where appropriate, in accordance with the arrangements referred to in Article 9(1) of Delegated Regulation [on supervision], and inform the Agency about their agreement and the outcome of their related supervision activities.
5.The Agency shall keep records of coordination activities and shall register them in the one-stop shop in accordance with Article 9.
Article 12
Categorisation of issues
1.The safety certification body and the national safety authorities concerned by the intended area of operation shall categorise issues identified in the course of their assessment of the application file as follows:
(a)‘Type 1’: issues that require a response from the applicant for the understanding of the application file;
(b)‘Type 2’: issues that may lead to an amendment of the application file or minor action from the applicant; the action to be taken shall be left to the judgement of the applicant and shall not prevent the issuing of the single safety certificate;
(c)‘Type 3’: issues that require specific action to be taken by the applicant, completion of which may be postponed until after the single safety certificate is granted; action to resolve an issue shall be proposed by the applicant and shall be agreed with the party that identified the issue;
(d)‘Type 4’: issues that require an amendment of the application file or specific action to be taken by the applicant; the single safety certificate shall not be granted unless the issue is resolved or restrictions or conditions of use are included in the certificate to address the issue; any action to resolve an issue shall be proposed by the applicant and shall be agreed with the party that identified the issue.
2.Following the response or the action taken by the applicant according to the issue, the safety certification body or the national safety authority concerned shall re-evaluate the issues it identified, re-classify them where relevant and assign one of the following statuses for each of the issues identified:
(a)‘Issue pending’ if the evidence provided by the applicant is not satisfactory and additional information is still required;
(b)‘Residual concern(s) for supervision’ if the matter does not have direct consequences on the safety performance of the railway undertaking and can be deferred for supervision;
(c)‘Issue closed out’ if a suitable applicant’s response has been provided and no residual concern remains.
Article 13
Review under Article 10(12) of Directive (EU) 2016/798
1.Where the safety certification body issues a negative decision, which includes the refusal of the single safety certificate, the exclusion of part of the network in accordance with a negative assessment as referred to in Article 10(7) of Directive (EU) 2016/798 and the identification of restrictions or conditions of use other than those requested in the application, the applicant may request the review of the decision.
2.The request for review shall be submitted by the applicant through the one-stop shop and include a list of any issues that, in the view of the applicant, have not been properly considered during the safety assessment process.
3.Any supplementary information provided after the adoption of the decision on issuing or refusing a single safety certificate shall not be admissible as evidence.
4.The safety certification body in coordination with the national safety authorities concerned by the intended area of operation shall ensure impartiality of the review process.
5.The review process shall target the issues justifying the deviation of the decision of the safety certification body from the applicant’s request.
6.Where the Agency acts as the safety certification body, the review shall be carried out in coordination with the national safety authorities concerned by the intended area of operation.
7.The safety certification body shall communicate its decision to confirm or to adapt the initial decision to all parties involved in the assessment, including the applicant, through the one-stop shop.
Article 14
Transitional provisions
1.Where a national safety authority recognises that it will not be able to issue a safety certificate in accordance with Directive 2004/49/EC before the date for transposition of Directive (EU) 2016/798 in the Member State concerned, it shall inform the applicant immediately and the following actions shall be taken:
(a)if the application is complete less than four months before the date for transposition of Directive (EU) 2016/798 in the Member State concerned, the national safety authority shall transfer that application to the Agency for its consideration. In that case, the national safety authority concerned and the Agency shall cooperate so that the applicant does not need to resubmit its application to the Agency. The national safety authority shall transfer all the available information to the Agency, including the part of assessment already carried out. In this case the national safety authority shall remain responsible for its part of the assessment. The date of receipt of the application shall be the first working day following the date for transposition of Directive (EU) 2016/798 in the Member State concerned;
(b)if the application is incomplete less than four months before the date for transposition of Directive (EU) 2016/798 in the Member State concerned, the applicant shall withdraw it and submit a new application in accordance with this Regulation and Delegated Regulation …[on conformity assessment].
2.Where the area of intended operation is not limited to one Member State, a single safety certificate issued by the Agency between 16 June 2019 and the date for transposition of Directive (EU) 2016/798 shall exclude the network or networks in any of the Member States that have notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798. The national safety authorities of the Member States that have made such a notification shall:
(a)
accept a single safety certificate issued by the Agency as equivalent to the part of the safety certificate issued in accordance with point (a) of Article 10(2) of Directive 2004/49/EC;
(b)issue safety certificates in accordance with point (b) of Article 10(2) of Directive 2004/49/EC from 16 June 2019 with a validity period not extending beyond that of the single safety certificate.
Article 15
Repeal
Regulation (EC) No 653/2007 is repealed with effect from 16 June 2019. However, it shall continue to apply until 15 June 2020 in respect of those Member States that have notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798 that they have extended the period for transposition of that Directive.
Article 16
Entry into force
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 33(2) of Directive (EU) 2016/798. It shall apply in all Member States from 16 June 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
Jean-Claude Juncker
