Commission Implementing Regulation (EU) 2018/763 of 9 April 2018 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. )

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 (¹) (‘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 with 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 with 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 with the intended area of operation;

(4) ‘residual concern’ means a minor issue identified during the assessment of an application for a single safety certificate which does not prevent its issuing and can be deferred for later supervision;

(5) ‘relevant date’ means 16 June 2019 as regards those Member States that have not notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798 that they have extended the transposition period of that Directive. It means 16 June 2020 as regards 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 transposition period of that Directive and that have not notified the Agency and the Commission in accordance with Article 33(2a) of Directive (EU) 2016/798. It means 31 October 2020 as regards those Member States that have notified the Agency and the Commission in accordance with Article 33(2a) of Directive (EU) 2016/798 that they have further extended the transposition period of that Directive.

Article 3

Responsibilities of the Agency and the national safety authorities

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 setting up of coordination arrangements between the relevant parties.

For the purposes of issuing single safety certificates, the safety certification body and the national safety authorities concerned with the intended area of operation shall, each for their own part, compile the following information:

(a) all relevant information concerning the different stages of the assessment, including the reasons for the decisions taken during the assessment and the identification of any restriction 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.

Article 4

Responsibilities of applicants

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.

If major non-compliances, which may affect safety performance or create serious safety risks, or any other areas of concern are identified during supervision activities since the previous assessment, the safety certification body and the national safety authorities concerned with the intended area of operation shall decide whether the whole application file needs to be re-assessed.

Article 5

Language

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 at the choice of the applicant;

(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 Annex I, the language determined by the Member State concerned and indicated in the application guide referred to in Article 3(8) of this Regulation.

Article 6

Procedural stages and timeframes

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 notify the applicant that its application is rejected.

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.

The timeframe 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

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 with 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 with the intended area of operation shall register all relevant information and the 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

Arrangements for visits and inspections on the sites of railway undertakings and audits

Article 11

Coordination between the Agency and national safety authorities

Before deciding on the issuing of a single safety certificate, the Agency and the national safety authorities concerned with 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 restrictions or conditions of use to be included in the single safety certificate.

The Agency shall take into account information on the outcome of supervision activities carried out by the national safety authorities concerned with the intended area of operation regarding the follow up of residual concerns to decide whether these can be closed during the assessment of the update or renewal application.

Article 12

Categorisation of issues

The safety certification body and the national safety authorities concerned with 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.

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 for supervision’ if a residual concern still exists;

(c) ‘Issue closed out’ if a suitable applicant's response has been provided and no residual concern remains.

Article 13

Competence of the staff involved in assessments

The Agency and the national safety authorities shall ensure that staff involved in assessments have the following competencies:

(a) knowledge of the relevant regulatory framework as it applies to assessment;

(b) knowledge of the functioning of the railway system;

(c) appropriate level of critical analysis;

(d) experience in the assessment of a safety or similar management system in the railway sector, or a safety management system in a sector with equivalent operational and technical challenges;

(e) problem solving, communication and team working;

(f) any other competency required by a particular assessment.

In the case of team work, the competencies may be shared amongst the team members.

Staff carrying out visits, inspections and audits as referred to in Article 10 shall also demonstrate knowledge of, and experience in interviewing skills.

With a view to ensuring the correct application of paragraph 1, the Agency and the national safety authorities shall put in place a competence management system which shall include:

(a) the development of competence profiles for each job, position or role;

(b) the recruitment of staff in accordance with the established competence profiles;

(c) the maintenance, development and assessment of staff competence in accordance with the established competence profiles.

Article 14

Review under Article 10(12) of Directive (EU) 2016/798

Article 15

Transitional provisions

In the case referred to in Article 10(8) of Directive (EU) 2016/798, the applicant shall decide whether the application should continue to be assessed by the national safety authority or transferred to the Agency. The applicant shall inform both and the following shall apply:

(a) In cases where the applicant has decided to use the Agency as safety certification body, the national safety authority shall transfer the application file and the results of the assessment referred to in point (a) of Article 10(2) of Directive 2004/49/EC to the Agency. The Agency and the national safety authority shall cooperate and assist the applicant to supplement the application in order to meet the additional requirements of Article 9 of Directive (EU) 2016/798.

(b) In cases where the applicant has decided to use the national safety authority as safety certification body, the national safety authority shall continue the assessment of the application and decide on the issue of the single safety certificate in accordance with Article 10 of Directive (EU) 2016/798 and this Regulation. That authority shall assist the applicant to supplement the application in order to meet the additional requirements of Article 9 of Directive (EU) 2016/798.

Where a NSA recognises that it will not be able to issue a safety certificate before 30 October 2020, it shall inform the applicant and the Agency immediately and paragraphs 2 to 4 shall apply.

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 16 June 2020 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 and that have not yet transposed that Directive and not brought into force its national transposition measures. The national safety authorities of the Member States that have made such a notification shall:

(a) treat 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.

Where the area of intended operation is not limited to one Member State, a single safety certificate issued by the Agency between 16 June 2020 and 30 October 2020 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(2a) of Directive (EU) 2016/798. The national safety authorities of the Member States that have made such a notification shall:

(a) treat 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, from 16 June 2020, safety certificates in accordance with point (b) of Article 10(2) of Directive 2004/49/EC with a validity period not extending beyond that of the single safety certificate.

Applications for safety certificates in accordance with this Regulation shall be accepted by the national safety authorities referred to in the first subparagraph for the purposes of Directive 2004/49/EC.

Article 16

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 and that have not notified the Agency and the Commission in accordance with 33(2a) of Directive (EU) 2016/798.

It shall continue to apply until 30 October 2020 in respect of those Member States that have notified the Agency and the Commission in accordance with Article 33(2a) of Directive (EU) 2016/798 that they have extended the period for transposition of that Directive.

Article 17

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 33(2) of Directive (EU) 2016/798.

It shall apply from 16 June 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798 and that have not notified the Agency and the Commission in accordance with Article 33(2a) of Directive (EU) 2016/798.

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

However, paragraphs (1), (2), (3) and (7) of Article 15 shall apply from 16 February 2019 and Article 15(6) shall apply from 16 June 2019, in all Member States.

Articles 15(6a) shall apply from 16 June 2020 in all Member States.

Article 15 (8) shall apply from 16 June 2020 in Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.

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

ANNEX I

Content of the application for a single safety certificate

Note: all information is mandatory, including the documents annexed to the application, except where indicated with ‘O’ (optional). Where the railway undertaking needs to establish a corrective action plan referred to in point 9, the information about it is mandatory.

1. Type of application:

1.1. New

1.2. Renewal

1.3. Update

1.4. EIN of the previous certificate (in case of renewal or update application only)

2. Type of operation requested (select one or more) (⁴):

2.1. Passenger transport including high-speed services

2.2. Passenger transport excluding high-speed services

2.3. Freight transport including dangerous goods services (⁵)

2.4. Freight transport excluding dangerous goods services

2.5. Shunting only

2.6. Other (specify)

3. Rail transport operations:

3.1. Expected date of starting services/operations (O)

3.2. Member State(s) concerned with the intended area of operation

3.3. Definition of the intended area of operation (for the concerned networks) (⁶)

3.4. Station(s) in neighbouring Member State(s) (in the cases referred to in Article 3(11) of Implementing Regulation (EU) 2018/763 and Article 10(8) of Directive (EU) 2016/798)

4. Safety certification body:

4.1. The Agency