ANNEX II

Safety assessment process

1. GENERAL

1.1. National safety authority should develop a structured and auditable process for the complete activity which takes into account the elements set out in this Annex. The safety assessment process should be iterative, as shown in the diagram below (see Figure 1 in the Appendix), that is the national safety authority is entitled to make reasonable requests for further information or re-submission in accordance with this recommendation.

2. RECEIPT OF APPLICATION

2.1. After receiving an application for a safety authorisation, the national safety authority should formally and promptly acknowledge receipt of the application and sets up the registered file in order to ensure information management at each stage of the assessment process.

2.2. The national safety authority should assign competent resources to deliver the assessment process.

3. INITIAL SCREEN

3.1. On receipt of the application, the national safety authority should undertake promptly an initial screen to check the following elements:

(a) the applicant has provided the basic information which is either required by the legislation or needed for it to be processed effectively;

(b) the application file contains sufficient evidence and is structured and internally cross-referenced so that it can be properly assessed against the safety management system requirements and relevant notified national rules. The national safety authority conducts an initial review of the actual content of the evidence contained in the application to make an initial judgement on the quality, sufficiency and appropriateness of the safety management system;

(c) if applicable, the current status of the action plan (or plans) established by the infrastructure manager to resolve any major non-compliance and any other area of concern identified during supervision activities since the previous assessment is included;

(d) if applicable, the current status of the action plan (or plans) established by the infrastructure manager to resolve residual concerns from previous assessment is included.

3.2. Following the initial screening referred to in point 3.1, the national safety authority should decide if there are any areas in which, for their respective part, further information is necessary. Where further information is necessary, the national safety authority should promptly seek the information, to the extent that they deem reasonably necessary to support their assessment.

3.3. The national safety authority should read a sufficient sample of the application to check that its content is understandable. If it is clearly not, the national safety authority should decide whether it needs to be returned, with a request for an improved version.

3.4. When assessing the infrastructure manager's capacity to operate trains, infrastructure inspection vehicles, on-track machines or other special vehicles, including the use of contractors where relevant, the national safety authority should refer to the relevant requirements defined in Annex I of Delegated Regulation (EU) 2018/762, in particular its points 1, 5.1, 5.2 and 5.5.

4. DETAILED ASSESSMENT

4.1. After the completion of the initial screen stage, the national safety authority should proceed to the detailed assessment of the application file (see Figure 2 in the Appendix), using the safety management system requirements and relevant notified national rules.

4.2. In undertaking the detailed assessment referred to in point 4.1, in accordance with Article 18(1) of Directive (EU) 2016/798, the national safety authority should exercise professional judgment, be impartial and proportionate, and provide documented reasons for conclusions reached.

4.3. The assessment determines whether the safety management system requirements and relevant notified national rules are met or whether further information is needed. During the assessment the national safety authority should also seek evidence that the safety management system requirements and relevant notified national rules have been met from the outputs of the safety management system processes, using sampling methods where appropriate, to ensure that the applicant has understood and can meet the requirements according to the type of the railway operations in order to ensure safe operation of the railway.

4.4. Any type 4 issue should be resolved to the satisfaction of the national safety authority leading to an update of the application file where appropriate before the safety authorisation can be issued.

4.5. Residual concerns may be deferred for consideration to supervision, or actions may be agreed upon with the applicant, based on its proposal for updating the application file, or both. In such a case formal resolution of the issue takes place after the issue of the safety authorisation.

4.6. The national safety authority should be transparent on how it judges the severity of each identified issue.

4.7. When identifying an issue referred to in point 33, the national safety authority should be specific and help the applicant understand the level of detail expected in the response. To that end, the national safety authority should take the following steps:

(a) refer accurately to the relevant safety management system requirements and notified national rules and help the applicant to understand the identified issues;

(b) identify the relevant part of related regulations and rules;

(c) state why the individual safety management system requirement or notified national rule, including any related legislation, is not met;

(d) agree with the applicant on further commitments, documents and any other supporting information to be provided, as required by the level of detail of the safety management system requirement or the notified national rule;

(e) specify and agree with the applicant on a timeframe for compliance, reasonable and proportionate to the difficulty of providing the information requested.

4.8. In application of Article 12(3) of Directive (EU) 2016/798, if the applicant significantly delays providing the requested information, the national safety authority should decide to extend the timeframe for the applicant's response or to reject the application after notice.

4.9. The timeframe for taking the decision on the issuing of the safety authorisation may only be extended, until the requested information has been submitted, upon decision of the national safety authority and with the agreement of the applicant in one of the following cases:

(a) type 1 issues that, considered individually or collectively, prevent the assessment or parts of it from continuing;

(b) type 4 issues or multiple type 3 issues that, considered collectively, may raise the category to a type 4 issue, preventing the issuing of the safety authorisation.

4.10. To be satisfactory, the applicant's written responses should be sufficient to allay the concerns expressed and to demonstrate that its proposed arrangements will meet the relevant criteria or notified national rules.

4.11. Where a response is considered unsatisfactory, it should be explained precisely why, identifying the further information or demonstration required of the applicant to make it satisfactory.

4.12. If concerns emerge that the application could be rejected, or that it will take a longer time to reach a decision than the timeframe allowed for the assessment, the national safety authority may consider possible contingency measures.

4.13. When it is concluded that either the application meets all requirements or that further progress in securing satisfactory responses to outstanding matters is unlikely, the national safety authority should complete the assessment by the following steps:

(a) stating whether all criteria have been met or whether there are still matters outstanding;

(b) identifying any residual concern;

(c) identifying any restriction or condition of use to be included in the safety authorisation;

(d) reporting on the follow-up of major non-compliances identified during supervision activities, as referred to in Article 5 of Delegated Regulation (EU) 2018/761, where appropriate;

(e) ensuring that the safety assessment process has been correctly applied;

(f) compiling the outcome of the assessment, including summary conclusions and where appropriate, an opinion concerning the issuing of the safety authorisation.

4.14. The national safety authority should record and justify in writing all findings and judgments in order to facilitate both the assurance process and the decision-making process, as well as to assist with any appeal against the decision to issue the safety authorisation or to reject the application.

5. DECISION-MAKING

5.1. Based on the conclusions of the completed assessment, a decision should be made on whether to issue a safety authorisation or to reject the application. Where a safety authorisation is to be issued, some residual concerns may be identified. A safety authorisation is not issued where any type 4 issue is identified and not resolved during the assessment.

5.2. The national safety authority may decide to restrict the scope of the safety authorisation, by identifying restrictions or conditions of use, if such restrictions or conditions of use address any type 4 issue that would prevent the issue of the safety authorisation. The safety authorisation should be updated on request of the applicant after all residual concerns have been addressed in its application file.

5.3. The applicant should be informed about the decision of the national safety authority, including the outcome of the assessment, and a safety authorisation is issued as appropriate.

5.4. If the application is rejected or if the safety authorisation contains restrictions or conditions of use other than those defined in the application, the national safety authority should inform the applicant, giving the reasons for the decision, and notify it of the procedure to request a review of or to appeal against the decision.

6. CLOSING ASSESSMENT

6.1. The national safety authority should complete the administrative closure by ensuring that all documents and records are reviewed, organised and archived. To continually improve its process, the national safety authority should identify historic information and lessons learned for use by future assessments.

7. SPECIFIC PROVISIONS FOR THE RENEWAL OF A SAFETY AUTHORISATION

7.1. A safety authorisation may be renewed upon request of the applicant before the expiry of its validity to ensure continuity of authorisation.

7.2. In the case of a renewal application, the national safety authority should check details of changes to the evidence submitted in the previous application and consider the results of past supervision activities as referred to in Article 5 of Delegated Regulation (EU) 2018/761 to prioritise or target the relevant safety management system requirements and notified national rules upon which to assess the renewal application.

7.3. The national safety authority should take a proportionate approach to re-assessment, based on the degree of changes proposed.

8. SPECIFIC PROVISIONS FOR THE UPDATE OF A SAFETY AUTHORISATION

8.1. A safety authorisation is updated whenever there is a substantial change proposed to the infrastructure, the signalling, any energy supply used in connection with the infrastructure or the principles of operation and maintenance of such infrastructure, signalling or energy supply in accordance with Article 12(2) of Directive (EU) 2016/798.

8.2. Where it intends to make any change referred to in point 8.1, the infrastructure manager holding the safety authorisation notifies the national safety authority without delay.

8.3. Following the notification by the infrastructure manager as referred to in point 8.2, the national safety authority:

(a) checks that the change relating to any potential application is clearly described and that potential safety risks are assessed;

(b) discusses with the infrastructure manager the need for an update of the safety authorisation.

8.4. The national safety authority may make further enquiries with the applicant. Where the national safety authority agrees that the proposed change is not substantial, it informs the applicant in writing that an update is not required, keeping a record of the decision for the registered file.

8.5. In the case of an application for un update, the national safety authority should take the following steps:

(a) check details of changes to the evidence submitted in the previous application upon which the current safety authorisation was issued;

(b) consider the results of past supervision activities as referred to in Article 5 of Delegated Regulation (EU) 2018/761, and in particular, issues relating to the ability of the applicant to effectively implement and monitor its change management process;

(c) prioritise or target the relevant safety management system requirements and notified national rules in order to assess the update application.

8.6. The national safety authority should take a proportionate approach to re-assessment, based on the degree of changes proposed.

8.7. An application to the national safety authority to update a safety authorisation should not lead to the extension of its validity period.

8.8. The national safety authority should decide at the request of the applicant whether the safety authorisation needs to be updated where the conditions under which the safety authorisation was issued are to be changed without any impact on the infrastructure, the signalling, any energy supply used in connection with the infrastructure or the principles of operation and maintenance of such infrastructure, signalling or energy supply.