Commission Implementing Regulation (EU) 2018/763Show full title

1. Introductory Text

2. Article 1. Subject matter and scope

3. Article 2. Definitions

4. Article 3. Responsibilities of the Agency and the national safety authorities

5. Article 4. Responsibilities of applicants

6. Article 5. Language

7. Article 6. Procedural stages and timeframes

8. Article 7. Communication

9. Article 8. Period of validity of single safety certificates

10. Article 9. Information management

11. Article 10. Arrangements for visits and inspections on the sites of railway undertakings and audits

12. Article 11. Coordination between the Agency and national safety authorities

13. Article 12. Categorisation of issues

14. Article 13. Competence of the staff involved in assessments

15. Article 14. Review under Article 10(12) of Directive (EU) 2016/798

16. Article 15. Transitional provisions

17. Article 16. Repeal

18. Article 17. Entry into force and application

19. Signature

20. 1. ANNEX I

       1. Content of the application for a single safety certificate

          2. 1. Type of application:

             1. 1.1. New

             2. 1.2. Renewal

             3. 1.3. Update

             4. 1.4. EIN of the previous certificate (in case of renewal or...

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

             1. 2.1. Passenger transport including high-speed services

             2. 2.2. Passenger transport excluding high-speed services

             3. 2.3. Freight transport including dangerous goods services

             4. 2.4. Freight transport excluding dangerous goods services

             5. 2.5. Shunting only

             6. 2.6. Other (specify)

          4. 3. Rail transport operations:

             1. 3.1. Expected date of starting services/operations (O)

             2. 3.2. Member State(s) concerned with the intended area of operation

             3. 3.3. Definition of the intended area of operation (for the concerned...

             4. 3.4. Station(s) in neighbouring Member State(s) (in the cases referred to...

          5. 4. Safety certification body:

             1. 4.1. The Agency

             2. 4.2. The national safety authority (in the cases referred to in...

          6. 5. Applicant's information:

             1. 5.1. Legal denomination

             2. 5.2. Acronym (O)

             3. 5.3. Complete postal address

             4. 5.4. Phone

             5. 5.5. Fax (O)

             6. 5.6. Email

             7. 5.7. Website (O)

             8. 5.8. National registration number

             9. 5.9. VAT number (O)

             10. 5.10. Other relevant information (O)

          7. 6. Contact person information:

             1. 6.1. First name

             2. 6.2. Surname

             3. 6.3. Title or function

             4. 6.4. Complete postal address

             5. 6.5. Phone

             6. 6.6. Fax (O)

             7. 6.7. Email

             8. 6.8. Language or languages spoken

       2. Documents annexed to the application

          1. 7. Documents submitted for the safety management system part of the...

             1. 7.1. Description of the safety management system and other documents demonstrating...

             2. 7.2. Information cross-referencing the safety management system (see point 7.1) against...

          2. 8. Documents submitted for the national part (for each Member State...

             1. 8.1. Description or other demonstration of how the safety management arrangements...

             2. 8.2. Information cross-referencing the safety management system (see point 7.1) against...

          3. 9. Corrective action plan(s)

             1. 9.1. The current status of the action plan or plans established...

             2. 9.2. The current status of the action plan or plans established...

    2. ANNEX II

       Safety assessment process

       1. 1. GENERAL

          1. 1.1. The safety certification body and the national safety authorities concerned...

       2. 2. RECEIPT OF APPLICATION

          1. 2.1. After receiving the application for a single safety certificate, the...

          2. 2.2. The safety certification body and the national safety authorities concerned...

       3. 3. INITIAL SCREEN

          1. 3.1. The safety certification body in coordination with the national safety...

          2. 3.2. The national safety authorities concerned with the intended area of...

          3. 3.3. Following the checks referred to in points 3.1 and 3.2,...

          4. 3.4. The safety certification body and the national safety authorities concerned...

       4. 4. DETAILED ASSESSMENT

          1. 4.1. After the completion of the initial screen stage, the safety...

          2. 4.2. In undertaking the detailed assessment referred to in point 4.1,...

          3. 4.3. The assessment shall determine whether the safety management system requirements...

          4. 4.4. Any type 4 issue shall be resolved to the satisfaction...

          5. 4.5. Residual concerns may be deferred for consideration to supervision, or...

          6. 4.6. The safety certification body and the national safety authorities concerned...

          7. 4.7. When identifying an issue referred to in Article 12(1), the...

          8. 4.8. If the applicant significantly delays providing the requested information, the...

          9. 4.9. The timeframe for taking the decision on the issuing of...

          10. 4.10. To be satisfactory, the applicant's written responses shall be sufficient...

          11. 4.11. Where a response is considered unsatisfactory, it shall be explained...

          12. 4.12. If concerns emerge that the application could be rejected, or...

          13. 4.13. When it is concluded that either the application meets all...

          14. 4.14. The safety certification body and the national safety authorities concerned...

       5. 5. DECISION-MAKING

          1. 5.1. Based on the conclusions of the completed assessment, a decision...

          2. 5.2. The safety certification body may decide to restrict the scope...

          3. 5.3. The applicant shall be informed about the decision of the...

          4. 5.4. If the issuing of the single safety certificate is refused...

       6. 6. CLOSING ASSESSMENT

          1. 6.1. The safety certification body shall complete the administrative closure by...

       7. 7. SPECIFIC PROVISIONS FOR THE RENEWAL OF A SINGLE SAFETY CERTIFICATE...

          1. 7.1. A single safety certificate may be renewed upon request of...

          2. 7.2. In the case of a renewal application, the safety certification...

          3. 7.3. The safety certification body and the national safety authorities concerned...

       8. 8. SPECIFIC PROVISIONS FOR THE UPDATE OF A SINGLE SAFETY CERTIFICATE...

          1. 8.1. A single safety certificate shall be updated whenever there is...

          2. 8.2. Where it intends to make any change referred to in...

          3. 8.3. Following the notification by the railway undertaking as referred to...

          4. 8.4. The safety certification body in coordination with the national safety...

          5. 8.5. In the case of an update application, the safety certification...

          6. 8.6. The safety certification body and the national safety authorities concerned...

          7. 8.7. An application to the safety certification body to update a...

          8. 8.8. The safety certification body shall decide at the request of...

       9. Appendix

          1. Safety assessment process

             1. Figure 1: Safety assessment process.

          2. Detailed assessment process

             1. Figure 2: Detailed assessment process.

    3. ANNEX III

       Content of the single safety certificate

       1. The single safety certificate confirming acceptance of the railway undertaking's...

       2. 1. European Identification Number (EIN) of the single safety certificate

       3. 2. Identification of the railway undertaking:

          1. 2.1. Legal denomination

          2. 2.2. National registration number

          3. 2.3. VAT number

       4. 3. Identification of the safety certification body:

          1. 3.1. Organisation

          2. 3.2. Member State (where applicable)

       5. 4. Certificate information:

          1. 4.1. New

          2. 4.2. Renewal

          3. 4.3. Update

          4. 4.4. EIN of the previous certificate (in case of renewal or...

          5. 4.5. Validity start and end dates

          6. 4.6. Type of operation

             1. 4.6.1. Passenger transport including high-speed services

             2. 4.6.2. Passenger transport excluding high-speed services

             3. 4.6.3. Freight transport including dangerous goods services

             4. 4.6.4. Freight transport excluding dangerous goods services

             5. 4.6.5. Shunting only

             6. 4.6.6. Other operations

       6. 5. Applicable national legislation

       7. 6. Area of operation

       8. 7. Restrictions and conditions of use

       9. 8. Additional information

       10. 9. Issuing date and authorised signatory/stamp of the authority