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1. Without prejudice to paragraph 9, access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate issued by the Agency in accordance with paragraphs 5 to 7 or by a national safety authority in accordance with paragraph 8. The purpose of the single safety certificate is to provide evidence that the railway undertaking concerned has established its safety management system and that it is able to operate safely in the intended area of operation.

2. In its application for a single safety certificate, the railway undertaking shall specify the type and extent of the railway operations covered and the intended area of operation.

3. The application for a single safety certificate shall be accompanied by a file including documentary evidence that:

(a) the railway undertaking has established its safety management system in accordance with Article 9 and that it meets the requirements laid down in TSIs, CSMs and CSTs and in other relevant legislation in order to control risks and provide transport services safely on the network; and (b) the railway undertaking, where applicable, meets the requirements laid down in the relevant national rules notified in accordance with Article 8. That application and information about all applications, the stages of the relevant procedures and their outcome, and, where applicable, the requests and decisions of the Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796.

4. The Agency, or in the cases provided for by paragraph 8 the national safety authority, shall issue the single safety certificate, or inform the applicant of its negative decision, within a predetermined and reasonable time, and, in any case, not more than 4 months after all information required and any supplementary information requested have been submitted by the applicant. The Agency, or in the cases provided for by paragraph 8 the national safety authority, shall apply the practical arrangements on the certification procedure to be established in an implementing act, as referred to in paragraph 10.

5. The Agency shall issue a single safety certificate to railway undertakings having an area of operation in one or more Member States. In order to issue such a certificate, the Agency shall:

(a) assess the elements set out in point (a) of paragraph 3; and (b) immediately refer the railway undertaking's file in its entirety to the national safety authorities concerned by the intended area of operation for an assessment of the elements set out in point (b) of paragraph 3.

As part of the above assessments, the Agency or the national safety authorities shall be authorised to undertake visits and inspections on the sites of the railway undertaking and audits, and may request relevant supplementary information. The Agency and the national safety authorities shall coordinate the organisation of such visits, audits and inspections.

6. Within 1 month of receipt of an application for a single safety certificate, the Agency shall inform the railway undertaking that the file is complete or ask for relevant supplementary information, setting a reasonable deadline for the provision thereof. With regard to the completeness, relevance and consistency of the file, the Agency may also assess the elements set out in point (b) of paragraph 3. The Agency shall take full account of the assessments under paragraph 5 before taking its decision on the issuing of the single safety certificate. The Agency shall take full responsibility for any single safety certificates it issues.

7. Where the Agency disagrees with a negative assessment carried out by one or more national safety authorities pursuant to point (b) of paragraph 5, it shall inform that authority or authorities in question, giving reasons for its disagreement. The Agency and the national safety authority or authorities shall cooperate with a view to agreeing on a mutually acceptable assessment. Where necessary, the Agency and the national safety authority or authorities may decide to involve the railway undertaking. If no mutually acceptable assessment can be agreed on within 1 month after the Agency has informed the national safety authority or authorities of its disagreement, the Agency shall take its final decision unless the national safety authority or authorities have referred the matter for arbitration to the Board of Appeal established under Article 55 of Regulation (EU) 2016/796. The Board of Appeal shall decide whether to confirm the Agency's draft decision within 1 month of the request of the national safety authority or authorities. Where the Board of Appeal agrees with the Agency, the Agency shall take a decision without delay.

Where the Board of Appeal agrees with the negative assessment of the national safety authority, the Agency shall grant a single safety certificate with an area of operations excluding the parts of the network which received a negative assessment. Where the Agency disagrees with a positive assessment of one or more national safety authorities pursuant to point (b) of paragraph 5, it shall inform the authority or authorities in question, giving reasons for its disagreement. The Agency and the national safety authority or authorities shall cooperate with a view to agreeing on a mutually acceptable assessment. Where necessary, the Agency and the national safety authority or authorities may decide to involve the applicant. If no mutually acceptable assessment can be agreed on within 1 month after the Agency has informed the national safety authority or authorities of its disagreement, the Agency shall take its final decision.

8. Where the area of operation is limited to one Member State, the national safety authority of that Member State may, under its own responsibility and when the applicant so requests, issue a single safety certificate. In order to issue such certificates, the national safety authority shall assess the file in relation to all the elements specified in paragraph 3 and shall apply the practical arrangements to be established in the implementing acts referred to in paragraph 10. As part of the above assessments, the national safety authority shall be authorised to undertake visits and inspections on the sites of the railway undertaking and audits. Within 1 month of receipt of the application, the national safety authority shall inform the applicant that the file is complete or ask for relevant supplementary information. The single safety certificate shall also be valid without an extension of the area of operations for railway undertakings travelling to stations in neighbouring Member States with similar network characteristics and similar operating rules, when those stations are close to the border, following consultation of the competent national safety authorities. This consultation may be carried out on a case-by-case basis or set out in a cross-border agreement between Member States or national safety authorities.

The national safety authority shall take full responsibility for any single safety certificates it issues.

9. A Member State may allow third-country operators to reach a station in its territory designated for cross-border operations and close to the border of that Member State without requiring a single safety certificate, provided that an appropriate level of safety is ensured through:

(a) cross-border agreement between the Member State concerned and the neighbouring third country; or (b) contractual arrangements between the third-country operator and the railway undertaking or infrastructure manager that has a single safety certificate or safety authorisation to operate on that network, provided that the safety-related aspects of those arrangements have been duly reflected in their safety management system.

10. By 16 June 2018, the Commission shall adopt, by means of implementing acts, practical arrangements specifying:

(a) how the requirements for the single safety certificate laid down in this Article shall be fulfilled by the applicant and listing the documents required;

(b) the details of the certification process, such as procedural stages and timeframes for each stage of the process;

(c) how the requirements laid down in this Article shall to be complied with by the Agency and the national safety authority through the different stages of the application and certification process, including in the assessment of applicants' files; and (d) the period of validity of single safety certificates issued by the Agency or by the national safety authorities, in particular in the case of updates of any single safety certificate resulting from changes to type, extent and area of operation.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 28(3). They shall take into account the experience gained during the implementation of Commission Regulation (EC) No 653/2007 () and of Commission Regulation (EU) No 1158/2010 () and the experience gained during the preparation of the cooperation agreements referred to in Article 11(1).

11. Single safety certificates shall specify the type and extent of the railway operations covered and the area of operation. A single safety certificate may also cover sidings owned by the railway undertaking if these are included in its safety management system.

12. Any decision refusing the issuing of a single safety certificate or excluding part of the network in accordance with a negative assessment as referred to in paragraph 7 shall be duly substantiated. The applicant may, within 1 month of receipt of the decision, request that the Agency or the national safety authority, as appropriate, review the decision. The Agency or the national safety authority shall have 2 months from the date of receipt of the request for review in which to confirm or reverse its decision.