European Railway Agency - ERA

Making the railway system work better for society

Safety certification

The application is made through the One-stop shop . When the area of operation is limited to one Member State the applicant chooses the safety certification body responsible for issuing the safety certificate, to be either the Agency or the national safety authority for the Member State. In all cases where an area of operation covers more than one Member State the safety certification body is the Agency.

Where the applicant has a choice of safety certification body and has made its selection, the applicant is not able to change its choice unless the initial application is terminated and the applicant triggers a new application to the other safety certification body. In such a case, the applicant has to restart the whole safety certification process from the beginning.

The safety certification body is required to carry out a completeness check of the application within one month, and to make a decision no later than four months after acknowledging the file is complete. This time scale may be extended if the assessment has to be suspended. The time scale for a suspension is agreed with the applicant and the national safety authorities concerned with the area of operation and is proportionate to the difficulty of providing the information requested.

If the application is for an area of operation limited to one Member State and the national safety authority is the safety certification body then the provisions for language in the relevant national legal framework apply. The language policy should be indicated in the application guide produced by that national safety authority.

In other cases the application and the file accompanying the application may be submitted by the applicant in any one of the official languages of the Union. Nonetheless the national safety authorities concerned with the area of operation can request that the applicant translates parts of the file accompanying the application (i.e. the evidence demonstrating compliance with the notified national rules). In order to reduce the need for translation and to facilitate exchanges during the assessment it is recommended to use English or a commonly agreed language for the assessment of the application. When applicable the choice of language for the assessment should be made during pre-engagement.

Pre-engagement is an optional stage that comes before the submission of an application for a single safety certificate, 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.

The safety certification body should during the assessment take into account the fact that it is impossible to verify all aspects of the new railway undertaking’s safety management system. It should then factor on the railway undertaking’s capability to operate and that its safety management system provides evidence of this. Subsequently after the award of the certificate the relevant national safety authority, based on the outcome of the assessment, may wish to put a higher priority on the supervision of the new railway undertaking to ensure that the safety management system is adequate in controlling the risks and confirm its ability to operate safely (e.g. during the first year following the granting of the safety certificate the national safety authority undertakes targeted audits/inspections).

Regulation (EU) 2018/763 empowers the safety certification and the national safety authority (or authorities) concerned by the intended area of operation to undertake audits and inspections on the sites of applicants for a safety certificate.

They may also request for any supplementary information during the assessment.

The content of an application for a safety certificate is specified in Annex I to Regulation (EU) 2018/763. The required information shall be provided by an application for a safety certificate by filling in the electronic forms in the One-stop shop.

The safety certification body is responsible for the safety certificate it issues. Nonetheless, the safety certification body can delegate some of its assessment tasks to external experts. The safety certification body must ensure that the experts are competent enough for performing the delegated tasks. In any case, the safety certification body takes the final decision over the issue of the safety certificate.

The network statement aims to provide all current and potential railway undertakings wishing to operate train services on the infrastructure with a single source of relevant information on a fair and non-discriminatory basis. The network statement is intended to fulfil the requirements of Directive 2012/34/EU.

In the present context, “co-operation” means the need for and commitment from the railway undertaking and the infrastructure manager to co-operate on issues where they have shared interfaces that are likely to affect the putting in place of adequate risk control measures. The management of shared risks associated with the activity of the railway undertaking and the infrastructure manager is a key element of their safety management system.

The detailed co-operation arrangements resulting from the management of shared risks does not necessarily appear in a network statement.

Railway undertakings must hold a safety certificate to be granted access to the railway infrastructure. Should a railway undertaking plays another role in the railway system (e.g. entity in charge of maintenance), it may be required to provide other certificates, authorisations, etc.

All those companies (i.e. railway undertakings as defined in Directive 2012/34/EU) whose principal business is to provide transport services must hold a licence. Those companies which carry out rail transport services but not as a principal activity are not required to obtain a licence.

However, the safety on the whole rail system must be respected by any company that uses the rail system (irrespective of whether it is a principal activity of the company or not). Therefore the requirements of the Railway Safety Directive (e.g. safety certification, SMS) applies also to those companies which are otherwise not licensed and would not fall under Directive 2012/34/EU.

The railway undertaking is expected to provide evidence on:

  • the decision processes for triggering application of the TSIs (within change control management) and, identification of relevant TSIs (in addition to national rules and other standards)
  • the process for implementing, and ongoing monitoring of relevant TSIs (national rules and other standards), where appropriate showing how these are applied throughout the lifecycle of any equipment or operation
  • how the safety management system facilitates corrective action when it is found that standards and other requirements are not being adhered to.

No, before a possible ‘type 3’ issue (i.e. (residual concern for supervision) is recorded as such it will be discussed with the relevant national safety authority or authorities and an agreement reached as to what should be recorded, how it will be addressed and how it will be reported on.

The assessing authority needs to check that the applicant meets these requirements and the national safety authority will likewise check these issues during supervision. The approach to this issue by the applicant should reflect the relative size of the organisation and who its representative bodies are. It should also be borne in mind that the requirements also apply to for example consultation with staff who are not in a Union. How the organisation manages this through its safety management system is up to it, assessment should check it is done and supervision should confirm this.

Even if the application file is complete, ERA or any national safety authority concerned with 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.

However, the timeframe for the safety assessment may only be extended, until the requested information has been submitted, upon decision of the safety certification body in coordination with the national safety authorities concerned with the intended area of operation and with the agreement of the applicant in particular circumstances (as described in Annex II.4.9 of Regulation (EU) 2018/763).

The timeframe may be extended by ERA (acting as safety certification body) in case of arbitration between authorities.

The timeframe may also be extended for the time necessary for the applicant to arrange a visit or inspection on its sites, or an audit of its organisation.

The use of the one-stop shop does not prevent other means of contact, such as phone calls, video conferences, face to face meetings etc. This is to be agreed between the applicant and the authorities concerned with the area of operation, in particular, during pre-engagement (which is voluntary for the applicant).