This Regulation sets out:

• The risk assessment process to be applied in case of technical, operational or organisational changes;
• The criteria to be fulfilled by the assessment body responsible for checking the correct application of the risk assessment process and the results of this application, and the necessary requirements for the accreditation or recognition of its competence in order to achieve a similar quality of independent assessment;
• The harmonised design targets for technical systems which should help with mutual recognition of those systems across the European Union.

It applies to the proposer as defined in Article 3(11) of Regulation (EU) No 402/2013 when making any change to the railway system in a Member State.

This Regulation sets out a harmonised framework for monitoring all safety-related processes. It shall be applied by railway undertakings, infrastructure managers and entities in charge of maintenance to enable the effective management of safety of the railway system during its operation and maintenance activities.

It should contribute to improve the safety management system of railway undertakings and infrastructure managers and the system of maintenance of entities in charge of maintenance.

This Regulation sets out the requirements to be complied with by railway undertakings and infrastructure managers when establishing their safety management system.

This Regulation provides a common purpose for supervision to make sure national safety authorities give appropriate effect to overseeing that the railway undertaking or infrastructure manager has and implements effectively its safety management system (SMS) so that the railway system operates safely.

It applies to national safety authorities only.

To support the assessment of how well a railway undertaking or infrastructure managers’ SMS is working, ERA has developed a maturity model. This model can be directly used via the ERA SMS app.

Download for mobile devices the ERA SMS app here:

This Regulation sets out Common Safety Targets (CSTs) with the aim of ensuring that safety performance does not decrease in any of the Member States. It provides in the short term control of safety performances and in the longer term, convergence of safety performance in Europe, through the use of national reference values (i.e. common ways of measuring and assessing safety performance on a macro level).

The assessment of achievement of CSTs is facilitated by the collection and use of a common set of rail safety data, the Common Safety Indicators (CSIs).

National safety authorities use CSIs to gather information from railway undertakings and infrastructure managers, which combined with other relevant data, makes a comparative analysis possible, and serves as basis for policy recommendations at EU level.

CSIs are based on common definitions and calculation methods, the data set is structured as follows:

• Significant accidents;
• Deaths and serious injuries;
• Suicides;
• Precursors of accidents;
• Economic impact of accidents;
• Technical aspects (level crossings by type and automatic train protection systems);
• Management of safety.

ERA publishes these indicators in the ERAIL database and in its biennial Report on Railway Safety and Interoperability in the EU.

The annual report on the assessment of achievement of CSTs and the Report on Railway Safety and Interoperability in the EU are available in corporate publications.

Monitoring safety performance is a priority task of the Agency in its mission to promote a harmonised approach to railway safety in Europe.

These Regulations set out:

• The procedure and criteria for assessing applications by railway undertakings for safety certificates and by infrastructure managers for safety authorisations respectively
• The principles for supervising compliance with the requirements of Directive 2004/49/EC after the national safety authority has granted the safety certificate/authorisation.