In the last decade, the procedures for getting approvals for rail vehicles for the EU market have changed significantly. To accelerate the approval of new rolling stock, the German Federal Railway Authority (Eisenbahn-Bundesamt, EBA) and the rail industry agreed on an interim arrangement. Under this arrangement, private-sector organisations can now also Support rail manufacturers here and can provide the required test services. In addition, new standards were issued to foster harmonisation and liberalisation in the EU market. These new arrangements are the result of the lengthy political process associated with the standardisation of the European rail Network.
Harmonisation and interoperability
Published in July 1996, Directive 96/48/EC on the interoperability of the trans-European high-speed rail system marked an important milestone in the history of the European rail system. It introduced essential requirements, technical specifications for interoperability (TSIs) and EC checking procedures carried out by a Notified Body (NoBo). Directive 2001/16/EC on the interoperability of the trans-European conventional rail system was added in 2001. In 2008 the two directives were merged into one directive (2008/57/EC), which – in spite of minor changes and additions – forms the basis of standardisation of European rail systems – until today.
Together with other EC regulations, directives and decisions, this directive breaks down the rail system into four structural subsystems.
- Control-command and signalling
- Rolling stock
Each of these subsystems includes components that need to fulfil interoperability requirements. Assessment of compliance with these requirements must be carried out by a Notified Body (NoBo).
Given this, getting one step closer towards full interoperability in Europe required harmonisation not only of procedures, but also of actions by the Notified Bodies. This concerns both basic questions and specific technical requirements.
In addition to changes in the EU legal framework and transposition of the EU Directive into national law, all new vehicles and structural subsystems must be in compliance with the relevant requirements in order for authorisations for placing into service to be granted. At least one “Technical specification for interoperability” (TSI) is available for each subsystem. The TSI includes information on the scope of application, essential requirements and functional and technical specifications regarding interoperability as well as the conformity assessment procedure, special cases and transitional periods.
Placing into service
On 29 March 2011, the European Commission published a recommendation based on EC Directives 2008/57 EC and concerning matters related to the placing into service of structural subsystems and vehicles. This recommendation defines the roles of the individual players and marks out the processes involved in placing rolling stock into service and the operation of structural subsystems.
To gain authorisation for placing into service, the Member States must check various aspects including whether the design, implementation and installation of the subsystem fulfils the essential requirements regarding technical compatibility, reliability, accessibility and environmental protection. Specifically, the Member States must verify that the safety of the rail system into which the subsystems will be integrated will be maintained.
To ensure technological compatibility, the subsystems’ conformity with the TSI is verified by a NoBo. Open issues and specific cases in the relevant TSIs and the Notified National Technical Rules (NNTR) are verified by a Designated Body (DeBo) in the Member State in which the rail vehicle or subsystem is to be approved. Only when the requirements of the TSI or NNTR are fulfilled will a safety certificate be issued. If verification of the safe integration of the subsystem is not possible using this approach, the requirements not covered by the TSI must be identified by means of an explicit risk estimation or similarity study. In principle, then, authorisation for placing into service requires verification of three cornerstones of conformity.
Conformity with the TSIs
Rail vehicles must be in conformity with the relevant TSIs. The manufacturer or client (applicant) must commission a Notified Body (NoBo) to perform conformity assessment. The stakeholders then agree on the modules that must be covered by the assessment, e.g. testing of the brake system. Depending on the selected test modules, a variety of documents will be issued to the manufacturer. Apart from the technical documentation, these documents include, but are not limited to the certificate of EC verification, the EC-type-approval certificate, an initial and surveillance certificate for the QMS and an EC type examination certificate.
Conformity with national regulations
Even though we have come a long way in the harmonisation of rail systems in the EU Member States, there are still certain differences. Any open issues that might persist in the relevant TSI must be assessed at national level. Typical examples include risk acceptance and the classification of safety functions (e.g. safety integrity levels) associated therewith.
However, the TSIs also include specific cases for which the Member States have not yet been able to agree on a common solution. These specific cases must also be assessed and evaluated at national level. Another focus of national assessments concerns the NNTR, rules which basically result from the differences in the various rail systems and/or legal regulations.
According to European directives and regulations, the Member States must notify the EU Commission of any differences in national requirements which are relevant for the safe integration of subsystems into the rail systems of the individual member states. These differences are then identified on the pertinent websites or national reference documents (RDD, 2015) These requirements are known as notified national technical rules (NNTR) and refer to national standards or special specifications of the Member States. The assessment involved is carried out by a Designated Body (DeBo). Designated Bodies are accredited by the competent authorities in the individual EU Member States.
Designated Body (DeBo)
DeBos are commissioned by the applicants to verify the subsystem in question. Verification is effected on the basis of technical documentation, specimens of the type, test reports and visual inspection. The NNTR, specific cases and open issues of the TSI are considered in all aspects. Subsequently, the DeBo issues a conformity report.
The DeBo must be independent and able to furnish evidence of their expertise and qualification in the field of the respective subsystem. Most DeBos that carry out inspections have been accredited according to ISO 17020 and thus fulfil the majority of formal requirements. They also have the required expertise.
However, is the subsystem really in conformity with the national requirements? The EC recommends assessing this question in a procedure, like the one carried out for the EU approval of rail vehicles. In this procedure, the NoBo issues the test certificate, including technical documentation, if all requirements have been fulfilled. On this basis, manufacturers can then declare conformity of their rolling stock and Subsystems.
Risk assessment and analysis
The safe integration of subsystems also covers control of possible hazards and risk-reduction actions addressing the probability of occurrence and the consequences of damage. The European Safety Directive (2004/49/EC) requires common safety methods (CSM). One of these methods refers to risk evaluation and assessment and was first published in 2009 as Regulation (EC) No. 352/2009. Its successor, Commission Regulation (EU) No. 402/2013, includes several amendments and improvements, describing a rather general risk management process and defining the scope of independent safety assessment.
Assessment Body (AsBo)
Assessment bodies are third-party organisations or companies that verify the suitability of new systems or systems that have undergone significant changes with respect to safety requirements. In case of a significant change, for example, AsBos must ensure that planning and implementation of the change will not adversely affect the safety of the system as a whole. Following completion of the assessment, the AsBo issues a safety assessment report. AsBos must be accredited or designated by a Member State of the European Union.
The new regulatory acts will significantly advance the harmonisation of the European rail system and the homologation process. Nevertheless, there are still many differences between the national regulations and safety objectives of the individual Member States of the European Union. Third-party testing and inspection associations such as TÜV SÜD Rail offer end-to-end support for market-authorisation procedures providing manufacturers access to the EU market.