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Where an area of operation covers more than one Member State the safety certification body is always the Agency. When the area of operation is limited to one Member State the applicant can choose the safety certification body responsible for issuing the safety certificate. In this case it can be either the Agency or the national safety authority for the Member State. In all cases the applicant submits its application through the one-stop shop.
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.
For applications made to the Agency, the application and any files accompanying the application may be submitted by the applicant in any one of the official languages of the Union. However, in order to address the national part of the application the relevant 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) into the relevant official language.
Pre-engagement is an optional stage that comes before the submission of an application for a single safety certificate. The aim is to enable 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.
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. and in Annex I of Regulation (EU) 2018/762. The required information shall be provided by an electronic application for a safety certificate in the one-stop shop.
The safety certification body is responsible for the safety certificate it issues. However, the safety certification body can delegate some of its assessment tasks to external experts under the condition that these experts do not belong to railway undertakings, infrastructure managers or contracting entities (i.e. a public or private entity which orders the design and/or construction or the renewal or upgrading of a subsystem in the meaning of Directive (EU) 2016/797).
The safety certification body must ensure that the experts are competent enough to perform the delegated tasks. In all cases it is the safety certification body that 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.
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).
A railway undertaking acting as Entity in Charge of Maintenance (ECM) and maintaining vehicles exclusively for its own operations has to comply with Annex II of ECM Regulation (EU) 2019/779 by 16 June 2022 at the latest.
From that date, any application for a single safety certificate shall demonstrate compliance against Annex II of ECM Regulation (EU) 2019/779. Nothing however precludes the railway undertaking to voluntarily comply with Annex II of the aforementioned Regulation before 16 June 2022.
It is not mandatory to identify the role of “ECM” in the application for a single safety certificate. The relevant information, such as the type of vehicles maintained (freight wagons/EMUs/DMUs/locos etc.), the maintenance functions performed in-house or outsourced etc., must be part of the evidence to be submitted in order to comply with point 1 of Annex I to the CSM on SMS Requirements (context of the organisation).
The documents pertaining to the ECM should be recorded in the Safety Management System (SMS) part of the application file and traced against Annex I to the CSM on SMS Requirements, in particular its points 5.2.4 and 5.2.5, by means of the SMS mapping table available in the one-stop shop.
ECM certificates delivered in accordance with Annex II to Regulation (EU) 779/2019 give a presumption of conformity against points 5.2.4 and 5.2.5 of Annex I to the CSM on SMS Requirements (i.e. Regulation (EU) 2018/762).
However, the railway undertaking should indicate in its safety management system which elements and which aspects are covered by the ECM certificate(s) and how the interface with the ECM is managed, in particular what information is exchanged between the railway undertaking and the ECM and how this is done.