Commission Regulation (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed) (c. 352)

ANNEX I U.K.

1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS U.K.

1.1. General principles and obligations U.K.

1.1.1. The risk management process covered by this Regulation shall start from a definition of the system under assessment and comprise the following activities: U.K.

(a)

the risk assessment process, which shall identify the hazards, the risks, the associated safety measures and the resulting safety requirements to be fulfilled by the system under assessment;

(b)

demonstration of the compliance of the system with the identified safety requirements; and

(c)

management of all identified hazards and the associated safety measures.

This risk management process is iterative and is depicted in the diagram of the Appendix. The process ends when the compliance of the system with all safety requirements necessary to accept the risks linked to the identified hazards is demonstrated.

1.1.2. This iterative risk management process: U.K.

(a)

shall include appropriate quality assurance activities and be carried out by competent staff;

(b)

shall be independently assessed by one or more assessment bodies.

1.1.3. The proposer in charge of the risk management process required by this Regulation shall maintain a hazard record according to section 4. U.K.

1.1.4. The actors who already have in place methods or tools for risk assessment may continue to apply them as far as they are compatible with the provisions of this Regulation and subject to the following conditions: U.K.

(a)

the risk assessment methods or tools are described in a safety management system which has been accepted by a national safety authority in accordance with Article 10(2)(a) or Article 11(1)(a) of Directive 2004/49/EC; or

(b)

the risk assessment methods or tools are required by a TSI or comply with publicly available recognised standards specified in notified national rules.

1.1.5. Without prejudice to civil liability in accordance with the legal requirements of the Member States, the risk assessment process shall fall within the responsibility of the proposer. In particular the proposer shall decide, with agreement of the actors concerned, who will be in charge of fulfilling the safety requirements resulting from the risk assessment. This decision shall depend on the type of safety measures selected to control the risks to an acceptable level. The demonstration of compliance with the safety requirements shall be conducted according to section 3. U.K.

1.1.6. The first step of the risk management process shall be to identify in a document, to be drawn up by the proposer, the different actors’ tasks, as well as their risk management activities. The proposer shall coordinate close collaboration between the different actors involved, according to their respective tasks, in order to manage the hazards and their associated safety measures. U.K.

1.1.7. Evaluation of the correct application of the risk management process described in this Regulation falls within the responsibility of the assessment body. U.K.

1.2. Interfaces management U.K.

1.2.1. For each interface relevant to the system under assessment and without prejudice to specifications of interfaces defined in relevant TSIs, the rail-sector actors concerned shall cooperate in order to identify and manage jointly the hazards and related safety measures that need to be handled at these interfaces. The management of shared risks at the interfaces shall be coordinated by the proposer. U.K.

1.2.2. When, in order to fulfil a safety requirement, an actor identifies the need for a safety measure that it cannot implement itself, it shall, after agreement with another actor, transfer the management of the related hazard to the latter using the process described in section 4. U.K.

1.2.3. For the system under assessment, any actor who discovers that a safety measure is non-compliant or inadequate is responsible for notifying it to the proposer, who shall in turn inform the actor implementing the safety measure. U.K.

1.2.4. The actor implementing the safety measure shall then inform all the actors affected by the problem either within the system under assessment or, as far as known by the actor, within other existing systems using the same safety measure. U.K.

1.2.5. When agreement cannot be found between two or more actors it is the responsibility of the proposer to find an adequate solution. U.K.

1.2.6. When a requirement in a notified national rule can not be fulfilled by an actor, the proposer shall seek advice from the relevant competent authority. U.K.

1.2.7. Independently from the definition of the system under assessment, the proposer is responsible for ensuring that the risk management covers the system itself and the integration into the railway system as a whole. U.K.