ANNEX I
2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS
2.5. Explicit risk estimation and evaluation
2.5.1.When the hazards are not covered by one of the two risk acceptance principles described in sections 2.3 and 2.4, the demonstration of the risk acceptability shall be performed by explicit risk estimation and evaluation. Risks resulting from these hazards shall be estimated either quantitatively or qualitatively, taking existing safety measures into account.
2.5.2.The acceptability of the estimated risks shall be evaluated using risk acceptance criteria either derived from or based on legal requirements stated in Community legislation or in notified national rules. Depending on the risk acceptance criteria, the acceptability of the risk may be evaluated either individually for each associated hazard or globally for the combination of all hazards considered in the explicit risk estimation.
If the estimated risk is not acceptable, additional safety measures shall be identified and implemented in order to reduce the risk to an acceptable level.
2.5.3.When the risk associated with one or a combination of several hazards is considered as acceptable, the identified safety measures shall be registered in the hazard record.
2.5.4.Where hazards arise from failures of technical systems not covered by codes of practice or the use of a reference system, the following risk acceptance criterion shall apply for the design of the technical system:
For technical systems where a functional failure has credible direct potential for a catastrophic consequence, the associated risk does not have to be reduced further if the rate of that failure is less than or equal to 10-9 per operating hour.
2.5.5.Without prejudice to the procedure specified in Article 8 of Directive 2004/49/EC, a more demanding criterion may be requested, through a national rule, in order to maintain a national safety level. However, in the case of additional authorisations for placing in service of vehicles, the procedures of Articles 23 and 25 of Directive 2008/57/EC shall apply.
2.5.6.If a technical system is developed by applying the 10-9 criterion defined in point 2.5.4, the principle of mutual recognition is applicable in accordance with Article 7(4) of this Regulation.
Nevertheless, if the proposer can demonstrate that the national safety level in the Member State of application can be maintained with a rate of failure higher than 10-9 per operating hour, this criterion can be used by the proposer in that Member State.
2.5.7.The explicit risk estimation and evaluation shall satisfy at least the following requirements:
(a)
the methods used for explicit risk estimation shall reflect correctly the system under assessment and its parameters (including all operational modes);
(b)
the results shall be sufficiently accurate to serve as robust decision support, i.e. minor changes in input assumptions or prerequisites shall not result in significantly different requirements.