# Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (Text with EEA relevance), Article 4: Significant changes

Extent: E+W+S+N.I.

1. The proposer shall consider the potential impact of a change on the safety of the railway system.
If the proposed change has no impact on safety, the risk management process described in Article 5 need not be applied.
2. If the proposed change has an impact on safety, the proposer shall decide, by expert judgement, on the significance of the change based on the following criteria:
(a) failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system under assessment;
(b) novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new for the organisation implementing the change;
(c) complexity of the change;
(d) monitoring: the inability to monitor the implemented change throughout the system life-cycle and intervene appropriately;
(e) reversibility: the inability to revert to the system before the change;
(f) additionality: assessment of the significance of the change taking into account all recent safety-related changes to the system under assessment and which were not judged to be significant.
3. The proposer shall keep adequate documentation to justify its decision.

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Source: https://www.legislation.gov.uk/eur/2013/402/article/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-402/article-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.