Ship strikes are one of the main human-induced threats to whale survival. A variety of measures have been used or proposed to reduce collisions and subsequent mortality of whales. These include operational measures, such as mandatory speed reduction, or technical ones, such as detection tools. There is, however, a lack of a systematic approach to assessing the various measures that can mitigate the risk of ship collisions with whales. In this paper, a holistic approach is proposed to evaluate mitigation measures based on a risk assessment framework that has been adopted by the International Maritime Organization (IMO), namely the Formal Safety Assessment (FSA). Formal Safety Assessment (FSA) is “a rational and systematic process for assessing the risk related to maritime safety and the protection of the marine environment and for evaluating the costs and benefits of IMO's options for reducing these risks”. The paper conceptualizes the use of a systematic risk assessment methodology, namely the FSA, to assess measures to reduce the risk of collisions between ships and whales.