The next section of the module will focus on setting the context and scope of the risk assessment. This step defines the boundaries within which the risk assessment is carried out and it composed of three main aspects:

1. Selecting relevant assessment endpoints or representative species
2. Establishing the baseline
3. Establishing the appropriate comparator(s)

When the regulatory process of a country triggers the need for a risk assessment, it usually results in a request from the competent authority to the risk assessor(s). This request includes the scope of the risk assessment to be carried out as well as some important elements that will set the context of the risk assessment. In a typical case-by-case scenario, in accordance with the Cartagena Protocol, these elements will include at minimum: the LMO(s), its(their) specific use(s) and, in cases of introduction into the environment, the likely potential receiving environment(s) where the LMO may be released and establish itself. As such, the case-by-case approach does not allow an existing risk assessment to be applied “as is” to different LMOs, uses or receiving environments. Any request to conduct or review a risk assessment that does not follow the case-by-case principle should lead the regulatory framework to request a new risk assessment with a scope that is specific to the case under consideration (i.e. the LMO, its specific use and the likely potential receiving environment).