problem formulation
The process of defining the specific problem being addressed in, for example, an environmental risk assessment. It involves articulating a question and defining how it may be answered (e.g. by identifying the endpoints to be measured)
In food safety, the problem formulation is the first step where the risk assessment is clearly defined and structured. It sets out what exactly needs to be assessed, which hazards are of concern, who or what may be exposed, and which questions the assessment must answer. In simple terms, it frames the problem before any detailed scientific analysis begins.
EFSA uses problem formulation to ensure that its assessments are focused, transparent, and relevant for risk managers. During this step, EFSA identifies the hazard, the food or source involved, the exposed population, and the type of effects to be evaluated, as well as the data and methods that will be used. This is particularly important for complex assessments, such as GMOs, pesticides, nanomaterials, or emerging risks, where many possible pathways and effects exist. A clear problem formulation helps EFSA choose appropriate models, endpoints, and assumptions, and ensures that the final scientific advice directly addresses the regulatory questions posed by the European Commission and Member States.