The term ‘risk assessment’ can be described as the overall process of risk identification, analysis and evaluation. In order to perform a risk assessment on a product, it is necessary to have a clear picture of the EU market. In this regard, we need to know which companies produce or import products, the number of SMEs, which products are of high-risk and require more attention, which companies have previously broken the laws, etc. However, the access and availability of such information are very limited to the public.
The risk assessment process has three main phases which, along with their corresponding steps, are described briefly below:
- Risk identification – this phase refers to the process of finding, recognising and describing various risks. It includes the following steps: defining the product, identifying the hazards and subjects at risk.
- Risk analysis - this is the process of understanding the nature of the specific risks identified and determine their magnitude. The results of the risk analysis represent a combination of consequences and their likelihood. The risk assessment steps in this phase are to describe how the identified hazards may harm the subjects and what the potential harm will be.
- Risk evaluation – it refers to the process of comparing the results of the risk analysis with the risk criteria, defined in the specific CE directive, to determine whether the risk and its degree are tolerable or not. Here, the steps required are to determine the severity and probability of harm, as well as the degree of risk in a hypothetical situation.
In case the level of the identified risk is not acceptable, risk management should be carried out immediately after the risk assessment. The risk management refers to the process of finding, selecting and implementing measures that can help for reducing the magnitude of a risk.