Risk characterisation is a process intended to calculate or estimate the risk to a given target organism, system, or (sub) population, following exposure to a chemical, taking into account the inherent characteristics of the chemical of concern as well as the characteristics of the specific target system. Risk characterisation is the final stage in a risk assessment and is carried out utilising the ourcomes of both the Hazard assessment and Exposure assessment elements of the scheme, i.e. a risk assessment consists of the following elements.
- Hazard assessment
- Exposure assessment
- Risk Characterisation
Risk characterisation can be carried out for the whole lifecycle of a chemical, for one or more stage of the lifecycle, for a concrete situation such as environmental releases (either generally or for a given site). Risk characterisation can be done at an initial (or “screening”) level or at a more detailed/comprehensive level. As detailed/comprehensive risk characterisation can be very resource intensive it could be considered to carry out such risk characterisations only for high priority/selected chemicals.
Risk characterisation is the qualitative and, wherever possible, quantitative determination, including uncertainties, of the probability of occurrence of known and potential adverse effects of the chemical in a given organism, system, or (sub)population under defined exposure conditions.
Risk characterisation can be an interative process whereby an initial risk characterisation is undertaken and used to identify areas where further data, either on exposure (e.g. monitoring data; see the Exposure assessment element) or hazard (see the Hazard data generation element) are generated and used to refine the risk assessment.
The Risk characterisation for the whole life cycle or stages of the life cycle could be done by a team of experts in the ministry responsible for the framework with input from ministries that are responsible for specific stages of the life cycle such as consumer use, worker use and environment release, using the risk assessment methodology for the selected implementation option. Training in risk assessment/risk characterisation may be needed. The risk assessment could be agreed at government level by the ministries involved in the management system for industrial chemicals. Stakeholder consultation on the results of the risk assessment can also be considered.
Use of the risk assessments by the government: Risk assessment is the basis for Risk management decisions. The information on risk assessments of chemicals could be stored in a National Database.
The activities which can be undertaken and the chemicals included in the scheme depend on the resources available. Please use the following content under More information: “Activities at different resource levels” and “Chemical selection related to resource level” to identify the relevant level for your country, and then select this level in the left-hand box.
The resources required for risk characterisation will depend on the numbers of chemicals included in the hazard assessment elements of the scheme, so the same level as for hazard assessment and exposure assessment should be selected in the left-hand box.