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Hazard assessment is the first step of the chemical safety assessment (CSA).
The gathering and evaluation of relevant information are required for registration. This information is documented into the technical dossier and the chemicals safety report when required. The type and quantity of information depends on the quantity that is manufactured or imported.
Human health hazard assessment
All effects on health and the toxicokinetic profile shall be taken into account. Toxicological information that is available or produced shall allow establishing, for each health effect and each relevant exposure pattern1, the external exposure level below which an adverse effect on human health is not expected (DNEL). In cases where DNEL cannot be derived (for example for non threshold effect such as genotoxic carcinogenicity), a semi-quantitative value known as the derived minimal effect level (DMEL) is established. These levels are derived from toxicological tests results and uncertainty factors which results from experimental, inter- and intra-species variability.
Human health hazard assessment due to physicochemical properties
The following potential effects of physicochemical properties to human health shall be assessed:
Environmental hazard assessment
The environmental hazard assessment focuses on potential effects on ecosystems in any environmental sphere (water, air, soils), predator in the food chain, and microbiological activity of sewage treatment systems. The environmental hazard assessment allows establishing the concentration below which adverse effects in the environmental sphere of concern are not expected to occur (PNEC). For each environmental compartment, PNEC is derived on the basis of the ecotoxicological tests results and an assessment factor. The more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the assessment factor.
PBT and vPvB assessment
Further evaluation of these properties is justified as the potential for long-term effects is difficult to predict. The assessment is meant to establish whether the substance meets the REACH annex XIII identification criteria for persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). If so, all emissions throughout the lifecycle of the substance shall be characterised.
Where a substance meets the classification criteria as dangerous or PBT or vPvB, the registrant has to perform the exposure assessment and risk characterisation as part of the CSA. Otherwise, the chemical safety assessment stops here.