Under REACH, the registrant of a dangerous substance has to demonstrate its safe use in the form of exposure scenarios (ES). These are generated in an iterative process in the context of the chemical safety assessment. This process is conducted for human health as well as for the environment.
In principle, any exposure to a substance has to be compared to a DNEL (derived no-effect level), the level of exposure where no adverse effects are expected. Three protection goals are considered: workers, consumers and persons indirectly exposed via the environment.
Workers may be exposed to a dangerous substance during production, further downstream use and finally during recycling operations. EBRC’s services in the context of occupational exposure include:
Consumers might come in contact with hazardous substances that are contained in consumer products, including detergents, disinfectants, paints and cosmetics. EBRC’s services for consumer exposure cover:
Indirect exposure is represented by (inevitable) intake of air, water, soil and food, where a hazardous substance may be present due to releases to the environment and subsequent transfers e.g. into food products.
EBRC’s services for indirect exposure via the environment consist of:
EBRC's experience in occupational, consumer and indirect exposure assessment arises from involvement in various EU Risk Assessments under the Existing Substances Regulation over more than a decade. In addition, EBRC was commissioned in 2005 to develop a technical guidance document specifically for the risk assessment of metals for human health: HERAG
The environmental risk assessment of chemical substances in the EU requires a comparison of predicted environmental (in the compartments air, soil, water and sediment) concentrations (PECs) with the concentration below which unacceptable effects to organisms will most likely not occur (i.e. the predicted no effect concentration - PNEC).
Respective PEC values can be generated using models (in this case, EUSES multimedia model 2.1) or monitoring data. EBRC has gained more than 10 years of experience in searching for published environmental monitoring data and validating these for relevance and reliability.
Predicted environmental exposure levels are required on a local (site-specific) and on a regional scale. The consideration of production volumes, as well as diffuse and point emissions and respective distributions have been a focal point of EBRC’s activities in exposure assessments of industrial chemicals over the past decade.
The PNEC derivation involves careful screening of effects data by applying appropriate quality control criteria. In addition, existing gaps in any effects data base need to be addressed with suitable experimental studies. Design and monitoring of respective studies are routinely performed by EBRC experts. Experience in statistical analyses of environmental effects data is also available.
The development of environmental Exposure Scenarios is part of the Chemical Safety Assessment required under REACH for hazardous substances. The generation of environmental ES entails a qualitative and quantitative understanding of all involved processes and respective emissions for the entire supply chain of a substance, including production, use, disposal and recycling. Environmental ES are generated using current templates provided by ECHA, can be copied and pasted into the chemical safety report and are suited to be used in the annex of the extended safety data sheet as required under REACH. In sum, EBRC’s services for environmental exposure assessments include: