Exposure Characterisation HH and ENV:

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.

Human health:

In principle, the 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:

• Occupational exposure assessments for the primary production and down-stream user sectors
  
  
• Model calculations, using established models like EASE or RISKOFDERM (screening approach)
  
  
• Extrapolation from existing data on analogous substances
  
  
• Compilation and evaluation of existing occupational exposure data
  
  
• Design, coordination and monitoring of occupational exposure surveys, including selection of suitable candidate monitoring sites and choice of appropriate sampling methodology
  
  

Consumers might come in contact with dangerous substances that are contained in consumer products, for example detergents, disinfectants, paints and cosmetics etc. EBRC’s services for consumer exposure cover:

• Surveys of known uses of a substance, via questionnaires, literature searches and access to product registers
  
  
• Quantitative assessment of release from consumer products and of the resulting exposure
  
  

Indirect exposure is represented by (inevitable) intake of air, water, soil and food, where a dangerous substance may be present due to release to the environment and subsequent transfer e.g. to food products.

EBRC’s services for indirect exposure via the environment consist of:

• Quantitative assessment of published monitoring data for a substance in the environmental compartments air, water and soil
  
  
• Review and analysis of dietary intakes (food basket studies, duplicate diet surveys)
  
  
• Model calculations (e.g. EUSES)
  
  
• Quantitative risk characterisation of indirect exposure
  
  

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

Environment

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 (PEC) with the concentration below which unacceptable effects on organisms will most likely not occur (i.e. the predicted no effect concentration (PNEC).

PEC values can be generated either by the use of models (in this case, EUSES 2.0), or from actual measured monitoring data. EBRC has more than 10 years of experience in searching published environmental monitoring data and validating these for quality and reliability.

Predicted environmental exposure levels are required both on a local (site-specific) as well as a regional scale. The consideration of production volumes, as well as diffuse and local emissions together with the collection of relevant emission and release data have been a focal point of EBRC’s activities in risk assessments on industrial chemicals over the past decade.

PNEC derivation involves careful screening of effects data by applying strict quality control criteria. In addition, existing gaps in any effects data base require filling by suitable experiment studies, the design and monitoring of which are regularly performed tasks at EBRC. In addition, especially for data-rich substances, experience in the application of statistical procedures (such as SSD derivation, species sensitivity distribution) is available.

Finally, the development of Exposure Scenarios is an intrinsic feature of the Chemical Safety Reports required under REACH. This is a communication tool which describes how the production and downstream use of a chemical substance impacts releases to the environment, and how tehse can be adequately controlled. EBRC has already been involved in the development of such ESs.