An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends others to control, exposures of humans and the environment.

Exposure scenarios need to be developed for manufacture in the Community, and all manufacturer’s and importer’s identified uses, following the steps in the life cycle for each use of the substance. Each exposure scenario needs to include a description of the waste management measure implemented, or recommended, by the manufacturer or importer.

The exposure scenarios may be as wide-ranging or specific as necessary and may describe conditions how to control exposure from one or several uses. Generic exposure scenarios and/or exposure categories can be developed by manufacturers and importers where appropriate.

Identified uses of substances can be the uses of substances on their own, in preparations or in articles.

The exposure has to be estimated for each exposure scenario developed and shall contain three elements:

(1) emission estimation: this needs to consider the emissions during all relevant parts of the life-cycle of the substance under the assumption that the risk management measures described in the exposure scenario have been implemented;

(2) evaluation of chemical fate and pathways: here, a characterisation of possible degradation, transformation, or reaction processes and an estimation of environmental distribution and fate shall be performed;

(3) estimation of exposure levels: this needs to be performed for all human populations (workers, consumers and humans liable to exposure indirectly via the environment) and all environmental spheres for which exposure to the substance is known or reasonably foreseeable. If monitoring data on exposure levels is available, interpretation of this data shall be given special consideration. Each relevant route of human exposure (inhalation, oral, dermal and combined through all relevant routes of exposure) has to be addressed. Such estimations shall take account of spatial and temporal variations in the exposure pattern.