5.1.: Step 1: Development of exposure scenarios

5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall be generated. Exposure scenarios are the core of the process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The first assessment will be based on the required minimum and all available hazard information and on the exposure estimation that corresponds to the initial assumptions about the operating conditions and risk management measures (an initial exposure scenario). If the initial assumptions lead to a risk characterisation indicating that risks to human health and the environment are not adequately controlled, then it is necessary to carry out an iterative process with amendment of one or a number of factors in hazard or exposure assessment with the aim to demonstrate adequate control. The refinement of hazard assessment may require generation of additional hazard information. The refinement of exposure assessment may involve appropriate alteration of the operational conditions or risk management measures in the exposure scenario or more precise exposure estimation. The exposure scenario, resulting from the final iteration (a final exposure scenario), shall be included in the chemical safety report and attached to the safety data sheet in accordance with Article 31.

The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of the use, consistent with those given in Section 3.5 of Annex VI. Exposure scenarios shall cover any manufacture in the Community and all identified uses.

In particular, an exposure scenario includes, where relevant, a description of:

Operational conditions

— the processes involved, including the physical form in which the substance is manufactured, processed and/or used,

— the activities of workers related to the processes and the duration and frequency of their exposure to the substance,

— the activities of consumers and the duration and frequency of their exposure to the substance,

— the duration and frequency of emissions of the substance to the different environmental compartments and sewage treatment systems and the dilution in the receiving environmental compartment.

Risk management measures

— the risk management measures to reduce or avoid direct and indirect exposure of humans (including workers and consumers) and the different environmental compartments to the substance,

— the waste management measures to reduce or avoid exposure of humans and the environment to the substance during waste disposal and/or recycling.

5.1.2. Where a manufacturer, importer or downstream user applies for an application for an authorisation for a specific use, exposure scenarios need only be developed for that use and the subsequent life-cycle steps.

5.0.

5.2.

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5.1.: Step 1: Development of exposure scenarios