ID 13429 | 28.04.2021
ECHA has revised its illustrative example of an exposure scenario (ES) to help suppliers generate exposure scenarios for their customers. It shows how a registrant can extract the relevant information from the comprehensive exposure scenarios in a chemical safety report (CSR) and communicate this effectively in the exposure scenarios for the downstream user, using standard phrases.
This illustrative example was generated using ECHA's tool for carrying out a chemical safety assessment (Chesar), which also generates exposure scenarios for communication.
The example includes the following elements:
Part 1: An Introductory Note
gives an overview of the format for the exposure scenario (ES) to be annexed to the safety data sheet (SDS), advice regarding the selection of standard phrases and how this was done in the illustrative example. It also includes general points to consider when preparing such exposure scenarios.
Part 2: An example of Exposure Scenarios
is an illustrative example of an exposure scenario (ES) to be annexed to the safety data sheet (SDS). It exemplifies how the information contained in the exposure scenarios developed for a chemical safety report can be extracted effectively and communicated in the ES annexed to SDS. This example is derived from the "Illustrative Example of a CSR" published on ECHA’s website for a hypothetical substance (the so-called "ECHA substance").
Part 3: Chesar 3.2 substance file (https://chesar.echa.europa.eu/it/home)
This file is the Chesar 3.2 file from which the exposure scenarios in the example have been generated. Chesar is ECHA's tool for generating a chemical safety assessment. The Chesar substance file was used to prepare both the illustrative example CSR and the exposure scenarios for communication.
Other practical examples
Exposure scenario for CSR. An example of consumer exposure to substances in articles
This is an illustrative example of an exposure scenario for the chemical safety report. It shows how the article service life can be assessed and how meaningful exposure scenarios can be generated from the assessment for a hypothetical substance. Factors to consider within such an assessment are explained. The exposure scenario for the chemical safety report has been generated with ECHA's Chemical Safety Assessment and Reporting tool, Chesar (version 2.3).
The files below show examples of ES in different sectors. These examples do not follow current practice in terms of format or use of standard phrases. They are currently under review and may be updated.
Annotated templates for an Exposure Scenario (ES)
The annotated templates show downstream users what they can expect to see in an exposure scenario for a substance. They may also be useful for registrants to understand how to structure the ES for communication. The templates follow the recommended structure and describe the type of information that is included in each section. They present different types of exposure scenarios, for industrial, professional and consumer uses.
An ES for communication typically consists of 4 sections:
2. Conditions of use affecting exposure
3. Exposure estimation and reference to its source
4. Guidance for Downstream Users on how to evaluate whether he works inside the boundaries set by the ES
Please note that:
- The format is not specified in the legal text. However, the templates shown here present the recommended structure based on practical experience and moves toward a harmonised format within the industry,
- Some elements of the template are subject to further development. These are identified in explanatory footnotes,
- Comments are included in black font to indicate the type of information contained in the sections,
- Examples are included in blue italics to illustrate the type of information. Examples correspond in most cases to the ES illustrative example and are not intended to be consistent with each other, but serve to illustrate the different sections.