Ejemplos prácticos de informes sobre la seguridad química
ECHA has revised its illustrative example of a chemical safety report (CSR) to support companies in complying with their obligations under REACH. The illustrative CSR includes 4 elements:
- What's new!
- Part 1: An Introductory Note
with hints and tips to consider when planning and preparing a Chemical Safety Report
- Part 2: A Chemical Safety Report
which presents a completed CSR for an imaginary substance and uses. Notes are included in the CSR to clarify various aspects.
- Part 3: IUCLID 6.1 substance dataset
This file contains the information that is reported in Sections 1 to 8 of the CSR. It illustrates where information entered in IUCLID is reported in a CSR. Note that it is not a complete IUCLID dossier for REACH compliance, as detailed below.
- Part 4: Chesar 3.2 substance file
This file contains the information that is reported in Sections 9 and 10 of the CSR. It illustrates how a CSA carried out with Chesar is reported in a CSR. It is also the source information for the exposure scenario for communication. When imported into Chesar 3.2, it may be also used to familiarise oneself with the Chesar tool.
The Chemical Safety Report (Part 2) was fully generated from the IUCLID 6.1 and Chesar 3.2 files. The notes were manually included. The full CSR was generated in Chesar 3.2 .
Please note that the IUCLID 6.1 substance dataset contains only the information that is reported in the CSR (Sections 1 to 8). REACH, however, also requires that the robust test summaries that form the basis for the hazard assessment part of the CSR are included in the IUCLID technical dossier. The details that are necessary to make the robust study summaries complete and thereby a compliant REACH technical dossier are not reported in the dataset, as these details are not meant to be transferred to the CSR. The IUCLID 6.1 substance dataset is limited to the establishment of a CSR only. It is not an example of IUCLID model data for REACH compliance with regard to completeness of the technical dossier.
ECHA has also developed suggested templates for Sections 9 and 10 of the Chemical Safety Report. These may be helpful for registrants who do not use Chesar for the exposure estimation and risk characterisation.