The European Chemicals Agency (ECHA) has published six Practical Guides to help registrants meet their information requirements for REACH registration.
The Practical Guides provide registrants with comprehensive and in-depth advice on preparing their registration dossiers using IUCLID 5. They also cover the options for the adaptation of information requirements and include the reporting practice for alternative (e.g. non-animal) testing methods. ECHA expects that the Guides will help registrants to make the best use of integrated testing strategies and be clear about the level of detail needed to meet their obligations under the law.
The six Practical Guides are:
- 1. How to report in vitro data: Explains the circumstances in which in vitro data can be used for REACH registration purposes as well as how to report the data in IUCLID 5.
- 2. How to report Robust Study Summaries: Covers the Robust Study Summaries (RSS) that need to be included in the technical dossier in IUCLID 5 for all relevant endpoints. It provides templates which demonstrate the necessary level of detail when drafting RSSs for the different endpoints.
- 3. How to report Weight of Evidence: Introduces the Weight of Evidence concept and provides a practical step-by-step illustration on how to prepare and report a weight of evidence approach in IUCLID 5.
- 4. How to report waiving: Explains the possible options for adapting (or waiving) of information requirements and provides practical examples on optimal reporting methods in IUCLID 5.
- 5. How to report (Q)SARs: Provides an overview of the most important aspects when predicting properties of substances using (Q)SAR models as defined in REACH. It alsogives practical examples of how to report (Q)SAR predictions in IUCLID 5. When industry wishes to build categories of substances, they may use (Q)SAR Application Toolbox. www.oecd.org/env/existingchemicals/qsar
- 6. How to report read-across and categories: Provides an overview of the most important practical points to be taken into account when developing and reporting read- across and chemical categories in IUCLID 5.
The Practical Guides are available at: