Taiwan’s EPA translates two ECHA and OECD documents for dossier preparation

In April 2023, Taiwan’s EPA published two draft documents for dossier preparation and is now searching for public comments. The first document is the Overview of QSAR Model Validation Methods (draft) (in Mandarin). The document was initially prepared by the European Chemicals Agency (ECHA) and the OECD. With the permission from the OECD, Taiwan’s Toxic and Chemical Substances Bureau (TCSB) translated the “Guidance Document on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models, OECD Series on Testing and Assessment, No. 69, OECD, 2014” into Mandarin to facilitate the preparation of dossiers for companies.

The second document considers the grouping of chemicals, based on the document the “Guidance on Grouping of Chemicals, Second Edition, OECD Series on Testing and Assessment, No. 194, OECD, 2017” published by the OECD. This document is also translated into Mandarin. The purpose of this document is to avoid unnecessary animal testing when alternative methods are available for data generation.

The authority specifies that these two documents can only be used as reference documents. Compliance obligations need to follow the Regulations of New and Existing Chemical Substances Registration.

Both documents are available on TCSB’s website. Comments for these two draft documents are welcome and should be sent via mail to Chemist@eri.com.tw.