In May 2022, ECHA published new advice to help companies deal with the obligations arising from Commission Regulation 2021/979, amending REACH annexes, which came into effect on January 8th, 2022. Since then, companies have been required to justify and document the use of grouping and read-across. Detailed summaries of each study conducted on source substances used to provide information on the target substance must also be included, along with justifications and evidence for the read-across hypothesis.
These changes clarify the need for companies to provide information on the composition of their products to demonstrate structural similarity, which is a prerequisite for grouping and read-across. For unknown or variable composition, complex reaction products or biological materials (UVCBs), this is done based on the information provided on the compositions of their substances.
Companies must also explain whether any structural changes between source and target compounds affect the prediction of harmful properties. Companies must establish structural similarity by other means and justify it if identifying all elements is not technically possible or practical.
ECHA’s Guidance on Information Requirements and Chemical Safety Assessment – Chapter R.6 is also being revised and should be published in the second half of 2022. This should help companies deal with the changes and create robust and complete read-across adaptations for their products, including the UVCBs.
Link to the advice published by ECHA: https://cutt.ly/RGNI9X8
Link to the article: https://echa.europa.eu/fr/-/new-advice-for-using-read-across