Based on the review of 14000 REACH registration files, ECHA proposed suggestions for improving the registration files

On February 28, 2023, ECHA issued a series of recommendations to improve the quality of REACH registration files, based on the results of ECHA's compliance review of 14000 registration files and taking into account new changes in REACH information requirements.

It is recommended to focus on adjusting the rules for using adaptations for evaluating chemical safety in non animal experiments to better help businesses avoid animal experiments. Suggestion for cross referencing, using source distance to predict the characteristics of similar target substances. This suggestion takes into account structural similarity, defining material groups, and predicting target material characteristics.

The suggestion also provides adjustment information based on the exposure scenarios outlined in the chemical safety report, as well as requirements for mutagenicity information and chronic aquatic toxicity research related to insoluble substances, which have been the focus of recent dossier evaluations.

From 2009 to 2022, EHCA conducted compliance reviews on over 2740 registered substances. Compliance review involves approximately 14000 registration dossiers, accounting for over 15% of registered substances and 20% of all submitted dossiers. For high tonnage substances with an annual registered volume of 100 tons or more, ECHA has reviewed 27% of them.

In order to follow up on the response of the registered enterprise to the resolution, ECHA will check whether the information provided by the registered enterprise meets REACH requirements. In 2022, conclusions were drawn regarding 249 substances: in approximately 60% of cases, companies provided the required information to ECHA. The remaining 40% have been notified to member states for implementation.

ECHA has also passed 9 substance assessment resolutions, requesting further information on assessing the safety of potential substances of concern.

Xin Zhun Dian Ping:

As of the end of January 2023, ECHA has received a total of 101791 registration files, covering 22309 substances. ECHA has invested a lot of effort in the evaluation of its files. In the evaluation of dossiers, ECHA usually requires additional testing. If companies do not respond in a timely manner, it will result in the registration number becoming invalid. Therefore, companies should pay attention to the evaluation status of registered substances in a timely manner. Xin Zhun Testing reminds again that registration is not the end point of REACH regulations, on the contrary, registration is the first step in REACH compliance.