ECHA has updated its recommendations to assist companies in improving their registration dossiers, including additional guidance on using read-across and weight of evidence. Statistics on the status of registered substances in 2021 are now available.

Based on observations made during compliance checks and recent changes in REACH information requirements, ECHA has refined its recommendations to registrants on how to improve their registrations. 

The enhancements focus on adaptation rules, such as how to apply read-across and weight of evidence, or how to combine the two approaches. These approaches should be used to meet legal requirements without further animal testing if they can be robustly justified. 

The recommendations also include advice on how to deal with read-across between unknown or variable composition substances, complex reaction products, or biological materials (UVCBs), as well as additional dose setting advice for toxicity testing Registrants should review the updated REACH annexes as well as the most recent recommendations and ensure that their dossiers meet the information requirements, where applicable. 

ECHA conducted 371 compliance checks in 2021, covering over 2100 registration dossiers and 341 substances. 300 of these checks were full compliance checks, which addressed all relevant endpoints of potentially hazardous substances. As a result, 280 draught decisions were sent to companies, requesting additional data to clarify long-term effects on human health or the environment. ECHA examined the compliance of 2 500 registered substances from 2009 to 2021.

In addition, in 2021, ECHA issued ten substance evaluation decisions requesting additional information to assess the safety of potentially hazardous substances. Among them was the toxicity of Nano forms of titanium dioxide, as inhaling this substance can be hazardous to human health. 

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