How to make your registration fulfil REACH information requirements

2022-02-28

ECHA has updated its recommendations to help companies improve their registration dossiers and has added more advice on using read-across and weight of evidence. Statistics are available on the progress made in evaluating registered substances in 2021.

Helsinki, 28 February 2022 – ECHA has further developed its recommendations to registrants on how they can improve their registrations, based on observations during compliance checks and following recent changes in information requirements under REACH.

The improvements particularly concern rules for adaptations such as how to apply read-across and weight of evidence, or combine the two approaches. These approaches should be used to fulfil legal requirements without further testing on animals if they can be justified in a robust manner.

The recommendations also cover suggestions on how to address a read-across between substances of unknown or variable composition, complex reaction products or of biological materials (UVCBs) as well as additional advice on dose setting for toxicity testing.

Registrants should check the amended REACH annexes as well as the latest recommendations and make their dossiers comply with the information requirements, where needed.

In 2021, ECHA conducted 371 compliance checks covering more than 2 100 registration dossiers and addressing 341 substances. 300 of these checks were so called full compliance checks, addressing all relevant endpoints of substances of potential concern. They resulted in 280 draft decisions sent to companies, requesting more data to clarify long-term effects on human health or the environment. Overall, in 2009-2021, ECHA has checked the compliance of 2 500 registered substances.

ECHA also adopted 10 substance evaluation decisions in 2021, requesting further information to assess the safety of substances of potential concern. Among them was the toxicity of nanoforms of titanium dioxide, as inhaling this substance can be a risk for human health.

A list of all substances that were evaluated in 2021 includes full details of the information requests to companies.

Read More

ECHA, 28-02-22
; https://echa.europa.eu/nl/-/how-to-make-your-registration-fulfil-reach-information-requirements