2021 Compliance Check Results: Over 90% Registration Dossiers Required More Data

In 2021, ECHA conducted 371 compliance checks covering more than 2100 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 (about 93%) sent to companies, requesting more data to clarify long-term effects on human health or the environment.

On 28 Feb. 2022, to help enterprises improve their registration dossiers, ECHA has updated its recommendations and has added more advice on using read-across and weight of evidence.

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.

Background

ECHA continued to step up its efforts to compliance checks. It aims to complete the full compliance checks for all registered substances in tonnages over 1 tonne per year before 2027. Overall, in 2009-2021, ECHA has checked the compliance of 2500 registered substances.

CIRS Recommendations

CIRS warmly reminds that completion of REACH registration is only the first step on REACH compliance. Once the registration information is altered, including the main registration body, the safe use information, the exposure information and the hazards information, related enterprises shall update their registration dossiers in time. Besides, enterprises should also pay attention to the evaluation requirements set by the competent authority and ECHA.

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Further Information

ECHA News

2020 Compliance Check Results: 88% Registration Dossiers Require More Data