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


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Results of the Compliance Checks show that 88% of the registration dossiers needed more data.

Dossier Evaluation

In 2020, ECHA checked 1 900 chemicals, as a part of its Integrated Regulatory Strategy, to identify a need for further assessment. Of all the 1900 substances, 38% were over 100 tonnes per year.

ECHA also conducted 271 compliances checks addressing 258 substances in 2020. A total of 240 draft decisions requiring for furthering information were issued (88%). This led to 1365 requests to generate information for clarifying the long-term effects on human health or the environment. These include effects on the development of unborn children, reproductive toxicity or genetic mutations; or, further clarifications on persistent, bioaccumulative and toxic properties of chemicals in the environment. 

Bjorn Hansen, ECHA’s Executive Director says: “We have a responsibility towards Europe’s citizens to make sure that chemicals data is correct and up to date. By checking chemicals in groups, we continue our assessment at full speed. Companies also need to speed up and review their registration dossiers. I welcome industry’s voluntary action plans on updating dossiers which many companies have already joined.”

Substance Evaluation

Substance evaluation is done by Member States to clarify if the use of a substance poses risks to people or the environment. In 2020, Evaluations decisions for 30 substances were published. Member States further concluded the assessment of 13 substances indicating a need for further regulatory follow-up action at EU level. ECHA has adopted 18 substance evaluation decisions, requesting further information to assess the safety of substances of potential concern.

To guide the dossier/substance evaluation, ECHA has updated its recommendations for companies on how they can improve their registration data. To increase transparency, ECHA also publishes for the first time a list of the substances evaluated in 2020. This list includes full details on the information requests that have been issued to companies as part of ECHA’s decisions.

Reference:

ECHA News