What is dossier evaluation?

Evaluation forms a key part of the REACH Regulation, it’s what the ‘E’ stands for after all. It is a process that can be divided into three distinct parts: dossier evaluation; examination of testing proposals, and substance evaluation. Dossier evaluation is a process performed by ECHA to ensure the information submitted with a registration aligns with that required by the REACH regulations and allows accurate conclusions to be drawn as to the safe use of the substance.

REACH requires that a proportion of dossiers submitted for each tonnage band are evaluated and the dossiers to be evaluated are selected in one of two ways: random or concern-based.

Is the whole dossier evaluated?

Randomly selected dossiers will receive a full compliance check however ECHA can also concentrate on concern-based or targeted checks. Under the targeted approach, IT tools are used to screen all submitted dossiers and select those for a targeted check. Dossiers with incomplete chemical safety reports and those submitted outside of a joint submission are likely to be subject to a targeted check. These checks will then focus on specific endpoints relevant to the substance (such as CMR status) and the information provided therein.

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Supporting documents

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