Evaluation process - phase 1

Dossier evaluation

• ECHA
• EU Companies

REACH requires EU companies manufacturing and importing chemicals to assess their chemicals and propose risk management measures. This assessment needs to be documented in a registration dossier which companies need to prepare and submit to ECHA. Information on properties and uses must be provided on all chemicals manufactured or imported in quantities of one tonne or more per year.

Under dossier evaluation, ECHA checks that information outlined in the standard information requirements of REACH is available in the dossier or proposed in a testing proposal. This information is crucial for understanding whether a chemical may pose a risk to human health and the environment.

Dossier evaluation covers two processes:

Compliance check

• ECHA
• Registrants

Compliance checks verify that the submitted information fulfils the legal requirements under REACH. The requirements depend on the quantity of the substance that is manufactured or imported.

A compliance check evaluates the information in a dossier on substance identity, substance properties and chemical safety assessment. ECHA may open a compliance check on any registration dossier at any time.

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Registrants must regularly review and update their registration dossiers on their own initiative with any relevant new information. An update may be needed because of new hazard information, changes in uses or exposure, updates to the chemical safety report, changes of classification or changes in the annual or total quantities manufactured or imported, as well as stopping the manufacture or import.

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Possible outcomes of the compliance check

No action towards the registrants

ECHA considers there to be no need to request new information at the moment. A new, additional compliance check can still start at any time for this registration dossier.

Decision to request additional information

ECHA concludes that additional testing or further information is required. ECHA prepares and sends a decision to the concerned registrants.

You can check the status of the evaluation of a dossier and see the adopted decisions on ECHA’s website.

Substance evaluation

• ECHA
• MSCAs
• eMSCA

The aim of substance evaluation is to clarify whether the use of a substance may cause harm to human health or to the environment. ECHA and the Member States authorities identify such substances of concern.

Together with the Member States, ECHA defines the risk-based criteria according to which substances are prioritised for evaluation and selects the substances to be included in the Community rolling action plan (CoRAP). Substances listed in the CoRAP are evaluated by the Member States. Only substances registered under REACH are subject to substance evaluation.

Each substance listed in the CoRAP is assigned to a Member State for evaluation. The evaluating Member State competent authority (eMSCA) of the substances scheduled for the first year, has 12 months from the publication of the CoRAP to evaluate whether further information is needed to clarify the identified concern.

Possible outcomes:

 

The eMSCA prepares a draft decision requesting further information from the registrants.

 

The eMSCA concludes that no further information needs to be requested to clarify the concern. The eMSCA prepares a conclusion document where, if the concern is confirmed, it can propose further regulatory actions for the substance.

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