Evaluation process - phase 2

Drafting a decision

• Registrants
• eMSCA
• ECHA

ECHA or eMSCA prepare a draft decision requesting further information from the registrants.

The draft decision is sent to the registrants. Registrants have 30 days to provide comments.

If registrants comment the draft decision, ECHA or the eMSCA consider these comments and may amend the draft decision.

Please read practical guides on How to act in dossier evaluation and How to act in substance evaluation.

MEMBER STATES INVOLVEMENT

• MSCAs
• ECHA
• Registrants

The decisions taken by ECHA must be unanimously agreed by the Member States. All Member State competent authorities are involved in the decision making process.

 

If no proposals for amendment are received, the draft decision does not need to be referred to the Member State Committee. ECHA will adopt the decision.

 

If proposals for amendment are received, the draft decision needs to be referred to the Member State Committee.

The proposals for amendments are sent to the registrants for comments.

Registrants have 30 days to provide their comments on the proposed amendments.

ECHA refers the draft decision and any comments from the registrants on the proposals for amendment to the Member State Committee. Learn more

ECHA’S DECISION

• Registrants
• eMSCA
• ECHA
• Member State Committee

The Member State Committee will assess whether the draft decision should be amended. It has 60 days from the date of referral to reach unanimous agreement on the draft decision, taking into account the comments from the registrants. View flowchart

If the Member State Committee cannot reach unanimous agreement, ECHA refers the case to the European Commission for decision making. ECHA informs the registrants about this outcome.

If the Member State Committee reaches unanimous agreement, ECHA adopts the decision accordingly.

• The adopted decision is legally binding and it includes the exact date by which the registrants must provide the requested information in an updated dossier.
• ECHA’s decision is notified to the registrants and the Member State competent authorities are informed. The non-confidential version is published on ECHA’s website.Learn more
• The registrants must inform ECHA within 90 days of receipt about who will perform the requested tests.
• The registrants can appeal against ECHA’s decision within three months of receiving the decision.Learn more