Evaluation process
Evaluation process
Phase 2 – Decision making
Drafting a decision
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
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.
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Draft decision sent to registrants
ECHA notifies registrants
Deadline for registrants' comments on draft decision
30
daysEvaluating Member State Competent Authority (eMSCA) or ECHA notifies (amended) decision to MSCAs & ECHA
X
daysDeadline for MSCAs & ECHA PfAs to the (amended) decision
30
days15
daysProposals for amendment (PfA) sent to registrants
Deadline for registrants' comments on PfAs
Referral to the Member State Committee (MSC)
Written procedure
Agreement / Stop / Referral to European Commission
MSC meeting
Agreement/Referral to European Commission (comitology)
30
days60
days10
days5
daysAdopted decision sent to registrants
X
daysECHA’S DECISION
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