Member Dossier

Active SIEF and nominated Lead Registrant

You are member of an active SIEF: a Lead Registrant was nominated, SIEF management can be made by a consortium, communications between all registrants and the registration process have started.

The main role of both the Lead Registrant and the consortium is to maintain a good communication between all registrants and to draft and submit the joint submission dossier for the SIEF.

For financial reasons, many registrants decide not to be part of the existing consortium. Being a "SIEF member" doesn't necessarily mean being a "Consortium member" for a substance.

Individual registrant obligations

To be able to register its substance, an individual registrant has to:

Communicate and share data with the Lead Registrant and/or the consortium

Acquire a Letter of Access referring to the joint submission dossier

Draft a member dossier in IUCLID 5.4 format

Draft a Chemical Safety Report (CSR) if necessary

EcoMundo drafts your Member Dossier

You can decide to entrust EcoMundo with all or any of the individual registrant tasks below.

We will then represent your company within the existing SIEF and /or Consortium and will take care of the registration process of your substances until their submission to ECHA.

EcoMundo manages the Letters of Access, data sharing, and the drafting your Individual Dossier in IUCLID 5.4 format.

Member Dossier preparation in 2 steps by EcoMundo

Securing your registration

- Assessment on the SIEF activity
- Sameness and use-cases
- Classification and Labeling

Draft of your
member dossier

- Collection and analysis of company specific data
- Acquisition of the Letter of Access from the Lead Registrant
- Validation and integration of data in IUCLID 5.4 format
- Assistance in ECHA submission of the individual dossier

EcoMundo drafts your Chemical Safety Report

Sometimes, the joint submission dossier, which the Letter of Access refers to:

doesn't include a Chemical Safety Report
doesn't cover one or more of your use-cases

You then have to draft a Chemical Safety Report just for your company.

CSR drafting in 3 steps by EcoMundo

Joint registration dossier data analysis

- Conclusions on the hazard assessment
- Evaluation of needs to do an exposure assessment
- Evaluation of needs to do a risk assessment

Exposure assessment

- Data collection on specific use-cases
- Draft of the corresponding exposition scenarios
- Evaluation of the final exposition

Risk Assessment

- Data collection on Risk Management Measures
- Iteration of steps 1 and 2 when necessary

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