SIEF (MBDF) Management
Support is provided in data sharing within the Substance Information Exchange Forum (SIEF/MBDF), coordinating joint registration work and managing the flow of information between the parties.
Request a quote for this serviceOur Services
Data Sharing & Registration Dossiers
We provide technical and operational support for data sharing, data access rights and the preparation of registration dossiers in joint registration processes.
Scope of Service
Data Sharing & LoA
Consultancy is provided on assessing and coordinating data sharing, data access rights and Letter of Access (LoA) processes in chemical substance registrations.
Request a quote for this serviceChemical Safety Report (CSR / KGR)
Support is provided with the data, risk assessment and reporting work needed to evaluate the effects of chemical substances on human health and the environment.
Request a quote for this serviceData Gap Analysis
Existing technical data and documentation are compared against the relevant regulatory requirements, gaps are identified and the work needed to close them is planned.
Request a quote for this serviceFrequently Asked Questions
Why is data sharing necessary?
Sharing existing test data and studies on the same substance can be important for reducing duplicate testing and carrying out joint registration processes. Data access, usage rights and costs must also be assessed separately.
What is a LoA?
A Letter of Access (LoA) is an arrangement that documents the right to access certain data or dossiers under certain conditions. Its scope, validity and pricing may vary depending on the data owner and the terms of the agreement.
When is a Chemical Safety Report (CSR / KGR) required?
Whether a CSR is required depends on the applicable regulation, the properties of the substance, tonnage and use scenarios. The requirement and the scope of the report are determined on a dossier basis.
What is a Data Gap Analysis for?
Existing information and documents are compared with the information the regulation requires. Gaps, possible data sources, priorities and next steps are identified, and a registration or compliance plan is drawn up.
What is the MBDF (SIEF), and does my company need to join?
The MBDF (Substance Information Exchange Forum, SIEF) is the forum in which registrants of the same substance coordinate information sharing and joint registration processes. Participation and obligations should be assessed according to the substance’s identity, registration status and the relevant legislation.
Let’s find the right regulatory path for your product
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