Prepare your registration as a IUCLID dossier

After you discuss and exchange data within the SIEF, the lead registrant and each member registrant should have all the relevant information available to create their registration dossiers using the IUCLID format. There are three options: IUCLID Cloud for SMEs, IUCLID 6 and REACH-IT.

If you are an SME or a consultant working for an SME, the IUCLID Cloud for SMEs helps you to avoid any installation and gives you easy access, automated, regular back-ups and updates by ECHA.

As a consultant, the cloud version enables you to transparently collaborate with your SME clients and to easily and securely share IUCLID information with them.

If you are a lead registrant
 
Your registration dossier includes the information submitted by you on behalf of all the co-registrants, such as the boundary composition of the substance, classification and labelling of the substance, uses, and (robust) study summaries, where applicable. In addition, as a lead registrant, you also add your own company-specific and substance-specific registration information in the same dossier.
 
It is good practice that you share the common parts of the registration dossier with the other members of the joint submission in the IUCLID format as it contains information related to the safe use of the substance that needs to be known by the co-registrants.
 
The lead dossier must be successfully submitted before the members can send their own dossiers to ECHA. Therefore, as a lead, prepare your registration dossier well before the deadline, so that your co-registrants have enough time to meet the deadline as well.
 
If you are a member registrant
 
Your registration dossier includes information specific to your company and your substance. This covers, for example, information about the identity of your substance (composition, analytical data), the identified uses that are relevant for your company, and the estimated volumes of manufacture or import.
 
If you choose not to participate in the joint submission for some information requirements, you need to include your own data for that requirement in your dossier, together with an appropriate justification on why you are opting out.
 

If you agree with all information submitted on your behalf by the lead registrant, you can also create your member registration dossier directly in REACH-IT. The dossier creation wizard in REACH-IT guides you through this process by showing you which data you need to provide.

Good to know
 
ECHA has developed supporting material and tools which are directly available in IUCLID to help you prepare your registration dossier:
 
  • The Validation Assistant will show if your registration dossier is complete, apart from information checked manually by the ECHA staff.
  • The Dossier Quality Assistant (included in the Validation Assistant) will help detect potential inconsistencies in your registration dossier. 
  • The Report generator will allow you to generate your chemical safety report (CSR).
  • The Dissemination preview will show which parts of your registration will be published by ECHA, based on the legal requirements and your requests to keep certain information confidential.