Prepare your registration as a IUCLID dossier

After the discussions and exchange of data within the SIEF, the lead registrant and each member should have all the relevant information available to create their registration dossiers. The registration dossier is created using the IUCLID software which is available for free on ECHA's website.

1. If you are a lead registrant

A lead IUCLID registration dossier includes the information that co-registrants must submit jointly, such as the classification and labelling of the substance and (robust) study summaries, if applicable. Within the lead registration dossier, you also submit your own registration information.

It is good practice for lead registrants to provide draft basic datasets in IUCLID for members.

As a lead registrant you are strongly advised to prepare your registration dossier well before the deadline, so that your co-registrants have enough time to meet the deadline as well.

2. If you are a member registrant

Your IUCLID dossier includes information specific to your company and your substance. This includes, for example, information about substance identity (composition, analytical data), your identified uses and your production volumes. Your IUCLID dossier does not need to include the information already provided by the lead registrant on your behalf.

Publishing information from dossiers and confidentiality claims

ECHA publishes certain information included in the registrations dossiers in the registered substances database on its website. In IUCLID you can flag certain data to be kept confidential and check what information will be made publicly available.

IUCLID plug-ins

ECHA has developed supporting IT tools to assist you in the process:

  • The Validation Assistant plug-in will show if your registration dossier is complete;
  • The Dossier Quality Assistant (included in the Validation Assistant plug-in) will help detect potential inconsistencies in your registration dossier;
  • The Fee calculation plug-in will display the expected registration fee and any fees related to confidentiality claims; and
  • The Dissemination plug-in will show which parts of the registration will be made publicly available on ECHA's website.

 

 

Upcoming

  • New version of Chesar, 21 June 2016

 

 

Practical examples & case studies