As pointed out in chapter B.1 Background and history of IUCLID, IUCLID 5 was primarily developed in order to meet the REACH requirements with regard to the management of data requirements. It enables industry and evaluators to maintain data on substances and prepare the required dossiers. Thus, it is the key tool for the Manufacturers and Importers registering substances and for the ECHA and Member State Competent Authorities for evaluating the data submitted by industry.
According to Article 10 of REACH a technical dossier and, depending on the tonnage band, a chemical safety report (CSR) has to be submitted by industry to the ECHA. The technical dossier is to be created based on IUCLID, which provides sections to cover company and substance identity, information on manufacture and uses, guidance on safe use, classification and labelling, exposure information (if applicable), and all standard information requirements set out in the REACH Annexes VI to XI. A guide to what IUCLID sections cover which data requirements of REACH is provided in chapter F.1 of this manual. The CSR is created and edited outside IUCLID. However, IUCLID section 13 Assessment Reports provides the possibility to attach the CSR document(s), thus enabling the registrant (also referred to as submitter under other jurisdictions) to deliver one single package to the ECHA. For the preparation of the CSR it is also possible to use or transfer information from the endpoint summaries of the technical dossier, which are aimed at giving an appraisal of all data compiled in a given Endpoint section and specifying the most critical results and conclusions.
The preparation of the registration dossier involves a step-wise approach from data collection via manual completion of the IUCLID sections or electronic exchange with other IUCLID applications, data review and commenting up to the selection of relevant data to be submitted in the registration dossier. To accomplish these steps, IUCLID is structured in following layers, as further described in chapter B.5 Structure of IUCLID 5:
Raw data layer: for entering and storing data
XML layer: for exchanging data
Annotation layer: for commenting on data (either internally by the registrant or by the ECHA and Competent Authorities)
Dossier layer: for creating and managing write-protected snapshots of selected raw data
Crucial features of IUCLID are the management of company information and substance identity. A Substance dataset is assigned to a Legal entity, which includes the company information. A substance is assigned to a Reference substance, which indicates the identity of the substance for which the registration is made. Both elements are managed centrally in IUCLID.
For the creation of a registration dossier the appropriate dossier template can be selected tailored to the respective REACH requirements. However, this step is flexible enough to allow also inclusion of data that are available to the registrant though not required.