El expediente de registro

The registrant of a substance needs to compile all the required information in a registration dossier, which consists of two main components:

  • A technical dossier, always required for all substances subject to the registration obligations
  • A chemical safety report, required if the registrant manufactures or imports a substance in quantities of ten tonnes or more per year.

The registration dossier has to be prepared using the IUCLID 5 software application. IUCLID 5 implements the Harmonised Templates developed by the OECD and it is compatible with other chemical legislations around the world.

Once the dossier has been created with IUCLID 5, it has to be submitted to ECHA through REACH-IT.

Technical dossier

Manufacturers and importers have to collect all existing available information on the intrinsic properties of a substance as well as on its manufacture, uses and exposure.

The technical dossier contains information about:

  • The identity of the substance
  • Information on the manufacture and use of the substance
  • The classification and labelling of the substance
  • Guidance on its safe use
  • (Robust) study summaries of the information on the intrinsic properties
  • Proposals for further testing, if relevant
  • For substances registered in quantities between one and ten tonnes, the technical dossier also contains exposure related information for the substance (main use categories, type of uses, significant routes of exposure)

Chemical safety report

This chemical safety report contains a detailed summary of information on the environmental and human health hazard properties of the substance, together with an assessment of exposure and risk where such an assessment is required.

Chesar is a tool developed by ECHA to help registrants perform the chemical safety assessment and generate the chemical safety report.

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