Cross regulatory

Report Template Output(s) Preview Report description
Literature References report for substance and mixture/product datasets and dossiers  RTF

Industry registrants applying for a new product authorisation under the BPR regulation are required to attach a Product Authorisation Report (PAR) to their submission. This report allows registrants to extract all their literature references from a Mixture/Product dataset or dossier, and re-use these as part of their PAR as well as to quality check the study information they have included in the Mixture/Product dataset. MSCAs also use the report to check if all studies that should be included, are included in the registrant’s dossier. Note: the report can also be generated from a Substance dataset or dossier if needed.

Literature References report for substance and mixture/product datasets and dossiers

This report has been expanded to cover additional study information from human health and environmental endpoints. If you wish to see what additional study information is included in the report, see this matrix.

CSV

Under Article 10(a) of REACH, a registrant is required to have legitimate access to the full study they use or refer to, in their registration dossier. To support this process, the ‘Study report’ provides a table of all Literature references contained within a dataset or dossier, and provides additional study information on top of this, such as the Test Material Information and the Adequacy of the Study. The report has been specifically used to support cost sharing in registration consortia and to exchange study information between registrants. Note: the report can also be generated from a Mixture/Product.

Attachments report for substances and mixture/product datasets and dossiers CSV

The report extracts all inline attachments which have been attached inside a substance or a mixture/product dataset or dossier. When extracting from a mixture/product, the attachments in components of the main entity will also be extracted (up to five levels deep).

This current report does not extract attachments from the metadata of a IUCLID Document (the attachments appended generically onto a IUCLID Document). Only the inline attachments made on IUCLID's structured fields will be extracted, such as the 'Attached documents' in the Literature reference.