IUCLID Reports

Hazard Assessment Reports

Chemical Safety Report (CSR REACH) (RTF/PDF/XML) preview download

The chemical safety report documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios. It also forms a basis for other REACH processes including substance evaluation, authorisation and restriction.

Substance of Very High Concern (SVHC REACH Annex XV) Report (RTF/PDF) preview download

The substance of very high concern report provides the possibility for Member States or the European Chemicals Agency to generate an SVHC report from IUCLID to attach to their IUCLID dossier submitted under Annex XV. The format of the report is in accordance with the format as provided on ECHA’s website.

List reports (All regulations)

List of Study Summaries  (CSV) preview download

This report can be used by any IUCLID user wishing to generate a preview of the study information contained in their dataset or dossier. The report has various uses, such as supporting Article 10(a) of REACH, in which a registrant is required to have legitimate access to the full study they use or refer to, in their registration dossier as well as supporting cost sharing in registration consortia and to exchange study information between registrants.

List of Confidentiality Claim (RTF/PDF/CSV) download(CSV) download(RTF/PDF)

This report lists all confidentiality claims and helps any IUCLID user to quickly get an overview of all confidentiality claims in a Substance or a Mixture (including the Mixture’s components).

List of Literature References (RTF/PDF/CSV) download(CSV) download(RTF/PDF)

This report can be used by any IUCLID user wishing to get an overview of all Literature References in their Substance or Mixture (including the Mixture’s components). An important use for this report is for 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 re-use the report 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.

List of Attachments  (RTF/PDF/CSV) download(CSV) download(RTF/PDF)

This report can be used by any IUCLID user wishing to get an overview of all Attachments in their Substance or Mixture (including the Mixture’s components). For example, during the evaluation and assessment of dossiers submitted under the Biocidal Products Regulation, registrants attach supporting information (in standalone documents) to individual IUCLID endpoints. To support this work, the report produces a table of all attachments inside the main Mixture/Product dataset or dossier, including all Substance and Mixture/Product components which are included in the composition of the main Mixture/Product.

List of Inbound References (RTF/PDF/CSV) download(CSV) download(RTF/PDF)

This report lists all inbound references, and helps any IUCLID user to quickly get an overview of all inbound references in a Substance or a Mixture (including the Mixture’s components).

List of Annotations  (RTF/PDF/CSV) download(CSV) download(RTF/PDF)

This report can be used by any IUCLID user wishing to get an overview of all Annotations in their Substance or Mixture (including the Mixture’s components). For example, under the Biocidal Products Regulation evaluation and assessment process, MSCAs often create IUCLID annotations on top of specific endpoints inside dossiers. These annotations are shared internally amongst the MSCAs. This report supports this process by listing the annotations which are found in a Mixture/Product dataset or dossier, and the endpoints they are attached to.

GHS Classification and Labelling report (CSV) preview download

This report provides information on the GHS (Classification and Labelling) information from a Substance or a Mixture (including the Mixture’s components). For example, under REACH Article 29(2)(b), one purpose of the Substance Information Exchange Forum (SIEF) is to agree on classification and labelling inside the joint submission. This report contains the classification and labelling information a lead registrant sends to the members of a joint submission in order to receive comments and approval on the classification and labelling.

List of use information (REACH) (CSV) download

Managing the use of a chemical is complex and is often done by particular IT systems, such as SAP. This report outputs a CSV (comma separated file) of use information from IUCLID, which can then be injected into an external system to help align the use information contained in IUCLID and other systems.

Note that this report has not been maintained in the latest IUCLID format and would need to be updated manually to be compatible.

CLP Report (Classification, Labelling and Packaging regulation)

PCN dossier viewer (CLP Annex VIII) (HTML) download

Based on Article 45 and Annex VIII to the CLP Regulation, companies placing hazardous mixtures on the market have an obligation to provide information on these mixtures to appointed bodies. As part of this obligation, there is a PCN dossier viewer [HTML] which summarises that information (including Group submission information). The reports are in-built inside IUCLID and can be launched from the web interface. The PDF report displays the information in one single file; the HTML report organises the information in tabs, making the navigation more user friendly. Both reports are printable.

SCIP reports (Waste Framework Directive (WFD))

SCIP Notification Preview report (PDF) download

Based on Article 9(1)(i) of the Waste Framework Directive (WFD), any supplier of an article containing a substance of very high concern (SVHC) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit information on that article to ECHA .The SCIP Notification preview report summarises that information.

SCIP Notification Preview without sensitive information (PDF) download

Based on Article 9(1)(i) of the Waste Framework Directive (WFD), any supplier of an article containing a substance of very high concern (SVHC) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit information on that article to ECHA . ECHA will publish the information, as received, on its website. In order to ensure the protection of confidential business information, ECHA will not make publicly available the required mandatory data that would allow the establishment of links between actors in the same supply chain. The SCIP Notification preview report without sensitive information, summarises the information reported in IUCLID for the specific article without including the information defined in SCIP as sensitive information to ensure the protection of confidential business information. This report will support companies to review what is the information that will be potentially disseminated in the SCIP database. The report can also be used to share information between companies. More detail information about Dissemination and confidentiality available at the document “Dissemination and confidentiality in the SCIP Database".

BPR Reports (Biocidal Products regulation)

Summary of Product Characteristics Reports (BPR Article 22(2))(RTF/PDF) download Single Product download Product Family

A Summary of Product Characteristics (SPC) is mandatory for all companies wishing to apply for product authorisations in the EU. To support companies in preparing their applications for the authorisation of their biocidal products, either on a national or European level, a Single Product report and a Product Family report are now available to:

  • Support a review of the Product by a Competent Authority
  • The Publication of the SPC by the European Commission
  • Support industry so that they can generate a translated version of the SPC from IUCLID without having to send XML files for translation (as was previously the case)

Confidentiality Report (BPR Article 66) (RTF/PDF/CSV)

ECHA and the MSCA’s work together to evaluate the confidentiality claims made on biocidal products and active substances as part of their work for the Biocidal Product Regulation. The report supports ECHA and MSCAs during the evaluation of these confidentiality claims by listing only the relevant confidentiality claims which are to be assessed. The completed assessment is sent to ECHA via the R4BP messaging system https://idp-authority.echa.europa.eu/idp/

EFSA Reports (Plant Protection Product regulation)

Reports relating to the EU Plant Protection Products regulation are maintained by EFSA in Zenodo, see the list below:

A presentation on the report generator for pesticides dossiers can be found here.