Latest update for IUCLID 5.5 on 2 April 2013
REACH Article 111 ("Formats and software for submission of information to the Agency") states,
"The Agency shall specify formats and make them available free of charge [...] on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats [...] in their submissions to the Agency pursuant to this Regulation. [...] For the purposes of registration, the format of the technical dossier [...] shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation."
Please note that the IUCLID 5 application follows this format intrinsically and IUCLID 5 users need not worry about Article 111 compliance.
To enhance the understanding of the format we have divided up the XML schema definitions into three sections. The format is expressed in the general-purpose mark-up language XML, and XML Schema definition files for all IUCLID 5 root objects and for all IUCLID 5 data Endpoints can be downloaded in the below sections. This collection of XML Schemas is complemented by Schematron files for further validation.
Section 1: The root objects
The IUCLID 5 datasets or dossiers contain information on chemical substances in different ways. The data base contains information on:
- mixtures/preparations (especially relevant for the EU biocides legislation)
- categories (groupings of (structurally) related chemicals
- templates (place holders for information that can relate to substances, mixtures or categories)
For these so-called 'root objects' The structure is described in this section. In addition to the mentioned elements other root-elements are:
- legal entity
- legal entity site
- reference substance
|XML Schema definitions for the root objects in IUCLID.||Root_Objects_XSD_5.5.zip|
|Schematron definition of the validation rules for each root object.||Root_Objects_Schematron_5.5.zip|
Section 2: Endpoint Study Records
In IUCLID Substance datasets or Dossiers, the term Endpoint is used in the following meaning: An endpoint is an information requirement or data point with regard to the physico-chemical properties of the substance, environmental fate and behaviour, ecotoxicological information, toxicological information and specific information (e.g. residues in food and feedingstuffs) according to a given chemical regulatory programme. For instance:
- Standard information requirements set out in the EU REACH Annexes VI to XI
- Data requirements on active substances and biocidal products as laid down in the Biocidal Products Directive 98/8/EC and specified in the TNsG on Data Requirements
- SIDS elements specified in the OECD Manual for Investigation of HPV Chemicals
An Endpoint generally corresponds to an IUCLID 5 (sub)section in. Some IUCLID 5 subsections are used to cover several Endpoints or information requirements. For instance, section 7.6.1 Genetic toxicity: in vitro is for entering study summaries on different genotoxic Endpoints, namely, gene mutation studies in bacteria, gene mutation studies in mammalian cells, and cytogenicity studies. In these cases, an additional field is provided for indicating the exact Endpoint study type.
|XML Schema definitions for the endpoints in IUCLID.||Endpoints_XSD_5.5.zip|
|Schematron definition of the validation rules for the different Endpoints.||Endpoints_Schematron_5.5.zip|
IUCLID 5 is the first IT system to implement completely the so-called OECD Harmonised Templates in the Endpoint sections 4 to 10. In the context of the OECD project on Harmonised Templates for reporting summary information from testing results on chemical safety, 87 templates were developed and published in March 2006. These documents, together with supplements and amendments, are available from OECD's public web site.
Section 3: Endpoint summaries
In the IUCLID 5 Endpoint sections 4 to 10, Endpoint summary records can be
created and used to give an appraisal of all data compiled in a given
Hence, an Endpoint summary addresses, in a very condensed form, the most relevant and reliable data. The summary may be confined to the highlights of one key study, if only one is available, or give a justification as to why the results of a given study are considered as key data in case several studies are available.
|XML Schema definitions for the endpoint summaries in IUCLID.||Endpoint_Summaries_XSD_5.5.zip|
|Schematron definition of the validation rules for the different endpoint summaries.||Endpoint_Summaries_Schematron_5.5.zip|
Section 4: Archive
The format of previous versions of IUCLID 5 (IUCLID 5.0, 5.1.x, 5.2.x and 5.3.x) is available for download in the table hereafter:
|XML Schema definitions for the root objects in IUCLID.||IUCLID 5.0 and 5.1.x||IUCLID 5.2.x||IUCLID 5.3.x||IUCLID 5.4.x|
|Schematron definition of the validation rules for each root object.||IUCLID 5.0 and 5.1.x||IUCLID 5.2.x||IUCLID 5.3.x||IUCLID 5.4.x|
|XML Schema definitions for the endpoints in IUCLID.||IUCLID 5.0 and 5.1.x||IUCLID 5.2.x||IUCLID 5.3.x||IUCLID 5.4.x|
|Schematron definition of the validation rules for the different Endpoints.||IUCLID 5.0 and 5.1.x||IUCLID 5.2.x||IUCLID 5.3.x||IUCLID 5.4.x|
|XML Schema definitions for the endpoint summaries in IUCLID.||IUCLID 5.0 and 5.1.x||IUCLID 5.2.x||IUCLID 5.3.x||IUCLID 5.4.x|
|Schematron definition of the validation rules for the different endpoint summaries.||IUCLID 5.0 and 5.1.x||IUCLID 5.2.x||IUCLID 5.3.x||IUCLID 5.4.x|