Development and Maintenance
IUCLID 5 is maintained under the responsibility of the European Chemicals Agency (ECHA) and is distributed free of charge.
The current version is IUCLID 5, which was developed during the period 2005-2007 and made public in June 2007. IUCLID 5 is the key tool for chemical industry to fulfil data submission obligations under REACH, a European Union law covering the production and use of chemical substances.
Information on the development and maintenance of IUCLID 5 can be found on this page:
- IUCLID 5.6
- IUCLID 6
- Background information on previous IUCLID versions
- Data format and exchange
- Possible IUCLID 5 uses
- IUCLID 5 technology
IUCLID 5.6.0 features new content and fixes. The main purpose for this release is to update the Classification and Labelling section according to the fourth revision of the GHS (incorporated in the fourth update of the CLP Regulation).
Among the improvements included in this version, there is also the possibility to transfer annotations made on one dossier to another dossier.
Files generated with IUCLID 5.6.0 remain compatible with IUCLID 5.5 (and IUCLID 5.4 for REACH data) except when new classification elements introduced in the 4th version of the GHS are used. More details on the changes included in this release and about the compatibility between IUCLID 5.6 and previous IUCLID 5 versions can be found in the presentation 'What is new in IUCLID 5.6?'.
The development of version 6 of IUCLID is performed in several steps.
- Architecture study and prototyping - end of 2012
- IUCLID core development (this includes all IUCLID documents and main IUCLID functions) - 2013
- IUCLID configuration (development of regulation-specific documents, dossier creation and implementation of IUCLID add-ons) - 2014
- IUCLID format update (update of the IUCLID format according to the most recent OECD Harmonised Templates) - 2015
In terms of release, a beta version will be made available in May 2015 and the official IUCLID 6 version will be published by Summer 2016. To learn more about IUCLID 6 beta version please see the below webinar.
01/04/2015: material from the 13 March webinar on IUCLID 6 distributed version
Webinar 'IUCLID 6 distribution version webinar', held on 13 March 2015
Presentations used during the webinar
Questions and Answers from the webinar
The first version of IUCLID 5 was published in 2007. Since then new challenges have arisen such as:
- the use of the application by companies and regulatory agencies on large collection of dossiers for evaluation purposes,
- the integration of the application with other information systems to allow a more efficient use of scientific data,
- the definition of a new security model and remote access,
- the improvement of the user experience for simple processes and also the support of new chemical legislations.
In addition to these new needs identified, the IT components on which IUCLID relies have evolved and new ones have been introduced on the market that could better support the functional requirements of IUCLID.
IUCLID 6 project
The IUCLID 6 project was initiated at the end of 2012. It started with a pre-analysis study aiming at identifying the new architecture for the IUCLID application and prioritising new user requirements.
The pre-study concluded on a set of technologies to be used with IUCLID 6.
The architecture of IUCLID will be reviewed to better manage information on large scale systems while, at the same time, simplifying the installation process on workstations.
In order to support all user requirements in the scope of IUCLID 6, a technical solution has been proposed which includes the transition from PostgreSQL to JavaDB for the database type, while Oracle database will continue to be supported. For the application server, a transition from Tomcat to Glassfish has been chosen. The software needed to use IUCLID 6 should be transparent for the user of the workstation version, as the aim is to simplify the installation on small scale systems. However, the changes in terms of software requirements will necessitate preparatory work for the users of the distributed version as IT departments of organisations using the server version of IUCLID will require the skill and expertise relevant to the new technology used.
Main functional requirements
IUCLID 6 should allow the implementation of a number of improvements that were requested for IUCLID 5 but could not be implemented in order, for example:
- to make possible the centralisation of all IUCLID instances that were created for security reasons,
- to enable a more flexible exchange of documents between registrants with the coverage, inter alia, of classification & labelling and use information,
- to provide a better integration with other IT systems,
- to customise the user interface for specific groups of users.
IUCLID 6 survey (18 March - 5 April 2013)
The purpose of the IUCLID 6 survey is to inform all IUCLID users about the plans for the future of their database and collect feedback on the choices made at an early stage of the project in order to verify to which extent they can be validated to continue with the next phases of the IUCLID 6 development.
With the IUCLID 6 survey, the IUCLID team aims at:
- communicating future changes for the IUCLID application,
- informing all IUCLID users of the status of the IUCLID 6 project,
- collecting information from users to validate the decisions taken for IUCLID 6,
- collecting information on which companies or organisations are interested in developing and integrating other applications with IUCLID,
- collecting names of potential IUCLID 6 testers.
The outcome of the survey is available in a report: IUCLID 6 survey results.
Background information on previous IUCLID versions[top]
Versions 1 to 4
- 1993: First version of IUCLID for the European Existing Substances Regulation (793/93/EEC)
- 1999: IUCLID becomes the recommended tool for the OECD HPV Programme.
- 2000: IUCLID is the software prescribed in the EU Biocides legislation to notify existing active substances (Art. 4 of 1896/2000/EC)
- IUCLID 4 is currently installed in about 500 organisations worldwide (chemical industry companies, EU Member State Competent Authorities, OECD Secretariat, US-EPA, Japan METI, third party service providers).
In 2003, when it became clear that the REACH proposal would be adopted sooner or later by the European Union, the European Commission decided to completely overhaul IUCLID 4 and to create a new version, IUCLID5, which is used by chemical industry companies affected by REACH to fulfil their data submission obligations.
IUCLID is also mentioned in article 111 of the REACH legislation as the tool to be used for data collection and submission dossier preparation
IUCLID 5.3 and maintenance releases[top]
The latest major service release of IUCLID (version 5.3) was published on the IUCLID website in February 2011. A first maintenance release (IUCLID 5.3.1) was then released in August 2011 that includes fixes and new improvements.
The IUCLID team is now preparing IUCLID 5.3.2, to be made available to the users by the end of 2011 that will contain the following items:
- A new administrative tool to display announcements within the IUCLID User Interface in order, for example, to inform users of a IUCLID distributed version of a forthcoming maintenance downtime.
- The enhancement of the password management to include:
- password recovery system
- minimum password length
- maximum failed login attempts
- password expiration
- user account expiration
- The following fixes:
- Back-up functionality: fix for the password export problem
- Dossier Comparison: fix for the comparison of Section 1.1
- Fix for the dossier fields disappearing momentarily from the User Interface
IUCLID 5.4 was released in June 2012. As with previous major service releases, a migration step is involved to upgrade from the previous IUCLID main release, but backward compatibility is as always ensured, meaning that all IUCLID documents created with previous versions of IUCLID 5 are still compatible with the latest version.
Amongst all changes introduced in IUCLID 5.4, the main ones are listed hereafter:
- PBT (Persistent, Bioaccumulative and Toxic chemicals) assessment: IUCLID will be adapted in order to be able to store the outcome of the PBT assessment performed under the REACH Regulation. The template will contain:
- the PBT / vPvB status of the substance assessed
- the likely routes of exposure
- the outcome of the assessment for each criterion (Persistence, Bioaccumulation, Toxicity)
- Modification of IUCLID section 3: IUCLID enables the reporting of information related to substance properties with a high degree of detail on the identity of chemical substances (section 1), their classification (section 2), physico-chemical properties (section 4), fate properties (section 5), eco-toxicological properties (section 6) and toxicological properties (section 7). Compared to that, very little information on condition of manufacture, conditions of use and on the related exposure (section 3) can be reported in a structured form. The objective of the proposed modifications is to increase the possibility to document information on manufacture and use of a substance and the related exposure and risk assessments in a structured and harmonised way. For example, the following information will be able to be reported in a new section of IUCLID: conditions of use, exposure estimates for humans and the environment, methods and tools used for the assessment. At the same time, slight modifications will be made to other parts of section 3.
- Endpoint summaries of IUCLID section 7 (toxicological information) will be enhanced in order to report more information on the hazard assessment (e.g. selection of the key study, assessment factors).
- Software requirements: as part of the IUCLID 5.4 development, it has been proposed to reduce the diversity of the softwares supported by IUCLID in order to optimise the IUCLID project and Helpdesk resources. WebLogic will not be supported as an application server anymore and only Tomcat will then be supported. This decision is based on the information collected during the survey performed early 2011, revealing that only five percent of the distributed version users relied on WebLogic. If this change would have important consequences for your IUCLID installations, please contact the ECHA Helpdesk.
- Group of IUCLID documents: currently all substances/dossiers are displayed in a list (limited to 2,000 entries). This is not very convenient for the users, as it does not allow handling documents for example per substance, client or project. In IUCLID 5.4, substances and dossiers will be 'categorised' via a new folder tree structure. Users will then be able to create folders (and subfolders) and feed them with substances (using for example 'drag & drop' or 'send to' options).
- Storage of attachments in the database: IUCLID 5 currently stores attachments in a referenced way that can result in the replication of the same information in the database. When, for example, two dossiers are created based on a substance dataset containing attachment A, this attachment is stored three times in the database. IUCLID 5.4 will improve the handling of attachments stored, by only saving one copy of the same file, thereby reducing the size of the database.
- Bulk user creation and update: IUCLID will allow the Administrator to manage the IUCLID users using an Excel template, enabling bulk creation / update / deletion of user accounts.
The analysis and design and development work of IUCLID 5.5 followed closely the end of the similar phases of IUCLID 5.4. IUCLID 5.5 has been published in April 2013. After this release, two maintenance releases should be able to be published until the end of 2013 containing bug fixes and functionality improvements.
Important information for the use of IUCLID under the European REACH Regulation: taking into consideration that this new release of IUCLID would be made available less than one year before the important deadline under the REACH Regulation in 2013, it is proposed to apply a new development procedure that would guarantee the full compatibility of the REACH information stored in IUCLID between IUCLID 5.5 and 5.4 versions. This is illustrated in the following picture.
Data Format and Exchange[top]
Data that can be stored and maintained with IUCLID 5 encompass information about:
- The party running IUCLID 5 (production sites, contact persons, etc.)
- The chemical substances managed by the company, namely their:
- Reference information like CAS number and other identifiers
- Classification and labelling
- Physical/chemical properties
- Toxicological properties
- Eco-toxicological properties
OECD and the European Commission have agreed on a standard XML format (OECD Harmonised Templates) in which these data are stored for easy data sharing. IUCLID5 will be the first application fully implementing this international reporting standard, which has been accepted by many national and international regulatory authorities.
Numerous parties were involved in the creation and the review of the OECD Harmonised Templates, among them the Business and Industry Advisory Committee (BIAC) to the OECD, the European Chemical Industry Council (Cefic) and other bodies and authorities.
Possible IUCLID 5 uses[top]
Anyone can use a local IUCLID 5 installation to collect, store, maintain and exchange relevant data on chemical substances.
In the case of a chemical industry company affected by REACH, all relevant IUCLID 5 data can be exported into a REACH dossier to be submitted to the European CHemicals Agency (ECHA).
Other IUCLID 5 uses
In addition to dossier creation for REACH, IUCLID 5 data can be (re-)used for a large number of other purposes, due to the compatibility of IUCLID 5 data with the OECD Harmonised Templates. The European Commission IUCLID 5 project team and international authorities are currently in deliberation in order to further promote acceptance of IUCLID 5 data in non-REACH jurisdictions. Other legislations and programs under which IUCLID 5 data are accepted include:
- OECD HPV Chemicals Program
- US HPV Challenge Program
- Japan HPV Challenge Program (provided OECD guidance for SIDS dossiers is followed there)
IUCLID 5 Development and Deployment
IUCLID 5 is a Java based application, using the Hibernate framework for persistence. It features a Java Swing graphical user interface (GUI) and can be deployed on both single workstation and distributed environments
IUCLID 5 offers the possibility to be deployed in:
- either a 100% open source system environment, using Tomcat as web container and PostgreSQL as Database Management System (DBMS)
- or a commercial system environment, using the Web Logic server from BEA Systems as application server and/or Oracle as Database Management System (DBMS)
IUCLID System Requirements
IUCLID can be deployed on any current PC. For optimal performance, RAM should not be less than 1 GB
Further Developments on IUCLID 5
Migration Tool 5.1.2
The IUCLID 5 Migration Tool plugin, which converts datasets created with IUCLID 4 into the IUCLID 5 format (i5z file format), was updated on 17.12.2007 and made available for download. The IUCLID 5 download package contains from that date the latest version of the migration tool as well. The core application did not change.
XML Schema for Pre-registration
The Pre-registration XML format format was published on 08.02.2008. This specific format is necessary in order to facilitate and validate the submission of the pre-registration data for REACH.
This plugin adds the functionality of creating single and bulk pre-registration XML files in a format that can be submitted to the European Chemicals Agency (ECHA).