IUCLID

IUCLID (International Uniform ChemicaL Information Database) is a software application that can be used by anyone (especially chemical industry companies and government authorities) to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances.

IUCLID is maintained under the responsibility of the Toxicology and Chemical Substances (TCS), commonly known as European Chemicals Bureau (ECB) within the Institute for Health and Consumer Protection (IHCP) of the Joint Research Centre (JRC) of the European Commission, and is distributed free of charge. Version 5 (IUCLID5) was made available on 13 June 2007.

IUCLID5 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.

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History

IUCLID 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).

Over the years, about 500 organisations worldwide (chemical industry companies, EU Member State Competent Authorities, OECD Secretariat, US EPA, Japan METI, third party service providers) have installed IUCLID4, and they will be able to migrate their data to the new IUCLID5 format.

IUCLID5

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 IUCLID4 and to create a new version, IUCLID5, which will be 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.

IUCLID5

Data Format and Exchange

Data that can be stored and maintained with IUCLID encompass information about:

• The party running IUCLID (production sites, contact persons etc.)
• The chemical substances managed by the company, namely their
  • composition,
  • 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 Harmonized 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 Harmonized 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 IUCLID5 uses

Anyone can use a local IUCLID5 installation to collect, store, maintain and exchange relevant data on chemical substances.

REACH

In the case of a chemical industry company affected by REACH, all relevant IUCLID data can be exported into a REACH dossier to be submitted to the European Chemicals Agency (ECHA).

Other IUCLID uses

In addition to dossier creation for REACH, IUCLID5 data can be (re-)used for a large number of other purposes, due to the compatibility of IUCLID5 data with the OECD Harmonized Templates. The European Commission IUCLID project team and international authorities are currently in deliberation in order to further promote acceptance of IUCLID5 data in non-REACH jurisdictions. Legislations and programmes under which IUCLID5 data are certainly be accepted are:

• OECD HPV Chemicals Programme
• US HPV Challenge Programme
• Japan HPV Challenge Programme(provided OECD guidance for SIDS dossiers is followed there).

The IUCLID5 data model also features Biocides/Pesticides elements. A dataset prepared for a substance under REACH can therefore be quickly complemented with data about possible biocidal or pesticidal properties and be re-used for data reporting obligations under the EU Biocides regulation

Availability

IUCLID5 is distributed free of charge to all interested parties since 13 June 2007 via the IUCLID Web Site.

Technology

IUCLID development and deployment

IUCLID5 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.

IUCLID5 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.

See also

• Institute for Health and Consumer Protection
• Joint Research Centre
• European Commission
• REACH
• OECD