IUCLID

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IUCLID (

REACH, the most important European Union legal document covering the production and use of chemical substances. The software is maintained by the European Chemicals Agency, ECHA.[1]
The latest version, version 6, was made available on 29 April 2016.

History

IUCLID versions 1 to 4

1993: First version of IUCLID for the European Existing Substances Regulation 793/93/EEC.[2]

1999: IUCLID becomes the recommended tool for the OECD HPV Programme.[3]

2000: IUCLID is the software prescribed in the EU Biocides legislation to notify existing active substances (Art. 4 of Commission Regulation (EC) No 1896/2000[4]).

IUCLID 4 was used worldwide by about 500 organizations. These included chemical industry companies,

EU Member State Competent Authorities, the OECD Secretariat, the US EPA, the Japan METI
, and third party service providers.

IUCLID 5

In 2003, when it became clear that the REACH proposal would be adopted by the

REACH
. Migration of data in the IUCLID 4 format was supported by IUCLID 5.1. IUCLID 5.1 became available on 13 June 2007.

IUCLID is also mentioned in article 111 of the REACH[5] of the REACH legislation as the format to be used for data collection and submission dossier preparation.

The following IUCLID 5 major versions have been released:

  • IUCLID 5.0: 12 June 2007
  • IUCLID 5.1: 16 January 2009
  • IUCLID 5.2: 15 February 2010
  • IUCLID 5.3: 24 February 2011
  • IUCLID 5.4: 5 June 2012
  • IUCLID 5.5: 2 April 2013
  • IUCLID 5.6: 16 April 2014

IUCLID 5

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

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. IUCLID 5 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.

IUCLID5 can be used to enter robust study summaries summarising toxicologically-relevant endpoints. A Klimisch score is assigned within robust study summary as one field.

Possible IUCLID 5 uses

Anyone can use a local IUCLID 5 installation to collect, store, maintain and exchange relevant data on chemical substances.

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 Harmonized Templates. The

REACH
jurisdictions. Legislations and programmes under which IUCLID 5 data are certainly accepted are:

The IUCLID 5 data model also features

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.

The data are available and can be searched through the OECD eChemPortal.

Technology

IUCLID development and deployment

IUCLID 5 is a

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%
    Database Management System (DBMS)
    ,
  • or a commercial system environment, using the
    Database Management System (DBMS)
    .

.i5z files

IUCLID 5 exports and imports files in the I5Z format. Files may be swapped between different IUCLID 5 installations and dossiers may be uploaded to

Zip file
compression.

IUCLID 5 system requirements

IUCLID can be deployed on any current PC. For optimal performance,

RAM
should not be less than 1 GB.

IUCLID 6

IUCLID 6 was made available on 24 June 2015 as a beta version so that large companies and other organisations could begin preparing their IT systems for the full release of IUCLID 6 in 2016. However, individual users and SMEs could also download the beta version to get a preview, and to become familiar with the user-interface.

The first official version of IUCLID 6 was published on 29 April 2016.[6]

See also

References

  1. ^ "IUCLID 5". Retrieved 2009-02-22.
  2. ^ Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances
  3. ^ OECD HPV Programme
  4. ^ Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products
  5. ^ Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
  6. ^ "IUCLID news - IUCLID". iuclid6.echa.europa.eu. Retrieved 2018-04-11.

External links

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