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Introduction

The IUCLID 5 project was initiated in 2003 when the European Commission decided to completely overhaul IUCLID 4 in order to propose a data submission tool that would support the European REACH Regulation as well as other Chemical Evaluation Programmes, such as the OECD HPVC Programme.

Data that can be stored and maintained with IUCLID 5 include information about:

The OECD and the European Commission have agreed on a standard XML format, called OECD Harmonised Templates (OHTs), in which most of the aforementioned data are stored for easy data exchange. IUCLID 5 was, in 2007, and is still today the first application that has fully implemented this international reporting standard.

Numerous parties are involved in the IUCLID Project that is managed in a joint effort by OECD and ECHA, helped in their tasks by OECD Member Countries, the Business and Industry Advisory Committee (BIAC) of OECD as well as by the entire IUCLID users community.

Overview

IUCLID (International Uniform ChemicaL Information Database) is a software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. It is a key software application essential for chemical industry to comply with the new legislation, which entered into force on 1 June 2007. The freely downloadable tool will assist chemical companies globally in fulfilling their obligation to submit data to the Agency under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation from 1 June 2008.

REACH starts a new era of how chemical industry and EU authorities co-operate in order to improve safety and control of production, import and use of chemicals in Europe. From 1 June 2008, chemical producers and importers will face the obligation to pre-register existing chemical substances in order to benefit from later registration and to register new chemical substances to the European Chemicals Agency (ECHA) in Helsinki. If a company fails to submit a REACH registration dossier on a substance within the relevant regulatory deadline this company cannot produce in or import this substance to the European market.

Without an appropriate IT tool, it would be extremely difficult for industry, especially for small and medium enterprises, to comply with the REACH data requirements. In order to structure these requirements, REACH requires a specific reporting format, namely the IUCLID 5 format. The European Commission has therefore since 2004 managed - as part of the REACH implementation strategy - the analysis, design and build of the IUCLID 5 software, which was contracted out.

Stakeholders - chemical industry, Member State Competent Authorities, OECD and NGOs - were closely involved in the development of IUCLID 5, which now allows entering, managing, storing and exchanging the REACH required data on intrinsic and hazard properties of chemical substances. It also facilitates the creation of dossiers to comply with REACH.

Although partially re-using concepts also seen in earlier IUCLID versions, IUCLID 5 is a complete new development, based on state-of-the art technology. However, stakeholders can easily migrate data from IUCLID 4 to IUCLID 5.

The IUCLID 5 software can now be obtained free of charge from the http://iuclid.eu server. The download of the IUCLID 5 installation kit is easy, and a professional service desk - also free of charge - will address stakeholder questions on the technical aspects of the IUCLID 5 application. While downloading the software, stakeholders will have to accept a License Agreement.

IUCLID 5 can be used for a large number of purposes. The data storage formats implemented have been developed in co-operation with the Organisation for Economic Co-operation and Development (OECD), and have been accepted by many national and international regulatory authorities. The use of IUCLID 5 for non-REACH jurisdictions is therefore explicitly endorsed. The fact that data in IUCLID 5 can be used for other purposes than REACH may offset some of the data collection costs.

The IUCLID 5 data model also features Biocides/Pesticides elements and data collected under REACH can thus be re-used once complemented with data on biocidal or pesticidal properties - for data reporting obligations under the EU biocidal products legislation. Similarly, data in IUCLID 5 can be used to prepare dossiers for the OECD High Production Volume (HPV) Chemicals Programme.

 

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