Dossiers IUCLID Regulatory requirements

Regulatory requirements

A tool for chemical information management


Enterprises which manufacture or import more than one tonne of a chemical substance per year will be reqired to register it in a central database administered by the new EU Chemicals Agency. The Agency will provide IT tools and guidance and Member States will offer helpdesk assistance to the impacted companies. The new Regulation aims to improve the protection of human health and the environment while maintaining competitiveness, and enhancing the innovative capability of the EU chemicals industry.

IUCLID 5 has been developed by the European Commission along with OECD (Organisation for Economic Cooperation and Development) and is available since the 12th of June 2007. It allows to enter, manage, store and exchange information on intrinsic and hazard properties of chemical substances and enables you to store chemicals information, prepare and submit dossiers to the Agency.

IUCLID 5 implements the Harmonised Templates developed by OECD. This means that IUCLID 5 is compatible with chemical legislation and programme requirements in different part of the world, among them REACH, the EU Biocides Directive and the OECD High Production Volume (HPV) Programme.

Data stored in IUCLID can be easily reused for any of these purposes and to support other requirements.

 

How companies can use IUCLID 5

Companies impacted by REACH can therefore use IUCLID 5 to create, manage, store, view and export data on chemical substances to fulfill their REACH legislation requirements. The software can be downloaded and used free of charge.

 

How the Agency and Member States authorities can use IUCLID 5

For the purposes of REACH, the Agency and Member States authorities can use IUCLID 5 to view dossiers submitted by industry. Therefore, they will be able to:

  • browse through registrations received
  • evaluate the risk of chemical substances
  • require additional information on chemical substances

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