IUCLID

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.

CSR Plug-in

Avril 2009

Chemical Safety Report

Every registrant (manufacturer, importer or Only-representative) of a substance manufactured or imported in quantities exceeding 10 tons per year shall write a ChemicalSafety Report (CSR) including a Chemical Safety Assessment (CSA) and Exposure Scenarios if the substance is:

- meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC;

- or persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

According to REACH, an exposure scenario means:

"the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate"

IUCLID in brief

IUCLID 5 (International Uniform ChemicaL Information Database) élaboré conjointement avec l’OCDE, est l'outil exclusif permettant la collecte des données sur les produits chimiques, mais aussi la préparation des dossiers pour les substances soumises à évaluation.

C’est également l’outil utilisé par l’Agence européenne des produits chimiques et les ACs (Assessment of chemicals) pour la récupération des dossiers soumis et préparation des dossiers pour les substances soumises à évaluation et des dossiers Annexe XV.

Les exigences réglementaires liées à IUCLID 5