The European Chemicals Agency (ECHA) says it is going to release a new version of IUCLID 5 (International Uniform Chemical Information Database; http://iuclid.eu) in late May 2012 and, subsequently, a new release of REACH-IT, the information technology infrastructure that underpins the REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation. Later this year, the agency will start publishing more information on chemical substances.
The new IUCLID 5.4 release will bring about changes mainly on how certain substance information included in the Chemical Safety Report (CSR) is reported. In addition, certain information included in the Safety Data Sheet (SDS) will be made publicly available. And, as a continuation of the IUCLID 5 update, a new version of REACH-IT will be released later in the summer. The new REACH-IT release will accept only IUCLID 5.4 dossiers. ECHA will publish a question-and-answer document to inform stakeholders in advance about the impact on the upcoming submission of registration and other dossiers.
ECHA says the information included in the CSR is an essential element to manage the conditions of a safe use of a substance. IUCLID 5.4 will include additional sections to allow the information on the conditions of manufacture/use, exposure assessment (including conditions of safe use) and risk characterization to be reported in a more structured, transparent and searchable manner. The standardization of reporting the CSR information in IUCID will enable the exchange and efficient processing of this information between companies either for preparing their registrations or for re-using part of it in their SDS. It will also enable authorities to process and evaluate this type of information more easily in their regulatory activities. The information, which is made publicly available from the SDS, includes the name of the registrant of a registered substance, the registration number and the outcome of the PBT (Persistent, Bioaccumulative and Toxic chemicals) assessment. IUCID 5.4 will facilitate distinction between SDS information considered confidential business information and information considered public. This distinction will enable automatic extraction, processing and publishing of selected (non-confidential) information on the ECHA website.
The aim of the Q&A document is to highlight the main effects on industry and Member State Competent Authorities both in terms of IUCLID 5 planning (for example, migration, dossier submission and data dissemination) and dossier preparation. It allows users to familiarize themselves with the new and amended IUCLID 5 sections before the release of the new version, and regulatory managers to keep up to date with the new requirements.