ECHA to update REACH-IT and IUCLID 5

The European Chemicals Agency (ECHA) is set to release a new version of IUCLID 5 in late May 2012 and subsequently a new release of REACH-IT. Later this year, ECHA 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. 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 publishes a Question and Answer (Q&A) document to inform stakeholders in advance about the impact on the upcoming submissions of registration and other dossiers. 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 characterisation to be reported in a more structured, transparent and searchable manner. The standardisation of reporting the CSR information in IUCLID 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. IUCLID 5.4 will facilitate distinction between SDS information considered confidential business information and information considered public. This 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 (e.g. data migration, dossier submission and data dissemination) and dossier preparation. It allows users to familiarise themselves with the new and amended IUCLID 5 sections well before the release of the new version, and regulatory managers to keep up-to-date with the new requirements. Planning of the REACH-IT release and the IUCLID 5.4 dossier submission timeline is explained further in the Q&A document. ECHA will publish further detailed information regarding dissemination of the additional information contained in a registration dossier in the near future. Questions and answers on IUCLID 5.4 changes and impact on submission and dissemination of information are available at: IUCLID5.4 Q&A

The European Chemicals Agency, 11 April 2012 ; ;