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- ECHA updates its key IT tools ahead of the 2013 deadline
- Stakeholders' Day focused on registration, evaluation and authorisation
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- "To achieve the common REACH goals, cooperation with EU Member States is crucial"
- To apply or not to apply - that is the question for business
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- Users help to test the new version of Chesar
- Guest column: Five year of REACH
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Article related to: REACH
ECHA updates its key IT tools ahead of the 2013 deadline
A new version of IUCLID 5 was released by the Agency on 5 June. IUCLID 5.4 introduces several changes on how to compile a dossier and submit certain data to ECHA. With this release and the subsequent upgrade of REACH-IT, certain information included in the Safety Data Sheet (SDS) will be made publicly available in the registered substances database on ECHA's website starting from autumn 2012.
IUCLID 5.4 includes new fields to report key information, currently in the Chemical Safety Report (CSR), in a more structured manner. In addition, it facilitates the publication of certain SDS information. IUCLID 5.4 was released before the upgraded REACH-IT to allow users to prepare for the transition from IUCLID 5.3 to IUCLID 5.4 and adapt their internal procedures. The upgrade of REACH-IT is foreseen for July.
CHEMICAL SAFETY INFORMATION REPORTED IN A MORE STRUCTURED AND TRANSPARENT MANNER
The information included in the CSR is an essential element for managing the conditions for the safe use of a substance. IUCLID 5.4 now includes 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. For example, it enables storing of the result of the PBT (Persistent, Bioaccumulative and Toxic chemicals) and vPvB (very Persistent and very Bioaccumulative) assessment performed under the REACH Regulation.
The standardisation of reporting the CSR information in IUCLID enables 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.
REACH-IT UPGRADED TO PROCESS DOSSIERS IN NEW IUCLID FORMAT
As a continuation of the IUCLID 5 update, ECHA plans to release a new version of REACH-IT in July 2012. The updated REACH-IT will accept only IUCLID 5.4 dossiers. This applies to all dossiers, initial or updated, submitted to ECHA via REACH-IT (registration dossiers, PPORDs, Inquiries, downstream user reports, substances in articles notifications, CLP notifications created in IUCLID etc.) or using one of the manual submission systems (e.g. application for authorisation, request for alternative chemical name under CLP Article 24, dossiers submitted by authorities). Before the upgrade of REACH-IT, ECHA will only accept IUCLID 5.3 dossiers.
SAFETY DATA SHEET INFORMATION TO BE PUBLISHED IN AUTUMN 2012
A few months after the release of the updated IT-tools, ECHA will start to publish online more information on chemical substances which is normally found in the Safety Data Sheet (SDS). The new information includes the identities of the registrant(s) of a registered substance, the registration number(s), an indication of whether a chemical safety assessment (CSA) was performed and the result(s) of the PBT (Persistent, Bioaccumulative and Toxic chemicals) and vPvB (very Persistent and very Bioaccumulative) assessment.
The SDS information will be disseminated from all registration dossiers regardless of whether the substance requires an SDS or not, unless the information is claimed confidential. If the substance does not require an SDS, ECHA will assume that the registrant volunteers to publish this information if it is not flagged as confidential.
The new dissemination policy affects all registrants.
Those registrants who have submitted their registrations prior to the update of REACH-IT are invited to review their dossiers and add any relevant confidentiality claims where and if needed. This needs to be done in the three months between the launch of the new REACH-IT and the new practice of publishing SDS information in November (resubmission window). The resubmission deadline is 31 October 2012.
OTHER SUPPORTING IT-TOOLS AND MANUALS
The manuals on how to create, check and submit IUCLID 5.4 dossiers using REACH IT (i.e. Data Submission Manuals and REACH-IT Industry User Manuals) will also be updated and published together with the new REACH-IT release. This includes as well the relevant manuals concerning the dissemination of information and confidentiality requests.
Similarly, ECHA has developed a series of IUCLID plug-ins to help registrants preparing their dossiers (i.e. technical completeness check, fee calculation, dissemination and CSR plug-ins). The plug-ins currently available for IUCLID 5.3 will be updated for IUCLID 5.4 and will also be made available at the same time as the release of the new version of REACH-IT.
A new version of ECHA's Chemical Safety Assessment and Reporting Tool, Chesar, will be released by the end of June 2012.
You can read more about the tool and the testing of the new release, Chesar 2.0, on page 20.
- Q&A on dissemination & confidentiality of Safety Data Sheet information, News alert 7 June 2012
- Questions and answers on dissemination and confidentiality claims of Safety Data Sheet information in IUCLID 5.4
- IUCLID 5.4 is now available, News alert 5 June 2012
- IUCLID website
- ECHA Helpdesk
Text by Vasileios Tsifoutis and Hanna-Kaisa Torkkeli
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)