Prerequisite: IUCLID, Chesar, REACH-IT, what is it?
a. IUCLID
IUCLID (International Uniform Chemical Information Database) is a free software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. The data of the REACH registration are to be submitted to ECHA in the IUCLID format, which was defined at European level by the OECD.
b. Chesar
Chesar (Chemical Safety Assessment and Reporting tool) is a tool which helps compiling the Chemical Safety Report, which is mandatory for some registration dossier. It includes the EUSES (European Union System for the Evaluation of Substances) risk-assessment template.
c. REACH-IT
REACH-IT is the web platform on which companies can submit their REACH registration dossier, do their PPORD notification (Product and Process Oriented Research and Development), fulfill their requirements under CLP and REACH regulations, etc. REACH-IT is hosted on ECHA’s website, where all the documentation about REACH-IT can be found. Please note that creating a REACH-IT account is mandatory before any submission.
What are the main changes?
IUCLID format changes for the registration dossier
According to the REACH Regulation 1907/2006/EC, The registration dossier has to be submitted to the ECHA, using IUCLID format.
Until June 21 2016, the current version is IUCLID 5.6 (the exchanged files format is .i5z).
From June 21 2016, the version will be IUCLID 6.0. (the exchanged files format will be .i6z). The users can prepare for UCLID 6 from April 29 2016, because the ECHA will start delivering the verion 6.0. Until the final version is delivered, a beta-version can be installed and tested.
REACH-IT 2 upgrades to REACH-IT 3
Until June 21 2016, the current REACH IT version 2. Only the IUCLID submission in the *.i5z format can be send (IUCLID 5). From June 21 2016, the REACH-IT version in use will be REACH-IT 3. From this moment, only IUCLID submission in the *.i6z format can be send (IUCLID 6).
Interfaces evolution
Simpler and more intuitive, these new versions of the IT tools will particularly help small companies needing a REACH registration for 2018 — Keep in mind the deadline is May 31 2018.It will also offer more possibilities for the registrant to transparently document their dossier.
Completeness check (REACH-IT and IUCLID 6)
Completeness checks are adapted to the IUCLID 6 format. It will change the requirements for the REACH registration, e.g. for reproductive toxicity. Following the new REACH-IT platform, a manual verification will complete the automatic one, for the elements which can’t be automatically checked.
Facilitated data exchange (Chesar)
The new Chesar version will be available at the same time as IUCLID 6. It will be adapted to the new submission format, and facilitate data exchange between the two softwares. It will also support the assessment of complex cases, such as multi-constituents or UVCBs.
Avoid duplicate submission (REACH-IT)
The last version of REACH-IT will strengthen ECHA’s capability to ensure that no dossier can be submitted separately if a REACH registration for the same substance already exists. For instance, a new automatic system will be introduced to ensure there won’t be any duplicate joint submission for the same substance and registration type.
Plus, substance identity profiles will be created to describe the scope of the joint registration. They will be required for lead registrants.
IUCLID 6 will be mandatory
Once the new REACH-IT platform starts working, only the files created with IUCLID 6 will be accepted. Until this moment, the companies will continue using IUCLID 5, although they should start preparing to switch to IUCLID 6.
Strengthened user support
User support will be gradually integrated to the ECHA platform. It will progressively be available in 23 EU languages for REACH-IT.
User manuals for IUCLID will be simplified and available on ECHA’s website in 23 EU languages. IUCLID plug-ins, such as the Validation Assistant, will be updated to enable the dossier’s verification before submitting them to the ECHA.
Trainings on the tools will be organized in the coming months. These include webinars offering practical advice on the transition from IUCLID 5 to IUCLID 6 and on the use of Chesar.
