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Editor-in-chief:
Johanna Salomaa-Valkamo
Johanna Salomaa-Valkamo
Editor:
Päivi Jokiniemi
New generation of IT tools - what changes?
ECHA will launch revamped IT tools this spring. The applications will be much more intuitive and easier to use. What are the new features of the tools?
IUCLID 6
Installing IUCLID 6 on a desktop computer will be much easier as no additional software is required. Help on different functionalities, such as dossier creation, will be available in your own language.
OECD harmonised templates
The updates to the harmonised templates (OHT) will help you to report your information in a clear and consistent way, improving the quality of your registration dossier.
Better structured information also makes evaluating, publishing and searching for data more effective.
The updated OHTs include:
- Revised templates for hazard information. The Administrative data section will be enhanced with a clearer field organisation and standard phrases to justify reliability scores for studies and data-waiving cases. The test material used in the studies can be defined in a separate object, which can be linked in the Materials and methods section of all study records where the same material was used.
- New templates on use and exposure information of the substance. You can report each use as a separate record which includes both the use description and the information related to the exposure assessment.
- Extension of the use description allows you to provide additional information on the type and conditions of use, making more transparent for the authorities and the public how the risks are controlled.
- Dedicated fields to report information on the intermediate status (chemical reaction, reaction products) and the application of strictly controlled conditions of the substance are also available.
Substance identity profile
If you are a lead registrant, IUCLID 6 will allow you to include information on the substance identity profile (SIP). The SIP describes the collectively agreed scope of the joint submission by defining the compositions and forms of the substance that are covered by the jointly submitted data, i.e. the hazard information and classification.
SIP compositions included in the IUCLID 6 lead dossier will be visible on the REACH-IT joint submission page to all members of the joint submission, so they can make sure that their substance is covered. It will also help connect potential registrants with the appropriate joint registration during the inquiry process.
Revised completeness check
The completeness check that ECHA performs on each incoming registration will be revised. It will be adapted to the new IUCLID formats and changed information requirements: for example, the extended one-generation reproductive toxicity study (EOGRTS) is now the standard information requirement for reproductive toxicity under REACH.
As before, the IUCLID Validation Assistant will be updated so that you can check your dossiers before submitting them to ECHA. The completeness check will be complemented by a manual verification of those elements that cannot be checked automatically.
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A new test version of IUCLID 6 has been released on the IUCLID 6 website. Try it and familiarise yourself with some of the new features. Keep in mind, however, that test versions do not contain all the features of the official release.
IUCLID 6 will be launched before the release of REACH-IT to allow you to install it and migrate your IUCLID 5 database. Once the new REACH-IT is published, you will only be able to submit IUCLID 6 dossiers. Information related to IUCLID 6 can be found on the IUCLID 6 website.
REACH-IT
User interface
Improved and simplified workflows will ease the submission of your dossier. You will also be able to see the upcoming deadlines and actions (e.g. submission of a requested update) at a glance. The contact management and the search function will be optimised and accessing already submitted information will be easier.
Online registrations
If you are a member of a joint submission, you will be able to build and submit your IUCLID 6 member dossier online in REACH-IT, through a simplified interface. However, you can only create your dossier online if you report standard information requirements, have only one composition and you fully rely on the hazard information provided by the lead.
If these conditions do not apply, you need to use the standard IUCLID application to build your dossier.
One substance, one registration
There has always been a requirement in REACH for ‘one substance, one registration'. However, following the Implementing Regulation on joint submission of data and data sharing, REACH-IT has been updated to make sure that dossiers for the same substance cannot be submitted outside of a joint registration. Individual registrations already in REACH-IT can only be updated under specific conditions.
If you need to submit an initial dossier or an update (e.g. requested update related to compliance check) after the release of the new REACH-IT, you need to make sure that you are using IUCLID 6.
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For IUCLID and REACH-IT, the user support will be integrated into the tools. For REACH-IT, it will be translated into 22 EU languages. ECHA will also simplify the user manuals, which will remain available in 23 EU languages on its website.
CHESAR 3
Chesar 3 will exchange data with IUCLID more effectively than before. It will also enable better assessment of complex substances, such as multi-constituents or UVCBs, or substances transforming during use or in the environment.
You will also be in a better position to report to the authorities how you have carried out your safety assessments.
In addition, Chesar 3 includes additional functionalities both for the environmental and human health assessments, for example, the possibility to edit several contributing scenarios at the same time when the same changes apply to all of them. The help text has also been integrated in the application and generating your chemical safety report (CSR) will also be easier.
Any assessments you have carried out with Chesar 2 will automatically be migrated to Chesar 3.
More information can be found on the Chesar website.
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Training and support on the new IT tools is currently under planning and will be announced soon on ECHA's website.
Further information:
- ECHA clarifies criteria for ‘one substance, one registration', News alert 27 January 2016
- Registrants of the same substance must be part of the same registration, News alert 25 January 2016
- REACH data-sharing principles clarified, News Alert 07 January 2016
- Information session on the new registration process, 4 Nov 2015
- Prepare for IUCLID 6, News item 24 June 2015
- REACH 2018 - step-by-step advice
- Terminology - in 23 languages
| | Timing of the launches The updated IUCLID used to create registrations and Chesar to prepare chemical safety assessments will be published on the last week of April, followed by an update of the submission tool REACH-IT at the end of May. |
Text by Hanna-Kaisa Torkkeli, Vasileios Tsifoutis
Top image: IT tool logos, ECHA
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Events
May-September 2019
Committee for Risk Assessment:
4-7 and 12-13 June
9-13 and 16-20 September (tentative)
Committee for Socio-Economic
Analysis:
11-14 June
9-13 and 16-20 September
Enforcement Forum:
18-19 June
Management Board meeting:
19-20 June
Member State Committee:
24-28 June (tentative)
Biocidal Products Committee:
27-28 June
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